The Henshall Hearing

Press Release from the doctors.

2008-07-06T06:51:00.000-07:00

Press Release
Friday 4th July 2008

Following the Determination by the GMC Fitness to Practise Panel in the cases of Dr Spencer, Dr Southall and Dr Samuels that there is No Case to Answer

This decision must put to an end the longstanding allegationsi that have been repeatedly quoted in the press regarding the CNEP trial (ii). This whole process has led to cruel and unnecessary anxiety for those families who may have thought that their children had been given harmful treatment.

After hearing detailed evidence from the complainants, from 22 GMC witnesses and from three experts, the GMC panel concluded that there was no case to answer and abandoned its case. No evidence was presented to the Panel to show that any baby had been damaged by CNEP or by poor quality care. One independent GMC expert described the conduct of the CNEP trial as outstanding and another expressed regret that the longstanding media campaign has deprived children of a very promising treatment.

PACA considers that this case is a disturbing demonstration of how the GMC ignores the findings of previous investigations. The issues in this case had already been investigated by the doctors’ employing Trustiii, the NHS Regional Office and Staffordshire Police. Professor Rod Griffiths concluded in 2006 that “CNEP did no more damage than any other treatment that might have been used to try and help these [sick, preterm] infants.(iv) Others had previously stated that “the conduct of the CNEP trial was exemplary”(v). Yet this is the third time the GMC have considered this complaint over 11 years and in doing so the GMC Panel acknowledged that delays in the GMC process had breached the human rights of the doctors under investigation as set out in Article 6 of the European Convention on Human Rights.

PACA is concerned that GMC reform has led to the pendulum swinging so far in the direction of protecting patients that the doctors’ rights are being abused and that this may deter those doctors who must act on behalf of the vulnerable child. The RCPCH passed a motion at its AGM in March 2008 expressing “grave concerns over current GMC procedures for dealing with cases related to child protection”. Whilst this Hearing was about a research study in newborn infants and not ostensibly about child protection, it is part of a pattern targeting doctors who have been involved in child protection. Two of these doctors had pioneered the use of covert surveillance to detect life-threatening child abuse. One of these, David Southall, is currently appealing his erasure from the medical register arising out of his child protection work. The GMC does not recognise vexatious complaints. These complainants are putting vulnerable children at risk by trying to discredit certain types of child abuse, particularly FII, and by recruiting the GMC to discredit those who make that diagnosis.

The GMC must reform its procedures to ensure justice for both patients and doctors and, in particular, to support those doctors whose duty is to protect vulnerable children.

i Allegations of forgery, fraud and killing babies have been repeatedly made against medical staff over the last 11 years, led by the complainants in the Fitness to Practise Hearing concluded today.
ii The CNEP trial was a research study undertaken to examine whether the use of Continuous Negative Extrathoracic Pressure (CNEP) could help reduce the incidence of chronic lung disease of prematurity. It was carried out in two newborn intensive care units at Queen Charlotte’s Hospital, London and the North Staffordshire Hospital, Stoke-on-Trent between 1989 and 1993.
iii The North Staffordshire Hospital suspended two out of the three doctors from 1999 to 2001 for 20 and 27 months, whilst undertaking inquiries into their work in research and child protection.
iv Quote from Griffiths R. CNEP and research governance. Lancet 2006;367:1037-38.
v Quote from Hey E, Chalmers I. Investigating allegations of research misconduct: the vital need for due process. BMJ 2000:321:1-8

Post Hearing Statements

2008-07-05T04:32:00.000-07:00

Sentinel Newspapers

From the Doctors

"This must at last put an end to the long-standing allegations.

"No evidence was produced to show that any baby was damaged by CNEP or by poor quality of care.

"One independent expert described the conduct of the trial as outstanding. This is the third time the GMC has considered this case, and in doing so it acknowledged that our human rights have been breached due to delays.

"The issues have also been investigated by the hospital, the NHS regional office and the police. On every occasion the conclusion has been the same.

"It is our sincere hope we can now put this case behind us and concentrate on caring for patients."

Comment - The doctors failed to thank those who assisted them when no other media outlet would feature their material. This includes the reason why a new expert was obtained by General Medical Council when they had not done so for a decade or more. The Article 6 Human Rights Act arguments and case law were all provided to the doctors for their use.

From Mr and Mrs Henshall.

After yesterday's ruling, Mrs Henshall, aged 40, of Melville Court, said: "We fight on for justice after this decision. I have finally lost patience with this perverse system. The process is seriously flawed and one-sided, and has no place in the modern world.

"Despite being joint complainants with the GMC, we were not allowed to have any say over what evidence was submitted or what expertise to call in support of our allegations.

"We have tried in vain to ensure that, through proper channels, some accountability and safety awareness for infants in research, using our appalling experience, be highlighted and acknowledged.

"By its present procedures, the GMC cannot provide a mechanism for ensuring patient safety or enabling a fair and thorough investigation of parents' concern about possible serious professional misconduct"
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The conclusion of this issue is that the doctors will continue to be hounded by Penny Mellor, Brian Morgan and the Henshalls.

No Case to Answer

2008-07-04T07:42:00.000-07:00

The Henshall case has been dismissed by the GMC.

Press Association lists a summary article.

The news was brought to us by access to Penny Mellor's website and not by PACA.

Adjournment of GMC Hearing AGAIN.

2008-06-30T01:53:00.000-07:00

Paediatricians and Psychiatrists
Pitching a Tent Near GMC Manchester.
They would rather pitch a tent rather
than recognise the threat of Scientology.

This is of course the umpteenth adjournment by the GMC. We predict that the GMC will make a finding that there is a case to answer. This is because the GMC has to be seen to be reacting to publicity. The GMC admitted to a Article 6 Violation of Human Rights of the doctors earlier on in the hearing. The Sentinel misinterpretes the facts again. The statistics report from Professor Hutton was supportive of the doctors' work.

We agree with Penny Mellor's sentiments, the doctors might as well pitch a tent in Manchester. We also suggest that Penny Mellor advises the Royal College of Psychiatrists as well as the paediatricians that tents will be required. She and her cohorts at CCHR are due to subject a majority of them to revolving door GMC procedures.

Sentinel

HEARING AGAINST CNEP TRIAL DOCTORS SUSPENDED IN LIGHT OF PLEAS

09:40 - 28 June 2008

A long-running disciplinary hearing against three North Staffordshire doctors accused of serious professional misconduct has been adjourned for a week.

The interruption after almost a month of evidence is to allow a panel set up by the General Medical Council to consider legal pleas that the medics have no case to answer.

The charges facing paediatricians Drs David Southall, Andrew Spencer and Martin Samuels relate to the so-called CNEP experiments on babies carried out at the North Staffordshire Hospital during the early 1990s.

They follow complaints first made 13 years ago by Clayton parents Carl and Deborah Henshall who claim the research caused the death of one of their baby daughters and brain damage in another.

The Henshalls have already given several days of evidence that they did not give informed consent for the infants to be used in the trial.

The GMC's professional conduct committee has also taken testimony from other North Staffordshire families whose babies were in CNEP, a statistician on how the research was evaluated and a specialist in medical ethics.

Dr Southall who has retired from the University Hospital of North Staffordshire has already been struck off the medical register for an unrelated matter, but been reinstated pending his appeal. The other two still work there.

At the start of the Manchester hearing, the panel ruled out submissions on behalf of Drs Spencer and Samuels that the events happened so long ago that they would be deprived of a fair trial.

CNEP involved premature babies into negative pressure tanks to allow them to breathe more naturally than by using traditional ventilation.

The hearing is scheduled to end on July 11.

Day 3 14/5/08 Henshall Hearing

2008-06-23T02:30:00.000-07:00

FITNESS TO PRACTISE PANEL

(applying the General Medical Council’s Preliminary Proceedings Committee

and Professional Conduct Committee (Procedure Rules) 1988)

On:

Wednesday, 14 May 2008

Held at:

St James’s Buildings

79 Oxford Street

Manchester M1 6FQ

Case of:

STEPHEN ANDREW SPENCER BM BS 1976 University of Nottingham

Registration No: 2305893

DAVID PATRICK SOUTHALL MRCS 1971 Royal College of Surgeons of England

Registration No: 1491739

MARTIN PHILIP SAMUELS MB BS 1981 University of London

Registration No: 2732178

(Day Three)

Panel Members:

Mr D Kyle (Chairman)

Mrs V Brickley

Mrs S Hollingworth

Dr T Okitikpi

Dr M Sheldon

Mr A Forrest (Legal Assessor)

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MR M FORDE, Queen’s Counsel, instructed by RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Spencer.

MISS M O’ROURKE, Counsel, instructed by Hempsons, Solicitors, appeared on behalf of Dr Southall.

MR C FOSTER, Counsel, instructed by RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Samuels.

MS J SULLIVAN, Counsel, instructed by Eversheds, Solicitors, appeared on behalf of the General Medical Council and the Complainants, Mr and Mrs C Henshall.

--------------------------------------

Transcript of the shorthand notes of

Transcribe UK Verbatim Reporting Services Ltd

Tel No: 01889 270708

INDEX

Page

ABUSE OF PROCESS APPLICATION

MR FOSTER on behalf of Dr Samuels continued 1

MR FORDE on behalf of Dr Spencer 2

MISS O’ROURKE on behalf of Dr Southall 3

THE LEGAL ASSESSOR 4

MS SULLIVAN on behalf of the Council 5

MR FORDE on behalf of Dr Spencer 21

MR FOSTER on behalf of Dr Samuels 27

THE LEGAL ASSESSOR’S ADVICE 33

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THE CHAIRMAN: Good morning everybody. Mr Foster, I think you had completed your submissions on behalf of Dr Samuels.

MR FOSTER: I had completed my submissions, sir, but there is one point I must make before we go on now.

THE CHAIRMAN: Very well.

MR FOSTER: Disclosure in this case continues. Just before coming in to the room, I was handed an attendance note dated 25 March 2008. It relates to a conversation between those instructing my learned friend and Dr Stimmler. It says, amongst other things, that he was asked to query whether there was any duty to warn of adverse effects:

“Dr Stimmler did not see that this was necessary as the adverse effects were not known until after the trial had finished. He thought that there had been quite extensive work to ensure that the effects on bonding were minimised.”

And it goes on. It is now perfectly plain that Dr Stimmler and Dr Nicholson no longer support a number of the allegations which they apparently originally supported, if they ever did, at the time that these charges were drafted.

We have, on this side, no idea what the experts the GMC proposes to call are currently supporting. We are entitled to know. We should have known a long time ago, we are entitled to know it now. It is pertinent, for all the reasons that I articulated yesterday in the process of this abuse of process argument. I was saying, and Mr Forde was supporting me in this, that you can conclude that this is a misconceived abusive prosecution because, amongst other things, there is simply no evidence whatever upon which a proper prosecutor could conclude that there was a chance of getting these allegations home.

I am formally asking my learned friend to say what is the final position about her expert evidence, which of these allegations levelled against the practitioners will finally be supported by the experts? They have plainly changed their position and we are entitled to know what their final position is going to be. If that means, and I suspect it does mean, the filing of further amended expert reports which reflect the positions embodied in the attendance note we have just seen, that is what should be done.

THE CHAIRMAN: The difficulty the Panel is in at the moment is that we are not at the moment at an evidence considering stage. I quite understand the point you are making, and no doubt this is a matter which you have discussed with Ms Sullivan and have now made the point in the open hearing that you do have these concerns. Presumably the document you have just been referring to is not one which you would wish the Panel to have at the moment in the context of the application which is currently being made.

MR FOSTER: I do not think there is any relevance other than the part which I have read out. The point is that we still do not know the case we have to meet. We are entitled to have disclosed to us the expert evidence upon which the Council is intending to rely. At the moment the expert evidence, such as it is, is contained in a mass of attendance notes as well as expert reports. Those attendance notes indicate a massive shift of mind. I am not clear that the Council has any expert evidence which even purports to support the allegations against Dr Samuels.

The disclosure which has been coming in piecemeal over the last few days, supports very strongly the contention I was making yesterday, namely that there must be an inappropriate motive for continuing at least against Mr Samuels because there is no evidence against him at all. That is something which is relevant at this stage for the two reasons I set out in my submissions.

THE CHAIRMAN: You indicated yesterday and it is contained in section 6 of your skeleton argument as to how you would present the merits of the case as having any relevance to the abuse of process argument.

MR FOSTER: Indeed.

THE CHAIRMAN: Thank you, Mr Foster. Mr Forde?

MR FORDE: Sir, might I briefly echo those concerns. It is not any criticism of my learned friend, and in many ways there is a certain irony that we are able to express consternation because of the completely transparent approach of Ms Sullivan and her instructing solicitor to disclosure, upon which they are to be congratulated. The document that I have been handed this morning, dated 25 March 2008, deals with two issues – the neck trauma, where Dr Stimmler appears not to be supporting the suggestion that that was an adverse incident which should have been reported to parents or, alternatively, to the trial. That is paragraph 6 of the charges against my client. The 28 March attendance note that I read part of yesterday, appears not to support charge 8, and this latest document appears in relation to the duty, which I was querying, of a consultant as set out in paragraph 11(d). Again it appears not to be supported because the attendance note suggests that the consultant treating the patient did not retain any responsibility once he delegated the consent taken to a junior doctor. Dr Stimmler thought that the doctor’s duty, that must be the consultant, ended with checking that the consent form had been signed. He did not think it was necessary to return to the parents to check that they had understood and you will recall the anxieties I was expressing about the fact that these babies had to be in the trial within four hours. It is a difficult area in any event.

I go back a stage in relation to Mr Foster’s submission. If it is indeed the case that the expert evidence relied upon by the General Medical Council does not support those charges in particular, you ought not to be required to consider them. They should have the same line through them as you have on the amended charge sheet in relation, for instance, to charges 3(b) and 4. That is the concern that we have. It would be an awful shame if you had to involve yourself in anxious deliberation of our submissions only to find that the General Medical Council were going to withdraw charges that you may or may not have ruled upon in relation to abuse. I think, not only in fairness to the doctors, but in fairness to you as a Panel, if the expert evidence is melting away, as it appears to us it is, then we all ought to be made aware of that fact.

MISS O’ROURKE: Sir, can I join in. Although I am not involved in the applications, this is an issue which concerns me. When Ms Morris handed me the attendance note, which I think is now the fourth that I have seen from Dr Stimmler, I said to her it is now imperative that we have a revised report from Dr Stimmler because experts have duties, both under the Civil Procedure Rules in a case authority called The Ikarian Reefer, but also from members of institutes of experts – and one would expect in GMC proceedings the same – that if they undergo a change of view from the time at which they have provided their report, then they should notify all parties of that change of view because they are independent.

The report served originally from Dr Stimmler pre‑dated the Notice of Inquiry, pre‑dated the charges and pre‑dated the charges as they now stand as of yesterday morning. I said to Ms Morris, on behalf of Dr Southall, that I would like to see – and two sides of A4 would do – something from Dr Stimmler referring to his original report, now referring to the heads of charge that remain standing and indicating in the light of the contents of those four subsequent attendance notes which, if any, of those heads of charge would he be supporting in his expert evidence.

My own belief, having looked at those attendance notes, is that, as far as Dr Southall is concerned, charges 6 to 9 must now be an issue and also, as Mr Forde had said, 11(d) must be an issue. If that is the case, I would like to know and as soon as possible, because our preparations for our case are ongoing. If those are charges which Dr Stimmler does not support – and he is the only medical expert you are going to hear because Professor Hutton is a medical statistician and is not a registered medical practitioner, and Dr Nicholson is an ethicist and is also not a registered medical practitioner – if the only medical expert evidence you are going to hear is from Dr Stimmler, and he is now is backing down on a number of the charges, then we need to know as soon as possible because it influences how we prepare our defence.

THE CHAIRMAN: Thank you, Miss O’Rourke. Ms Sullivan, before I ask you, I think our Legal Assessor has something to say.

THE LEGAL ASSESSOR: I am not sure we are all concentrating on abuse of process at the moment. I entirely accept the doctors need to know the case against them. What the two counsel who are party to the application are really saying in respect of this part of the evidence, is an application, an equivalent, to quashing the indictment or quashing various counts on the indictment on the basis of insufficient evidence.

My preliminary view is that I am not prepared to advise the Panel to do that by this very selective quotation of various bits of evidence. That is the sort of thing they could only do, as a judge would do, by looking at the whole of the, as it were, committal evidence which I do not imagine anyone wants to put before the Panel. That may be something you wish to think about further. If you want to make a full blown attack on charges on the basis that there is no evidence to support them, then it will have to be done that way rather than just saying, “The charge says that, and I have this attendance note that says something different”. Is there any difficulty about producing a revised report from Dr Stimmler to consolidate his views?

MS SULLIVAN: I can understand the request for that and I do not see any difficulty with that, apart from timing because he is away at the moment. I certainly understand that request and we will do our best to supply that.

THE LEGAL ASSESSOR: I imagine the next question is when?

MS SULLIVAN: We are just finding out when he is returning. Can I say in the interim that I agree with the Legal Assessor that the issues that have been raised now are different from the way in which the abuse application has been put hitherto. I propose now to deal with the application as it was made yesterday by Mr Forde and Mr Foster. It would not be right for you to look at the merits of the case without seeing all the evidence, and that has not been something that you have been asked to do so far. Sir, Dr Stimmler is back on 23 May.

MR FOSTER: Could I respond to your observation. I set out in my skeleton argument where I dealt with the merits the evidence which has been produced by the General Medical Council in relation to the heads of charge against Dr Samuels. In other words, I put the case against Dr Samuels as high as on the GMC’s own evidence it could be put. I will be waiting to hear what the answer in Ms Sullivan’s response is. If her response is, “You have misrepresented the GMC’s case and in addition to what you put before the Panel in your skeleton argument, there is a lot of other evidence and here it is”, which makes it sensible still to level those allegations against Dr Samuels, then of course that will be a ground for those allegations to remain levelled against Dr Samuels. If there is no such response from Ms Sullivan, you can conclude there is no answer and you should take out your pencil and put a line through the corresponding charges against Dr Samuels.

THE LEGAL ASSESSOR: What I am wondering about is, if the case is opened and Ms Sullivan details what her evidence is, then you should know the case against you. I do not know whether she is proposing to do that in answer to your submissions, because it is fair to say you made many of these points yesterday by attendance notes arising. It is not brand new this morning. I wonder whether that should go off until after the opening to see how she intends to set about proving these issues or whether she is prepared to do that in answer to your submissions.

MR FOSTER: I do submit she is bound to do that in answer to the submissions.

THE LEGAL ASSESSOR: She has, presumably, prepared an opening and so, given a little time, could you deal with it in that way, Ms Sullivan?

MS SULLIVAN: This application has primarily been based on the question of delay and that is what I want to deal with now. My response is going to be to say that this Panel should not look at the merits of the case now, that that is not an appropriate approach when an application has been based on primarily delay.

THE LEGAL ASSESSOR: I do not want to embarrass you, but are you in a position to say to the Panel that you are satisfied that you have evidence to support each of the allegations which remain?

MS SULLIVAN: Yes, we do have evidence. We have evidence from a number of different experts. They do not all have the same view of particular heads of charge, but we do have evidence, for example from Dr Nicholson, in relation to heads of charge, I think 6 to 10 were the ones just mentioned by Miss O’Rourke ‑‑ 6 to 9. Dr Nicholson is supportive of those heads of charge and has not changed is view on that.

THE LEGAL ASSESSOR: It is not a case that you need to wait until Dr Stimmler is back before deciding whether you are pursuing?

MS SULLIVAN: No, that is right. Dr Stimmler has a different view of some of those heads of charge. It will be for the Panel hearing the expert evidence to evaluate that evidence and which evidence they prefer and whose expertise they may prefer in relation to particular heads of charge. I do have evidence to support it, otherwise I would not be pursuing it. It is a question of what weight is to be attached to that evidence and the respective experts. My learned friends know that, that is no surprise them. There is nothing that has been disclosed in this note this morning that fundamentally alters that position.

THE LEGAL ASSESSOR: I think we must let Ms Sullivan proceed as she wishes and then we can resume this argument, if appropriate, once she has made those submissions and Mr Foster and Mr Forde have answered.

THE CHAIRMAN: It seems to me, picking up on the points raised by Mr Forde and Mr Foster, and also the discussion which the Legal Assessor just indicated, there are really two dimensions at the moment to the matters which have been raised this morning. The first is not a directly live issue at the moment. It is a matter of what the evidence in support of the charges might be in due course. Obviously, one of the matters which you, as counsel for the General Medical Council, have to keep under review is the state of the evidence as it appears to you at any given time and the evaluation you make of it. As has been accepted, I think on both sides of the room, particular mention having been made of Dr Stimmler, that there have been some recent disclosures which tend to suggest that Dr Stimmler may be changing his position. I do not know whether that is correct or not, but certainly the indication you have just given us is that perhaps it would be desirable for Dr Stimmler to review his evidence against the charges as they now are and produce a supplemental report. We know that cannot happen until 23 May at the earliest because he is not back until then. That is one dimension.

The second dimension which is more immediately relevant, is in the context of the submissions which Mr Foster was making yesterday, in which he submitted to the Panel that the merits of the case have a relevance, as he describes it, to his application around abuse of process on two bases. First, he suggests that the exercise of discretion in an abuse of process argument a tribunal will be understanding or reluctant to stay for abuse a case which otherwise has a high prospect of success.

The second point was that they indicated something about the motive for bringing the proceedings if the prospects of proceedings are extremely low, it plainly suggests that something other than an objective assessment of prospects and public benefit is acting. As I understand what Mr Foster is saying in relation to the attendance note he has referred to this morning, he would say that that is some support for the submission as he puts it in his argument. Whether he is right or not in that submission is a matter which is now open to you respond to as part of your response, and it is a matter for the Panel to consider when they determine this part of the application. There are two dimensions, one for the future and one in the context of the submissions Mr Foster was making yesterday.

If I am right in the expressing the Panel’s understanding of the expression in that way, and I see that Mr Foster and Mr Forde are both nodding, that, I think, is that second dimension as I describe it which is of more immediate relevance in the context of this application and it is open for you to deal with that in your response.

MS SULLIVAN: Yes, I was proposing to deal with it in my response.

THE CHAIRMAN: Now that that matter has been raised and discussed and seemingly put in the appropriate two contexts, I think if that is all that Mr Foster, Mr Forde and Miss O’Rourke wish to say, we will now give the floor to you, Ms Sullivan, for your response to the submissions which were made yesterday.

MS SULLIVAN: Can I begin by handing out the documents upon which I would propose to rely in responding to this application, the first of which is a skeleton argument prepared by me in anticipation of these applications.

THE CHAIRMAN: That will be C1. (Document handed)

MS SULLIVAN: The second document is a chronology which will be C2. (Document handed) The next document is an authority, R v Smolinski [2004] 2 Cr App R 40, C3. (Document handed)

THE LEGAL ASSESSOR: A Panel Member has asked me is this an agreed chronology? Have the other parties seen it?

MS SULLIVAN: The other parties have seen it. They are probably not in a position to agree it. The next is another authority, R (on the application of Henshall) v General Medical Council [2005] EWCA Civ 1520, if that could be C4. (Document handed) Finally a one page but two-sided document which is an additional judgment in the case of Henshall dated 31 January 2006, C5. (Document handed)

Sir, as you know from the skeleton arguments produced by Mr Forde and Mr Foster, the essential submission in this case is based on delay in that what they are saying is that as a result of delay these proceedings should not be permitted to continue because they violate the rights of the doctors, they violate their rights contrary to Article 6 of the European Convention on Human Rights to a hearing within a reasonable time and/or are an abuse of process under the common law.

What I have sought to do in my skeleton argument, first of all, is to set out the legal framework for you and the differences between Article 6(1) and the common law. I have set out there that there is a distinction between Article 6 and the common law in that Article 6(1) is concerned with procedural delay in the course of proceedings whereas the common law is concerned with delay between the commission of the allegedly wrongful actions and the commencement of the proceedings. Therefore in this case the common law test would apply from 1992. Under Article 6(1), the starting point in disciplinary proceedings, as I think is accepted, is the date of the letter notifying the doctor of the allegations as indicated in the General Medical Council v Pembury [2002] Lloyds Rep Med 434. The date for the purposes of Article 6 in this case would be 2001.

Obviously in assessing the reasonableness of any delay regard must be had under the ECHR to the complexity of the case, the applicant’s conduct and the manner in which the matter was dealt with by the administrative and judicial authorities. It is essential for you to look at this case because cases need to be assessed on an individual basis and the courts have made clear that the threshold is high before it can be said in any particular case that a period of delay is unreasonable. That is the first question to assess and ask yourselves under Article 6, whether the period of delay has been unreasonable and that applies from 2001.

Just going on to indicate how to approach the Article 6 question, I have indicated in paragraph 5 of my argument that where a public authority, and of course the GMC is a public authority, has caused or permitted delay such as to amount to a breach of the right under Article 6(1) to a hearing within a reasonable time, there is necessarily then a breach of Article 6(1). However, what is important is this. In the Attorney General’s Reference (No 2 of 2001) [2004] 2 AC 72, Lord Bingham said if there is such a breach:

“… there must be afforded an appropriate remedy, but it would not be appropriate to stay or dismiss the proceedings unless (a) there can no longer be a fair hearing, or (b) it would otherwise be unfair to try the defendant.”

Obviously this was dealing with criminal cases but it is a simple principle.

“The public interest in the final determination of criminal charges requires that such a charge should not be stayed or dismissed if any lesser remedy will be just and proportionate in all the circumstances.”

What that means is that it is not necessary to show prejudice to establish a breach of the right to trial within a reasonable time, but it is necessary, and this is key, the Council would say, to show that it is not possible to have a fair trial, or that it would not be fair to try the accused if the proceedings are to be stayed as an abuse, and such cases will be exceptional and it is for the defence for the doctors in this case to prove on a balance of probabilities that a fair trial is not possible or it would not be fair to try the accused. That is the legal framework as far as Article 6 is concerned in the submission of the Council and of course Mr and Mrs Henshall for whom I also act.

I have then set out the common law position. As I have already said to you, the common law is concerned with delay from the outset and goes up to the commencement of the proceedings, so the delay would be subject to common law considerations from 1997 through until 2001 and beyond of course; that is where it overlaps with the Article 6 arguments. I have set out in paragraph 7 the common law principles relating to cases in which it is contended there has been an unjustifiable delay. The relevant decision as far as common law delay is concerned is another Attorney General’s Reference but this is No 1 of 1990 [1992] QB 630. I have just summarised the rationale of that decision:

1. A stay should never be imposed where the delay has been caused by the complexity of the proceedings

2. It would be rare for a stay to be imposed in the absence of fault on the part of the prosecutor or complainant.

3. Delay contributed to by the actions of the defendant should not found the basis of a stay.

4. In order to succeed, the burden and standard of proof are the same. The defendant must show on the balance of probabilities that, owing to the delay, he will suffer prejudice to the extent that no fair trial can be held, and lastly of importance, the GMC would say, in the context of these proceedings,

5. The prejudice the defendant must show is prejudice that cannot be cured by appropriate rulings during the hearing.

To summarise the position as I understand it, the difference between Article 6.1 and the common law is that there is no need to show prejudice to establish a breach of the right to a trial within a reasonable time under Article 6. There is a need to show prejudice under the common law. However, in both cases there is an important overlap in that it is necessary in both cases to show that no fair trial can be held. I have cited there an authority in relation to the common law but I will come back to deal with that at a later stage.

Could I just deal with the case of John Rogers which was a first instance decision of the PCC, your document D1-D. This is a case that is in fact referred to by the editors of Fitness to Practise Healthcare Regulatory Law Principle and Process at paragraph 18-019. Really what the authors are saying is that little benefit is to be derived from describing these decisions and relying upon them. It says:

“The case of Dr Rogers is sometimes cited at the General Medical Council as a decision that should be taken to reflect the Preliminary Proceedings Committee’s views on the issue of delay and reasonable time in medical disciplinary cases.”

It points out:

“It has never been submitted to judicial scrutiny and is not obviously reported because of the nature of the decision.”

It indicates that:

“Although this decision was cited in Haikel v General Medical Council [2002] UKPC 37, it is submitted that little weight can be attached to it because the full facts on which the decision turned are not known.”

There is little weight, the Council would say, to be attached to that decision which of course in any event pre-dated the Attorney General’s Reference No 2 of 2001 to which I have referred in paragraph 5. The Council’s submission would be that that is not a decision that should influence you in your consideration of this particular case.

Sir, having dealt with the legal framework, as I understand it, and I know the Legal Assessor will advise you in due course as to how to approach the law, I have then gone on to attempt to apply those principles as I understand them to the facts of this case. What I have done in my skeleton argument at page 2 onwards is I have divided up the different periods of time in this case into these periods: 1992-1997, 1997-2001 and 2001-2008. Article 6 only comes into play in 2001. The reason I have divided it up in this way is that 1992-1997 is the period before any complaint was made to the General Medical Council. What the Council would say, and indeed on behalf of the Henshalls as well in relation to this period of time is that there was no unreasonable delay on the complainants’ part, because we are only talking about the complainants at this point in time. I say that for these reasons:

The Henshalls’ children who, as you know, were both born prematurely and entered into the CNEP trial, were born in 1992. The dates are there in paragraph 9 for you. Patient 7 was born on 12 February 1992 and Patient 6 on 14 December 1992. As you know, Patient 7 died just over 60 hours after her birth and Patient 6 was subsequently found to have cerebral palsy. In fact, and this comes from Dr Stimmler’s report, it was not until 18 March 1994 that an adequate assessment of Patient 6’s neurological function was carried out. That gives you an indication of the state of knowledge of the parents, the complainants.

Following on from the diagnosis of cerebral palsy, the Henshalls had then to make their own investigations about what had happened.

They now have considerable knowledge about the trial. In fact the Court of Appeal judgment, to which I will refer later, describes Mrs Henshall’s knowledge of the case as encyclopaedic. That was not the position in 1994 when they were ordinary non‑medically qualified parents. It was only in the course of pursuing civil proceedings that they came to hear and learn more about the treatment their children had received. They only discovered, they say, in 1997 that their daughters had been part of that trial. I make the point here that of course you have heard no evidence and should not in the council’s submission be prejudging it at this stage. But that, on the face of it, is what the Henshalls say. They say that after meeting with the chairman of the Ethics Committee and after a meeting, I think subsequently, with Dr Spencer on 18 March 1997, they wrote their letter of complaint to the GMC, which is in the bundles before you. That is dated 27 April 1997.

Therefore, it is said on their behalf and the council’s behalf that there was no unreasonable delay in this period. In any event, any delay was not such as to cause serious prejudice to the extent that no fair trial could be held. You may think that Dr Spencer would undoubtedly have been aware of the potential civil proceedings in relation to Patient 6 and would have been able to collate and preserve evidence in relation to her and her involvement in the trial, as would the solicitors acting in those proceedings.

You also, Sir ‑ and this is where I will mention to you the case of R v Smolinski, which is C3 in the documents that I handed to you ‑ need to take this case into account in the submission of the council because this makes clear that any application for a stay based on delay in reporting misconduct, and that is what we are talking about here, should not be made at the outset of the case. You will see from the head note on the first page of the authority that the appellant in this case was charged with offences of indecent assault. These offences were first reported to the police some 20 years later. An application was made on his behalf to stay the proceedings for abuse of process, the submission being that he could not receive a fair trial as a result of delay, and ‑ and this is something being alleged in this case ‑ that he would be prejudiced by lack of memory because of the time that had elapsed. The trial judge in this case came to the conclusion that on the balance of probabilities it had not been shown that a fair trial was impossible.

The appeal in this case was successful for different reasons, but what was said in this case was that applications to stay proceedings based on abuse of process where there had been delay had become prevalent, but should be discouraged. It was indicated that in the normal way it was better not to make an application based on abuse of process. About six lines from the bottom of page 661, it was said:

“Unless the case was exceptional, the application would be unsuccessful. If an application were to be made to a judge, the best time for doing so was after any evidence had been called and for the judge then, having scrutinised the evidence with particular care, to come to a conclusion whether or not it was safe for the matter to be left to the jury. That was a particularly helpful course if there was a danger of inconsistencies between the witnesses of the sort that; it was common ground, had occurred in this case”.

The council says that that is the approach that you should adopt in this case in relation to this period of time. Indeed, it may well be the case that by 1997 any prejudice that either of these doctors had suffered might have occurred by that stage in time, although obviously with the passage of time the point can be made that the longer the time the more memories may fade.

I now deal with the second period of time that I have identified in my skeleton argument. That is 1997 to 2001. This period is still governed by the common law, therefore again it is necessary for the doctors to show on a balance of probabilities that they will suffer serious prejudice to the extent that no fair trial can be held. Of course I accept that the GMC have subsequently apologised to the doctors for the delay in this period and indeed in the latter period to which I shall come. I am not seeking to go behind that. However, the point needs to be made in the council’s submission and on behalf of the Henshalls, that there would inevitably have been some delay. I say that because of the nature of the case.

As I have set out in paragraph 11 of the skeleton argument, Mr and Mrs Henshall were not alone in complaining about the trial. Complaints were also made against other doctors involved in the trial, including Dr Southall. The GMC had to investigate a number of complaints in a clinical trial that involved 244 patients, so it was a complex and serious case. The chronology has been supplied to you to show that it was not the case that nothing was happening between 1997 and 2001. You might have been left with the impression that nothing was happening. But you can see that inquiries and investigations were occurring during that period of time. Also, it is not necessarily wrong to say that the outcome of the other inquiries was something of an irrelevance because those other inquiries, such as the Griffiths inquiry, may have revealed evidence that was relevant to the trial and to the doctors` conduct. So you can see that inquiries were being made during that period of time.

However, even if you are to conclude that, as the GMC has accepted in correspondence, that some of the delay was excessive in that period of time, that is not enough. The delay in this period of time between 1997 and 2001 has to have caused serious prejudice such that no fair trial can be held. The council would say that is fair trial can be held because of the procedural safeguards in the hearing process. I have referred to that in paragraph 13 of my skeleton argument, where I have set out that there are procedural safeguards in the hearing process itself; namely, the burden and standard of proof and the assistance of the Legal Assessor who can advise about the admissibility of evidence or the weight that should be attached to it.

I have also indicated that this is a case where a considerable amount of documentation relating to the trial has been retained. Dr Southall kept his material. That is what he has indicated in various articles that have appeared over the years. So a lot of documentation that is relevant to the allegations is available.

I come then to 2001 to 2008. Sir, I just propose to go through the chronology in this period, not the chronology that I have handed to you but the chronology as I have set it out at page 3 of the skeleton argument and paragraphs 14 to 19 because this case has taken an unusual course. I think that it is sometimes difficult to take on board the exact chronology of events. I want to ensure that we all know what occurred when.

So the first screening of the complaints took place in 2001. It was on 30 March 2001 that the GMC wrote to Drs Spencer and Samuels enclosing affidavits by Dr and Mrs Henshall, and you have been told, although you have not seen those ‑ that is an example of having only seen part of the material and not all of it ‑ those affidavits were sworn on 1 November 2000. The doctors’ comments were invited on them. They responded; their representatives responded. As and Mr and Mrs Henshall are the complainants in the case ‑ this is an old rules case ‑ they were entitled to a copy of the doctors` responses and to make their own comments on them. That again explains that part of the essential process of referral in itself takes some time.

Thereafter the cases of each doctor were considered by the GMC screeners, and in Dr Spencer’s case by the Preliminary Proceedings Committee. Dr Spencer was informed by letter dated 28 January 2002 that the PPC had decided to not to refer his case to the Professional Conduct Committee. Dr Samuels was informed by letter, I think dated 15 March 2002 that the screeners had decided not to refer the complaint against him to the PCC, so the proceedings at this stage stopped at an earlier point in relation to Dr Samuels.

Then on 2 May 2002, the GMC wrote to both doctors ‑ again you have seen this ‑ informing them that Mr and Mrs Henshall had written challenging the GMC`s decisions and that in the course of investigating this challenge, the GMC discovered that because of an oversight over 1600 pages of documents submitted by Mr and Mrs Henshall in support of their allegations against the doctors, had been omitted from the case papers provided both to the screener and to the PCC. It was therefore proposed that the decisions of the screener and the PCC should be taken afresh.

It is then common ground that there was quite an exchange of correspondence which in itself took quite some time between the GMC and those representing the doctors between the legality of reconsidering the allegations. However, the GMC decided to do so in fairness to the complainants, whose fault it was not that these documents had not been considered. On 28 January 2004, as you see from paragraph 17, both doctors were informed that Mr and Mrs Henshall`s complaint had been referred to the PPC.

Then on 12 March 2004 the doctors were informed that the PPC having considered that material had decided not to refer the allegations to the PCC on the basis that there was no real prospect of proving serious professional misconduct. A similar decision was taken in relation to the allegations against Dr Southall.

Mrs Henshall then applied for permission to claim judicial review in respect of the PPC’s decision not to refer her and her husband’s complaints against all three doctors, so that is Drs Southall, Samuels and Spencer to the PCC. Mr Justice Pitchford refused her application. However, on 13 December 2005 the Court of Appeal, after hearing full argument, allowed her appeal. There were a couple of reasons for doing so. One of which was that the PPC when deciding against referring the case purported to resolve disputed factual issues.

Following that, in which it was indicated that the only fair outcome was that the PPC should be reconstituted to do the job it had so far failed to do, on 2 November 2006 the Investigation Committee, sitting as the Preliminary Proceedings Committee referred the majority of the Henshalls’ allegations for hearing by a Fitness to Practise Panel. The case obviously then had to be investigated and listed for hearing, which the council would say was done within a reasonable time.

So the point in relation to the delay between 2001 and 2008 is this, although the delay in May 2002 to February 2004 was caused by the need to re‑open the case because of the error in the screener and the PPC not considering those 1600 pages of documents. Thereafter, there was not in fact any culpable delay because the Henshalls were pursuing judicial review, which they had every right to do. As you know, the judgment, as you can see from the decision itself, which I will ask you just to take up a moment. This is C4.

That judgment was handed down on 13 December 2005. That in fact was not the end of it because Miss O’Rourke went back to the Court of Appeal to argue further about this matter, and the final judgment is dated 31 January 2006. So, as I indicated, it is by no means the case that there is culpable delay in this period, and the time after the referral in November 2006 obviously had to be taken up with gathering evidence in a form that could be presented to you in what was a complex matter.

In the submission of the Council, the judgment of the Court of Appeal is key to these applications that are based on delay. As I said, essentially, by a majority of two to one, the Court of Appeal held that the Preliminary Proceedings Committee had erred in law. It had erred in not allowing the complainants sight of Dr Southall’s responses and also, as I just indicated to you, in purporting to resolve disputed factual issues. Can I just read to you a part of the headnote of the judgment, the second page of the report. It is the last paragraph of the headnote where it begins, “The only fair outcome”, towards the top of the page, the fourth paragraph at the top of the page where the Court of Appeal said:

“The only fair outcome was that the PPC should be reconstituted in order to do the job it had so far failed to do. It should make it clear first of all, that unless, unless [Dr Southall] agreed to let the complainants see his submissions, if necessary on suitable undertakings, the submissions would be put aside. Secondly, it should act on the published literature only if, having considered the BMJ article alongside the [Griffiths] report, the [Hull] report and any other relevant material placed before it, it was satisfied that there was in sum no evidence capable of raising a question within section 11(2). It was not the PPC’s task to evaluate conflicting professional views of issues raised by the complaint. Its final task was to apply, with whatever exegetic help it found useful, the test set by rule 11(2): whether the material advanced for and against the complaint raised a question whether one or more of the practitioners had committed serious professional misconduct.”

In other words, the Court of Appeal were granting Mrs Henshall the relief that she had sought. The point is that by the time this case comes before the Court of Appeal, there had already been considerable delay. The doctors had been told twice that the case was not to proceed against them. The GMC had already apologised for the delay, and it is also quite apparent from this judgment that the Court of Appeal were aware of the delay.

I now refer you to paragraph 11 of Lord Justice Auld’s judgment. Paragraph 11 begins:

“There was considerable delay on the part of the GMC in responding to Mr and Mrs Henshall’s complaints. Instead of proceeding to investigate the complaint through its established machinery, it decided to await the publication of the Griffiths Report, commissioned by the NHS Executive in February 1999.”

For these purposes I do not need to read on further.

MR FORDE: I would like Ms Sullivan to read the whole paragraph.

MS SULLIVAN: So be it:

“The panel’s terms of reference were ‘to look in the general framework for the both the approval and monitoring of clinical research projects in North Staffordshire, that is, to examine the design of trials, including the CNEP trial, as distinct from clinical issues arising from them. In relation to the CNEP trial, the main conclusion in the Griffiths Report published on 8 May 2000 (some ten years after the local ethics committee had approved it) was that its design did not match what would at the time of publication be considered best practice. Professor Griffiths also made it clear in the report that the Panel had not sought to determine the truth of allegations of poor practice or to apportion blame if practice could have been better, or to determine whether any actions taken at the end of the trial were wrong.”

Can I then refer you to another paragraph in that report, paragraph 18, which is just on the next page. Lord Justice Auld is dealing with the chronology. In paragraph 17 he refers to the Hull report, but it is paragraph 18 that I wish to draw your attention to, and the fact that:

“The GMC had yet to consider Mr and Mrs Henshall’s complaints”.

Mr Foster quoted to you in paragraph 76 of this judgment, so perhaps we could turn forward to paragraph 76. Lord Justice Auld was the dissenting judge. Having rejected the ground of appeal referred to, he said at paragraph 76:

“In consequence, I would dismiss the appeal. I add that, given the considerable lapse of time, 13 years, since the CNEP trial and the considerable body of medical exploration that it has engendered to little or no identifiable advantage to Mr and Mr Henshall’s complaints, and to much unjustified professional disruption and personal distress of the doctors, I would, in event have been inclined to refuse relief in the exercise of my discretion.”

I quote you that because it shows that delay was very much in the mind of the court. Although this was the dissenting judgment, this was the lead judgment in that the other two lord Justices agreed with Lord Justice Auld’s factual analysis, but they differed in their conclusion because they said the case should go back for consideration by the PPC.

What follows from that is that the majority in the Court of Appeal were fully aware of the delay, fully aware of the distress to the doctors, and yet, nonetheless, they exercised their discretion to remit the case. They have to decide whether it is equitable to grant relief. It is not automatic and, therefore, prejudice is very much part of their considerations.

Could I make reference to the court’s discretion in relation to judicial review. It is referred to in the White Book at 54‑1‑10 which, in relation to the court’s discretion, says:

“Even if the claimant, [the Henshalls] establishes one of the grounds of judicial review, the court is not bound to grant a remedy. The remedies are discretionary and, whilst a court will usually grant an appropriate remedy if the claimant establishes that the public body has acted unlawfully, there are cases where the courts may decline to grant a remedy. Grounds for refusing to grant a remedy include the following: where there was undue delay in making a claim but the courts have extended the time limits, the courts may still refuse a remedy if granting a remedy would cause substantial hardship to or substantially prejudice the rights of any person or would be detrimental to good administration.”

So the court has a discretion, which was exactly what Miss O’Rourke, who was instructed on this appeal on behalf of Drs Spencer and Samuels, went back to the Court of Appeal to do.

If you just go to the reverse of the judgment of 31 January 2006, you will see in the first paragraph, five lines down, that at the request of Miss O’Rourke on behalf of Drs Spencer and Samuels, the court had reconvened to reconsider, in the case of those doctors, whether it has, and if so whether, it should exercise a discretion to remit. Having heard arguments they did not change their minds.

The reason they did not is because, as Miss O’Rourke said to you at the outset of these applications, even though there has been what she described as inordinate and inexcusable delay, Dr Southall can have a fair trial, so can Drs Spencer and Samuels. With the exception of the specific allegations in relation to Dr Spencer, which relate to Patient 6, all the doctors face the same allegations. There are just fewer of them in the case of Dr Samuels. So if Dr Southall can have a fair trial, so indeed can they. The reason they can is because there is no prejudice of a degree to prevent that happening.

If I can just go through some of the points that were made on the question of prejudice. Of course recollections can fade with time, but that can be dealt with in the hearing process. In any case, where there is delay, the Legal Assessor has to direct you about the effects of delay and how to approach it, so there is the safeguard for the doctors.

Reference has been made to what were the standards at the time. The experts will tell you, and point you to, what the standards were at the time. That is what they have been asked to address in their reports. There are publications which indicate what the standards were at the time.

You will hear from a number of witnesses who those instructing have managed to trace. They will be called and will give evidence, obviously to the best of their recollections. As was demonstrated yesterday, their evidence is by no means entirely unfavourable to the doctors in this case. They are therefore able to defend the allegations despite the length of time. I think I am right in saying that no particular missing witness has been specified in the arguments put before you.

I think Mr Foster yesterday quoted one witness who made a statement ten years previously, so there are earlier, more contemporaneous recollections in some cases in any event. As I said, the documentation from the trial, including correspondence from the ethics committee and correspondence between the doctors, has been retained. You will be hearing from a witness called Barbara Cannings from North Staffordshire who began work there it is right to say in 1994, but she says she first became aware of the CNEP trial when the Griffiths inquiry started. At that time, because of the Griffiths inquiry, she was asked to locate and photocopy all the local research ethics committee papers in connection with the CNEP trial and supply those to the Griffiths inquiry. That is what she did and we have those papers for you, together with all the scoring sheets which were retained and have been obtained through Dr Southall.

We also have the medical notes for Patient 6. We have a file of those which have been retained for some time, no doubt because of the proposed civil proceedings. I think I am right in saying that the only item that has been identified as missing, and I agree this is missing, is the ultrasounds for the patient. What we have are the radiologists’ written reports in the records of those ultrasounds. It is the content of those reports that the Council are saying should have been communicated to Mr and Mrs Henshall.

You have also seen some of the letters that have been written on behalf of the doctors over the years responding to the various allegations. They have been able to respond in some detail to them. So, the Council would say, there is not such prejudice as to prevent the holding of a fair trial because of delay.

I have already referred to you to the Legal Assessor advising on delay and how to approach it. He will also advise, where appropriate, about the admissibility of evidence. The doctors are also protected by the burden and standard of proof. The burden is on the Council and the complainants, and the standard of proof in this case is the criminal standard ‑‑ you have to be sure before you can find any allegations proved. That is a high burden and standard and a great protection for the doctors concerned.

You also have within the hearing process the fact that the rules provide for submissions being made at appropriate stages. It is then, the Council say, that you should consider the adequacy and strength of the evidence, not now when you have not even seen it in any form at all. It is for you to consider and evaluate the competing expert opinions to which I referred earlier. You will be hearing from three experts in the course of this case. They will not all say the same about certain matters and it will be for you to determine whose expertise you prefer in any given case. Again, the Legal Assessor will advise you, but you are not obliged to accept expert evidence, again another safeguard in the hearing process.

Had this case been without foundation, as seemed to be claimed this morning, or in part without foundation, it is open to anyone under the rules to apply for cancellation of the case. That is not something that has occurred in this case. There is power under rule 19 in the rules in relation to that.

The Council’s submission in relation to the points made by Mr Foster are that it is not the correct time now for you to consider the merits of the case when the application was in fact put before you yesterday on the basis of delay, saying that, in so far as the merits of the case were concerned, that should affect you in exercising your discretion and indicates motive. How can you judge motive without hearing or seeing the evidence in the case? How can you properly take that into account in exercising your discretion?

The Council’s submission in relation to that is that that is not something that you should take into account at this stage. An application has not been made as to there being insufficient evidence. As the Legal Assessor said, were such an application to have been made it would be necessary for you to see it all, but that is not the way in which it has been approached. That was just raised this morning prompted by a two paragraph piece of paper indicating some matters raised by Dr Stimmler which I think in any event are referred to elsewhere, but so be it. That is not the way in which this application has been put and it is, in the Council’s submission, not appropriate to take into account the merits of the case. The rules provide for that at other stages.

Questions were also raised yesterday really in relation to the charges about what do they relate to and it seemed to be suggested that the defence did not know what the case was. For example, Mr Forde said well, what is the Council saying about blood pressure? He knows what the Council are saying about blood pressure because he has Dr Stimmler’s report. Dr Stimmler, at page 18 of his report, when asked to comment about whether Patient 6 was appropriately monitored, Dr Stimmler says that he could not see one blood pressure measurement which, in an infant that was being ventilated and has respiratory distress syndrome, represents a poor standard of care. It is possible that blood pressures might have been recorded on some sheets that I have not been able to discover, but blood pressure measurements are certainly part of the protocol of the trial. He knows what is being said, that there are no blood pressure measurements recorded in the notes for this child.

MR FORDE: That is not what is being said. I hesitate to interrupt, but I am asking, and I make this absolutely clear, for periods to be identified between 14 December when this child was born and 7 January. That is conspicuous by its absence. All we have here is a suggestion that whilst the child was ventilated was but for a few hours during that period there were no blood pressure measurements. I am grateful to my learned friend for indicating that this doctor appears to countenance there being notes he has not seen, because that is a concern of ours that there might have been one or two but those could have been lost. We still do not have chapter and verse in relation to the specific periods and we are still awaiting that. It makes it difficult for us to know what case we have to meet.

The other point is my learned friend well knows that this report was drafted before the charges of 8 April and since the end of March Dr Stimmler has been suggesting that he could not support his original contentions in relation to the taking of blood pressures and he required that the charge be slightly narrowed from that which was originally proposed. We got that yesterday from 28 March attendance notes.

MS SULLIVAN: Not in relation to blood pressure. That was in relation to hypoxia. His position is clear from that report that there are no blood pressure readings. That was also the position, as Mr Forde will be aware, when civil proceedings were in train because the notes were looked at then in relation to this child, so that is way back.

Sir, I was just dealing with that issue in relation to the charge raised by Mr Forde. Can I now deal with the points that were raised in Mr Foster’s skeleton argument about the number of people required for consent. I have referred Mr Foster to the evidence in this case which is that in the limb of the trial carried out at Queen Charlotte’s Hospital, one day, Dr Raine, took consent except when he was on leave or away for some reason.

We know that in North Staffordshire 34 people were involved in taking consent for babies to enter this trial. We know that because Dr Southall carried out an audit of how many people had been involved and that many people had been involved covering a whole span, as you can imagine, of clinicians. To say in the light of that that too many people have been involved in consent I think makes quite clear what the Council’s position is and really the key to it, as I am sure Mr Foster realises, is this, that in order for any doctors to be consenting patients, especially for a trial, they need to be adequately trained, and so therefore it is not a case of being able to specify an exact number; it is a case of saying to Mr Foster that really what should have happened is something more akin to what happened in Queen Charlotte’s where a senior doctor was involved in the consent-taking process.

Those in fact yesterday were the essential complaints about the lack of specificity of the charges, so the Council would say they have been answered and they can be answered. It is not really something again that you need to take into account on this or should take into account on this application. The matter of Dr Samuels’ involvement as the administrator was raised yesterday and in the opinion of Dr Nicholson, Dr Samuels’ assistance to Dr Southall in this trial, which was a considerable involvement – he was very senior at the time and it was not long before he became a consultant himself – that included an acceptance and sharing of all responsibilities relating to the trial which would include responsibility not for actually obtaining consent, but for ensuring that there were procedures in place to obtain parental consent, because that is what is alleged in relation to all of the doctors in this case.

There are two other matters that the Council would say are not relevant to your considerations. The point was made on behalf of Dr Samuels that he had had no opportunity to deal with some of the allegations or an allegation. Can I remind Mr Foster of the rules. Rule 11(2) of the Old Rules entitles the solicitor or the complainant where a case has been referred to include further allegations in the charge if such evidence emerges in the course of the investigation, even when they have not been referred to the PPC or form part of the subject of a determination by the PPC. There is no requirement that Dr Samuels has to be given an opportunity to respond to any allegations that are contained within the Notice of Hearing. In any event, you may wonder whether the allegation that was quoted is really so different in any event from the one which was originally included.

Lastly on the question of what you should take into account, the Council would say the references to the five-year rule are not relevant because it does not apply to this case. This case is governed by the rules that were extant at the time it was instituted; the rules are not retrospective in operation. That has to be right, sir, because otherwise that would have been advanced in the Court of Appeal and dealt with by them. You have the judgment which you will be able to read. There is no mention of it.

Really what it amounts to is this. No case should be stayed or stopped on grounds of delay unless it amounts to an abuse of the process, so unless a fair hearing is impossible. There is no prejudice here that cannot be accommodated by the trial process. I think Mr Foster used the expression “an affront to justice” that the doctors were told that the case was not going ahead. Sir, the Henshalls had every right to challenge the decision-making process, and not only had they the right to do that, they did it successfully. Just think of the consequences of saying a case cannot go ahead because the doctors have been told by the GMC that they are not pursuing it. It would prevent the courts – the Court of Appeal in this case – giving the remedy that they gave to the Henshalls. Those representing the doctors would be fully aware that that is something that can occur, that decisions can be judicially reviewed, and you must think that it would follow from that that these doctors must have been advised of that possibility.

At the end of the day the Court of Appeal, by sending this case back, have determined themselves that it was not an affront to justice. They rejected Miss O’Rourke’s submissions that they should exercise their discretion to refuse a remedy because of the delay. That, you may consider, is key to Miss O’Rourke now on behalf of Dr Southall indicating she is not instructed to argue that these proceedings are an abuse. That speaks volumes. They are not an abuse because these doctors can have a fair trial because there is no prejudice that cannot be dealt with within the trial process. It is very much in the public interest that these allegations, about which Mr and Mrs Henshall understandably feel very strongly, be heard.

Sir, that is the response that I would make on their behalf and on behalf of the GMC to the application that has been made on behalf of these doctors.

THE CHAIRMAN: Thank you very much, Ms Sullivan. Do any Panel Members wish to ask any points of clarification?

DR OKITIKPI: You just said that the prejudice can be dealt with. I think you meant prejudice cannot be dealt with?

MS SULLIVAN: If there is prejudice it can be dealt with within the trial process. That is what I meant to say certainly.

DR SHELDON: You have not, as far as I heard, dealt with Mr Forde’s comment in his paragraph 3.16 that these ten complaints that the Henshalls brought, which is what the Appeal Court was considering, most of them are not now being dealt with, so does that make a difference the number of complaints made by the Henshalls that are now actually on the charge sheet?

MS SULLIVAN: In my submission it would not make any difference to the principle. In practice one could say that because there are fewer allegations there is likely to be less prejudice to the doctors and so to that extent it is helpful to them that there are fewer allegations that they have to meet, otherwise it would not, in the Council’s submission, be a material consideration for you at this stage as to whether to stay these proceedings or not. That would be the way in which I would respond to that. I am sure the Legal Assessor will advise you also as to how to approach it.

THE LEGAL ASSESSOR: Do you concede that there is any unjustifiable delay by the GMC within Article 6?

MS SULLIVAN: They themselves have conceded that there was excessive delay. As I said at one point, I am not seeking to go behind that. All I am seeking to say is that when they have said there has been excessive delay, they have not actually said there is excessive delay throughout. They are still saying that there would have been reasons for delay but I accept that they have said that there is excessive delay and that must apply to the part of the time covered by Article 6, though not its entirety.

THE LEGAL ASSESSOR: Then it becomes important to know what the period of delay is that is excessive or culpable, and then, if there is culpable delay by a public authority, it has to be marked somehow. Mr Forde’s point is that one cannot mark it as one would in a criminal trial by a reduction in sentence or something like that.

MS SULLIVAN: I do not necessarily agree with that submission that he has made. Delay is something that could be taken into account by a panel in a variety of ways at a variety of different stages.

MR FORDE: Could I ask for something to be stated on the record? I want to know whether my learned friend has specific instructions from the General Medical Council that, in cases involving delay, it is appropriate for a panel such as this to impose a lesser sanction than they otherwise would have done. That is the point I am making. I quite accept that the learned Legal Assessor can give guidance in relation to delay and the submissions of no case can be made, but specific to sanction. We would all be very interested to know, not only for this case but in future cases, whether the General Medical Council’s position is in old cases that you as a panel could impose a lesser sanction by reason of delay?

MS SULLIVAN: I have no specific instructions in relation to that. I was merely thinking out loud in relation to it. I think the point that I would make is that it is not enough for there to be excessive delay and therefore a breach of Article 6. It is still necessary to go on, as I have set out in the legal framework, to consider whether a fair trial can be held.

THE LEGAL ASSESSOR: Certainly a breach of Article 6 does not necessarily make the case hit the buffers, but the indications are that some marker that there has been a breach should be given and some of the cases say the mere finding is sufficient vindication of the person’s rights. I would just like to identify so that one can go on to that what would be the periods which you certainly would accept were unreasonable or excessive in this context. Any delay caused by the oversight in submitting 1600 pages is presumably culpable?

MS SULLIVAN: Yes.

THE LEGAL ASSESSOR: That would embrace all the time devoted to trying to sort out the legal ramifications.

MS SULLIVAN: Yes. I think I have tried to identify that at some stage.

THE LEGAL ASSESSOR: Is the fact then that the Preliminary Proceedings Panel got it wrong culpable delay and anything flowing from that?

MS SULLIVAN: It does not seem to me right that that should be culpable delay because it is an exercise of discretion, albeit they applied the wrong test the Court of Appeal found, but of course that is no fault of the doctors, but it is part of the decision-making process that can be cured by an appeal. I would have thought that was part of the judicial process.

LEGAL ASSESSOR: That is something that I would like to hear Mr Foster on later.

THE CHAIRMAN: Mr Forde, no doubt you have a response.

MR FORDE: I do. The only question is whether you want to hear it now or after a coffee break.

THE CHAIRMAN: I was going to suggest that we have a break now and come back at half eleven. We will hear from you then.

(The Panel adjourned for a short time)

MS SULLIVAN: I wanted to correct something that I said earlier. I have been told that there is a document suggesting that Mr and Mrs Henshall knew about their children being involved in a trial by 20 March 1996. I do not know how soon before they knew, but I think that it is important to indicate that to you, so that the position is not in any way misrepresented.

THE CHAIRMAN: The date you mentione was?

MS SULLIVAN: I am being told 20 March 1996. I think that I said 1997. There is a document suggesting that they knew by that stage.

THE CHAIRMAN: Thank you very much.

MR FORDE: I deal with the last point. As you are aware, we are incredulous at the suggestion that this family did not know that Patient 6 was involved in a CNEP trial. As you know, her sibling died ten months before, and the appearance of the equipment should have made it manifestly obvious. That is an issue. Be that as it may, I deal firstly with what my learned friend said about the law, and then I will deal with some of her submissions about the prejudice that we clearly were experiencing.

We are now agreed that, so far as time is concerned, under Article 6 the General Medical Council first indicated to these doctors in 2001 that they were interested in them potentially facing charges. I have dealt with that in my skeleton argument. It is 3.4, 30 March 2001. That is the time from which we say the Article 6 delay arises, so you have something over seven years.

It cannot be right that the deficiencies of the General Medical Council in relation to the 1600 pages of documents and their inability to control the Preliminary Proceedings Committee in a way that was satisfactory to the Court of Appeal can count against this doctor; so the whole matter, as a matter of fact, should be included as far as Article 6 delay is concerned, in my submission to you. At best, the procedural shenanigans could be regarded as neutral, but you will be aware of the fact ‑ this is paragraph 4 of C1, Miss Sullivan’s skeleton argument ‑ that under the ECHR in assessing the reasonableness of any delay, regard must be had to the complexity of the case. This is said to be a complex case; we do not accept that. The applicant’s conduct ‑ here you do not have any conduct on the part of the doctors which the General Medical Council are advancing in support of any submission that we have contributed to the inordinate delay in this case; Ms Sullivan was entirely silent on that issue. And, most importantly, the manner in which the matter was dealt with by the administrative, here authorities. You assess, we quite accept, the reasonableness of the duration on a case-by-case basis. We have always accepted that the threshold is high, and that the burden of proof is on us on a balance of probabilities.

Simply put, no professional within or without this room, would relish the prospect of dealing with allegations as old as these. The real deficiency of the General Medical Council was, when it realised in 1997 that a complaint had been made, to sit on the case that was by then already approaching five years old. If ever there was a case that should have been dealt with with alacrity, it was this case.

My initial bundle, which is D(a1) indicates 18 March 1997, nearly five years on. It is clear from the second paragraph, the meeting having been arranged by Dr Hughes, who is not a witness in the case, it should be noted that until the morning of 18 March 1997 Dr Spencer did not appreciate that the case was the subject of ongoing medical/legal proceedings. So to suggest, as my learned friend does, that the Henshalls, I believe, having indicated ‑ we have not see the documentation ‑ that they were interested in pursuing legal proceedings in 1994 or 1995, could have caused my client, who would never have been sued in an individual capacity anyway, to scurry around the medical records department, scanning departments, retrieving nursing rotas, clinical rotas, outpatients rotas and the like is frankly nonsensical. He, as I indicated ‑ this will now be approaching eight years after the application, which was made in November 1989 ‑ was unaware of the fact that this was being contemplated. As a matter of form the responsibility of defending the proceedings would have been that of North Staffordshire, the doctor then I think would be covered by Crown indemnity.

It is believed that some of the notes may have done missing as a result of the Trust’s solicitors’ involvement with the Henshalls. I think they have instructed several, and, as you know, several experts. So that is not a point that can be taken against this doctor.

It is quite clear that matters have progressed in a way that was not expected at the time the initial concerns were notified. It ill behoves the General Medical Council to suggest that the recently drawn allegations... I remind you that they are April of this year; the witness statements we have been served predominantly date from the last couple of months of 2007 and early 2008, whereas Mr Foster indicated many witnesses simply say they cannot remember. So, as far as the common law is concerned, my submission is that you look at the whole of the period and ask whether a fair hearing can be conducted at this distance in time.

One of my main submissions that does not appear to have been answered by the GMC is to be found in my paragraph 1.5. This a very serious proposition on my part. The point I make is that it does not really matter whether some of the notes are available; we believe that minutes of ethical committee meetings are missing, despite what is said by an employee of the Trust who says that she gathered documentation together for the Griffiths inquiry in 2000. You know, and it is an agreed fact, that she did not start working in the Trust until 1994. We are talking about applications in 1989 approved in 1990. The difficulty ‑ and it is my submission this is a difficulty which is manifest in the Stimmler attendance notes that we have ‑ is in recalling, as I have put it, “subtleties, nuances and prevailing medical culture”. There will always be a risk of those called on behalf of the General Medical Council trying their level best to reconstruct events ‑ and we know that human memory fails. Those of us who used to practise in the county court regularly encountered the following scenario: witness interviewed by police officer; heard bang, turned around, saw cyclist’s front wheel under car; did not witness accident. He comes to court three years later and saw the cyclist being knocked off by the driver of the car. Human memory plays tricks. That is the reason for the five‑year rule. I have said that none will be able to without consciously or unconsciously importing into their evidence acquired knowledge or current views and values. That, in my submission, is an undisputed fact.

It is of interest that in the Court of Appeal case with Lord Justice Woolf, as he then was, presiding in the case of R v Smolinski, they decided that they were going to try to put an end to the industry of alleged sex offenders, saying, “This all happened so long ago I cannot remember whether I indecently assaulted these two young women or not”. That is a million miles away from the position here where you have health professionals doing their level best in front of their regulatory body to reconstruct events. I maintain that the approach you should adopt in a case such as this is the one I have set out in my skeleton argument, I think under section 5.1. The Dyer v Watson approach is the one that on behalf of Dr Spencer I would commend to you.

It is all well and good for the criminal courts to suggest that you listen to the evidence of young children and then decide, now adults, whether or not they can be believed. That is not something that is important here. This is a case where we are concerned about missing documentation and the prevailing culture of the time, where an alleged sexual offender is being prosecuted, and one is thinking of a case which is 56, 26 or 30 years after the event, the prevailing culture has always been that one does not indecently assault young children.

What the court decided at the end of Smolinsky, which you have as C3, is:

“As this Court appreciates, it is sometimes very difficult for young children to speak about these matters and therefore it is only many years later that they come to light”.

Therefore, in my submission, that case does not assist you at all.

Similarly, in relation to the Court of Appeal judgment which you have as C4, a number of important comments were made by their Lordships. I footnoted in my skeleton argument the fact that there were ten matters of complaints before their Lordships. That is at the bottom of page 9. You now helpfully have them supplied to you by Miss Sullivan. One, an allegation of deception. That is no longer maintained in relation to the local Ethics Committee. That was something which had been around in 1997. We may have been able to do something about that. Performing unnecessary Caesarean sections specifically in order to ensure an adequate supply of premature neonatal babies for the trial. That is a scurrilous allegation. It is no longer pursued, but one to which the doctors` minds were directed from 2001 onwards. The forging of Mrs Henshall’s signature is no longer pursued. The informed consent matter is not pursued in quite the same way, and certainly not specific to the Henshalls. Number five is no concern, from your perspective, regarding the other child and is no longer pursued. Number 6 is pursued, 7 is pursued, and 8, 9 and 10 are not, including a conspiracy to misreport post‑mortem results with a view to preventing any death being attributable to the trial.

Conspicuous by its absence is any specific allegation as you now have here in relation to the ultrasound scans which causes a particular difficulty, the alleged hypoxia on a Tuesday in December 1992. There does not appear at that time to have been placed before their Lordships the concerns about the inappropriate delegation to too many members of staff. You know that Dr Stimmler does not support that. He says that babies are born 24 hours a day. And there is nothing about surfactant, which is number eight, so far as the charges against Dr Spencer are concerned.

What that means is that since we have had theses matters specified on 8 April and the draft charges and the Preliminary Proceedings Committee charges have changed dramatically over time, and you can see that by going through by bundle. But it is only once we get the charges at this distance in time that we can really address our minds to likely witnesses and likely defences. We might have broad themes, but not much beyond that. There is where there is the real prejudice in terms of delay. It simply is not good enough to say that we should be able to find witnesses now. Suggesting that we have not identified any particular witness who is dead, deceased or incompetent, again, as a matter of common sense, this number of years after the event is nothing to the point. It is a bit like saying, “Where did you lose your keys?” If you knew that they would not be lost. We cannot remember all the main actors in this trial at this distance in time. We might have been able to in the middle or early 1990s.

It is clear that Lord Justice Auld was critical of the delay. That is why I required Ms Sullivan to read the whole of paragraph 11. If you read paragraph 17, he is setting out the Hull and Griffiths inquiries and the timing of those. It is my submission as an aside that the public interest has been more than satisfied by those two inquiries, and there is no real public interest in continuing with this one. The judge says this at paragraph 18:

“Meanwhile, the GMC had yet to consider Mr and Mrs Henshall`s complaints”.

So they sat on it for something in excess of three years. I maintain that criticism because I am more than happy to take you to certain aspects of the chronology that my learned friend has very helpfully supplied to you as C2. It makes instructive reading.

In 1994, it would appear that the Henshalls were asking for an investigation of a medical negligence claim related to this trial and to the scans. That is something almost approaching 14 years ago. In my submission, it is simply unsustainable to suggest that the time does not run in relation to, certainly, the latter paragraphs of our charge 18, 19 and 20, from then. The scans were forwarded to the expert ‑ as we know they are now missing ‑ as long ago as 19 December 1995. Again, under the common law, we say that time clearly runs from then.

The GMC recorded a complaint at the top of page 2 on 28 April 1997. For the next two or three years lot of letters are written, no action is taken, and in fact the GMC is entirely reliant on the North Staffordshire hospital to try to conduct bits and pieces of inquiries throughout 1999. It is clearly waiting, as it must have informed Lord Justice Auld, for the completion in December 2000 of the Griffiths report.

That is an unacceptable position, that delay between 1997 and 2000, and highly prejudicial to my client against the background of the Henshalls taking nearly five years to make a complaint to the General Medical Council. It is also of interest to note, when my learned friend is indicating that the court had a discretion not to accede to the judicial review application if they were concerned about delay, clearly that was a concern of Lord Justice Auld, it is conspicuous by its absence in the judgments of the other two judges. What they decided overall was the concern for them was the PPC applying a wrong test, weighing competing claims of Hey and Chalmers, without looking at the Griffiths report, and Dr Southall’s stance that he would not allow his comments to be disclosed.

That is why it is perfectly understandable that Miss O’Rourke, who at that time represented Drs Spencer and Samuels, effectively said that, “The main thrust of your judgment does not appear to concern my clients”. A very brief judgment was given suggesting, not only that the majority found reliance on the Hey and Chalmers article to be in error, but that may well have been, in terms of the articles, paragraph 2, something that loomed large in the consideration of the PPC and not in an insignificant way in respect of Dr Spencer and Dr Samuels. The court said that the matter should be remitted with the utmost expedition.

My learned friend appeared to suggest that they were sanctioning a referral to the Professional Conduct Committee at on stage. I am sure she suggested that in error. They were simply saying, “Go back and make your decision again”. If you look at the decision of the PPC which led to our ultimate referral, you will find that they fell into precisely the same trap as the previous one. There are many references to competing academic claims.

The concern for us is that, because those matters to which we were referred bear little relation to the current charges, effectively we have started afresh in looking how to defend these charges since April 2008. We were hoping for, and I know Mr Foster supports me in this hope, the Further and Better Particulars we have been seeking since we received the charges. We still do not have them.

Turning to the charges, it is still of importance to us to know what the General Medical Council’s case is, for instance in relation to charge 17. I only deal with that one by way of illustration. Patient 6 was booked in under the care of Dr Spencer on 14 December 1992 and she was discharged on 7 January 1993, a three week period.

I will read to you the extract from the Stimmler report dealing with this matter. He says:

“I could not see one blood pressure measurement which in an infant that was being ventilated and has respiratory distress syndrome, represents a poor standard of care. It is possible that blood pressures might have been recorded on some sheets that I have not been able to discover, but blood pressure measurements are certainly part of the protocol for this trial.”

So, there is doubt being expressed about the availability of records. One reading of that criticism, and this is what we would seek elucidation upon, is that the blood pressure criticism in paragraph 17 is supported only whilst the infant was being ventilated, not for the whole three week period. It is something of importance to us. As you will well understand, Dr Spencer and I have been looking at the records trying to decipher doctors’ signatures, which is not easy at the best of times, to see if he is likely to have been on duty during the twelve hours, we think on 16 December, when this child was ventilated. We are struggling at the moment, in a sense, to prove the negative – that he was not there. That is something we ought to be in a position to do.

Similarly, in relation to charges 18 and 19, my learned friend is absolutely correct to suggest to you that we have, I think at page 161 and 162 of the relevant bundle, the ultrasound reports. What we do not have is any indication which may or may not have been apparent from the scan itself, as to when that report found its way in to the notes, who was informed of the appearances on the scan, and who this person was, it would appear, from the correspondence I read to you yesterday, was present with Mrs Henshall at the time of one or both of the scans. That is something which causes us a real difficulty.

My learned friend in her submissions to you accepted that recollections fade and indicated that the safeguards were sufficient by reason of the direction you are likely to get relating to delay if we proceed in this matter, and also by reason of the standard of proof. I have said specifically in my skeleton argument, that that does not provide sufficient safeguard. One can imagine with the publicity that this case is likely to attract a member of nursing staff reading a report and perhaps a week or two after any Determination saying, “I could have helped you, I was the person who spoke to Mrs Henshall, that is my signature, I remember popping the blood pressures into my pocket I probably did not put them into the notes”. These are the sorts of possibilities which are truly concerning from Dr Spencer’s perspective.

The suggestion that the Court of Appeal considered delay I have dealt with. My learned friend did read an extract from the White Book which dealt with the delay in the bringing of the claim. My understanding, and I am happy to be corrected, is that that is not a reference to the delay in terms of the substantive case here – in other words 1997 to 2008, or 1989 to 2008 – it is the delay in seeking the remedy of judicial review, because it is described as “the claim”, and the claim is the judicial review claim. There is no specific reference to the age of the events, because all judicial review achieves, if it is successful, is a court saying, “Please make your decision again”. It is the decision that is being attacked in terms of delay rather than that being a reference to old cases being of such concern that the court itself ought not to give a remedy.

Clearly Lord Justice Auld felt, as I have quoted in my skeleton, that this was not going to be a situation which would satisfy the Henshalls in any event. I have quoted that at paragraph 6.7 and you will find, within the judgment, the relevant paragraph is paragraph 76, that he is the only judge who appears to have dealt with the exercise of his discretion given the considerable lapse of time.

It is not dealt with, in terms, by Lord Justice Parker. His judgment is one and a half pages, but you can see Lord Justice Parker’s reasoning, which is at paragraph 101, Professor Southall’s refusal to relay his responses, and paragraph 102 the Hey and Chalmers article. That really founds the basis of the decision made by Lord Justice Sedley, who, interestingly enough, said this, and this underlines the fact that it was really an invitation to the Preliminary Proceedings Committee to reconsider matters:

“I do not consider that this court can say that the medical literature disposed of any possible question of serious professional misconduct. Nor, however, can I accept Mr Havers’ submission that it manifestly required a referral to the PCC.”

So the court was not prepared to adjudicate on that matter.

They said to do so would risk substituting the court for the PPC. Sometimes judges are a little bolder, but they wanted the decision remade and the only delay, so far as the rules were concerned, would be the delay in applying for judicial review, which normally requires an application within three months of the decision that was made in 2004.

Finally, the only other point I make on Dr Spencer’s behalf is that I very carefully, with the exception of the disclosure to me of certain aspects of this case thwarting Dr Spencer’s medical career, set out the prejudice in paragraph 6, on pages 14 and 15, which I say this doctor will suffer as a result of the age of this case. It did not appear to me that those matters were specifically dealt with. They were dealt with in a very generic way. They are checks and balances, they are safeguards, submissions of no case can be made etc.

I maintain my stance on behalf of this doctor that there is severe prejudice here and it is, as outlined with the one addition, the career ambitions, in paragraph 6, pages 14 and 15, of my skeleton argument. That is all I wish to say by way of reply, and I extend an invitation to the Panel. If there is anything the Panel need by way of clarification, I am happy to assist.

THE CHAIRMAN: Thank you Mr Forde.

THE LEGAL ASSESSOR: On page 14 of your skeleton, where you are talking about prejudice, almost all the allegations are of evidential prejudice. Ms Sullivan’s point was that that is all that is relevant. The question is, can we still have a fair trial? It is true that at the second bullet point from the end, you talk about the stress, you have added to that the career blight, and there is the point about the balance of publicity. Do you accept or not, Ms Sullivan’s point that, on a stay, it is actually evidential prejudice which is relevant, that is why she did not respond in detail, I think?

MR FORDE: Yes. That may be right but, assuming that is the case, I would readily concede that if you are looking at a stay on the basis of delay, your primary concern should be the ability of the doctor to defend himself and cross‑examine witnesses adequately, and the ability of the doctor to be able to furnish you with relevant contemporaneous documentation and, further, the abilities of any expert called to truly – I am not suggesting they would be dishonest but truly – reconstruct the prevailing medical culture at the time. Those are the main areas. I certainly would not be inviting you to say that the stress of the proceedings and attendant publicity was reason enough to grant a stay. I am sure Ms Sullivan would be full of consternation if that was the basis of your decision. Evidential prejudice should rule the day.

THE CHAIRMAN: Mr Foster.

MR FOSTER: However, sir, all those other sorts of prejudice – stress, effect on a doctor’s career and so on – are relevant to the issue of legitimate expectation. I have set out at paragraph 3.1 of my skeleton argument, the comment from Lord Justice Staughton:

“It seems to us that, whether or not there was prejudice, it would bring the administration of justice into disrepute if the Crown Prosecution Service were able to treat the court as if it were at its beck and call, free to tell it one day that it was not going to prosecute and another day that it was.”

One of the issues which you will have to consider, is the one which is averted to by Ms Sullivan in the final paragraph of her skeleton argument. She says that it is in the best interests, it is in the public interest, to allow these proceedings to go on. One of the issues which you will have to weigh, in deciding whether it is in the best interests of the public at large for these proceedings to go on, is the effect which these proceedings have on the doctors concerned. Under that umbrella, as Lord Justice Staughton said, you can take into consideration the other aspects of prejudice.

On the question of delay, I respectfully adopt everything my Mr Forde has said. The response of Ms Sullivan to our contentions on delay is basically that there are sufficient procedural safeguards for the undoubted inordinate and inexcusable delay not to be a danger. In particular, she highlighted the burden and standard of proof, and the fact that we would be able to make a half‑time submission, if the evidence were really so weak by reason of delay, that case should not go any further.

If that is her only response, it is a poor one because it could be said in every case in which there has been inordinate and inexcusable delay that these procedural safeguards are in place. If that were a sufficient answer, and it is Ms Sullivan’s only answer, no submission on the basis of delay would ever succeed. They plainly do and this is a classic case where they should.

Ms Sullivan can gain no comfort from what the Court of Appeal said in the two main judgments. There is not a word about delay. The case, as I understand it, was not put to the Court of Appeal on behalf of the practitioners on the basis that discretion should not be exercised because there had been delay. The only comment about delay is in the judgment of Lord Justice Auld at paragraph and it is wholly against Ms Sullivan. He says that the delay is something which was inexcusable and should weigh heavily in deciding the outcome of that application, and by extension too, the decision which you have to make.

It is interesting and significant that Ms Sullivan did not say anything whatsoever on the issue of legitimate expectation. There is a good deal in my skeleton argument about it; there was not a word. There was not a word because, of course, there cannot be a response.

THE LEGAL ASSESSOR: I had a question about that. I remember distinctly – I do not have the transcript – thinking yesterday that you had moved very quickly over one aspect of legitimate expectation which is at the top of page 6 of your skeleton. The quotation of the case starts at the bottom of page 5:

“...an unequivocal assurance that a suspect will not be prosecuted and the suspect, in reliance upon that undertaking, acts to his detriment.”

We find in the most recent review at the bottom of page 6, that:

“These authorities suggest that it is not likely to constitute an abuse of process to proceed with a prosecution unless (i) there has been unequivocal representation...”

which you have argued is the letter, and (ii) that the defendant has acted on that representation to his detriment.

MR FOSTER: Yes.

THE LEGAL ASSESSOR: You were very clearly making a case yesterday that he had detrimental effects imposed on him, but not that he had acted in reliance. I wonder if you could identify for the Panel the actions which your doctor took in reliance on the representations, and then the final sentence there:

“Even then, if facts come to light which were not known when the representation was made, these may justify proceeding …”

One of the facts is that 1600 pages have been overlooked at one stage.

MR FOSTER: There are two broad actions in reliance. The first is failing, because of the representations which have been made, to gather the evidence which would now be helpful. Once all the practitioners were told that they would not have to face the charges, they assumed that there was no need to preserve documents, namely to preserve diaries, namely to keep in contact with witnesses and get statements from witnesses who might be helpful. That is an action which is of course more conveniently and more conventionally dealt with under the general head of delay.

THE LEGAL ASSESSOR: It is not my duty to stray into fact but I think it would help the Panel if, firstly, if this chronology is right, the first notification that the GMC would not continue was on 15 March 2002, and then by a letter dated 2 May. You seem to be putting a lot of stress on the period of six week delay there. Then in the ordinary way of the further decision that was indicated, and then subject to judicial review, I do not actually know when the judicial review was started, but the usual period is within three months of the communication of the decision seemed to be comparatively short periods.

MR FOSTER: What I would say is had there not been this representation there may have been recollections which would have been refreshed for the purposes of proceedings, there may have been documents which were retained, but all of those sorts of issues are more conveniently dealt with under the general head of delay. The better point is in relation to the act – it is properly described that way – of getting on with their lives. They relied on the assertion that they would not be prosecuted by getting on with their medical careers. Those hopes of being able to continue unpersecuted by the GMC were dashed on two occasions. That, in my submission, is plain detriment within the meaning of this head of legitimate expectation. Indeed, that seems to be contemplated by the Court of Appeal in the case of Mulla which I have cited at paragraph 3.2. This was not a case in which the defendant’s hopes were raised later to be dashed. That appears to be being identified by the Court of Appeal as detriment of this kind. This happened to these practitioners not once but twice.

Can I move on to the contention made by Ms Sullivan that the appropriate way to deal with the issue of merits is by way of an application for cancellation. The first point to make is that there has been no attempt by Ms Sullivan to respond at all to my contentions about merits and their relevance. She has simply said you should not consider them. She has not addressed the two reasons why I say that you should. She has not said in response to my explicit setting out of her own case from her own experts on the heads of charge against Dr Samuels that I have misrepresented things, that there is further evidence which could be and will be adduced by her which support these heads of charge. The only conclusion which you can draw from that is that there can be no answer.

Should there then have been, as she suggests, an application for cancellation? That is a wholly unrealistic suggestion. We did not get the Notice of Inquiry in this case until 8 April of this year. As you have had demonstrated to you, the evidence from the General Medical Council has come in in huge quantities, mutating as it does so, between 8 April and now.

I sought further and better particulars of allegation 3(a). I am not sure if I have got them. What I heard from Ms Sullivan was well Dr Raine at Queen Charlotte’s was the only person who took consent. If she is saying that we should conclude from that that only one person should have been able to take consent in relation to the 244 children enrolled in the trial at Stoke over the four years then those are further and better particular indeed, but laughably unarguable as an allegation. I do not imagine she is saying that. If she is saying that then of course I am very pleased. I would like her to nail her colours to the mast. If that is not the answer then we still do not have one and I do not know what allegation I face in relation to charge 3(a).

THE LEGAL ASSESSOR: I was slightly puzzled when you formulated it because I almost ended up with the impression that any number would have been appropriate provided they were properly trained, in which case the allegation as to numbers is probably not material and it is the training that is important.

MS SULLIVAN: It is in part important but not in its entirety because the fact that there were 34 people of varying different levels of experience consenting for the trial the Council would say is too many. I am not saying it should just have been one – of course that is totally unrealistic – but it should not have been as many as that and of as many different standards of experience.

MR FOSTER: I am none the wiser nor better informed. Mr Forde invites me to observe, as is the case, that there is not a single statement from any of the doctors who the General Medical Council proposes to call saying that they were inadequately trained, that they did not know what they were doing, another point which goes to merits.

There is then the issue of whether the charges were, to use legal shorthand, validly committed. The Chairman put to me a question yesterday afternoon about what had happened after the Court of Appeal considered the matter. What happened was that the Court of Appeal said that the Preliminary Proceedings Committee should reconsider the matter. It was not that the Court of Appeal said that the whole process should start again, there should be re-screening and the process should go on from there. The matter was ordered to go back to the Preliminary Proceedings Committee. The documentation which resulted thereafter you have seen in the second small bundle which was handed up to you yesterday. The Henshalls were invited to, and did, produce some further comments and in response to those comments those instructing me on behalf of Dr Samuels responded further.

Rule 11(2) which is relied upon by Ms Sullivan has to be read together of course with Rule 4A and Rule 4D. The fact of the matter here is that Dr Samuels has been wholly deprived of the basic protection of Rule 4A and 4D because we have in what he now faces allegations which are, because of the GMC’s procedural default, wholly uncommented on. Rule 11(2) does not begin to help my learned friend. It says that:

“Provided that where the Committee refer any cases relating to conduct to the Professional Conduct Committee, and the solicitor or the complainant later adduces grounds for further allegations of serious professional misconduct of a similar kind …”

You can hear me italicising those final four words,

“… such further allegation may be included in the charge or charges in the case.”

The allegations which we now have are not of a similar kind to those which Dr Samuels commented on.

I have commented already that Ms Sullivan closes with an invitation to you to allow this case to go on because it is in the public interest to do so. I ask rhetorically, as Mr Forde has already done, what conceivable public interest can there be in a further airing of these issues? It is not as if these allegations have been brushed under the carpet in some sinister way which should give the Henshalls real grounds for concern. I have demonstrated by reference to the evidence which the GMC proposes to rely on that there is no prospect of making out any of these allegations, let alone a finding of serious professional misconduct against Dr Samuels. It cannot be in the public interest to pursue charges which are doomed. Indeed, as I have said too in my skeleton argument, it brings the whole process of proceedings before the General Medical Council Professional Conduct Committee into disrepute if they are used in this way. It is not in the public interest that they should be so abused. It is not in the public interest to keep doctors who should be on the wards looking after patients sitting here facing baseless allegations. Those are my submissions.

MR FORDE: May I mention one matter and, if necessary, Ms Sullivan may wish to comment on it. I adopted Mr Foster’s submissions in relation to legitimate expectation and I am aware of the fact that I have not pointed to reliance to my client’s detriment. I do rely in your bundle D1-C upon his letter of 23 April 2004 where he indicates, and this goes to prejudice initially:

“I was severely hampered in obtaining two senior posts …”

But after the case was dismissed the first time he relies upon that dismissal and enters into a positive discussion with a medical director of a trust in relation to a newly created post. As soon as the case is re-opened he is told you cannot apply. He goes on to explain that his personal life and work has been affected in many other ways as you might imagine. If you are looking for prejudice and detriment, in my submission, it was professionally embarrassing for him to enter into discussions in reliance upon the first dismissal as communicated to him by the GMC with a senior colleague in relation to that newly created post and then of course he is told in terms you are not eligible because this matter is still outstanding.

MS SULLIVAN: Could I just correct one matter? My understanding is that delay was something that featured in the Court of Appeal, but neither Mr Foster nor myself were there.

MR FOSTER: If it was, it was not referred to by either of the judges who gave the main judgments.

MISS O’ROURKE: Sir, I am in a difficult position because I represent here today different clients to those I represented in the Court of Appeal. I continue to owe Dr Samuels and Dr Spencer duties of confidentiality in respect of my representation of them in those proceedings and so I do not think it would be appropriate for me to say anything. All that I can say is that there obviously were pleadings in documents and affidavits and things filed which are of course matters of public record, but I do not think I can say anything beyond that. I do not think my professional duties would allow me.

THE CHAIRMAN: I think we have now reached the point where I can call on Mr Forrest as the Panel’s Legal Assessor to give us the appropriate legal advice before we retire to consider these applications. Having had a quick whispered conversation with Mr Forrest, the suggestion he was making was to allow him time to put his thoughts together in articulating the advice he would wish to give us, it would be sensible if we were to break for lunch now and return at half past one, and then at half past one we will receive our legal advice from Mr Forrest. Once we have the advice the Panel is going to go into camera to consider the applications but we will deal with the question of how long we think that might be and how long it will be sensible to release people until at that point.

(Luncheon adjournment)

THE CHAIRMAN: Welcome back everybody.

MR FOSTER: Before your Legal Assessor directs you, we have been investigating the matter of what was and what was not told to the Court of Appeal in relation to delay. It seems that there was some mention of the issue before the Court of Appeal. I am not sure of the details. What I can say about it is, as I have observed already, the two judges who gave the prevailing judgment in that case do not seem to have relied on delay at all in coming to the conclusion they did about what happened to the case. The only detailed comment on it is the one from Lord Justice Auld, which I have read out.

THE CHAIRMAN: I suppose that the best one can say about that, Mr Foster, is that from what you say, if there was some mention of delay, the two judges who gave the majority judgment allowing the appeal did not find it necessary to make any observation about delay, it not being directly an issue in the case.

MR FOSTER: They have not commented on it. What one concludes from that, I do not know.

THE CHAIRMAN: Lord Justice Auld was saying at paragraph 76, “Well, I have reached the conclusion I have, but even if I reached a different conclusion I might then have exercised my discretion”.

MR FOSTER: Absolutely.

THE CHAIRMAN: Thank you. That is helpful.

MS SULLIVAN: I am sorry to stand up in relation to this. Of course that relates to the first judgment. The question of whether to exercise discretion was argued on the second occasion on 31 January 2006. The only other point I would make is that Lord Justice Auld’s analysis of what had happened in the case was adopted by the other two judges who were in the majority.

THE CHAIRMAN: The best we can do is to look at the judgment that we have in relation to the supplemental hearing. Miss O’Rourke has quite rightly I think indicated that she would fell diffident if not embarrassed in going further than what is apparent from the judgment. We will just have to make the best we can from the judgment as it appears.

MS SULLIVAN: Yes, we have set in train to try to get those documents that Miss O’Rourke said would be a matter of public record. As of yet we do not have them.

THE CHAIRMAN: If they were to arrive during the time the Panel is deliberating on the application in private, and if it was thought we might be assisted if we had access to them, would there be any problem in their being made available to us?

MS SULLIVAN: We would agree to that.

MR FOSTER: Certainly not from my part.

MR FORDE: I would be more than happy for you to receive them.

THE CHAIRMAN: Then, if having arrived and if having seen them you think they might be of assistance, by all means steer them in our direction. Mr Forrest.

THE LEGAL ASSESSOR: Sir, I remind the Panel, as I did yesterday, that what follows is my advice, not a direction, and the Panel is free to disagree with any advice which I give. I remind the Panel too that I have no view. I am not allowed to have a view, and in fact I have no view concerning the merits of the application. If I mention some facts to give illustrations, it is purely illustrative and not because my mind is turning in any particular way.

It always happens, and I apologise in advance, but because the cases are criminal cases I shall by oversight inevitably refer sometimes to the prosecution and the defendants. If I do so it is an oversight. The prosecution equates to the GMC in this case and the defendants are the doctors.

The application is for a stay of proceedings on the ground of abuse of process. The first thing to tell the Panel is what constitutes an abuse of process. No court should allow itself to be used as an instrument of injustice, so a power has been devised to stay proceedings, which includes a power to safeguard an accused person from oppression or prejudice. A court may stay proceedings, for example, where to allow them to continue would bring the administration of justice into disrepute among right‑thinking people. That would be the case if the court were allowing its process to be used as an instrument of oppression, injustice or unfairness.

What is at stake? It means that the case comes to a stop. There is no adjudication on the merits of the case whatever; the case simply does not proceed. The burden of proof lies on those making the application. That is the doctors, and it is for them to prove on the balance of probabilities that a stay is justified - although once the facts have been proved there is a large degree of judgment to be exercised in assessing whether a fair trial is still possible.

It is an unusual feature of this case that of the three doctors only two are making an application. The Panel should draw no inferences whatever from Dr Southall’s having declined to enter into this particular fray. As I understood the doctor’s position through Miss O’Rourke it is a case of, what seems to be the popular phrase now, “bring it on and let us have a fight regardless”, so that the doctor may be vindicated on the merits rather than being left in the unsatisfactory position, as he may regard it, of the case simply having come to a stop. But you should not draw any inferences from that as to merits of the present application.

Although there is a large degree of overlap between the arguments, you must look at each doctor’s application separately because there may be factors that apply to one doctor but not to the another. It is also accepted on all sides that you should look at each factual allegation separately. Counsel for the doctors say that the whole case should be stayed, but each has made arguments in relation to particular factual allegations, and it is open to you to stay further proceedings in relation to particular allegations while allowing the reminder of the allegations to proceed. That is, in a sense, the doctors` fallback position: if things are not so bad that the whole case should be stayed, then nonetheless you should stay some particular allegations. For example, the reason you must look at the allegations separately is you may think there is a difference between setting up a protocol for a trial, which would be a process spread over many months, and what was said to a patient’s parent on a particular day many years ago in the course of a doctor’s ordinary duties. That is only an example of the sort of distinction you could draw if so minded.

As all parties agreed yesterday, but I remind you again, this is not the time to make findings on the substantive issues that arise in the case. You must carefully avoid doing that.

You have had drawn to your attention various extracts from disclosed witness statements and expert reports, which the doctors say make it impossible for the GMC to prove various of the factual allegations. My advice to you is that these are selective excerpts. You do not know yet the whole of the evidence. If it is indeed a thin case and the evidence will not bear the weight Ms Sullivan puts on it, then it will be appropriate for the application to be reconsidered, possibly once Ms Sullivan has concluded her opening, certainly at the close of the GMC case; and it would be possible at any stage to renew the present applications once it is seen what the evidence actually is, or to make a submission that there is in effect no case to answer.

Mr Foster raised arguments about the admissibility of evidence and in particular the evidence of Dr Nicholson, I should say. Matters of admissibility can be dealt with in the course of a substantive hearing, either by an application to exclude the evidence or by cross‑examination. As I may have to explain again, an expert is only allowed to give evidence if he is indeed expert in a relevant field of expertise. An application can be made that the evidence should not be allowed at all, or the expert can be subject to cross‑examination. My advice to you is that questions of admissibility should not feature in your deliberations at this stage.

The principal plank of the doctor’s argument arises out of delay. Other points arise which are not connected with delay. For convenience I deal with those together. There is an argument based on insufficiency of particularity of various allegations. We have investigated those this morning. How many is too many in the case of doctors and nurses being delegated to take consents, and what is the period over which regular blood pressures should have been taken? My advice again is that at this stage, at least, those matters should be left out of the count by you. Again, this is an application that can be renewed and may helpfully be done so once Ms Sullivan has opened the case and made clear precisely how she puts each of those allegations against the doctor. It is certainly true that the doctors are entitled to know the case against them before the evidence starts. If there remains after the opening sufficient doubt as to what is being alleged then I suggest that you invite, and they will probably require no invitation, Mr Forde and Mr Foster to renew their application.

It would be unfair to describe it as bickering. There has been a degree of polite disagreements concerning continuing disclosure. It is of course the duty of the GMC in a case such as this to give continuing disclosure of relevant documents as they come to light. That is not in itself a ground for staying the proceedings. If of course an important points arises out of continuing and late disclosure then it is a matter for the doctors to consider their position. Again, if something comes up which changes the complexion of the case the present application could be renewed. Again, I invite you to leave out of consideration at the moment the late disclosure as is alleged as a grounds for a stay, although it forms part of the general background to the subsequent considerations you will have concerning delay.

Mr Foster raised a procedural point. This is dealt with at section five of Mr Foster’s argument. It concerns Dr Samuels only. You will recall this is the point about the failure to obtain the comments of the doctor. You heard Ms Sullivan’s response to that under Rule 11(2). It is my advice to you that in any event the rule requiring that the doctor’s comments be sought is directory. In other words it should be done, but it is not fatal to the proceedings if it is not done. That is a technical legal distinction between directory and mandatory rules.

I move on to an argument which was most fully deployed in Mr Foster’s skeleton argument, but of course adopted by Mr Forde and therefore applies to both doctors. It is the argument concerning legitimate expectations. Mr Foster has helpfully set out at page five, paragraph 3.3 of his skeleton argument, an extract from the Court of Appeal in R v Abu Hamza which is the most recent authority on this subject. The cases which he set out previously, with the exception of the first case to which he refers, deal with cases where expectations were raised by dashed, but the court held that that was not sufficient ground for a stay.

The overall conclusion of the Court of Appeal was that a stay may be appropriate in some circumstances such as these. This is at the bottom of page five of Mr Foster’s skeleton argument. For example,

“if police, who are carrying out a criminal investigation, give an unequivocal assurance that a suspect will not be prosecuted and the suspect, in reliance upon that undertaking, acts to his detriment. Thus in R v Croydon Justices... a 17‑year‑old youth, who had assisted in destroying evidence after a murder had taken place, was invited by the police to provide evidence for the prosecution and assured that, if he did so, he would not himself be prosecuted. He thereupon provided evidence against those who had committed the murder and admitted the part that he had played. In these circumstances, which Staughton LJ presiding in the Divisional Court described as ‘quite exceptional’, it was held to be an abuse of process subsequently to prosecute him”.

You will realise that it was the defendant himself who had irrevocably changed his position by making confessions which he had been promised would not used against him, but which subsequently the prosecution did seek to use against him. You may think that in those circumstances it is not hard to see why the court thought that that was abusive and oppressive.

The conclusion is at the bottom of bottom of page 6, 54. After reviewing the authorities, including Bloomfield, in which there was no change of circumstances, the conclusion in Abu Hamza was:

“These authorities suggest that it is not likely to constitute an abuse of process to proceed with a prosecution unless (i) there has been an unequivocal representation by those with the conduct of the investigation or prosecution of a case that the defendant would will not be prosecuted and (ii) that a defendant has acted on that representation to his detriment.”

Applying for a job, for example, is not in itself acting to one’s detriment, it is trying to act to one’s advantage. The fact that a different party then refuses to give the job, is not a case where the defendant has acted to his detriment.

I draw attention to the last part of the Abu Hamza judgment:

“Even then, if facts come to light which were not known when the representation was made, these may justify proceeding with the prosecution despite the representation.”

In this case, at least so far as the first assurance is concerned that there would be no further action, that does seem to have proceeded on the basis of a mistake, which subsequently came to light, namely that 1600 pages of documents had been overlooked. Mr Foster did argue that the doctors had acted to their detriment in not obtaining documents and so on, not chasing up witnesses. That is a matter for you and you bear in mind the comparatively short periods between the notification on 15 March 2002 that the case was not proceeding and the intimation on 2 May of the same year that it was proceeding because a mistake had been made, and then on the second decision, communicated on 12 March 2004, which was reversed because of the judicial review.

It is right to say that any decision of a public body is, in a sense, provisional in that the public body is always subject to judicial review, and it may be that hopes cannot be raised too far until the period for judicial review, when usually the application has to be made within three months from the date of communication of the decision, whether that sort of raising of hopes is a matter of significance.

Mr Foster also raised the argument in his skeleton at paragraph 6.1(b), that there was an improper motive in this case. Perhaps, but it is us matter for you, he did not make it absolutely plain whose improper motive it was. I remind you that it is for the defendants to prove this on the balance of probabilities, in so far as there has been talk of the Henshalls having an agenda of their own or anything of that sort. I draw your attention to this paragraph of Archbold, the leading text book on Criminal Law. It is paragraph 4‑63a for those interested:

“A complainant’s unreliability as a witness and his obsession about his cause do not justify a decision to stay proceedings on the basis of abuse of process.”

That seems to me, but again it is a matter for you, to be about as high as the case has been put to you, and it is a matter for you whether any improper motive amounting to oppression, manipulation of the system, or something such as that, has been proved on the balance of probabilities.

I then turn to what may be described as the main thrust of the doctors’ argument, the issue of delay. There has been talk of public interest. It is right that I should remind you of the context in which you have to consider these allegations. This is not simply a civil dispute between two parties as to whether, for example, one owes money to the other. There is indeed a degree of public interest. You will remember, no doubt, from the Indicative Sanctions guide that, as far as the GMC is concerned, that the public interest includes, amongst other things, protection of patients, maintenance of public confidence in the profession and declaring and upholding proper standards of conduct and behaviour.

Fairness requires fairness to the GMC in its endeavour to uphold public interest as well as fairness to the doctors. The common law has devised protection for defendants, in this case doctors, in cases where it is no longer possible to have a fair trial of the action.

It is summarised this way, again in Archbold:

“On an application for a stay on the ground of delay, a court should bear in mind the following principles: (i) even where delay is unjustifiable, a permanent stay should be the exception rather than the rule; (ii) where there is no fault on the part of the complainant or the prosecution, it will be very rare for a stay to be granted; (iii) no stay should be granted in the absence of serious prejudice to the defence so that no fair trial can be held; and (iv) on the issue of possible serious prejudice, there is power to regulate the admissibility of evidence and the trial process itself should ensure that all relevant factual issues arising from the delay will be placed before the jury. If, having considered all those factors, a judge’s assessment is that a fair trial will be possible, a stay should not be granted.”

So the focus, as you will see, under the common law is whether a fair trial of the action remains possible. The only remedy is that if a fair trial is no longer possible, there should be a stay.

Separately, since the introduction of the Human Rights Act, it may be alleged, as it is indeed alleged in this case, that there is a breach of article 6 of the European Convention on Human Rights – the right to a fair trial within a reasonable time. So far as the fair trial aspect is concerned, requirement for a stay of the proceedings due to delay are similar whether the court has been asked to consider common law principles or article 6. This needs a little further explanation.

Article 6 requires various disjointed rights. In other words, it may still be possible to have a fair trial even after a period of delay, but that delay may constitute a breach of the requirement to have that trial within a reasonable time. The starting date for the article 6 inquiry is 30 March 2001. If a breach is found, then a remedy is required, but that remedy need not be a stay, and indeed should not be a stay unless it is possible to have a fair trial of the action.

It is put this way in the leading authority to which your attention has already been drawn, the Attorney‑General’s Reference (No 2 of 2001) [2004] 2 AC 72. It is at paragraph 24 in Lord Bingham’s speech:

“If the through the action or inaction of a public authority, a criminal charge is not determined at a hearing within a reasonable time, there is necessarily a breach of the defendant’s Convention right under article 6(1). For such a breach there must be afforded such remedy as may be just and appropriate in terms of the Human Rights Act or (in Convention terms) effective, just and proportionate. The appropriate remedy will depend on the nature of the breach and all the circumstances, including particularly the stage of the proceedings at which the breach is established. If the breach is established before the hearing, the appropriate remedy may be a public acknowledgement of the breach, action to expedite the hearing to the greatest extent practicable and perhaps, if the defendant is in custody, his release on bail. It will not be appropriate to stay or dismiss the proceedings unless (a) there can no longer be a fair hearing or (b) it would otherwise be unfair to try the defendant. The public interest in the final determination of criminal charges requires that such a charge should be stayed or dismissed if any lesser remedy will be just and proportionate in all the circumstances. The prosecutor and the court do not act incompatibly with the defendant’s Convention right in continuing to prosecute or entertain proceedings after a breach is established in a case where neither of conditions (a) or (b) is met, since the breach consists in the delay which has accrued and not in the prospective hearing. If the breach of the reasonable time requirement is established retrospectively, after there has been a hearing, the appropriate remedy may be a public acknowledgement of the breach, a reduction in the penalty imposed on a convicted defendant or the payment of compensation to an acquitted defendant. Unless (a) the hearing was unfair or (b) it was unfair to try the defendant at all, it will not be appropriate to quash any conviction. Again in any case where neither of conditions (a) or (b) applies, he prosecutor and the court do not act incompatibly with the defendant’s Convention right in prosecuting or entertaining the proceedings but only in failing to procure a hearing within a reasonable time.”

So it is open to you to find that, if the GMC has been guilty of delay since 13 March 2001, which has had the effect that the hearing has not taken place within a reasonable time, then there is a breach of article 6 and there should be declared to be a breach. It is open to you to say that it is sufficient vindication of the defendant’s rights that that declaration has been made by you, and a stay could be the answer unless a fair trial is no longer possible.

Mr Forde put forward the argument that in regulatory proceedings different principles apply concerning the sanctions which, of course, are not intended to be punitive, from the principles which apply in sentencing a convicted offender. You must make of those arguments what you think fit in the light of the response which was given to you by Ms Sullivan on behalf of the GMC.

The periods which you should regard as culpable by a public authority are those which could properly be laid at the door of the GMC. Ms Sullivan was suitably demure and circumspect in the concessions which she made. Certainly the Panel may think that the fact that the GMC overlooked 1600 pages of documents, that set the clock running for culpable delay, though of course what timescale would have been observed if those 1600 pages had not been overlooked has not been investigated. It is debatable whether, once the Preliminary Proceedings Panel in 2004 made a decision which was wrong and corrected subsequently by the court, it is debatable whether that should be laid at the door of a public authority in this context, or whether it is a judicial decision, but at best, as Mr Forde has said, that should be regarded as neutral. No‑one believes that it could be laid at the door of the GMC that from the time of the High Court decision in the judicial review to the time when the Court of Appeal finally gave its decision, but that delay can be laid at the door of the GMC so the clock in effect stops running during that period.

Your attention was drawn to the case of Rogers. Ms Sullivan’s submissions concerning that case gave no particular force because she was able to refer to a text book. She was entitled to, and did, adopt the argument of the authors, but it is for you to judge the merits of that. My advice to you is that not every case, as has been emphasised to you, turns on its own facts. It is not clear what the facts in Rogers were. Most importantly it was decided before what is now, and I am struggling to find the words for, locus classicus, but the authoritative source of learning on this topic is now the case in the House of Lords which I mentioned, The Attorney‑Generals Reference (No 2 of 2001) which was decided after Rogers. At the time of Rogers the Human Rights Act had only recently been introduced and there was controversy and some disagreement between England and Scotland as to the effect of it.

Rogers could never be an authority. It is something you can take into account and my advice is that you should give it little weight.

The five year rule - all except that this did not apply at the time of the events which are the subject of the present hearing, my advice to the Panel is that you may take it into account insofar as you think it casts light on the issues concerning delay. Clearly delay is never desirable and that has now been enshrined by what perhaps is a somewhat arbitrary cut-off point in the GMC. You may find that helpful in your considerations as to whether a fair trial is possible or not, but of course the five year rule only applied and was judged by the time between the happening of the events and the making of the complaint to the GMC and you are concerned with delay other than during that period.

I have already read to you the passage which says a lot of the concerns which are raised in this type of application can be addressed by the trial process; points about fading memory and so on. Ms Sullivan rightly reminds you that the burden of proof in this case will be on the GMC and the standard of proof is that the GMC will have to satisfy you, if the case proceeds, that you are sure of the factual allegations.

In trying to satisfy you to that degree of certainty, evidence will be called, the witnesses will be subject to cross-examination, the accuracy or otherwise of their recollection will be fully explored and no doubt submissions will be made and will be investigated in cross-examination whether documents might have helped. The only documents which we know at this stage are missing are ultrasound scans and Ms Sullivan reminds you that the reports of those scans are still available.

It might help you to know the sort of advice which I would be giving you at the end of this case if you were to reach the stage of considering the facts because that may help you appreciate the protections which are built into the trial process. The suggested directions which the Judicial Studies Board provides for judges dealing with old cases are along these lines:

You are concerned with events which are said to have taken place a long time ago. You must appreciate that, because of this, there may be a danger of real prejudice to the practitioner. This possibility must be in your mind when you decide whether the Council has made you sure of the practitioner’s guilt. You are entitled to consider why these matters did not come to light sooner. Is that a reflection on the reliability of the complaint?

You have been given an explanation for this and that will be whatever explanation the Henshalls give concerning the first period of delay and the cross-examination thereof and the submissions which are made and any evidence which is led in relation to subsequent periods. The direction goes on like this:

You should make allowance for the fact that with the passage of time memories fade. Witnesses, whoever they may be, cannot be expected to remember with crystal clarity events which occurred many years ago. Sometimes the passage of time may even play tricks on memories.

You should also make allowances for the fact that, from the practitioner’s point of view, the longer the time since an alleged incident, the more difficult it may be for him to answer it. For example, has the passage of time deprived him of the opportunity to put forward and alibi and evidence in support of it? You only have to imagine what it would be like to have to answer questions about events which are said to have taken place, in this case up to 18½ years ago, to appreciate the problems which may be caused by delay. Even if you believe that the delay in this case is understandable, if you decide that because of this the practitioner has been placed at a real disadvantage in putting forward his case, take that into account in his favour when deciding if the prosecution has made you sure of his guilt.

In other words, the implication of that advice is this that, once you have heard all the cross-examination, it may not be necessary to cross-examine because witnesses may not come up to proof, say what they were expected to say, even in-chief, but the trial process will take care of those doubts and, if appropriate, result in an acquittal. Unless the doctors’ counsel have persuaded you on the balance of probabilities that those safeguards cannot ensure a safe trial, then the proper course for you is to allow this to go forward to a hearing.

There is talk in some of the extracts from cases about a discretion whether to stay a case as an abuse of process. My advice to you is this, that there is really no discretion in this sense if you find on the balance of probabilities that it is impossible to have a fair trial of any particular issue or of all the issues, you should say so and you should stay that part of the proceedings. It would not be a proper judicial decision to say well, a fair trial is impossible but in the exercise of my discretion I think I will let it go ahead anyway. That would not be the right process.

Sir, as a legal assessor, my main function is to prevent you from falling into error. In view of the amount of material which has been put before you there may well be matters which arise in the course of your considerations which will require further advice. If that happens, I shall of course give advice and it would be necessary to reconvene and repeat that advice in public so as to hear the submissions of the parties. I believe, after my discussions with counsel for all the parties, except Miss O’Rourke, who is not participating in the application in any event, that I have covered all the matters which I wished to do so. That is my advice unless any Member of the Panel requires further clarification at this stage.

DR OKITIKPI: This is not a clarification as such, but if we want a copy of what you have just read out would it be possible?

THE LEGAL ASSESSOR: Yes, it is incorporated into the transcript which should be available by the end of the afternoon, which I think is likely to be the earliest you will come to consider the application of this advice to the facts. I ought to have said that clearly you need to read all the skeletons again and the documentation which has been put before you before you start detailed consideration of the applications.

MR FORDE: There is one matter I may need to check but I would like to comment on two aspects of the advice that has been given to make our position absolutely clear. It is our case that, under the common law, time runs against the Henshalls, who are jointly instructing my learned friend, from their concerns being expressed in relation to the CNEP trial. We were told 20 March 1996. I am looking at my learned friend’s chronology, C2, and we know that by 21 July 1994 this family were instructing solicitors and the Newall Report that I have seen of November 1995 deals with concerns of the sort in relation to scans which comprise the charges that my client faces in paragraphs 18, 19 and 20 and therefore it is my strong submission that the time period in relation to those allegations which were not specifically dealt with by the Court of Appeal have been matters of concern to the Henshalls since the middle Nineties, throughout the period of time, right up until April 2008. We suspect their knowledge may have been prior to 21 July 1994.

So far as Article 6 is concerned, the learned Legal Assessor suggested that time might run from March 2001 and then be held in a sort of neutral abeyance as a result of the judicial review proceedings. Can I make it absolutely clear that our position is that the Court of Appeal, in the short judgment that you have been handed which I think was in January 2006, said the matter should proceed “with expedition”. I do rely upon the period between January 2006 and April 2008. I would only be prepared to concede that their Lordships did not assist matters in taking six months to deliver their judgment as far as Article 6 is concerned.

There is just one section of Archbold that it occurs to me, but this is subject to the view of the learned Legal Assessor, might assist you when you are looking at these overlapping periods and culpability. It is a little passage just above paragraph 4-68 on page 387 of the 2008 edition of Archbold. I will read it into the transcript:

“Where substantial delay has occurred which can be attributed in part to, for example, inefficiency on the part of the prosecution [for that read GMC] and in part to the conduct of the defendant [we say there is no culpable delay on the part of the doctors here] the court must consider to what extent the delay is attributable to prosecution inefficiency. If the delay, so attributable, is substantial, and if the court considers that the defendant [for which read doctor] has, or must have been, prejudiced thereby, so that the continuance of the prosecution can be regarded as an abuse of process, the jurisdiction may be exercised in the defendant’s favour.”

The point I wish to make is even when there is joint culpability your duty is clear in the sense that you can exercise your discretion in favour of the doctors. The General Medical Council can point to no culpability. The delays in court might be regarded properly as neutral, but in any event the substantial delay that had occurred up to the judicial review proceedings in 2004 should be taken into account by you in then looking at the delays since 2004. I just wanted to make that clear.

For the record, on the five year rule, and you have been reminded of this, I am not saying that it was applicable at the relevant time simply because it might be an approach that you could consider adopting. I hope that makes matters a little clearer.

MR FOSTER: I adopt those submissions.

THE CHAIRMAN: Ms Sullivan, have you anything you wish to say about the advice we have been given?

MS SULLIVAN: No, sir, except to say that I agree with the advice that you have been given and it would seem on the basis of what was just quoted by Mr Forde at 4-67(a) that you would need to consider to what extent the delay is attributable to GMC inefficiency, so it is still necessary to consider that prior to coming to any determination.

MR FORDE: I would say the GMC and Henshall.

THE LEGAL ASSESSOR: It was just something that arose out of what Mr Forde was just saying but I think it would only complicate matters if I were to embark on it.

MR FORDE: If it is thought necessary, I am more than happy to discuss it with the Legal Assessor.

THE CHAIRMAN: Thank you, Mr Forrest, for those observations. That brings us to the point where the Panel can now retire to deliberate on the applications which have been made and to reach a determination. In terms of what we propose to do, as Mr Forrest has just indicated, we will start that process by reading all the material which has been put in as part of your respective submissions and Ms Sullivan’s response and of course we will remind ourselves of the amplification which has been given to the skeleton arguments through oral submissions. Once we have done that we will then go on to deliberate and reach a determination.

I cannot at this stage say exactly how long that process is going to take. If it helps the parties, and I hope it will, I think I can say with some certainty that we will not have reached a position where we can call you all back to give a determination ---

DR OKITIKPI: Mr Forde read out the extract and Ms Sullivan agreed with the extract. I am not quite sure what we are to make of the extract?

MR FORDE: It is 4-67(a), page 387, the penultimate paragraph. I am happy for you to deal with it.

THE LEGAL ASSESSOR: I do not think it adds significantly to the advice which I gave. I am very happy to endorse it as a statement of the law. There is no reason why this paragraph should not be shown to the Panel if they wish to look at it, or indeed any of the paragraphs.

MR FORDE: Yes, if they want to see it. We can photocopy the section from section 4-66 onwards, but it is on the transcript.

THE CHAIRMAN: That is fine. We have Archbold here to which reference has been made and if we wish to look at it we will be able to do so. I should probably have caught your eye before I embarked on the next stage. I think I can say with certainty that we can release the parties until 2 o’clock on Monday simply because, doing the best that I can at this stage, I think that is a reasonable assessment of a time within which I can say we will not be in a position to have reached a final decision and produced the determination and be in a position to give it.

If, come Friday afternoon, it is apparent to us all that it is not going to be finished even by Monday lunchtime, then we will endeavour to contact all of you and let you know, so if you can make sure the Panel Secretary has contact mobile phone numbers. I think you were indicating, Ms Khan, that we could give an update on Friday in any event and we will endeavour to do that.

The Panel will now go into camera for the purpose of deliberating and reaching a determination on the applications which have been made. Parties, counsel and everybody else involved in the case is released from attendance here until at least 2 o’clock on Monday afternoon, but if it looks as if it might be later than that we will endeavour to get in touch with you and let you know, subject to the need to reconvene if any new legal issue arises.

STRANGERS THEN, BY DIRECTION FROM THE CHAIR, WITHDREW

AND THE PANEL DELIBERATED IN CAMERA

(All parties provisionally released until 2 pm on Monday 19 May 2008)

Transcripts of the Hearing - Day 2

2008-06-19T03:20:00.000-07:00

Now that we have the transcripts of the hearing, we will be posting these online every few days. We start with Day 2

GENERAL MEDICAL COUNCIL

FITNESS TO PRACTISE PANEL

(applying the General Medical Council’s Preliminary Proceedings Committee

and Professional Conduct Committee (Procedure Rules) 1988)

On:

Tuesday, 13 May 2008

Held at:

St James’s Buildings

79 Oxford Street

Manchester M1 6FQ

Case of:

STEPHEN ANDREW SPENCER BM BS 1976 University of Nottingham

Registration No: 2305893

DAVID PATRICK SOUTHALL MRCS 1971 Royal College of Surgeons of England

Registration No: 1491739

MARTIN PHILIP SAMUELS MB BS 1981 University of London

Registration No: 2732178

(Day Two)

Panel Members:

Mr D Kyle (Chairman)

Mrs V Brickley

Mrs S Hollingworth

Dr T Okitikpi

Dr M Sheldon

Mr A Forrest (Legal Assessor)

--------------------------------------

MR M FORDE, Queen’s Counsel, instructed by RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Spencer.

MISS M O’ROURKE, Counsel, instructed by Hempsons, Solicitors, appeared on behalf of Dr Southall.

MR C FOSTER, Counsel, instructed by RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Samuels.

MS J SULLIVAN, Counsel, instructed by Eversheds, Solicitors, appeared on behalf of the General Medical Council and the Complainants, Mr and Mrs C Henshall.

--------------------------------------

Transcript of the shorthand notes of

Transcribe UK Verbatim Reporting Services Ltd

Tel No: 01889 270708

INDEX

Page

ALLEGATIONS 1

APPLICATION TO AMEND

MS SULLIVAN 8

MR FORDE 9

MS O’ROURKE 10

MR FOSTER 10

LEGAL ASSESSOR’S ADVICE 10

DETERMINATION 11

ABUSE OF PROCESS APPLICATION

MR FORDE on behalf of Dr Spencer 17 MR FOSTER on behalf of Dr Samuels 51

------------------------

THE CHAIRMAN: Good morning, everybody. Ms Sullivan, could I look to you to start with to let us know where you think we are?

MS SULLIVAN: I am very grateful for the time that you have given us. We are ready to proceed. It is agreed that we should start with the Notice of Hearing being read out.

THE LEGAL ASSESSOR: Yes, sir. That opens the inquiry by reading of the existing charges although we all understand that there will subsequently be an application to amend.

THE CHAIRMAN: Before I ask the Panel Secretary to read out the charges as they currently are, I should formally ask each of the doctors to confirm their name and registration number. Dr Spencer, could I ask you to stand and confirm your name and registration number?

DR SPENCER: Dr Stephen Andrew Spencer, 2305893.

DR SOUTHALL: Dr David Patrick Southall, registration number 1491739.

DR SAMUELS: Dr Martin Philip Samuels, GMC registration number 2732178.

THE CHAIRMAN: I will now turn to the Panel Secretary and ask her to read the charges.

THE PANEL SECRETARY: The Panel will inquire into the following allegation against

Dr Stephen Andrew Spencer, BM BS 1976 University of Nottingham.

“That being registered under the Medical Act;

1. At all material times you were practising as a Consultant Paediatrician at North Staffordshire Hospital, Stoke-on-Trent;

2. On 29 November 1989, you applied to the Ethics Committee of the North Staffordshire Royal Infirmary (“the Ethics Committee”) for approval of a trial entitled “A randomised controlled trial of continuous sub-atmospheric (negative) extra thoracic pressure (CNEP) in neonatal respiratory failure.” (“the CNEP trial”);

3. The application inaccurately described,

a. the procedures that would be applied to each patient and/or,

b. the number of patients that would be required for the trial;

4. The design of the trial was such that it did not sufficiently minimise the possibility of bias;

5. The trial received Ethics Committee approval on 11 January 1990;

6. In or around February 1990, at Queen Charlottes Hospital, a trial patient was found to have experienced neck trauma,

a. This was an adverse event which should have been reported to the Ethics Committee of both Queen Charlottes and North Staffordshire Hospitals,

b. You failed to report the matter to the North Staffordshire Ethics Committee,

7. On 15 May 1990, two changes were made to the scoring system,

a. These were changes to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the changes to the Ethics Committee;

8. In or around July or August 1991, artificial surfactant was introduced as a treatment option for patients in the trial,

a. This was a change to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

9. On 11 September 1991, the exclusion criteria were amended to include patients were born following prolonged ruptured membranes, providing this was of not more than 7 days’ duration,

a. This was an amendment to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

10. By the time that 100 patients from North Staffordshire had participated in the trial it was apparent that substantially more patients from North Staffordshire would be required to participate,

a. This was a change to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

11. In your role as a responsible investigator in the conduct of the CNEP trial you failed to ensure that appropriate procedures were in place to obtain informed parental consent to the patients’ participation in the CNEP trial, in particular,

a. You inappropriately delegated the task of taking consent to too many different medical and nursing staff,

b. You failed to provide adequate training to those taking consent for the trial,

c. You misrepresented within the parental information leaflet that the technique had been shown to be safe,

d. You failed to ensure that every parent had a copy of the parental information leaflet;

12. In your role as a responsible investigator in the conduct of the CNEP trial,

a. You used a scoring system that was not validated,

b. You failed to ensure that the scores were allocated correctly,

c. You failed to ensure that the scores were calculated correctly,

d. You failed to ensure that there was an appropriate method of scoring,

e. You thereby failed to produce valid results from the trial;

13. You co-authored a paper entitled “Continuous Negative Extrathoracic Pressure in Neonatal Respiratory Failure” published in Paediatrics on 6 December 1996 (“the Paediatrics Paper”),

a. The abstract states “The overall outcome score showed an overall significant benefit for CNEP”,

b. This statement should not have been made in view of the defects in the scoring system referred to in Head 12 above;

14. On 14 December 1992 Patient A was born by Caesarean section at the North Staffordshire Maternity Hospital;

15. Following her birth, Patient A was entered into the CNEP trial;

16. Between the hours of 00:03 on 15 December 1992 and 12:30 hours on 15 December 1992;

a. Patient A’s PO2 level was recorded to be low at levels varying between 4.5 to 4.7,

b. Patient A’s oxygen saturation level was recorded to be normal at levels varying between 94% to 99%,

c. Patient A’s pH level was recorded at levels between 7.23 and 7.28 suggesting that she was acidotic,

d. Patient A’s PCO2 level was raised at levels varying between 6.3 to 7.4,

e. This combination of results suggested that the oxygen saturation monitor was faulty,

f. This combination of results suggested that Patient A was hypoxic,

g. You failed to ensure that the appropriate steps were taken to treat Patient A’s hypoxia until 12:30pm on 15 December 1992;

17. During your involvement in Patient A’s care, you failed to ensure that appropriate and regular blood pressure checks were undertaken and/or recorded in her notes;

18. On 22 December 1992, an ultrasound scan taken of Patient A’s skull was reported to show “increased density on the left. Suspicious of clot attached to the choroid plexus and associated with mild lateral ventricular dilatation”;

a. You failed to inform Patient A’s parents of this abnormality,

19. On 29 December 1992, a further ultrasound scan taken of Patient A’s skull was reported to show “mild symmetrical dilatation of the lateral ventricles consistent with haemorrhage, although no clot is definitely identified within the ventricular system”,

a. You failed to inform Patient A’s parents of this abnormality;

20. On 7 January 1993, Patient A was discharged from the Neonatal Unit,

a. You failed to arrange for Patient A to have a further ultrasound scan prior to her discharge from the Neonatal Unit;

21. Your actions as outlined above were,

a. inappropriate,

b. inadequate,

c. not in the patients’ best interests,

d. likely to bring the medical profession into disrepute;

And that in relation to the facts alleged you have been guilty of serious professional misconduct.”

B The Panel will inquire into the following allegation against Dr David Patrick Southall, MRCS 1971 Royal College of Surgeons of England.

“That being registered under the Medical Act;

1. At all material times you were practising as a Consultant Paediatrician at the Royal Brompton and North Staffordshire Hospitals;

3. The application inaccurately described

a. the procedures that would be applied to each patient and/or,

b. the number of patients that would be required for the trial;

4. The design of the trial was such that it did not sufficiently minimise the

possibility of bias;

5. The trial received Ethics Committee approval on 11 January 1990;

6. In or around February 1990, at Queen Charlottes Hospital, a trial patient was found to have experienced neck trauma

a. This was an adverse event which should have been reported to the Ethics Committee of both Queen Charlottes and North Staffordshire Hospitals,

b. You failed to report the matter to the Ethics Committee of North Staffordshire Hospital;

7. On 15 May 1990, two changes were made to the scoring system,

a. These were changes to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

8. In or around July or August 1991, artificial surfactant was introduced as a treatment option for patients in the trial

a. This was a change to the Trial Protocol which should have been

reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

9. On 11 September 1991, the exclusion criteria were amended to include patients who were born following prolonged ruptured membranes, providing this was of not more than 7 days duration

a. This was an amendment to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

10. By the time that 100 patients from North Staffordshire had participated in the trial, it was apparent that substantially more patients from North Staffordshire would be required to participate

a. This was a change to the Trial Protocol which should have been reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

a. You inappropriately delegated the task of taking consent to too many different medical and nursing staff,

b. You failed to provide adequate training to those taking consent for the trial,

c. You misrepresented within the parental information leaflet that the technique had been shown to be safe,

d. You failed to ensure that every parent had a copy of the parental information leaflet;

12. In your role as a responsible investigator in the conduct of the CNEP trial

a. You used a scoring system that was not validated,

b. You failed to ensure that the scores were allocated correctly,

c. You failed to ensure that the scores were calculated correctly,

d. You failed to ensure that there was an appropriate method of scoring,

e. You thereby failed to produce valid results from the trial;

13. You co-authored a paper entitled “Continuous Negative Extrathoracic Pressure in Neonatal Respiratory Failure” published in Paediatrics on

6 December 1996 (“the Paediatrics Paper”)

a. The abstract states “The overall outcome score showed an overall significant benefit for CNEP”,

b. This statement should not have been made in view of the defects in the scoring system referred to in Head 12 above;

14. Your actions as outlined above were

a. inappropriate,

b. inadequate,

c. not in the patients’ best interests,

d. likely to bring the medical profession into disrepute;

And that in relation to the facts alleged you have been guilty of serious professional misconduct.”

C The Panel will inquire into the following allegation against Dr Martin Philip Samuels, MB BS 1981 University of London.

“That being registered under the Medical Act;

1. At all material times you were practising as a paediatrician at the Royal Brompton and North Staffordshire Hospitals;

2. In 1990 a trial was commenced to determine the benefit or otherwise of continuous negative extrathoracic pressure (CNEP) in babies with respiratory failure (“the CNEP trial”);

3. In your role as an administrator of the CNEP trial you failed to ensure that appropriate procedures were in place to obtain informed parental consent to the patients’ participation in the CNEP trial, in particular,

a. You inappropriately delegated the task of taking consent to too many different medical and nursing staff,

b. You failed to provide adequate training to those taking consent for the trial,

c. You misrepresented within the parental information leaflet that the technique had been shown to be safe,

d. You failed to ensure that every parent had a copy of the parental information leaflet;

4. In your role as an administrator of the CNEP trial,

a. You used a scoring system that was not validated,

b. You failed to ensure that the scores were allocated correctly,

c. You failed to ensure that the scores were calculated correctly,

d. You failed to ensure that there was an appropriate method of scoring,

e. You thereby failed to produce valid results from the trial;

5. You co-authored a paper entitled “Continuous Negative Extrathoracic Pressure in Neonatal Respiratory Failure” published in Paediatrics on 6 December 1996 (“the Paediatrics Paper”),

a. The abstract states “The overall outcome score showed an overall significant benefit for CNEP”,

b. This statement should not have been made in view of the defects in the scoring system referred to in Head 4 above;

6. Your actions as outlined above were,

a. inappropriate,

b. inadequate,

c. not in the patients’ best interests,

d. likely to bring the medical profession into disrepute;

And that in relation to the facts alleged you have been guilty of serious professional misconduct.”

MS SULLIVAN: I can indicate that since last Thursday I have been able to take instructions in relation to the charge and can say that in the light of Professor Hutton’s evidence – you will recall that Professor Hutton is a medical statistician – on behalf of the complainants and the GMC we will not be pursuing the following heads of charge. The numbers are the same in relation to Drs Spencer and Southall and the heads of charge that are not being pursued are 3(b), 4, 10, 12(a), (c) and (e) and 13 in its entirety.

In relation to Dr Samuels the heads of charge that are no longer being pursued in relation to him are head 4(a), (c) and (e) and head 5 in its entirety. All my learned friends are aware of this because I was able to notify them of this shortly after midday on Friday.

In addition there are a couple of typographical errors to correct. You may have noticed in head 14 of the charge faced by Dr Spencer “caesarean” is incorrectly spelt and I proposed to amend that so that it is spelt correctly. There should in fact be an “s” on the reference to “Ethics Committee” and it should be “Ethics Committees” in head of charge 6 as it relates to Drs Spencer and Southall.

THE CHAIRMAN: The copy I have already has an “s” on. The other was the spelling of “caesarean” which should be “ean” rather than “ian”.

MS SULLIVAN: That is right. Those are obviously minor matters. The other matter, and I have notified Mr Forde of this, is that instead of referring to Patient A and these are the heads of charge relating to Dr Spencer from head 14 onwards, we are going to refer to her as Patient 6 because that accords with the numbering of patients who will be referred to in the course of the case. I think an amended charge will be available to you so that you do not have to go through this one and correct it at each stage in the heads of charge.

Finally, Ms O’Rourke has reminded me of one other matter, so I might as well deal with it now. The date in head 5 of the charge, faced again by Doctors Spencer and Southall, should be 10 January not 11 January. I cannot imagine there is any real objection to that, but I am sure my learned friends will say. That is the Council’s position.

THE CHAIRMAN: Thank you very much, Ms O’Sullivan. Mr Forde.

MR FORDE: It may be a forlorn hope, but it may be of assistance to those who sit at the back of the room to indicate what the impact of these changes is upon that which these doctors face. There is no objection to the amendments themselves, but it is clear from the Notice of Inquiry that I have that the General Medical Council are no longer pursuing an allegation that the original application to the ethics committee inaccurately described the number of patients that would required for the trial. That is as a result of Professor Hutton’s involvement. She was not prepared to support that allegation.

No longer pursued against my client is an allegation that:

“The design of the trial was such that it did not sufficiently minimise the possibility of bias.”

In addition to charge 10, the suggestion that because substantially more than one hundred patients would be required to participate in the trial, that was a change that should have been notified to the ethics committee and there was a failure to report the matter. That is no longer pursued.

In relation to the scoring system, which unfortunately it looks as if you will be asked to look at, in the light that you feel this matter can be fairly dealt with, in some instances eighteen years after the event, the allegation that the system was not validated is no longer pursued. The allegation that the scores were not calculated correctly is no longer pursued and, perhaps most importantly, the allegation that, by reason of those facts, we failed to produce valid results of the trial, as I understand it, is no longer pursued.

There is no issue before you now that the paper published in 1996 entitled “Continuous Negative Extrathoracic Pressure in Neonatal Respiratory Failure” was in any way, shape or form inaccurate or capable of being criticised. That has specifically been abandoned as a head of charge. You should be aware that Professor Hutton did not appear to support the allegations between paragraphs 6 and 9, but my understanding is that my learned friend will seek to rely upon other experts in that regard.

Those are the only comments I wish to make at this stage.

MISS O’ROURKE: As your Legal Assessor will undoubtedly advise you, the test that you have to apply in making amendments is whether, in making these amendments, any injustice would be caused to the practitioner. We cannot say that injustice will be caused by the dropping of the charges because clearly that would not be the case. Indeed it would be justice being done to the practitioner because the charges are dropped because there is no merit in their substance and no evidence to support them.

All I say on behalf of Dr Southall is that it is extremely regrettable that we have these charges dropped on what would have been Day 4 of the hearing, in a case where a complaint was first made to the General Medical Council in 1997 and it has been under consideration with the doctors since 2001. For a period of seven years Dr Southall has had aimed at him a number of charges which the GMC now admits it has no evidence to support. He has suffered injustice as a result of those charges remaining against him until now, not least in recent weeks because we have been putting our preparation towards preparing to meet charges that we now effectively have accepted are of no substance and no merit. Yes, sir, you should allow those amendments because to leave them on the Notice of Inquiry in circumstances where there is no evidence, would serve no purpose. The injustice is passed and it would be justice now to remove them.

MR FOSTER: I associate Dr Samuels with the expressions of regret and I do not object to them.

THE CHAIRMAN: Thank you very much, everybody. Legal Assessor?

THE LEGAL ASSESSOR: Sir, since this is the first time I have spoken, I take the opportunity to remind the Panel that what I give is advice to the Panel. The Panel is free to disagree with any of the advice which I give at any stage of this inquiry.

The Panel is dealing with the matter under the old rules. The relevant rule is 24(4):

“Where at any stage of the inquiry it appears to the Panel that a charge should be amended, the Panel may, after the hearing the parties and consulting the Legal Assessor, if they are satisfied that no injustice would be caused, make such amendments to the charges if they appear desirable.”

I simply comment that Miss O’Rourke gave you half the test. It is not a case of no injustice to the doctor, it is no injustice to the world at large.

Everyone must bear in mind that at this stage the Panel has seen no witness statements and no documents in relation to the case other than the charge sheet. In those circumstances, since Ms Sullivan represents both the GMC and has taken instructions, as she tells us, from the Henshalls, it may be that she is the best judge of injustice towards those parties and indeed to the world at large.

You have heard that, on behalf of the doctors, none consider that they would suffer any injustice. In those circumstances it is open to the Panel to make the amendments. It should not do so merely as a matter of form, but I suggest to the Panel that they should discuss the matter, albeit perhaps briefly. Thank you, sir.

THE CHAIRMAN: Thank you. There are one or two amendments which might be regarded as technical in the sense that they are changing an “A” to a “6” and some typographical ones, but the indication that the GMC would wish not to proceed with some of the charges in the way that has been described, is a matter of significance which the Panel would wish to discuss and so we will go into camera and do that, so if everybody but the Panel could retire, please.

MR FORDE: You mentioned paragraph 10, is that paragraph 10 in its entirety?

MS SULLIVAN: In its entirety. I am sorry if I did not make that clear.

STRANGERS WITHDREW, BY DIRECTION OF THE CHAIR

AND THE PANEL DELIBERATED IN CAMERA

STRANGERS HAVING BEEN READMITTED

D E T E R M I N A T I O N

THE CHAIRMAN: Ms Sullivan, the Panel has given consideration to your application to amend the charges. The Panel understands that you can make such amendments as appear necessary or desirable provided we are satisfied that no injustice would thereby be caused. We have accepted the Legal Assessor’s advice about the impact of injustice in the evidence of the practitioners, but it is apparent to us that the amendments which are requested would not cause injustice to the practitioners. Indeed, counsel for all three doctors have suggested that they would have the contrary effect.

So far as the wider interests of injustice are concerned, we have taken into account that you have made your own evaluation of Professor Hutton’s evidence, which appears to be the trigger for the application, and prior to making your application you have taken instructions from the General Medical Council and the complainants. That being the case, the Panel is happy that no injustice would be caused within the terms of the rules and therefore determined that the requested amendments should be made.

I think at this stage it would be appropriate, having reached that determination, that, for the record, I should indicate what those amendments are. As I do that, I shall also rely on the Panel secretary to jump in – and I also invite anyone else to correct me – if I omit anything. As I understand it copies of the charges, as amended, have been prepared and they will retain the same numbering so there will be some gaps in the numbering of the amended version. Dealing first with the allegations against Dr Spencer.

Charge 3(b) in its entirety will be withdrawn;

Charge 4 is withdrawn;

So far as 5 is concerned, that should be amended to read “10 January”;

So far as 6(a) is concerned, that should be amended so that it refers to:

“... the Ethics Committees (in the plural) of both Queen Charlottes and North Staffordshire Hospitals.”

Charge 10 has been withdrawn in its entirety;

Charge 12 allegations (a), (c) and (e) have been withdrawn;

Charge 13 has been withdrawn in its entirety;

Charge 14, the reference to “Patient A” should be replaced by a reference to “Patient 6” and the word “caesarean” should be amended so it is correctly spelt with an “e” rather than an “i”;

Charges 15 to 20 is concerned, ever every time there is a reference to “Patient A”, that will be replaced with a reference to “Patient 6”.

Moving on to the allegations against Dr Southall:

Allegation 3(b) is withdrawn;

Allegation 4 is withdrawn;

Allegation 5 is amended to read “10 January” rather than “11 January”;

Allegation 6(a) is amended so it refers to the Ethics Committees in the plural;

Allegation 10 is withdrawn by the GMC;

Allegation 12(a), (c) and (e) are withdrawn by the GMC; and

Allegation 13 in its entirety is withdrawn by the GMC.

Finally the allegations against Dr Samuels:

Allegation 4(a), (c) and (e) are withdrawn by the GMC;

Allegation 5 in its entirety is withdrawn by the GMC.

I think after an early error in my reading, that places correctly on the record the amendments which have been made.

MS SULLIVAN: That is right, sir.

THE CHAIRMAN: We are still in the process of the proceedings where we are dealing with rule 24 which permits any practitioner who has any objections to the charges on grounds of law to make such objection at this point. If I am right about that, perhaps I can invite any such objections.

MISS O’ROURKE: Before Mr Forde and Mr Foster on behalf of their clients make objections, as I indicated last Thursday when we started, I am not making any objections. I am rising to my feet therefore for two purposes. First, to explain why I am not, so that it does not cast any aspersions or anything else on any application about to be made and, secondly, to see whether my client might be excused from the inquiry for the next couple of days if you are to be considering those submissions in respect of objections to the charges. It seems that neither of us might be required, but I might choose to stay in order to hear what is said and ensure that no documentation is referred to which might later prejudice my client.

In respect of the applications about to be made, Dr Southall is not supporting them, not because he does not think there is any merit in them, but he believes, as it is going to be asserted in due course, that there has been inordinate and inexcusable delay on the part of the General Medical Council in bringing these matters to a hearing now in 2008 when they relate to events going back to 1989 and terminating in 1992 and 1993.

Dr Southall believes this delay cannot be explained and justified and most of it lies at the door of the GMC itself and, indeed, the complainants. But for his part, in order to make objections as a matter of law, he would be happy to assert that there is no prejudice to him that would not guarantee him a fair trial. He believes that with the allegations as now worded he can have a fair trial and can defeat the allegations one by one on their merits. That is what he wishes. He wishes to defeat it by my cross‑examination, on his behalf, of the witnesses who attempt to support these charges if we get there.

I highlight that because it may be, as far as we are concerned, we save our fire for the half‑time submission stage, if we get there, and if he goes into the witness box to defend these charges. That is why we do not join in the applications. That should not be taken in any way to say these applications are wrong, and that we do not support them, should members of the press choose to make any such point. We do not join in because he chooses to instruct me to cross‑examine the witnesses to show that these charges are hollow and baseless and that is what I would be doing.

Secondly, in the circumstances, I may choose on his behalf to stay and listen, but Dr Southall no longer lives in this area of the country. He is therefore having to find himself hotel accommodation. We anticipate that these objections are on grounds of law and will take most of today and tomorrow and then the Panel will need time for determination. We ask, in the circumstances, that he is able to leave, bearing in mind he is securing accommodation in the locality and that you would excuse his presence. He is not required at any stage in the inquiry, but it may seem to be discourteous to absent himself and be somewhere else.

In the circumstances we are now about to embark on a couple of days hearing of legal submissions, he would like to excuse himself with no disrespect meant to the Panel.

As to my position, I would like to be excused, if I choose to be excused. It may be I will stay today and part of tomorrow to hear what is said and what documentation is put before the Panel, but it is highly unlikely because I am not making any submissions and I have no right to say anything unless there is a document that goes in and it is a document you will have when we come to the next stage in the inquiry.

THE CHAIRMAN: Certainly, unless I see any indication from any of my colleagues, I do not think we will feel in any way offended or any disrespect by Dr Southall if he chooses, as he is entitled, not to be present during submissions in which you have indicated he is not actively participating.

Of course it is a matter for you whether you choose to stay or not in those circumstances. It may be that it might be sensible if we hear briefly from Mr Forde and Mr Foster before they embark on their submissions as to how long they are going to take to ensure that if Dr Southall is away from Manchester that he is back at a time when proceedings are likely to resume. Mr Forde, can you give us any help as to how long you are likely to be?

MR FORDE: I may well take the rest of the day. I am sorry if that seems daunting.

THE CHAIRMAN: There is no need to apologise.

MR FORDE: I am undertaking the burden of the scene setting so that Mr Foster does not have to duplicate that work, and I am hoping that you will then have available to you a fairly comprehensive transcript, which should ultimately lighten your load.

THE CHAIRMAN: That is a helpful indication. Mr Foster.

MR FOSTER: Sir, I shall be no more than an hour.

THE CHAIRMAN: I will look to my colleagues as to whether they feel anything different from what I am about to say, in which case we can consider the matter further, but it seems to me that, on that indication, it is safe to assume that with the submissions that you are both going to make and the consideration that the Panel will need to give to matters, it is unlikely in a realistic sense that we shall be resuming the hearing, in whatever form it then may take, until Thursday morning.

MR FORDE: Sir, there is something that you have not factored in. I am sure that Ms Sullivan will want to reply to our submissions and I can see that taking her either a morning or an afternoon session. We then have the ability to respond on points of law, and I am certainly more than happy at any stage for the Panel to require me to answer any questions on any point of clarification either directly or through the learned Legal Assessor. We have made available our skeleton arguments electronically because again we appreciate that it is far better for you to be able to factor into your determination some of the non-controversial aspects of that which we are going to say, so again we are hoping that that will speed up matters.

I have already commented to those of us on this side that the considerable burden that you will have is in determining these applications in far less time than the Court of Appeal took to determine the judicial review, and it will not be an easy task for either you or your learned Legal Assessor, but we will do the best we can to assist.

MISS O’ROURKE: Sir, can I just indicate that when we all discussed it among ourselves we were thinking in terms of the matter perhaps not resuming until sometime mid-Friday and therefore more likely Monday? As Mr Forde says, it is a question of him making submissions for the rest of the day, Mr Foster then makes his tomorrow morning, Ms Sullivan then replies, and I have had the advantage that you, of course, have not, of seeing that she refers to completely different case authorities from those that my learned friends refer to, so you will have different case authorities put to you. There will then be a question of both of them having a right to reply, Mr Forde says on matters of law, but certainly my experience of similar applications is that they have a much wider right to reply, should they choose take it, and your Legal Assessor can advise on that, but they are not restricted to points of law. Then, of course, your Legal Assessor has to give you advice and the Panel has to retire. Of course, you have to make two decisions and the decision will not necessarily stand the same for both practitioners, and of course you may have to make individual decisions in respect of certain heads of charges.

Sir, looking at it all together, I think we thought that you may be ready to resume at some stage on Friday, but more realistically it may be that if that were the case and we were only about to start again on Friday afternoon, it would be more sensible to say that we should start clean on Monday morning with the re-reading of whatever charges are left, so that the practitioners can make relevant admissions at that stage of time and Ms Sullivan can open her case.

Sir, it was on that basis that I made the application that Dr Southall effectively be told that he can go away from Manchester and probably not have to reappear until Monday. Of course, if matters moved a lot quicker than that, telephone communication is such that we could call him back from wherever he is to attend, but I think that is how we saw it going in terms of having the benefit of the skeleton ---

THE LEGAL ASSESSOR: Sir, I wonder if I may just interrupt. Are you actually asking that the Panel, if it finishes early, should adjourn until Professor Southall comes back, or are you just saying that that is your best plan, that he will keep in telephone contact and come back?

MISS O’ROURKE: He will keep in telephone contact, but if say you finished and delivered your decision on these matters on Friday morning, that you were going to hand down your ruling, it would seem that no real time would then be lost by bringing him back for 12 noon on Friday to have Ms Sullivan at that stage start to open her case, that it would in all the circumstances be better to leave it until Monday morning. Apart from anything else, when you hand down your determination, I would guess that both Mr Forde and Mr Foster may wish to have time to absorb and consider it, and indeed possibly their next move, but that is obviously for them to say.

If, of course, you thought that you were going to reach your determination by midday on Thursday, I would not be asking for you to adjourn it and we should get on with it; but, looking at it realistically, if Mr Forde is going to take the rest of today, Mr Foster will be a little while tomorrow morning and Ms Sullivan will have to reply, on the timetable and having read the skeleton arguments that I have, I cannot see how the Panel will retire to consider its position until sometime on Thursday, and therefore it would seem very unlikely that you will hand down a determination, which you will have to put in writing and with reasons, before sometime on Friday, and if that is the case, it would seem in the circumstances that to start at 2 o’clock on Friday would gain very little, bearing in mind the weekend. However, if that is the case and Dr Southall is asked to come back for Friday lunchtime, so be it, but I am simply saying that if it reaches that stage it would seem more sensible to say that we will have a clean start on Monday morning and take it all in one go.

THE CHAIRMAN: Thank you, Miss O’Rourke, for stopping me running away with myself in making what might be a somewhat hasty calculation of where we may be. Ms Sullivan, I should have asked whether you have anything to add and now stop me running away with myself.

MS SULLIVAN: Sir, obviously it is impossible to predict how long you will take, but given that Dr Southall can stay in contact with Miss O’Rourke and his instructing solicitors, if he is needed to come back, I am sure that he can come back. Otherwise, sir, I cannot see a problem.

THE CHAIRMAN: Thank you very much. I suspect that as you have all had an opportunity of considering the situation among yourselves, you are at the moment in a better position than we to assess how long this is likely to take. Unless I receive any contrary indication from any of my colleagues, it seems that the sensible thing to do is to go along with the assessment that is made, which would tend to suggest that we are not going to move to the next stage, whatever that may be and in whatever form it may be, until the beginning of next week, but if anything changes radically, as Dr Southall has indicated, he would be available. Are all Panel members happy with that? (Non-verbal assent)

In that case, Dr Southall, with no feeling of offence on the part of the Panel, please feel free to absent yourself if you wish. Of course, you do not have to, but if you wish to, you can, with a view to coming back here on Monday morning.

THE LEGAL ASSESSOR: Sir, just before the doctor leaves, I wonder whether I might interrupt. Ms Sullivan, I have just been looking through the finalised charge sheet that has been handed to me. Looking at paragraph 3a – and this is of some importance because I think it has probably been handed to the press as well – as it concerns both Dr Spencer and Dr Southall ---

MS SULLIVAN: Yes, something has gone wrong.

THE LEGAL ASSESSOR: Something has crept in. There is a patient number there. The original read, “the procedures that would be applied to each patient and/or” and a number 6 has crept in there.

MS SULLIVAN: It has. I think that it should read, “The application inaccurately described the procedures that would be applied to each patient”, because, of course, we do not need the “and/or” any more.

THE LEGAL ASSESSOR: So it should end with “each patient”?

MS SULLIVAN: Yes. Thank you.

THE CHAIRMAN: In the absence of any objection or contrary indication from anyone, the charge at 3a in relation to Drs Spencer and Dr Southall will be amended so that it reads, “the procedures that would be applied to each patient”.

(Dr Southall withdrew)

THE CHAIRMAN: Mr Forde, unless there is any pressing reason not to do so, we will continue now until 1 o’clock or some convenient point at about that time to break for lunch.

MR FORDE: Sir, first of all, can I ask that a copy of my skeleton argument be distributed to you? (Same handed) As we have three doctors whose surnames all begin with S, it is a bit of a challenge to decide whether they should be D1 and following or prefixed with the letter ‘S’. My client, as you will see from the notes, is denoted as SAS. I do not know whether you want to give his exhibits that lettering.

THE CHAIRMAN: Ms Khan’s view is that so far as the submission of exhibits on behalf of the practitioners is concerned, it would be easier just to give them running D numbers. This will therefore be D1, and it should not be too difficult thereafter to identify the document as necessary and its source, so we will call your skeleton argument D1.

MR FORDE: Thank you. In that respect then, it seems sensible to Mr Foster and I that you also have a copy of his skeleton argument, which will be D2, because we agree on certain matters and I will be adopting certain points that he has made, and vice versa. (Same handed)

Sir, I have supplied and paginated a 75-page bundle, which I do not need to refer to for a little while. I do not know whether that has been copied for you.

THE CHAIRMAN: No.

MR FORDE: Then perhaps we can have copies made of that bundle. If I can just explain what the bundle comprises, it is really all the interaction between Dr Spencer and officers of the General Medical Council since about the year 2000 or 2001, as well as the document that appears to us – and we do not know whether there is any earlier document – to indicate that the Henshalls first contacted the General Medical Council in April 1997. My original bundle went up to 2004. I have now found the documents that take us right up to date in 2006, so we will paginate those consecutively. Mr Foster has a section in his skeleton argument about legitimate expectation, and we have available for you as well, but I will probably ask that it be distributed a little later, another bundle that comprises various representations made by officers of the General Medical Council, including the Chief Executive, expressing regret that the matter has taken so long and placing the blame very fairly and squarely on the shoulders of the General Medical Council.

Sir, if I can deal with the skeleton, the Notice of Inquiry that we received in its final form was on 8 April 2008, lamentably close, in my submission, to the proposed date of the hearing of 8 May 2008. We still find ourselves being supplied with material not denoted as used or unused as recently as the end of last week, which has made preparation for this case a little difficult, but you will see from the second paragraph of my skeleton that you are being asked to deal with events that took place between nearly 18 and a half and 15 and a half years ago, and that causes obvious difficulties for the doctor.

Perhaps the best example that I can give, whilst you have the Notice of Inquiry in front of you, relates to your new charge 16, which, as you can see from the stem, requires my client to justify clinical care between three minutes past midnight and 12.30 in the afternoon of 15 December 1992. All I can tell you about his involvement on that date is that it was a Tuesday and that my client was probably asleep for more than half the period of time, but there are obviously very real difficulties in reconstructing his movements on that date – hospital rotas, the timing of clinics and matters of that sort. That is just a stark example of the sort of difficulty that we face.

I have described the delay in dealing with this matter as unconscionable and I stand by that submission. None of it is the responsibility of this doctor. Neither have we ever had, as I will be submitting the law requires, a sensible explanation for the considerable delay. It is possible to discern reasons as a result of the slow progress of the administration of this case, but we have never had a constructive and still await a constructive explanation of the delay.

We have the advantage over you in having read the witness statements, but I do not think it is contentious that recollections have faded dramatically. Some of the witness statements with which we have been served seem to have been signed this January and ask patients to recall events in the late 80s and early 90s, and their recollections have faded. In our submission, it is well known within medicine that it is often very difficult to get patients to recall matters such as informed consent even a very few years after the event. So there is a very real issue in this case as to whether or not there can be a fair trial of the issues in relation to fading recollections.

This is probably as old a case as any panel has had to deal with. It is interesting to note that obviously your rules changed in 2004; many of you will have been trained, I suspect, in relation to those rules; some of you may even during the process of consultation in relation to the standard of proof have been trained in relation to the sliding scale, and you will have to remove from your consideration the new regime.

Documentation may well have been lost, including likely contemporaneous correspondence between relevant medical staff and investigators. My client believes that there may have been some documentation emanating from him dealing with matters such as scoring with the other doctors. We are aware, thanks to the assistance of Miss O’Rourke, that it appears that there were meetings, which were minuted, and that the minutes have gone missing. The GMC apparently propose to call in relation to the 1989 application (your charge 2 so far as my client is concerned) and its approval (charge 5) a witness who purports to tell us that she is quite satisfied that nothing is missing as a result of matters being archived for an inquiry that took place in 2000, but she did start working at the hospital until 1994, five years after the events in question.

We also lack any contemporaneous documentation in relation to any changes to trial protocols. Again my client is struggling to recall whether in fact he spoke to the chairman of the local Ethics Committee, either in passing in corridors or more formally, in 1989 or 1990, but believes that there may be in or have been in existence minutes that have now been lost. He also believes that he commented on drafts of the medical paper, but that is not an allegation that is now being pursued, so I can move swiftly on from that

There are concerns about scans, particularly ultrasound scans; they form the latter part of the charges.

We have not seen the originals of those scans. We have seen reports of the scans which are quoted in the charges but I have absolutely no way of demonstrating on this doctor’s behalf whether or not those reports found their way into the notes on any date when he was responsible for the clinical care of Patient 6 or not. He may have had other clinical duties. That information may have been gained by radiology departments, junior doctors and appropriately delegated, so we are struggling in relation to the charges that you have set out at paragraphs 18 and 19 in particular.

Witnesses will have to attempt not only to reconstruct events, and this is a very real concern on our part, but to recall, as I have set out, the subtleties, nuances and prevailing medical culture at the time of the matters the subject of these proceedings. That is a concern because after acquired knowledge and current standards are likely to taint the views, both of experts and witnesses.

A lot of people are going to be extremely defensive and a number of practitioners that the General Medical Council is going to call about their role back in 1989/1990. You will see from the document that is being copied at the moment that there are a number of doctors against whom the Henshalls initially made complaints – eight or nine in all – and some of them will feature as General Medical Council witnesses, perhaps surprisingly. We are going to have to suggest to some of them that these clinical responsibilities may well have been theirs because that is what the notes appear to indicate. It will be difficult for them in the knowledge that they were once the subject of criticism and in the knowledge that standards may be very different now not to allow that to colour their evidence.

These matters have already been in terms of the central facts twice investigated. There was an inquiry which we do not regard as being a well thought out inquiry by Griffiths in 2000 and Professor Hull, commissioned by the North Staffordshire Health Authority also provided a report which certainly in relation to consent suggested that something in excess of 90 per cent of the patients recalled being adequately consented. The General Medical Council’s proposal, as I understand it, is only to call those patients who do not have a good recollection of the consenting process or who say adamantly that they were not able to give informed consent.

I deal with the outline facts in paragraph 2 and they are important because of both the timescale and what I say about the prevailing culture. I deal with my client’s acceptance he was a consultant paediatrician at the Neonatal Unit of the North Staffordshire Hospital. He qualified in 1976 and he had been a consultant since 1985, so these events took place three or four years after he became a consultant.

He came to this trial in the sense that it is believed the randomised study of what we will all become familiar with as “CNEP” commenced in 1984 and it would appear that in 1989 Dr Southall sought to recruit other centres to the trial and two centres expressed a particular interest – Queen Charlottes Hospital, whose investigators were Drs Modi and Harvey, and I say in passing they were the subject of allegations made by the Henshalls and represented by the Medical Protection Society but no longer pursued, and Drs Brookfield and Spencer were the responsible investigators at North Staffordshire and the relevant nurses were Wright and Lockyer, who were specifically trained to deal with CNEP. It is also important to recognise at this time the neonatal departments were staffed by highly skilled, highly qualified nursing staff. They are an entirely different calibre, in my submission, to those that operate within other areas of the hospital and they are usually assiduous in their duties as we shall see from the nursing care plan in due course.

We applied, on 29 November 1989, to our Local Research Ethics Committee. The whole process at this time, it seems to be accepted by all, was a fairly fledgling one in terms of medical ethics. Standards were extremely variable between district health authorities. Again, it will be difficult for us to reconstruct the prevailing culture at the time. The General Medical Council experts attempted to do so through various papers but it is quite clear that standards were extremely variable and there is a very real concern on this side of the room that we may be judged not by 1989/1990 standards, but by the standards of 2008.

I then set out further matters of history on that page but it is important for you to be aware of the fact that the Staffordshire Hospital recruited infants between April 1990 and October 1993 and there is complaint about the fact that they continued the trial for longer than some other centres. The aim of the study was to determine the benefit or otherwise of CNEP in babies with respiratory failure in an attempt to determine whether CNEP reduced 10 markers of disease in the newborn infant. Those were markers that Dr Southall had determined.

Again, of importance when one is dealing with issues of informed consent and recollection is the fact that the entry criteria required suitable infants who had developed a need for oxygen within four hours of birth. Again, the subtleties and nuances of the late 1980s, early 1990s, are unlikely to be capable of being demonstrated. There was identifiably a more paternalistic approach to neonatology than there is now, a real concern not to worry patients. We now know with various patient groups and agitation that the whole process of informed consent has changed dramatically in the last four or five years, but at this stage the intention of these doctors at all material times was to try and benefit these children.

I emphasise the fact that many of them were extremely ill and extremely premature and it is not suggested by the General Medical Council through these charges that any active harm was caused to anybody within North Staffordshire. There is a concern about one child with neck trauma and how that was dealt with but it is certainly our case that that was not an adverse event. Remarkably, despite the reporting, this case, as I indicated, is not about, as the Henshalls have been at pains to establish as you will see through the documentation, the death of their daughter in 1992 and the unfortunate brain damage sustained by Patient 6. That is the case that the Henshalls are anxious to bring before you. It is not the case that is pursued by the General Medical Council.

I have indicated that the explanation of the practicalities is to be found in the Parents’ Information Leaflet and there is an issue as to whether that was handed to each and every patient. Again, the burden that the GMC seek to place upon Dr Spencer is onerous and unrealistic. In charge 11(d) it is said that this doctor should have ensured that every parent had a copy of the parental information leaflet. That was a task sensibly delegated to junior doctors and trained nurses and in certain of the notes we have a note that the Parents’ Information Leaflet was given and a tick, but it cannot be the case, in my submission, that a consultant in this position with more duties than CNEP had a duty to ensure that every single parent had received the relevant form, particularly as you will be aware that children are born at all hours. Many of these children were born in the early hours of the morning when my client was not on duty and they had to be in the trial within four hours of birth. That is another example, in my submission, of the difficulties of this case.

I have set out what was said in lay terms – I hope it is useful – about CNEP. Some of you will be aware that the conventional way of ventilating children with respiratory difficulties was to do so through intermittent positive pressure. That of itself can damage the lungs because the oxygen is forced into the lungs under pressure. The theory behind CNEP was that if you placed a chamber rather like an iron lung, and you will see photographs of the baby’s head just poking through and it being in a chamber, and created a situation of negative pressure, that that might assist the respiration of the child and reduce the length of time the child was in respiratory distress. That was the theory. You will see in due course photographs. There is hardly anything one can imagine more dramatic than seeing a child who is encased in the chamber and it makes it all the more remarkable that some of the parents are likely to say we understand that they did not know that their infants had been entered into a trial, but visually it would have been of tremendous impact.

The approval was given on 11 January 1990 and on 22 March the Medical Research Council gave the study an alpha rating, one of the highest possible. Far from being a poorly-conducted trial, or one that was administratively deficient, it was seen by those dealing with it at the time as a first-class trial. That is something which should weigh heavily with you in the exercise of your discretion. You see Patient 6’s mother referred to. She was known by a different name at the time, then aged 28, an experienced mother who had had 11 previous pregnancies and had delivered seven children between 28 and 40 weeks gestation and had a previous child in CNEP who unfortunately died at the age of 10 months due to extreme prematurity, possibly associated with intrauterine infection, not a product of CNEP, although it would appear as recently as last Friday I have seen a newspaper report where the Henshalls hold to the view that there is a causative relationship between the use of CNEP and the unfortunate demise of one child and the brain damaging events suffered by another.

We know from witness statements and the lengthy letters that have been written on my client’s behalf that a Dr Clare Newell, then an SHO, entered Patient 6 into the trial. Appropriate consent was taken by her and she has provided a witness statement to that effect. She was concerned about respiratory distress syndrome and the child was in CNEP for 112 hours and then went into air, discharged home aged 24 days on 7 January 1993.

I have made an error. I said that the previous child died after 10 months. It was 10 months before and she died after a couple of days and I apologise for that.

What was happening in the background after 7 January 1993? At 22 months, according to my researches, so nearly at the age of two, Patient 6 was found to have quadriplegia but her mother had been expressing concern about her development from late 1993 and clearly relating her late development to CNEP. The family pursued medico-legal proceedings as far as they could and as far as we are aware sought the advice of many eminent doctors, none of whom were prepared to support the contention which they have always held to that there was a causative relationship between Patient 6’s brain injury and CNEP. We are not sure when they first consulted solicitors but we have seen a report dated November 1995 which is not supportive of any allegation of negligence.

Matters did not rest there. The family appear to have, in conjunction with other parents, sought still to pursue the matter. There were meetings that took place between them and Dr Spencer which I shall come to in a moment. Perhaps of importance dealing with the issue of delay, given my learned friend’s view of whom she represents, is the fact that as we know by late 1995 a report had been commissioned, it is suggested by myself, I think supported by Mr Foster in his skeleton in paragraph 3.2, that they were questioning the use of CNEP in late 1994, early 1995, 13 years ago. The General Medical Council were aware of complaints against a multiplicity of doctors from 1997, 11 years ago.

The General Medical Council for the purposes of this application are saddled with the Henshalls’ delay. It has nothing to do with the doctor. We were busy cooperating and when they attended outpatients, which they did not always do, we consulted with them. North Staffordshire made themselves available in various guises but for some reason they did nothing between 1995 and 1997, it would appear, so that is two years’ delay, which is regrettable.

In March 1997 they attended a meeting with Dr Spencer and others to discuss their concerns regarding CNEP. The documents are not yet available so I will take you back to them in due course. The minutes of that meeting indicates that they were pursuing medic-legal proceedings. In February 1999 a review of research procedures was set up by the Department of Health, now known as the Griffiths Report, and it reported in May 2000. We say it was demonstrably flawed, but putting that to one side much of it really was to try and set up a watershed in relation to research across the board because there had been no real bringing together of the practice of practitioners. That is some 10 to 11 years after the initial application.

As far as we can discern, part of the reason why the GMC did nothing between 1997 and 2000 is because they were waiting to see what was happening with the Griffiths’ report, and certainly recent case law suggests that that is not a justifiable excuse. They should have progressed their own enquiries during that three year period. Henshalls we say two years, GMC another three years, we are up to five years now of unconscionable delay by 1997, and of course we are now 11 years on almost to the day since they were seized of the matter in 1997.

I wonder if those bundles could be distributed now, please?

THE CHAIRMAN: We will call these D1(A), Mr Forde. (Documents handed)

MR FORDE: That should be numbered 1-75 and we have now copied 76-88 which takes us up to date. I had not appreciated – I do not know whether there is any objection being raised – that my highlighting seems to have come out on your initial photocopy. Please ignore it. You will obviously reach your own decision. It has not come out on the supplementary bundle. My understanding was that the highlighter I used did not photocopy.

MS SULLIVAN: Sir, I am sure you will come to your own conclusions. It is not highlighted throughout.

THE CHAIRMAN: On a very quick flick through it seems to be two particular documents. We are obviously going to be looking at it for some time and if you want to replace these at any stage with a clean copy ---

MR FORDE: Let’s see what we can do. The very first page is the meeting that I refer to as a footnote on page 5 of my skeleton, the meeting of 18 March 1997.

THE CHAIRMAN: We will call the second bundle D1(B). (Documents handed)

MR FORDE: The next document at this stage you will see is there to establish the Henshalls’ concerns going back to March 1997 and the nature of their concerns which change unfortunately throughout this matter, but then the third page which I have denoted as 2A is the first letter you find to the General Medical Council dated 27 April 1997.

THE CHAIRMAN: Which page are you on now?

MR FORDE: It should be 2A at the top, but it is the third document in, a 2A and a 2B. You can see the matters of complaint, most of which are no longer pursued. The pejorative term which finds its way into the press reporting is that this was experimental. None of the parents were informed verbally or written that this treatment was not a proven method for controlling Respiratory Distress Syndrome; again that is dispute.

The suggestion that researchers have lied to ethics committees, the Chairman of the LYRIC, Mr Hughes, is then quoted. If you go over the page, they are making it clear that there is a serious breach of the protocol by researchers and doctors and “would like to make formal complaint”.

Reassurance that the matters will be properly investigated:

“The persons in breach will be formally and publicly for what they have done.”

Interestingly, they see a joint responsibility between researchers and the ethics committee, something which we will certainly be advancing should this matter progress. It goes on to say that they would like a public inquiry, and in the penultimate paragraph:

“...investigate the hospitals conduct and are certain that you too will find several areas of misconduct resulting in loss of life or severe brain damage for many of those babies that survived.”

This is all about causation at this stage.

THE CHAIRMAN: So I do not forget this in the future, this will was sent to whom?

MR FORDE: To the General Medical Council. You can discern that from the second page of the letter. The first full paragraph:

“We feel there has been a serious breach of the protocol...and would like to make this a formal complaint to yourselves the General Medical Council.”

Not a lot seems to have happened with that complaint, again possibly because the General Medical Council were waiting for the May report and from Griffiths. What then appears to have occurred, and we have not burdened you with the affidavit, although if you wish to see it you can, is that on 1 November, the Hens halls both swore lengthy affidavits detailing their concerns in relation to events that are between nine and eleven years old. Quite why it took the General Medical Council four months to get us a copy of that affidavit, I do not know and we have had no explanation; this, in an old case which needed to be got on with.

We gave a detailed response on 16 May 2001, which you will find top right number 3, right the way through to number 7. It was drafted with alacrity within six weeks detailing the allegations, setting out on its second page how the CNEP trial works – that is the third full paragraph – how the consent form was dealt with, accepting at the bottom of that page that Dr Spencer did not take part in either obtaining consents or allocating babies to one or other method of treatment, which we say was the clinical norm at the time.

An awareness then of the problem with the nexials dealt with in the second full paragraph, which forms the subject of a charge, said by the standards of the day and disputed by us, to have been a sufficiently adverse event to have been reported. The General Medical Council know that they are in possession of a report from Professor Hutton that does not support that view. The problem never occurred in North Staffordshire and so query whether a problem occurring in another trial centre needs to be reported to the trial centre that Dr Spencer was operating in. Tremendous care was taken was the neck seal, as is indicated in the letter.

You are not currently being asked to deal with the patient named on the fifth page, although you will discern that that was initially an allegation made against us, dismissed ultimately for the reason that that patient was under the care of a Dr Brookfield, from whom you may be hearing and against whom serious allegations were made.

Patient 6’s progress is then set out. At various times Mr and Mrs Henshall have alleged that the clear signature in relation to the consent form was a forgery, or alternatively that she was too distressed or under the influence of anaesthesia, having had a caesarean section, to give valid consent; not an allegation currently proceeded with by the General Medical Council, but something which may have informed the decision of subsequent preliminary proceedings committees, a very serious allegation indeed.

We then have the suggestion that CNEP compromised the care in relation to the blood gases, but that does not seem to include the situation which existed, that the umbilical artery catheter was doing that constantly. There is then an allegation in relation to the ultrasounds, again possibly with the benefit of hindsight. There is a suggestion of conversation between my client and the Hens halls in the documentation which I will take you to, but he simply cannot remember the precise terms in which he discussed the scan or scans with Mrs Henshall on 22 December 1992 or 29 December 1992. There is then some scurrilous allegations made which we deal with in the conclusion where, effectively, as has long been the case, my doctor is accused of lying.

On 12 December, the Henshalls having raised another thirty new points on 13 July which we did not comment upon, we were told that the matter would be considered by the Preliminary Proceedings Committee, which you will see at page 8 under the old rule 4. On 28 January 2002, we were told, in terms, that the matter could not be going any further. You will see in the third paragraph:

“The Committee carefully considered the allegations against you and concluded that the allegations did not raise an issue of serious professional misconduct. Accordingly the Committee decided not to take any action in relation to this complaint. In reaching that decision the Committee took account of the following...”

No real prospect of allegations being proved; substantial efforts to show the programme should be carried out and parents dealt with; a team of professionals; the protocol was peer reviewed; the fact that the research programme was not completed indicates that those involved had been properly prepared and properly managed – a very sensible approach, which I commend to this Panel. In relation to the taking of consent, it was needed soon after birth. The practice between 1993 and 1995, and we are dealing with practice between 1992 and 1993, 7 January, when the practice on consent was less rigorous than it is today. It noted that statements and affidavits of those patients who alleged that informed consent was never given, most concede that some consent was given but they are not in a position to assess it properly.

“The Committee noted the emotional stress they were under at the time of giving consent. In view of this, it did not consider that there was a real prospect of these allegations being proved to the required standard. It also considered that there was a wider issue involved about the taking of informed consent for the treatment of very young children.”

They then raise some concerns about the information provided. They go on to say, importantly, in 2002, so some six and a half years ago, and I have quoted it in my skeleton argument at page 7:

“That the concerns were with the benefit of hindsight and in the light of how informed consent may be obtained today... but in summary the Committee felt that those criticisms which could be sustained in relation to those issues were sufficient to reach the threshold of serious professional misconduct required for a reference to the Professional Conduct Committee.”

Dr Spencer, Dr Samuels, Dr Southall all written to in similar terms, along with Palmer, Raine, Modi and Harvey et al.

From Dr Spencer’s perspective, back to work with a sigh of relief, but no. On 2 May 2002, the General Medical Council write and say, “We are going to re‑open this case because we have forgotten to consider 1600 pages of documentation”. Again, nothing that can be said to have been influenced by doctor’s actions. We took the view, and still maintain the view, that those documents added absolutely nothing to the serious allegations that the Henshalls were making.

As I have said, four lever arch files were received which did not advance the original allegations follows by another detailed submission dated December 2002 which it took the General Medical Council about five months to supply; no explanation for that.

It is right to say that there was considerable toing and froing then as to whether or not the General Medical Council had jurisdiction to re‑open the case. A lot of jousting in correspondence, with the General Medical Council taking leading counsel’s advice, but the letter of December 2002 should not have been written if they were not sure of their legal ground. It cannot be seen as any fault on the part of the doctor to indicate considerable unhappiness in relation to that matter.

It took the GMC until January 2003, which is document 16 in the bundle, eight months after they said they were going to re‑open matters, to actually do so. We supplied a response on 24 March 2003, which you have at page 19.

Again you will see that the sibling, page 20, was involved, but no longer pursued now. You find that the other issues that you should be concerned with started at page 23, internal page 5 of that letter. We still have the forgery allegation. That was ultimately to be placed very fairly and squarely at the door of a Dr Kate Palmer, whose involvement in this case ended at the time of the judicial review proceedings, to which I shall turn to in a moment, and whose case – and we will supply you with this document – was dismissed in very similar terms to that which this doctor’s case was dismissed, never revisited despite the seriousness of the forgery allegations.

We invite comparison. We rely on the Newell report, which was 1995, and then there is a suggestion, no longer pursued, on page 24 that there was a delay, in appropriate treatment for the benefit of research, a failure to give surfactant at the relevant time, that is no longer pursued. The thoroughly scurrilous allegation was being maintained that these doctors were involved in procuring caesarean sections against the interest of the foetus in order to provide the requisite number of babies for the trial. No longer pursued, but something which had been hanging over these doctors’ heads for many, many years.

You will see from the top of page 24 that there have even been criminal investigations, as in fact there should be because if any of those children were subjected to caesarean section against their medical interests and subsequently died, there would be very serious charges faced by these doctors; nothing came of that at all.

Then they there are concerns about the monitoring of Mrs Henshall, not pursued. The problem that we have on page 25 regarding the scan, Dr Newell is quoted at the top of the next page:

“Patient 6’s respiratory distress syndrome was satisfactory. He makes no adverse comment on the use of oxygen saturation monitors...”

now pursued:

“...nor does he suggest that arterial blood gas analysis was given too late. He says it was not neglect to fail to do a scan prior to 8 days.”

which was an allegation being made against us:

“Standard of care and note keeping was commendable...no evidence of negligence or care of a poor standard.”

It would appear that the brain damaging event occurred in his view before birth. That, we believe, is the view of all the experts who have been instructed, but it has not deterred the Henshalls from making a causal connection.

The concern we have about the ultrasound scans is reflected under (iv). It is the last paragraph:

“There is no record about Mr and Mrs Henshall being told about the scan results. However it was usual practice to share scan results with parents. In this case Mr and Mrs Henshall would have been told the scan results were encouraging which Dr Newell confirms was appropriate.”

Again I have indicated the difficulties of us locating either that somebody would divulge that information or, more importantly, Dr Spencer recalling, after this length of time, the precise nature of the conversation, which we can demonstrate from other documentation, must have taken place. There is a delay in diagnosis, no longer pursued; exclusion of Patient 6 from the trial because of gestational diabetes, no longer pursued; false claims in relation to the value and safety of CNEP, not pursued in relation to the paper but pursued, it would appear, in relation to the informed consent allegations.

Then you will see under the section headed paragraph 51/35:

“Dr Spencer is accused of ‘lying to us about the nature of the trial and the trial result and about the status of [Patient 6’s] neurological damage’.”

Again it is a constant theme:

“Mr and Mrs Henshall do not specify these alleged lies (ie what Dr Spencer has said and when).”

The next page, page 27, deals with the clinical care aspect. We highlight the fact that the Henshalls tried and failed to make out a case of negligence in Patient 6’s clinical management:

“Since serious professional misconduct means a falling short of the expected standard of care to a serious degree, it follows a fortiori that a disciplinary case against Dr Spencer cannot be made out.”

That comment holds as good today as it did then.

A little more on the CNEP trial and a concern on the last page about the Griffiths report which we do not need to go into because, ultimately, the Court of Appeal were to criticise the DPC for weighing the competing claims of the Hey and Chalmers article against the Griffiths report.

You then have, and we think this must have been about April or so, further allegations from page 29 onwards, made by the Henshalls. Just to give you a flavour of that which this doctor has faced, if you turn to page 36, with a slight change of position it is not that, “I do not recognise my signature, it has been forged”, it is now, “I did not sign it knowingly”, and then, “I would never knowingly have risked my children’s lives for an experiment. I was duped. If I sign the form and the one produced does indeed bear my signature, all I can say is that it means nothing, it does not mean I knew what I was signing for, or that I had made an informed choice”. Of course you recall the first document you have, the complaints that were being made, including number 4. Monitoring of a child while undergoing CNEP was not the same as a previous child of theirs had. These are reasonably well‑informed parents.

There is a suggestion of conspiracy upon conspiracy that Professor Hull has been Dr Spencer’s mentor and he was asked to look into the Beverly Allitt case, they have co‑written papers; allegation of forgery specifically made against somebody. On page 38, a fairly detailed information being given about the placing of umbilical arterial catheters.

We are accused on page 39 at letter 6 of again lying and problems with the temperature of children and so on and so forth. At page 41, the large paragraph at the bottom of the page, we are said to have adopted estate agents’ language.

What we are really here for, in my submission, appears at the end of page 42:

“We trusted twice and it cost us the life of one much wanted and loved little girl and robbed the other of a fair chance of fulfilling a happy and normal life unnecessarily.”

That is what has motivated this complaint.

On page 43, up to page 46, we dealt with matters after the matter was reopened. We believe that that should be 28 January 2004 rather than 2003. We have a number of allegations set out, a lengthy document that deals with that which is to be considered by the Preliminary Proceedings Committee. Again I am not going to burden you with going through all of it, but it bears little or no relation to the charges that the doctor now faces.

On 19 February 2004 we sent another lengthy letter to the General Medical Council, dealing with the allegations as they then stood, and that would appear to have satisfied the General Medical Council to the extent that we received – and this is the document that you will have starting at page 67 – a very lengthy letter from the General Medical Council, considering now, in March 2004, the documentation that the General Medical Council had somehow managed to overlook when they considered the matter in 2003.

This is paragraph 3.15:

“On 27^th February 2004 the decision of the PPC not to refer the matter was communicated by a very brief letter…” –

which I have not included in my bundle but I know that Mr Foster has in his –

“… On 12^th March 2004, nearly 14½ years after the application for approval, 14 years after MRC alpha rating and more than 11 years after the birth of [Patient 6] the detailed reasons concluded as follows…”

This detailed document was then produced by the General Medical Council, going through all the documentation that had been supplied, and, as was later to be suggested by the Court of Appeal, the weighing of the competing claims was said to have been an inappropriate exercise. On page 70, the rationale that was given, in my submission, holds good, and I have quoted it in paragraph 3.15 of my skeleton argument:

“The Committee carefully considered the information before it. It also took account of the amount of time which had elapsed since the events in question and was conscious that the human memory could be unreliable in stressful situations. The Committee considered the majority of the allegations were unsupported by any evidence before it and had no real prospect of being proved to the required standard. Moreover, the Committee was of the opinion that where there was, or might be in the future, some evidence in support of the allegations, they would not reach the threshold for serious professional misconduct even if proved. Therefore, the Committee determined that the matter should not be referred for public inquiry before the Professional Conduct Committee and it directed that no further action should be taken in relation to these complaints against you.”

What then happened was that the Henshalls applied for judicial review in 2004 and that was refused by the judge at first instance on 15 December 2004, so that is nine months after we had been told for the second time that this was an end of the matter.

The appeal was the directed to the Court of Appeal. That appeal took place on 27 and 28 June 2005. Of the ten matters of complaint put before the court, only three topics are now pursued, and we can identify those if you need to; I do not think there can be any dispute about that. Lord Justice Auld dissented; Lord Justice Sedley gave the leading judgment. The two substantive grounds on which the matter was referred, neither of which dealt with my client’s handling of the matters, were that Dr Southall had withheld his comments on the Henshall allegations, that he had been subjected to some concerning behaviour in the past, I think including a burglary, and was concerned about confidentiality going to the press, and the court was not happy about that and was not happy about the competing claims of the Hey Chalmers report against the Griffiths report. It took the Court of Appeal until 13 December 2005 for the judgment to be handed down, and one possibly discerns problems in deciding how the case should be determined, but again that is not something that is the doctor’s fault.

What then happened was that the Henshalls put in some more observations in September 2006 and the matters were then reconsidered for the third time on 2 November 2006, and that is the point at which we need to take up D1-B. Just to assist you, basically what happened – that first letter should be 28 January 2004 – was that the same potential charges were just sent out again in 2006 and then the Panel invited our comments on 13 October 2006 and we referred them to our previous letters, which you have seen, and then on 2 November 2006 we got the disappointing, but perhaps not entirely surprising, observations from the PPC, indicating that the matter should be referred to you. They were conscious, looking at our page 85, the third full paragraph, of the fact that the events were alleged to have happened 14 to 16 years ago and conscious that it should consider the allegations according to the standards of the time.

Quite how the PPC were able to do that certainly remains a mystery to us. They fall into the very trap, it would appear, that the Court of Appeal were disapproving of in comparing the Raine thesis against the Lancet article, because they are not judges of the evidence. They described the consent form as misleading or disingenuous, which is not something that we accept, rather skate over the fact that the Ethics Committee passed the application, said that it was not made sufficiently clear that premature babies were the primary subject of the study, which frankly is astonishing, given that the supporting documentation made it clear that the babies had to be within four hours of birth. If that is not premature, I ask rhetorically, what is?

They go on to decide on which charges, by reference to the first document that you have, should go forth and which should not. Apparently Mrs Henshall was able to indicate that only one day’s training took place. There was a conflict of evidence that they could not seek to resolve in relation to training. The ultrasound scan was in there, could not be resolved, gestational diabetes they decided should not be referred. Neck trauma: clear that there was a nexial problem with the apparatus – well, there never was – at Stafford, so that has to be referred, and that is effectively why we are here today. As I have said, it took them until November 2006, judgment having been given a year previously.

I am going to deal very briefly, if I may, with the law, and I do so relying only on the passages that I have in my skeleton argument, but can I summarise the position in this way: Ms Sullivan and I had a fruitful conversation this morning and in essence I think our agreed approach, subject to the views of the learned Legal Assessor, is that the two routes that you can go down in deciding that there has been abuse of process by reason of delay are either by way of Article 6 of the European Convention on Human Rights, which effectively suggests that the time runs from the moment that the General Medical Council are seized of matters. So, depending on your views as to the Henshalls’ delay, it would appear that that is only from April 1997. However, under the common law we are able to argue that you can look at the whole of the period, so that is from 1989 to 2008, and therefore under the common law you can express dissatisfaction about the length of time that it took the Henshalls to progress matters. In any event, there is no real explanation for the General Medical Council’s delay between 1997 and 2001, and certainly any delay occasioned by the failure to consider 1,600 pages of notes is not something that can be the subject of any criticism on the part of the doctor, and at the end of the skeleton – I will come to it in a moment – I quote a recent decision that suggests that the GMC cannot hide behind administrative delay under its new five-year rule. That is the basic position.

I have summarised what Article 6 allows. It is a fair and public hearing within a reasonable time before an independent and impartial tribunal. The right to a determination within a reasonable time is a separate guarantee, so, in other words, you do not have to find that it is fair and public, that you are independent, that you are impartial, and therefore, because those are all ticked, the time delay is not an issue. It is a stand-alone right that any doctor has appearing before this tribunal.

I say, I hope fairly, that so far as a breach of Article 6 is concerned, time has been held to run from the time that a practitioner is notified of the allegations made against him and procedural delays thereafter. You know that the initial notification was in 2001, so that would suggest a time period under Article 6 from 2001 to 2008, so it is seven years. However, I remind you of the fact that so much time had passed before then that a fair trial was almost certainly impossible even at the time we were initially notified.

It is right that you are informed of the fact that the case law – and I am sure that Ms Sullivan will rely on this – suggests that a stay can only be imposed on the grounds of unjustifiable delay in exceptional circumstances. We cannot countenance circumstances more exceptional than these, given the unconscionable and considerable delay. No default on the part of the practitioner, and I do not think that anybody is pointing to any.

One matter that you may be invited to consider is the approach of the criminal law. What is often said in the criminal context – and although you approach this applying the criminal rules of evidence, you are not a criminal court – is “Well, the defendant has had a long time awaiting his trial but the judge can sort that out, because if the judge was going to give the defendant nine years, he can say ‘You have waited five, so I will give you four’, or ‘three’ or ‘six’.” In my submission, there is a very real difficulty in importing that approach into disciplinary proceedings. You are aware of the fact that this case has attracted a great deal of publicity and you are aware of the fact that regardless of any decision that you make, whether it is ultimately that this application succeeds or whether it is ultimately that the case is not found proven rather at the end or at half-time, the press will almost certainly report that the General Medical Council is pro-doctor; that is the reality of the situation. Similarly, in my submission, you would be very constrained, if this matter was anything like approaching serious professional misconduct, if in the announcement of your sanction you were to say, “This is a case where we would have erased but, because the doctor has had to wait 18 years, we are going to impose conditions”. There would be outrage, and it would be justifiably asked whether you were acting in the public interest, if this doctor had practised since 1989 without restrictions and you now thought it sufficiently serious to erase. So, in my submission, the criminal cases do not assist because you are unable to tinker with sanction in the way that the criminal courts can. It is interesting to note that in the cases in which that has been alleged it has been prison sentence-lessened rather than, “You would have gone to prison but now I am going to give you community service”. It is not a huge difference in sanction.

I say in paragraph 4.6 that the state of the neonatal art and attitude to trials in the late 1980s, nearly 20 years ago, will have to be considered by any Conduct Committee and that this cannot be done fairly at this distance in time; and everybody, in my submission, will struggle to do that.

We say that the delay of itself, regardless of prejudice, which I shall demonstrate probably after lunch now, is sufficient for you to be satisfied that for these proceedings to continue would be an abuse or process, and I come back to the question: what were you doing on Tuesday, 15 December 1992, doctor? Surely you can tell us”. It just is not something that is necessarily going to be capable of proof one way or another.

I suggest an approach to be adopted by you, and I have quoted the passage from Dyer v Watson. Again this is, of course, subject to not only the views of your learned Legal Assessor but you will no doubt be addressed by Mr Foster possibly briefly, but Ms Sullivan at greater length, about whether this is an appropriate approach, but in my submission the first step is to consider the period of time that has elapsed, and if on its face that gives ground for real concern, as I suggest it should here, it is almost certainly unnecessary to go further. I accept that the threshold is a high one and not easily crossed, but it goes on to say:

“But if the period which has elapsed is one which, on its face and without more, gives ground for real concern, two consequences follow. First, it is not necessary for the courts to look into the detailed facts and circumstances of the particular case … Secondly, it is necessary … to explain and justify any lapse of time which appears to be excessive.”

We are still awaiting explanation, as I say in paragraph 5.2, and I come back to the period of time that I say should give you cause for concern.

It is right that you are informed, as I set out in paragraph 5.3, that the burden of establishing unjustifiable delay lies on the practitioner, but it is only upon a balance of probabilities, so is it more probable than not that the delay will prejudice the defence of this doctor many years after the event? The answer is “yes”. In my submission, that is the only answer that you can sensibly reach.

We do not concede that we need to demonstrate prejudice, but we can clearly do so, as I say in paragraph 5.4, and I give a further reason why you cannot regard yourselves as operating as a criminal tribunal. A judge, of course, cannot really influence how quickly a matter progresses to court, but you are embodying the General Medical Council, who certainly since 1997 were part of the investigatory process as well as prosecuting this action, so they are able to fulfil every aspect of the investigation and prosecution. A judge cannot ring up the local constabulary and say, “I had a bail application three years ago in this case. Can you tell me what is going on?” That is not what happens, but the GMC, through its offices, are well able to do that.

Can I then just deal with prejudice? I am thankfully going a little faster than I thought I might. We are able to demonstrate prejudice in this case in numerous respects, and I set them out on pages 14 and 15. I will add in an additional matter of prejudice that my client has informed me of this morning and I understand that Dr Samuels has similarly been affected. The first is obvious - the overall delay. 16 to 18 years makes, we say, a fair trial well nigh impossible, even in a case which may be said to be document heavy, you are dealing with attitudes of some years ago.

The evolving science and difficulties of recollection on the part of both the practitioner’s witnesses and any experts as to the state of neonatal art and the approach to trials in the late Eighties and early Nineties. The only General Medical Council guidance in 1989 that I can find effectively said if you are conducting a trial can you please make sure you are not getting a backhander from the pharmaceutical company. Your current guidance is far more detailed in relation to ethics and ethical trials and those of you who were practising at this time will know that there has been a sea-change in attitude in terms of ethics and ethical trials. There is no suggestion here upon the charges that any child came to harm as a result of this trial, whatever the Henshalls may believe. Nowhere will you find a charge that their child was damaged or adversely affected by CNEP.

We have a problem with the communication of the ultrasound scans which I have already flagged up to you. We do not know when the scan report was entered into the notes and, if so, by whom. We have a problem reconstructing Dr Spencer’s likely working pattern and whether any junior doctor can now be identified as having communicated the results of the scan so that after the event we suspect that is likely to have happened.

There are very real problems around this time period – 22 to 29 December – with the doctor recollecting what his duties were. He instructs me that in keeping with many in the profession he is unlikely to have worked both Christmas and New Year. He remembers that his son’s birthday is 28 December, as one would hope any father would, but that is about as far as he is able to go. It, in my submission, beggars belief that a failure of communication, non-causative as it demonstrably is in any event, could found a finding of serious professional misconduct 16 years ago. You forgot to tell a patient about a scan which was probably non-sinister.

The training allegation is another one that causes us difficulties. The difficulties of the recollection of systems relating to training, in particular communication of oral notification of changes to protocols which may well have occurred because that is the way things operated at that time, we certainly cannot identify potential witnesses very easily. We delegated quite properly training to senior nurses. The training offered to doctors at the time was very much on the job. Now we are in the world of 360 degree appraisals, clinical governance and that just was not in operation at this time, so it is difficult for us to demonstrate in a documentary way precisely what was going on.

My client tells me that he cannot find, but knows that they were in existence, the relevant clinical protocols that were there on the ward in the late Eighties, early Nineties. He has been able to find a 1994 protocol which we may be able to put to somebody such as Dr Brookfield, but he cannot find the ones extant in 1992. There is a very real prejudice there because these protocols would have been drafted by clinicians and nursing staff and should have been adhered to and that may be a particular importance when one comes to look at the allegations in relation to the taking of blood pressures at this time delegated to highly trained, highly competent nursing staff. As I have indicated, the majority of the time he was probably asleep in relation to one of the allegations and I can take you, as I know Mr Foster would like you to have the Panel bundles to the nursing care plan which indicates that the taking of blood pressures and the observation of vital signs was something which the nurses undertook in that care plan to do.

The stress of the proceedings is not to be underestimated. Ironically we have had several letters from officers of the General Medical Council regretting the delays in this case which we shall place before you after lunch. This is not to be underestimated, particularly if assurances had been given that matters were not being pursued. On two occasions these doctors had thought they could resume their careers unblemished and beyond criticism. I also complain, as you will have seen as a recurrent them with me, about the usual attendant unbalanced publicity and potentially remediable damage to professional reputation. You are not going to get a “Doctor not guilty” headline in this case. The reporting will be unbalanced and inflammatory. It is interesting that the moment I rose to my feet the press disappeared because all they were interested in was the appearance of the Henshalls. They are not interested in the justice or injustice of the situation of dealing with events that happened two decades ago.

The unavailability of witness – this is extremely prejudicial, particularly due to the lack of particularity that still exists in the charges. We have asked about this. Mr Foster, I know, has developed his skeleton argument to suggest that this is a further abuse of process. Dealing with the charges that we now face, we in particular have been concerned about charge 11. That suggests that we failed to ensure that appropriate procedures were in place to obtain informed parental consent to the patient’s participation in the CNEP trial.

The initial application had a Parental Information form which we are instructed was exemplary by the standards of the time. What we have never been told is exactly what it was that we should have done in order not to have to face this charge. In what material respects are our procedures deficient and what should they have been? We still await confirmation of what that should be because it is not something which appears to be supported by the paediatrician instructed by the General Medical Council, but by an ethicist who, as far as we are aware, never conducted a clinical trial in a clinical setting.

What training is it said would have been adequate for the time? Is there anything more than the technique being shown to be safe which is said to be a misrepresentation? Again, one is looking at the standards of the time. You will recall that Dr Spencer came to this in 1989/1990 and certainly papers published by his colleagues, Dr Samuels and Dr Southall, in 1986 indicated that it was a safe procedure. It is our submission that he was entitled to rely upon their research up to that point. I have dealt with 11(d). A clinician in Dr Spencer’s position simply cannot ensure that every parent has a copy of the Parental Information sheet and the likelihood is that those that said they did not get it have simply forgotten.

Allocation of scores – we are still debating that and we understand a little more of the General Medical Council’s position but, simply put, clinicians involving statisticians, to what extent would that ever found SPM?

I have dealt with charge 16, the difficulties that we have in recalling where we were and what we did but you can rest assured that it is unlikely this doctor was in the hospital before about 8.30/9 o’clock on Tuesday 15 December if he was there at all. The period of time from 003 to let’s say 9.30, because it seems to us is not a fair period to allege against this doctor if he was at home asleep. We may be able to reconstruct from the notes that Dr Brookfield was on duty at the relevant time. He is no longer the source of your inquiry.

We require to have identified to us, even at this late stage as far as paragraph 17 is concerned, every single period between this child’s birth on 14 December 1992 and 7 January 1993 when she was discharged when it is alleged that there was a failure, whether by us or nursing staff, to ensure that appropriate and regular blood pressure checks were undertaken and/or recorded in the notes. We have never been given that and there are real difficulties in this area. Some of you will be aware that it was not uncommon at this time for nursing staff to record notes on a private document or notebook and then complete the formal record at the end of the shift because they are busy looking after some of the sickest children in the hospital. Note-taking whilst important is not as much of a priority as dealing with saturation levels plummeting, alarms going off, arrests, concerns about shunts and hydrocephalous. It has a priority but how high? We cannot identify from the notes who might have been on duty. We can certainly look at the nursing care plan and see that the nursing staff appeared to have taken responsibility for that role.

We are still awaiting finalisation of the General Medical Council’s witness list and we are still getting as recently as last Friday more material though it would appear to be a completion of material rather than entirely new material, so I would not want you to think that it is entirely new, but it will still take a bit of looking at. We understand that somebody is going to be called to deal with the ethical position who did not work within the trust at the relevant time and we have certainly seen documentation which suggests that the views held by that witness may not be adverse to our position.

I then deal finally on the question of prejudice in the skeleton at least with the lack of availability of notes, training materials and the scans, documentary evidence of written communications regarding alleged adverse events, scoring systems and modifications to protocols. My doctor believes that he would have had some contact with Queen Charlottes but he cannot recall now and we know that, apart from minutes of the Local Ethics Committee dealing with the application in 1989, there is nothing else and we are certainly of the view, my client ironically having been involved in medical ethics shortly after this incident from 1992, there would have been more minutes. There may have been communicated amendments to protocols which were criticised for not having undertaken, either in writing or verbally or recorded somewhere, not a chance of finding them now. As I have said,

“This is a considerable handicap to practitioners and experts trying to reconstruct at this distance in time, treatment modalities, thought processes and the exercise of clinical judgment in an evidential vacuum.”

It also causes us, as representatives, some difficulties. I conclude by saying:

“Such prejudice is so severe it cannot be remedied by the burden and standard of proof.”

Sir, would you be prepared to adjourn a little early. It is ten to one. I just want to ensure that the next slim bundle that we have is ready to be handed out. I want to have a discussion with Ms Sullivan about whether she is happy for you to have the Panel bundles in advance of her opening because there are four or five pages I would like to take you to, but in fairness to her I have not raised the issue.

THE CHAIRMAN: I am sure we are happy to adjourn a little earlier. Before we do so, could I ask for clarification on a couple of points? Taking the most recent first, you submit in the skeleton argument at 5.4 that it is not conceded on your part that in this situation “the practitioner needs to demonstrate prejudice”.

MR FORDE: Yes.

THE CHAIRMAN: Would you think, however, that the matters which you have just been talking to us about at section 6 under the heading “prejudice” would be the sorts of considerations which the Lord Chief Justice had in mind in Dyer v Watson when saying that it is necessary for the courts to look into the detailed facts and circumstances and the outcome is closely dependent on the facts of each case.

MR FORDE: My primary position is that you ought to be able to go back into your room and say this is so old we do not really need to find prejudice, but if you do need to find it, then we have it in spades.

THE CHAIRMAN: As you have helpfully set out in the passage which you rely on in Dyer v Watson, you would argue that we would follow that.

MR FORDE: You can certainly read 5.1 alongside 6.1, yes.

THE CHAIRMAN: That was the first point. Secondly, when you were making points to us around the application of the criminal law and the fact that we should be wary about reading too much across, the point you were making I think was that the criminal court would have greater latitude on sentence than we would have on sanction if it gets to that stage.

I can quite understand that a criminal court could say in relation to a defendant having been convicted after a fair trial well because these matters occurred so long in the past the lapse of time, if I can put it this way, is a mitigating factor which justifies a reduction in sentence. Do I understand you to be saying that the criminal jurisdiction goes further and says we do not think you can have a fair trial, but no matter, we can reduce the sentence to take account of that?

MR FORDE: No. If the primary decision is that you cannot have a fair trial, then that is the end of the matter. Just to give you a couple of examples, it was somewhat ironic to those of us practising in crime at the time the police officers were accused of perjury in the Guildford Four and Birmingham Six cases were able to say because our alleged perjury was undiscovered as a result of our nefarious actions for 20 years we cannot have a fair trial and the court agreed and then abuse of process started to be looked at a little more closely.

There is a case in Archbold which is 56 years old and, in my submission, although the High Court have always suggested there is a discretion open to a judge if there has been delay, again it is extremely rarely exercised. If you think about the sex abuse cases, particularly arising out of children’s homes, some of which are 30 years plus old, no suggestion that a judge says I am going to reduce your life sentence, even though you are a danger to children, because of the delay. It is a discretion which, in my submission, is sparingly used but not one which is, in reality, open to you because of the way in which this body is perceived by the public. If you were to conclude that a doctor should be erased it would be difficult, in my submission, to justify a lessening of sanction, but you will understand that Mr Foster, Ms O’Rourke and myself are reasonably confident that that is not a decision you will have to make ultimately.

THE CHAIRMAN: Thank you very much. We will adjourn for an hour and resume at two o’clock.

(Luncheon adjournment)

MR FORDE: I have been made aware I have been going rather quickly, so I will try and slow down a little.

Before I return to the skeleton argument in relation to prejudice, I think it may be of assistance to the Panel if I take you through the charges, so you are able to consider them separately, as I am sure you will be advised, and indicate the prejudice that I suggest this doctor has suffered from, or will suffer from, if the matter proceeds.

Might I deal with first matter, which is charge 3(a). You have not seen the application, but we apprehend that the fact that it also referred to an infra red trial at the time of application, is criticised because not all babies who were subject to CNEP, at least initially, were also subject to the other trial, which is known as NIRS.

It is our case that in 1989 it was not uncommon for applications to go above and beyond that which was the subject matter of initial trial, in other words not all changes to protocols were necessarily notified. We are supported in that view, to some extent, by the General Medical Council’s paediatric expert, Dr Stimmler, and with the agreement of my learned friend I will read into the transcript a record of the conversation which took place with him recently. This is very much a charge which will require all witnesses to try and recreate the culture in 1989 which may be extremely difficult.

Similarly in relation to charge 6, there is no dispute that in February 1990 a patient at another hospital, Queen Charlotte’s Hospital, was found to have experienced neck trauma. As you are aware, our entry point for babies was not until April 1990. Our application had gone in on 29 November and had been approved on 10 January. Our case is, by the standards at the time, that was not an adverse event which mandated a re‑referral to the ethics committee of North Staffordshire Hospital. It did not occur at our hospital.

It is also possible it was discussed by my client with the chairman, but he cannot recall, and there is the possibility of further minutes revealing the reporting of the matter; again, not something which appears to be supported by the General Medical Council’s paediatrician, although I believe commented upon by their ethicist.

As far as changes to the scoring system are concerned, you know that those are dealt with in paragraphs 7(a) and (b). It is our case that eighteen years ago such a change did not mandate going back to the ethics committee. Again, first point, the relevant culture at the time; second point, difficulties of recollection; third point, possibility of missing minutes or notes.

The surfactant point is another criticism. Again, it is our case that this was not a change of the protocol which should have been reported. I make the points I have made in relation to paragraph 6 and 7. There may well be different views as to whether it was or was not something which should have been reported all that time ago. My client may not have reported it but, in any event, you will see from his correspondence in our bundle that it was introduced across the board, and I will take you to some comments made in conversation with Dr Stimmler.

The same point can be made in relation to paragraph 9 and paragraphs (a) and (b). There is no dispute that there was a change to the exclusion criteria from that at the time of the application in 1989. It may or may not have been notified, it did not place any child at risk, it was not sufficiently serious by the standards at the time to be something which needed to be notified to the ethics committee in any event. That is something which you will see reiterated in the correspondence in our D/AB1 and we have denoted it.

The difficulties with charge 11 I have touched upon already, and they only bear very brief repetition. The role of a responsible investigator in 1992, which is really the period we are most concerned with – but perhaps between 1990, 1991 and 1992 – again will require investigation of the responsibility of an investigator, and whether there was appropriate delegation to medical and nursing staff. We have asked for particulars of this as to whether there was a set limit. It seems to encompass both staff at Queen Charlotte’s and North Staffordshire. As far as the charge against my client is concerned, it is not clear. You will see the charge is mirrored in the Southall charges, although he was not working at the North Staffordshire Hospital at the relevant time.

We are still struggling to know what “adequate training” would have been, as set out in 11(b), what the misrepresentation is said to have been in 11(c), because, as I have indicated, the contemporaneous documents, certainly the studies in 1986 by Samuels and Southall, suggested safety. We struggle to, first, demonstrate that every parent had a copy of the parental information leaflet at this distance in time; secondly, to see why that is not a responsibility that could be delegated to an appropriate junior member of staff or appropriately trained nurses; and, thirdly, that allegation is maintained despite the fact that the Hull report seems to suggest 90 per cent plus of parents, again it has been dealt with in correspondence, were happy that they had been given adequate information.

The role of the responsible investigator in paragraph 12, in relation to the statistical evidence, again will require examination of the state of the art between, perhaps 1989 and 1992 in my client’s case, are difficult. There is no dispute but that a statistician, Mr Alexander, was part of the original team and it is really a matter for you as to whether you feel at this distance in time that you are able to assess the responsibility of clinical members of the trial team when they are employing a dedicated statistician.

The remaining charges perhaps cause us the most difficulty in terms of recollection and specific times and the reconstruction of events. I start with paragraph 16. I have made the point that my client believes – but it would be of course joyous from our perspective if we could produce work rotas and clinic times – that he would not have been present until about three hours before the end of that time period. We will have to, and we have struggled to, identify, and probably will never be able to, relevant nursing staff who would have been responsible, we say, for ensuring that vital signs were appropriately monitored.

I have managed to identify – and my learned friend is happy for me to read these into the transcript – the care plans. The first point to make is that with Patient 6’s sibling, born some ten months before, for the benefit of my learned friend it is page 3 behind tab 4 in panel bundle 2, there is an entry which makes it clear that the nursing staff, as part of their care plan, the need is identified as to breath unaided in air, and the care plan is, ventilation, monitor, respirations, oxygen, saturation, and I think that word is apex. That must be the heart. There is an umbilical catheter in situ and the blood pressures to be monitored via a transducer. That was 12/2/1992, so that gives you an indication of the normal standards within the unit and we say the doctor’s reasonable expectation of that which would be undertaken by nursing staff.

Then dealing with Patient 6, behind tab 5 at page 13, the nursing staff on 14 December are indicating that they will explain, something my client cannot decipher, but it looks like “explain IFC to parents”, “encourage parents to participate in care”, and then, more importantly, “inform parents of any changes in treatment or condition”. On the next page, page 14, “To observe respiratory pattern and rate, record oxygen saturations and to record and report any brachycardias or apnoeas”.

On page 16, again recorded as the responsibility of the nurse, “To administer oxygen as necessary, to observe breathing pattern and rate, to record saturations and vital signs, to record pressures and oxygen requirements, oral suction and endotracheal suction as required, to observe perfusion colour of lower limbs”, a whole raft of things properly delegated to experienced nursing staff which appear now to be levelled against us as criticisms. Never mind the time period in paragraph 16, in my submission the suggestion that a clinician was entirely responsible for these failures, if failures they were, is most unfair and difficult to defend at this distance in time. If we had been in a position to call the relevant nurses or identify the handwriting, it may have been possible to call them in rebuttal, but that is not something we seem to be in a position to do at this time.

That is a submission I make only in relation to paragraph 16. If I turn to paragraph 17, we have asked for each time period when it is alleged that during this doctor’s involvement in Patient 6’s care he failed to ensure that appropriate and regular blood pressure checks were undertaken or recorded in the notes. We had taken that possibly to be the same time period between 0.003 on 15 December and 12.30 on 15 December. It is right that this patient was booked in under Dr Spencer’s name and you know was born on 14 December and was discharged on 7 February. If it is the General Medical Council’s case that there were defined periods within that three week period or so, when we failed to ensure that appropriate and regular blood pressure checks were under or recorded, we would have liked them to be identified. At the moment we are struggling with this charge.

It is possible, for instance, or would have been had they been more closely defined, for this doctor to try and reconstruct events. He has, for instance, suggested to me that if the records existed of his outpatient clinic letters on any given day, he might then be able to say, “I know sixteen years ago that I did an outpatient clinic on a Wednesday afternoon”, and if that coincided with the time period when this criticism was being made of my client, we would be able to rebut it. But with the lack of particularity in that allegation, we are struggling to meet it because of the delays in this case.

THE LEGAL ASSESSOR: I am sorry to interrupt, Mr Forde, there seems to be a non sequitur in that last comment. You would be struggling in the same way with that charge because you say it is so vague quite regardless of that.

MR FORDE: Yes, we would.

THE LEGAL ASSESSOR: Would the proper way to deal with that not be to say that that is an abuse for quite different reasons to delay because it is too vague, unless and until

Ms Sullivan provides you with the information and, if necessary then to adjourn while you got the information?

MR FORDE: We very much doubt that we will ever have it available to us, which is the problem of the delay, but you are right to point out that it is a subtle variation on the delay abuse argument, and in fact has been dealt with I think most adequately by Mr Foster in his skeleton argument, where he is suggesting that lack of particularity is of itself an abuse. He also complains about the difference between matters placed before a PPC and those with which we currently stand charged, because one of our concerns is that if the expert evidence had been available to the PPC in the form that it is now, this matter may not have come to a Professional Conduct Committee, but that is not something that we will ever know.

If I can take 18 and 19 together then and just to give you some indication of the difficulties that we face in this regard, we again have some of the entries in the notes; just bear with me for one moment. There is alleged here a failure to inform parents of an abnormality on two separate occasions, 22 December and 29 December. It is not clear when the ultrasound report found its way into the notes. We have not seen the ultrasound scans and we do not know whether we were on duty at a time when they were available to us. What we do have, however, is some correspondence between the Henshalls and the Directorate of Child Health, Child Development Centre, Stoke-on-Trent, and for the benefit of my learned friend it is proposed Panel bundle 2, behind tab 5, page 209. That is a letter from Dr Heycock, a female practitioner, to Dr Spencer. It was typed on 30 June 1994, dictated on the 29^th, and it refers to a clinic on 28 June 1994, therefore nearly 14 years ago.

In essence, the Henshalls during their consultation with this consultant paediatrician apparently initiated a lot of discussion about Patient 6’s management on the neonatal unit and were concerned as to why Patient 6 was ventilated on day 3 rather than day 1, but importantly, in terms of finding of witnesses and recollection, because my client simply cannot remember whether he had a discussion but believes that he is likely to have done or one of his junior staff may well have done, it says this:

“And she was also concerned that although she was present at the time of [Patient 6’s] ultrasound scan of the head, she was told this was normal.”

There have been suggestions that she was never told about the abnormality until such time as Dr Newell reported in November 1995, and again it is the subtleties and the nuances. It may have been that she was told that it was normal. She may also have been told, as my client believes she ought to have been told, that it was virtually or essentially normal, and therefore we are now dealing with an allegation of failure to inform of abnormality. These are shades of grey, I am afraid, which, to mix metaphors, must now be lost in the mists of time.

My client wrote in response to Dr Heycock on 28 July 1994 – and that is our page 211 – saying:

“I have offered to see this mother in my office on two occasions to discuss her concerns re [Patient 6]. The first appointment was cancelled and on the second the parents did not attend.

With regard to conflicting advice about the scan, I would note that [Patient 6] had mild symmetrical dilatation of the lateral ventricles and at one stage there was the possibility of a clot attached to the choroids plexus on the left side.”

You will see that in paragraph 18. He continues:

“The ultrasound changes could be considered virtually normal in a

pre-term infant and would not in any event be associated with increased risk of handicap.”

You will recall what I described as the motivating factor in 1997 for the complaint that a causal connection in the minds of the parents between this scan, although Mr Newell was to say that he thought the brain damage occurred prior to delivery, but they remained convinced that there is a causal link between the scans and their daughter’s current condition.

We have also been supplied with some of the comments that have been made by Dr Stimmler, who is to be called by the General Medical Council if this matter continues. In relation to surfactant, he is recorded as saying that he hopes the surfactant had been evenly distributed between both limbs of the trial, otherwise it could have affected the results. He said that the introduction of surfactant could not have been foreseen at the beginning of the trial and it was not a good enough reason to stop the trial.

In relation to the handing of booklets and information sheets, he thought that two leaflets should have been given, one medical and one nursing. It was most important that they had the medical information sheet. Well, we have a note that says that the parental information sheet was given to the Henshalls and that it had a tick next to it in the clinical notes, and that is the best we can do. In an ideal world there could have been a similar leaflet describing how positive pressure ventilation worked, but you will appreciate that we are not dealing in an ideal world.

He was asked about the neck injury and he is recorded as saying that injuries occur very easily in premature babies. Dr Stimmler was not surprised by the injury seen in the photograph. He did not believe that it could have been foreseen, and you will recall that it did not even happen at our hospital.

Dr Stimmler was asked whether the researchers should have returned to the Ethics Committee at this point and he said “No, it was probably just to proceed with the trial”.

He was then asked about the weaning off of CNEP and he apparently said that it would be the SHOs who would do the weaning and the consultants would rely on them.

In relation to head scans, he thought that one at discharge would have been appropriate, but we have one very close to discharge; and he expressed a personal view that the abnormality shown on one of the scans – it is not clear which but I think it is the first – should be told to the parents. He said that it was a personal view but he thought that it was generally accepted.

Once he had received the draft charges, he appears to have had a further conversation on 25 March 2008. He said in relation to randomisation that he had never come across it before, this specific method, but that it seemed reasonable, and suggested that a statistician should be asked to comment on this. You are aware that Professor Hutton’s views have led to an amendment of the charges.

With regard to the allegations relating to the failure to return to the Ethics Committee, he was not sure that an average person would have returned to the Ethics Committee at such junctures or whether an Ethics Committee would demand constant appraisal.

In relation to the charge that consent had been delegated to too many people, which I think is our charge 11, he said that given that the babies were being born at all times during the day and night, he did not see that it was unreasonable to delegate consent to the staff members on duty, and he did not see how this could be avoided. He commented on how the members of staff had given a reasonable account of how they would have taken consent. In his opinion, the technique had been shown to be safe on older babies and it was the introduction of the technique to younger babies that was new. He thought that generally it was acceptable to extrapolate the findings in older babies. So that gets round the alleged misrepresentation that the technique had been shown to be safe in paragraph 11c.

He was asked about the 12-hour period of monitoring and the readings that are the subject matter of charge 16. He thought that he had maybe been slightly too harsh in his report and that the period of criticism is really a 12-hour period, which therefore affects the readings that are to be included in the charge. Dr Stimmler mentioned that he was not sure that an FTP Panel would find this to be misconduct, as it is the type of incident that are frequently the subject of compensation claims. So, at best, negligence, which we know is not enough for SPM.

Then Dr Nicholson, whose impartiality I know is questioned by Mr Foster ---

THE LEGAL ASSESSOR: May I interrupt again? I am struggling a bit with the logic behind this at the moment, Mr Forde. My understanding of abuse of process is that the Panel should not be deciding any substantive facts. Certainly they have to decide the facts leading up to the application, but they are not called on to decide, “What is the decision that we would make if we reached that?”

MR FORDE: No.

THE LEGAL ASSESSOR: At the moment, with that last bit, you are in danger of proving that you can defend the case.

MR FORDE: No, no, it is not that. What I am suggesting is that if there is a lack of certainty on the part of an expert, he is having a discussion – for instance, “Not sure the average person would have returned to the Ethics Committee; it was probably okay because babies are being born at all times during the day and night” – to then have charges that are critical of this, where there is wavering on the part of the General Medical Council expert possibly as a result of his inability to reconstruct events at the time, puts us in a very difficult position. It is my submission that we are not here dealing with a case which, when you come to exercise your discretion, should concern you because it is overall a strong case in any event, but we do have very real difficulties – and I know that Mr Foster will develop this in his submissions – in dealing with certain aspects of this case that have not been particularly strongly put by the General Medical Council’s experts.

We compare and contrast that, which is another aspect of our complaint as regards abuse, with the strong views expressed by the Preliminary Proceedings Committee, and having had no opportunity to deal with these aspects of the expert evidence until we have a Professional Conduct Committee hearing. That, it seems to us, cannot be a fair position. These comments could have gone back to the Preliminary Proceedings Committee for review. We have not had an opportunity to comment on the stance of these experts until I am doing so now.

I do not labour the point, and it will obviously be a matter for you, sir, as to how you advise the Panel as to whether I have strayed into the merits of the case to too great an extent, but I hope that the Panel can appreciate that when tentative views are being expressed, it could be, and I cannot put it higher than that, because even the GMC experts are struggling to reconstruct the culture at the time.

Bearing in mind your comments, sir, I do not think that I need to trouble you with the Nicholson comments, because on reflection they are probably straying into the arena of what can be proved and disproved.

My client wishes me to make the point – and I cannot find the reference in my bundle so far – but when I was taking you through the initial 75 pages there is a reference – and this is just the point that he wishes me to make despite the views of the Henshalls – to the fact that the Henshalls were consulted during a post-trial study, a long-term follow-up study was conducted comparing the outcomes in CNEP babies with babies on standard care, they were part of the steering group and it did not demonstrate any detriment to the patients in CNEP. I think that reference will be found for me.

Sir, can I just return then to the skeleton argument briefly, if I may. I think I had almost finished the prejudice as set out in paragraph 6. The one additional aspect of prejudice of which I have forewarned my learned friend about, and I think Mr Foster has a similar submission to make, relates to the thwarting to some extent of my client’s career whilst these matters have been hanging over him. He is quite confident that had he not been the subject of these proceedings for so long, he would not only have the qualifications but is likely to have been invited to have been the Medical Director of this Trust. He has been a long-standing consultant, and obviously his attitude to research has been quite severely affected by these allegations.

I am told, sir, that that reference is D1-B at page 83. That is the reference to the outcome. It is quoted in italics. Can I make it clear, both for the benefit of my learned friend and the Panel, that I do not place reliance on that? It is obviously important to Dr Spencer in terms of his view of his scientific credibility, but I would not invite you to necessarily adopt those findings. You have not heard the evidence and you would be falling into the very trap that the Court of Appeal criticised the previous PPC for, namely accepting one version against another. Dr Spencer was just anxious that I make the point that we had replied in that way.

Can I then move to the position under the new rules? I appreciate that this is not necessarily something that the Panel will have had to consider, and I can find no authority dealing with this point, so we are in uncharted waters here and I fully accept that.

The primary submission that I make is that the reason for the amendment to the 1988 rules initially in 2002, which introduced a five-year rule, and to the retention of that in Rule 4(5) of the 2004 rules is because of a very real concern on behalf of the public, practitioners and the GMC that old allegations would or might be unfairly pursued, and we are all concerned here about fading recollection and reconstruction of events.

The only exceptional circumstance that we were given at the time of the reconsideration that led to delay back on 17 January 2003 was that the loss of the documentation of itself amounted to an exceptional circumstance. In my submission, that only has to be stated for it to be quite obvious that there is nothing exceptional about that position at all. The courts have been visiting and revisiting this matter in relation to Rule 4(5), and at the end of my skeleton I quote two recently decided cases, which I am happy to supply to the Legal Assessor if he wishes to see them, but I hope that I have quoted them fairly.

It is my primary submission that you should look at the five-year rule and use it to inform you decision. I cannot pretend that it was in existence in 2001. It came into force between the first decision that this matter would go no further and the second. We were told in no uncertain terms that we could not import the new rule 6.8 into these allegations because they were too old, ironically, and we are really caught between a rock and a hard place. If the allegations had been even further delayed we would have had a run post 2002 on the five-year rule and obviously if they were being brought post 2004 we would be seeking to place an onus upon Ms Sullivan to say what was exceptional about this case. It is not exceptional because the Henshalls want it pursued – all complainants want their complaints pursued. It is not exceptional because they believe, erroneously we say, that there was a causative link between CNEP and the demise of one child and the brain damaging events relating to another. There is in truth and fact nothing exceptional about this case apart from the length of time it has taken the GMC to pursue it.

The case of Gwynn I deal with in paragraph 6.5 which did involve an administrative error on the part of the GMC and the court was unimpressed by the attempt of the GMC to elevate that to a level such that it could be regarded as exceptional. In Peacock, Sullivan J (no relation) repeated the rationale of Gibbs J. I have quoted what I hope is the most relevant passage of the case. There was a concern about the prematurity of the challenge, that there is a debate about what is exceptional and what was said at page 17 of Rule 4(5):

“The rule under consideration provides a distinct and free-standing safeguard which sets a general prohibition against the pursuit of long-delayed complaints. It provides only for very limited – i.e. exceptional – circumstances in which such complaints may proceed. I am not persuaded in the event of a wrong decision under that rule which allows a complaint to proceed further, there would be any satisfactory remedy later in the proceedings.”

He was suggesting also that in terms of serious professional misconduct something beyond “serious misconduct”, which is possibly the highest this case could be put, and not as high as that in my submission, could justify waiving Rule 4(5).

“It is possible the alleged misconduct may be so serious as to amount, of itself, to exceptional circumstances, but if that is the Registrar’s view, it should be clearly stated.”

It has never been suggested this is an exceptionally poor case of unethical research or failures in consent; far from it. As you are aware there have been those consulted by the GMC who regard it as being a good, if not model, trial.

I have quoted the aide memoir but I probably do not need to delay your deliberations by going through that and a requirement to give reasons, which of course under the Old Rules we have not been given and I will come in a moment to the statements that have been made by officers of the GMC in relation to delay.

I therefore say in conclusion that:

“The recent robust view of the High Court in relation to delay, as encapsulated in the interpretation of Rule 4(5) should be regarded as instructive and reflecting the current judicial view in attempting to adjudicate upon the merits of this case proceeding against the background of considerable and unexplained delay.”

I quote Lord Justice Auld in his dissenting judgment saying that, in essence, this is the position that we are still in. No identified advantage to Mr and Mrs Henshall in that the charges drafted barely scratch the surface of the matters that they are truly concerned about and they have led to professional disruption and personal distress on the part of the doctors which we will see in a moment has been acknowledged by the General Medical Council in the past.

It will be apparent to you, and it is again a question of weight for you, that it can be submitted that this is not the hearing the Henshalls want and there will be a considerable degree of cross-examination upon prior inconsistent statements as well. In looking at the public interest, you might want to consider whether it really is in their interests to be subjected to that with such documentation as we do have tending to allow us to dispute quite strenuously some of the claims that they made in the past.

Could I have handed up to you, sir, a final clip of documents. I am conscious that I have not dealt with one aspect of Mr Foster’s skeleton argument which relates to legitimate expectation. I am happy to leave him to deal with the case law, but it is perhaps something which can be suggested on behalf of Dr Spencer as well.

THE CHAIRMAN: This will be D1-C. (Document distributed)

MR FORDE: There is one other document and I probably should have given it to the clerk at the same time. I know Mr Foster is going to come back on this. We found a recent decision, the case of John Rogers, 14-16 September 2001, where the facts were that the time elapsed was only two years and 10 months from when time ran against the General Medical Council, but nevertheless the Panel, having heard submissions on the question of delay, made a decision that the case could not continue. Again, you may or may not find that instructive. Ms Sullivan has seen it and she will be addressing you on the basis of every case depends on its own facts; I do not dispute that. To underline the point, she has written next to the doctor’s name “depends on the facts” and again I am happy for you to see the document as I have had some photocopying which has gone to you with my comments on it.

THE CHAIRMAN: This will be D1-D. (Document handed)

MR FORDE: If there were ever needed a demonstration of a change in culture, as a Panel you must be marvelling at the fact that six or seven years ago a panel were able to uphold an abuse submission in less than a page. Those were the days!

Can I ask you to go through D1-C with me very briefly and, as I have said, if you bracket these under the “Legitimate Expectation” heading that Mr Foster will deal with.

On 25 March 2004, Finlay Scott, the Chief Executive, wrote in relation to the fact that we had been told on 24 March the matter would go no further and he writes in the following terms:

“I am writing to apologise that it took so long to bring the CNEP related complaints to a conclusion. This should not have taken almost seven years. As you know, some of the excessive delay was a consequence of the decision to await the outcome of other inquiries. However, even allowing for this, we were clearly at fault because our handling of the complaints was poor and because the original screening and PPC decisions could not stand. I very much regret the distress that has been caused to you and to the other doctors.

I realise that it will be of scant comfort to you, but I am confident that we have addressed the causes of the evidence handling problems. I am only sorry that we did not do so earlier.”

Once again, I apologise for our failings.”

That was written in excess of four years ago.

My client replied to the letter. This is an unsigned copy but he assures me that this was his response. He acknowledges the apology in the first paragraph and then sets out the difficulties that he has experienced in terms of his career. He says:

“I was severely hampered in obtaining two senior posts, one as head of postgraduate medicine in the new medical school at Keele University, a post to which I was invited to apply. After my case was dismissed the first time, I had a very positive discussion with the Medical Director of the Trust in relation to a newly created post of associate medical director for Research and Development. When my case was re-opened I was told that it would be inappropriate for me to apply. Having previously had both considerable research and management experience I was very well placed to be successful in applying for either of these posts. In addition, both my personal life and my work has been affected in many other ways as you might imagine.”

Then he deals with the area which I am sure you are aware has attracted a deal of controversy recently. Paediatricians are feeling slightly put upon, I think, to say the least at the present time. Then he asks if he can contribute in any positive way to the training of staff and discussions just to address the underlying problems to result in better case management. He does not believe he received a response to that letter.

Dr Samuels meanwhile had written a much lengthier letter and he appears to have got a reply to a letter written at an equivalent time to the unsigned letter I have just taken you to. Ours is 23 April and he wrote on 14 April following a letter of 25 March which was in exactly the same terms as page 1 of D1-C, so both Drs Spencer and Samuels, as you will hear, received letters from Finlay Scott. In this letter, he acknowledges:

“… the delay in your case was excessive and arose from a combination of factors, including serious error on our part.”

He then goes through the pressures that the General Medical Council has been under historically, the increase in claims and what the proposals were on the second page:

“… within four months of receipt of a complaint a decision will be made whether to conclude the case or refer the doctor to the PPC … where referred by the PPC to the PCC, the hearing should take place within 12 months.”

The new Orders of 2000 and 2002, the 2002 Order bringing in the five-year rule under the 1988 Preliminary Proceedings Committee and Professional Conduct Committee Rules. Then he deals with the reviewing of decisions in the penultimate paragraph on page 4 and how they have a duty to process complaints. I think that is all I need to take you to in this letter. The rest of it is really a policy statement.

This is something my client wished you to be made aware of – the last document from Peter Swain, who is the current head of Case Presentation Standards & Fitness to Practise as short a time ago as 24 October 2007, in response to a letter written by my client to Professor Sir Graeme Catto, dealing with the difficult history of this case and the Court of Appeal decision, he indicates that the case is an extremely complex one – this is the fifth paragraph – possibly the nearest we have ever come to an explanation for the delay, but in many ways it has become less complex than it was if you look at the initial assertions being made by the Henshalls back in 2000-200.

“We aim to open cases at hearings not more than nine months after referral but in more complex cases such as this one such a timetable is often not realistic.”

We have concerns and my learned friend has helpfully provided me with a copy of the supplementary judgment in the Court of Appeal matter when the Court of Appeal as long ago as January 2006 were suggesting that the matter be dealt with as swiftly as possible.

“The matter should be remitted with the utmost expedition.”

We say implicit in that is also “and dealt with”. We are now nearly 18 months on from that and certainly the main judgment was in 2005. The nine month time period, ironically as we still find ourselves receiving expert reports, is said at the bottom of page 6 to

“… include a significant element for the defence to prepare its case after all the GMC’s evidence has been obtained and disclosed together with finalised draft charges.”

You may know that we were scheduled to start this case on 6 May. The reason that we started on the 8^th was because the General Medical Council served their 8 April Notice of Inquiry within the 28-day period, so we were then asked if we would mind starting on the Thursday rather than the Tuesday, so that gave us under a month to prepare our defence and you are aware of the position with the Hutton Report arriving a week Friday. We were told and assured by Mr Swain in the penultimate paragraph:

“We are committed to seeing this case resolved as quickly as possible while ensuring that we properly and effectively discharge our statutory duty to inquire into the fitness to practise of doctors.”

Can I see if there is any other matter my client wishes me to deal with and then I should be able to sit down. (Short pause)

Sir, I end my submissions as I end my skeleton argument. The charges, if proven, can find a founding of serious professional misconduct but that may or may not be something that weighs with you in the exercise of your discretion, but I do maintain that this is a very weak case and it has been made weaker by delay on both sides in terms of the credibility of evidence, but entirely on the General Medical Council’s side in terms of culpability for the length of the delay and against that background and for all the reasons and the submissions that I have addressed you upon, it would be unfair for this matter to continue.

Sir, those are my submissions, although as I have indicated I am happy to answer any questions from the Panel.

THE CHAIRMAN: Thank you, Mr Ford. There is just one matter that would help me. This may be a misunderstanding or not quite following the points you have made, but could you help me a little more as to where and in what respect you say the five-year rule bears on this case?

MR FORDE: What I have tried to do, and as I have said, we are in somewhat uncharted territory, but the reason we perceive for the five-year rule coming into effect is because of a general concern about old cases. Whilst I cannot point to that rule being in existence at the time that these matters came before the GMC – in other words, 1997 – it is my submission, and again you are to be guided by the learned Legal Assessor as to the weight you attach to this submission, if any, but it is quite instructive to look at current jurisprudence and current thought about old cases as encapsulated in the five-year rule.

If you reach the view that if the case were brought now and was six years old there was nothing exceptional about it therefore you would be constrained in the exercise of your discretion to decide that the hearing should not go ahead, then that might help you in trying to work out where in the scale of gravity this delay lies. We are talking in terms of common law delay in excess of three times that length of delay and in terms of the notification of concerns from November 2000 expressed by the Henshalls a four month delay, we then find out in early 2001 and time at the very least runs from then, I think we are all agreed that that is the case, so we are seven years on.

It may be, and I put it no higher than that, that if you look at some of the rationales expressed in Gwynn and Peacock and you think that really does meet the merits of this case in 2008 that you could not rely upon the five-year rule but look at the approach to the five-year rule as encapsulated by the courts in deciding whether to exercise your discretion in our favour. I am not suggesting that as a stand-alone point that would win the day for us, but it might help you reach your decision.

THE CHAIRMAN: Thank you very much, Mr Forde, that assists me in my understanding. We will doubtless receive advice from the Legal Assessor in due course. Since you extend the invitation, I look to my colleagues. Dr Sheldon.

DR SHELDON: Might I direct my question to the Legal Assessor first. That last letter we have been reading, 24 October 2007, can I ask whether the second paragraph is something that we should pay attention to or is that not advised in this particular application?

THE LEGAL ASSESSOR: That is, of course, correct. I do not think anyone has made a secret of that. No one has yet, and I was not clear whether this was going to happen, actually referred to the judgment.

MR FORDE: I have it and I have tried in my skeleton to say that the reason it was referred back was two‑fold and I have set out the two reasons. It is a fact that following the March decision of 2004, the Henshalls sought a judicial review. I do not know when they instigated that action. Initially the single High Court judge turned down that application. They then appealed that to the Court of Appeal who heard the matter in the summer of 2005. It is a matter for you as to whether you see that additional delay as being neutral, which I think is the best it can be for the GMC, or culpable failure, but in either event it is certainly not the fault of the doctor that the court ultimately decided that the GMC had applied the wrong test. I would be suggesting that time runs against the General Medical Council throughout that period of time. I do not know if that is helpful.

MS SULLIVAN: Might I just I clarify that I am intending to put the judgment before you and I have told my learned friends that that is what is going to happen, so there will be no secret about the history of the case and the reasons for the Court of Appeal’s decision.

MR FORDE: I have made a reference in my outline facts, it is paragraph 3.16. Judicial review refused on 15 December 2004, appealed to the Court of Appeal on 27 and 28 June, and when you get the judgment you will see that in the tenth paragraph of the judgment of Lord Justice Auld, of the ten matters that were said to be matters of serious complaint which were placed before the court, I think including – Miss O’Rourke was there and will correct me – the improper use of caesarean section, of the ten, three now remain.

THE CHAIRMAN: Does any other Panel member wish for clarification? (No points raised). Ms Sullivan, I am assuming from the way matters have been presented so far, that Mr Foster will make his submissions in this context now and you will then reply to both submissions.

MS SULLIVAN: Yes, sir, because I think they have a lot in common in the submissions they are going to make, so it is probably better that I deal with them globally.

MR FOSTER: Sir, do you wish to hear from me now, or is this an appropriate time for a break?

THE CHAIRMAN: In some respects it seems indulgent to have a break after an hour, but on the other hand if we have a break now for fifteen minutes and come back at 3.20 pm, we will invite you to address us then.

MR FOSTER: Before you break, perhaps I can take this opportunity to pass up the two small bundles on which I will be relying. (Bundles handed)

THE CHAIRMAN: We will call the larger D2A and the smaller D2B. (Documents distributed and labelled D2A and D2B).

MR FOSTER: Can I alert you to an error in the pagination of D2B. Page 1 will make sense if it is put in front of existing page 11.

MS SULLIVAN: Can I clarify the numbering of the two documents?

THE CHAIRMAN: The larger of the two starts off with the letter dated 30 March 2001, that is D2A and the other is D2B. Page 1 of D2B we have been advised actually ought to go between pages 10 and 11, but I think if we leave it at that, because if we give it another page number we will get more confused. I think we know that is the first page of the letter and the second page is page 11. We will rise now and come back at 3.20 pm.

(The Panel adjourned for a short time)

MR FORDE: I am sorry, sir. The reason for the delay is that I was helpfully supplied with two additional new attendance notes from our point of view, dated 28 March, by my learned friend, Ms Sullivan’s, instructing solicitor – helpful and properly supplied, but does not have an impact on my submissions.

THE CHAIRMAN: Thank you, Mr Forde. Mr Foster?

MR FOSTER: I hope a copy of my skeleton argument has reached the Panel. Any objective observer looking at this case will wonder what on earth Dr Samuels is doing here. That incredulity will have been increased this morning when a number of the remaining allegations against him were struck out. His involvement in these allegations is extremely peripheral. He was not at Stoke for most of the material time and he was never a clinician of any of the babies involved in this trial.

Because of the submissions which Mr Forde has made on behalf of Mr Spencer, I can be much shorter. From the chronology under paragraph 1 of my skeleton argument, I would make only these points. Almost all the documents which you need to look at have already been referred to in detail by Mr Forde. There are lots of documents to which he has referred in the context of Dr Spencer which are exactly mirrored in the case of Dr Samuels. The page references to the documents in Dr Samuels’ case are in the skeleton argument. I am not going to repeat them. You will be interested in the documents because of the dates on the letter heads.

Secondly, in relation to the documents which set out the allegations, and the responses to the allegation, the documents in the two bundles which I have just handed up will be mainly of interest to you for what they do not say, by which I mean there are almost no allegations which Dr Samuels was asked to comment on which now appear in the charges against him.

You will be interested in the documents for a third reason. The documents contain copious apologies and acknowledgments of fault on behalf of the GMC. So it will not be possible for Ms Sullivan, on behalf of the GMC, to say with a straight face, “We are not at fault here”, there is no inexcusable contumelious delay. She is stuck with that.

The three documents I particularly invite your attention to are the letter at page 7 of the first bundle, from the General Medical Council to Dr Samuels dated 15 March 2002. It apologises for the delay and says that no further action will be taken. There is then the letter of 25 March 2004 at page 2 in the second bundle. Mr Forde referred to it a moment ago, so I am not going to read it again into the record, but it apologises specifically and abjectly for delay in bringing the matter to a conclusion. In my chronology I have set out the most important section of it.

In the supplemental bundle at page 4, there is letter from the GMC to Dr Samuels dated 3 June 2004, again apologising abjectly for the delay. So far as the delay is concerned, I repeat and adopt the submissions made by Mr Forde. I respectfully agree that the analysis which you should adopt is the Dyer v Watson analysis. It is not necessary to show it is specific prejudice, but there is a good deal of specific prejudice which we can demonstrate in this case.

In a moment I will go through the remaining allegations against Dr Samuels and demonstrate what the prejudice is in relation to each. I make the following general comments. It is notoriously difficult for panels like this, for judges in clinical negligence cases and in lots of other medical contexts, to determine after a lapse of any significant time, let alone such a gargantuan time as this, what the standards appropriate to the material time were. That prejudice almost always redounds against the practitioner, as it does here.

Secondly, in relation to the issue of training, many of the medical witnesses who the GMC, if this case goes any further, would call, would say that they have no recollection of the instruction they were given, have no recollection about the training which they were given. I can exemplify that by reference to some of the witness statements which have been given to us. For example, here is Dr Claire Newell:

“I have very little memory of the trial, it was fifteen years ago, it formed only a very small part of my role as an SHO. Approximately ten years ago I gave a statement about consent to a firm of solicitors whose name I cannot remember. I would expect if I had been asked then I would have been a lot more accurate, I would have had a clearer memory then. I do not now, some fifteen years later, have any recollection of taking consent on this occasion, nor do I remember Mrs Henshall or Patient 6. I can only remember very little about the CNEP trial, although I recall that the aim of the trial was to see if it reduced respiratory problems in premature babies. I cannot remember the information we were given from the consultants about the trial to pass on to parents. I could not say whether it was something you picked up or whether we were given specific training about. It was such a small part of my workload, I just do not remember.

In terms of my usual procedure for taking consent, I can only say what I would do now, which is not the same as recording what I did then. I do not remember if I did things any differently than I did then.”

Asked about a specific patient:

“In relation to the amount of information I gave her, I cannot remember.”

Dr Arya:

“I had not worked with the CNEP before I arrived in Stoke. I do not remember how it was introduced to me. I think I would have been introduced to the CNEP by the doctors and nurses. I do not remember who in particular and I do not remember any formal training sessions. When you start a new job you get so much information thrown at you, it is hard to remember.

I think I was given some instructions, but I do not remember what I was told. I cannot remember what I was told to say, but I do remember what I would have said.”

Dr Wheatley:

“I seem to recall that there was a training session held on CNEP. Dr Spencer was very keen on research so I believed it would have been him who held the session, although I do not remember. I have quite a hazy recollection of the session and I do not recall any of the detail of what we were told.”

Dr Livera:

“I do not remember details of training or who conducted it. I have no reason to believe that any of the staff who worked with CNEP did so unless they had been adequately trained and were confident in its use.

I have been asked if I remember using the term ‘kinder’ and ‘gentler’ to parents. I do not remember using this term, I do not believe it likely. I do not remember if the consultants explored the exclusion criteria during the telephone call. I have been asked if the consultants checked if consent had been given. I do not remember exactly what was discussed.”

So it goes on and on; samples from the evidence which is being led by the GMC upon which they will invite you to say that these charges are made out. If the proceedings had been brought in reasonable time, one would expect a number of these witnesses, who go to crucial issues between Dr Samuels and the GMC, to have clearer recollections. The gist of the statements of the medical witnesses, some of which I have referred to, is entirely exculpatory so far as the adequacy of training is concerned and the standard of training generally.

One would expect, if their memories were as good as they would have been had the proceedings been brought in time, that the overall evidence would have been even more exculpatory than it in fact is. Also potentially available, had these proceedings been brought in time, would have been diary details, schedules and other documentary evidence of the amount of time that Dr Samuels spent at Stoke before he moved there, and of time which the staff from Stoke spent down in London before Dr Samuels moved on to Stoke. We have been deprived of that potentially crucial evidence by the GMC’s culpable delay.

I would invite you to turn to the remaining charges against Dr Samuels. Head 3(a):

“You inappropriately delegated the task of taking consent to too many different medical and nursing staff.”

How has the lapse of time affected our ability to defend that allegation, to whom was it delegated? What, according to the standards at the time, would have been the appropriate number to delegate it to, what was the process by which the delegations happened, are there documents somewhere in existence in a dusty filing cabinet which indicate exactly the terms in which the delegation was done?

Head 3(b):

“You failed to provide adequate training to those taking consent for the trial.”

What training was provided, what training according to the standards of the day should have been provided, what handouts were given to those who were being trained? Did the people who were being trained express any dissatisfaction or feel inadequate in any way with the training which they were given?

3c: “You misrepresented within the parental information leaflet that the technique had been shown to be safe”. What was the process by which that parental information leaflet was generated? Who were the responsible authors? Who had input into its production? What, again, were the standards that would be expected of such a parental information leaflet at the time.

3d: “You failed to ensure that every parent had a copy of the parental information leaflet”. It is difficult to see, of course, how Dr Samuels, being in Stoke and not a treating clinician, could have any impact at all on that. Assuming that this is an allegation that there was an inadequate system in place to ensure that every parent had a copy of the parental information leaflet and that Dr Samuels is in some way responsible for that system, being in London when this was being done at Stoke, questions such as this arise: What should he have done? Who was told what and when about the distribution of this leaflet to the parents? What parents were given copies of this leaflet? By whom were they given it? We have been deprived of potentially crucial evidence.

4b: “You failed to ensure that the scores were allocated correctly”. Whose responsibility was it for the allocation of the scores? What had been decided in the trial protocol about how responsibility for that allocation would be distributed? What, by the standards at the time, is the yardstick by which correct allocation should be judged?

4d: “You failed to ensure that there was an appropriate method of scoring”. The same questions arise as under 4b.

As I have said, Ms Sullivan must begin her submissions on delay in the light of what the GMC has specifically and abjectly said by saying, “Ever so sorry, we made a tremendous mistake here, there is obviously an inexcusable delay, but it does not matter”. For all the reasons that I have just gone through, she cannot begin to do that.

I move on to paragraph 3, legitimate expectations. Just before I do that, I should remind the Panel of other types of prejudice that result from the delay in Dr Samuels’ case: the stress that results from having his hopes raised and dashed on two occasions over a long time; the torpedoing of some of his professional ambitions; these allegations effectively stopped his research career dead for a while; if it had not been for this, he would now have been Professor Samuels; his clinical excellence award was delayed significantly by the delay in processing these allegations.

“Legitimate expectations”. There is a lot of law that I have put down in paragraph 3. The gist of it is this: people have a right to know where they stand. If a promise is made and that promise is later withdrawn, that is regarded by the courts in some circumstances as so unfair that the proceedings should be stopped. In my respectful submission, this is a classic case where that principle applies.

In paragraph 3.1 I deal with R v Bloomfield, Lord Justice Staughton. What had happened here was that the prosecution had said that they would offer no evidence against the defendant at a subsequent hearing and they then went back on that and sought to prosecute him:

“The statement of the prosecution that they would offer no evidence at the next hearing was not merely a statement made to the defendant or to his legal representative. It was made coram judice, in the presence of the judge.”

Pausing there, what we have here, of course, is not an informal comment from a prosecutor to us, saying “We might not be pursuing that allegation”. We have express written documents from the highest level at the GMC not only admitting that there is a failure in the system but also saying expressly that these practitioners will not hear any more about it.

That quotation continues:

In my submission, the public would be appalled if they knew that on two occasions here, over many years, these practitioners were told “Go away, get on with your lives, you are not going to hear any more of this” and then to be told by subsequent letters, “You have to face career-endangering allegations yet again”. That is the sort of change of mind that brings the administration of justice in this jurisdiction into disrepute, and it is one of the reasons why you have this jurisdiction to stop at case at this stage.

In the case of Mulla, the defendant was charged with causing death by dangerous driving. On the first morning of the trial the prosecution said that they would accept a plea of guilty to careless driving, the judge frowned at that and said to the prosecutor, “Go away and have another think”. That afternoon the prosecution came back and said, “We are going on with the original charge”. There was an application by the defendant that this was an abuse of process and the Court of Appeal said “no”, and it is not surprising that they said “no”. This is reported at the bottom of my page 4:

“This was not a case in which the defendant’s hopes were raised, later to be dashed.”

Pausing there, the case of Dr Samuels is, of course, precisely one in which the defendant’s hopes were raised not once but twice and then dashed. The quotation continues:

“He knew from the beginning of the proceedings in court, on August 14, that the judge did not approve of the course which the prosecution were proposing to take.”

The judge, in a sense, in this case is analogous to the GMC. The GMC itself is saying, “You will hear no more about it.

“He had not had his hopes raised by anything which counsel had privately said to him. It is true that, in the words of Staughton LJ in Bloomfield, the prosecution indicated to the court what its view was, but that, as it seems to us, is only one of the factors to be considered in a case of this kind. Other factors include what view is expressed by the judge when the prosecution gives its indication…” –

which is not relevant here –

“… the period of time over which the prosecution reconsiders the matter…”

There it was over the morning and the afternoon that they reconsidered the matter; her is it over years.

“… whether or not the defendant’s hopes had been inappropriately raised…”

Here, of course they have, repeatedly.

“…and whether there has been, by reason of the change of course by the prosecution, any prejudice to the defence.”

There is massive prejudice; I have just been through it.

There was a systematic review of the authorities by the Court of Appeal in the case of R v Abu Hamza:

“As the judge held, circumstances can exist where it will be an abuse of process to prosecute a man for conduct in respect of which he has been given an assurance that no prosecution will be brought. It is by no means easy to define a test for those circumstances, other than to say that they must be such as to render the proposed prosecution an affront to justice. The judge expressed reservations as to the extent to which one can apply the common law principle of ‘legitimate expectation’ in this field, and we share those reservations.”

Effectively, they did not like the label.

“That principle usually applies to the expectation generated in respect of the exercise of an administrative discretion by or on behalf of the person whose duty it is to exercise that discretion. The duty to prosecute offenders cannot be treated as an administrative discretion, for it is usually in the public interest that those who are reasonably suspected of criminal conduct should be brought to trial. Only in rare circumstances will it be offensive to justice to give effect to this public interest.”

Pausing there, one can well understand the reluctance of judges in the criminal sphere to let off, because of lapse of time, a terrorist, a rapist or a murderer. That is not the situation that you are dealing with here. You are dealing with practitioners who, as Mr Forde has demonstrated by some of his citations, are not roundly criticised by just the experts who the GMC proposes to call in terms of culpability. Even at the height of the GMC’s own case, this is right at the bottom of the scale. The quotation goes on:

“Such circumstances can arise if police, who are carrying out a criminal investigation, given an unequivocal assurance that a suspect will not be prosecuted and the suspect, in reliance upon that undertaking, acts to his detriment.”

I do not want to weary you too much with my voice, but I pick it up at paragraph 52, which deals with the case of Townsend:

“Rose LJ, giving the judgment of this court, approved the propositions: where a defendant has been induced to believe that he will not be prosecuted this is capable of founding a stay for abuse; where he then co-operates with the prosecution in a manner which results in manifest prejudice to him, it will become inherently unfair to proceed against him.”

That is precisely this case, in my submission.

“He added that a breach of promise not to prosecute does not inevitably give rise to abuse but may do so if it has led to a change of circumstances.”

For the reasons that I have been through in this case, it does.

The summary is at paragraph 54, as follows:

We have two unequivocal representations in this case, not just one –

“… and (ii) that the defendant has acted on that representation to his detriment.”

He has, as I have pointed out.

“Even then, if facts come to light which were not known when the representation was made, these may justify proceeding with the prosecution despite the representation.”

Nobody has suggested that that applies, and in fact, as has been demonstrated by Mr Forde, as this case has evolved facts are coming to light which tend to exculpate. For example, a few minutes ago, just before we came back into this chamber, I was handed an attendance note from Dr Nicholson. It was dated the end of March this year and it indicated that he acknowledged that he was not an appropriate expert to deal with the design or conduct of clinical trials – precisely what in his earlier reports he had said he was able to comment on, and indeed about which he had commented in enormous detail.

My submissions under paragraph 3.4 are self-explanatory and I have made them already in the course of considering the relevant authorities.

I move on to paragraph 4. This is headed “Uncertainty about charge 3a.” Charge 3a reads, “You inappropriately delegated the task of taking consent to too many different medical and nursing staff”. That clearly raises the question: how many is too many? Accordingly, Dr Samuels’ solicitors sought clarification. I have set out there the relevant exchanges of correspondence. We have had no answer, except an assertion by Eversheds on behalf of the General Medical Council that it is a matter for the Panel to consider how many people it would have been appropriate to delegate to; not true. What the General Medical Council is doing by bringing an allegation against a practitioner is saying, “We think that this is the standard that the Council expects, and you have fallen below it”.

In order properly to respond to that allegation, we are entitled to know exactly where the bar is, so that we can determine (a) whether we have fallen beneath it and (b) if so, by how much. We have continued to press them and they have continued to refuse to give us proper particulars. I am not, on Dr Samuels’ behalf, in a position to respond to that allegation and I say that since one of the most fundamental principles of justice is that we should be able to know the case that is brought against us, it is abusive to continue with that allegation without giving particulars. Accordingly, unless and until those particulars are provided, you should stay that charge.

Paragraph 5 is headed, “Failure to give Dr Samuels an opportunity to comment on the allegations”. The 1988 rules say, insofar as material, this:

“Rule 4

Where the Medical Screener refers a case to the Preliminary Proceedings Committee under this rule, he shall direct the Registrar to give written notice to the practitioner:

(a) notifying him of the receipt of a complaint or information and stating the matters which appear to raise a question as to whether the conduct of the practitioner constitutes serious professional misconduct …

(d) inviting the practitioner to submit any explanation which he may have to offer.”

The rationale for the rule is obvious. It would be unfair if a practitioner was referred to the Professional Conduct Committee when either he did not know what the allegation against him was or, if he did know it, he had not had an opportunity to make an explanation which might convince the Preliminary Proceedings Committee not to refer him. It is an important safeguard. The rules have been ignored in this case. Dr Samuels has been deprived of that essential safeguard.

Of the allegations that impute fault that presently face Dr Samuels, he was given an opportunity to comment only about those in head of charge 3c, and that only in 2001 and not subsequently, and those in 3d. I say that in relation to 3c the failure to invite submissions specifically in relation to the 2006 referral is fatal. Effectively what the General Medical Council was doing in 2006 was saying, “We are going to start all over again, we will have your representations please, these are the allegations that you are facing at this stage”. They had not asked anything that can be construed as covering 3c since 2001, and they were obliged to. Therefore, head of charge 3c has not been validly committed.

In relation to 3d, you will see my submissions at paragraph 5.3. There is a very significant discrepancy between the existing form of 3d and the allegation which, it might be argued, covers 3d. The draft allegation is “You did not ensure that parents had adequate information about the CNEP technique to provide properly informed consent for the participation of their children in the CNEP trials, including a patient information leaflet”. It is a very different allegation from the existing one, which is “You failed to ensure that every parent had a copy of the parental information leaflet”, which implies that there was a duty on an absent consultant somehow to ensure that each parent received a copy. Precisely that point about the vagueness of the charges was taken by RadcliffesLeBrasseur on behalf of Dr Samuels. I have set out the terms in which they put the point. We are in a position now of Dr Samuels not having been given an opportunity to reply to the allegation that he now faces.

I now come to paragraph 6. I take entirely the point that the learned Legal Assessor made in response to Mr Forde, namely that I have to be careful to appear to be inviting the Panel at this stage to make any adjudication on the merits; and, of course, I do not invite them to do that.

I have said at paragraph 6.1 that there are two ways in which the prospects of success can be relevant at this stage. First, they go to how you exercise your discretion in deciding this abuse of process application. Even if a case is well out of time or otherwise abusive, a panel is going to be understandably more reluctant to accede to an abuse of process application if the case is obviously a good one. It would be reluctant to give a practitioner a procedural, technical, unmeritorious way out. The second relevance is that consideration of the merits is necessary because the merits indicate something about the motive for bringing these proceedings, by which I mean that if the prospects of success are extremely low, it plainly suggests that something other than an objective assessment of prospects and public benefit is acting.

There are in this case three notionally supportive expert witnesses who, if this case goes further, apparently the Council proposes to call. There is Dr Stimmler, who is a consultant paediatrician, Professor Hutton, a medical statistician and the third is Dr Nicholson. About the first two of those experts I cannot quibble. I cannot say that their credentials are such that they do not have the expertise necessary for their evidence to be validly adduced. I can say that about Dr Nicholson and it rather sounds in light of the memorandum which I have just referred to that Dr Nicholson is beginning to realise that too.

Dr Nicholson is an expert in no discipline which is pertinent to these proceedings. He was involved in paediatrics as a registrar and a clinical medical officer. He gave up medical practice in or around 1986 and he has edited a publication called The Bulletin of Medical Ethics since then. He has not been on the Medical Register for some time. He has never designed or run a clinical trial although he has sat on ethics committees. He has stood shoulder to shoulder with the Henshalls in their campaign against these practitioners over many years.

His inadequacy as an expert appears to be acknowledged now not only by himself in that memo, but also by the General Medical Council, because of course when Ms Sullivan stood up this morning and said that she was not going on with a number of the allegations which were originally pleaded against Dr Samuels, the ones which went were allegations which had originally been supported by Dr Nicholson, entirely out of his specialty.

I am not going to read into the record paragraphs 6.4 through to 6.7. What I do there is to cite long sections from the report of Dr Stimmler. He is the expert who is relevant to all the allegations under charge 3 and the only expert whose evidence is relevant to charge 3. It follows that there is no possibility of succeeding against Dr Samuels in relation to charge 3. My submissions under paragraphs 6.9 through to 6.11 similarly stand alone.

Ms Sullivan is in a very unfortunate position because of the rules. The rules necessarily create a possible conflict of interest. It is difficult to act objectively in the public interest while also acting, as the rules appear to allow one to do, in a partisan way for a complainant who has an agenda of their own.

I do not criticise Ms Sullivan for the way in which she has tried to resolve those two competing interests but it is perfectly plain that an objective look at the evidence in this case forces one to the conclusion, firstly, that there is no serious prospect of success in relation to any of these charges as against Dr Samuels. Even if there were, the charges are charges which comes nowhere near serious professional misconduct. If I had stood up this morning and on Dr Samuels’ behalf admitted everything which stands currently against him, we could have move seamlessly onto the stage of deciding whether these charges amounted to serious professional misconduct and the inevitable answer would be no.

In my respectful submission what we have here is a set of allegations brought effectively by the Henshalls. The General Medical Council in the letter which I have cited at paragraph 6.14 have assured Dr Spencer that they will have the final say over the form of the charges. Dr Spencer and Dr Samuels have a right to expect that that sort of objective assessment would be carried out. If it has not been, and it unfortunately seems that it has not been, it is for you to police your own proceedings and make sure that they are not hijacked abusively by people with their own agendas.

In my respectful submission the only just result in this case in relation to the allegations against Dr Samuels is that the case should be stopped. Sir, those are my submissions. Unless there is anything else I can help you with?

THE CHAIRMAN: There is something you can help me with by way of clarification and once I have raised that with you I will see whether any of the other Panel Members have anything that they would like clarification on.

The matter I would appreciate your assistance with is the impact and significance, if any, of the intervening proceedings in the High Court in December 2004 and then the Court of Appeal in 2005. First of all, in relation to your submissions about the failure to give Dr Samuels the opportunity to comment, you indicate in your skeleton argument at paragraph 5.2 in relation to the failure to give the opportunity to comment that the failure to invite submissions about charge 3(c) in relation to the 2006 referral is fatal.

MR FOSTER: Yes.

THE CHAIRMAN: The Preliminary Proceedings Committee in 2006 was acting on the direction of the Court of Appeal to reconsider the matter.

MR FOSTER: The Court of Appeal, as I understand it, did not give a specific direction as to exactly how it should be considered. They just said we think there has been an error in the process by which the earlier PPC considered the matter, go back and have another look. Had it been more directive it might have been more helpful, but it was not. I expect that you will hear lengthy citation from the High Court and/or the Court of Appeal decision but that, so far as I can see, is wholly irrelevant to the consideration which you have got to make.

THE CHAIRMAN: I think Ms Sullivan said that we were going to get copies of the respective judgments. All I am looking at at the moment is what Mr Forde put in his skeleton argument that the Court of Appeal remitted the matter for reconsideration by the Preliminary Proceedings Committee.

MR FOSTER: They did, sir, and when it got to the Preliminary Proceedings Committee the Preliminary Proceedings Committee plainly applied the wrong test and plainly did not consider the material in the way that it should have done and the Court of Appeal did not get a second chance to put them right.

THE CHAIRMAN: I do not want to labour the point but I am trying to take myself through the applicable rule which, as I understand it from what you have been telling us, is that giving the doctor the opportunity to comment on allegations is an opportunity which is afforded to the doctor before the matter is referred to the PPC.

MR FOSTER: Yes, sir.

THE CHAIRMAN: If the Court of Appeal says this goes back to the PPC because they erred in their consideration of it, does that mean that you go right back to the start?

MR FOSTER: Yes. The Court of Appeal were saying start again and get it right this time. It did not decree what the exact consideration of the PPC should be. It did not say consider these allegations.

THE CHAIRMAN: That clarifies that point. The second point has the same possible impact of the proceedings in the High Court and the Court of Appeal in relation to your submissions on legitimate expectation in the sense that it seems to me at the time prior to the matter being referred to the High Court by way of judicial review the decisions by the PPC had been in Dr Samuels’ favour and the reason they went back to the PPC and were resolved if I can put it in a neutral sense against him in the sense that we are now here considering the allegations, that was as a result of the court intervention rather than a change of heart by the PPC in terms of acting against a view they had already expressed.

MR FOSTER: Yes. Dr Samuels was a victim of default by other people. The case was primarily remitted because Dr Southall had not commented.

THE CHAIRMAN: The force of your submission in relation to legitimate expectation then presumably is put at its most forceful in relation to the decision to reconsider the matter in the light of the discovery of the 1600 pages of documents which had not earlier been considered.

MR FOSTER: It is strong in relation to both of the representations, sir.

THE CHAIRMAN: Thank you very much indeed. Dr Sheldon has a point of clarification he would like to ask.

DR SHELDON: I am not really sure whether it is a correct question at this time so I am prepared to be stopped if it is inappropriate. I am well familiar with the concept of a principal or responsible investigator in an ethics trial which is clear in the other two heads of charge, but I have never heard of an administrator in a trial. As I understand it, when the trial started Dr Samuels was not even in the hospital and it was two years later that he came.

MR FOSTER: Yes, sir.

DR SHELDON: What exactly was his role in the trial? Is it possible to explain what responsibility an administrator has?

THE LEGAL ASSESSOR: I think that would be better addressed by Ms Sullivan as to how she intends to put the case.

THE CHAIRMAN: It may be that she can answer the question now or would she rather consider her position overnight?

MS SULLIVAN: I think I might have a word with Mr Foster before I say anything at this stage but I am happy to deal with it if necessary.

MR FORDE: Sir, very briefly, whilst listening to Mr Foster I realised that I had not drawn your attention specifically to a letter that we received in identical terms from Mr Peter Swain. I took you to certain parts of it and it is the very last document in D1-C. It is the first paragraph on which he has already addressed you and I am not going to address you any further on the final veto aspect of the letter. I just wanted to ensure that you had appreciated that we received a letter in exactly similar terms as to how the GMC perceived their role in October 2007.

THE CHAIRMAN: Thank you, Mr Forde. The Legal Assessor would like to ask a point of clarification.

THE LEGAL ASSESSOR: This is actually addressed to Mr Forde. It was a question that a Member of the Panel asked me over the adjournment and each Panel Member may be mulling over matters tonight so it is better that we should clear it up.

In a criminal trial there is an indictment and the abuse of process argument is normally to stay the whole proceedings, however many counts are in the indictment. There is only one charge in these proceedings and that is serious professional misconduct. The allegations simply go to make up a single charge. What I want to be clear about is do you say if there is a difficulty in relation to one or two heads of charge then the whole proceedings must be stopped, or would it be permissible just, for example, without expressing any views, to say well there is a difference between those allegations concerning the planning of a CNEP trial and, for example, in the treatment given to an individual patient on a particular day 15 years ago?

MR FORDE: I would point to the rules as suggesting that the preliminary issue that we can take is capable of being related to not only the separate heads but the sub-heads of charge and we would hope that the Panel would perceive a difficulty with more than one or two even at this stage.

Putting that to one side, it seems to all three of us, and I know Ms O’Rourke had this discussion with me this morning, that if you are with us in relation to matters such as training or neck trauma as a surfactant as against whether there should have been a more detailed conversation which we should recollect about an ultrasound scan in 1992 you are entitled and it is within your jurisdiction to strike out aspects of the Notice of Inquiry which go to the single charge. It would be somewhat ludicrous, because you are masters of your own procedure, if in your own mind you had already decided there were aspects of the Notice of Inquiry which were prejudiced by delay but we did not know and evidence was still called and we had to make submissions at half time. It is far better from everybody’s point of view, both Ms Sullivan’s and ours, that we know if there are aspects of the charge that you are seriously concerned about sufficient to say that they should be stayed by reason of abuse and delay.

THE LEGAL ASSESSOR: That is not the same as striking out.

MR FORDE: No.

THE LEGAL ASSESSOR: You invite the Panel to say in relation to each factual allegation, and perhaps then in relation to the entire ---

MR FORDE: Ms O’Rourke might be able to assist you on this point because I think she has experience of a case where the approach I am suggesting was adopted. That may help both the learned Legal Assessor and the Panel.

MS O’ROURKE: Sir, I did have a case three years ago now in January 2005, the case of Chai Patel, where I made abuse arguments and asked for certain heads of charge to be stayed and the Panel did do that. The case then ended up in the Administrative Court because they did not do quite as much as I wanted them to do and the Administrative Court judge, Mr Justice Collins, gave permission for a full judicial review and stayed any further GMC proceedings. The GMC then collapsed the case by indicating that in respect of the rest of the charges that I had made objection they were conceding that they could not pursue them for the reasons that we had outlined in the judicial review, but the court had approved the fact that the Panel had already – I think there had been five or six applications under the head you are now looking at to stay things – they approved the fact that the Panel had stopped some of them and indeed on the advice of the Legal Assessor. I am sure we can get the transcripts if there is any doubt about it, but that is what had happened. They took a charge by charge approach, although it was one charge of serious professional misconduct and it was an Old Rules case. They took it as each individual one could be looked at in the terms of the prejudice.

I have also recently had a case before the Nursing and Midwifery Council which also ended up in the Administrative Court and they endorsed the same approach and indeed the judge, Mr Justice Beatson, said three months ago that it was appropriate that you looked at each one separately and looked at the prejudice in respect of each one because the test, as Ms Sullivan is going to tell you, she will say involves looking at prejudice and so you do then look at them differently because there may be heads of charge that involve prejudice and others that do not.

THE LEGAL ASSESSOR: That was how I intended to advice the Panel and I will leave it that way. If Ms Sullivan wants to submit arguments to the contrary she may do so in the morning of course.

THE CHAIRMAN: Thank you very much for your assistance on that point, Ms O’Rourke and Mr Forde. Ms Sullivan, I am proposing that we should call a halt to proceedings for today and allow you to have a clean start tomorrow at half past nine.

MS SULLIVAN: I am happy with that, sir.

THE CHAIRMAN: If there is nothing else, we will adjourn until tomorrow morning at 9.30 am.

(The Panel adjourned until 9.30 am on Wednesday 14 May 2008)

Day 8 Extract of Determination - GMC Violates Doctor's Human Rights

2008-05-24T14:39:00.000-07:00

The Panel considers that, once the error of the GMC’s failure to submit the full documentation to the original screeners was realised, the case should have attracted expeditious handling thereafter. The Panel finds that there was a significant lack of expedition based on the delay between May 2002 and February 2004. The GMC is not to be blamed for the delay that occurred in resolving the judicial review applications; but, once the Court of Appeal gave its judgment, the case again needed to be managed expeditiously, and again the Panel is critical of the delay between the court’s judgment in December 2005 and the service of the Notice of Hearing in April 2008. It was already an old case and the Panel recognises the blight on the career of any doctor to have disciplinary proceedings pending against them for such a long time. The Panel therefore finds that there was unreasonable delay during this period. In the circumstances, the Panel considers that there has been a breach of Dr Spencer’s right under Article 6 of the European Convention on Human Rights to have his case resolved within a reasonable time.

The Panel accepts that the ultrasound scans relating to Patient 6 are missing, although the radiology reports of the scans are apparently available. It is possible that other relevant documentation is missing in respect of both sets of allegations. It is also possible that relevant witnesses may not be available. The Panel further accepts that the passage of time is likely to have had an adverse effect on the recollection of those witnesses who are available. It bears in mind that the standards to be applied are the standards which prevailed in the early 1990s. It recognises the risk that the opinions of experts may be influenced by their knowledge of current standards. It is possible that because of the passage of time the doctor will find it more difficult to recollect events and therefore to mount an effective defence.

The Panel considers that, once the error of the GMC’s failure to submit the full documentation to the original screeners was realised, the case should have attracted expeditious handling thereafter. The Panel finds that there was a failure in this regard based on the delay between May 2002 and February 2004. The GMC is not to be blamed for the delay that occurred in resolving the Judicial Review applications, but once the Court of Appeal gave its judgment, the case again needed to be managed expeditiously and again the Panel is critical of the delay between the Court’s judgment in December 2005 and the serving of the Notice of Hearing in April 2008. It was already an old case and the Panel recognises the blight on the career of any doctor to have disciplinary proceedings pending against them for such a long time. The Panel therefore finds there was unreasonable delay during this period. In the circumstances the Panel considers that there has been a breach of Dr Samuels’s right under Article 6 of the ECHR, to have his case resolved within a reasonable time.

21st May 2008 Update

2008-05-21T01:00:00.001-07:00

The teams continue to argue the merits of the Article 6 HRA. NHS Behind the Headlines had the update.

No determination has been forthcoming as yet.

Statement from PACA about the Henshall Hearing

2008-05-18T06:40:00.001-07:00

Statement about the Hearing at the GMC over the CNEP Study 1989-1992

13th May 2008, 12:12 am

An 8-week Fitness to Practice Hearing is just starting at the General Medical Council for three consultant paediatricians from the University Hospital of North Staffordshire, namely David Southall, Andy Spencer and Martin Samuels. This is with regard to complaints about the administration of a research project involving newborns in a randomised controlled trial of negative pressure ventilation (CNEP) run in two centres, Queen Charlotte’s in London and North Staffordshire Hospital in Stoke, between 1989 and 1992. The GMC will be looking at whether these issues warrant sanctions against the doctors involved, including erasure of these consultants from the medical register.

The study was set up in 1989 by David Southall, Principal Investigator and at that time, Senior Lecturer at the National Heart and Lung Institute, with the help of Martin Samuels, research registrar at the Royal Brompton Hospital / Lecturer at the NHLI in London and Dr Spencer, the Consultant Neonatologist based in North Staffordshire.

The first complaints about these issues were made to the GMC by the complainants in the late 1990’s. The allegations were investigated twice by the GMC and dismissed. The second review was because the complainants accused the GMC of an unfair process, as they had not examined first time round all the material (1600 pages) submitted by them. In 2004, the complainants lodged an appeal in the High Court over an issue of GMC process and in late 2005, the Appeal Court ordered the GMC to review the complaint. On third review by a newly created investigation panel, the GMC decided that there were issues relating to the Research Ethics Committee submission, the obtaining of consent, the trial scoring system and the write-up in Pediatrics that could represent the possibility of serious professional misconduct.

From 1997 onwards, the complainants lodged their complaints over the research study with numerous other authorities, as well as obtaining national media coverage. Their Member of Parliament, Llin Golding, helped establish the West Midlands Regional Health Authority Inquiry into research governance (Griffiths Inquiry May 2000) - this extended its remit to also look at the diagnosis of Munchausen Syndrome by Proxy. The complainants reported the Medical Director of the North Staffordshire Hospital to the GMC, when in 2000, he released the complainant’s consent forms to counter allegations in an imminent Channel 4 television programme that the form signed for the CNEP study was forged. In a public hearing in May 2001, the GMC accepted the Medical Director’s defence that he was protecting the reputation of the hospital and its children’s unit, and found him not guilty of serious professional misconduct. The complainants have reported ten other doctors to the GMC and two nurses to the UKCC.

The current GMC Hearing follows numerous previous enquiries, including:

a review of Professor Southall’s research for his Trust by Professor Sir David Hull (late 2000)
a Staffordshire Police enquiry into allegations of forged consent (completed October 2002)
a Trust audit of consent, in which forms for all 244 patients included in the trial were available (October 2001)
the West Midlands Regional Inquiry led by Professor Rod Griffiths and reported on 9th May 2001
the Hey-Chalmers Inquiry rebutting the highly critical Griffiths Report (almost every statement made about the design, conduct and reporting of the neonatal continuous negative extrathoracic pressure (CNEP) trial in the Griffiths report was ill-informed, misguided or factually wrong”), published September 2000, and
the outcome from a long term follow-up study by Professor Marlow and colleagues in Nottingham, published in the Lancet in April 2006, which showed no harm from CNEP, and possibly some slightly better outcomes for the treatment group.

The research study’s protocol had previously been passed by four different hospital Research Ethics Committees (Queen Charlotte’s, North Staffordshire, Hillingdon and Doncaster Royal Infirmary); it was also alpha-rated by the MRC in a funding application and the final paper was peer reviewed for publication in the world’s leading paediatric journal, Pediatrics.

The GMC’s case is principally based on the evidence of Richard Nicholson, a doctor who has practised as an ethicist and a former editor of the Bulletin of Medical Ethics. He has allied himself with the complainants since 1997 and made numerous statements to newspapers, TV and radio objecting to David Southall’s research and child protection work, including the concept of fabricated and induced illness, and the use of covert video surveillance. Dr Nicholson removed his name from the medical register in 2000 for ‘administrative reasons’.

Like previous enquiries into the work of Professor Southall, the GMC have again failed to use appropriate expertise and ignored the outcomes of previous investigations. Their actions are part of a concerted campaign against David Southall by those accused of child abuse and their advocates, such as Mrs Mellor. She is a self-appointed advocate for parents and has led a highly public campaign against paediatricians and other professionals who have given opinions in child protection cases, many of which she has described as false allegations. She was convicted some years ago of conspiring to abduct a child from social services. The judge said of her in 2002 that:

“impervious to debate, convinced you are right, you have traduced, complained about and harried dedicated professional people working in this difficult area” [Munchausen syndrome by proxy].

In 2006, Professor Griffiths wrote in the Lancet

“I think that David Southall and his team have to be congratulated on having done a randomised trial when they did. After our report, material became available which suggested that the design of the trial was better than we had been led to believe, and had it been made available to us we would have written some paragraphs differently, making less of some of the criticisms and referring to the register of clinical trials. The important thing, which we acknowledged in the report, was that the randomised design gave a good possibility of effective longer-term follow-up, which has proved to be the case.”

In January 2008, Baroness Golding wrote to the Sentinel, a newspaper based in North Staffordshire, apologising to Professor Southall and stating how sorry she was that her initial concern gave fuel to what could only be described as a witch hunt, aided and abetted by some professional people who surely should know better.

Recently, paediatricians voted overwhelmingly in favour of a motion at the Annual General Meeting of the Royal College of Paediatrics and Child Health which declared grave concerns over the Fitness to Practice procedures at the GMC in child protection cases, based principally on the GMC’s actions against Professors Southall and Meadow.

Delays, Inconsistency and the GMC's Fitness to Practise

2008-05-18T01:55:00.000-07:00

NHS - Behind the Headlines covers Mr Martin Forde's excellent performance.

They go onto examining the GMC's trait of inconsistent decision making. It is clear that NHS - Behind the Headlines are not convinced by the panel's "gloss over the facts" effect.

Great Expectations describes yet another delay until Tuesday 20th May 2008.

DAY 2 GMC v Southall, Samuels and Spencer

2008-05-14T13:23:00.000-07:00

The side panel of this website has the relevant representatives. Please use this before reading our report. These quotes in the GMC's hearing are designed to give the audience a flavour of the true incompence of the General Medical Council. Mr Forde who represents Mr Spencer was superb in his attention to detail and robust defence based on the law as it stands.

Drs Samuel and Spencer decided to fight for their human rights. It started on Day 2 of the hearing. The GMC had taken an unusual break to read the new statistics report they had commissioned. Following that report after 18 years, they dropped the charges and the panel claimed there was no prejudice to the doctors. We disagree with the panel's decision.

The Chairman stated "Before I ask the Panel Secretary to read out the charges as they currently are, I should formally ask each of the doctors to confirm their name and registration number. Dr Spencer, could I ask you to stand and confirm your name and registration number?

DR SPENCER: Dr Stephen Andrew Spencer, 2305893
DR SOUTHALL: Dr David Patrick Southall, registration number 1491739
DR SAMUELS: Dr Martin Philip Samuels, GMC registration number 2732178.

Ms Sullivan then stated

I can indicate that since last Thursday I have been able to take instructions in relation to the charge and can say that in the light of Professor Hutton’s evidence – you will recall that Professor Hutton is a medical statistician – on behalf of the complainants and the GMC we will not be pursuing the following heads of charge. The numbers are the same in relation to Drs Spencer and Southall and the heads of charge that are not being pursued are 3(b), 4, 10, 12(a), (c) and (e) and 13 in its entirety”

In relation to Dr Samuels the heads of charge that are no longer being pursued in relation to him are head 4(a), (c) and (e) and head 5 in its entirety. All my learned friends are aware of this because I was able to notify them of this shortly after midday on Friday.

In addition there are a couple of typographical errors to correct. You may have noticed in head 14 of the charge faced by Dr Spencer “caesarean” is incorrectly spelt and I proposed to amend that so that it is spelt correctly. There should in fact be an “s” on the reference to “Ethics Committee” and it should be “Ethics Committees” in head of charge 6 as it relates to Drs Spencer and Southall.

The General Medical Council can be seen to be making typographical errors everywhere.

The doctor’s barrister told us all

“It may be a forlorn hope, but it may be of assistance to those who sit at the back of the room to indicate what the impact of these changes is upon that which these doctors face”

Mary O Rouke known to the legal profession as the “irish terrier” due to her ability not to represent her clients to a high standard. She told the GMC

“All I say on behalf of Dr Southall is that it is extremely regrettable that we have these charges dropped on what would have been Day 4 of the hearing, in a case where a complaint was first made to the General Medical Council in 1997 and it has been under consideration with the doctors since 2001. For a period of seven years Dr Southall has had aimed at him a number of charges which the GMC now admits it has no evidence to support. He has suffered injustice as a result of those charges remaining against him until now, not least in recent weeks because we have been putting our preparation towards preparing to meet charges that we now effectively have accepted are of no substance and no merit. Yes, sir, you should allow those amendments because to leave them on the Notice of Inquiry in circumstances where there is no evidence, would serve no purpose. The injustice is passed and it would be justice now to remove them”

The amendments to the charges were made after a decade. The Panel stated “That being the case, the Panel is happy that no injustice would be caused within the terms of the rules and therefore determined that the requested amendments should be made”

Mary O Rouke made further submissions “In respect of the applications about to be made, Dr Southall is not supporting them, not because he does not think there is any merit in them, but he believes, as it is going to be asserted in due course, that there has been inordinate and inexcusable delay on the part of the General Medical Council in bringing these matters to a hearing now in 2008 when they relate to events going back to 1989 and terminating in 1992 and 1993.

Dr Southall believes this delay cannot be explained and justified and most of it lies at the door of the GMC itself and, indeed, the complainants. But for his part, in order to make objections as a matter of law, he would be happy to assert that there is no prejudice to him that would not guarantee him a fair trial. He believes that with the allegations as now worded he can have a fair trial and can defeat the allegations one by one on their merits. That is what he wishes. He wishes to defeat it by my cross‑examination, on his behalf, of the witnesses who attempt to support these charges if we get there.

After a number of submissions and discussions Dr Southall withdrew while the others in the legal teams continued to fight the issues.

Mr Forde then stated

“to indicate that the Henshalls first contacted the General Medical Council in April 1997. My original bundle went up to 2004. I have now found the documents that take us right up to date in 2006, so we will paginate those consecutively. Mr Foster has a section in his skeleton argument about legitimate expectation, and we have available for you as well, but I will probably ask that it be distributed a little later, another bundle that comprises various representations made by officers of the General Medical Council, including the Chief Executive, expressing regret that the matter has taken so long and placing the blame very fairly and squarely on the shoulders of the General Medical Council.

Then perhaps we can have copies made of that bundle. If I can just explain what the bundle comprises, it is really all the interaction between Dr Spencer and officers of the General Medical Council since about the year 2000 or 2001, as well as the document that appears to us – and we do not know whether there is any earlier document – to indicate that the Henshalls first contacted the General Medical Council in April 1997. My original bundle went up to 2004. I have now found the documents that take us right up to date in 2006, so we will paginate those consecutively. Mr Foster has a section in his skeleton argument about legitimate expectation, and we have available for you as well, but I will probably ask that it be distributed a little later, another bundle that comprises various representations made by officers of the General Medical Council, including the Chief Executive, expressing regret that the matter has taken so long and placing the blame very fairly and squarely on the shoulders of the General Medical Council.

Sir, if I can deal with the skeleton, the Notice of Inquiry that we received in its final form was on 8 April 2008, lamentably close, in my submission, to the proposed date of the hearing of 8 May 2008. We still find ourselves being supplied with material not denoted as used or unused as recently as the end of last week, which has made preparation for this case a little difficult, but you will see from the second paragraph of my skeleton that you are being asked to deal with events that took place between nearly 18 and a half and 15 and a half years ago, and that causes obvious difficulties for the doctor.

Perhaps the best example that I can give, whilst you have the Notice of Inquiry in front of you, relates to your new charge 16, which, as you can see from the stem, requires my client to justify clinical care between three minutes past midnight and 12.30 in the afternoon of 15 December 1992. All I can tell you about his involvement on that date is that it was a Tuesday and that my client was probably asleep for more than half the period of time, but there are obviously very real difficulties in reconstructing his movements on that date – hospital rotas, the timing of clinics and matters of that sort. That is just a stark example of the sort of difficulty that we face.

I have described the delay in dealing with this matter as unconscionable and I stand by that submission. None of it is the responsibility of this doctor. Neither have we ever had, as I will be submitting the law requires, a sensible explanation for the considerable delay. It is possible to discern reasons as a result of the slow progress of the administration of this case, but we have never had a constructive and still await a constructive explanation of the delay.

We have the advantage over you in having read the witness statements, but I do not think it is contentious that recollections have faded dramatically. Some of the witness statements with which we have been served seem to have been signed this January and ask patients to recall events in the late 80s and early 90s, and their recollections have faded. In our submission, it is well known within medicine that it is often very difficult to get patients to recall matters such as informed consent even a very few years after the event. So there is a very real issue in this case as to whether or not there can be a fair trial of the issues in relation to fading recollections.

This is probably as old a case as any panel has had to deal with. It is interesting to note that obviously your rules changed in 2004; many of you will have been trained, I suspect, in relation to those rules; some of you may even during the process of consultation in relation to the standard of proof have been trained in relation to the sliding scale, and you will have to remove from your consideration the new regime.

Documentation may well have been lost, including likely contemporaneous correspondence between relevant medical staff and investigators. My client believes that there may have been some documentation emanating from him dealing with matters such as scoring with the other doctors. We are aware, thanks to the assistance of Miss O’Rourke, that it appears that there were meetings, which were minuted, and that the minutes have gone missing. The GMC apparently propose to call in relation to the 1989 application (your charge 2 so far as my client is concerned) and its approval (charge 5) a witness who purports to tell us that she is quite satisfied that nothing is missing as a result of matters being archived for an inquiry that took place in 2000, but she did start working at the hospital until 1994, five years after the events in question.

We also lack any contemporaneous documentation in relation to any changes to trial protocols. Again my client is struggling to recall whether in fact he spoke to the chairman of the local Ethics Committee, either in passing in corridors or more formally, in 1989 or 1990, but believes that there may be in or have been in existence minutes that have now been lost. He also believes that he commented on drafts of the medical paper, but that is not an allegation that is now being pursued, so I can move swiftly on from that

There are concerns about scans, particularly ultrasound scans; they form the latter part of the charges.

We have not seen the originals of those scans. We have seen reports of the scans which are quoted in the charges but I have absolutely no way of demonstrating on this doctor’s behalf whether or not those reports found their way into the notes on any date when he was responsible for the clinical care of Patient 6 or not. He may have had other clinical duties. That information may have been gained by radiology departments, junior doctors and appropriately delegated, so we are struggling in relation to the charges that you have set out at paragraphs 18 and 19 in particular.

Witnesses will have to attempt not only to reconstruct events, and this is a very real concern on our part, but to recall, as I have set out, the subtleties, nuances and prevailing medical culture at the time of the matters the subject of these proceedings. That is a concern because after acquired knowledge and current standards are likely to taint the views, both of experts and witnesses.

A lot of people are going to be extremely defensive and a number of practitioners that the General Medical Council is going to call about their role back in 1989/1990. You will see from the document that is being copied at the moment that there are a number of doctors against whom the Henshalls initially made complaints – eight or nine in all – and some of them will feature as General Medical Council witnesses, perhaps surprisingly. We are going to have to suggest to some of them that these clinical responsibilities may well have been theirs because that is what the notes appear to indicate. It will be difficult for them in the knowledge that they were once the subject of criticism and in the knowledge that standards may be very different now not to allow that to colour their evidence.

These matters have already been in terms of the central facts twice investigated. There was an inquiry which we do not regard as being a well thought out inquiry by Griffiths in 2000 and Professor Hull, commissioned by the North Staffordshire Health Authority also provided a report which certainly in relation to consent suggested that something in excess of 90 per cent of the patients recalled being adequately consented. The General Medical Council’s proposal, as I understand it, is only to call those patients who do not have a good recollection of the consenting process or who say adamantly that they were not able to give informed consent.

I deal with the outline facts in paragraph 2 and they are important because of both the timescale and what I say about the prevailing culture. I deal with my client’s acceptance he was a consultant paediatrician at the Neonatal Unit of the North Staffordshire Hospital. He qualified in 1976 and he had been a consultant since 1985, so these events took place three or four years after he became a consultant.

He came to this trial in the sense that it is believed the randomised study of what we will all become familiar with as “CNEP” commenced in 1984 and it would appear that in 1989 Dr Southall sought to recruit other centres to the trial and two centres expressed a particular interest – Queen Charlottes Hospital, whose investigators were Drs Modi and Harvey, and I say in passing they were the subject of allegations made by the Henshalls and represented by the Medical Protection Society but no longer pursued, and Drs Brookfield and Spencer were the responsible investigators at North Staffordshire and the relevant nurses were Wright and Lockyer, who were specifically trained to deal with CNEP. It is also important to recognise at this time the neonatal departments were staffed by highly skilled, highly qualified nursing staff. They are an entirely different calibre, in my submission, to those that operate within other areas of the hospital and they are usually assiduous in their duties as we shall see from the nursing care plan in due course.

We applied, on 29 November 1989, to our Local Research Ethics Committee. The whole process at this time, it seems to be accepted by all, was a fairly fledgling one in terms of medical ethics. Standards were extremely variable between district health authorities. Again, it will be difficult for us to reconstruct the prevailing culture at the time. The General Medical Council experts attempted to do so through various papers but it is quite clear that standards were extremely variable and there is a very real concern on this side of the room that we may be judged not by 1989/1990 standards, but by the standards of 2008.

I then set out further matters of history on that page but it is important for you to be aware of the fact that the Staffordshire Hospital recruited infants between April 1990 and October 1993 and there is complaint about the fact that they continued the trial for longer than some other centres. The aim of the study was to determine the benefit or otherwise of CNEP in babies with respiratory failure in an attempt to determine whether CNEP reduced 10 markers of disease in the newborn infant. Those were markers that Dr Southall had determined.

Again, of importance when one is dealing with issues of informed consent and recollection is the fact that the entry criteria required suitable infants who had developed a need for oxygen within four hours of birth. Again, the subtleties and nuances of the late 1980s, early 1990s, are unlikely to be capable of being demonstrated. There was identifiably a more paternalistic approach to neonatology than there is now, a real concern not to worry patients. We now know with various patient groups and agitation that the whole process of informed consent has changed dramatically in the last four or five years, but at this stage the intention of these doctors at all material times was to try and benefit these children.

I emphasise the fact that many of them were extremely ill and extremely premature and it is not suggested by the General Medical Council through these charges that any active harm was caused to anybody within North Staffordshire. There is a concern about one child with neck trauma and how that was dealt with but it is certainly our case that that was not an adverse event. Remarkably, despite the reporting, this case, as I indicated, is not about, as the Henshalls have been at pains to establish as you will see through the documentation, the death of their daughter in 1992 and the unfortunate brain damage sustained by Patient 6. That is the case that the Henshalls are anxious to bring before you. It is not the case that is pursued by the General Medical Council.

I have indicated that the explanation of the practicalities is to be found in the Parents’ Information Leaflet and there is an issue as to whether that was handed to each and every patient. Again, the burden that the GMC seek to place upon Dr Spencer is onerous and unrealistic. In charge 11(d) it is said that this doctor should have ensured that every parent had a copy of the parental information leaflet. That was a task sensibly delegated to junior doctors and trained nurses and in certain of the notes we have a note that the Parents’ Information Leaflet was given and a tick, but it cannot be the case, in my submission, that a consultant in this position with more duties than CNEP had a duty to ensure that every single parent had received the relevant form, particularly as you will be aware that children are born at all hours. Many of these children were born in the early hours of the morning when my client was not on duty and they had to be in the trial within four hours of birth. That is another example, in my submission, of the difficulties of this case.

I have set out what was said in lay terms – I hope it is useful – about CNEP. Some of you will be aware that the conventional way of ventilating children with respiratory difficulties was to do so through intermittent positive pressure. That of itself can damage the lungs because the oxygen is forced into the lungs under pressure. The theory behind CNEP was that if you placed a chamber rather like an iron lung, and you will see photographs of the baby’s head just poking through and it being in a chamber, and created a situation of negative pressure, that that might assist the respiration of the child and reduce the length of time the child was in respiratory distress. That was the theory. You will see in due course photographs. There is hardly anything one can imagine more dramatic than seeing a child who is encased in the chamber and it makes it all the more remarkable that some of the parents are likely to say we understand that they did not know that their infants had been entered into a trial, but visually it would have been of tremendous impact.

The approval was given on 11 January 1990 and on 22 March the Medical Research Council gave the study an alpha rating, one of the highest possible. Far from being a poorly-conducted trial, or one that was administratively deficient, it was seen by those dealing with it at the time as a first-class trial. That is something which should weigh heavily with you in the exercise of your discretion. You see Patient 6’s mother referred to. She was known by a different name at the time, then aged 28, an experienced mother who had had 11 previous pregnancies and had delivered seven children between 28 and 40 weeks gestation and had a previous child in CNEP who unfortunately died at the age of 10 months due to extreme prematurity, possibly associated with intrauterine infection, not a product of CNEP, although it would appear as recently as last Friday I have seen a newspaper report where the Henshalls hold to the view that there is a causative relationship between the use of CNEP and the unfortunate demise of one child and the brain damaging events suffered by another.

We know from witness statements and the lengthy letters that have been written on my client’s behalf that a Dr Clare Newell, then an SHO, entered Patient 6 into the trial. Appropriate consent was taken by her and she has provided a witness statement to that effect. She was concerned about respiratory distress syndrome and the child was in CNEP for 112 hours and then went into air, discharged home aged 24 days on 7 January 1993.

I have made an error. I said that the previous child died after 10 months. It was 10 months before and she died after a couple of days and I apologise for that.

What was happening in the background after 7 January 1993? At 22 months, according to my researches, so nearly at the age of two, Patient 6 was found to have quadriplegia but her mother had been expressing concern about her development from late 1993 and clearly relating her late development to CNEP. The family pursued medico-legal proceedings as far as they could and as far as we are aware sought the advice of many eminent doctors, none of whom were prepared to support the contention which they have always held to that there was a causative relationship between Patient 6’s brain injury and CNEP. We are not sure when they first consulted solicitors but we have seen a report dated November 1995 which is not supportive of any allegation of negligence.

Matters did not rest there. The family appear to have, in conjunction with other parents, sought still to pursue the matter. There were meetings that took place between them and Dr Spencer which I shall come to in a moment. Perhaps of importance dealing with the issue of delay, given my learned friend’s view of whom she represents, is the fact that as we know by late 1995 a report had been commissioned, it is suggested by myself, I think supported by Mr Foster in his skeleton in paragraph 3.2, that they were questioning the use of CNEP in late 1994, early 1995, 13 years ago. The General Medical Council were aware of complaints against a multiplicity of doctors from 1997, 11 years ago.

The General Medical Council for the purposes of this application are saddled with the Henshalls’ delay. It has nothing to do with the doctor. We were busy cooperating and when they attended outpatients, which they did not always do, we consulted with them. North Staffordshire made themselves available in various guises but for some reason they did nothing between 1995 and 1997, it would appear, so that is two years’ delay, which is regrettable.

In March 1997 they attended a meeting with Dr Spencer and others to discuss their concerns regarding CNEP. The documents are not yet available so I will take you back to them in due course. The minutes of that meeting indicates that they were pursuing medic-legal proceedings. In February 1999 a review of research procedures was set up by the Department of Health, now known as the Griffiths Report, and it reported in May 2000. We say it was demonstrably flawed, but putting that to one side much of it really was to try and set up a watershed in relation to research across the board because there had been no real bringing together of the practice of practitioners. That is some 10 to 11 years after the initial application.

As far as we can discern, part of the reason why the GMC did nothing between 1997 and 2000 is because they were waiting to see what was happening with the Griffiths’ report, and certainly recent case law suggests that that is not a justifiable excuse. They should have progressed their own enquiries during that three year period. Henshalls we say two years, GMC another three years, we are up to five years now of unconscionable delay by 1997, and of course we are now 11 years on almost to the day since they were seized of the matter in 1997.

I wonder if those bundles could be distributed now, please?

Mr Forde who was representing in fine form continued

Mr Forde Continued

To the General Medical Council. You can discern that from the second page of the letter. The first full paragraph:

“We feel there has been a serious breach of the protocol...and would like to make this a formal complaint to yourselves the General Medical Council.”

Not a lot seems to have happened with that complaint, again possibly because the General Medical Council were waiting for the May report and from Griffiths. What then appears to have occurred, and we have not burdened you with the affidavit, although if you wish to see it you can, is that on 1 November, the Hens halls both swore lengthy affidavits detailing their concerns in relation to events that are between nine and eleven years old. Quite why it took the General Medical Council four months to get us a copy of that affidavit, I do not know and we have had no explanation; this, in an old case which needed to be got on with.

We gave a detailed response on 16 May 2001, which you will find top right number 3, right the way through to number 7. It was drafted with alacrity within six weeks detailing the allegations, setting out on its second page how the CNEP trial works – that is the third full paragraph – how the consent form was dealt with, accepting at the bottom of that page that Dr Spencer did not take part in either obtaining consents or allocating babies to one or other method of treatment, which we say was the clinical norm at the time.

An awareness then of the problem with the nexials dealt with in the second full paragraph, which forms the subject of a charge, said by the standards of the day and disputed by us, to have been a sufficiently adverse event to have been reported. The General Medical Council know that they are in possession of a report from Professor Hutton that does not support that view. The problem never occurred in North Staffordshire and so query whether a problem occurring in another trial centre needs to be reported to the trial centre that Dr Spencer was operating in. Tremendous care was taken was the neck seal, as is indicated in the letter.

You are not currently being asked to deal with the patient named on the fifth page, although you will discern that that was initially an allegation made against us, dismissed ultimately for the reason that that patient was under the care of a Dr Brookfield, from whom you may be hearing and against whom serious allegations were made.

Patient 6’s progress is then set out. At various times Mr and Mrs Henshall have alleged that the clear signature in relation to the consent form was a forgery, or alternatively that she was too distressed or under the influence of anaesthesia, having had a caesarean section, to give valid consent; not an allegation currently proceeded with by the General Medical Council, but something which may have informed the decision of subsequent preliminary proceedings committees, a very serious allegation indeed.

We then have the suggestion that CNEP compromised the care in relation to the blood gases, but that does not seem to include the situation which existed, that the umbilical artery catheter was doing that constantly. There is then an allegation in relation to the ultrasounds, again possibly with the benefit of hindsight. There is a suggestion of conversation between my client and the Hens halls in the documentation which I will take you to, but he simply cannot remember the precise terms in which he discussed the scan or scans with Mrs Henshall on 22 December 1992 or 29 December 1992. There is then some scurrilous allegations made which we deal with in the conclusion where, effectively, as has long been the case, my doctor is accused of lying.

On 12 December, the Henshalls having raised another thirty new points on 13 July which we did not comment upon, we were told that the matter would be considered by the Preliminary Proceedings Committee, which you will see at page 8 under the old rule 4. On 28 January 2002, we were told, in terms, that the matter could not be going any further. You will see in the third paragraph:

“The Committee carefully considered the allegations against you and concluded that the allegations did not raise an issue of serious professional misconduct. Accordingly the Committee decided not to take any action in relation to this complaint. In reaching that decision the Committee took account of the following...”

No real prospect of allegations being proved; substantial efforts to show the programme should be carried out and parents dealt with; a team of professionals; the protocol was peer reviewed; the fact that the research programme was not completed indicates that those involved had been properly prepared and properly managed – a very sensible approach, which I commend to this Panel. In relation to the taking of consent, it was needed soon after birth. The practice between 1993 and 1995, and we are dealing with practice between 1992 and 1993, 7 January, when the practice on consent was less rigorous than it is today. It noted that statements and affidavits of those patients who alleged that informed consent was never given, most concede that some consent was given but they are not in a position to assess it properly.

“The Committee noted the emotional stress they were under at the time of giving consent. In view of this, it did not consider that there was a real prospect of these allegations being proved to the required standard. It also considered that there was a wider issue involved about the taking of informed consent for the treatment of very young children.”

They then raise some concerns about the information provided. They go on to say, importantly, in 2002, so some six and a half years ago, and I have quoted it in my skeleton argument at page 7:

“That the concerns were with the benefit of hindsight and in the light of how informed consent may be obtained today... but in summary the Committee felt that those criticisms which could be sustained in relation to those issues were sufficient to reach the threshold of serious professional misconduct required for a reference to the Professional Conduct Committee.”

Dr Spencer, Dr Samuels, Dr Southall all written to in similar terms, along with Palmer, Raine, Modi and Harvey et al.

From Dr Spencer’s perspective, back to work with a sigh of relief, but no. On 2 May 2002, the General Medical Council write and say, “We are going to re‑open this case because we have forgotten to consider 1600 pages of documentation”. Again, nothing that can be said to have been influenced by doctor’s actions. We took the view, and still maintain the view, that those documents added absolutely nothing to the serious allegations that the Henshalls were making.

As I have said, four lever arch files were received which did not advance the original allegations follows by another detailed submission dated December 2002 which it took the General Medical Council about five months to supply; no explanation for that.

It is right to say that there was considerable toing and froing then as to whether or not the General Medical Council had jurisdiction to re‑open the case. A lot of jousting in correspondence, with the General Medical Council taking leading counsel’s advice, but the letter of December 2002 should not have been written if they were not sure of their legal ground. It cannot be seen as any fault on the part of the doctor to indicate considerable unhappiness in relation to that matter.

It took the GMC until January 2003, which is document 16 in the bundle, eight months after they said they were going to re‑open matters, to actually do so. We supplied a response on 24 March 2003, which you have at page 19.

Again you will see that the sibling, page 20, was involved, but no longer pursued now. You find that the other issues that you should be concerned with started at page 23, internal page 5 of that letter. We still have the forgery allegation. That was ultimately to be placed very fairly and squarely at the door of a Dr Kate Palmer, whose involvement in this case ended at the time of the judicial review proceedings, to which I shall turn to in a moment, and whose case – and we will supply you with this document – was dismissed in very similar terms to that which this doctor’s case was dismissed, never revisited despite the seriousness of the forgery allegations.

We invite comparison. We rely on the Newell report, which was 1995, and then there is a suggestion, no longer pursued, on page 24 that there was a delay, in appropriate treatment for the benefit of research, a failure to give surfactant at the relevant time, that is no longer pursued. The thoroughly scurrilous allegation was being maintained that these doctors were involved in procuring caesarean sections against the interest of the foetus in order to provide the requisite number of babies for the trial. No longer pursued, but something which had been hanging over these doctors’ heads for many, many years.

You will see from the top of page 24 that there have even been criminal investigations, as in fact there should be because if any of those children were subjected to caesarean section against their medical interests and subsequently died, there would be very serious charges faced by these doctors; nothing came of that at all.

Then they there are concerns about the monitoring of Mrs Henshall, not pursued. The problem that we have on page 25 regarding the scan, Dr Newell is quoted at the top of the next page:

“Patient 6’s respiratory distress syndrome was satisfactory. He makes no adverse comment on the use of oxygen saturation monitors...”

now pursued:

“...nor does he suggest that arterial blood gas analysis was given too late. He says it was not neglect to fail to do a scan prior to 8 days.”

which was an allegation being made against us:

“Standard of care and note keeping was commendable...no evidence of negligence or care of a poor standard.”

It would appear that the brain damaging event occurred in his view before birth. That, we believe, is the view of all the experts who have been instructed, but it has not deterred the Henshalls from making a causal connection.

The concern we have about the ultrasound scans is reflected under (iv). It is the last paragraph:

“There is no record about Mr and Mrs Henshall being told about the scan results. However it was usual practice to share scan results with parents. In this case Mr and Mrs Henshall would have been told the scan results were encouraging which Dr Newell confirms was appropriate.”

Again I have indicated the difficulties of us locating either that somebody would divulge that information or, more importantly, Dr Spencer recalling, after this length of time, the precise nature of the conversation, which we can demonstrate from other documentation, must have taken place. There is a delay in diagnosis, no longer pursued; exclusion of Patient 6 from the trial because of gestational diabetes, no longer pursued; false claims in relation to the value and safety of CNEP, not pursued in relation to the paper but pursued, it would appear, in relation to the informed consent allegations.

Then you will see under the section headed paragraph 51/35:

“Dr Spencer is accused of ‘lying to us about the nature of the trial and the trial result and about the status of [Patient 6’s] neurological damage’.”

Again it is a constant theme:

“Mr and Mrs Henshall do not specify these alleged lies (ie what Dr Spencer has said and when).”

The next page, page 27, deals with the clinical care aspect. We highlight the fact that the Henshalls tried and failed to make out a case of negligence in Patient 6’s clinical management:

“Since serious professional misconduct means a falling short of the expected standard of care to a serious degree, it follows a fortiori that a disciplinary case against Dr Spencer cannot be made out.”

That comment holds as good today as it did then.

A little more on the CNEP trial and a concern on the last page about the Griffiths report which we do not need to go into because, ultimately, the Court of Appeal were to criticise the DPC for weighing the competing claims of the Hey and Chalmers article against the Griffiths report.

You then have, and we think this must have been about April or so, further allegations from page 29 onwards, made by the Henshalls. Just to give you a flavour of that which this doctor has faced, if you turn to page 36, with a slight change of position it is not that, “I do not recognise my signature, it has been forged”, it is now, “I did not sign it knowingly”, and then, “I would never knowingly have risked my children’s lives for an experiment. I was duped. If I sign the form and the one produced does indeed bear my signature, all I can say is that it means nothing, it does not mean I knew what I was signing for, or that I had made an informed choice”. Of course you recall the first document you have, the complaints that were being made, including number 4. Monitoring of a child while undergoing CNEP was not the same as a previous child of theirs had. These are reasonably well‑informed parents.

There is a suggestion of conspiracy upon conspiracy that Professor Hull has been Dr Spencer’s mentor and he was asked to look into the Beverly Allitt case, they have co‑written papers; allegation of forgery specifically made against somebody. On page 38, a fairly detailed information being given about the placing of umbilical arterial catheters.

We are accused on page 39 at letter 6 of again lying and problems with the temperature of children and so on and so forth. At page 41, the large paragraph at the bottom of the page, we are said to have adopted estate agents’ language.

What we are really here for, in my submission, appears at the end of page 42:

“We trusted twice and it cost us the life of one much wanted and loved little girl and robbed the other of a fair chance of fulfilling a happy and normal life unnecessarily.”

That is what has motivated this complaint.

On page 43, up to page 46, we dealt with matters after the matter was reopened. We believe that that should be 28 January 2004 rather than 2003. We have a number of allegations set out, a lengthy document that deals with that which is to be considered by the Preliminary Proceedings Committee. Again I am not going to burden you with going through all of it, but it bears little or no relation to the charges that the doctor now faces.

On 19 February 2004 we sent another lengthy letter to the General Medical Council, dealing with the allegations as they then stood, and that would appear to have satisfied the General Medical Council to the extent that we received – and this is the document that you will have starting at page 67 – a very lengthy letter from the General Medical Council, considering now, in March 2004, the documentation that the General Medical Council had somehow managed to overlook when they considered the matter in 2003.

This is paragraph 3.15:

“On 27th February 2004 the decision of the PPC not to refer the matter was communicated by a very brief letter…” –

which I have not included in my bundle but I know that Mr Foster has in his –

“… On 12th March 2004, nearly 14½ years after the application for approval, 14 years after MRC alpha rating and more than 11 years after the birth of [Patient 6] the detailed reasons concluded as follows…”

This detailed document was then produced by the General Medical Council, going through all the documentation that had been supplied, and, as was later to be suggested by the Court of Appeal, the weighing of the competing claims was said to have been an inappropriate exercise. On page 70, the rationale that was given, in my submission, holds good, and I have quoted it in paragraph 3.15 of my skeleton argument:

“The Committee carefully considered the information before it. It also took account of the amount of time which had elapsed since the events in question and was conscious that the human memory could be unreliable in stressful situations. The Committee considered the majority of the allegations were unsupported by any evidence before it and had no real prospect of being proved to the required standard. Moreover, the Committee was of the opinion that where there was, or might be in the future, some evidence in support of the allegations, they would not reach the threshold for serious professional misconduct even if proved. Therefore, the Committee determined that the matter should not be referred for public inquiry before the Professional Conduct Committee and it directed that no further action should be taken in relation to these complaints against you.”

What then happened was that the Henshalls applied for judicial review in 2004 and that was refused by the judge at first instance on 15 December 2004, so that is nine months after we had been told for the second time that this was an end of the matter.

The appeal was the directed to the Court of Appeal. That appeal took place on 27 and 28 June 2005. Of the ten matters of complaint put before the court, only three topics are now pursued, and we can identify those if you need to; I do not think there can be any dispute about that. Lord Justice Auld dissented; Lord Justice Sedley gave the leading judgment. The two substantive grounds on which the matter was referred, neither of which dealt with my client’s handling of the matters, were that Dr Southall had withheld his comments on the Henshall allegations, that he had been subjected to some concerning behaviour in the past, I think including a burglary, and was concerned about confidentiality going to the press, and the court was not happy about that and was not happy about the competing claims of the Hey Chalmers report against the Griffiths report. It took the Court of Appeal until 13 December 2005 for the judgment to be handed down, and one possibly discerns problems in deciding how the case should be determined, but again that is not something that is the doctor’s fault.

What then happened was that the Henshalls put in some more observations in September 2006 and the matters were then reconsidered for the third time on 2 November 2006, and that is the point at which we need to take up D1-B. Just to assist you, basically what happened – that first letter should be 28 January 2004 – was that the same potential charges were just sent out again in 2006 and then the Panel invited our comments on 13 October 2006 and we referred them to our previous letters, which you have seen, and then on 2 November 2006 we got the disappointing, but perhaps not entirely surprising, observations from the PPC, indicating that the matter should be referred to you. They were conscious, looking at our page 85, the third full paragraph, of the fact that the events were alleged to have happened 14 to 16 years ago and conscious that it should consider the allegations according to the standards of the time.

Quite how the PPC were able to do that certainly remains a mystery to us. They fall into the very trap, it would appear, that the Court of Appeal were disapproving of in comparing the Raine thesis against the Lancet article, because they are not judges of the evidence. They described the consent form as misleading or disingenuous, which is not something that we accept, rather skate over the fact that the Ethics Committee passed the application, said that it was not made sufficiently clear that premature babies were the primary subject of the study, which frankly is astonishing, given that the supporting documentation made it clear that the babies had to be within four hours of birth. If that is not premature, I ask rhetorically, what is?

They go on to decide on which charges, by reference to the first document that you have, should go forth and which should not. Apparently Mrs Henshall was able to indicate that only one day’s training took place. There was a conflict of evidence that they could not seek to resolve in relation to training. The ultrasound scan was in there, could not be resolved, gestational diabetes they decided should not be referred. Neck trauma: clear that there was a nexial problem with the apparatus – well, there never was – at Stafford, so that has to be referred, and that is effectively why we are here today. As I have said, it took them until November 2006, judgment having been given a year previously.

I am going to deal very briefly, if I may, with the law, and I do so relying only on the passages that I have in my skeleton argument, but can I summarise the position in this way: Ms Sullivan and I had a fruitful conversation this morning and in essence I think our agreed approach, subject to the views of the learned Legal Assessor, is that the two routes that you can go down in deciding that there has been abuse of process by reason of delay are either by way of Article 6 of the European Convention on Human Rights, which effectively suggests that the time runs from the moment that the General Medical Council are seized of matters. So, depending on your views as to the Henshalls’ delay, it would appear that that is only from April 1997. However, under the common law we are able to argue that you can look at the whole of the period, so that is from 1989 to 2008, and therefore under the common law you can express dissatisfaction about the length of time that it took the Henshalls to progress matters. In any event, there is no real explanation for the General Medical Council’s delay between 1997 and 2001, and certainly any delay occasioned by the failure to consider 1,600 pages of notes is not something that can be the subject of any criticism on the part of the doctor, and at the end of the skeleton – I will come to it in a moment – I quote a recent decision that suggests that the GMC cannot hide behind administrative delay under its new five-year rule. That is the basic position.

I have summarised what Article 6 allows. It is a fair and public hearing within a reasonable time before an independent and impartial tribunal. The right to a determination within a reasonable time is a separate guarantee, so, in other words, you do not have to find that it is fair and public, that you are independent, that you are impartial, and therefore, because those are all ticked, the time delay is not an issue. It is a stand-alone right that any doctor has appearing before this tribunal.

I say, I hope fairly, that so far as a breach of Article 6 is concerned, time has been held to run from the time that a practitioner is notified of the allegations made against him and procedural delays thereafter. You know that the initial notification was in 2001, so that would suggest a time period under Article 6 from 2001 to 2008, so it is seven years. However, I remind you of the fact that so much time had passed before then that a fair trial was almost certainly impossible even at the time we were initially notified.

It is right that you are informed of the fact that the case law – and I am sure that Ms Sullivan will rely on this – suggests that a stay can only be imposed on the grounds of unjustifiable delay in exceptional circumstances. We cannot countenance circumstances more exceptional than these, given the unconscionable and considerable delay. No default on the part of the practitioner, and I do not think that anybody is pointing to any.

One matter that you may be invited to consider is the approach of the criminal law. What is often said in the criminal context – and although you approach this applying the criminal rules of evidence, you are not a criminal court – is “Well, the defendant has had a long time awaiting his trial but the judge can sort that out, because if the judge was going to give the defendant nine years, he can say ‘You have waited five, so I will give you four’, or ‘three’ or ‘six’.” In my submission, there is a very real difficulty in importing that approach into disciplinary proceedings. You are aware of the fact that this case has attracted a great deal of publicity and you are aware of the fact that regardless of any decision that you make, whether it is ultimately that this application succeeds or whether it is ultimately that the case is not found proven rather at the end or at half-time, the press will almost certainly report that the General Medical Council is pro-doctor; that is the reality of the situation. Similarly, in my submission, you would be very constrained, if this matter was anything like approaching serious professional misconduct, if in the announcement of your sanction you were to say, “This is a case where we would have erased but, because the doctor has had to wait 18 years, we are going to impose conditions”. There would be outrage, and it would be justifiably asked whether you were acting in the public interest, if this doctor had practised since 1989 without restrictions and you now thought it sufficiently serious to erase. So, in my submission, the criminal cases do not assist because you are unable to tinker with sanction in the way that the criminal courts can. It is interesting to note that in the cases in which that has been alleged it has been prison sentence-lessened rather than, “You would have gone to prison but now I am going to give you community service”. It is not a huge difference in sanction.

I say in paragraph 4.6 that the state of the neonatal art and attitude to trials in the late 1980s, nearly 20 years ago, will have to be considered by any Conduct Committee and that this cannot be done fairly at this distance in time; and everybody, in my submission, will struggle to do that.

We say that the delay of itself, regardless of prejudice, which I shall demonstrate probably after lunch now, is sufficient for you to be satisfied that for these proceedings to continue would be an abuse or process, and I come back to the question: what were you doing on Tuesday, 15 December 1992, doctor? Surely you can tell us”. It just is not something that is necessarily going to be capable of proof one way or another.

I suggest an approach to be adopted by you, and I have quoted the passage from Dyer v Watson. Again this is, of course, subject to not only the views of your learned Legal Assessor but you will no doubt be addressed by Mr Foster possibly briefly, but Ms Sullivan at greater length, about whether this is an appropriate approach, but in my submission the first step is to consider the period of time that has elapsed, and if on its face that gives ground for real concern, as I suggest it should here, it is almost certainly unnecessary to go further. I accept that the threshold is a high one and not easily crossed, but it goes on to say:

“But if the period which has elapsed is one which, on its face and without more, gives ground for real concern, two consequences follow. First, it is not necessary for the courts to look into the detailed facts and circumstances of the particular case … Secondly, it is necessary … to explain and justify any lapse of time which appears to be excessive.”

We are still awaiting explanation, as I say in paragraph 5.2, and I come back to the period of time that I say should give you cause for concern.

It is right that you are informed, as I set out in paragraph 5.3, that the burden of establishing unjustifiable delay lies on the practitioner, but it is only upon a balance of probabilities, so is it more probable than not that the delay will prejudice the defence of this doctor many years after the event? The answer is “yes”. In my submission, that is the only answer that you can sensibly reach.

We do not concede that we need to demonstrate prejudice, but we can clearly do so, as I say in paragraph 5.4, and I give a further reason why you cannot regard yourselves as operating as a criminal tribunal. A judge, of course, cannot really influence how quickly a matter progresses to court, but you are embodying the General Medical Council, who certainly since 1997 were part of the investigatory process as well as prosecuting this action, so they are able to fulfil every aspect of the investigation and prosecution. A judge cannot ring up the local constabulary and say, “I had a bail application three years ago in this case. Can you tell me what is going on?” That is not what happens, but the GMC, through its offices, are well able to do that.

Can I then just deal with prejudice? I am thankfully going a little faster than I thought I might. We are able to demonstrate prejudice in this case in numerous respects, and I set them out on pages 14 and 15. I will add in an additional matter of prejudice that my client has informed me of this morning and I understand that Dr Samuels has similarly been affected. The first is obvious - the overall delay. 16 to 18 years makes, we say, a fair trial well nigh impossible, even in a case which may be said to be document heavy, you are dealing with attitudes of some years ago.

The evolving science and difficulties of recollection on the part of both the practitioner’s witnesses and any experts as to the state of neonatal art and the approach to trials in the late Eighties and early Nineties. The only General Medical Council guidance in 1989 that I can find effectively said if you are conducting a trial can you please make sure you are not getting a backhander from the pharmaceutical company. Your current guidance is far more detailed in relation to ethics and ethical trials and those of you who were practising at this time will know that there has been a sea-change in attitude in terms of ethics and ethical trials. There is no suggestion here upon the charges that any child came to harm as a result of this trial, whatever the Henshalls may believe. Nowhere will you find a charge that their child was damaged or adversely affected by CNEP.

We have a problem with the communication of the ultrasound scans which I have already flagged up to you. We do not know when the scan report was entered into the notes and, if so, by whom. We have a problem reconstructing Dr Spencer’s likely working pattern and whether any junior doctor can now be identified as having communicated the results of the scan so that after the event we suspect that is likely to have happened.

There are very real problems around this time period – 22 to 29 December – with the doctor recollecting what his duties were. He instructs me that in keeping with many in the profession he is unlikely to have worked both Christmas and New Year. He remembers that his son’s birthday is 28 December, as one would hope any father would, but that is about as far as he is able to go. It, in my submission, beggars belief that a failure of communication, non-causative as it demonstrably is in any event, could found a finding of serious professional misconduct 16 years ago. You forgot to tell a patient about a scan which was probably non-sinister.

The training allegation is another one that causes us difficulties. The difficulties of the recollection of systems relating to training, in particular communication of oral notification of changes to protocols which may well have occurred because that is the way things operated at that time, we certainly cannot identify potential witnesses very easily. We delegated quite properly training to senior nurses. The training offered to doctors at the time was very much on the job. Now we are in the world of 360 degree appraisals, clinical governance and that just was not in operation at this time, so it is difficult for us to demonstrate in a documentary way precisely what was going on.

My client tells me that he cannot find, but knows that they were in existence, the relevant clinical protocols that were there on the ward in the late Eighties, early Nineties. He has been able to find a 1994 protocol which we may be able to put to somebody such as Dr Brookfield, but he cannot find the ones extant in 1992. There is a very real prejudice there because these protocols would have been drafted by clinicians and nursing staff and should have been adhered to and that may be a particular importance when one comes to look at the allegations in relation to the taking of blood pressures at this time delegated to highly trained, highly competent nursing staff. As I have indicated, the majority of the time he was probably asleep in relation to one of the allegations and I can take you, as I know Mr Foster would like you to have the Panel bundles to the nursing care plan which indicates that the taking of blood pressures and the observation of vital signs was something which the nurses undertook in that care plan to do.

The stress of the proceedings is not to be underestimated. Ironically we have had several letters from officers of the General Medical Council regretting the delays in this case which we shall place before you after lunch. This is not to be underestimated, particularly if assurances had been given that matters were not being pursued. On two occasions these doctors had thought they could resume their careers unblemished and beyond criticism. I also complain, as you will have seen as a recurrent them with me, about the usual attendant unbalanced publicity and potentially remediable damage to professional reputation. You are not going to get a “Doctor not guilty” headline in this case. The reporting will be unbalanced and inflammatory. It is interesting that the moment I rose to my feet the press disappeared because all they were interested in was the appearance of the Henshalls. They are not interested in the justice or injustice of the situation of dealing with events that happened two decades ago.

The unavailability of witness – this is extremely prejudicial, particularly due to the lack of particularity that still exists in the charges. We have asked about this. Mr Foster, I know, has developed his skeleton argument to suggest that this is a further abuse of process. Dealing with the charges that we now face, we in particular have been concerned about charge 11. That suggests that we failed to ensure that appropriate procedures were in place to obtain informed parental consent to the patient’s participation in the CNEP trial.

The initial application had a Parental Information form which we are instructed was exemplary by the standards of the time. What we have never been told is exactly what it was that we should have done in order not to have to face this charge. In what material respects are our procedures deficient and what should they have been? We still await confirmation of what that should be because it is not something which appears to be supported by the paediatrician instructed by the General Medical Council, but by an ethicist who, as far as we are aware, never conducted a clinical trial in a clinical setting.

What training is it said would have been adequate for the time? Is there anything more than the technique being shown to be safe which is said to be a misrepresentation? Again, one is looking at the standards of the time. You will recall that Dr Spencer came to this in 1989/1990 and certainly papers published by his colleagues, Dr Samuels and Dr Southall, in 1986 indicated that it was a safe procedure. It is our submission that he was entitled to rely upon their research up to that point. I have dealt with 11(d). A clinician in Dr Spencer’s position simply cannot ensure that every parent has a copy of the Parental Information sheet and the likelihood is that those that said they did not get it have simply forgotten.

Allocation of scores – we are still debating that and we understand a little more of the General Medical Council’s position but, simply put, clinicians involving statisticians, to what extent would that ever found SPM?

I have dealt with charge 16, the difficulties that we have in recalling where we were and what we did but you can rest assured that it is unlikely this doctor was in the hospital before about 8.30/9 o’clock on Tuesday 15 December if he was there at all. The period of time from 003 to let’s say 9.30, because it seems to us is not a fair period to allege against this doctor if he was at home asleep. We may be able to reconstruct from the notes that Dr Brookfield was on duty at the relevant time. He is no longer the source of your inquiry.

We require to have identified to us, even at this late stage as far as paragraph 17 is concerned, every single period between this child’s birth on 14 December 1992 and 7 January 1993 when she was discharged when it is alleged that there was a failure, whether by us or nursing staff, to ensure that appropriate and regular blood pressure checks were undertaken and/or recorded in the notes. We have never been given that and there are real difficulties in this area. Some of you will be aware that it was not uncommon at this time for nursing staff to record notes on a private document or notebook and then complete the formal record at the end of the shift because they are busy looking after some of the sickest children in the hospital. Note-taking whilst important is not as much of a priority as dealing with saturation levels plummeting, alarms going off, arrests, concerns about shunts and hydrocephalous. It has a priority but how high? We cannot identify from the notes who might have been on duty. We can certainly look at the nursing care plan and see that the nursing staff appeared to have taken responsibility for that role.

We are still awaiting finalisation of the General Medical Council’s witness list and we are still getting as recently as last Friday more material though it would appear to be a completion of material rather than entirely new material, so I would not want you to think that it is entirely new, but it will still take a bit of looking at. We understand that somebody is going to be called to deal with the ethical position who did not work within the trust at the relevant time and we have certainly seen documentation which suggests that the views held by that witness may not be adverse to our position.

I then deal finally on the question of prejudice in the skeleton at least with the lack of availability of notes, training materials and the scans, documentary evidence of written communications regarding alleged adverse events, scoring systems and modifications to protocols. My doctor believes that he would have had some contact with Queen Charlottes but he cannot recall now and we know that, apart from minutes of the Local Ethics Committee dealing with the application in 1989, there is nothing else and we are certainly of the view, my client ironically having been involved in medical ethics shortly after this incident from 1992, there would have been more minutes. There may have been communicated amendments to protocols which were criticised for not having undertaken, either in writing or verbally or recorded somewhere, not a chance of finding them now. As I have said,

“This is a considerable handicap to practitioners and experts trying to reconstruct at this distance in time, treatment modalities, thought processes and the exercise of clinical judgment in an evidential vacuum.”

It also causes us, as representatives, some difficulties. I conclude by saying:

“Such prejudice is so severe it cannot be remedied by the burden and standard of proof.”

Sir, would you be prepared to adjourn a little early. It is ten to one. I just want to ensure that the next slim bundle that we have is ready to be handed out. I want to have a discussion with Ms Sullivan about whether she is happy for you to have the Panel bundles in advance of her opening because there are four or five pages I would like to take you to, but in fairness to her I have not raised the issue.

The chairman then stated “Would you think, however, that the matters which you have just been talking to us about at section 6 under the heading “prejudice” would be the sorts of considerations which the Lord Chief Justice had in mind in Dyer v Watson when saying that it is necessary for the courts to look into the detailed facts and circumstances and the outcome is closely dependent on the facts of each case. Mr Forde then submitted “My primary position is that you ought to be able to go back into your room and say this is so old we do not really need to find prejudice, but if you do need to find it, then we have it in spades”

If the primary decision is that you cannot have a fair trial, then that is the end of the matter. Just to give you a couple of examples, it was somewhat ironic to those of us practising in crime at the time the police officers were accused of perjury in the Guildford Four and Birmingham Six cases were able to say because our alleged perjury was undiscovered as a result of our nefarious actions for 20 years we cannot have a fair trial and the court agreed and then abuse of process started to be looked at a little more closely.

There is a case in Archbold which is 56 years old and, in my submission, although the High Court have always suggested there is a discretion open to a judge if there has been delay, again it is extremely rarely exercised. If you think about the sex abuse cases, particularly arising out of children’s homes, some of which are 30 years plus old, no suggestion that a judge says I am going to reduce your life sentence, even though you are a danger to children, because of the delay. It is a discretion which, in my submission, is sparingly used but not one which is, in reality, open to you because of the way in which this body is perceived by the public. If you were to conclude that a doctor should be erased it would be difficult, in my submission, to justify a lessening of sanction, but you will understand that Mr Foster, Ms O’Rourke and myself are reasonably confident that that is not a decision you will have to make ultimately.

Clearly, Mr Forde had his three shredded wheat and continued to work in defending the doctors. This is what he said

I have been made aware I have been going rather quickly, so I will try and slow down a little.

Before I return to the skeleton argument in relation to prejudice, I think it may be of assistance to the Panel if I take you through the charges, so you are able to consider them separately, as I am sure you will be advised, and indicate the prejudice that I suggest this doctor has suffered from, or will suffer from, if the matter proceeds.

Might I deal with first matter, which is charge 3(a). You have not seen the application, but we apprehend that the fact that it also referred to an infra red trial at the time of application, is criticised because not all babies who were subject to CNEP, at least initially, were also subject to the other trial, which is known as NIRS.

It is our case that in 1989 it was not uncommon for applications to go above and beyond that which was the subject matter of initial trial, in other words not all changes to protocols were necessarily notified. We are supported in that view, to some extent, by the General Medical Council’s paediatric expert, Dr Stimmler, and with the agreement of my learned friend I will read into the transcript a record of the conversation which took place with him recently. This is very much a charge which will require all witnesses to try and recreate the culture in 1989 which may be extremely difficult.

Similarly in relation to charge 6, there is no dispute that in February 1990 a patient at another hospital, Queen Charlotte’s Hospital, was found to have experienced neck trauma. As you are aware, our entry point for babies was not until April 1990. Our application had gone in on 29 November and had been approved on 10 January. Our case is, by the standards at the time, that was not an adverse event which mandated a re‑referral to the ethics committee of North Staffordshire Hospital. It did not occur at our hospital.

It is also possible it was discussed by my client with the chairman, but he cannot recall, and there is the possibility of further minutes revealing the reporting of the matter; again, not something which appears to be supported by the General Medical Council’s paediatrician, although I believe commented upon by their ethicist.

As far as changes to the scoring system are concerned, you know that those are dealt with in paragraphs 7(a) and (b). It is our case that eighteen years ago such a change did not mandate going back to the ethics committee. Again, first point, the relevant culture at the time; second point, difficulties of recollection; third point, possibility of missing minutes or notes.

The surfactant point is another criticism. Again, it is our case that this was not a change of the protocol which should have been reported. I make the points I have made in relation to paragraph 6 and 7. There may well be different views as to whether it was or was not something which should have been reported all that time ago. My client may not have reported it but, in any event, you will see from his correspondence in our bundle that it was introduced across the board, and I will take you to some comments made in conversation with Dr Stimmler.

The same point can be made in relation to paragraph 9 and paragraphs (a) and (b). There is no dispute that there was a change to the exclusion criteria from that at the time of the application in 1989. It may or may not have been notified, it did not place any child at risk, it was not sufficiently serious by the standards at the time to be something which needed to be notified to the ethics committee in any event. That is something which you will see reiterated in the correspondence in our D/AB1 and we have denoted it.

The difficulties with charge 11 I have touched upon already, and they only bear very brief repetition. The role of a responsible investigator in 1992, which is really the period we are most concerned with – but perhaps between 1990, 1991 and 1992 – again will require investigation of the responsibility of an investigator, and whether there was appropriate delegation to medical and nursing staff. We have asked for particulars of this as to whether there was a set limit. It seems to encompass both staff at Queen Charlotte’s and North Staffordshire. As far as the charge against my client is concerned, it is not clear. You will see the charge is mirrored in the Southall charges, although he was not working at the North Staffordshire Hospital at the relevant time.

We are still struggling to know what “adequate training” would have been, as set out in 11(b), what the misrepresentation is said to have been in 11(c), because, as I have indicated, the contemporaneous documents, certainly the studies in 1986 by Samuels and Southall, suggested safety. We struggle to, first, demonstrate that every parent had a copy of the parental information leaflet at this distance in time; secondly, to see why that is not a responsibility that could be delegated to an appropriate junior member of staff or appropriately trained nurses; and, thirdly, that allegation is maintained despite the fact that the Hull report seems to suggest 90 per cent plus of parents, again it has been dealt with in correspondence, were happy that they had been given adequate information.

The role of the responsible investigator in paragraph 12, in relation to the statistical evidence, again will require examination of the state of the art between, perhaps 1989 and 1992 in my client’s case, are difficult. There is no dispute but that a statistician, Mr Alexander, was part of the original team and it is really a matter for you as to whether you feel at this distance in time that you are able to assess the responsibility of clinical members of the trial team when they are employing a dedicated statistician.

The remaining charges perhaps cause us the most difficulty in terms of recollection and specific times and the reconstruction of events. I start with paragraph 16. I have made the point that my client believes – but it would be of course joyous from our perspective if we could produce work rotas and clinic times – that he would not have been present until about three hours before the end of that time period. We will have to, and we have struggled to, identify, and probably will never be able to, relevant nursing staff who would have been responsible, we say, for ensuring that vital signs were appropriately monitored.

I have managed to identify – and my learned friend is happy for me to read these into the transcript – the care plans. The first point to make is that with Patient 6’s sibling, born some ten months before, for the benefit of my learned friend it is page 3 behind tab 4 in panel bundle 2, there is an entry which makes it clear that the nursing staff, as part of their care plan, the need is identified as to breath unaided in air, and the care plan is, ventilation, monitor, respirations, oxygen, saturation, and I think that word is apex. That must be the heart. There is an umbilical catheter in situ and the blood pressures to be monitored via a transducer. That was 12/2/1992, so that gives you an indication of the normal standards within the unit and we say the doctor’s reasonable expectation of that which would be undertaken by nursing staff.

Then dealing with Patient 6, behind tab 5 at page 13, the nursing staff on 14 December are indicating that they will explain, something my client cannot decipher, but it looks like “explain IFC to parents”, “encourage parents to participate in care”, and then, more importantly, “inform parents of any changes in treatment or condition”. On the next page, page 14, “To observe respiratory pattern and rate, record oxygen saturations and to record and report any brachycardias or apnoeas”.

On page 16, again recorded as the responsibility of the nurse, “To administer oxygen as necessary, to observe breathing pattern and rate, to record saturations and vital signs, to record pressures and oxygen requirements, oral suction and endotracheal suction as required, to observe perfusion colour of lower limbs”, a whole raft of things properly delegated to experienced nursing staff which appear now to be levelled against us as criticisms. Never mind the time period in paragraph 16, in my submission the suggestion that a clinician was entirely responsible for these failures, if failures they were, is most unfair and difficult to defend at this distance in time. If we had been in a position to call the relevant nurses or identify the handwriting, it may have been possible to call them in rebuttal, but that is not something we seem to be in a position to do at this time.

That is a submission I make only in relation to paragraph 16. If I turn to paragraph 17, we have asked for each time period when it is alleged that during this doctor’s involvement in Patient 6’s care he failed to ensure that appropriate and regular blood pressure checks were undertaken or recorded in the notes. We had taken that possibly to be the same time period between 0.003 on 15 December and 12.30 on 15 December. It is right that this patient was booked in under Dr Spencer’s name and you know was born on 14 December and was discharged on 7 February. If it is the General Medical Council’s case that there were defined periods within that three week period or so, when we failed to ensure that appropriate and regular blood pressure checks were under or recorded, we would have liked them to be identified. At the moment we are struggling with this charge.

It is possible, for instance, or would have been had they been more closely defined, for this doctor to try and reconstruct events. He has, for instance, suggested to me that if the records existed of his outpatient clinic letters on any given day, he might then be able to say, “I know sixteen years ago that I did an outpatient clinic on a Wednesday afternoon”, and if that coincided with the time period when this criticism was being made of my client, we would be able to rebut it. But with the lack of particularity in that allegation, we are struggling to meet it because of the delays in this case.

And having taken a deep breath Mr Forde continued again

We very much doubt that we will ever have it available to us, which is the problem of the delay, but you are right to point out that it is a subtle variation on the delay abuse argument, and in fact has been dealt with I think most adequately by Mr Foster in his skeleton argument, where he is suggesting that lack of particularity is of itself an abuse. He also complains about the difference between matters placed before a PPC and those with which we currently stand charged, because one of our concerns is that if the expert evidence had been available to the PPC in the form that it is now, this matter may not have come to a Professional Conduct Committee, but that is not something that we will ever know.

If I can take 18 and 19 together then and just to give you some indication of the difficulties that we face in this regard, we again have some of the entries in the notes; just bear with me for one moment. There is alleged here a failure to inform parents of an abnormality on two separate occasions, 22 December and 29 December. It is not clear when the ultrasound report found its way into the notes. We have not seen the ultrasound scans and we do not know whether we were on duty at a time when they were available to us. What we do have, however, is some correspondence between the Henshalls and the Directorate of Child Health, Child Development Centre, Stoke-on-Trent, and for the benefit of my learned friend it is proposed Panel bundle 2, behind tab 5, page 209. That is a letter from Dr Heycock, a female practitioner, to Dr Spencer. It was typed on 30 June 1994, dictated on the 29th, and it refers to a clinic on 28 June 1994, therefore nearly 14 years ago.

In essence, the Henshalls during their consultation with this consultant paediatrician apparently initiated a lot of discussion about Patient 6’s management on the neonatal unit and were concerned as to why Patient 6 was ventilated on day 3 rather than day 1, but importantly, in terms of finding of witnesses and recollection, because my client simply cannot remember whether he had a discussion but believes that he is likely to have done or one of his junior staff may well have done, it says this:

“And she was also concerned that although she was present at the time of [Patient 6’s] ultrasound scan of the head, she was told this was normal.”

There have been suggestions that she was never told about the abnormality until such time as Dr Newell reported in November 1995, and again it is the subtleties and the nuances. It may have been that she was told that it was normal. She may also have been told, as my client believes she ought to have been told, that it was virtually or essentially normal, and therefore we are now dealing with an allegation of failure to inform of abnormality. These are shades of grey, I am afraid, which, to mix metaphors, must now be lost in the mists of time.

My client wrote in response to Dr Heycock on 28 July 1994 – and that is our page 211 – saying:

“I have offered to see this mother in my office on two occasions to discuss her concerns re [Patient 6]. The first appointment was cancelled and on the second the parents did not attend.

With regard to conflicting advice about the scan, I would note that [Patient 6] had mild symmetrical dilatation of the lateral ventricles and at one stage there was the possibility of a clot attached to the choroids plexus on the left side.”

You will see that in paragraph 18. He continues:

“The ultrasound changes could be considered virtually normal in a

pre-term infant and would not in any event be associated with increased risk of handicap.”

You will recall what I described as the motivating factor in 1997 for the complaint that a causal connection in the minds of the parents between this scan, although Mr Newell was to say that he thought the brain damage occurred prior to delivery, but they remained convinced that there is a causal link between the scans and their daughter’s current condition.

We have also been supplied with some of the comments that have been made by Dr Stimmler, who is to be called by the General Medical Council if this matter continues. In relation to surfactant, he is recorded as saying that he hopes the surfactant had been evenly distributed between both limbs of the trial, otherwise it could have affected the results. He said that the introduction of surfactant could not have been foreseen at the beginning of the trial and it was not a good enough reason to stop the trial.

In relation to the handing of booklets and information sheets, he thought that two leaflets should have been given, one medical and one nursing. It was most important that they had the medical information sheet. Well, we have a note that says that the parental information sheet was given to the Henshalls and that it had a tick next to it in the clinical notes, and that is the best we can do. In an ideal world there could have been a similar leaflet describing how positive pressure ventilation worked, but you will appreciate that we are not dealing in an ideal world.

He was asked about the neck injury and he is recorded as saying that injuries occur very easily in premature babies. Dr Stimmler was not surprised by the injury seen in the photograph. He did not believe that it could have been foreseen, and you will recall that it did not even happen at our hospital.

Dr Stimmler was asked whether the researchers should have returned to the Ethics Committee at this point and he said “No, it was probably just to proceed with the trial”.

He was then asked about the weaning off of CNEP and he apparently said that it would be the SHOs who would do the weaning and the consultants would rely on them.

In relation to head scans, he thought that one at discharge would have been appropriate, but we have one very close to discharge; and he expressed a personal view that the abnormality shown on one of the scans – it is not clear which but I think it is the first – should be told to the parents. He said that it was a personal view but he thought that it was generally accepted.

Once he had received the draft charges, he appears to have had a further conversation on 25 March 2008. He said in relation to randomisation that he had never come across it before, this specific method, but that it seemed reasonable, and suggested that a statistician should be asked to comment on this. You are aware that Professor Hutton’s views have led to an amendment of the charges.

With regard to the allegations relating to the failure to return to the Ethics Committee, he was not sure that an average person would have returned to the Ethics Committee at such junctures or whether an Ethics Committee would demand constant appraisal.

In relation to the charge that consent had been delegated to too many people, which I think is our charge 11, he said that given that the babies were being born at all times during the day and night, he did not see that it was unreasonable to delegate consent to the staff members on duty, and he did not see how this could be avoided. He commented on how the members of staff had given a reasonable account of how they would have taken consent. In his opinion, the technique had been shown to be safe on older babies and it was the introduction of the technique to younger babies that was new. He thought that generally it was acceptable to extrapolate the findings in older babies. So that gets round the alleged misrepresentation that the technique had been shown to be safe in paragraph 11c.

He was asked about the 12-hour period of monitoring and the readings that are the subject matter of charge 16. He thought that he had maybe been slightly too harsh in his report and that the period of criticism is really a 12-hour period, which therefore affects the readings that are to be included in the charge. Dr Stimmler mentioned that he was not sure that an FTP Panel would find this to be misconduct, as it is the type of incident that are frequently the subject of compensation claims. So, at best, negligence, which we know is not enough for SPM.

Then Dr Nicholson, whose impartiality I know is questioned by Mr Foster ---

The legal assessor stated "

At the moment, with that last bit, you are in danger of proving that you can defend the case."

Undeterred, Mr Forde continued

No, no, it is not that. What I am suggesting is that if there is a lack of certainty on the part of an expert, he is having a discussion – for instance, “Not sure the average person would have returned to the Ethics Committee; it was probably okay because babies are being born at all times during the day and night” – to then have charges that are critical of this, where there is wavering on the part of the General Medical Council expert possibly as a result of his inability to reconstruct events at the time, puts us in a very difficult position. It is my submission that we are not here dealing with a case which, when you come to exercise your discretion, should concern you because it is overall a strong case in any event, but we do have very real difficulties – and I know that Mr Foster will develop this in his submissions – in dealing with certain aspects of this case that have not been particularly strongly put by the General Medical Council’s experts.

We compare and contrast that, which is another aspect of our complaint as regards abuse, with the strong views expressed by the Preliminary Proceedings Committee, and having had no opportunity to deal with these aspects of the expert evidence until we have a Professional Conduct Committee hearing. That, it seems to us, cannot be a fair position. These comments could have gone back to the Preliminary Proceedings Committee for review. We have not had an opportunity to comment on the stance of these experts until I am doing so now.

I do not labour the point, and it will obviously be a matter for you, sir, as to how you advise the Panel as to whether I have strayed into the merits of the case to too great an extent, but I hope that the Panel can appreciate that when tentative views are being expressed, it could be, and I cannot put it higher than that, because even the GMC experts are struggling to reconstruct the culture at the time.

Bearing in mind your comments, sir, I do not think that I need to trouble you with the Nicholson comments, because on reflection they are probably straying into the arena of what can be proved and disproved.

My client wishes me to make the point – and I cannot find the reference in my bundle so far – but when I was taking you through the initial 75 pages there is a reference – and this is just the point that he wishes me to make despite the views of the Henshalls – to the fact that the Henshalls were consulted during a post-trial study, a long-term follow-up study was conducted comparing the outcomes in CNEP babies with babies on standard care, they were part of the steering group and it did not demonstrate any detriment to the patients in CNEP. I think that reference will be found for me.

Sir, can I just return then to the skeleton argument briefly, if I may. I think I had almost finished the prejudice as set out in paragraph 6. The one additional aspect of prejudice of which I have forewarned my learned friend about, and I think Mr Foster has a similar submission to make, relates to the thwarting to some extent of my client’s career whilst these matters have been hanging over him. He is quite confident that had he not been the subject of these proceedings for so long, he would not only have the qualifications but is likely to have been invited to have been the Medical Director of this Trust. He has been a long-standing consultant, and obviously his attitude to research has been quite severely affected by these allegations.

I am told, sir, that that reference is D1-B at page 83. That is the reference to the outcome. It is quoted in italics. Can I make it clear, both for the benefit of my learned friend and the Panel, that I do not place reliance on that? It is obviously important to Dr Spencer in terms of his view of his scientific credibility, but I would not invite you to necessarily adopt those findings. You have not heard the evidence and you would be falling into the very trap that the Court of Appeal criticised the previous PPC for, namely accepting one version against another. Dr Spencer was just anxious that I make the point that we had replied in that way.

Can I then move to the position under the new rules? I appreciate that this is not necessarily something that the Panel will have had to consider, and I can find no authority dealing with this point, so we are in uncharted waters here and I fully accept that.

The primary submission that I make is that the reason for the amendment to the 1988 rules initially in 2002, which introduced a five-year rule, and to the retention of that in Rule 4(5) of the 2004 rules is because of a very real concern on behalf of the public, practitioners and the GMC that old allegations would or might be unfairly pursued, and we are all concerned here about fading recollection and reconstruction of events.

The only exceptional circumstance that we were given at the time of the reconsideration that led to delay back on 17 January 2003 was that the loss of the documentation of itself amounted to an exceptional circumstance. In my submission, that only has to be stated for it to be quite obvious that there is nothing exceptional about that position at all. The courts have been visiting and revisiting this matter in relation to Rule 4(5), and at the end of my skeleton I quote two recently decided cases, which I am happy to supply to the Legal Assessor if he wishes to see them, but I hope that I have quoted them fairly.

It is my primary submission that you should look at the five-year rule and use it to inform you decision. I cannot pretend that it was in existence in 2001. It came into force between the first decision that this matter would go no further and the second. We were told in no uncertain terms that we could not import the new rule 6.8 into these allegations because they were too old, ironically, and we are really caught between a rock and a hard place. If the allegations had been even further delayed we would have had a run post 2002 on the five-year rule and obviously if they were being brought post 2004 we would be seeking to place an onus upon Ms Sullivan to say what was exceptional about this case. It is not exceptional because the Henshalls want it pursued – all complainants want their complaints pursued. It is not exceptional because they believe, erroneously we say, that there was a causative link between CNEP and the demise of one child and the brain damaging events relating to another. There is in truth and fact nothing exceptional about this case apart from the length of time it has taken the GMC to pursue it.

The case of Gwynn I deal with in paragraph 6.5 which did involve an administrative error on the part of the GMC and the court was unimpressed by the attempt of the GMC to elevate that to a level such that it could be regarded as exceptional. In Peacock, Sullivan J (no relation) repeated the rationale of Gibbs J. I have quoted what I hope is the most relevant passage of the case. There was a concern about the prematurity of the challenge, that there is a debate about what is exceptional and what was said at page 17 of Rule 4(5):

“The rule under consideration provides a distinct and free-standing safeguard which sets a general prohibition against the pursuit of long-delayed complaints. It provides only for very limited – i.e. exceptional – circumstances in which such complaints may proceed. I am not persuaded in the event of a wrong decision under that rule which allows a complaint to proceed further, there would be any satisfactory remedy later in the proceedings.”

He was suggesting also that in terms of serious professional misconduct something beyond “serious misconduct”, which is possibly the highest this case could be put, and not as high as that in my submission, could justify waiving Rule 4(5).

“It is possible the alleged misconduct may be so serious as to amount, of itself, to exceptional circumstances, but if that is the Registrar’s view, it should be clearly stated.”

It has never been suggested this is an exceptionally poor case of unethical research or failures in consent; far from it. As you are aware there have been those consulted by the GMC who regard it as being a good, if not model, trial.

I have quoted the aide memoir but I probably do not need to delay your deliberations by going through that and a requirement to give reasons, which of course under the Old Rules we have not been given and I will come in a moment to the statements that have been made by officers of the GMC in relation to delay.

I therefore say in conclusion that:

“The recent robust view of the High Court in relation to delay, as encapsulated in the interpretation of Rule 4(5) should be regarded as instructive and reflecting the current judicial view in attempting to adjudicate upon the merits of this case proceeding against the background of considerable and unexplained delay.”

I quote Lord Justice Auld in his dissenting judgment saying that, in essence, this is the position that we are still in. No identified advantage to Mr and Mrs Henshall in that the charges drafted barely scratch the surface of the matters that they are truly concerned about and they have led to professional disruption and personal distress on the part of the doctors which we will see in a moment has been acknowledged by the General Medical Council in the past.

It will be apparent to you, and it is again a question of weight for you, that it can be submitted that this is not the hearing the Henshalls want and there will be a considerable degree of cross-examination upon prior inconsistent statements as well. In looking at the public interest, you might want to consider whether it really is in their interests to be subjected to that with such documentation as we do have tending to allow us to dispute quite strenuously some of the claims that they made in the past.

Could I have handed up to you, sir, a final clip of documents. I am conscious that I have not dealt with one aspect of Mr Foster’s skeleton argument which relates to legitimate expectation. I am happy to leave him to deal with the case law, but it is perhaps something which can be suggested on behalf of Dr Spencer as well.

On 25 March 2004, Finlay Scott, the Chief Executive, wrote in relation to the fact that we had been told on 24 March the matter would go no further and he writes in the following terms:

“I am writing to apologise that it took so long to bring the CNEP related complaints to a conclusion. This should not have taken almost seven years. As you know, some of the excessive delay was a consequence of the decision to await the outcome of other inquiries. However, even allowing for this, we were clearly at fault because our handling of the complaints was poor and because the original screening and PPC decisions could not stand. I very much regret the distress that has been caused to you and to the other doctors.

I realise that it will be of scant comfort to you, but I am confident that we have addressed the causes of the evidence handling problems. I am only sorry that we did not do so earlier.”

Once again, I apologise for our failings.”

That was written in excess of four years ago.

My client replied to the letter. This is an unsigned copy but he assures me that this was his response. He acknowledges the apology in the first paragraph and then sets out the difficulties that he has experienced in terms of his career. He says:

“I was severely hampered in obtaining two senior posts, one as head of postgraduate medicine in the new medical school at Keele University, a post to which I was invited to apply. After my case was dismissed the first time, I had a very positive discussion with the Medical Director of the Trust in relation to a newly created post of associate medical director for Research and Development. When my case was re-opened I was told that it would be inappropriate for me to apply. Having previously had both considerable research and management experience I was very well placed to be successful in applying for either of these posts. In addition, both my personal life and my work has been affected in many other ways as you might imagine.”

Then he deals with the area which I am sure you are aware has attracted a deal of controversy recently. Paediatricians are feeling slightly put upon, I think, to say the least at the present time. Then he asks if he can contribute in any positive way to the training of staff and discussions just to address the underlying problems to result in better case management. He does not believe he received a response to that letter.

Dr Samuels meanwhile had written a much lengthier letter and he appears to have got a reply to a letter written at an equivalent time to the unsigned letter I have just taken you to. Ours is 23 April and he wrote on 14 April following a letter of 25 March which was in exactly the same terms as page 1 of D1-C, so both Drs Spencer and Samuels, as you will hear, received letters from Finlay Scott. In this letter, he acknowledges:

“… the delay in your case was excessive and arose from a combination of factors, including serious error on our part.”

He then goes through the pressures that the General Medical Council has been under historically, the increase in claims and what the proposals were on the second page:

“… within four months of receipt of a complaint a decision will be made whether to conclude the case or refer the doctor to the PPC … where referred by the PPC to the PCC, the hearing should take place within 12 months.”

The new Orders of 2000 and 2002, the 2002 Order bringing in the five-year rule under the 1988 Preliminary Proceedings Committee and Professional Conduct Committee Rules. Then he deals with the reviewing of decisions in the penultimate paragraph on page 4 and how they have a duty to process complaints. I think that is all I need to take you to in this letter. The rest of it is really a policy statement.

This is something my client wished you to be made aware of – the last document from Peter Swain, who is the current head of Case Presentation Standards & Fitness to Practise as short a time ago as 24 October 2007, in response to a letter written by my client to Professor Sir Graeme Catto, dealing with the difficult history of this case and the Court of Appeal decision, he indicates that the case is an extremely complex one – this is the fifth paragraph – possibly the nearest we have ever come to an explanation for the delay, but in many ways it has become less complex than it was if you look at the initial assertions being made by the Henshalls back in 2000-200.

“We aim to open cases at hearings not more than nine months after referral but in more complex cases such as this one such a timetable is often not realistic.”

We have concerns and my learned friend has helpfully provided me with a copy of the supplementary judgment in the Court of Appeal matter when the Court of Appeal as long ago as January 2006 were suggesting that the matter be dealt with as swiftly as possible.

“The matter should be remitted with the utmost expedition.”

We say implicit in that is also “and dealt with”. We are now nearly 18 months on from that and certainly the main judgment was in 2005. The nine month time period, ironically as we still find ourselves receiving expert reports, is said at the bottom of page 6 to

“… include a significant element for the defence to prepare its case after all the GMC’s evidence has been obtained and disclosed together with finalised draft charges.”

You may know that we were scheduled to start this case on 6 May. The reason that we started on the 8th was because the General Medical Council served their 8 April Notice of Inquiry within the 28-day period, so we were then asked if we would mind starting on the Thursday rather than the Tuesday, so that gave us under a month to prepare our defence and you are aware of the position with the Hutton Report arriving a week Friday. We were told and assured by Mr Swain in the penultimate paragraph:

“We are committed to seeing this case resolved as quickly as possible while ensuring that we properly and effectively discharge our statutory duty to inquire into the fitness to practise of doctors.”

Can I see if there is any other matter my client wishes me to deal with and then I should be able to sit down. )

Sir, I end my submissions as I end my skeleton argument. The charges, if proven, can find a founding of serious professional misconduct but that may or may not be something that weighs with you in the exercise of your discretion, but I do maintain that this is a very weak case and it has been made weaker by delay on both sides in terms of the credibility of evidence, but entirely on the General Medical Council’s side in terms of culpability for the length of the delay and against that background and for all the reasons and the submissions that I have addressed you upon, it would be unfair for this matter to continue.

Sir, those are my submissions, although as I have indicated I am happy to answer any questions from the Panel.

Barely taking a breath, Forde continued

“What I have tried to do, and as I have said, we are in somewhat uncharted territory, but the reason we perceive for the five-year rule coming into effect is because of a general concern about old cases. Whilst I cannot point to that rule being in existence at the time that these matters came before the GMC – in other words, 1997 – it is my submission, and again you are to be guided by the learned Legal Assessor as to the weight you attach to this submission, if any, but it is quite instructive to look at current jurisprudence and current thought about old cases as encapsulated in the five-year rule.

If you reach the view that if the case were brought now and was six years old there was nothing exceptional about it therefore you would be constrained in the exercise of your discretion to decide that the hearing should not go ahead, then that might help you in trying to work out where in the scale of gravity this delay lies. We are talking in terms of common law delay in excess of three times that length of delay and in terms of the notification of concerns from November 2000 expressed by the Henshalls a four month delay, we then find out in early 2001 and time at the very least runs from then, I think we are all agreed that that is the case, so we are seven years on.

It may be, and I put it no higher than that, that if you look at some of the rationales expressed in Gwynn and Peacock and you think that really does meet the merits of this case in 2008 that you could not rely upon the five-year rule but look at the approach to the five-year rule as encapsulated by the courts in deciding whether to exercise your discretion in our favour. I am not suggesting that as a stand-alone point that would win the day for us, but it might help you reach your decision.

Finally Mr Forde had chance for a sip of water. Mr Foster took over for Dr Samuels

: I hope a copy of my skeleton argument has reached the Panel. Any objective observer looking at this case will wonder what on earth Dr Samuels is doing here. That incredulity will have been increased this morning when a number of the remaining allegations against him were struck out. His involvement in these allegations is extremely peripheral. He was not at Stoke for most of the material time and he was never a clinician of any of the babies involved in this trial.

Because of the submissions which Mr Forde has made on behalf of Mr Spencer, I can be much shorter. From the chronology under paragraph 1 of my skeleton argument, I would make only these points. Almost all the documents which you need to look at have already been referred to in detail by Mr Forde. There are lots of documents to which he has referred in the context of Dr Spencer which are exactly mirrored in the case of Dr Samuels. The page references to the documents in Dr Samuels’ case are in the skeleton argument. I am not going to repeat them. You will be interested in the documents because of the dates on the letter heads.

Secondly, in relation to the documents which set out the allegations, and the responses to the allegation, the documents in the two bundles which I have just handed up will be mainly of interest to you for what they do not say, by which I mean there are almost no allegations which Dr Samuels was asked to comment on which now appear in the charges against him.

You will be interested in the documents for a third reason. The documents contain copious apologies and acknowledgments of fault on behalf of the GMC. So it will not be possible for Ms Sullivan, on behalf of the GMC, to say with a straight face, “We are not at fault here”, there is no inexcusable contumelious delay. She is stuck with that.

The three documents I particularly invite your attention to are the letter at page 7 of the first bundle, from the General Medical Council to Dr Samuels dated 15 March 2002. It apologises for the delay and says that no further action will be taken. There is then the letter of 25 March 2004 at page 2 in the second bundle. Mr Forde referred to it a moment ago, so I am not going to read it again into the record, but it apologises specifically and abjectly for delay in bringing the matter to a conclusion. In my chronology I have set out the most important section of it.

In the supplemental bundle at page 4, there is letter from the GMC to Dr Samuels dated 3 June 2004, again apologising abjectly for the delay. So far as the delay is concerned, I repeat and adopt the submissions made by Mr Forde. I respectfully agree that the analysis which you should adopt is the Dyer v Watson analysis. It is not necessary to show it is specific prejudice, but there is a good deal of specific prejudice which we can demonstrate in this case.

In a moment I will go through the remaining allegations against Dr Samuels and demonstrate what the prejudice is in relation to each. I make the following general comments. It is notoriously difficult for panels like this, for judges in clinical negligence cases and in lots of other medical contexts, to determine after a lapse of any significant time, let alone such a gargantuan time as this, what the standards appropriate to the material time were. That prejudice almost always redounds against the practitioner, as it does here.

Secondly, in relation to the issue of training, many of the medical witnesses who the GMC, if this case goes any further, would call, would say that they have no recollection of the instruction they were given, have no recollection about the training which they were given. I can exemplify that by reference to some of the witness statements which have been given to us. For example, here is Dr Claire Newell:

“I have very little memory of the trial, it was fifteen years ago, it formed only a very small part of my role as an SHO. Approximately ten years ago I gave a statement about consent to a firm of solicitors whose name I cannot remember. I would expect if I had been asked then I would have been a lot more accurate, I would have had a clearer memory then. I do not now, some fifteen years later, have any recollection of taking consent on this occasion, nor do I remember Mrs Henshall or Patient 6. I can only remember very little about the CNEP trial, although I recall that the aim of the trial was to see if it reduced respiratory problems in premature babies. I cannot remember the information we were given from the consultants about the trial to pass on to parents. I could not say whether it was something you picked up or whether we were given specific training about. It was such a small part of my workload, I just do not remember.

In terms of my usual procedure for taking consent, I can only say what I would do now, which is not the same as recording what I did then. I do not remember if I did things any differently than I did then.”

Asked about a specific patient:

“In relation to the amount of information I gave her, I cannot remember.”

Dr Arya:

“I had not worked with the CNEP before I arrived in Stoke. I do not remember how it was introduced to me. I think I would have been introduced to the CNEP by the doctors and nurses. I do not remember who in particular and I do not remember any formal training sessions. When you start a new job you get so much information thrown at you, it is hard to remember.

I think I was given some instructions, but I do not remember what I was told. I cannot remember what I was told to say, but I do remember what I would have said.”

Dr Wheatley:

“I seem to recall that there was a training session held on CNEP. Dr Spencer was very keen on research so I believed it would have been him who held the session, although I do not remember. I have quite a hazy recollection of the session and I do not recall any of the detail of what we were told.”

Dr Livera:

“I do not remember details of training or who conducted it. I have no reason to believe that any of the staff who worked with CNEP did so unless they had been adequately trained and were confident in its use.

I have been asked if I remember using the term ‘kinder’ and ‘gentler’ to parents. I do not remember using this term, I do not believe it likely. I do not remember if the consultants explored the exclusion criteria during the telephone call. I have been asked if the consultants checked if consent had been given. I do not remember exactly what was discussed.”

So it goes on and on; samples from the evidence which is being led by the GMC upon which they will invite you to say that these charges are made out. If the proceedings had been brought in reasonable time, one would expect a number of these witnesses, who go to crucial issues between Dr Samuels and the GMC, to have clearer recollections. The gist of the statements of the medical witnesses, some of which I have referred to, is entirely exculpatory so far as the adequacy of training is concerned and the standard of training generally.

One would expect, if their memories were as good as they would have been had the proceedings been brought in time, that the overall evidence would have been even more exculpatory than it in fact is. Also potentially available, had these proceedings been brought in time, would have been diary details, schedules and other documentary evidence of the amount of time that Dr Samuels spent at Stoke before he moved there, and of time which the staff from Stoke spent down in London before Dr Samuels moved on to Stoke. We have been deprived of that potentially crucial evidence by the GMC’s culpable delay.

I would invite you to turn to the remaining charges against Dr Samuels. Head 3(a):

“You inappropriately delegated the task of taking consent to too many different medical and nursing staff.”

How has the lapse of time affected our ability to defend that allegation, to whom was it delegated? What, according to the standards at the time, would have been the appropriate number to delegate it to, what was the process by which the delegations happened, are there documents somewhere in existence in a dusty filing cabinet which indicate exactly the terms in which the delegation was done?

Head 3(b):

“You failed to provide adequate training to those taking consent for the trial.”

What training was provided, what training according to the standards of the day should have been provided, what handouts were given to those who were being trained? Did the people who were being trained express any dissatisfaction or feel inadequate in any way with the training which they were given?

3c: “You misrepresented within the parental information leaflet that the technique had been shown to be safe”. What was the process by which that parental information leaflet was generated? Who were the responsible authors? Who had input into its production? What, again, were the standards that would be expected of such a parental information leaflet at the time.

3d: “You failed to ensure that every parent had a copy of the parental information leaflet”. It is difficult to see, of course, how Dr Samuels, being in Stoke and not a treating clinician, could have any impact at all on that. Assuming that this is an allegation that there was an inadequate system in place to ensure that every parent had a copy of the parental information leaflet and that Dr Samuels is in some way responsible for that system, being in London when this was being done at Stoke, questions such as this arise: What should he have done? Who was told what and when about the distribution of this leaflet to the parents? What parents were given copies of this leaflet? By whom were they given it? We have been deprived of potentially crucial evidence.

4b: “You failed to ensure that the scores were allocated correctly”. Whose responsibility was it for the allocation of the scores? What had been decided in the trial protocol about how responsibility for that allocation would be distributed? What, by the standards at the time, is the yardstick by which correct allocation should be judged?

4d: “You failed to ensure that there was an appropriate method of scoring”. The same questions arise as under 4b.

As I have said, Ms Sullivan must begin her submissions on delay in the light of what the GMC has specifically and abjectly said by saying, “Ever so sorry, we made a tremendous mistake here, there is obviously an inexcusable delay, but it does not matter”. For all the reasons that I have just gone through, she cannot begin to do that.

I move on to paragraph 3, legitimate expectations. Just before I do that, I should remind the Panel of other types of prejudice that result from the delay in Dr Samuels’ case: the stress that results from having his hopes raised and dashed on two occasions over a long time; the torpedoing of some of his professional ambitions; these allegations effectively stopped his research career dead for a while; if it had not been for this, he would now have been Professor Samuels; his clinical excellence award was delayed significantly by the delay in processing these allegations.

“Legitimate expectations”. There is a lot of law that I have put down in paragraph 3. The gist of it is this: people have a right to know where they stand. If a promise is made and that promise is later withdrawn, that is regarded by the courts in some circumstances as so unfair that the proceedings should be stopped. In my respectful submission, this is a classic case where that principle applies.

In paragraph 3.1 I deal with R v Bloomfield, Lord Justice Staughton. What had happened here was that the prosecution had said that they would offer no evidence against the defendant at a subsequent hearing and they then went back on that and sought to prosecute him:

“The statement of the prosecution that they would offer no evidence at the next hearing was not merely a statement made to the defendant or to his legal representative. It was made coram judice, in the presence of the judge.”

Pausing there, what we have here, of course, is not an informal comment from a prosecutor to us, saying “We might not be pursuing that allegation”. We have express written documents from the highest level at the GMC not only admitting that there is a failure in the system but also saying expressly that these practitioners will not hear any more about it.

That quotation continues:

“It seems to us that, whether or not there was prejudice, it would bring the administration of justice into disrepute if the Crown Prosecution Service were able to treat the court as if it were at its beck and call, free to tell it one day that it was not going to prosecute and another day that it was.”

In my submission, the public would be appalled if they knew that on two occasions here, over many years, these practitioners were told “Go away, get on with your lives, you are not going to hear any more of this” and then to be told by subsequent letters, “You have to face career-endangering allegations yet again”. That is the sort of change of mind that brings the administration of justice in this jurisdiction into disrepute, and it is one of the reasons why you have this jurisdiction to stop at case at this stage.

In the case of Mulla, the defendant was charged with causing death by dangerous driving. On the first morning of the trial the prosecution said that they would accept a plea of guilty to careless driving, the judge frowned at that and said to the prosecutor, “Go away and have another think”. That afternoon the prosecution came back and said, “We are going on with the original charge”. There was an application by the defendant that this was an abuse of process and the Court of Appeal said “no”, and it is not surprising that they said “no”. This is reported at the bottom of my page 4:

“This was not a case in which the defendant’s hopes were raised, later to be dashed.”

Pausing there, the case of Dr Samuels is, of course, precisely one in which the defendant’s hopes were raised not once but twice and then dashed. The quotation continues:

“He knew from the beginning of the proceedings in court, on August 14, that the judge did not approve of the course which the prosecution were proposing to take.”

The judge, in a sense, in this case is analogous to the GMC. The GMC itself is saying, “You will hear no more about it.

“He had not had his hopes raised by anything which counsel had privately said to him. It is true that, in the words of Staughton LJ in Bloomfield, the prosecution indicated to the court what its view was, but that, as it seems to us, is only one of the factors to be considered in a case of this kind. Other factors include what view is expressed by the judge when the prosecution gives its indication…” –

which is not relevant here –

“… the period of time over which the prosecution reconsiders the matter…”

There it was over the morning and the afternoon that they reconsidered the matter; her is it over years.

“… whether or not the defendant’s hopes had been inappropriately raised…”

Here, of course they have, repeatedly.

“…and whether there has been, by reason of the change of course by the prosecution, any prejudice to the defence.”

There is massive prejudice; I have just been through it.

There was a systematic review of the authorities by the Court of Appeal in the case of R v Abu Hamza:

“As the judge held, circumstances can exist where it will be an abuse of process to prosecute a man for conduct in respect of which he has been given an assurance that no prosecution will be brought. It is by no means easy to define a test for those circumstances, other than to say that they must be such as to render the proposed prosecution an affront to justice. The judge expressed reservations as to the extent to which one can apply the common law principle of ‘legitimate expectation’ in this field, and we share those reservations.”

Effectively, they did not like the label.

“That principle usually applies to the expectation generated in respect of the exercise of an administrative discretion by or on behalf of the person whose duty it is to exercise that discretion. The duty to prosecute offenders cannot be treated as an administrative discretion, for it is usually in the public interest that those who are reasonably suspected of criminal conduct should be brought to trial. Only in rare circumstances will it be offensive to justice to give effect to this public interest.”

Pausing there, one can well understand the reluctance of judges in the criminal sphere to let off, because of lapse of time, a terrorist, a rapist or a murderer. That is not the situation that you are dealing with here. You are dealing with practitioners who, as Mr Forde has demonstrated by some of his citations, are not roundly criticised by just the experts who the GMC proposes to call in terms of culpability. Even at the height of the GMC’s own case, this is right at the bottom of the scale. The quotation goes on:

“Such circumstances can arise if police, who are carrying out a criminal investigation, given an unequivocal assurance that a suspect will not be prosecuted and the suspect, in reliance upon that undertaking, acts to his detriment.”

I do not want to weary you too much with my voice, but I pick it up at paragraph 52, which deals with the case of Townsend:

“Rose LJ, giving the judgment of this court, approved the propositions: where a defendant has been induced to believe that he will not be prosecuted this is capable of founding a stay for abuse; where he then co-operates with the prosecution in a manner which results in manifest prejudice to him, it will become inherently unfair to proceed against him.”

That is precisely this case, in my submission.

“He added that a breach of promise not to prosecute does not inevitably give rise to abuse but may do so if it has led to a change of circumstances.”

For the reasons that I have been through in this case, it does.

The summary is at paragraph 54, as follows:

“These authorities suggest that it is not likely to constitute an abuse of process to proceed with a prosecution unless (i) there has been an unequivocal representation by those with the conduct of the investigation or prosecution of a case that the defendant will not be prosecuted…” –

We have two unequivocal representations in this case, not just one –

“… and (ii) that the defendant has acted on that representation to his detriment.”

He has, as I have pointed out.

“Even then, if facts come to light which were not known when the representation was made, these may justify proceeding with the prosecution despite the representation.”

Nobody has suggested that that applies, and in fact, as has been demonstrated by Mr Forde, as this case has evolved facts are coming to light which tend to exculpate. For example, a few minutes ago, just before we came back into this chamber, I was handed an attendance note from Dr Nicholson. It was dated the end of March this year and it indicated that he acknowledged that he was not an appropriate expert to deal with the design or conduct of clinical trials – precisely what in his earlier reports he had said he was able to comment on, and indeed about which he had commented in enormous detail.

My submissions under paragraph 3.4 are self-explanatory and I have made them already in the course of considering the relevant authorities.

I move on to paragraph 4. This is headed “Uncertainty about charge 3a.” Charge 3a reads, “You inappropriately delegated the task of taking consent to too many different medical and nursing staff”. That clearly raises the question: how many is too many? Accordingly, Dr Samuels’ solicitors sought clarification. I have set out there the relevant exchanges of correspondence. We have had no answer, except an assertion by Eversheds on behalf of the General Medical Council that it is a matter for the Panel to consider how many people it would have been appropriate to delegate to; not true. What the General Medical Council is doing by bringing an allegation against a practitioner is saying, “We think that this is the standard that the Council expects, and you have fallen below it”.

In order properly to respond to that allegation, we are entitled to know exactly where the bar is, so that we can determine (a) whether we have fallen beneath it and (b) if so, by how much. We have continued to press them and they have continued to refuse to give us proper particulars. I am not, on Dr Samuels’ behalf, in a position to respond to that allegation and I say that since one of the most fundamental principles of justice is that we should be able to know the case that is brought against us, it is abusive to continue with that allegation without giving particulars. Accordingly, unless and until those particulars are provided, you should stay that charge.

Paragraph 5 is headed, “Failure to give Dr Samuels an opportunity to comment on the allegations”. The 1988 rules say, insofar as material, this:

“Rule 4

Where the Medical Screener refers a case to the Preliminary Proceedings Committee under this rule, he shall direct the Registrar to give written notice to the practitioner:

(a) notifying him of the receipt of a complaint or information and stating the matters which appear to raise a question as to whether the conduct of the practitioner constitutes serious professional misconduct …

(d) inviting the practitioner to submit any explanation which he may have to offer.”

The rationale for the rule is obvious. It would be unfair if a practitioner was referred to the Professional Conduct Committee when either he did not know what the allegation against him was or, if he did know it, he had not had an opportunity to make an explanation which might convince the Preliminary Proceedings Committee not to refer him. It is an important safeguard. The rules have been ignored in this case. Dr Samuels has been deprived of that essential safeguard.

Of the allegations that impute fault that presently face Dr Samuels, he was given an opportunity to comment only about those in head of charge 3c, and that only in 2001 and not subsequently, and those in 3d. I say that in relation to 3c the failure to invite submissions specifically in relation to the 2006 referral is fatal. Effectively what the General Medical Council was doing in 2006 was saying, “We are going to start all over again, we will have your representations please, these are the allegations that you are facing at this stage”. They had not asked anything that can be construed as covering 3c since 2001, and they were obliged to. Therefore, head of charge 3c has not been validly committed.

In relation to 3d, you will see my submissions at paragraph 5.3. There is a very significant discrepancy between the existing form of 3d and the allegation which, it might be argued, covers 3d. The draft allegation is “You did not ensure that parents had adequate information about the CNEP technique to provide properly informed consent for the participation of their children in the CNEP trials, including a patient information leaflet”. It is a very different allegation from the existing one, which is “You failed to ensure that every parent had a copy of the parental information leaflet”, which implies that there was a duty on an absent consultant somehow to ensure that each parent received a copy. Precisely that point about the vagueness of the charges was taken by RadcliffesLeBrasseur on behalf of Dr Samuels. I have set out the terms in which they put the point. We are in a position now of Dr Samuels not having been given an opportunity to reply to the allegation that he now faces.

I now come to paragraph 6. I take entirely the point that the learned Legal Assessor made in response to Mr Forde, namely that I have to be careful to appear to be inviting the Panel at this stage to make any adjudication on the merits; and, of course, I do not invite them to do that.

I have said at paragraph 6.1 that there are two ways in which the prospects of success can be relevant at this stage. First, they go to how you exercise your discretion in deciding this abuse of process application. Even if a case is well out of time or otherwise abusive, a panel is going to be understandably more reluctant to accede to an abuse of process application if the case is obviously a good one. It would be reluctant to give a practitioner a procedural, technical, unmeritorious way out. The second relevance is that consideration of the merits is necessary because the merits indicate something about the motive for bringing these proceedings, by which I mean that if the prospects of success are extremely low, it plainly suggests that something other than an objective assessment of prospects and public benefit is acting.

There are in this case three notionally supportive expert witnesses who, if this case goes further, apparently the Council proposes to call. There is Dr Stimmler, who is a consultant paediatrician, Professor Hutton, a medical statistician and the third is Dr Nicholson. About the first two of those experts I cannot quibble. I cannot say that their credentials are such that they do not have the expertise necessary for their evidence to be validly adduced. I can say that about Dr Nicholson and it rather sounds in light of the memorandum which I have just referred to that Dr Nicholson is beginning to realise that too.

Dr Nicholson is an expert in no discipline which is pertinent to these proceedings. He was involved in paediatrics as a registrar and a clinical medical officer. He gave up medical practice in or around 1986 and he has edited a publication called The Bulletin of Medical Ethics since then. He has not been on the Medical Register for some time. He has never designed or run a clinical trial although he has sat on ethics committees. He has stood shoulder to shoulder with the Henshalls in their campaign against these practitioners over many years.

His inadequacy as an expert appears to be acknowledged now not only by himself in that memo, but also by the General Medical Council, because of course when Ms Sullivan stood up this morning and said that she was not going on with a number of the allegations which were originally pleaded against Dr Samuels, the ones which went were allegations which had originally been supported by Dr Nicholson, entirely out of his specialty.

I am not going to read into the record paragraphs 6.4 through to 6.7. What I do there is to cite long sections from the report of Dr Stimmler. He is the expert who is relevant to all the allegations under charge 3 and the only expert whose evidence is relevant to charge 3. It follows that there is no possibility of succeeding against Dr Samuels in relation to charge 3. My submissions under paragraphs 6.9 through to 6.11 similarly stand alone.

Ms Sullivan is in a very unfortunate position because of the rules. The rules necessarily create a possible conflict of interest. It is difficult to act objectively in the public interest while also acting, as the rules appear to allow one to do, in a partisan way for a complainant who has an agenda of their own.

I do not criticise Ms Sullivan for the way in which she has tried to resolve those two competing interests but it is perfectly plain that an objective look at the evidence in this case forces one to the conclusion, firstly, that there is no serious prospect of success in relation to any of these charges as against Dr Samuels. Even if there were, the charges are charges which comes nowhere near serious professional misconduct. If I had stood up this morning and on Dr Samuels’ behalf admitted everything which stands currently against him, we could have move seamlessly onto the stage of deciding whether these charges amounted to serious professional misconduct and the inevitable answer would be no.

In my respectful submission what we have here is a set of allegations brought effectively by the Henshalls. The General Medical Council in the letter which I have cited at paragraph 6.14 have assured Dr Spencer that they will have the final say over the form of the charges. Dr Spencer and Dr Samuels have a right to expect that that sort of objective assessment would be carried out. If it has not been, and it unfortunately seems that it has not been, it is for you to police your own proceedings and make sure that they are not hijacked abusively by people with their own agendas.

In my respectful submission the only just result in this case in relation to the allegations against Dr Samuels is that the case should be stopped. Sir, those are my submissions. Unless there is anything else I can help you with?

Ms O Rourke summarises her role in some interesting cases

Sir, I did have a case three years ago now in January 2005, the case of Chai Patel, where I made abuse arguments and asked for certain heads of charge to be stayed and the Panel did do that. The case then ended up in the Administrative Court because they did not do quite as much as I wanted them to do and the Administrative Court judge, Mr Justice Collins, gave permission for a full judicial review and stayed any further GMC proceedings. The GMC then collapsed the case by indicating that in respect of the rest of the charges that I had made objection they were conceding that they could not pursue them for the reasons that we had outlined in the judicial review, but the court had approved the fact that the Panel had already – I think there had been five or six applications under the head you are now looking at to stay things – they approved the fact that the Panel had stopped some of them and indeed on the advice of the Legal Assessor. I am sure we can get the transcripts if there is any doubt about it, but that is what had happened. They took a charge by charge approach, although it was one charge of serious professional misconduct and it was an Old Rules case. They took it as each individual one could be looked at in the terms of the prejudice.

I have also recently had a case before the Nursing and Midwifery Council which also ended up in the Administrative Court and they endorsed the same approach and indeed the judge, Mr Justice Beatson, said three months ago that it was appropriate that you looked at each one separately and looked at the prejudice in respect of each one because the test, as Ms Sullivan is going to tell you, she will say involves looking at prejudice and so you do then look at them differently because there may be heads of charge that involve prejudice and others that do not.

Latest Media

2008-05-14T06:40:00.001-07:00

Two streamlined articles today

1. The Metro

2. Controversial medic hearing resumes.

Salient features of the this week's events can be read here.

Most of the antics by the GMC was omitted by the media including the recent supportive statistics report obtained by the GMC.

3. DOCTORS ARGUE THEY CAN'T HAVE FAIR TRIAL
Source - Sentinel

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DAVE BLACKHURST
DAVE.BLACKHURST@THESENTINEL.CO.UK

09:40 - 14 May 2008

Two North Staffordshire doctors facing disciplinary charges over their involvement in a breathing study on sick babies say it happened so long ago they will be robbed of a fair trail.

But a third medic, Dr David Southall, intends to, "defend the allegations one by one and show them as hollow and baseless", the General Medical Council heard yesterday.

Along with fellow paediatricians, doctors Andrew Spencer and Martin Samuels, he is before the GMC's fitness to practice panel in Manchester to answer complaints by Clayton couple Carl and Deborah Henshall.

They claim one baby, Stacey, died after two days and another, Sofie, now 15, has brain damage because they were placed into low pressure CNEP tanks as part of a research programme in the early 1990s.

More than 100 babies were subject to the programme, to see if they could breath without ventilators in their wind pipes.

The GMC opened the two month hearing by dramatically withdrawing a number of charges relating to statistical parts of the study and clearing an academic paper the doctors published on it.

But Dr Spencer is still facing charges over his care of Sofie soon after her birth at the then North Staffordshire Hospital in December 1992 and the way he took consent from parents.

Dr Southall faces concerns both over taking consent and his application for ethical approval of the research.

And Dr Samuels faces claims that, as research administrator, he failed to ensure appropriate procedures were in place to obtain informed consent.

For Dr Southall, who has just resigned from his job at the hospital, Mary O'Rourke said: "He believes there has been an inordinate and inexcusable delay in this case caused by the GMC and the complainants and that will stop him having a fair trial.

"But he still wants to defeat all allegations one by one and he wants me to cross-examine the complainants."

Martin Ford QC, for Dr Spencer, described the case as being as old as any to come before the panel with one charge expecting witnesses to remember what happened at three minutes past midnight on December 15, 1992.

He said: "This delay is not the doctors' responsibility. A lot of witnesses will be extremely defensive about their role in the 1990s. There is a real fear they will not be judged by 1990s' standards, but by those of 2008.

"These matters have been twice investigated already and 90 per cent of parents recall giving consent. There is no suggestion in the charges that any child came to harm from CNEP, whatever the Henshalls say.

"In the study there was a higher death and disability rate among the babies undergoing CNEP than those having normal ventilation. But the doctors argue that with such sick infants it was not significant

Henshall Hearing Continues

2008-05-13T12:09:00.000-07:00

NHS - Behind the Headlines has an interesting update of this week's antics at the GMC.

It is said that the charges have been streamlined and half the original ones have been dropped. The hearing will continue next week.

The Henshall Case - the FACTS behind the Myth

2008-05-08T05:25:00.000-07:00

Extract from Response to a Report of a review of the research framework in North Staffordshire Hospital NHS Trust (The Griffiths Report), released by the NHS Executive on May 8th 2000 Dated 23rd September 2000

4.3 Origin of the inquiry.

Comment

"The Review began because there were complaints about the conduct of research trials in North Staffordshire". [Part One]

Response

Mr and Mrs X, one set of parents making complaints, have made very public their views that 1) they were not told that CNEP was being offered to their children as part of a randomised controlled study, 2) they believe that CNEP caused brain injury to their child and 3) they had not signed consent, alleging that it was forged.

It is evident that parents have to cope with extreme stress when their child is critically ill. Evidence was also presented to the panel outlining that during this stressful period some parents enrolled into another published study had no recollection of having signed a consent form. It is therefore possible that Mr and Mrs X genuinely believed that they had not signed a consent form. However, some of the following information does not support the claims of this family.

During the recovery of their daughter from neonatal respiratory failure, Mr and Mrs X received a letter and completed a questionnaire on maternal child bonding. It is not possible for them to have failed to understand that their daughter had been entered into a controlled study of CNEP. A letter was sent to them beginning " "Dear [NAME OF PARENT(S)],
You will remember that shortly after [NAME] was born you kindly agreed to enroll him/her into our study comparing negative pressure respiratory support with standard treatment. As part of this study we have devised a questionnaire which attempts to compare the effect of these two methods of treatment on the way you were able to relate to your baby."

Mrs X replied to this questionnaire and indicated that in her opinion CNEP was more effective than standard treatment.

Mr and Mrs X stated in a letter in October 1999 to the British Medical Association the following: "..this group of parents who have raised concerns about the clinical implications of CNEP, have no connection whatsoever with Mrs Penny Mellor or Mr Morgan who are apparently campaigning on child abuse issues". The Guardian newspaper on 13th October 1999 published a correction in response to a letter from Mr and Mrs X concerning an article in the Guardian of 11th October reviewing the campaign against my child protection work. The correction was written as follows: they "would like to make it clear they have not criticized Southall's work in child protection and have no connection with those who have campaigned against Southall's work on Munchausen Syndrome by Proxy".

However, evidence for the existence of a connection is as follows:

· Mr and Mrs X's story first appeared in an article by a reporter called Brian Morgan in the Sunday Independent on 11 May 1997. The same reporter Mr Brian Morgan is quoted as saying in the Mail on Sunday on April 5th 1998 the following: "his and the mothers' aim is to see Southall struck off the medical register, his work discredited and a public inquiry instigated".
· In a letter to my employer on 3rd June 1997 and given to me, Mr and Mrs X wrote the following: "Why then would he slowly suffocate my child with his machine and lie in order to cover up what he had done? How many other babies like… have been subjected wrongly to this torture and when will he realize that it is the case of the pot calling the kettle black and that he has no rights criticizing Mums for how they look after their children when he experiments on hundreds at a time in the name of science even with knowledge of adverse effects. Have the courts seen the photographs of the tiny babies who were strangled by the neck seal on his gentle form of ventilation? ".
· In April / May 1997, Mr Brian Morgan, and Mr and Mrs X wrote similar letters to the Editor of ‘Pediatrics’ criticising my work in North Staffordshire
· In June 1997, Mr and Mrs X wrote to Keele University, Mr Brian Morgan's letter to Pediatrics was mentioned, the response of the editor to Mr Brian Morgan was quoted and Mr Brian Morgan was described as a friend.
· In March 1999, Mr Brian Morgan, Mrs Penny Mellor and Mrs X all wrote electronic responses to an article in the BMJ about my humanitarian aid work in Afghanistan [33]
· A person calling herself Penny posted on the internet on 25 April 1999 details of the alleged problems with Mrs X's consent form:
"Re:Negative Pressure
The previous respondent has been very circumspect with what they said, it is not an allegation but a fact. Mrs X's (one of the mothers taking action) consent form that she was supposed to have signed two hours after the birth of her daughter, had the name of her child on the form…..except that her and her husband had not even chosen a name for their child at that point. So who signed the form? Who entered her child's name? GMC responses please… Also all you British lawyers and QC's whom I have heard look at this site and know who I am will you finally have the ***** to help? Just in case any of you are in any doubt, The Mr and Mrs X's were due for CVS according to an inside source. What would have happened then? Accused of putting her on a bit of research machinery in order to damage her……are there any lengths these people will not go to….?".
· A person calling himself Brian Morgan posted the following on the MAMA website on 28th October 1999:
o The CNEP scandal emerged because the X family in Staffordshire were told by a doctor looking at medical notes belonging to their brain damaged daughter CHILD"S NAME that she had been in a study, as if they already knew knew about this.
o They didn't, and this led to them getting hold of further documents, one of which purported to be a research consent form signed by Mrs X, with CHILD"S name on it, spelled incorrectly as NAME.
o The problem for the hospital is that the parents did not decide on a name for several days and NAME was not even thought of initially.
o The other problem is that the form needed to be signed between between 2 and 4 hours after birth - during these hours Mrs X was in recovery from anaesthesia following a C section.
o Her signature on the form is perfectly formed - not the sedated scrawl you might expect from somebody still out for the count.
o Hardly informed consent. And as Dr NAME the medical director admitted on TV it was not possible anyway.
o The hospital has still to explain how her signature appears on this form.
o This is the theory though - Mrs X got her own notes from the hospital and (I can confirm this) there are a number of consent forms for other procedures she underwent - you can see clearly as a bell where someone has tried to alter the forms and then tried to correct the alterations - but most interestingly - one consent form Mrs X knows she signed a good while after CHILD"S NAME was born is missing. Work it out.
o This scenario is duplicated to some degree or another in other cases I have researched.
o The X family did a major amount of work on their case and on a number of other cases that came forward on the back of articles in their local newspaper.
o This first of all resulted in a General Medical Council investigation being set up, and then the Griffiths Inquiry set up by the NHS Executive in the West Midlands on the insistence of the then health minister Baroness Hayman.
o Then when this was underway Penny Mellor took her concerns about false allegations of child abuse and other very serious allegations about child protection work of doctors at North Staffs and elsewhere to the same team.
o A number of other investigations have been set up, in all around 6.
o I haven't done more than scratch the surface of what my own research and the X family's research into CNEP has shown.

Professor Griffiths and the Panel made clear their acceptance of Mr and Mrs X's criticisms. In the Sentinel newspaper (local to Stoke), it was stated on 10 May 2000: “The dogged determination of Mr and Mrs X drew high praise from Prof Rod Griffiths as he delivered his stinging report on child health research in North Staffordshire. Professor Griffiths … said: ‘we were impressed by their attitude’…”

In a recent local newspaper article Mr and Mrs X signalled their intention to claim damages from the North Staffordshire Hospital for many millions of pounds"

The rest of the document can be downloaded here.

Henshalls " Memory Lapse" [Complaint Against Dr Keith Prowse]

2008-05-08T05:18:00.000-07:00

Of course, no one suffered a memory lapse that seems to have occurred many years after 1992. Our question is this, is the " memory lapse" defence a desperate attempt to mitigate the accusations the Henshalls have made in all the media outlets for many many years - ie that the consent forms were forged. Of course, they were never forged. The article and defence shows that no one believes this Memory Lapse story listed as a " get out clause" "once caught red handed". Infact the GMC Committee at the time did not believe it either. If it indeed a lie, then we should seriously question the level of NHS funds and doctors subscriptions invested in relatives of dubious credibility. If these accusations of forgery were ever made in a statement of truth..... it is interesting what Penny Mellor would say.

After the Prowse case, the GMC should have questioned the credibility of the Henshalls. They didn't question this.

From the BBC Article.

"Parents would have been reluctant to accept the advice of doctors they believed to be guilty of forgery.

The allegation of forgery was "entirely false", the committee said.

Lawyers acting for Mrs Henshall complained that the finding implied that Mrs Henshall had lied.

They said it "coloured" the committee's ruling to the extent that the whole decision should be overturned.

But on Thursday, Mr Justice Keith refused Mrs Henshall permission to challenge the decision.

He held that the finding did not reflect on Mrs Henshall's honesty or credibility.

The committee, which had heard evidence that she might have suffered from a memory lapse because she signed under the after-effects of anaesthetic, was simply saying that she had indeed signed the consent form.

The judge also rejected a plea that the reference to the falsity of the forgery claim should be deleted from the record of the committee's decision because it could prejudice a medical negligence damages claim being brought against the hospital on behalf of her disabled child.

Mr Justice Keith said the forgery issue had no bearing on the pending damages claim, which concerned the quality of the research and care provided by the hospital.

The Discredited Griffiths Inquiry

2008-05-08T05:05:00.000-07:00

This is described by Hey and Chalmers here.
Their summary findings are listed below

Summary points

: We believe that almost every statement made about the design, conduct, and reporting of the neonatal continuous negative extrathoracic pressure (CNEP) trial in the Griffiths report was ill informed, misguided, or factually wrong. Errors include:
: A false assertion that the trial's design had not been subjected to external peer review
: A failure to understand the trial's statistical design, as evinced by their erroneous belief that Professor Southall was single handedly responsible for its size and shape
: A failure to recognise the expertise of the nurses involved in the study
: A false statement that some of the consent forms could not be found
: A false statement that it was not possible to be sure who had completed some of these forms
: A false statement that there was no way of checking that consent had been obtained properly
: An inaccurate statement that the process of consent was not managed consistently and that no system of management or documentation was in place to prove that it was
: A false assertion that parents were not given clear opportunities to withdraw their child from the study at any time
: A failure to take sufficiently into account evidence showing that parental recall of events in the newborn period can be fallible
: An overreliance on the evidence of the small group of parents who asked to testify to the panel at the expense of contemporaneous evidence from a questionnaire sent to all parents and returned by 79% at discharge

Desperate GMC Seeks Delay

2008-05-08T04:39:00.001-07:00

The BBC reports a delay in the case relating to Southall, Samuels and Spencer. The Guardian summarises the case but both leave out the fact that the Nottingham Study vindicated the CNEP trials and the Department of Health Inquiry by Professor Griffiths was discredited.

The reason for the delays requested by the GMC is because the GMC is in serious trouble. This trouble will be reported later.