Tor Hoerman Law Blog

Federal Appellate Court Approves $2 Million Verdict For Vaginal Mesh Victim

Fri, 15 Jan 2016 10:03:57 EST

All in all, the federal appellate court's decision is a tremendous victory for women nationwide. The appellate court completely rejected all of the mesh manufacturer's complaints about the trial, thereby affirming the right of other injured women to present the same type of evidence in their trials. TorHoerman Law is still fighting hard for women injured by transvaginal mesh, including by getting several of our own “bellwether” cases ready for trial.

Kentucky Risperdal Claim Settled for $15.5M

Tue, 05 Jan 2016 10:49:12 EST

On December 22, 2015, Janssen Pharmaceuticals and its parent company, Johnson & Johnson, entered into a settlement with the Commonwealth of Kentucky, agreeing to pay $15.5 million to the state, sufficiently disclose the associated risks of the drug, and cease the company’s promotion of Risperdal for non-FDA approved uses.

Low Dose Radiation Significantly Increases Risk of Solid Cancer, According to Recent Large Study

Thu, 22 Oct 2015 08:38:16 EDT

This week the esteemed British Medical Journal (BMJ) published an editorial discussing the findings of a large (>300,000 subjects) cohort study confirming that extended exposure to even low dose ionizing radiation significantly increases a person’s risk of cancer.

Benicar MDL Established in New Jersey - Cases Move Forward

Sun, 12 Apr 2015 11:31:15 EDT

A federal judicial panel has granted a request to consolidate lawsuits claiming that blood-pressure medication Benicar could cause severe gastrointestinal injuries.

We Pledge Allegiance to Local Food - Will You Join Us?

Fri, 10 Apr 2015 11:42:30 EDT

TorHoerman Law is proud to announce its partnership with Grassroots Grocery through their “corporate membership” program that will promote local sustainable food for all of our community and encourage the THL staff to eat healthy while supporting the local economy.

Pregnant Women Contemplating Zofran During Pregnancy Advised to Take Caution

Thu, 09 Apr 2015 22:44:05 EDT

Pregnant women should be cautious about use of Zofran to curtail morning sickness. Recent studies link Zofran to birth defects and fetal death.

Coldwater Creek Judge Strikes Down Defense Motion to Dismiss - Cases Move Forward

Wed, 01 Apr 2015 13:11:07 EDT

Coldwater Creek cases move forward after a February 27, 2015 order striking down defense motion to dismiss cases filed by Mallinckrodt, Inc. and Cotter Corporation. Judge Audrey G. Fleissig ruled that a strict liability standard will be used with regards to Mallinckrodt, which requires plaintiffs prove their injuries were caused by toxic contamination of North St. Louis County and Mallinckrodt would then be held liable liable without needing to prove how Mallinckrodt was negligent.

Transvaginal Mesh Lawsuit Update and Frequently Asked Questions

Tue, 10 Mar 2015 21:57:27 EDT

Lawyers representing women injured by transvaginal mesh products post frequently asked questions video and update plaintiffs on transvaginal mesh lawsuit.

Zofran Lawsuits Claim Birth Defects

Sat, 21 Feb 2015 09:58:29 EST

Research studies and mounting lawsuits question the safety of Zofran, a prescription medication taken by pregnant women to combat morning sickness. Studies suggest ingesting Zofran during the first trimester may be the cause for increased risk in severe birth defects and injury to the mothers. What is Zofran? Zofran (also known as ondansetron)…

Xarelto MDL Established in Louisiana

Fri, 20 Feb 2015 09:55:23 EST

Numerous lawsuits filed against Bayer and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals over the blood thinner, Xarelto have been consolidated into a multidistrict litigation (MDL) in the Eastern District of Louisiana. Judge Eldon E. Fallon, who is familiar with complex pharmaceutical drug liability cases, will be presiding over…

Questionable Drug Safety Reporting System FAERS

Thu, 19 Feb 2015 09:51:32 EST

According to a report by the Institute for Safe Medication Practices (ISMP), the FDA’s Adverse Event Reporting System (FAERS) is flawed and needs modernization. ISMP’s report is based on the analysis of 847,039 reports gathered over a 1 year period between 2013 and 2014 by FAERS. With mounting lawsuits over pharmaceutical drugs…

Diabetic Drugs, Januvia and Byetta Lawsuits Continue to Grow

Wed, 18 Feb 2015 10:00:39 EST

In August 2013, the increasing number of lawsuits against drug manufacturers, Merck and Amylin led to the creation of a multidistrict litigation in the Southern District of California. Plaintiffs claim that diabetic drugs, Januvia and Byetta, cause side effects such as pancreatic cancer and pancreatitis. Januvia and Byetta Januvia and Byetta…

THL to sponsor Taste of Edwardsville

Fri, 13 Feb 2015 14:27:52 EST

TorHoerman Law, LLC believes in giving back to the local community. This year we are proud to be a sponsor of the 7th Annual Taste of Edwardsville, which will be held on March 7th from 7pm to 9 pm at the LeClaire Room.

Corn Seed Litigation Moving Forward in Kansas

Fri, 12 Dec 2014 12:25:41 EST

Lawsuits brought by businesses affected by declining U.S. corn market prices due in part to Chinese rejection of Syngenta's Agrisure Viptera have been consolidated under MDL No. 2591 and will be heard by Judge John W. Lungstrum in the District of Kansas.

TorHoerman Law is Giving Away 250 Turkeys this Thanksgiving

Tue, 11 Nov 2014 18:45:12 EST

THL is giving away 250 turkeys to local needy families on November 18th at 10 am at the Salvation Army of Alton. Email info@torhoermanlaw.com for more information.

THL Announces Settlement of Pradaxa Litigation

Fri, 30 May 2014 17:16:39 EDT

TorHoerman Law is pleased to announce that the Pradaxa litigation that it has helped lead since before the Multi-District Litigation (MDL) was formed is set to be resolved by settlement. Boehringer Ingelheim, which manufactures the drug, and lead plaintiffs’ counsel, including Tor Hoerman, reached an agreement yesterday that will…

Benicar Does Not Cause Celiac Disease - Lawsuits Filed Claim Individuals Have a Sprue-Like Enteropathy

Thu, 24 Apr 2014 17:31:57 EDT

It is important to understand that Celiac disease is an autoimmune disease and has not been linked to any drug – the lawsuits being filed do not claim that individuals taking Benicar have Celiac disease. Instead, the lawsuits that are currently being filed on behalf of individuals severely injured while taking Benicar claim that Benicar caused…

HeartBleed Help from an Amateur

Thu, 10 Apr 2014 10:40:07 EDT

Okay, I’ll admit it, I have been known to use “password” on a few sites – on occasion a site requires me to add numbers or even capitalize which results a capitalized “P” and an occasional number at the end. Tricky, huh? So, given the immense amount of news in the past 24 hours that was clearly designed to keep…

Marseilles IL Flooding Update

Wed, 26 Feb 2014 12:57:33 EST

Months after historic floods hit Marseilles, IL, the word that strikes us about this community is resilience. There is no other way to describe a community that works so hard to help neighbors dig out from damages suffered during the floods so they can go back to the life they knew as proud community members of Marseilles, a small town with a prime…

Federal Law Does Not Prevent Plaintiff's Failure to Warn Claims in Chicago Actos Litigation

Tue, 11 Feb 2014 14:15:41 EST

This morning in preparation of the first Actos trial in Cook County, Judge Deborah Dooling heard oral arguments from both parties on Takeda Pharmaceutical's Motion for Partial Summary Judgment based upon federal preemption. Ken Brennan of TorHoerman Law argued for the Plaintiffs and cited numerous cases and regulations for the conclusion that federal…

First Actos MultiDistrict Litigation Case Begins Today

Mon, 03 Feb 2014 12:26:13 EST

Today begins the first Actos MDL case in the US District Court, Western District of Louisiana. Jury was selected on Friday and today begins opening statements in the case of Terrence Allen, a man who was diagnosed with bladder cancer in January 2011 after taking Actos pursuant to a prescription starting in June 2006. Mr. Allen’s lawsuit claims…

Seventh Circuit Court of Appeals Calls Boehringer Ingelheim Order "Weak Kneed"

Thu, 30 Jan 2014 18:10:31 EST

In a dissent that reads like an angry mother grounding a child for complaining about punishments provided by dad, Judge Hamilton tells Boehringer Ingelheim (hereinafter Boehringer) that the petitioner-defendant’s use of a procedure referred to as a “writ of mandamus” was weak-kneed. A “writ of mandamus” is an extraordinary…

Actos Cases Move Ahead Rules MDL Judge

Tue, 14 Jan 2014 16:12:09 EST

On January 7, 2014, Judge Doherty, the Louisiana federal judge assigned to the multidistrict litigation (MDL) In Re:Actos, denied a Motion for Partial Summary Judgment filed by Takeda Pharmaceuticals. In ruling for the plaintiffs, Judge Doherty found that the plaintiffs did in fact satisfy their burden to show that the facts and circumstances of this case warrants the Actos cases to move forward towards a day in court.

Drug used to Treat Lennox-Gastaut Syndrome Linked to Severe Skin Reactions

Thu, 19 Dec 2013 14:04:48 EST

FDA warns that anti-seizure drug Onfi can cause rare but serious skin reactions that can result in permanent harm and death.

Research Mounts Between Increased Risk of Pancreatic Cancer and the Type 2 Diabetes Drug Class Known as Incretin Mimetics

Wed, 18 Dec 2013 14:24:30 EST

Scientific journals, studies and advocacy groups join the FDA in questioning the safety of the Type 2 diabetes drug class referred to as incretin mimetics, which includes brand name drugs such as Byetta, Bydureon, Victoza, Januvia and Janumet.

Despite One Loss, Juries and Regulatory Agencies Continue To Quetion Safety of Actos

Tue, 17 Dec 2013 11:50:19 EST

Three Actos trials have made their way through courtrooms with two juries finding Takeda guilty of a negligence to warn and one jury finding for Takeda. Large litigations such as the Actos litigation will see some losses with different factual situations. The jury loss yesterday does not change the fact that Actos increases the risk of bladder cancer. The FDA and a few independent agencies have stated as much and, while Actos is currently on the market in the U.S., several countries have taken it off the market.

Pancreatic Cancer from Diabetes Drugs Litigation Moves Forward

Sun, 17 Nov 2013 21:52:36 EST

As lawsuits move forward, individuals diagnosed with pancreatitis or pancreatic cancer after taking type 2 diabetes medications are advised to determine their legal rights - fill out this survey for a quick, no cost/obligation legal consultation.

THL is "Tank Full" for the Main Street Community Center

Tue, 05 Nov 2013 10:39:30 EST

TorHoerman Law is proud to sponsor the Main Street Community Center (MSCC) Tank Full Trivia event. All proceeds for this event benefit a door-to-door transportation program for seniors and the disabled in the community.

Is the FDA's Safety Data for Pradaxa Trustworthy?

Fri, 25 Oct 2013 15:24:51 EDT

Shortly after FDA approval in October of 2012, adverse events mounted for the anticoagulant, Pradaxa and as of October of 2013, it was the single most-reported drug. Critics now question the data used to inform patients and doctors about the safety and efficacy of Pradaxa.

Diabetes Drugs Pancreatic Cancer Litigation Proceeds - THL Attorneys Named as Leaders

Wed, 23 Oct 2013 13:17:44 EDT

Tor Hoerman and Jake Plattenberger named to leadership roles in diabetes drugs pancreatic cancer lawsuit consolidated in front Judge Anthony J. Battaglia in the Southern District of California.

Marseilles Flooding Lawsuit Update

Fri, 18 Oct 2013 15:49:24 EDT

Six months after the devastating flooding that forced the evacuation of 1,500 Marseilles residents, TorHoerman Law continues to work toward finding justice for residents experiencing near devastation when seven barges owned by Ingram Barge company slammed into the I & M dam. Like many other things, our work on this case was affected by…

Vaginal Mesh Manufacturers Begin Settlement Discussions

Tue, 15 Oct 2013 11:11:19 EDT

After several plaintiffs were awarded million dollar verdicts and others settled for undisclosed amounts, five of the largest transvaginal mesh manufacturers have begun discussing settlement for the thousands of remaining plaintiffs.

Pradaxa Lawsuits Filed in France

Fri, 11 Oct 2013 13:38:22 EDT

In 2012, Pradaxa cases in the United States were consolidated into Multidistrict Litigation 2385 in the Southern District of Illinois. The MDL began with 21 actions, and currently has 1422 cases pending. Similar to the new lawsuits filed in France, U.S. plaintiffs allege that the pharmaceutical company failed to warn patients of the risks and that they suffered life-threatening injuries as a result of the effects of Pradaxa and the lack of an antidote.

Takeda Put Actos Profits Before Safety - Actos Attorneys Argue at Second Trial

Wed, 25 Sep 2013 15:19:36 EDT

In the second Actos case to go to trial, attorneys representing the family of a former U.S. Army translator who died of bladder cancer after taking Actos, argued that Takeda put sales over safety when they failed to warn consumers about the risk of bladder cancer associated with Actos. Specifically, attorneys representing the family of Diep An…

Judge Herndon Imposes Fines and Injunctions on Boehringer Ingelheim for Clear Pattern of Violating Court Orders in Pradaxa Litigation

Wed, 18 Sep 2013 17:52:20 EDT

At a discovery conference today, the Court ruled that defense violations of discovery orders were so numerous and ongoing that they amounted to a pattern that prejudiced the plaintiffs and demonstrated a low regard for the court and its authority. Judge Herndon noted that defense can’t continue to fail-then-apologize, then start from scratch as in this litigation. He noted that conduct is what counts and it has a cumulative effect. He therefore ordered defendants to pay sanctions and imposed mandatory injunctions to avoid future delays and violations.

Bard Settles Vaginal Mesh Case Before Trial Begins

Tue, 17 Sep 2013 15:05:51 EDT

C.R. Bard Inc. has recently agreed to settle a vaginal-mesh implant case that was set for trial later this month according to undisclosed sources who spoke to Bloomberg News. The settlement amount, as of now, is also undisclosed. The case, which was filed in New Jersey, centered on Melanie Virginal’s claims that Bard’s Avaulta…

FDA Investing Brain Infection in Patient on Novartis' Multiple Sclerosis drug Gilenya

Wed, 04 Sep 2013 14:06:23 EDT

Recently, the U.S. Food and Drug Administration (“FDA”) announced that it is investigating the occurrence of a rare and serious brain infection that developed in a European patient, who was being treated with Novartis’s multiple sclerosis drug, Gilenya.

According to the report, this was the first instance of the infection, called progressive multifocal leukoencephalopathy (“PML”) reported in a patient who had not previously received Biogen Idec’s drug Tysabri. Tysabri is a multiple sclerosis drug that had already drawn much scrutiny due to its association with a higher risk of PML. As a result, the drug’s demand has sharply declined in recent years and for a brief period, the drug was withdrawn from the market.

First Federal Hip Replacement Trial to Begin in Cleveland

Tue, 03 Sep 2013 17:40:21 EDT

The first federal trial regarding DePuy Orthopaedics Inc.’s ASR XL metal-on-metal hip replacement device is set to begin on September 9 in Cleveland. There are roughly 10,000 similar lawsuits filed across the country. The plaintiffs in these cases suffered severe injuries after being implanted with this device and allege that DePuy knew that there were problems with the device and failed to warn doctors. Some of these injuries include pain, grinding or clicking in the hips and a high metal content in blood tests. As a result of these problems, many plaintiffs were forced to undergo revision surgery. After realizing these harmful issues with their device, DePuy actually pulled this product from the market on August 24, 2010.

More Plaintiffs Join Granuflo Litigation

Thu, 29 Aug 2013 14:29:23 EDT

Litigation involving chronic kidney failure after undergoing dialysis continues to progress in the District of Massachusetts. Plaintiffs and their families throughout the country have alleged that they have suffered injury or death caused by the use of GranuFlo and/or NaturaLyte products during hemodialysis. The plaintiffs further allege that Fresenius,…

Byetta, Januvia, Janumet and Victoza Cases Consolidated in Southern District of California

Tue, 27 Aug 2013 15:14:15 EDT

Litigation over diabetes drugs that manage blood insulin levels, referred to as Incretin Mimetics, continues to move forward. Plaintiffs and their families throughout the Country have alleged that they now suffer or have died from pancreatic cancer as a result of taking these types of drugs.
Yesterday, a panel of federal judges entered an order consolidating all current and future Byetta, Januvia, Janumet and Victoza cases into one courtroom in the Southern District of California under the title In re:Incretin Mimetics-Based Therapies Products Liability Litigation.
Given the complexity of this litigation and anticipated resource demands that accompany “mass tort” (multiple plaintiffs injured in a similar fashion by a defective product) cases, the consolidation is intended to allow the litigation to move forward in an efficient, organized and timely manner.
According to a Transfer Order filed on August 26, 2013, the 53 actions currently pending in seven districts will be transferred to the courtroom of the Honorable Anthony J. Battaglia for coordinated or consolidated pretrial proceedings in MDL No. 2452. We expect the number of cases filed in San Diego to increase substantially.
These actions involved a common question of fact making mulitidistrict litigation an efficient option for the courts to promote the just and efficient conduct of this litigation. Despite the fact that the courts are generally hesitant to create an MDL for multiple defendants, the panel of judges proceeded with centralization with the support of the defendants - Merck, Amylin, Eli Lily and Novo Nordisk.

Second Transvaginal Mesh Trial Ends in Settlement

Wed, 21 Aug 2013 14:38:50 EDT

TorHoerman Law is happy to announce more good news for transvaginal mesh plaintiffs. The second bellwether case to go to trial, Queen v. C.R. Bard, Inc., regarding C.R. Bard’s Avaulta transvaginal mesh settled for an undisclosed amount on the day it was set to go to trial, August 21, 2013.

Wanda Queen, the North Carolina plaintiff, allegedly suffered permanent vaginal mesh injuries after she was implanted with the Avaulta Solo Anterior Synthetic Support System. She was forced to undergo six revisionary surgeries.

The case never made it to court as the settlement happened on the morning the trial was scheduled to begin. This success comes a week after a West Virginia Federal Court awarded $2 million to a plaintiff who also suffered irreparable harm from a C.R. Bard Avaulta transvaginal mesh device.

These are just two of the 4,408 cases currently filed by women who suffer from injuries allegedly caused by C.R. Bard’s Avaulta transvaginal mesh. Transvaginal mesh lawsuits against C.R. Bard and five other medical device manufacturers have been consolidated before Honorable Joseph Goodwin in the United States District Court Southern District of West Virginia.

Federal Transvaginal Mesh Case is a Win for Injured Women

Mon, 19 Aug 2013 14:31:11 EDT

THL is proud to report that injured women took a step closer to justice with a victory for the plaintiff against C.R. Bard on Friday. This is the first of four bellwether trials against C.R. Bard has ended with a verdict in favor of the plaintiff, Donna Cisson. The jury of four men and four women took just 12 hours to determine that C.R. Bard, Inc. was liable for Cisson’s severe injuries resulting from her Avaulta Plus mesh device. The jury awarded the plaintiff $2 Million consisting of $250,000 for compensatory damages and $1.75 million in punitive damages.

Granuflo Litigation Progressing in Boston and More Individuals Expected to Join

Mon, 12 Aug 2013 13:53:53 EDT

Granuflo litigation is moving forward in MDL 2428 in the U.S. District Court for the District of Massachusetts. The first status conference for this case is scheduled to take place in Boston on August 30, 2013 under Federal Judge Douglas P. Woodlock. This initial meeting will allow the Judge to meet with legal counsel to discuss pending motions and go over the structure and organization of the consolidated proceedings. Currently, there are 188 cases pending in the District of Massachusetts, however, products liability attorneys expect many more tag-along actions to be included in the MDL.

Granuflo and Naturalyte are products used in dialysis by the world’s largest integrated provider of products and services, Fresenius Medical Care. Plaintiffs in these cases are alleging that Fresenius products withheld vital information about adverse Granuflo side effects that were known as early as 2010. Furthermore, plaintiffs allege that Fresenius, the provider of these products failed to adequately warn consumers and health care professionals about the importance of monitoring patient’s bicarbonate levels, as both products were shown to substantially increase these levels. An increase in these levels leads to problems with low blood pressure, low potassium, low blood oxygen, excessive carbon dioxide in the blood, cardiac arrhythmia and cardiac arrest.

It is our hope that this initial status conference will get the ball rolling in holding Fresenius liable for their negligence in deliberately failing to warn about these life-threatening side effects. If you or a loved one has suffered any side effects from the use of Granuflo or Naturalyte, please call our office to discuss your legal options.

TorHoerman Law Looking Into Tylenol Litigation

Mon, 12 Aug 2013 13:37:04 EDT

Tylenol has been a household pain reliever since it was first introduced to the market in the 1970’s. However, recently, Tylenol has been the center of several lawsuits claiming that the common pain reliever may be causing more trouble than relief. Specifically, the plaintiffs in these lawsuits allege that Tylenol’s manufacturer, Johnson and Johnson, failed to adequately warn about the risk of liver failure or liver damage from Tylenol when marketing and distributing the drug.

TorHoerman Law is currently looking into litigating cases involving individuals who suffered harm from Johnson and Johnson’s deliberate failure to warn. If you or a loved one has suffered liver damage or failure from Tylenol, please contact our office for a free evaluation of your case.

First Transvaginal Mesh Trial Begins - Favorable Evidence Presented for Women Similarly Injured by Transvaginal Mesh

Mon, 05 Aug 2013 14:53:32 EDT

The first of four bellwether trials of the C.R. Bard transvaginal mesh lawsuits is underway for the second time in the United States District Court for the Southern District of West Virginia. The initial trial was declared a mistrial after an expert witness gave improper testimony. This transvaginal mesh lawsuit, brought by Donna and Dan Cisson…

Procedure Checklist Developed for Robotic Surgeries

Fri, 26 Jul 2013 11:31:02 EDT

Recently in an article titled, The Second “time-out”: A Surgical Safety Checklist for Lengthy robotic surgeries, doctors suggested a new protocol checklist that includes a second time-out. This new protocol stemmed from a recent surge in longer more complex robotic surgeries because doctors are becoming more comfortable with these operations to try using them in new previously unexplored areas of surgery. The new checklist incorporates four areas consisting of general patient factors, surgeon factors, anesthesia factors, and nursing factors. This time-out, which is to occur three to four hours after the beginning of the procedure, is meant to incorporate all of the medical staff together to help monitor things such as patient positioning, level of blood loss, and surgeon performance. "The Second “Time-Out”: A Surgical Safety Checklist for Lengthy Robotic Surgeries", doctors suggested a new protocol checklist that includes a second time-out. This new protocol stemmed from a recent surge in longer more complex robotic surgeries because doctors are becoming more comfortable with these operations to try using them in new previously unexplored areas of surgery.

The new checklist incorporates four areas consisting of general patient factors, surgeon factors, anesthesia factors, and nursing factors. This time-out, which is to occur three to four hours after the beginning of the procedure, is meant to incorporate all of the medical staff together to help monitor things such as patient positioning, level of blood loss, and surgeon performance.

Federal Court Rules Amylin Can't Avoid Byetta Pancreatic Cancer Cases in California State Court

Sun, 14 Jul 2013 22:36:30 EDT

On July 10, 2013, a federal district court judge in San Diego rejected Amylin Pharmaceutical's bid to avoid having to defend Byetta-induced pancreatic cancer cases in California state court.

Actos Classified as Probably Carcinogenic as Actos Lawsuits for Bladder Cancer Make Their Way Through the Courts

Fri, 12 Jul 2013 11:33:38 EDT

As the number of Actos cases filed in Cook County against Takeda jumps to over 2,800, the manufacturer of the drug is now facing more problems. An international independent study published on July 5, 2013 has found Actos (pioglitazone) to be “probably carcinogenic.” In June 2013, 23 experts from nine countries met at the International Agency for Research on Cancer (IARC) to assess the carcinogenicity of 14 drugs and herbal products. After a detailed review of one large randomized controlled study, four cohort studies, and three case controlled studies, the Agency determined that pioglitazone (the active ingredient in Actos) should be classified as probably carcinogenic to humans based on the evidence that it causes bladder cancer.

In addition to the Cook County court cases, there are currently more than 1,500 cases consolidated before a federal judge in Louisiana (as of May 2013) and hundreds more in state courts.

In April 2013, the first Actos bladder cancer lawsuit was heard in front of a California state court jury. After hearing evidence that Takeda knowingly withheld bladder cancer risk information from the public, the jury awarded Mr. Cooper, an Actos user who was later diagnosed with bladder cancer, $6.5 million. The judge disagreed with the jury award and overturned it. This case will now be decided in the appellate court.

#Actos Drug Banned in India

Wed, 10 Jul 2013 11:41:15 EDT

As Takeda’s legal battles continue in the United States, its regulatory battles continue all over the world. India, on June 18, became the most recent country to ban the use of Pioglitazone (Actos), Takeda’s blockbuster diabetes drug. The ban includes all combination products that contain Pioglitazone. Regulators cited safety concerns over bladder cancer and heart failure as the reasons for the ban. Bladder cancer has been a concern for Pioglitazone since the drug was first introduced into the market, but it was only added to the U.S. warning in 2011. While Pioglitazone continues to be marketed in most countries, its sales dropped by more than 50% after a generic version became available and bladder cancer was added to the product’s label.

FDA Creates New Consumer Driven Reporting to MedWatch

Tue, 02 Jul 2013 14:09:46 EDT

Consumers can now directly report side effects and adverse events from taking prescription drugs directly to MedWatch using a more consumer friendly reporting system. MedWatch is the online system for collecting information about problems with drugs and other FDA regulated products. Formerly, adverse event reporting was often done by physicians. This new form, which is more concise and less technical, gives consumers a better opportunity to file reports directly to MedWatch without having to go to their doctor.

Stories from the Marseilles Flood

Wed, 26 Jun 2013 12:16:14 EDT

One of TorHoerman Law’s clients, Kim Daniels, lost an irreplaceable part of her family’s home after the Marseilles flood in April. The Times has written a piece highlighting Kim’s story.

Deadline to File Marseilles Flood Claims Extended to August 30, 2013

Thu, 20 Jun 2013 14:07:47 EDT

Federal District Court Judge Amy St. Eve has extended until August 30, 2013 the deadline for filing claims against Ingram Barge Company arising from the flooding of Marseilles that began on April 18, 2013. On May 8, 2013 Ingram Barge Company filed suit in federal court to be exonerated from liability or in the alternative to limit its liabiliy to approximately $4.2 million. This additional time will allow victims of the flood to seek legal counsel if they have yet to do so.

Link to the Federal District Court Notification of Docket Entry Here

Scrutiny over Diabetes Drugs Warranted - More Studies Needed to Determine Link to Pancreatic Cancer

Tue, 18 Jun 2013 14:59:23 EDT

As scrutiny over diabetes drugs increases, the FDA and other independent researchers report that more studies are required to determine the connection between these drugs and pancreatic cancer. Commercially known as Januvia, Byetta, Victoza, Onglyza, and Trajenta, a two-day conference hosted by the National Institute of Diabetes and Digestive and Kidney Diseases last week put these drugs under the microscope. In April, an analysis of the FDA's adverse event reporting system showed an increase in reports for pancreatitis and pancreatic cancer in people taking incretin mimetics as conpared with those taking other anti-diabetic drugs. In an effort to dismiss allegations that their product was unsafe, Merck funded a study about the effect of sitaglipton (Januvia) on rats that have diabetes similar to that in humans. When the rats were examined after the 12-week study, every rat given sitagliptin had an enlarged pancreas. After these results were published, Merck met with a professor of digestive diseases who said the results could suggest an increase of pancreatic cancer. Had the pharmaceutical companies adequately tested these diabetes drugs before rushing them to the market, they would likely have found these results before the drug caused pancreatic damage to thousands of users.

Pancreatic Cancer Specialists Meet to Consider Whether Increase in Cancer Tied to Type2 Diabetes Medication

Wed, 12 Jun 2013 19:35:34 EDT

Why the increase in pancreatic cancer and what can be done to stop this tragic trend? This topic is front and center in a two-day workshop hosted by the National Institute of Diabetes and Digestive and Kidney Diseases on June 12 -13, 2013 in Bethesda Maryland. One of the main topics tackled in this workshop is the association between the increase in pancreatic cancer and the anti-diabetic treatments currently on the market. Recent studies have shown that the so-called incretin mimetic class of anti-diabetic drugs, known commercially as Byetta, Bydureon,Victoza, Januvia, and Janumet may very well increase the risk of pancreatic cancer. There is also reasearch showing how these drugs can serve as cancer accelerators. TorHoerman Law has attorneys attending the conference and will bring updates to our blog as we get further into the litigation.

Pradaxa...The Rest of the Story

Thu, 16 May 2013 15:06:30 EDT

A new study in the Journal of Cardiology refutes Boehringer Ingelheim's claim that Pradaxa is more effective than warfarin, adding to the increasing information that leads us to ask - why should a well-controlled patient switch from warfarin (Coumadin) to Pradaxa? To begin, BI's claimed context of safety appears to be inaccurate. Using RE-LY data (the open-label clinical trial that studied more than 18,000 patients) are more likely to suffer severe bleeds; often, these have occured as GI bleeds. Further, unlike warfarin, Pradaxa has no reversal agent, meaning the doctors cannot administer a drug to reverse Pradaxa's effects. In the event a Pradaxa patient experiences a bleed, a traumatic injury, or the need for emergency surgery, doctors must often delay treatment until Pradaxa has been eliminated from the patient's body. Compromised kidney function increases the risk further. Pradaxa, unlike warfarin, is eliminated through the kidneys. Compromised kidney function slows the body's availability to eliminate Pradaxa, meaning that needed treatment may be delayed even further. In some cases, delayed treatment has led to death. In other cases, treatment could not be delayed and patients bled to death because doctors could not reverse Pradaxa's effects. Given the increased risk of bleeds and the increased difficulty in reversing Pradaxa's effects, one might question whether Pradaxa really is as safe as warfarin.

Marseilles IL Residents Holding Parties Accountable for Flood Damage

Fri, 10 May 2013 15:51:20 EDT

The Aquinos count themselves as lucky - they have learned that their home survived the recent flood in Marseilles IL without structural damage. Sadly, there are others less fortunate and TorHoerman Law is doing our part to hold those parties responsible for this damage accountable. It appears that the rush of water occurred when several barges that broke free damaged the Marseilles dam. Investigations are underway to determine the extent of responsibility that should rest with the barge company and others, and TorHoerman Law is doing its part to make sure the responsible parties are held accountable. We will be back in Marseilles for a third visit on Friday, May 17th to continue to investigate legal options for property damage clains. If you are uable to attend the meeting, please contact Jake Plattenberger at (312) 372 - 4800 or email him at jplattenberger@torhoermanlaw.com.

New Warfarin Reversal Agent - Can It Help #Pradaxa Patients?

Tue, 30 Apr 2013 16:21:24 EDT

The FDA has approved a new reversal agent to the commonly-used vitamin K agonist anticoagulant warfarin (brand name: Coumadin). This reversal agent, Kcentra (manufactured by CSL Behring) is the second reversal agent approved to treat bleeding in patients using vitamin K agonists; the other is human plasma. While Kcentra is made in part from human plasma, unlike with the use of plasma, no thawing or blood group tying is required. The reversal agent was approved following a study of patients receiving vitamin K agonists. No such study has been performed with regards to patients receiving other, non-vitamin K agonist anticoagulants, such as Pradaxa and Xarelto. Anticoagulants, including vitamin K agonists like warfarin and other, non-vitamin K agonists, such as Pradaxa and Xarelto, are used to thin human blood to reduce the risk of clotting and stroke. A risk of anticoagulation therapy is uncontrollable bleeding. In an emergency, such as trauma or the need for life-preserving surgery, the effects of anticoagulants must be reversed. Human plasma and Kcentra are only indicated for this use in patients taking vitamin K agonists. No such reversa agent l has been approved for Pradaxa and Xeralto.

6.5 Million Jury Verdict in First Actos Trial

Fri, 26 Apr 2013 18:42:17 EDT

A California state court jury has reached a verdict for the plaintiff in the first Actos trial in the country. The verdict comes after almost two months of trial, and jury deliberations that lasted more than a week. The jury ruled Takeda failed to warn plaintiff, Jack Cooper, of the risks of bladder cancer and awarded him 6.5 million dollars in damages. Cooper's attorney, Michael Miller, argued that Takeda downplayed risks of bladder cancer to protect profits. More than 3,000 cases have been filed nationwide that contain similar allegations. If you or a loved one has been injured as a result of taking Actos, make sure to contact our office to discuss your legal options.

$7 Million "Popcorn Lung" Lawsuit Upheld

Tue, 23 Apr 2013 15:26:07 EDT

A federal court in Colorado has dismissed the defendant’s post-trial motions for judgement as a matter of law for a new trial thus upholding a $7.5 million jury award to plaintiff, Wayne Watson, who sued the manufacturer and retailers of microwave buttered popcorn that caused him to develop “popcorn lung” after eating two bags daily for 10 years. "Popcorn lung", medically known as constrictive bronchiolitis obliterans, is a severe and potentially lethal lung disorder in which the smallest airwaves of the lung become scarred and constricted, thus blocking off movement of air. Dr. Cecile Rose, a lung specialist at the National Jewish Medical Research Center in Denver, and Watson's doctor, was initially unsure of the cause for the ailment, but knew it came from something he inhaled. When Watson's medical history turned up nothing but eating two bags of popcorn for ten years, Dr. Rose took action to see what others knew of the dangers. She wrote a letter to federal agencies warning that an unidentified person may have developed the first case of the disease outside factory workers. Even with Dr. Rose's warnings many people are working with this substance and consumers are risking their health using products containing diacetyl in their homes on a daily basis. According to the Colorado federal court, punitive damages were appropriate in this case because, "a reasonable jury could conclude that the Defendants knew about the risk posed to consumers from diacetyl in their microwave popcorn products, and that this conduct could be construed as willful and wanton."

Study Indicates Type-2 Diabetes Drugs Carry up to a 25 Times Risk of Pancreatic Cancer

Fri, 19 Apr 2013 18:02:41 EDT

Today an independent body released the results of its research indicating that an entire class of type-2 diabetes drugs known as incretin mimetics may carry up to 25% times the risk of developing pancreatic cancer for patients taking these drugs. These drugs are known commercially as Januvia, Byetta, Victoza, Onglyza, and Tradjenta. The Institiue for Safe Medication Practices "ISMP" analyzed data from the FDA Adverse Event Reports between July 1, 2011 and June 30, 2012 from 1,723 patients taking the drug, and concluded that the increased risk of developing pancreatic cancer for these patients could be as much as 25% higher than those who were taking other medications to control their type-2 diabetes. The FDA and the EMA are continuing to investigate the connection between this class of drugs and pancreatic cancer. Tom Moore, a senior scientist for drug safety and policy as the ISMP stated that additional analysis is required, but "if the results are confirmed in a broader patient population, it raises questions about the entire class of drugs."

Despite Rising US Lawsuits, Scandanavian Study Offers Safety Assurances about #Pradaxa.

Thu, 04 Apr 2013 19:08:38 EDT

Despite intense concerns over the safety and efficacy of Pradaxa in a real-world population, a new Scandinavian study attempts to ease concerns of the higher bleeding rates of Pradaxa over warfarin. Using data from the Danish Registry of Medicinal Product Statistics, researchers compared 4978 patients treated with Pradaxa to 8936 patients who received warfarin. The study found similar rates of stroke or systemic embolism and major bleeding with Pradaxa and warfarin. However, this study did analyze the 110 mg Pradaxa pill, which has not been approved in the U.S, so it is hard to say whether this reassurance could be applied to the US population.

Rachel Maddow Show highlights Nuclear Waste with Regards to Hanford Nuclear Site

Wed, 03 Apr 2013 05:02:08 EDT

The Rachel Maddow Show highlighted the barrels of plutonium waste that still exist at the Hanford Nuclear site in Hanford Washington, but she may as well have been speaking about North County, St. Louis. In the 1940's and 1950's, the Hanford site was used to create a number of atomic bombs, including the famous atomic bomb that was detonated over Nagasaki, "Fat Man." The nuclear by-product from these bombs still exist in endless barrels the US still doesn't know what to do with it. According to Rachel Maddow, "during the later half the 20th century, we got really good as a country at creating radioactive material - we created it to create nuclear weapons, we created them to fuel nuclear power plants. And we did that without ever really figuring out how it was all going to end and how we were going to clean it up. The end products, the radioactive deadly mess produced inherently by these processes, we never figured out what we were going to do with it when we got to that part of the process. We built something that we could not ultimately handle and now we do not know what to do with it." Now in Hanford, those tanks containing the nuclear waste are leaking into the groundwater because they were located close to the Columbia River.

Merck Fails to Submit Report to FDA Investigating Januvia and Janumet's Risk of Pancreatitis

Thu, 28 Mar 2013 14:57:28 EDT

Merck & Co., the manufacturer of Januvia and Janumet, is facing heat from the FDA for failing to comply with FDA requirements. In 2009, in response to mounting complaints of acute pancreatitis associated with the use of Januvia and Janumet, the FDA required Merck to investigate the risk of acute pancreatitis in a rodent population treated with these drugs. The manufacturer, who pulled in over a billion dollars in the sale of Januvia in 2012, has not produced the final report that the FDA required

$5 Million Verdict in Gadolinium Case Proves Justice Can Occur with Persistence and Passion

Fri, 22 Mar 2013 14:52:43 EDT

It is a great day for justice. TorHoerman Law would like to extend a huge congratulations and thanks to the Decker family and the lawyers at Ashcraft & Gerel, LLP and Spangenberg, Shibley & Liber LLP who were awarded a $5 million verdict in Paul Decker and Karen Decker v. GE Healthcare, Inc . This was the first verdict in a gadolinium case that has been litigated over the course of the last five years. The courageous plaintiffs and hard working attorneys in this case proved that justice could be achieved in the face of great obstacle if you are persistent and passionate enough.

Ban Januvia, Byetta and Victoza Because of Their Link to Pancreatic Cancer?

Fri, 22 Mar 2013 14:31:19 EDT

The health watchdog group Public Citizen issued a statement today asking the FDA to consider a ban of all GLP-1 mimicking diabetes drugs, which includes Byetta, Victoza and Januvia, as a result of their link to Pancreatic cancer. Public Citizen previously petitioned the FDA to ban Victoza because of concerns about pancreatic disease and thyroid cancer.

This recommendation from Public Citizen comes on the heels of a study published today on the online journal "Diabetes” claiming to have proof that certain type-2 diabetes drugs are causing pancreatic cancer. The study was led by Dr. Alexandra Butler and Dr. Peter Butler of the University of California, Los Angeles and it provides evidence of increased pre-cancerous changes in diabetic patients taking the drugs known as incretin mimetics and includes the brand name drugs Byetta, Januvia, and Victoza.

Examinations of pancreases from 20 diabetics showed a 40% increase in pancreatic cells as well as cell damage in the patient population taking incretins. The research further showed that use of incretins resulted in a "marked" cell proliferation and damage with a potential for evolution into cancer.

Just last week the FDA said that it was reviewing unpublished findings by a group of academic researchers that suggests pre-cancerous cellular changes may be associated with incretins.

Increased Risk of Acute Kidney Injury Found in High-Dose Statin Users

Thu, 21 Mar 2013 19:22:06 EDT

According to a March 19, 2013 BMJ Research Paper, users of “high potency statins” were 34% more likely to be hospitalized with acute kidney injury within 120 days after starting treatment. More than 20 million Americans take statins. They are a class of medicines that are frequently used to lower blood cholesterol levels. Statins lower the chances of a heart attack and death in people who have an elevated risk of developing heart disease or who already have heart disease.

While there are seven statins, “high potency statins” include: Zocor (at least 40 mg), Lipitor (at least 20 mg), Crestor (at least 10 mg).

The BMJ study included more than two million statin users aged 40 years or older and newly treated with statins between January 1, 1997 and April 20, 2008. The outcome measured was hospitalization for acute kidney injury.

Bayer Agrees to Pay on Yaz, Yasmin and Ocella Gallbladder Removal Cases

Thu, 21 Mar 2013 11:38:58 EDT

Bayer has entered into an agreement to settle lawsuits filed by plaintiffs who claim to have suffered gallbladder injuries from the company's Yasmin and Yaz birth control pills.

In an agreement filed on Friday, Bayer agreed to pay up to $24 million to settle gallbladder injury claims consolidated in the U.S. District Court for the Southern Distric of Illinois, as well as in state courts in California, New Jersey and Pennsylvania.

Under the agreement, Bayer will pay $2,000 to plaintiffs who suffer gallbladder injuries and $3,000 to individuals who had their gallbaldders removed.

FDA Conducts Inquiry into Link Between Type 2 Diabetes Medications and Pancreatic Cancer

Thu, 14 Mar 2013 10:13:25 EDT

More concerning news today surrounding popular type-2 diabetes (T2D) medication and its link to pancreatic cancer. Independent academic and scientific researchers have called on the FDA to take a serious look at their data concerning certain T2D meds and their potential to cause this serious and often times fatal form of cancer.

At the urging of these researchers the FDA is currently reviewing a recent body of research that suggests pre-cancerous cellular changes in the body may be triggered by T2D medications such as Januvia, Byetta, and Victoza. These changes may produce an inflammation of the pancreas, which has been shown to cause pancreatic cancer.

More and more research continues to emerge linking these T2D medications with pancreatic cancer, pancreatitis, and thyroid cancer. However, in the last year alone, Januvia brought in $4 billion dollars in sales and Byetta brought in $148 million. Manufacturers are not going to give up these products without a fight.

Bayer Pays $1 billion to those Injured by Yaz, Yasmin or Ocella - Many Women Still Unaware of Their Legal Right to a Settlement

Mon, 04 Mar 2013 11:13:18 EST

According to the Bayer Annual Report from 2012, issued on February 28, 2013, Bayer has settled with 4,800 individuals claiming injuries from Yaz, Yasmin and Ocella.

Once positioned as the “go to” oral contraceptive, Yaz, Yasmin and Ocella carried health risks not see with older birth control pills. Yaz, Yasmin and Ocella contain a type of progestin called drospirenone, which has been associated with stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease and other life-threatening injuries.

Although Bayer has already spent $1 billion to settle with those who have suffered venous clot injuries (deep vein thrombosis or pulmonary embolism), Bayer acknowledges that there are still about 3,200 pending unsettled claims with individuals who endured similar injuries.

Additional lawsuits are anticipated as more women become aware of their legal rights. In fact, it appears the number of women that qualify for the settlement but are not yet aware of their legal rights is fairly substantial – over 3,000 women.

According to Adverse Events, Inc. (and their proprietary software, the RxFilter), there have been 11,261 reports of pulmonary embolism and deep vein thrombosis events through August 2012 reportedly linked to Yaz or Yasmin. The RxFilter uses information that has been provided to the FDA by individuals and doctors. Based on this information, as compared to the 2012 Bayer Annual Report, it appears that Bayer is not yet aware of over 3,000 injured parties that should qualify for the Yaz/Yasmin/Ocella Settlements.

Transvaginal Mesh Verdict Sends Powerful Message to Johnson & Johnson

Thu, 28 Feb 2013 11:58:56 EST

Unaccountability in business is unacceptable. In the case of Gross v. Johnson & Johnson, the jury awarded $7.76 million in punitive damages today, adding to the $3.35 million they awarded in compensatory damages this past Monday, sending a powerful message to Johnson & Johnson.

The punitive damages verdict is not only meant to punish Johnson & Johnson for their reckless disregard for human safety, but also as a crystal clear message to other manufactures to stop similar unjust business practices. In this instance, Johnson & Johnson improperly decided to forego testing their transvaginal mesh product before placing it on the market for sale, choosing instead to compare it to Gynecare Prolift, a similar product already on sale. Further, Johnson & Johnson placed their product for sale prior to FDA approval.

The jury set a commanding precedent for future decisions. Unethical business practices with zero accountability and only profit margins as the goal are no longer tolerable. The safety and well-being of consumers must be first priority.

Please Join Us for a G-PAC Reception Honoring U.S. Senator Dick Durbin

Mon, 25 Feb 2013 15:44:33 EST

TorHoerman Law, along with Meyers & Flowers, is honored to host an important fundraising event on March 15th in Chicago honoring one of the greatest advocates of sensible gun laws, Senatory Dick Durbin. Information can be found on this invitation, or please feel free to call Travis Brooks at 773-791-8090 for more details.

Jury Awards Plaintiff Millions in Compensatory Damages for Failed Transvaginal Mesh

Mon, 25 Feb 2013 10:32:34 EST

In a resounding victory for Plaintiff, Ms. Linda Gross, in the Superior Court of Atlantic County, N.J., the jury reached a verdict in her favor for $3.35 million in compensatory damages against Johnson & Johnson for their defective transvaginal mesh implant.

Transvaginal mesh implants are implanted to help strengthen pelvic muscles following prolapse. The mesh will harden in the tissues, causing scaring and inflammation; the mesh fused with muscles and tissues, which makes removing it very difficult. Women who have mesh implants may suffer from perforation of organs, erosion of vaginal tissue, vaginal bleeding, vaginal scaring, and sever pain. Gross, a former nurse, had the device implanted in mid-2006 for pelvic organ prolapse, but instead of strengthening and relieving pain, the device actually caused more agony. Gross was so uncomfortable and in such excruciating pain, she was unable to sit down.

Johnson & Johnson released the product prior to FDA approval; instead of conducting lengthy tests, the company compared the Gynecare Prolift to another one of its mesh products already on the market, Gynecare Gynemesh. Internal emails show the pharmaceutical company was aware of the failure rate during testing, disregarded the potential risks, and placed the implant on the market for sale.

Dialysis Drug Omontys - Urgent Recall

Sun, 24 Feb 2013 12:05:26 EST

The U.S. Food and Drug Administration announced a recall of all lots of Omontys (pegniesatide) after serious hypersensitivity reactions occurred.

Omontys injection is produced by Affymax and Takeda and is used in the treatment of anemia due to chronic kidney disease in adult patients on dialysis. It was approved the FDA in March 2012.

Fatal reactions have occurred in approximately 0.02% of patients and the reaction has occurred within 20 minutes of administration of the injection. More than 25,000 patients have received Omontys since its release.

Diaylysis organizations have been instructed to discontinue use of Omontys immediately. If you are a dialysis patient, it is worth it to confirm your center has discarded this medication.

Did Actos Manufacturer Have Reason to Worry about Cancer Link?

Fri, 15 Feb 2013 12:07:37 EST

In 2003, Takeda Pharmaceutical Co. was already starting to worry that its diabetes drug Actos might be linked to cancer - so much so that the company secretly surveyed a dozen doctors to see if a warning label mentioning a fatal ailment would decrease the likelihood that a doctor would prescribe the drug. According to allegations made in California court filings, the survey found that “a bladder cancer warning would destroy the sales of Takeda’s most important drug.”

This isn’t the first time allegations that Takeda withheld knowledge had been made. Past allegations brought to light the possibility that Takeda underreported the incidents of bladder cancer in Actos users.These allegations will play a central role when the first Actos case goes to trial in California on February 19.

More than 3,000 lawsuits are already pending, each alleging that Actos was the cause of bladder cancer. Recent studies have confirmed that long term usage of Actos can result in an increased risk of bladder cancer.

As trials in California begin, and as cases continue to push forward in federal court in Louisiana and state court in Illinois, the truth concerning Takeda’s actions and decisions will hopefully be exposed.

TorHoerman Law appointed Lead Counsel in Coldwater Creek Litigation

Fri, 15 Feb 2013 11:05:47 EST

TorHoerman Law has teamed up with two other law firms - Napoli, Bern, Ripka, Shkolnik, LLP and Bryon, Carlson, Petri & Kalb (“Coldwater Creek Litigation Team”) - pooling our resources in order to continue to advance this complex litigation. We are proud to announce that TorHoerman Law was recently appointed “lead counsel” by Federal Judge Audrey G. Fleissig in the United States District Court – Eastern District of Missouri (Link to Coldwater Creek Lawsuit Court Document Here)

As “Lead Counsel” in the Coldwater Creek litigation, we act on behalf of all those residents that seek to hold those companies responsible for mishandling the storage, handling and transportation of radioactive waste from the Manhattan project.

The Coldwater Creek Litigation team currently has 3 cases on file with 31 plaintiffs listed. We have hundreds of additional clients and add more everyday as residents continue to be made aware of the toxic secrets that exist in Coldwater Creek.

TorHoerman Law - Four Attorneys Selected as Top Illinois Attorneys by Super Lawyers

Thu, 31 Jan 2013 09:20:11 EST

TorHoerman Law has been honored for the second year in a row with a “Super Lawyers Superfecta” – four of our attorneys have once again been selected as top rated attorneys in Illinois. Congratulations to Eric M. Terry, Steven D. Davis and Jacob Plattenberger for their selection as Illinois “Rising Stars” which includes no more than 2.5 percent of Illinois attorneys forty years or younger. When asked about the honor, Tor noted

"Other than serving our clients, there is no greater honor than being singled out for professional achievement by one's peers. I am proud to have my three associates recognized by the Super Lawyers rating process. This is a reflection of their hard work and dedication to our clients impressive achievement"

Super Lawyers selects attorneys using a rigorous, multiphase rating process. Peer nominations and evaluations are combined with third party research. Each candidate is evaluated on 12 indicators of peer recognition and professional achievement. Lawyers cannot buy their way onto the list. The selection process is recognized as legitimate by bar associations and courts across the United States.

Zoloft Litigation Moved Forward

Wed, 30 Jan 2013 12:15:00 EST

Since the first Case Management Order, setting the initial policies and protocols for the litigation, was entered in October, Zoloft litigation under the honorable Cynthia M. Rufe in the Eastern District of Pennsylvania has continued to move forward.

On November 15, 2012, the Court issued a Joint Discovery and Scheduling Plan. Thus, discovery has already begun, with Pfizer beginning the process of producing documents and identifying witnesses for trial. Furthermore, the scheduling for Daubert motions (arguments for admissibility of expert testimony) have been set, as has the date for the first trial, which is to begin no later than September 12, 2014.

On January 17th, the Court issued Pretrial Order No. 17, which established that an initial discovery group of 25 cases was appropriate. Selection of these 25 cases will be divided among Plaintiffs’ Counsel and Defense Counsel and will serve as the initial group for discovery and trial preparation.

Bayer's Diane-35 and Méliane Linked to Blood Clots - France Haults Sales

Wed, 30 Jan 2013 12:11:44 EST

France’s National Security Agency for Medicines and Health Products (“ANSM”) announced today that swift action has been taken to halt the sale of the hormonal acne drug, Diane-35. Linked to the deaths of four women recently, the drug manufactured by Bayer was also being prescribed as a birth control pill in Europe. Women in France will need to find a new birth control/acne medication within the next three months.

In addition to today’s action, France’s ANSM initiated an investigation into Méliane, another of the newer generation contraceptives manufactured by Bayer. Meliane has also been linked to life threatening blood clots.

France has indicated that the investigations will not end with Diane-35 and Meliane. Bayer’s Yasmin line (Yaz, Yasmin and Ocella) are also newer generation contraceptives that have been linked to blood clots and are likely to be added to the French investigation. In the United States, there have been just short of 23,000 adverse health reports where Yaz was found to be the primary suspect.

FDA Warns Against Prescribing Pradaxa to Heart Valve Patients

Thu, 20 Dec 2012 12:19:04 EST

The FDA is now warning that the anticoagulant dabigatran (also known by its brand name Pradaxa) should not be prescribed to prevent stroke or thromboembolic events in patients with mechanical heart valves. The warning is one that has already been issued to European doctors by the European Medicines Agency (EMEA).

The warning was announced just two weeks after the FDA’s recent decision to stop the RE-ALIGN trial. RE-ALIGN is a global, Phase II trial that was created to evaluate the safety and pharmacokinetics of Pradaxa in 400 patients who have mechanical heart valves. The 12-week study compared three doses of Pradaxa to warfarin in patients with both aortic valve replacements and mitral valve replacements. Investigators stopped RE-ALIGN because the Pradaxa users were more likely to experience strokes, heart attack, and thrombosis forming on the mechanical heart valves than were users of warfarin. There was also more bleeding after valve surgery in the Pradaxa users, according to the FDA.

In the United States, Pradaxa has been approved by the FDA for the treatment of non-valvular atrial fibrillation. The drug, which works by thinning the blood to prevent blood clots and strokes, was hailed because its use required no blood testing, and it quickly captured a large portion of the market. However, now the FDA is stressing that this does not include patients with atrial fibrillation caused by heart-valve problems.

Questioning Pradaxa's Safety

Fri, 07 Dec 2012 12:23:47 EST

Boehringer Ingelheim has announced that it will publish additional data on its controversial and relatively new anticoagulant Pradaxa. Pradaxa is indicated for the prevention of stroke in patients with non-valvular atrial fibrillation (a heart rhythm disorder that can cause strokes). For the past several decades, warfarin (sometimes referred to by the brand name Coumadin) was the leader in the anticoagulant market, and its risks and benefits are well-known. Pradaxa was approved by the FDA in late 2010 and immediately began to grab market share. Boehringer Ingelheim has marketed Pradaxa as more effective than warfarin, but a large number of adverse event reports following the marketing of Pradaxa has led patients and physicians to question the safety profile of the new blockbuster drug.

New Blood Thinner Drugs Hit the Market

Tue, 04 Dec 2012 12:27:19 EST

Atrial fibrillation affects more than five million people in the U.S. It is a dangerous condition – a type of cardiac arrhythmia that greatly increases the risk of stroke. For years, an anticoagulant called warfarin (often known by the brand name Coumadin) has been used to treat the disease. However, patients on warfarin must regularly undergo blood tests to confirm that they are properly anticoagulated. Now, several pharmaceutical companies are trying to capture the large market that has for so long been held by warfarin.

FDA's Drug Safety Communication Ignores Lack of Reversal Agent for Pradaxa

Sun, 04 Nov 2012 12:32:14 EST

On Friday, the FDA released an updated Drug Safety Communication regarding the anticoagulant Pradaxa, manufactured by Boehringer Ingelheim. According to the Communication, the FDA has examined insurance claims and administrative data to compare bleeding rates between Pradaxa and warfarin (known mostly by the brand name Coumadin). The FDA reports that bleeding rates do not appear to be higher with Pradaxa therapy than with warfarin therapy. The FDA reports that these findings are consistent with the RE-LY trial, which was a large clinical trial that served as the basis for the approval of Pradaxa.

On the same day that the FDA released its updated Drug Safety Communication, the New York Times published an article calling Pradaxa a "promising drug with a flaw." The article recounts the short history of Pradaxa, and mentions the fact that, though the drug has generated more than a billion dollars in revenue, it has been linked to more than 500 deaths in the two years it has been on the market. The article also points out that, while the incidence of bleeding may be no higher for patients on Pradaxa, the FDA has not addressed the lack of a reversal agent for Pradaxa. Because there is no reversal agent, physicians may have great difficulty reversing a bleed that occurs in a patient on Pradaxa.

More than 100 lawsuits have been filed across the country by patients claiming they were injured by taking Pradaxa. The vast majority of those claim injuries related to bleeds that could not be reversed easily.

Off-Label Usage of Infuse Exposes Children to Risks

Fri, 02 Nov 2012 12:38:46 EDT

Not only was Medtronic recently investigated by the Senate Finance Committee for improperly influencing journal articles to hide side effects, new research suggests that children have been placed in harm’s way.

In the October 10th issue of the Journal of the American Medical Association it was reported that 9.2 percent of pediatric spinal fusion surgeries use Infuse, or products very similar to it. Infuse has not been approved for use in children, but off-label use of Infuse has been common since the product was approved in 2002.

Given the fact that Infuse has recently been discovered to have many serious side effects in adults, it is appalling to think of the harm that children may have been exposed to with this off-label usage. Many of the problems associated with Infuse come from long-term excessive bone growth, yet this product was used in children whose bones have not even fully developed.

No public long-term studies have been conducted to determine the product’s safety in children. Infuse’s dangerous propensities should worry any parent of a child who received Infuse.

Risk of Pancreatic Cancer for Users of Byetta

Fri, 02 Nov 2012 12:35:56 EDT

Concerns are growing over the possible relationship between the Type II Diabetes drug Byetta and pancreatic cancer.

For several years there has been concern that Byetta can cause acute and chronic pancreatitis. By 2008, the FDA received more than 30 reports of acute pancreatitis in Byetta users. Now, new research has been published questioning whether long term Byetta use increases the risk of pancreatic cancer.

In 2011, researchers at UCLA published a study showing that Byetta users are three times more likely to develop pancreatic cancer than those not taking the drug. Researchers based their conclusions on an evaluation of the FDA Adverse Event Database for the years 2004-2009. One of the study’s authors, Dr. Peter Butler cautioned that further research is necessary.

Looking Ahead Waste War Looms as Cities Grapple Over Sites, Funds

Mon, 22 Oct 2012 09:30:50 EDT

The final of a seven-part series appearing in the St. Louis Post-Dispatch February 12 - 19th, 1989 By - Carolyn Bower, Louis J. Rose and Theresa Tighe of the Post Dispatch Staff Pictures include those from the original story as well as others that we were able to find when relevant. St. Louis is by no means alone in trying to figure…

Weldon Spring Now - Contamination Site to State Park

Wed, 17 Oct 2012 10:57:12 EDT

In the building that used to house a radioactivity check for workers, now stands the Weldon Spring Conservation Area and KATY Trail State Park. This building and park was opened to the public in 2002, after 16 years of clean up work.

A timeline of the projects that have gone into the clean up of Weldon Spring, a complex that was so contaminated that federal officials once required visitors to check in with a guard and, for the most part, stay in federal vehicles while at the site. According to a February 1989 article in the St. Louis Post Dispatch

"No one was allowed to walk in cerain areas without latex rubber boots and protective clothing. Bright yellow and purple signs warn of radioactive contamination in and around the buildings. Several years ago, the Army sprayed thick orange polyurethene foam on some particularly hot equipment in on of the buildings to preven the spread of contamination."

Rediscovering 4 Forgotten Sites Government lost track of nuclear operations here and nationwide

Mon, 15 Oct 2012 09:14:53 EDT

Tom Green described Kay Drey, a local environmental activist, how he worked for 12 years as a truck driver hauling radioactive material in the St. Louis area.

Green, who had been a smoker, blamed the cancer on radiation exposure from his job.

As they talked in 1979, Green had no way of knowing that nearly a decade later his comments would lead to the discovery and testing of a potentially contaminated site long forgotten by federal officials.

Green, then 63, told how he had driven truckloads of heavy uranium ingots across the McKinley Bridge to a plant in Madison during the latter half of the 1950s.

He described how the barrel-shaped ingots, 18 inches in diameter and height, were heated and reshaped at the plant at College and Weaver streets then operated by Dow Chemical Co.

Three months after his conversation with Drey in the hospital at 915 North Grand Boulevard, Green died of the cancer that had spread through his spine and intestines.

Now his account is prompting federal officials to take a new look into whether the former Dow plant may be contaminated.

The Madison plant is one of four ''forgotten'' sites the Post-Dispatch has discovered in the St. Louis area - sites where radioactive material was processed or stored in virtual secrecy after World War II.

Department of Energy officials say there is no reason to believe that any of the four St. Louis-area sites poses a serious health threat. In at least one case - the former Tyson Valley powder plant in far west St. Louis County - there appears to be no threat at all.

But the agency plans to conduct tests within the next several months at the old Dow plant and at another Illinois site, the old General Casting plant in Granite City. The tests would determine whether buildings or equipment in those two places are contaminated by radioactivity.

What follows is a discussion of the four area sites that were lost in the shuffle:
http://www.torhoermanlaw.com/news/rediscovering-4-forgotten-sites/

Parents Fight Health Threat Cleanup of plant brings questions but few answers

Mon, 15 Oct 2012 08:09:30 EDT

The fifth of a seven-part series appearing in the St. Louis Post-Dispatch February 12 - 19th, 1989 By - Carolyn Bower, Louis J. Rose and Theresa Tighe of the Post Dispatch Staff Pictures include those from the original story as well as others that we were able to find when relevant. Roger Nelson, a feisty man, looks forward to bantering…

Contamination of 'The Clean One' How Weldon Springs went from model to mess

Sun, 14 Oct 2012 16:24:31 EDT

The fourth of a seven-part series appearing in the St. Louis Post-Dispatch February 12 - 19th, 1989 By - Carolyn Bower, Louis J. Rose and Theresa Tighe of the Post Dispatch Staff Pictures include those from the original story as well as others that we were able to find when relevant. Like an abandoned set from a science-fiction movie, the Weldon…

Some Feared for Health of Ore Handlers

Tue, 09 Oct 2012 10:07:57 EDT

Uranium-processing workers on the night shift filed into the lunchroom at the Mallinckrodt Chemical Works in north St. Louis for one of Mont Mason's lectures on the safe handling of nuclear materials. Mason, just two years out of the Marine Corps, sized up his audience. Most were in their 20s, and they were cutting up and cracking jokes like bad…

Infuse Medical Journal Articles Influenced by Manufacturer

Mon, 08 Oct 2012 12:41:14 EDT

In 2011 a U.S. Senate committee began an investigation into reported financial ties Medtronic had to doctors that wrote influential journal articles. In 2011, the Spine Journal published an entire volume on misleading Infuse research. In the editorial, “A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth” the authors noted that none of the articles with financial ties to Medtronic had accurate adverse event report numbers.

Now it appears we have a reason why those adverse events went unreported. The Senate Finance Committee report found Medtronic was heavily involved in writing and editing the content of 13 influential medical journal articles. The Committee said that Medtronic failed to disclose its role in influencing these articles. The Senate report found that the physicians who wrote these articles were compensated a total of $210 million for supposedly unrelated work, although in some instances the work appears closely aligned. For example, one doctor received $34 million from Medtronic for patents. According to the Wall Street Journal some of those royalties were for a device that Infuse is encased in when it is inserted into the spine.

The Committee findings raise serious questions about the integrity of the scientific findings that support using Infuse. Doctors cannot make an informed decision if the company manufacturing the product is also influencing supposed independent research.

5 Bellwether Trial Dates Picked for Pradaxa Litigation

Fri, 05 Oct 2012 12:44:33 EDT

On Wednesday afternoon, a courtroom full of attorneys gathered in the Southern District of Illinois Court for the initial conference in the multidistrict litigation for Pradaxa in front of Chief Judge David Herndon.

In Case Management Order Number 6 – Unified Case Management Plan there were five bellwether trial dates selected for the summer and fall of 2014, a time that we are referring to as the “bellwether season.”

I am very proud to have worked with my fellow co-lead attorneys on negotiating the Case Management Plan that was entered. While it is only eight pages long, it is the result of countless hours of work, revision and compromise.

The bellwether season will be an exciting time in this litigation. Bellwether cases are chosen to represent all the plaintiffs (which as of October 2012 includes over 130 plaintiffs in the Pradaxa MDL) in an effort to determine common claims or theories. While this doesn’t mean that every case will be decided at the end of the bellwether season, the results from the bellwether cases will be critical information in evaluating the strength of this case.

Building a Mountain of Radioactive Waste

Wed, 03 Oct 2012 07:55:08 EDT

In the summer of 1966, Leo Vasquez, 13, and his friends run out and pick up the yellow dirt that falls from trucks lumbering past his family's farmhouse north of Lambert Field. The youngsters take the dirt and swirl it in water. They are panning for gold. Every six minutes or so, a truck rumbles east on Frost Avenue headed for Latty Avenue from…

Judge Announces Plaintiff's Leadership Counsel for Pradaxa

Thu, 27 Sep 2012 12:47:17 EDT

Chief Judge David R. Herndon of the Southern District of Illinois, the judge presiding over the federal Pradaxa litigation, has announced the plaintiffs’ leadership counsel who will oversee the interests of the plaintiffs in the Pradaxa litigation. TorHoerman Law is proud to announce that Tor Hoerman has been named as Co-Lead Counsel and Steven Davis has been named as Co-Liason Counsel. Tor and Steven look forward to cooperating with attorneys on both sides of the litigation in order to advance the litigation in a timely manner.

As of today, about 125 cases are on file with the Southern District of Illinois. We anticipate those numbers will continue to rise.

Risk of Heart Failure Linked to Mirapex

Thu, 20 Sep 2012 12:50:04 EDT

The FDA issued a Safety Communication yesterday warning of the potential risk of heart failure with use of Mirapex (pramipexole), a prescription drug used to treat the signs and symptoms of Parkinsons disease and restless leg syndrome. Mirapex is also sometimes used off-label as a treatment for cluster headache and to counteract problems with sexual dysfunction experience by some users of selective serotonin reuptake inhibitor (SSRI) antidepressants.

The FDA is continuing studies to clarify the risk of heart failure and will warn the public when that information is available.

In the meantime, patients should continue to take Mirapex as directed by their doctors. However, if any of the following side effects are experienced, you should consult your doctor immediately: Shortness of breath, Swelling of the feet, ankles, legs or abdomen, Fatigue and weakness, Rapid or irregular heartbeat, Chest pain, Persistent cough or wheezing with blood-tinged phlegm.

A Miracle With A Price

Tue, 18 Sep 2012 13:23:07 EDT

Part 1 in a 7 part series published in the St. Louis Post-Dispatch from February 12-19, 1989. The special series unlocked the secrets behind radioactive waste in St. Louis and took months of effort by three Post Dispatch reporters - Carolyn Bower, Louis J. Rose and Theresa Tighe. The series was called "Legacy Of The Bomb - St. Louis Nuclear Waste" and what came out of their investigation was a graphic picture of how waste was generated, how it was spread haphazardly throught the area, the difficulty in cleaning it up and the lingering confusion over how hazardous it really is.

Diacetyl Linked to Respiratory Problems

Wed, 22 Aug 2012 12:52:12 EDT

Sometimes change isn’t always for the better.

When the first exposed risks to diacetyl, a chemical used in butter flavoring, was linked to lung damage in workers at microwave popcorn factories, several manufacturers decided to start using a different ingredient: 2,3-pentanedione (“PD”). However, recent studies have found PD to be just as toxic.

The study, which was published in The American Journal of Pathology, indicates that acute PD exposure has respiratory toxicity which is comparable to diacetyl in laboratory animals. In the study, lab rats were exposed to one of three subgroups for six hours: PD, diacetyl, or filtered air. The rats exposed to PD had airway lining damage in the upper nose comparable to harm caused by in the diacetyl.

This type of damage is believed to be the primary cause of bronchiolitis obliterans, or what has become known as “popcorn worker’s lung.”

With many people working, unprotected, with diacetyl everyday and consumers risking their health using products containing diacetyl in their homes, one would hope that the replacement chemicals manufacturers utilize eliminate potential dangers: not maintain, or worse, intensify them. Yet, as in the case of popcorn factory workers, this does not always seem to be the case.

Coldwater Creek Case Update - August 2012

Tue, 21 Aug 2012 11:07:13 EDT

The Coldwater Creek cases continue to move forward procedurally in front of U.S. District Judge Audrey G. Fleissig in the Eastern District of Missouri. We will continue to make our best efforts to keep clients apprised of the litigation as it moves forward.

A case management conference is part of normal court procedure. It is a meeting between the judge and the lawyers representing the plaintiffs and defendants. The goals of these conferences are to settle procedural issues in dispute before going to trial and set important dates and deadlines for the completion of the case. These early conferences improve the quality of the trial and expedite the lawsuit.

Complex litigation takes a significant amount of time in order to make sure that all sides of the litigation get a chance to be heard and have all issues resolved in a just manner.We will continue to make our best efforts to keep clients apprised of the litigation as it moves forward, but please understand that a lot of this work is procedural in nature.

Study Confirms Bladder Cancer Risks in Actos and Avandia Users

Mon, 13 Aug 2012 12:54:31 EDT

According to a new study published earlier this month in the Journal of the National Cancer Institute, one of the major classes of diabetic drugs increases patients’ risk of bladder cancer.

The class of drugs under scrutiny, thiazolidinedione (TZD) drugs, accounts for nearly one out of every five drugs prescribed to diabetics in the United States. The researchers who performed the study at the University of Pennsylvania’s medical school found that patients taking TZD drugs are two to three times more likely to develop bladder cancer than those who took another common class of medications for diabetes.

The two most common types of TZD drugs are marketed under the names Actos and Avandia.

According to the study, patients treated with either Actos or Avandia for five or more years had a two-to-three-fold increase in risk of developing bladder cancer when compared to those who took another class of diabetes medications called sulfonylurea drugs.

The risks and dangers associated with Avandia and Actos continue to increase. In November of last year, Avandia was removed from retail pharmacies because of its links to severe cardiovascular problems. Earlier this year, an unsealed whistleblower lawsuit exposed the possibility that drug manufacturer Takeda downplayed the risks associated with Actos usage. Just this summer, research exposed the possibility of vision risks being associated with Actos and Avandia usage.

With over 285 million persons worldwide suffering from diabetes, physicians and patients are faced with a double edged sword: fight diabetes without the usage of medication or risk unforeseen risks when using diabetic medications.

Pradaxa Litigation to be Consolidated in Illinois

Wed, 08 Aug 2012 13:09:28 EDT

According to an order entered today, all Pradaxa cases in the federal court system, now pending and filed in the future, will be consolidated in front of Judge Herndon in the Southern District of Illinois.

Despite objections by the defense and proposals of alternative venues, Judge Heyburn and the judicial panel agreed with many plaintiffs, including TorHoerman Law, that proper venue for the Pradaxa litigation should be the Southern District of Illinois.

As we wrote last month:

Pradaxa (dabigitran) was introduced in late 2010 for the prevention of stroke among patients with non-valvular atrial fibrillation. Pradaxa was designed to thin blood and reduce blood clots, which can cause strokes.Yet, in the less than two years since its release, Boehringer Ingelheim’s anticoagulant Pradaxa is already beginning to create considerable controversy.

Recent studies have found that an increasing number of people who have suffered fatal or severe bleeding events may have done so as result of their use of Pradaxa. Many of these sufferers are elderly patients, patients whose age provides convenient alternative explanations for drug companies who are accused of harming patients.

Bayer Second Quarter Revenue Highlights Profits Over People

Wed, 08 Aug 2012 13:06:30 EDT

Last week drug and chemical mogul Bayer AG announced promising news to its shareholders in regard to its second quarter earnings. Revenues rose 10 percent and the company raised its full-year outlook. "Following the good business performance in the first half of 2012…[we are] confident for the second half of the year," said chief executive Marijn Dekkers.

While on the waterfront things may seem great for Bayer, there’s one important factor that remains troublesome for the corporation: the birth control contraceptive Yaz or Yasmin.

Released in 2006, the contraceptive Yaz generated sales of nearly $2 billion in its first year alone, making it the one time leading birth control pill on the market and Bayer’s top-selling drug. Yet, Yaz is no longer Bayer’s promising venture. Instead, Yaz has proved to be quite problematic for both Bayer and even worse, its consumers.

Recent studies have shown that Yaz’s marketing was both misleading and dangerous and women were harmed after relying on that marketing. Independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills. As the injuries continued to increase, and the dangers of Yaz became exposed, lawsuits evolved.

With that kind of trouble with a top-selling drug, you would think a corporation would suffer financially. But, according to Bayer's second quarter financial statements, agreements have been reached to settle the claims of 1,877 claimants in the U.S. for a total cost to Bayer of about $402.6 million. These numbers increased since the first quarter statements, when Bayer announced they had settled the claims of 651 plaintiffs in the U.S. for a total of about $142 million.

Pradaxa Litigation Consolidated in Southern District of Illinois

Wed, 08 Aug 2012 12:56:39 EDT

Litigation over the blood thinner Pradaxa (dabigitran) is moving forward. Today, the Joint Panel on Multidistrict Litigation, a panel of federal judges that manages coordination of mass cases, entered an order consolidating all current and future federally-filed Pradaxa cases in front of Judge David R. Herndon, chief judge of the Southern District of Illinois.

Given the complexity of this litigation and anticipated resource demands that accompany “mass tort” (multiple plaintiffs injured in a similar fashion by a defective product) cases, the consolidation is intended to allow the litigation to move forward in an efficient, organized and timely manner.

Consolidation in the Southern District of Illinois before Judge Herndon should prove to be fair to all parties involved in the litigation. Judge Herndon is an experienced MDL judge and we believe he will move the litigation forward expeditiously, which is in the best interest of the injured patients, most of whom are elderly.

Pradaxa was approved in late 2010 for the prevention of stroke among patients with non-valvular atrial fibrillation. Marketed as a therapeutic simplification to Coumadin (a drug that had been on the market for over 60 years), Pradaxa has achieved blockbuster status by generating sales of more than one billion dollars a year. Pradaxa was designed to thin blood and reduce blood clots, which can cause strokes. Yet, in less than two years since its release, Boehringer Ingelheim’s anticoagulant is already the subject of considerable controversy.

Nearly 15,000 serious adverse events identifying Pradaxa as the primary suspect drug have been reported through March 31, 2012. Although the order entered today identifies 21 actions pending in eleven district courts, we expect this number to grow considerably.

Medical Field Skeptical of Diet Drug Qysemia

Fri, 27 Jul 2012 13:12:41 EDT

According to the Centers for Disease Controls and Prevention, obesity in America now affects more than one third of U.S. adults. In 2008 alone, medical costs associated with obesity were estimated at almost $150 billion.

In the last few months, two of these drugs have garnered the Food and Drug Administration’s blessing: Belviq and Qsymia (pronounced kyoo-sim-ee-uh).

Hyped as a prescription diet drug that is “effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds,” Qsymia is supposed to be a new tool to help physicians’ battle the beast that is obesity.

However, while the drug may be new to the market, its foundation has a more familiar pattern.

Qsymia is actually a combination of two older drugs: phentermine and topiramate. Phentermine suppresses the appetite by triggering the release of the brain chemical norepinephrine, while topiramate, an epilepsy drug for seizures/migraines, increases feelings of fullness, makes foods taste less appealing, and increases calorie burning.

Topiramate, which is marketed under the name Topamax, already carries with it the risk of birth defects; a risk that many critics suspect will be carried over to Qsymia.

Phentermine, the half of fen-phen that's still legal, has long been prescribed by doctors for weight loss because of its appetite suppression effects. However, in 2007, Phentermine was reported by the UN International Narcotics Control Board as one of the most commonly abused prescription drugs in the world.

Qsymia comes with several warnings. First, Qsymia carries a warning that it can increase heart rate and should not be used by people who have heart disease or have suffered a stroke. Pregnant woman should also not take Qysmia because of the possibility of birth defects such as cleft lips or palates. Additional risks associated with Qysmia are an increase in the risks of glaucoma, kidney stones, mood problems such as anxiety and depression, and suicidal behavior or thinking about suicide.

Even with approval, it’s understandable why some in the medical field are skeptical of drugs like Qsymia. The drug’s clinical studies involved 3,700 patients, where obese and overweight people who took Qysmia for one year lost 3.5 to 9.3 more pounds than those who took a placebo. Thus, the benefit is not one of incredible difference. Furthermore, Qsymia was found to be effective only when given along with a balanced diet and exercise, a combination that many fighting obesity already lack. These facts certainly give rise to skepticism.

$5.5 Million Dollar Verdict for Vaginal Mesh's First Trial

Mon, 23 Jul 2012 13:15:53 EDT

In the first case involving vaginal mesh to go to trial, medical manufacturer C.R. Bard Inc. has been handed a $5.5 million dollar verdict. The trial, which was held in California, revolved around a woman whose vaginal-mesh implant left her incontinent and in chronic pain.

Christine Scott and her husband were awarded the damage award because of injuries caused by Bard’s Avaulta Plus product. The jury found that Bard was negligent in their handling of the vaginal implant devices; devices which were used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

While Christine and her husband’s case may have been the first to go to trial, it is only the beginning. Hundreds of lawsuits have been initiated against Bard and other manufacturers regarding vaginal implants because of injuries women have suffered.

Manufacturers Johnson & Johnson, American Medical Systems, Bard, Boston Scientific Corp., and several others are among those facing allegations that their implants caused multiple problems including organ damage.

In 2008, the FDA issued a Public Health Notification stating that the issues with the use of synthetic vaginal mesh was a growing concern, and as recently as January the FDA ordered 33 manufacturers of vaginal mesh devices to conduct post-market safety studies on their products.

Johnson & Johnson, the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device. This information is even more troubling, when it’s partnered with the fact that Johnson & Johnson marketed their Gynecare Prolift device for three years before the FDA even approved its use.

On July 13th, 2011, the FDA released an updated safety concern that stated "serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and "this is a change from what the FDA previously reported…Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk."

These factors are just a few of the concerns that have surfaced since allegations involving these devices began.

In February, the U.S. Judicial Panel on Multidistrict litigation (JPML) issued an order consolidating several vaginal mesh multidistrict litigations into a single proceeding to be heard in the Southern District of West Virginia. The cases are against Bard, Johnson & Johnson, American Medical Systems, and Boston Scientific.

Things We Wish We Knew Yaz-terday

Fri, 20 Jul 2012 13:18:23 EDT

The one-time poster child of birth control prescriptions, Yaz has quickly become one of the riskiest oral contraceptives available.

Released in 2006, the contraceptive Yaz generated sales of nearly $2 billion in its first year alone, making it at one time the leading birth control pill on the market and Bayer HealthCare Pharmaceutical’s top-selling drug.

Promoted as the choice for women seeking relief from premenstrual symptoms and acne, Yaz’s marketing touted the birth control pill as one with multiple benefits.

“Yaz is the only birth control pill proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life,” claimed many of the advertisements; advertising statements that have since been removed.

Instead, recent studies have shown that this marketing was not only misleading but also dangerous. These independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills.

While all birth controls come with some risk, Yaz is unique in that it contains a hormone called drospirenone that some experts believe may trigger more blood clots than other birth control pills because of elevated levels of potassium in the body.

In 2008, the FDA said that Yaz was shown not to be effective for common premenstrual symptoms, just a rare and serious form of them, and that Yaz’s success was misleadingly overstated.

According to the AdverseEvents Monitor, as of March of this year, there have been over 18,000 adverse health reports where Yaz was found to be the primary suspect.

Boehringer Ingelheim Initiates Lifestyle Behavior Modification Program

Thu, 12 Jul 2012 13:25:53 EDT

With chronic diseases hitting significant numbers and continuing to grow, pharmaceutical giant Boehringer Ingelheim is looking to take a more involved approach with patient management in the future.

Collaborating with digital health specialist Healthrageous, Boehringer has planned to initiate a pilot study of a program they are categorizing as a “lifestyle behavior modification program” to monitor the health status of people with Type 2 diabetes.

The pilot, which will be managed by Healthrageous, a company launched in 2010 to provide consumers with commercialized personalized health technology solutions, will involve 200 adults in the United States and revolve around coaching them on how to manage their condition, and seek to encourage them to stick to a specific regimen (i.e. exercise, dieting).

Participants in the plan will receive behavior improvement goals, biometric feedback, incentives for progress, medication reminders, and social network support availability. The program will use the internet and smartphones to deliver these interactive features.

Viewed in a positive light, the program will give corporations like Boehringer a wide array of clues and information as to which types of treatment work and which need modifying to suit common behavior. Sufferers of chronic diseases like diabetes, chronic obstructive pulmonary disease, and high blood pressure can often see measureable improvements in wellbeing if nutrition, exercise, and medication regiments are strictly adhered to.

However, a program utilizing this form of an intervention certainly has to be questioned.

What will a patient do if forced with conflicting recommendations from their doctor and Boehringer’s program? Will this program open the door for other prospective online interventions in other areas? Will this lead to more prescriptions for drugs produced by Boehringer? Does allowing a program to monitor your daily habits help companies like Boehringer create reasons to avoid liability if it happens that one of their drugs ends up being dangerous or worse yet, fatal?

The theory behind the idea is without question a great one. Motivating individuals to become and remain engaged in self-managing their health is something that all pharmaceutical corporations should encourage. However, anytime a program seeks such a drastic intervention in a person’s daily life, one has to wonder: is this self-managing your health or is it letting someone else manage your life?

Blood Thinner Xarelto Receives FDA Priority Review

Thu, 12 Jul 2012 13:22:51 EDT

When a new drug is introduced and the manufacturer claims that the drug is supposed to either offer a major advancement in treatment or provide a treatment where no adequate treatment exists, the U.S. Food and Drug Administration gives the drug “priority review” status, meaning more FDA resources will be directed towards reviewing the drug than would be typical, with the goal of completing review of the drug in six months rather than the ten to twelve months the FDA usually spends reviewing standard drugs.

Anticoagulant Pradaxa Users Suffer Fatal Bleeding Events

Tue, 03 Jul 2012 13:29:03 EDT

Risk increases with age – heart attack, weight gain, risk of stroke, blood pressure, and even our susceptibility for falls.

Sometimes when an elderly person passes away, factors other than aging are overlooked. Often, there’s no investigation, no serious questioning. The assumption is that getting older brings health risks. Yet, many times it’s more than just age that brings risk.

There are non-age explanations – factors that can be overlooked if not examined carefully. Sometimes, those explanations are medical treatments that are actually supposed to reduce risk. Pradaxa is one of those treatments.

Pradaxa (dabigitran) was introduced in late 2010 for the prevention of stroke among patients with non-valvular atrial fibrillation. Pradaxa was designed to thin blood and reduce blood clots, which can cause strokes.Yet, in the less than two years since its release, Boehringer Ingelheim’s anticoagulant Pradaxa is already beginning to create considerable controversy.

Recent studies have found that an increasing number of people who have suffered fatal or severe bleeding events may have done so as result of their use of Pradaxa. Many of these sufferers are elderly patients, patients whose age provides convenient alternative explanations for drug companies who are accused of harming patients.

From January 1, 2004 to March 31, 2012, nearly 15,000 serious adverse event reports have identified Pradaxa as the primary suspect drug.

Could Actos and Avandia Be Putting Your Vision at Risk

Wed, 13 Jun 2012 13:33:36 EDT

Recently, a new study suggests that diabetes drugs such as Avandia and Actos could cause eye problems in those who take them.

The study, published in The Archives of Internal Medicine, observed over 100,000 people with Type 2 diabetes for nearly a decade.

The results demonstrated that of those who used either Avandia or Actors the risk of macular edema was roughly two to three times higher. Overall, about 1.3 percent of diabetes drug users developed the disease while only 0.2 percent of those who were not on one of the medications did. Combinations with insulin, a common practice for diabetes drug users, seemed to increase this risk even more.

Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye (an area on the retina) and causes it to thicken and swell, which consequently may distort a person’s central vision (the section of the eye that controls the sharpness in straightaway vision).

Iskandar Idris, author of the study and a consultant in diabetes and endocrinology in England, said that persons taking Avandia or Actos should get their vision checked regularly.

While the study was not able to pinpoint what exactly it is in the drugs that may cause the damage, Dr. Idris believes that it may have something to do with the greater sodium and fluid retention or changes in blood vessels caused by the drugs.

Scrutiny of drugs such as Avandia and Actos is no new topic. Recent studies have confirmed alarming connections between Actos usage and bladder cancer. Thus, as studies continue to be released, the one factor that is becoming more concerning is that the risks diabetes drug users face as a result of their prescriptions continues to grow.

FDA Study Confirms Risk of Bladder Cancer in Actos Users

Tue, 05 Jun 2012 13:42:44 EDT

Takeda Pharmaceutical has had their share of bad news recently with respect to their diabetes drug, Actos (pioglitazone). The FDA issued a warning last June regarding the increased risk of bladder cancer followed by a few European Markets removing Actos from the market and the filing of multiple lawsuits as a result of bladder cancer. Now, add to this string of bad news a study that confirms FDA studies and warnings – Actos has been found to have an 83% higher risk of bladder cancer.

Ethicon Pelvic Floor Systems Pulled from the Market

Tue, 05 Jun 2012 13:35:58 EDT

Prompted by the prospect of more litigation, Johnson & Johnson’s Ethicon unit told a federal judge in West Virginia it intends to stop marketing four vaginal mesh implant systems as a result of lawsuits filed by women who say the products caused them internal injuries.Those four Gyencare products are:

•TVT Secur
•Prosima Pelvic Floor Repair System
•Prolift Pelvic Floor Repair System
•Prolift MTM Pelvic Floor Repair System

Diabetes Drugs Have Their Users Questioning Safety

Mon, 04 Jun 2012 13:45:46 EDT

Recently the U.S. Food and Drug Administration denied approval of Takeda’s newest diabetes drug alogliptin. Citing a need for more research and data, alogliptin’s denial brings to light the stark reality of what has developed into a series of stumbling blocks for diabetes drug development.

In 2007, studies revealed that GlaxoSmithKline’s popular diabetes drug Avandia increased the risk of heart attack, cardiovascular disease, stroke and death. Consequently, this led to the FDA requiring Avandia to use a black box warning to alert consumers of the risks. These warnings were still not enough.

By late 2011, Avandia was no longer available through retail pharmacies. And then came Actos.

Waiting one day after Avandia received restrictions from the FDA, Takeda began a new advertising campaign for its diabetes product Actos.

Boasting taglines such as “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack of stroke,” diabetes sufferers quickly shifted from Avandia to Actos.

What Takeda failed to mention initially though was their diabetes drug carried its own risks – it was linked to bladder cancer in long term users.

Just last year, independent researchers discovered that Actos users have a 40% higher chance of developing cancer after they have taken the drug for longer than a year. The FDA issued a warning regarding this link between bladder cancer and Actos users and continues to review the data Following the FDA warning, a few Eurpoean markets (France, Germany, and Luxembourg) took the additional step of suspending use of Actos.

Around this same time, MannKind’s Afrezza, an inhalable form of insulin, was denied approval by the FDA as well. Without additional clinical studies and at least one trial comparing the new inhaler with an earlier version, Afrezza will never hit the market.

Furthermore, Afrezza wasn’t the only diabetic medication whose market potential was rightfully stunted by the FDA in the last year. AstraZeneca and Bristol-Myers Squibb’s drug dapagliflozin was denied approval because of significant concerns about breast and bladder cancers seen in patients taking the drug.

A month after dapagliflozin was denied, major manufacturer Merck received an FDA warning for failing to conduct timely and complete post marketing studies on drugs Januvia and Janumet. The FDA stressed that Merck’s studies were insufficient to deter worries about the possibility of pancreatic cancer in the medication’s prescribers.

Even as recently as May 31, 2012, medications for diabetics are being pushed for approval by manufacturers. Janssen Research & Development recently submitted a New Drug Application to the FDA for a once-daily, oral drug for type-2 diabetes called canagliflozin. Like its predecessors, all we can do is wait and hope for better results than what the past has presented.

Given the history of diabetes drugs, diabetics have to seriously question and monitor the release of new diabetes medications such as Takeda’s hopeful alogliptin, especially when the FDA is already requesting additional research.

Vagina Mesh & the FDA 510(k) Approval Method

Tue, 29 May 2012 13:52:35 EDT

The FDA has allowed the manufacturers of polypropelene transvaginal mesh and other devices to enter the US marketplace with very few safety checks. Congress is taking some important steps toward changing this system, but, it is important to remember that the manufacturers of these devices are in the best position to warn the public of known dangers and they should be held accountable when their silence leads to people being injured.

Best Sunscreens and Tips for Using Them

Tue, 29 May 2012 13:47:47 EDT

As summer approaches, the opportunities for fun in the sun grow exponentially. Most of us are aware of the dangers of too much summer sun, skin cancer, rapid aging of the skin, etc. and as such we reach for our favorite sunscreen and lather before heading outdoors. But before you lather up this summer, there are some things that you should know. SPF is not the only important factor to consider when choosing a sunscreen, how you use it is just as important as the type you decide to buy.

The MD Anderson Cancer Center offers some advice on what kinds of sunscreen to buy and the best ways to apply it:

1.Get UV-A and UV-B protection- this is critical, don’t trust labels that merely read “broad spectrum”. Turn the bottle around and make sure UV-A protection is listed in the drug fact label. Some active ingredients to look for if the words “UV-A protection” are missing from your label are Zinc Oxide, Titanium Oxide, Avobenzone/ Parasol 1789, and Mexoryl Sx. All of these indicate both UV-A and UV-B protection.

2.Choose SPF 30 or higher-even if you choose a sunscreen with an SPF above 30, apply it as though you are using SPF 30 because the protection provided by higher SPF products isn’t as significant as you might think. When properly appplied, SPF 30, provides 97% blockage of the suns harmful rays. SPF 50 only increases that protection by 1% (98% percent protection).

3.Apply your sunscreen EARLY & OFTEN! Failure to apply sunscreen early enough or often enough is one of the primary reasons people do not get adequate protection from the products they use. It is recommended sunscreen be applied 30mins prior to heading outdoors. This gives the product adequate time to soak into the skin. Sunscreen should be reapplied every two hours regardless of the SPF, and every hour to and hour and a half if you are swimming or sweating heavily.

4.Make sure to wear enough. Each exposed body part needs approximately 1oz of sunscreen to be protected which is a squirt roughly the size of a golf ball. Be sure to remember body parts like your ears, feet and the back of your neck.

5.Don’t let sunscreen be your only defense. The best protection from the sun is a wide brimmed hat and a long sleeved shirt. Avoid the sun during peak hours from 10am-4pm, wear lip balm with SPF 30, and purchase sunglasses that offer UV protection.

6.Avoid products with Vitamin A . Vitamin A has been shown to speed the growth of skin tumors and lesions in sun exposed skin. Nearly 40 sunscreens on the market contain Vitamin A. It is listed as Retinyl Palmitate in the ingredients. So please READ THE LABELS CAREFULLY!

Rates of Cleft Lips Higher in Infants Exposed to Topomax

Thu, 24 May 2012 13:55:06 EDT

One in 600 babies born will be born with a cleft lip or palate. During normal fetal development between the 6th and 11th week of pregnancy, the clefts in the lip and palate fuse together. In babies born with cleft lip or cleft palate, one or both of these splits failed to fuse.

Contrary to popular belief, this craniofacial malady has more than cosmetic consequences. A cleft palate can range from a small ridge in the upper lip which results in minimal problems to a large separation of the palate that interferes with eating, speaking, and even breathing.

The larger the separation, the greater the possible effects of the condition. Common ongoing effects of cleft lip and palate include: nasal obstruction, sleep apnea, sinusitis, laryngitis, rhinitis, and progressive hearing loss.

According to the North American Antiepileptic Drug Pregnancy Registry, Birth defects, such as, cleft palate/cleft lip occurred in 1.4% of newborns that had been exposed to Topamax. Newborns of mothers who didn't exhibit epilepsy or take anti-epilepsy drugs demonstrate a rate of 0.07%. This data indicates that infants whose mothers took Topamax are 21 times more likely to have Topamax birth defects, then normal.

Risks of Actos and Celexa for Depression

Mon, 21 May 2012 13:57:30 EDT

A preliminary study performed at the Tehran University of Medical Sciences suggests that adding pioglitazone (Actos) to a commonly prescribed anti-depressant, citalopram (Celexa), boosts the effects of antidepressants in patients whether they have diabetes or not.

Although this study was performed on only 40 patients, the conclusion of the study suggests that it will be repeated using a larger group of patients and may lead to new uses for the diabetes drugs, Actos.

This study begs the question, is the University of Tehran Psychiatric Research Centre reading the same news we are? In June of 2011, The U.S. Food and Drug Administration (FDA) warned the public that using Actos for more than one year may be associated with an increased risk of bladder cancer. Health Canada followed suit with a similar warning and France and Germany took the additional step of pulling Actos from their market.

Does it make sense to look for additional uses for a drug that has gathered this much negative attention? Takeda Pharmaceutical, the manufacturer of Actos, is currently facing a large amount of lawsuits from individuals who believe they got bladder cancer as a result of their Actos usage. These lawsuits come from individuals who took Actos for Type 2 diabetes because there were very few options available for treating their disease. To now increase the market of Actos users to include those without Diabetes but who have a major depressive disorder would be to ignore the guidance of regulatory agencies in the U.S, Canada and Europe.

And, to make matters worse, Celexa, a selective serotonin reuptake inhibitor prescribed commonly as an anti-depressant, has been linked to a wide range of birth defects. It seems completely irresponsible to combine two drugs with so such serious and varied side effects and to increase the number of people exposed to risks such as these.

Takeda's Replacement for Actos Delayed by the FDA

Fri, 18 May 2012 14:02:34 EDT

Takeda Pharmaceutical received more bad news last week when the FDA requested more information with regards to its new Type2 Diabetes Drug chemically knows as alogliptin and currently marketed in Japan as Nesina. Takeda had hoped to introduce alogliptin into the US as a replacement for its troubled Type2 Diabetes drug, Actos, before Actos goes generic in August and it now appearsthat release will not occur.

Takeda has seen a string of bad news with regards to Actos as a result of an increased risk of bladder cancer. In June of 2011 The FDA issued a warning regarding this risk while several European markets took it a step further, suspending the use of actos over these same concerns.

Global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010 alone and Takeda had hoped that alogliptin would help capture a part of that market.

This rejection of alogliptin’s approval marks the second time that the replacement drug has failed to gain approval in the United States. Given the dangers and risks associated with Actos, it is important that the F.D.A. continues to proceed only with caution before approving any replacement drug.

Is Pradaxa a Misfire?

Fri, 18 May 2012 13:59:48 EDT

According to Dr. Mark Wurster, M.D.:

The problem with dabigatran is that it has been presented as a "fire-and-forget" medicine. That is, the doctor can write a prescription and not think about it again. But anticoagulation is not like that. Just because patients on dabigatran don't need to have regular INR measurements doesn't mean they don't need monitoring.

Dr. Wurster made this statement after he presented preliminary results from his study “Dabigatran in the Real World” at the Thrombosis & Hemostasis Summit of North America (THSNA) in Chicago this month. This study, done over the course of more than a year, followed each of 113 patients for six months after each had been switched from warfarin to Pradaxa.

According to Dr. Wurster, there were 13 total incidents of serious adverse reactions to Pradaxa, including a death resulting from a Pradaxa-related bleeding incident, as compared to a single incident of warfarin toxicity resulting from warfarin treatment.

While Dr. Wurster is reluctant to call Pradaxa a “bad drug”, he has concerns regarding appropriate patient selection and regarding monitoring of those who use Pradaxa. His results indicate that Pradaxa’s adverse effects appear more frequently in elderly populations and in female populations. The mean age for adverse event suffers was 73.4, and 71% of adverse event suffers were female.

He adds that the price of Pradaxa exacerbates this problem. "Many patients will start cutting the tablets in half or stop taking them altogether because of the expense. And that will be a big problem. If a patient was not compliant on warfarin, they will fare worse on these new drugs."

This study is only one item in a string of bad news reports for Boehringer Ingelheim since Pradaxa hit the market in late 2010. Last month, Pradaxa earned a spot on the Top Ten Drugs with the Most Adverse Reports List for 2011, and lawsuits from serious and fatal bleeding events continue to mount.

Eric Terry Appointed to Board of Directors of the YMCA Edwardsville

Wed, 09 May 2012 11:52:26 EDT

TorHoerman Law is proud to announce the appointment of Eric M. Terry to the Board of Directors of the Edwardsville YMCA.

The Edwardsville YMCA is a charitable, non-profit organization serving the Edwardsville and Glen Carbon community. Through their two facilities, the YMCA positively impacts more than 20,000 members as well as other community residents that take part in YMCA programs.

Eric is a long time resident of Edwardsville, IL and a 14 year veteran coach of the YMCA’s excellent children’s recreational sports teams. Eric has always been a big advocate of the YMCA’s philosophy “Everyone plays, Everyone wins.”

Being the father of three kids in Edwardsville and members of the YMCA, there have been very few days that Eric and his wife Carie have not been visitors to the YMCA’s state of the art facilities. Eric looks forward to using his contacts in the community to assist in fundraising efforts for further expansion of the YMCA facilities and programs. He is very proud to be included on the Board of Directors with some of the most respected members of the community and looks forward to impacting the social, mental and physical lives of community members.

Reported Injured from Pradaxa Use Continues to Grow

Thu, 26 Apr 2012 14:06:57 EDT

What am I missing here? The number of reported injuries arising from use of Pradaxa continues to grow at an unparalleled pace and yet financial and pharmaceutical analysts celebrate Boehringer Ingelheim as profits on its blockbuster drug, Pradaxa, continue to surge.

In the last three months of 2011, the FDA collected 3,000 reports of adverse events for Pradaxa, earning Boehringer Ingelheim’s blockbuster drug the fifth spot on the Top Ten Drugs with the Most Adverse Reports List for 2011 Q4. Of those 3,000 reported adverse events, 459 deaths, 69 disabilities, and 1,331 hospitalizations resulted – making it the drug with the most associated deaths for the quarter.

Meanwhile, Boehringer Ingelheim is enjoying an increase in after-tax profits by 66% and sales increases of 5% as the financial and pharmaceutical journals attribute a large percentage of the increased sales to Pradaxa which officially graduated to “blockbuster” status as a result (blockbuster status is defined as generating annual sales of $1 billion or more).

FDA Announces Link Bewteen Topamax and Human Fetal Risk

Tue, 24 Apr 2012 14:11:39 EDT

Federal drug regulators approved Topamax (and its generic equivalent, Topiramate) as an anti-epileptic drug and for prevention of migraines. On March 4, 2011, The FDA announced that Topamax would carry a pregnancy “Category D” warning which means that there is positive evidence of human fetal risk. Other Category D drugs include alcohol, lithium and most chemotherapy drugs to treat cancer.

This month the Therapeutic Goods Administration (TGA), Australia’s regulatory authority similar to the FDA, followed suit and announced a change in pregnancy category for Topamax (topiramate). The Australian Pregnancy Category D is defined as:

Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.

Data from pregnancy registries indicate that infants exposed to Topamax in utero have an increased risk of cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age need to be extremely careful when taking Topamax.

Ontario Public Drug Program Limits Access to Actos

Tue, 24 Apr 2012 14:09:40 EDT

Takeda’s Type2 Diabetes drug, Actos (pioglitazone) has been the subject of FDA warnings as a result of its link to an increased risk of bladder cancer amongst patients who use the drug the longest. On June 17, 2011, two days after the FDA issued their warning, Health Canada issued a similar warning.

On April 19, 2012 Health Canada followed their previous warning with a change in labeling to indicate the link to bladder cancer.

It now appears that the Ontario Public Drug (OPD) Program has taken the additional step of limiting patient access to Actos.

The ODB Program provides coverage for over 3,800 drug products that are listed in the ODB Index or formulary. If a drug is not listed in the ODB formulary, patients are required to submit a request for the unlisted drug which then becomes part of the Exceptional Access Program (EAP) and the Executive Officer makes decisions regarding its funding on a case by case basis. Effective April 24, 2012, Actos has been moved to the “exceptional access” list. This change comes at the midway point of Takeda’s 10-year study which Health Canada believes to be pointing to a real link between Actos and bladder cancer.

According to Dr. David Jurlink, head of the division of clinical pharmacology at the University of Toronto:

At this point there is little need to resort to this drug, unless a patient has done extraordinarily well on it in the past. I personally would not be comfortable using it as a long-term therapy because bladder cancer is…not something that’s reversible. Its not a skin rash that goes away when you stop the drug.

Giving Back - One Cubs Win at a Time!

Mon, 23 Apr 2012 09:15:13 EDT

The TorHoerman Law Donation Committee was inspired to action when we learned of a family member in need. Taylor Naggs-Aquino, a beautiful 4 ½ year old girl is the niece of one of our THL team members who was diagnosed with Pontocerebellar Hypoplasia (PCH), a very rare genetic disease. As they have done in the past, the THL Donation Committee jumped to action looking for creative ways to raise money for Taylor and came up with some fun activities revolving around one of our favorite days – the Cubs versus Cardinals home opener.

The THL Donation Committee team developed came parlay tickets predicting various outcomes of the game and blind squares predicting the final score as well as auctioning off tickets to a future Cardinals game. Although our office is predominantly Cardinals fans, there are a few very vocal Cubs fans to keep the “action” interesting and a fun day was had by all. Cardinals fans came away disappointed by the day’s events as the Cubs were able to spoil the Cardinals home opener with a 9-5 win (although the Cardinals ended up taking the weekend series) but nobody was disappointed at the end result – raising money for a child in need.

Yaz Ordered to Change Their Warning Labels

Mon, 16 Apr 2012 14:14:26 EDT

After studies reported as high as a threefold increase in the risk of blood clots for Yaz and similar products, the FDA has ordered Yaz, Yasmin, Beyaz, Safyral, and some generics to change their label warnings.

The new labels are required to report the findings of the studies reporting a threefold increase in the risk of blood clots when compared to products containing some other progestin. The increased warnings come from the recommendation of an outside panel of medical experts.

Along with the increased label changes, the FDA also reminded women to speak with their doctor about their individual risks for developing blood clots. Deep vein thrombosis and pulmonary embolisms are two types of blood clots associated with Yaz and related products.

Second Coldwater Creek Lawsuit Filed Against Hazelwood-Based Covidien and Its Mallinckrodt Division, Hazelwood Patch, April 13, 2012

Fri, 13 Apr 2012 08:25:02 EDT

Second group of North St. Louis County residents file a lawsuit alleging that nuclear waste in Coldwater Creek has caused their various illnesses including cancer, and for some death.

North County Residents Seek Answers on Coldwater Creek Contamination - St. Louis Public Radio, April 12, 2012

Thu, 12 Apr 2012 08:29:33 EDT

NPR Article discussing the town hall meeting on April 11, 2012 where attorneys involved talked about options for residents. Also, a link to the Goggle Map showing the Coldwater Creek cancer cluster.

Pradaxa Life-Altering Side Effects Continue to Rise

Wed, 11 Apr 2012 14:16:40 EDT

The number of deaths and life-altering side effects associated with Pradaxa continue to rise. Pradaxa is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation.

Although it has only been on the market for a year and a half, Pradaxa was listed as a suspect drug in 856 reported cases from the second quarter of 2011. This number is higher than all other regularly monitored drugs. Of the reported cases from this quarter, 117 were reported patient deaths.

QuarterWatch, an independent publication of the Institute for Safe Medication that monitors all domestic, serious adverse drug events reported to the FDA reiterated their concerns that:

“Vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.”

Pradaxa’s instructions do not require routine kidney function testing, or blood level tests. Lower dosage options to tailor prescriptions to individuals’ needs are not available. QuarterWatch points to these factors as some of the causes of overdoes and hemorrhages in the oldest patients on Pradaxa.

Journal of Clinical Neuroscience Study Criticizes Pradaxa

Wed, 04 Apr 2012 14:19:11 EDT

A new study published in the Journal of Clinical Neuroscience highlights the substantial problem of emergency surgery for individuals taking Pradaxa (dabigatran). Pradaxa’s effect, acting as an anticoagulant, cannot be rapidly reversed in order to perform emergency surgery, causing uncontrollable bleeding.

The study identifies the pros and cons of Pradaxa, weighing the usefulness of this drug, marketed as a better alternative to Warfarin, against its severe risks. Determining that the risks of Pradaxa are great, the authors conclude, “It is only a matter of time before we see case reports of irreversible bleeding during dabigatran-treated surgical emergencies and urgent attention must be paid to the provision of an effective, rapidly acting antidote. Surely it is irresponsible of any pharmaceutical company to release such a drug into the market and promote it extensively as a potential life-saving replacement for existing therapies without fully detailing the very real risk of irreversible hemorrhagic complications following trauma or at emergency surgery, no matter how small the numbers at such risk may be. These patients cannot be regarded simply as collateral damage.”

Actos Risks Highlighted on Alert Day

Fri, 30 Mar 2012 14:21:03 EDT

Alert Day, sponsored by the American Diabetes Association, was created to raise Americans’ awareness of their risks of developing type-2 diabetes. Celebrated earlier this week, Alert Day once again brought the growing concerns over Actos into focus. With the number of diabetic Americans expected to rise with our aging population, Actos was once viewed as a viable alternative to Avandia.

The belief in Actos as a viable alternative to the type-2 diabetes pill Avandia was dashed as complaints in 2011 for side effects including bladder cancer and heart failure increased 250% over complaints in 2010. Independent researchers have found that Actos users have a 40% higher chance of developing bladder cancer after they have taken the drug for longer than a year. Both Germany and France have pulled Actos off the shelves. The FDA is yet to pull the drug from American shelves, but has added stronger warnings to the label and continues to monitor ongoing research.

Johnson & Johnson Marketed Gynecare Prolift without FDA Clearance

Thu, 29 Mar 2012 14:23:11 EDT

A new report published by Newsinferno recently revealed that Johnson & Johnson marketed their Gynecare Prolift device for three years before the FDA approved its use.Johnson & Johnson introduced the vaginal mesh product into the market in 2005 without applying for FDA clearance. The product continued to be marketed, undetected by the FDA, until 2007 when Johnson & Johnson cited Gynecare Prolift as the predicate in the 510(k) application for a similar product, the Prolift + M. Neither mesh product was officially approved for market by the FDA until 2008.

Those involved with the mass tort cases against Johnson & Johnson believe that the unapproved marketing of the Gynecare Prolift device may increase the cost for Johnson & Johnson to resolve the lawsuits currently filed against them.

New Controversy Surrounding Yaz FDA Advisory Panel

Wed, 21 Mar 2012 14:25:09 EDT

The original controversy surrounding the FDA’s advisory panel on the benefits and risks of Yaz and Yasmin birth control pills focused on the professional conflicts of interests of the panel members. Some members of the panel were revealed to have funding ties to Bayer, conflicts that the FDA did not disclose.

Now, new controversy and possible evidence of irregularities in the panel’s decision have come to light. A coalition of women’s health groups allege that key questions directed to the panel members were vague and confusing. The group also claims that a number of the panelists are currently practicing obstetricians and gynecologists, raising concerns over their intellectual conflicts of interests as they have made individualized patient decisions regarding the safety of oral contraceptives.

The confusing wording relates to how the FDA Advisory Panel was questioned regarding the risks versus benefits of using DSRP-containing oral contraceptives (such as Yaz/Yasmin). The Panelists were asked whether “the benefits of DSRP-containing oral contraceptives for prevention of pregnancy outweigh their risks.”

Those panelists that voted “no” (risks do not outweigh benefits) appeared to be comparing the risks of Yaz/Yasmin to the risks of those oral contraceptives not containing DRSP. These panelists further noted the availability of safer forms of oral contraceptives as their rationale.

On the other hand, those panelists that voted “yes” (risks outweigh benefits) appeared to be comparing the safety of oral contraceptives containing DRSP to the risks of pregnancy. Ann Burke, a panelist who voted “yes” explained her vote saying:

“I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderate increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be - to take the product off the market. I’m not quite sure that’s necessary at this point.”

As seen in the responses from both the “yes” and “no” voters, their understanding of the question greatly affected their focus and possibly their final decision on the benefits and risks of Yaz and Yasmin. The coalition of women’s groups has not asked the FDA to hold a new meeting. Instead, they request a review of policies to ensure this does not happen again.

Pradaxa Manufacturer in Direct Violation of British Code of Practice

Tue, 20 Mar 2012 14:27:05 EDT

Boehringer Ingelheim (BI), the maker of Pradaxa, is accused of intentionally misusing their medical-professional-only website. An anonymous general practitioner has accused the company of intending to market Pradaxa to the general public through their site that is supposedly intended only for medical professionals.

The Prescription Medicines Code of Practice Authority (PMCPA) is the British organization responsible for monitoring the promotion of prescription medicines to health professionals and the provision of information to the public about prescription-only medicines.

Although the PMCPA did not find that BI’s medical professionals website was being used to target the public, it did cite BI for not providing a clear, prominent statement as to where the prescribing information can be found. This was a direct violation of clause 4.6 of the Code of Practice.

On a much larger scale, Pradaxa is under scrutiny for large numbers of reported hemorrhages among those using the medication. In response to the alarming number of adverse events, the number of lawsuits against Boehringer Ingelheim continues to rise.

SSRI's Risk Child Malformation for Pregnant Women

Thu, 15 Mar 2012 14:28:49 EDT

Today the Danish National Board of Health is reporting that data from a large registry study launched by the Danish National Board of Health suggest that the risk of malformations in children is slightly increased in women who were treated in early pregnancy with a selective serotonin reuptake inhibitors (SSRIs) antidepressant. Familiar SSRIs include Zoloft, Prozac, Paxil, Celexa and Lexapro. As a result of this new study the Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.

Review of the safety of SSRIs in pregnant women

The review of earlier studies showed an increase in birth defects affecting the in the cardiovascular system in newborns whose mothers had been treated with Prozac and Paxil in the first trimester. Based on the present knowledge, the conclusion was that similar defects, especially heart malformations, could be associated with Zoloft, Celexa and other SSRIs.

Metal-on-Metal Hip Implants Linked to High Failure Rates

Tue, 13 Mar 2012 14:31:13 EDT

Experts in England found “unequivocal evidence” of high failure rates in metal-on-metal hip implants leading them to call for a complete ban of such implants. In a study published today in the Lancet, experts reported a 6.2% revision rate after five years on data collected from 400,000 hip implants.

This warning is a second blow this month to metal-on-metal hip implants - two weeks ago the Medicines and Healthcare Regulatory Agency (MHRA) issued new guidance on the implants, which warned that almost 50,000 patients in the UK will need annual blood or MRI checks as a result of their implants.

The most recent Lancet study explains that the increase in failure rate appears to be related to the size of the implant - comparing revision rates for ceramic implants of 2.3% and metal-on-plastic implants of 1.7%.

This study further concluded that women, in particular, with metal-on-metal implants should be carefully monitored since their failure rates were particularly high - four times greater than failure with other implants.

Takeda Accused of Underreporting Risk of Bladder Cancer in Actos Users

Tue, 13 Mar 2012 13:07:34 EDT

Did Takeda downplay reports of bladder cancer and congestive heart failure in Actos patients? Helen Ge, former Takeda medical reviewer, accuses the Japanese pharmaceutical company of exactly that in her whistleblower lawsuit which was unsealed last week.

Takeda's Type2 Diabetes drug, Actos (pioglitazone), grew in popularity after use of Avandia, GlaxoSmith Kline's controversial drug, was severely restricted in the US because of concerns of an increased risk of heart attack and heart failure.

However, like Avandia before it, the safety issues surrounding Actos have come to the attention of the FDA and have left the public questioning whether there is a diabetes drug worth the risk.

On June 15, 2011, the FDA issued a warning regarding the link between Actos and the increased risk of bladder cancer amongst those who had used the drug the longest. According to the warning, there is also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

The FDA issues warnings such as the one on Actos as a result of clinical reviews of information provided in a database called the Adverse Event Reporting System (AERS). These reports come to the FDA from three places - physicians, the public and from the drug manufacturer. It is imperative to the safety of the public that the FDA receive all adverse event reports that occur with a product.

Helen Ge was hired to review these adverse event reports on behalf of Takeda. According to Ge’s complaint Takeda underreported the instances of bladder cancer in Actos patients to the FDA by nearly thirty cases, creating what she called a “serious discrepancy.” According to Ge, Takeda asked her to change her assessment of the reports from "related" to "unrelated" to the diabetes drug Actos. In so doing, Takeda would not be required to submit the adverse event report to the FDA.

Pink Slime Served in School Lunches

Fri, 09 Mar 2012 12:46:06 EST

If you have been paying attention to the news this week, you may have noticed stories running with regards to “pink slime” being served in school lunches. This “slime” consists of beef by-products: cow intestines, connective tissue and other parts that are not used in traditional beef cuts. Although I read these news stories with distant disgust, it didn’t really hit home until I saw something that looked a lot lot this pink slime being served in the cafeteria of my local elementary school this week.

This is the same "pink slime" that repulsed the public when it was learned that fast food giants like McDonalds and Burger King were using it. Although these fast food giants have stopped serving the "slime" as a result of the public outcry, the federal government continues to allow its use in school food.

If the thought of serving our Nation’s children "pink slime" infuriates you as much as me, then I suggest you join me in asking the USDA to reconsider their reported plan to purchase an additional 7 million pounds of "pink slime" for use by our public schools.

Although the "pink slime" did appear in a school lunch locally in the form of a hamburger, I am very proud to report that many of the children in our local school did not choose this option for lunch. In fact, I witnessed a handful of 5th graders choose the hamburger, look closely at it and throw it out. But, at our school, these 5th graders have an alternative to "pink slime" on a bun – last year we were the lucky recipients of a super shiny, rocket ship looking salad bar as a result of the "Let’s Move Salad Bars to School" campaign.

Application for this grant is super easy. The PTO was able to do most of the work for the school. Although the PTO has had to donate time to making sure the salad bar line moves smoothly, it is worth every bit of our time because the salad bar continues to receive rave reviews from the harshest critics – our kids.

Pradaxa Patient Bleeding Deaths Continue

Wed, 07 Mar 2012 12:42:38 EST

The University of Utah Department of Neurosurgery published an article today analyzing the death of an elderly man from a massive brain hemorrhage after a routine ground-level fall at home that highlights the problem surrounding use of dabigatran (brand name: Pradaxa).

After the fall, the 83-year-old man was evaluated at the University of Utah, where he was found to be fully alert and oriented. He was able to respond to verbal commands, and his neurological exam produced no findings of great concern, according to the clinicians at the University.

However, within a few hours, a CT scan showed the patient had a small hemorrhage in his brain. His condition worsened as efforts to stop the hemorrhage failed. The patient fell into a coma at the hospital and died soon thereafter.

Sadly, this story is not rare among patients using Pradaxa. As of today, Boehringer Ingelheim acknowledges that 260 patients that have died as a result of a drug that has been on the market for just over a year. There are other similar stories – a patient taking Pradaxa for atrial fibrillation suffers a severe injury because bleeding can’t be treated.

The FDA is now looking into the safety of Pradaxa as more and more of these stories come to light. The FDA is asking patients and doctors to report incidents of this type when they occur in order to provide the FDA with as much information as possible about the safety of Pradaxa.

Hairstylists Harmed From Brazilian Blowout Exposure

Tue, 06 Mar 2012 12:38:34 EST

For seven months we have watched GIB LLC market their popular “Brazilian Blowout” product as “formaldehyde-free” while simultaneously being investigated by the FDA, OSHA, California’s Attorney General, and Oregon OSHA for exposing stylists and users to that same harmful chemical.

Although there was no public action taken in response to the FDA warning letter issued on August 22, 2011, it will be hard for GIB LLC to ignore the effect that the two most recent blows will have.

On January 30, 2012, GIB LLC settled a lawsuit filed by California’s attorney general who accused the maker of Brazilian Blowout of deceptive advertising since the solutions were not formaldehyde-free, although the labels indicated they were. The settlement required the company to make changes to its website and to pay a fine of $600,000.

Pursuant to the settlement, the website now includes safety sheets for each of the Brazilian Blowout products, but there now appears to be less news regarding the controversy. In the past, the Brazilian Blowout website included a note stating that the company was “working directly with the FDA to help clear up the controversy.” That note is now gone. Although there have been lots of articles regarding the formaldehyde controversy lately, the Brazilian Blowout press webpage only includes articles from fashion magazines, and no mention of the company’s action (or inaction) regarding this issue.

The second blow comes in the form of a class action settlement. The settlement of $4.5 million will be shared by consumers harmed by the products. Each eligible consumer will receive $35 for each treatment and $75 for each bottle of the product purchased.

The question that we asked in September 2011 still bothers us today: where are the stylists and hair care workers harmed from repeated exposure to Brazilian Blowout treatments? Do they trust the company that is now paying for its deception to protect them?

Studies Uncover Serious Pradaxa Risks

Mon, 05 Mar 2012 12:33:40 EST

A group of hematologists in New Zealand, concerned by what they were witnessing in the short time Pradaxa had been available there (since July 1, 2011), sparked a review that was done in collaboration with the Haematology Society of Australia and New Zealand. The review panel identified 78 bleeding episodes over the two-month review period, including 44 cases handled by the panelists. Of the 44 cases with which the panelists were intimately familiar, 12 were severe.

Actos Cases Consolidated in Cook County

Thu, 01 Mar 2012 12:22:41 EST

Since filing the first Cook County Actos case against Takeda Pharmaceutical, the attorneys at TorHoerman Law, in cooperation with other leading law firms, have been working diligently to coordinate the Illinois litigation against Takeda Pharmaceutical, the manufacturer of Actos, a Japanese Corporation that has its U.S. headquarters in Illinois.

Eliquis Delayed by FDA - Is Pradaxa to Blame?

Wed, 29 Feb 2012 12:17:18 EST

There may be trouble on the horizon for the new bloodthinner from Pfizer and Bristol-Myers Squibb. Eliquis, the new bloodthinner, is rumored to be the subject of an upcoming FDA advisory meeting scheduled for May 23rd.

Concerns about the safety of Pradaxa may be to blame for the FDA’s increased wariness of Eliquis. Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals has been linked to 505 cases of hemorrhaging in the first quarter of 2011. Anderson comments that, “Our best guess remains that FDA may be seeking cover, given the safety experience following competing drug Pradaxa’s approval in 2010."

Lawsuit links illnesses to north St. Louis County Creek - STLToday.com, February 29, 2012

Wed, 29 Feb 2012 08:21:18 EST

STLToday.com article with details regarding the fIrst lawsuit filed on behalf of 13 people with injuries they believe are linked to toxic contamination of Coldwater Creek. They allege Mallinckrodt and other corporations acted recklessly and negligently in the manufacturing and disposal of the nuclear waste.

Zantac Medication Linked to Fatal Outcomes for Low Birth Weight Babies

Fri, 24 Feb 2012 12:03:12 EST

Babies with acid reflux (gastroesophageal reflux disease or GERD) are often given Zantac syrup containing ranitidine to block acid production in the stomach. To date, there have not been any side effects of Zantac syrup reported, other than causing sleepiness.

However, a new study of premature infants (between 24 and 32 weeks) and full term infants weighing less than 3.5 pounds links ranitidine heartburn medication (Zantac) with a very high risk of infections, death of intestinal tissue and fatal outcomes.

A group of researchers from the Department of Women’s Health and Territorial Medicine, University La Sapienza, Rome, Italy evaluated 274 very low birth weight infants, 91 of who were given ranitidine versus 183 who were not.

The study found thirty-four (37.4%) of the 91 children exposed to ranitidine and 18 (9.8%) of the 183 not exposed to ranitidine had contracted infections representative of a 450% increased risk.

The risk of death of the intestines was 6.6-fold higher in ranitidine-treated infants than in control subjects.

The over-all death rate was over 6-times higher in newborns receiving ranitidine (9.9% vs 1.6%).

These researchers concluded that ranitidine therapy is associated with an increased risk of infections, intestinal death, and fatal outcome in very low birth weight infants.

Qnexa Diet Pill Likely To Receive FDA Approval

Fri, 24 Feb 2012 11:08:31 EST

On Wednesday, an FDA Advisory Committee overwhelmingly voted in favor of recommending the approval of a diet pill, Qnexa. This recommendation reverses years of caution with regards to diet pill drugs by the FDA after fen-phen was withdrawn from the market in 1997.

Transvaginal Mesh Lawsuits Consolidated in Southern District of West Virginia

Thu, 23 Feb 2012 11:53:24 EST

Transvaginal mesh is a medical device implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Some women who underwent surgery to treat POP & SUI with vaginal mesh are suffering from severe and debilitating complications such as pelvic pain, infections, bleeding, and migration of the mesh within the body causing the need for repeat surgeries.

Legal Claims May be Filed Over Illnesses Near Former Radioactive Waste Site, KMOV.com, February 9, 2012

Thu, 09 Feb 2012 08:33:37 EST

Short article at KMOV.com summarizing the site prior to the filing of lawsuits.

Post-Market Reports Reveal Serious Bleeding Events for Pradaxa Users

Mon, 23 Jan 2012 11:50:25 EST

There are real consequences to post-market drug investigations such as the ongoing investigation of Pradaxa, Boehringer Ingelheim’s new blockbuster drug used in the treatment of atrial fibrilation. In the first year Pradaxa was on the market, at least 500 people reported serious bleeding events as a result of Pradaxa use. The FDA is evaluating these post-marketing reports, but in the meantime, people suffer injury because they are unaware of the risks they take while on Pradaxa.

Smokeless Tobacco Now in the Form of Candy

Fri, 20 Jan 2012 11:47:58 EST

This week, the FDA met to evaluate the safety and risks of dissolvable smokeless tobacco products. These smokeless tobacco products are not stop-smoking aids that many Americans turn to fulfill their New Years resolutions. These dissolvables are instead intended to satisfy nicotine cravings in situations where smoking is not allowed (like at your local public school). They usually come in the form of flavored mints, strips, and sticks of smokeless tobacco. Cigarettes that make your breath smell good? What seems to be the problem?

FDA Members to Keep Yaz and Yasmin on the Market

Thu, 12 Jan 2012 11:45:34 EST

The British Medical Journal (BMJ) reports that at least four members of a recent special safety committee advising the US Food and Drug Administration on the safety of drospirenone had financial ties to its manufacturer, Bayer, raising questions about the rigor with which the agency minimizes potential conflicts of interest. Bayer sells drospirenone under four popular birth control brands - Yaz, Yasmin, Beyaz and Safyral, all of which remain on the market.

Pradaxa Adverse Event Reports Continue to Rise

Thu, 12 Jan 2012 11:42:33 EST

Reports of adverse events continue to mount among users of Pradaxa, a new drug approved to reduce the risk of stroke by inhibiting blood coagulation. A new study identified more than 500 reports of fatal, disabling, or other severe hemorrhages. Last month, Boehringer Ingelheim acknowledged 260 deaths from serious bleeding, and published yesterday was a study showing an increased risk of heart attacks associated with Pradaxa. The FDA is studying these reports, but has not yet taken action.

More Studies Needed to Assess Safety of Pradaxa

Tue, 10 Jan 2012 11:40:18 EST

Last month, the FDA announced it is continuing to monitor patients taking Pradaxa as the result of reports of serious and even fatal bleeding events. In fact, Boehringer Ingeleheim, the manufacturer of Pradaxa, acknowledged 260 deaths as a result of bleeding. Although the FDA has not yet issued enhanced warnings, the European Medicines Agency (EMA) recommended updated product information for Pradaxa regarding the bleeding risk, and the FDA asked for users to report complications so that further studies could be done.

MICROWAVE LAVA CAKE IN A MUG

Wed, 21 Dec 2011 19:32:35 EST

Looking for a last minute simple, inexpensive gift? Make your friends a do-it-yourself microwave molten chocolate cake. Look for discounts on mugs in the stores - we found this one at Kohls and others at Target for less than $3 each. Mix up a few of the ingredients and throw them inside in bags and then include instructions for each of your recipients!

Report Complications from Pradaxa to FDA

Tue, 13 Dec 2011 11:31:39 EST

There has never been a more important time for Pradaxa users to vigilantly report complications from the drug. Specifically, users of the drug need to let physicians know of any symptoms of gastrointestinal bleeding, such as abdominal pain and changes in the color of your stool.

FDA to Review the Safety of Multaq

Tue, 15 Nov 2011 11:28:13 EST

A drug used successfully to reduce the risk of death, stroke, and hospitalization for patients with occasional atrial fibrillation has been found to double the risk of death for those with a permanent form of the erratic rhythm. Sanofi’s Multaq is approved for the treatment of patients whose hearts intermittently race with quick and inefficient contractions. Sanofi had hoped that a study of 3,236 patients would prove that Multaq would also have success in patients with a more serious form of the condition. That study was halted in July because of the increased danger of stroke and heart failure.

"Be First, Be Best, Be Focused"

Sun, 13 Nov 2011 11:20:37 EST

...This according to Boehringer Ingelheim's Annual Report and early reports on Pradaxa, their breakthrough thrombin inhibitor, seemed to prove their guiding principles. But, it now appears that Boehringer Ingelheim should add "Be Careful" as a guiding principle.

Infuse Bone Graft Linked to Cancer

Thu, 10 Nov 2011 11:17:04 EST

Amidst allegations of omission of known safety issues during clinical trials and promotion of off-label use, Infuse Bone Graft, a product from Medtronic, is under investigation by the U.S. Senate and the Department of Justice. Infuse is a bone graft that contains a bone growth protein, designed to stimulate bone formation. The June issue of Spine Journal focused solely on growth products and the potential dangers of their use. Spine Journal reported that surgeons being paid by Medtronic did not report their findings of serious side effects from the use of Infuse including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. Data reported in the journal stated that complications occurred in 10% to 50% of patients included in 13 clinical trials run by Medtronic between 2000 and 2010.

Avandia Safety Concerns Cause FDA to Limit Access

Fri, 04 Nov 2011 11:12:20 EDT

Avandia will no longer be available through retail pharmacies starting November 18, 2011. The FDA has mandated an access program because of safety concerns. Starting November 18 Avandia will only be available through specially certified pharmacies that are participating in the program. Healthcare providers will also have to enroll in the access program if they want to continue to prescribe Avandia. The providers must also enroll each patient in the access program in order for the patient to start receiving or continue receiving Avandia. The FDA ordered Avandia’s manufacturer, GlaxoSmithKline, to send “Dear Health Care Provider” letters to prescribers to make them aware of current Avandia information.

The history of diabetic medications is one that causes pause. As details continue to emerge exposing the dangers these drugs bring, diabetics need to be informed and aware of the risks associated with the drugs they use and the remedial measures they can take to limit these risks.

Yaz Misleading Advertising Under Scrutiny

Fri, 04 Nov 2011 11:08:01 EDT

Although it is still one of the highest selling birth control pills on the market, Bayer’s blockbuster birth control pill, Yasmin or Yaz, has been under scrutiny for misleading advertising and health-concerns for years. It now appears that the future of Yaz could be decided before the end of the year.

In 2008, The FDA sent Bayer a warning letter as a result of their distracting and misleading ads that gave the impression that using Yaz resulted in clear, acne-free skin as well as allowing women to say “good-bye” to their Premenstrual Dysphoric Disorder (PMDD) symptoms. The FDA warned Bayer that there was no evidence or clinical experience to demonstrate this, and they would need to pull the ads.

Bayer bounced back from their advertising disaster, and Yaz continued to be Bayer’s top-selling pharmaceutical drug and the “go to” birth control pill for many women. However, by late 2009, health concerns over the popular contraception began to cloud the image of Yaz. Health advocates started to get word out that Yaz put women at a higher risk for blood clots, strokes and other health problems, than other birth control pills.

Many women reported strokes, pulmonary embolisms, deep vein thrombosis, gallbladder diseases and other life-threatening injuries as a result of their use of Yaz. In fact, as of July 16, 2011, the number of lawsuits pending in the United States and served upon Bayer was about 9,300 (as reported by Bayer’s 2nd Quarter Stockholders’ Newsletter). That number is expected to rise.

The FDA said it hasn’t reached a final conclusion on the drugs’ safety but will hold a meeting with scientific advisers on December 8, 2011. Based on the large amount of scientific studies that are now available, we look forward to the FDA taking affirmative action to prevent the unnecessary injuries incurred by women taking Yaz. It is imperative that women be given all information necessary to make an informed choice about their birth control options. There certainly appears to be enough evidence now existing to say that there are safer options on the market than Yaz.

FDA Soon to Decide Fate of YAZ

Fri, 04 Nov 2011 08:18:32 EDT

Since it hit the market in 2006, Yaz has been the "go to" birth control pill for women. This is the case despite the numerous occassions that Bayer has been under scrutiny with this drug

Diabetes Drugs Under Investigation

Mon, 31 Oct 2011 11:05:13 EDT

Actos (pioglitazone) is an oral diabetes medication in the class of drugs known as the thiazolidinediones (TZD). Diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.

More Trouble For Diabetes Drugs

Mon, 31 Oct 2011 08:37:14 EDT

Although Actos is currently in the spotlight, it is not the only diabetes drug to come under scrutiny. Avandia and Actos have both been linked to increased risks of harm. Read more here.

TorHoerman Law Announces Dr. John M. Restaino, DPM, JD, MPH as Guest Blogger

Fri, 28 Oct 2011 11:01:31 EDT

TorHoerman Law is proud to announce that Dr. John M. Restaino, DPM, JD, MPH has agreed to guest blog with us at our Chicago-Land Injury Board Blog.

The Importance of Community in Chicago - Rogers Park/West Ridge HIstorical Society

Tue, 25 Oct 2011 12:52:00 EDT

TorHoerman Law is a true believer in a strong local community and we are proud to support the Rogers Park/West Ridge Historical Society in their vital role for this north side Chicago neighborhood.

Quick Tips to Keep Your Furry Friend Happy on Halloween

Tue, 25 Oct 2011 09:32:39 EDT

Ding-Dong! Ding-Dong! BARK BARK BARK! Trick-or-Treat! MEOW! Halloween trick-or-treaters can be stressful on your pet.

Dental Hygiene and Halloween

Tue, 25 Oct 2011 07:42:15 EDT

Dr. Margaret Mitchell, a Chicago dentist, explains that the key to preventing tooth decay is limiting how long sugar remains in the mouth in addition to the actual amount of candy children eat.

By brushing teeth right after eating candy, you may prevent harmful bacteria from developing. Also, eating the candy quickly limits the amount of time the sugar has contact with your teeth.

Dr. Mitchell gives parents and children several steps to protect teeth this Halloween

(1) Parents should pre-sort their children’s candy and remove anything they find unacceptable
(2) Avoid tacky or gummy candies as these easily stick to teeth and cause decay
(3) Always remind children to practice good dental hygiene
(4) Prior to Halloween, dentists can put sealants into children’s teeth grooves to shield the teeth from damage caused by too much sugar.

EMA Recommends Restrictions for Multaq Use

Wed, 05 Oct 2011 10:55:42 EDT

The European Medicines Agency's Committee for Medicinal Products for Human Use (CMHP) recommended on September 23, 2011 that use of Multaq, an anti-arrhythmic medication manufactured and marketed by Sanofi-Aventis, be restricted.

The CMHP began evaluating data as a result of post-marketing reports of severe liver injuries among users of Multaq. The CMHP also reviewed potential cardiovascular injuries following the early termination of a clinical trial of Multaq in an off-label population. Ultimately, the CMHP determined that use of Multaq as approved increased the user's risk of injury to the liver and the lungs.

As a result of the increased risk of liver and lung injury, the CMHP has recommended that Multaq be used only after other treatment options have been considered, and only in patients in whom atrial fibrillation is no longer present. Patients currently taking Multaq should discuss the CMHP's recommendations with their physicians, and lung function, liver function, and heart rhythm should be monitored for patients on Multaq.

Cosmetic Industry Declares Formaldehyde Unsafe

Thu, 29 Sep 2011 10:46:34 EDT

As a result of a meeting this week, the Cosmetic Ingredient Review panel, an unbiased scientific advisory board established by the major American cosmetics manufacturers, has declared that formaldehyde and methylene glycol are unsafe for use in hair smoothing products, the use of which involves application of high temperatures (i.e. the Brazilian Blowout Service).

Although the FDA publicly admonished Brazilian Blowout, the FDA stopped short of banning all formaldehyde in hair services. GIB, LLC ("GIB"), the company behind Brazilian Blowout, has not complied with the FDA warning, but, instead, is fighting the charges with a public relations attack, using stylists to contact the FDA on their behalf, U.S. Rep. Early Blumenauer urged GIB to voluntarily pull the product from the market. Responding to Rep. Blumenauer’s request, Mike Brady, President of GIB LLC responded, "We’re going to continue to offer a product that gives people the hair of their life."

If GIB is allowed to continue to offer it, the likelihood is that despite the FDA warnings, the product will continue to sell. Thomas Cluderay of the Environmental Working Group explains:

"The incentive to downplay mounting health concerns is substantial when you can charge several hundred dollars for a single treatment. Until regulators pull the plug on Brazilian Blowout, I think it’s clear the company is prepared to do just about anything to peddle these products."

Epileptic Drugs Linked to Risk of Birth Defects

Thu, 29 Sep 2011 10:35:29 EDT

Many medications taken during pregnancy are proving to increase the risk of birth defects. Most drugs are not tested on pregnant woman due to the risks to the unborn. Yet, the drugs are still given to pregnant women without first being tested.

Honor Flight - A Day to Remember our WWII Veterans

Tue, 27 Sep 2011 14:16:16 EDT

Honor Flight is a program that is dedicated to paying a small tribute to those who gave so much – a memorable, safe, and rewarding tour of honor – visit memorials honoring their service and sacrifice in Washington D.C..

This fall, TorHoerman Law is honored to recognize the service of one our own – Bob Weishaupt, a veteran and father to Sue Tanney, a member of our medical team.

$25 Million Jury Verdict Awarded in Accutane Case

Fri, 23 Sep 2011 18:15:00 EDT

In an order entered on September 12, 2011, Judge Higbee upheld the $25 million jury verdict for Andrew McCarrell who was diagnosed with inflammatory bowel disease (IBD) as a result of his use of Accutane, the blockbuster acne drug made by Hoffman LaRoche (“Roche”)...

McCarrell $25 million Accutane Verdict Upheld

Fri, 23 Sep 2011 12:39:13 EDT

Andrew McCarrell has jumped through yet one more hoop in his quest for justice from Roche, the maker of the blockbuster acne drug, Accutane which a jury found to be the cause of Andrew's debilitating inflammatory bowel disease. Read more about Andrew's long quest for justice at our Injury Board Blog.

Attached is the order filed on September 12, 2011 by Judge Higbee of the Superior Court of New Jersey upholding the previous $25million verdict.

European Agency Warns of Multaq Use

Thu, 22 Sep 2011 18:09:45 EDT

Multaq, Sanofi-Aventis’ $1 billion heart-drug, “should only be prescribed after alternative treatment options have been considered”, according to the European Medicines Agency (EMA).

In January 2011, the FDA issued a warning to patients with atrial fibrillation (abnormal heart rhythms) that Multaq showed twice as many deaths as compared to those who did not take the drug. This warning came as a result of a 3,000-patient trial that Sanofi-Aventis halted after they noticed an increased risk of cardiovascular events among patients with permanent atrial fibrillation.

The FDA is currently conducting a separate review and is expected to make a statement with regards to this trial soon. In the meantime, it is advisable to follow the advice set out by the EMA. If you are currently taking Multaq (or dronedarone), you should have your treatment reassessed by your physician at your next scheduled visit.

Take the Savage Love "it Gets Better" Pledge

Thu, 22 Sep 2011 18:03:37 EDT

Though Dan Savage, syndicated sex columnist, may spend a lot of his time these days as a political pundit condemning culturally conservative politicians who seek to use gay issues as a stepping stone in their political careers, today he is a supportive shoulder for this quivering youth. His take away message - I understand it is hard, but, "It Gets Better."

Nine out of 10 gay teenagers experience bullying and harassment at school and gay teens are four times more likely to attempt suicide. Many lesbian, gay, bisexual and transgender (LGBT) kids who do kill themselves live in rural areas and suburban areas - places with no gay organizations or services for queer kids. These are the kids Dan worries about and these are the kids that inspired him and his partner, Terry Miller, to create the "It Gets Better Project."

The "It Gets Better Project" was meant to fill this void and to be a support group where none existed. The project started with the goal of collecting one hundred videos made by LGBT adults telling their stories of coming out, overcoming bullying and then creating a life worth living to LGBT kids at risk. It was a simple and powerful truth - things did get better and they keep getting better. Dan and Terry felt they needed to reach out to show LGBT kids that their future would be bright if they could just hold on for now.

The "It Gets Better Project" has now grown to include action steps for continuing to speak out for LGBT youth as well as a pledge to help spread the message of hope to LGBT youth.

Currently, 448,419 people have taken the pledge to respect people for who they are and who they choose to love.

Brazilian Blowout Manucaturer Accused of Misleading Public

Wed, 21 Sep 2011 12:00:40 EDT

On August 22, the FDA sent a warning letter to GIB LLC, the manufacturer of Brazilian Blowout, accusing them of misleading the public about the safety of its hair straightening service. Despite the fact that OSHA, Congress and FDA studies warn of dangerous levels of formaldehyde in Brazilian Blowout products, GIB LLC continues to deny these allegations.

FDA Warns of Actos and Bladder Cancer Link

Tue, 20 Sep 2011 17:44:59 EDT

The FDA warns of increased bladder cancer risk associated with the use of the diabetes drug Actos (pioglitazone).

This warning comes after a review of data from a five-year interim analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceutical Co.

The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer amongst those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

Takeda's Type2 Diabetes drug, Actos, grew in popularity after use of Avandia; GlaxoSmith Kline's controversial drug was severely restricted in the US because of concerns of an increased risk of heart attack and heart failure last fall. Takeda had profits from sales of Actos in the U.S of over $3 billion in 2009 and just under $3 billion in 2010.

Given the publicity over the health risks of the two most popular anti-diabetic drugs, it leaves diabetics in a difficult position. Is there a drug that is worth the risk?

If you are a diabetic, it is imperative that the focus remain on your health - although the bad news can seem overwhelming, we believe that it is important to provide you with full information so that you can make informed health decisions. Unfortunately, that information has historically not been available with respect to Avandia and Actos. At this point, it is advisable that you discuss these risks with your physician to determine the best treatment option for you.

Diabetics left Questioning - Is Actos Worth the Risk?

Tue, 20 Sep 2011 10:47:32 EDT

The FDA warns of increased bladder cancer risk associated with the use of the diabetes drug Actos (pioglitazone).

Takeda's Type2 Diabetes drug, Actos, grew in popularity after use of Avandia; GlaxoSmith Kline's controversial drug was severely restricted in the US because of concerns of an increased risk of heart attack and heart failure last fall. Takeda had profits from sales of Actos in the U.S of over $3 billion in 2009 and just under $3 billion in 2010.

Given the publicity over the health risks of the two most popular anti-diabetic drugs, it leaves diabetics in a difficult position. Is there a drug worth the risk?

If you are a diabetic it is important to focus on your health. Although the bad news can seem overwhelming, we believe it is important to provide you with full information so you can make informed health decisions. Unfortunately, this information has historically not been available with respect to Avandia and Actos. At this point, it is advisable that you discuss these risks with your physician to determine the best treatment option for you.

Christopher's Story

Mon, 12 Sep 2011 07:57:39 EDT

Jennifer Hilton was an exhausted mother of four who spent her nights nursing and caring for her infant and then spent her days working part time. Jennifer went to great pains to make sure that when she was unable to be with them, her children were in safe locations. But, like most mothers of infants, Jennifer existed for months on end with very little sleep – spending her evenings with Christopher, her infant that wouldn’t sleep through the night. She often felt worn down and exhausted, but, didn’t think it was a big deal.

On October 6, 2010 her exhaustion became a big deal.

The normal routine that Jennifer had in place changed – on most days, Jennifer’s fiancé took Christopher to daycare, but, circumstances changed that day and Jennifer was now in charge of Christopher. Christopher fell asleep in his rear-facing car seat and, in her exhausted haze; Jennifer proceeded with her normal routine – driving straight to work, leaving a very quiet infant asleep in the backseat. Although Christopher was discovered by a co-worker right away, the police were called and left Christopher in the car for over two hours.

On average, 38 children die in hot cars each year from heat-related deaths after being trapped inside motor vehicles. Even the best of parents or caregivers can overlook a sleeping baby in a car; and the end result can be injury or even death.

Christopher was one of the lucky survivors. He was discovered before any serious injuries could occur. Jennifer is now an advocate for KidsandCars.org, a not-for-profit organization dedicated to preventing injuries and death to children in and around motor vehicles. She is helping to get the word out about this danger and to provide new parents with safety tips about how this danger can be avoided.

Mesh is "Complete Torture"

Fri, 09 Sep 2011 16:02:47 EDT

Mounting reports of injuries from the use of vaginal mesh prompted the FDA advisory panel to come out in favor of a more rigorous premarket approval process.

A few women whose lives were significantly harmed as the result of vaginal mesh products testified at the panel hearing.

Read their account of the "complete torture" they experienced here.

Brazilian Blowout - Where are the Victims?

Fri, 09 Sep 2011 15:55:51 EDT

There are likely thousands of stylists that have been put at risk because of the actions of GIB LLC, the manufacturer of Brazilian Blowout. Although OSHA, Congress, the FDA and public interest groups have been vocal in their outrage, there have not been very many stylists speaking out against the company. Our Chicago-Land Injury Board Blog attempts…

FDA Fails to Pull Mesh From Market

Fri, 09 Sep 2011 13:34:48 EDT

Safety concerns over the use of vaginal mesh to treat pelvic organ prolapse prompted the FDA advisory panel to come out in favor of a more rigorous premarket approval process. Although no votes have been taken yet, the panel informally indicated they are in favor of reclassifying the mesh devices from a medium risk category (Class II) to a high risk category (Class III), which would require the devices to get premarket approval with the FDA as well as require the manufacturers to prove the safety and effectiveness of the products on an ongoing basis.

Although the FDA is urging closer scrutiny of vaginal mesh used to treat pelvic organ prolapse in women, the advisory panel stopped short of pulling vaginal mesh from the market.

Straighten Up Brazilian Blowout!

Wed, 07 Sep 2011 14:26:45 EDT

The FDA wasted little time in taking action on a letter submitted to them in May from Jan Schakowsky (D-IL) and others in Congress. As we describe in more detail at our ChicagoLand Blog at the Injury Board Blog Network - Brazilian Blowout, the company responsible for this "adulterated" product now has…

FDA Warns Brazilian Blowout - Straighten Up!

Wed, 07 Sep 2011 12:12:08 EDT

The FDA issued a warning letter to GIB LLC, the California manufacturer of Brazilian Blowout, giving them 15 days to correct their violations of the FDA Cosmetics Act.

Amvets Picnic Donation

Tue, 06 Sep 2011 08:22:56 EDT

THL is happy to support organizations such as the Madison, IL Amvets who enhance the quality of life for local veterans and our nation's citizens.

Recentyl, we were thrilled to purchase two bicyles to be used to in an auction to raise funds for the different programs provided to veterans by Amvets Post 204 in Madison, IL. We were even more happy when we got word the Past Commander of the Madison Amvets purchased the bikes for his grandchild. We hope he enjoys it for years to come and thank Amvets Post 204 for the services they provide to all of our local veterans!

FDA Acts on Vaginal Mesh Complications - Where are the Manufacturers?

Thu, 01 Sep 2011 16:20:15 EDT

Manufacturers of the vaginal mesh products are in the best position to warn the public of the medical risks in using the products.

Through our Injury Board Blog, we will continue to apply pressure to the manufacturers of the vaginal mesh products until they take steps to get women the information they need to make important decisions about their health and safety.

Manufacturers Need to Warn Public of Vaginal Mesh Safety Concerns

Thu, 01 Sep 2011 12:16:59 EDT

It appears that news of the complications arising from vaginal mesh kits has prompted the FDA to take action, with meetings scheduled regarding the safety of the kits taking place next week. This is an important step, but, we must continue to ask - where are the manufacturers of the mesh kits?

While the FDA Continues to Look Into Safety of Vaginal Mesh Products

Thu, 01 Sep 2011 11:57:12 EDT

As the FDA plans for meetings regarding the safety of vaginal mesh, we continue to press the manufacturers for more public warnings.

Every year 300,000 women choose to undergo surgery to correct their pelvic organ prolapse, and as we have learned through our daily conversations with women who have had life-altering complications, mesh erosion is a risk that should have been highlighted before they made their decision.

Follow our blogs at the Injury Board where we continue to be a voice for the women dealing with these complications on a daily basis.

Our Lady Queen of Peace "Scrambling for a Difference" Golf Tournament

Thu, 01 Sep 2011 08:35:05 EDT

THL is once again proud to support the mission trip of the OLQP Youth Group. We agree with Norm Frisch that "by supporting youth organziaiton of any sort is a 'pay it forward' action for the future of our youth."

We are thrilled that Norm and Amy Frisch have taken on the mission to show the youth of today what it means to be "giving" people. Through the generous gift of their time and fundraising efforts, we believe Norm and Amy will continue to make a difference in the lives of many of our youth.

Through fundraising efforts such as the "Scrambling for a Difference" Golf Tournament and other activities, Norm and Amy have been able to take their Youth Group to various locations that would not otherwise be available to the youth of the OLQP community. The last of these trips was to Spain in August, where Norm and Amy spent a week touring this beautiful country with the youth group.

Thank you Norm and Amy for the gift of your time and efforts and we look forward to supporting your activities in the future!

Bringing the Salad Bar Project to a School Near You

Tue, 23 Aug 2011 12:39:01 EDT

If you haven't visited your local school cafeteria in a while - I would suggest that now might be a good time to do so. Does your school have a salad bar? If not, why not? Thanks to Whole Foods and Chef Ann's Salad Bar Project, all public schools within a 50-mile radius of a Whole Foods Market are eligible to apply for a Salad Bar Project grant.

THL is proud to support the Civil Justice Foundation

Mon, 22 Aug 2011 12:55:09 EDT

Along with a great group of lawyers, THL proudly donated money to support a great grassroots organization so it can continue to protect our civil justice system.

Women and Depression - Are SSRI's Worth The Risk?

Mon, 22 Aug 2011 12:06:50 EDT

Women who find themselves at crossroads in their life in terms of career and family often find themselves depressed and looking for help which often leads to the use of antidepressants. In fact, women between the ages of 25 and 44 incur a higher rate of depression than any other group and studies have shown that 1 in 10 women in America are taking antidepressants. The most widely prescribed antidepressants belong to a class of medication known as selective serotonin reuptake inhibitors (SSRIs). This class includes the well known drugs Paxil, Prozac and Zoloft...

Women and Depression - Should SSRI's be an Option?

Mon, 22 Aug 2011 10:41:28 EDT

Women who find themselves at crossroads in their life in terms of career and family often find themselves depressed and looking for help which often leads to the use of antidepressants. Unfortunately, women are not given all the information they need to make a proper risk/benefit analysis of using SSRI's during their child-bearing years.

Medtronic's Bone Graft Safety Data - Have We Seen it All?

Wed, 17 Aug 2011 17:43:12 EDT

Medtronic, Inc., based in Minneapolis, Minnesota, is the world’s largest medical technology company. Recently Medtronic came under fire after independent researchers questioned the safety studies surrounding Medtronic’s new Infuse Bone Graft product...

Medtronic's Bone Graft Safety Data - Have We Seen It All

Wed, 17 Aug 2011 11:49:40 EDT

Back To School Tips

Wed, 17 Aug 2011 08:32:08 EDT

One of the major problems that children deal with going back to school is the risk of illness. It is important for parents to teach their children how to prevent getting sick, to know how to treat their child if they become sick, and to know how to prevent their child from getting others sick. Here is a list of quick tips

Are Your Child's Sack Lunches Safe?

Tue, 16 Aug 2011 08:14:26 EDT

Sack lunches can help save money, can appease picky eaters and are often healither than cafeteria food. However, a newly released study questions the safety of perishable foods packed in sack lunches.

Kids Taught to Wash Hands Avoid Sick Days

Mon, 15 Aug 2011 11:53:35 EDT

Turns out you should listen to mom and your teachers - A three-month study of students in Denmark proved that children who washed their hands properly were absent significantly less than those that did not.

Middle-Aged Women on SSRIs Face Increased Stroke Risk

Fri, 12 Aug 2011 07:43:26 EDT

The UK Daily Mail is reporting that scientists have completed a study looking at the long-term effects of SSRIs on middle-aged women. The report concluded that middle-aged women who took Prozac or similar SSRIs are almost 40 percent more likely to suffer a stroke.

BP Oil Spill Victims Still Without Healthcare

Sat, 06 Aug 2011 09:43:35 EDT

"It is time for us to provide the families of the Gulf Coast with the health care they deserve" - we applaud Kerry Kennedy in her efforts to obtain proper health care for the residents of the Gulf Coast effected by the BP Oil Spill.

EPA Fails to Achieve Children's Health Protection

Fri, 05 Aug 2011 17:33:56 EDT

According to the U.S. Environmental Protection Agency Office of the Inspector General (OIG), the EPA did not achieve children’s health protection goals as explained in a scathing report published July 21, 2011...

Who is Monitoring the Safety of Vaginal Mesh Kits?

Fri, 05 Aug 2011 13:51:45 EDT

If medical device companies are going to use this expedited regulatory process, they should have a greater responsibility to make sure the product they take to market is safe since it did not go through normal safety channels. Medical device companies stand to make a substantial profit off of devices like vaginal mesh kits that went through the expedited approval process. It is not unfair to expect these same companies to be responsible for the monitoring of these devices as they make their way through market and, subsequently, be held responsible if the device is later found to cause injury.

Vaginal Mesh Kits Approved Under FDA's Flawed System

Fri, 05 Aug 2011 11:45:54 EDT

Approximately 7 years ago, vaginal mesh kits were introduced to the market in an attempt to obtain the benefits of a more durable repair as well as to simplify and standardize the technique of mesh placement vaginally...

EPA Fails to Review Chemicals that Endanger Children

Thu, 04 Aug 2011 08:33:14 EDT

The EPA has not demonstrated that it can achieve children's health goals with a voluntary program after their flawed program to report on the safety of chemicals on children failed. This according to a scathing report publishe by the Office of the Inspector General of the EPA at the end of July 2011.

SSRIs May Not be the Best Choice for Those over 65

Thu, 04 Aug 2011 08:24:15 EDT

New research published in the British Medical Journal suggests that popular SSRIs such as Prozac and Effexor may not be the best choice for antidepressants for seniors. SSRIs are associated with more side effects than older antidepressants. The researchers suggest that antidepressants known as tricyclic antidepressants may be a better choice…

Doctor's hired to study safety of Medtronic's Infuse Bone Graft found to have significant financial ties to Company

Thu, 04 Aug 2011 07:55:58 EDT

Doctors paid to study Medtronic's Infuse Bone Graft product were found to have significant financial ties to the company and came under fire for misrepresenting the safety of the product. Medtronic has now agreed to give $2.5 million for an independent review of the product.

Pfizer Finds New Ways to Squeeze Money Out of Lipitor

Thu, 04 Aug 2011 07:48:12 EDT

Pfizer is due to lose its patent protection in November for Lipitor, the world’s highest selling drug, but already has a plan to continue raking in money from the cholesterol lowering drug. The drug company plans to market an over-the-counter version of Lipitor…

Chronic Diflican Use Linked to Risk of Birth Defects

Wed, 03 Aug 2011 16:59:22 EDT

FDA Warns of Risk of Birth Defects With Chronic Diflucan Use

Wed, 03 Aug 2011 12:09:10 EDT

The FDA is warning the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. The FDA noted that the risk of birth defects does not appear to be associated with a single, low dose of Diflucan…

Medical Device Approval Process is Flawed

Tue, 02 Aug 2011 07:13:58 EDT

The Institute of Medicine (IOM) recently called into question the process by which many medical devices are approved through the FDA. The FDA asked the IOM to review their process for approving “moderate-risk devices” which can include anything from contacts to pacemakers.

Many Generics Considered Less Safe After 2011 Supreme Court Ruling

Wed, 27 Jul 2011 16:52:46 EDT

In a short time you will find you are saving money on your prescription medicine, but be aware that it comes at a risk – generic drug manufacturers no longer have to warn consumers of newly discovered dangers associated with their drugs....

Generics Could Save You Money - But, At What Cost?

Wed, 27 Jul 2011 10:44:58 EDT

Vaginal Mesh Injuries Continue to Mount

Tue, 26 Jul 2011 16:37:37 EDT

As reports of injuries relating to vaginal mesh continue to mount, we are learning more details about the types of injuries this product is causing, and the lessons are alarming...

F.D.A. Warns About Multaq Safety

Tue, 26 Jul 2011 15:04:40 EDT

The F.D.A. recently issued a warning for Multaq, which is a drug used to treat abnormal heart rhythms. The drug is used by people who suffer from atrial fibrillation that lasts less than six months. The drug was approved in 2009 and approximately 241,000 Americans have received prescriptions. Analysts previously estimated that Sanofi-Aventis would earn $1.35 billion in annual sales by 2014.

It now appears that Sanofi hit a snag in those estimates. Hoping to boost Multaq's prospects, Sanofi began a new trial last year, aiming to show that the drug can stave off cardiovascular episodes, such as stroke and heart attack, in patients with permanent atrial fibrilation. The study had to be halted after a monitoring committee found that people taking the drug experienced two-fold increases in death, stroke, and heart failure.

Multaq was already being probed for potential liver injuries and failures. The F.D.A. urged patients who had already taken Multaq to speak with their physicians.

New Regulations Issued, More Confusion Results in Mammogram Timing Advice

Tue, 26 Jul 2011 15:01:10 EDT

The American College of Obstetricians and Gynecologists made changes to its recommended timing for mammograms. Now, the group recommends that women at average risk for breast cancer should be offered a mammogram every year, starting at age 40. This is a change from the previous recommendation that women in their 40s get a test every two years, and women in their 50s get a test every year.

Other expert groups have encouraged women to look beyond their age when determining how often to have a mammogram. Other risk factors such as breast-tissue density, history of biopsy and family history of breast cancer should factor into a woman’s decision, the group says.

To throw other complications into the discussion, the U.S. Preventative Services Task Force advises average-risk women from 50 to 74 have a mammogram every other year. The American Cancer Society and the American College of Radiology recommend mammograms every year for women, starting at age 40.

The risks of false-positives followed by invasive follow-up tests sometimes deter physicians and expert groups from recommending annual exams at a younger age. There is hope for a more specific risk calculation in the future. An increase in digital mammography may change screening procedures for younger women in the future.

Reports of Vaginal Mesh Injuries Continue to Mount

Tue, 26 Jul 2011 09:17:53 EDT

As reports of injuries relating to vaginal mesh continue to mount, we are learning more details about the types of injuries this product is causing women.

VAGINAL MESH INJURIES

Once the mesh is implanted it can move around the body, and the frayed edges can cut through tissue and sometimes puncture nearby organs. Some women have become septic, suffering infections so bad that their entire torso turns a deep purple. These infections attack the body from the inside, and if not treated promptly can lead to death. At least 10 women have reportedly died as a result of a punctured bowel and resultant septic infection following a vaginal mesh surgery.

Other common injuries being reported due to vaginal mesh exposures:
•Prolapse recurrence
•Infection
•Erosion into vagina
•Dyspareunia (painful sexual intercourse)
•Internal bleeding
•Vaginal scarring
•Vaginal wall-narrowing
•Urinary Problems
•Punctured bladder
•Punctured uterus
•Chronic postoperative pain
•Incontinence

These injuries are caused by frayed edges of the mesh material and movement of the mesh within the body.

WHAT CAN BE DONE TO AVOID OR MINIMIZE A VAGINAL MESH INJURY?

First and foremost, alert your physician if you suffer any complications or symptoms that you think could be related to the placement of a mesh implant. We suggest you follow the advice of a qualified physician.

The failed mesh implants commonly require a removal surgery. Unfortunately, this is much easier said than done. In several instances, it is impossible to remove all of the mesh in a single surgery because the mesh fuses with body tissue and the doctor must then take the mesh out in pieces. In these cases, some or all of the mesh remains implanted for life even after multiple removal surgeries.

Vaginal Mesh Injuries Underreported to FDA

Thu, 21 Jul 2011 16:34:40 EDT

The number of complications related to transvaginal mesh, also referred to as a bladder sling, is staggering. There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA. Official reports of complications, made in the form of Adverse Event Reports (AERs), currently number in the thousands with at least 10 deaths being reported.

These reports are voluntarily made by physicians or patients who become aware of the complications by various means. Recent studies estimate that the actual rate of injury may be 1,000 times what is reported in the AER database. This rate of injury would not be surprising considering that more than 100,000 of these types of procedures are performed annually.

AERs are an important and helpful tool for the FDA. The FDA will use this in their post-approval surveillance. But it is important to remember that the FDA is a regulatory body, and a severely underfunded one at that. The manufacturers of these types of products are in the best position to know what is happening with their product. They have representatives that are in doctors offices daily and actually assist with surgery. It may surprise some to learn that these company representatives actually “scrub in” for surgery to help doctors with the placement of the mesh. It defies logic to think that these representatives, and in turn the manufacturer of the transvaginal mesh, did not know that so many women were getting hurt.

What the Reports of Vaginal Mesh Injuries Really Tell Us

Thu, 21 Jul 2011 12:23:38 EDT

The number of complications related to transvaginal mesh and bladder slings are staggering with the numbers expected to rise. Tor Hoerman blogs at the Injury Board about how Adverse Event Reports (AERs) are an important tool for the FDA, but, injuries resulting from medical devices are ultimately the responsibility of the device manufacturers.

FDA Updates Vaginal Mesh Warning

Tue, 19 Jul 2011 16:28:13 EDT

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue (specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). It is made from either porous synthetic material or biologic material.

In 2008, the FDA issued a Public Health Notification stating that the issues with the use of synthetic vaginal mesh was a growing concern. However, on July 13th, the FDA updated the previous Notice with an Alert stating that serious complications associated with surgical mesh for transvaginal POP repair are not rare. In fact there are now reports of thousands of complications from the mesh, with at least 10 deaths being reported.

The mesh product is implanted during surgery to repair POP and SUI. The synthetic mesh has edges that are in some cases piercing the surrounding tissue and puncturing the bladder, uterus, or bowel. The “patches” can also migrate doing irreparable damage as they move around. Women are also suffering horrible infections because of the mesh.

These types of mesh underwent virtually no safety review by the FDA or any other regulatory agency before being put on the market by manufacturers. Once the mesh is implanted it is very difficult to remove. Even after multiple surgeries doctors are sometimes unable to remove all of the mesh which by that point has become infused to the surrounding tissue.

The injuries that women are suffering from this mesh implant are severe and debilitating and could have been avoided if the proper information had been provided. There are other safer alternatives to synthetic mesh (biological mesh for example) that should be considered before the decision is made to use synthetic materials.

Train Crash Victims Undercompensated

Tue, 19 Jul 2011 14:55:57 EDT

Last week a judge allocated $200 million to 125 different victims of a commuter train crash. The train’s engineer failed to stop at a red light because he had been texting. The injuries these people suffered were tragic and horrendous. Twenty-five people were killed and many more were permanently injured. Attorneys for the victims requested between $320 and $350 million, which the judge agreed was a reasonable amount of money because of the nature of the accident. However, because of a federal damage cap of $200 million the judge was forced to make decisions that took rightful compensation away from victims.

The judge ruled that $4.2 million would go to the family of each adult killed and $1.2 million would be paid for each child who died. The judge said, "Impossible decisions had to be made. What was given to one victim had to be taken from another."
The highest amount of compensation was $9 million for an exchange student who was left brain damaged. It was estimated that she would need $18 million to cover future medical expenses alone.

U.S. Representative Elton Gallegly (R-CA), who represents the district where many of the victims resided, tried to pass legislation that would have increased the federal damage cap. However, he was unsuccessful in his efforts. Gallegly a self proclaimed backer of tort reform said he was just trying to right the wrongs.

The sad truth about tort reform is that often times it is passed without most of the public noticing. Rep. Gallegly supported tort reform until it personally affected him because he witnessed firsthand the pain these victims and their families will be forced to live with for the rest of their lives. Whether or not tort reform personally affects someone though should not be the reason for changing viewpoints. Tort reform will personally affect someone by robbing them of adequate compensation, and just because someone does not normally witness it firsthand does not mean it isn’t harming innocent people.

Electronic Health Records? There's an app for that!

Fri, 15 Jul 2011 13:19:49 EDT

About one out of five private practice physicians already have an iPad. Thenew iPad app DrChrono wants to put those iPads to use for patients. The new iPad application has numerous uses such as medical speech to text, paperless billing, customized clinical note forms, photos and videos, and an ePrescribing feature. Not only will this app allow patients to access their medical records anytime and anywhere, everything will be digital. No more trying to decipher your doctors’ handwriting!

Keeping a focus on security, DrChrono also hired a team of experts to make sure that the records are secure and HIPPA compliant.

The standard service is free, but prices increase with the amount of functionality the doctor requests. Taking advantage of technology such as DrChrono, will allow consumers to take control of their own medical records and treatment plans and make physicians more accessible to their patients.

Barbecue Safety Tips

Fri, 15 Jul 2011 10:28:03 EDT

FDA Consumer Updates issued a quick guide to summer barbeque safety to avoid creating or spreading illness to your friends and family. Although seemingly basic, these are tips worth remembering.
(1) Wash your hands
You haul all the coolers, grills, and charcoal out to the park, set up the picnic table, then reach in your basket to start passing out snacks. Did you wash your hands? If your picnic is outside and away from clean running water, make sure to pack hand sanitizer or disposable wipes.
(2) Keep marinated food cool
As your kids unpack your picnic basket you whip up your famous marinade and put in the chicken breasts to start the magic. Letting meat marinate in the warm air can encourage bacteria and other foodborne illnesses to develop on your legendary chicken. Instead, marinate the meat in the refrigerator, and then keep it cold until it hits the grill by keeping it in a cooler packed with ice. Keep all your cold food colder by putting the coolers in the car with the passengers where it is cooler, instead of the trunk!
(3) Separate the raw food
You smile as your children cooperatively unpack the coolers, until one of them pulls a package of steaks out, dripping the juices onto all the food left in the cooler. Instead, pack your raw meats in a separate cooler, making sure they are wrapped up tightly. And though you hate to waste that awesome marinade left in the ziploc bag, avoid the temptation - plan ahead and reserve a separate potion that hasn't touched raw meat. And don’t forget to bring enough utensils to use different tools to cook raw meat and serve the food.
(4) Cook thoroughly
Between kids, dogs, and Frisbees, its easy to loose track of cooking time. Pack a food thermometer to make sure your food is cooked thoroughly and all bacteria has been destroyed. If you’re in your backyard – partially microwave the food, then throw it on the hot grill to finish cooking.
(5) Keep all foods at the correct temperature
Hot food should be kept at 140 degrees or higher. Cold food should be kept at 40 degrees or below. Hot or cold perishable food should not sit out longer than one hour is the outdoor temperature is above 90 degrees. The food can be out for up to two hours if it is below 90 degrees outside.

Changes Coming to Tamiflu Dosage

Fri, 15 Jul 2011 09:37:00 EDT

This flu season, new lower dosage Tamiflu will be available. Amid concerns of medication errors and confusion about prescribing dosage, the FDA ordered the lower dosage recommendations in July. This lower dosage option will only be available in the oral suspension form of Tamiflu. The lower dosage will not be available in the capsule form. The concentration of Tamiflu is now 6 mg/mL, replacing the previous 12 mg/mL. The new 6mg/mL Tamiflu will also come with new dosing instructions based on the patient’s weight.

In the coming months, both concentrations of Tamiflu will be available, making dosage decisions even harder. Be an active consumer! Double check with your pharmacist to ensure you are receiving the proper dosage, and contact your health care provider if you have any questions or concerns about the change in dosage.

Can "Food Deserts" in America Be Prevented?

Wed, 13 Jul 2011 09:45:24 EDT

Recent studies point to a significant rise in obesity in most states in the U.S - Adult rates climbed across 16 states through the past year, with 12 states now having obesity rates above 30 per cent.

One reason for this is the availability of fast food especially in areas defined as "food deserts “Researchers found that so-called "food deserts," where there are few or no supermarkets and fast food is what's most available, tend to draw locals to the fast food. But, in areas where there are also supermarkets and grocery stores, food choices appear unrelated to healthy eating.

Low-income neighborhoods had the strongest association between the availability of fast food and how much of it was part of their diet, according to the study. Sadly, there was no strong association between living near a supermarket and eating more fruits or vegetables.

Based on this recent study and other sources, it is clear that more information is needed to get people to understand they have options to take command of their own health, even in low income neighborhoods.

The WIC Farmers’ Market Nutrition Program (FMNP) is associated with the Special Supplemental Nutrition Program for Women, Infants and Children, popularly known as WIC. The WIC Program provides supplemental foods, health care referrals and nutrition education at no cost to low-income pregnant, breastfeeding and non-breastfeeding post-partum women, and to infants and children up to 5 years of age, who are found to be at nutritional risk. A variety of fresh, nutritious, unprepared, locally grown fruits, vegetables and herbs may be purchased with FMNP coupons - a list of participating Farmers Markets by state can be found at this link.

One organization that we have found to be the most effective in helping our children to understand the effect food has on their health is What's on your plate project. This organization came out of a witty and provocative documentary - What's On Your Plate? - that follows two eleven-year-old multi-racial city kids as they explore their place in the food chain. It is well worth sitting your children down to watch.

Big Pharma Protections in the Crosshairs

Mon, 11 Jul 2011 08:05:23 EDT

As negotiations to raise revenue in coordination with the debt ceiling debacle continue, profit protections for Big Pharma keep coming to the forefront of the discussion. Giving Medicare negotiating authority to bring down costs of drugs for Medicare beneficiaries is part of the solution proposed by Democrats.

Chris Van Hollen, the top Democrat on the Budget Committee, explained the current situation. “The proposals that we’ve put on the table have to do with rebates for the pharmaceutical industry. The idea of giving Medicare negotiating authority and going to the same rebate policy that was in place in 2005, yeah, those are things that we’ve actually proposed.”

FDA Special Report Details Struggles of Imported Food Safety

Mon, 11 Jul 2011 07:44:28 EDT

In an action highly unusual for the FDA, the agency has released a new "special report" on what it is up against as it tries to get a handle on the safety of imported foods.

In the last seven years, imported foods have increased by 10 percent and are expected to continue the upward trend. Currently 10 to 15 percent of all food consumed by all U.S. households are imported and the FDA may not be able to keep up with the trends.

The FDA report, “Pathway to Global Product Safety and Quality" recognizes the ever increasing difficulty of identifying the source of all products and ensuring that all “players along the supply chain meet their safety and quality responsibilities.”

The Health and Human Services Inspector General’s office also released a study that blatantly reported that, “the FDA cannot ensure the safety of the Nation’s food supply.” In our increasingly globalized world it will become increasingly important to track our nation’s food supply to keep our population safe and healthy. Without FDA protections, we wonder how consumers will be able to make safe and informed choices.

Sex, Lies, and Pharmaceuticals; How Drug Companies Plan to Profit from Female Sexual Dysfunction. By Roy Moynihan and Dr. Barbara Mintzes

Tue, 05 Jul 2011 12:38:43 EDT

Using an investigative journalism style, Roy Moynihan and Dr. Barbara Mintzes expose the pharmaceutical industry’s ploys to create a new condition branded as female sexual dysfunction (FSD). Relying on questions such as, “has there been a period of several months or more when you lacked interest in having sex?” to determine if women are suffering from this disorder, pharmaceutical companies “created” a need for a drug to “cure” female sexual dysfunction, claiming that 43% of all women would benefit from its use.

The authors of the book criticize industry leaders for their lack of candor throughout the development of both the “condition” of FSD and the creation of a drug to treat the disorder. Educational sessions promoted as a way to inform doctors about the new options in treating FSD functioned much more like a promotional pitch from the pharmaceutical industry. Huge amounts of money were spent to entertain the doctors while they were being “educated” by the pharmaceutical companies about FSD. Doctors targeted by the pharmaceutical companies enjoyed ski trips, football and baseball games, casino outings, and Broadway-type shows all as part of the educational process to raise awareness about FSD.

In order to fight back against Big Pharma’s goal of pushing treatment options for FSD into the market, a group of doctors, nurses, academics, practitioners, and academics created the New View campaign. The New View campaign successfully fought against P&G’s proposed testosterone patch for women, proposed as treatment for FSD. The FDA determined that the proposed testosterone patch did not demonstrate long-term safety and found insufficient scientific data to support approval of the testosterone patch in the United States.

The authors conclude the book by calling on medical professionals to push back against the old ways of interacting with pharmaceutical companies. Through taking action such as rejecting gifts and entertainment from pharmaceutical companies, funding their own research, and promoting an overall goal of transparency between doctors and the pharmaceutical industry, doctors and advocates will be able to keep pharmaceutical companies more accountable to both the medical profession and patients.

Senator Grassley to Harvard Scientists - Show Me the Money

Tue, 05 Jul 2011 12:36:01 EDT

Joseph Biederman, Thomas Spencer, and Timothy Wilens, the three psychiatrists widely cited as pioneering the use of antipsychotic drugs in children, were recently the target of an investigation led by Iowa Republican Senator Charles Grassley. The investigation revealed the three psychiatrists received millions of dollars from pharmaceutical companies as they worked on research leading to a huge increase in the number of drugs prescribed to children diagnosed with bipolar disorder. Biederman’s work is credited with increasing pediatric bipolar disorder diagnoses by 40-fold. Unsurprisingly, the 40-fold increase in pediatric bipolar disorder diagnoses also created a large increase in prescription drugs designed to treat this disorder in children.

In response to Senator Grassley’s investigation, the Massachusetts General Hospital announced that “appropriate remedial actions” were being taken against the three psychiatrists. The three individuals are currently banned from participating in “industry-sponsored outside activities” for one year. After the year ban, the scientists will be subject to a “two-year period of close monitoring and a delay in consideration for promotion.”

The Physician Payment Sunshine Act, Grassley’s proposed legislation that would require organizations to report all cumulative payments over $100,000 to physicians to the government, is still moving forward. A violation of the proposed legislation would result in a fine between $10,000 and $100,000.

A New Study Now Links SSRIs to Autism in Children

Tue, 05 Jul 2011 08:15:02 EDT

A new study from the Archives of General Psychiatry points to a link between the use of selective serotonin reuptake inhibitors (SSRIs), the most widely prescribed antidepressants, and the occurrence of autism in unborn kids.

The SSRIs include such popular drugs as: Paxil, Prozac, Zoloft, Celexa, Effexor, Wellbutrin, Lexapro, and Symbyax.

For years now, we have been working with children and families suffering from terribly deforming and debilitating malformations. All of these injuries were avoidable, resulting from the expecting mother innocently taking one of these pills during pregnancy. Warnings should have been given. It angers and saddens us to learn that these same pills may also cause autism in the children. Unfortunately, we are not surprised by the study.

The science surrounding the injuries that these drugs cause to the unborn child has evolved over the years. First, we thought it was limited to lung and heart injuries. But now we know that injuries include: Club Foot, Cleft Lip and/or Cleft Palate, Spina bifida, Plagiocephaly, Omephalli- aocele, Tethered spinal cord, Craniosyostosis, Hypospadias, Heart Defects (including Atrial Septal Defects, Ventricular Septal Defects, Patent Ductus Arteriosus, Patent foraman ovale, Tetralogy of Fallot, Transposition of the Arteries & Bicuspid Aortic Valve), PPHN, Cerebal palsy, Resip-ratory distress, Pulmonary Stenosis, Chiari malformation, Anencephaly, Gastroschesis.

So, to now add autism to this ever growing list is not shocking. When will we stop allowing our children to be put at such risk?

As we have said before, we need to fight back against the efforts at corporate protectionism. We need to hold these companies responsible for the harm they are causing, and fight against those seeking methods to shield corporations from responsibility. There is no more perfect example of the type of innocent victim we need to protect than these innocent children that are being born with such terrible injuries.

No Hot Dogs for the 4th of July?

Mon, 04 Jul 2011 15:50:23 EDT

I've decided to finally read the studies that I've ignored for years - why is everyone so angry about the great American hot dog?

So, I start my research in my kitchen, with my kid's beloved Kosher Hot Dogs. I know its still a prepared food and I can't really locate the animal that a "hot dog" is derived from, but, it was always my understanding that a "kosher" food passed certain religious dietary laws removing certain impurities and the slaughter of the animal was approved by a rabbi.

Well, not so fast. While my early assumptions were true, Kosher hot dogs are no less processed than other hot dogs. The way the animal was raised, the food the animal ate, and how fatty the animal was are not factors taken into account for "kosher" purposes. In fact, salmonella has been found in kosher meats.

A recent blog in fooducate compared Hebrew National to Oscar Meyer (Kraft's top-selling processed meat brand) and didn't find a whole lot of differences. In fact, although Hebrew National started out as a kosher brand for Jewish people, it has been owned by Con-Agra for almost 20 years. And, the biggest kicker is that Hebrew National is able to charge 87 cents per hot dog as opposed to Oscar Meyer at 25 cents per hot dog.

Okay, so, no Kosher Hot Dogs - what am I going to tell my kids? No hot dogs?

Okay, so the biggest issue with hot dogs is something called nitrite additives. If you research nitrites/nitrates on the internet you will find petitions to ban it and all sorts of studies showing how nitrites are a risk factor for childhood cancer.

According to the Cancer Prevention Coalition at the Univeristy of Illinois at Chicago, there are four things you can do to decrease the risk of childhood cancer through hot dog consumption, and they are: Do not buy hot dogs containing nitrite - It is especially important that children and potential parents do not consume 12 or more of these hot dogs per month, request that your local supermarket have nitrite-free hot dogs available, contact your local school board to request nitrite free hot dogs in the cafeteria, and write to the FDA and express your concern that nitrite-hot dogs are not labeled for their cancer risk to children.

So, on my quest for the perfect hot dog, I have come full circle. Apparently Oscar Meyer produces an All Natural Uncured Beef Frank. Of course, there are more expensive options as well and Coleman's Natural Beef Hot Dogs is often ranked the tastiest, but, if you've spent as much money on hot dogs as I have over the years, maybe you too have some making up to do.

F.D.A. warns to avoid or lessen the use of some anemia drugs

Thu, 30 Jun 2011 12:30:30 EDT

The FDA recently warned doctors to only use Epogen, Aranesp, and Procrit for patients suffering from severe anemia. In the past, doctors have used these medicines to increase chemotherapy doses for those undergoing the treatment, or simply as a way to make patients feel better. The F.D.A. issued this warning after mounting evidence that these drugs may cause deadly strokes, heart problems, and actually increase the speed of cancer tumor growth.

For years, these drugs cost the Medicare program more than any other drug type - $60 billion since their introduction in 1989. These drugs have also made a lot of money for oncologists who receive a mark-up for these types of medication.

Dennis Cotter, president of Medical Technology and Practice Patterns questions the government’s spending on these types of drugs. “Sixty billion dollars have gone out the window on these drugs, and what do we have t show for it?”

Senators Durbin and Blumenthal Introduce Legislation Designed to Protect Consumers of Dietary Supplements

Thu, 30 Jun 2011 08:37:27 EDT

U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) today introduced legislation that would ensure that consumers have the information they need to distinguish between products that are safe and others that contain potentially dangerous ingredients which haven’t been approved by the Food and Drug Administration (FDA). The Dietary Supplement Labeling Act would improve the information available to consumers, and to curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the FDA.
Supplements vs. conventional foods with food additives: The FDA would be required to establish a clear definition of which products are food and should be regulated as such and which products are meant to be health aids and should be regulated as dietary supplements.
Enhanced FDA registration requirements: Companies will have to list the names of their products, the ingredients in those products, and provide a label to FDA as part of their registration submission.
Enhanced labeling requirements: FDA will require warning labels for certain products where the government decides there is risk of an adverse event, drug interactions (as with St. John’s Wort and antidepressants), or may be contraindicated for subpopulations like pregnant women. In addition, the precise weight or amount of the different dietary ingredients will have to be disclosed for products that are sold as proprietary blends, and product labels will have to include a batch number to help facilitate any possible recall.

DIabetes Cases Double to 347 MIllion

Mon, 27 Jun 2011 08:08:52 EDT

The number of adults with diabetes has doubled world-wide over the last three-decades to nearly 350 million and has increased nearly threefold in the U.S., according to the Wall Street Journal, a sign that the epidemic will impose an ever-greater cost burden on health systems.

While about 70% of the increase was attributed to population growth and aging, the balance was linked to changing diets, rising obesity and growing rates of physical inactivity.

Diabetes is a debilitating condition that can lead to kidney failure, blindness or amputation of limbs and it is hard to prevent or treat diabetes.

Diabetes is one of the largest health care costs in the U.S. and it appears to be growing. In the U.S., the total cost of diagnosed diabetes was estimated at $174 billion in 2007, according to the American Diabetes Association.

First Bladder Cancer - Now Blindness? More trouble for Actos.

Mon, 27 Jun 2011 07:45:37 EDT

People taking Actos, Takeda Pharmaceutical Co's best-selling diabetes treatment, have a 3 to 6 times increased risk of developing diabetic macular edema (DME), a condition in which the retina thickens and swells, according to a study of more than 100,000 people.

According to this study, patients at high-risk of sight-threatening DME should avoid this class of drugs which includes both Actos and Avandia.

Source: Bloomberg News

Women using epilepsy drugs have an increased risk of pregnancy and delivery complications.

Fri, 24 Jun 2011 15:27:43 EDT

The British Journal of Obstetrics and Gynaecology is reporting today that women using anti-epileptic drugs have an increased risk of pregnancy and delivery complications.

The drugs studied in this analysis included Lamictal (lamotrigine), Tegretol (carbamazepine) and Depacon and Depakote (valproate).

Source: Restaino Law Firm

TorHoerman Law proudly supports KidsAndCars.org

Thu, 23 Jun 2011 12:16:02 EDT

TorHoerman Law proudly supports KidsAndCars.org, a national nonprofit child safety organization dedicated to preventing injuries and death to children in or around motor vehicles. KidsAndCars.org has been pioneering a national prevention movement since 1996 by promoting the highest level of awareness among parents, caregivers, and the public at-large about the dangers inherent to children in or around motor vehicles.

As parents and safety advocates, the people at TorHoerman Law have committed to assisting KidsAndCars.org get out their message locally and nationally. We will use our blog and this discussion board to post the good work done by KidsAndCars.org.

Sadly, part of the work of a child safety advocate is to make the public aware of the sudden tragic events that occur so that we can work to prevent them in the future through policy change, regulations and survivor advocacy. To that end, we will also use this page to highlight these events with the goal of prevention in mind.

We hope you will join us in supporting KidsAndCars.org by liking them on Facebook, following them on twitter and reaching out to the media to get word out that we need to make vehicles safer for our children.

"Hot Coffee" - A look at how one lawsuit catapulted tort reform in the U.S.

Thu, 23 Jun 2011 08:50:45 EDT

Remember the McDonald's hot coffee case from February 1992? If you do, its likely you remember that Stella Liebeck, a 78 year-old Albuquerque woman, spilled hot coffee on herself and ended up with third-degree burns after purchasing coffee from McDonalds. Stella Liebeck sued McDonalds and the jury awarded her $2.7 million in punitive damages setting in motion the wheels of the mighty tort reform movement.

Although most people remember that case, and the late night comedians that spoofed it endlessly, most don't know that the trial judge decreased the damages to $480,000 and the award was eventually settled out of court for a confidential amount (presumably less).

Why do most people only know the first part of the lawsuit? Because the very powerful backers of "tort reform" (ie, the pharmaceutical industry and tobacco companies) ran with the image that this lawsuit evoked and didn't look back, even when they ended up spreading "half-truths."

And the result? The public believed the image of the out of control jury, the money grubbing lawyer taking on frivolous lawsuits and McDonalds -a company that was making $1.3 million per day in coffee sales and who was clearly at fault with regards to the burns but refused to pay for Ms. Liebeck's medical bills - got the marketing bonus of being able to play the role of the victim. Thus giving the tort reform movement huge momentum at a crucial time for them.

Now a filmmaker, Susan Saladoff, has created a documentary that looks at this case, and three other cases to tell the truth about "tort reform." We have not yet seen the movie, but, plan to host a few premieres to watch the movie and to discuss the implications of it. We urge all of you to take a couple of hours to watch it and we hope you will join in our discussions of tort reform.

Supreme Court makes it less safe for patients to take generic prescription drugs

Thu, 23 Jun 2011 08:09:26 EDT

Does it make sense that a manufacturer of prescription drugs does not have to warn consumers of dangers that they learn about their drug, WHEN THEY LEARN OF THEM? Should they be able to hide behind regulation and the FDA, or a legal term called preemption, or should they simply do what all of us would do, and let people know the minute we learn that somebody might be in danger. Better safe than sorry is a cliché for a reason, because it is the right way to act!

7 out of 10 prescriptions these days are generic. Billions of dollars of profit are made by the generic drug industry. In some instances dangers inherent in a drug are not learned until years after the drug has been on the market, and "gone generic".

Yet, today, our Supreme Court of the United States, through Justice Thomas, decided that victims will no longer be allowed to bring failure to warn claims for injuries suffered as a result of taking generic prescriptions. Instead, the Court would have these companies go thru the "regulatory process" which could take months and cost lives before they let the public know. To me it is like waiting for the fire department to show up to confirm there is a fire before evacuating a building. It is absurd.

The Supreme Court decision is based on a legal principal called preemption. We need not get into the strained legal principals that led to this "corporate protectionism" to understand the practical result. What the American people need to understand and should care about is that their generic drug makers do not have to warn us when they learn that one of their drugs that might cause injury to the people taking it.

Are your Pharmaceutical Records for Sale?

Thu, 23 Jun 2011 03:38:03 EDT

The Supreme Court of the United States gave the pharmaceutical industry a big victory when it held that the purchasing of your prescription drug information is protected under free speech.

Settlement Calls Into Question Relationship Between Military Doctors and Pharmaceutical Companies

Mon, 20 Jun 2011 14:48:35 EDT

The relationship between military physicians and pharmaceutical companies is coming under fire after the recent settlement between Novo Nordisk and the Justice Department. The Justice Department charged Novo Nordisk with illegally promoting their hemophilia drug, NovoSeven. The drug company was charged with promoting NovoSeven for unapproved uses such as blood trauma and intercranial hemorrhage. This type of off-label use is illegal and dangerous and has resulted in large settlements between pharmaceutical companies and the Justice Department.

Furthermore, Novo Nordisk is accused of making payments to influential military physicians and personnel to encourage the drug’s use in these unapproved situations. The drug company was accused of channeling the payment through nonprofits masking these payments as educational grants.

The Army surgeon general and commanding general United States Army Medical Command have re-opened their investigation of the medical research environment.

Phantom Pharmacies

Mon, 20 Jun 2011 14:43:02 EDT

Criminals are creating sham pharmacies in order to defraud Medicare, Medicaid or private insurance companies. Matching up stolen doctor ID numbers and patient insurance numbers, phantom pharmacies submit fake claims for reimbursement.

Shimon Richmond, a Department of Health and Human Services field agent said, “These scams are exploding. They’re a huge issue for the department.” Federal officials estimate that these scams have already cost taxpayers and insurers more than $60 billion a year. Fraud is a key factor contributing to rising health care costs.

The basic scheme is that a criminal writes a phony subscription for a medicare recipeint (or a privately insured individual) whose ID has been stolen then submits this for repayment. Medicare requires a two-week repayment. The criminals set up shop at an actual address for a short amount of time (generally less than 60 days) and collect a lot of taxpayer money very quickly. Since the crimes are done so quickly, regulators are having a hard time shutting them all down.

FDA Warns - Actos Linked to Increased Risk of Bladder Cancer

Thu, 16 Jun 2011 08:20:05 EDT

June 15, 2011 - The FDA has issued a new warning of increased bladder cancer risk associated with the use of the diabetes drug Actos (pioglitazone).

Prior to the FDA warning - several Eurpoean Markets, France and Germany, suspended the use of Actos, citing concerns over an increased risk of patients developing bladder cancer.

Takeda's Type2 Diabetes drug, Actos, grew in popularity after use of Avandia, GlaxoSmith Kline's controversial drug was severely restricted in the US because of concerns of an increased risk of heart attack and heart failure last fall. Takeda had profits from sales of Actos in the U.S of over $3 billion in 2009 and just under $3 billion in 2010.

Online Whistleblowing is a Risky Idea

Wed, 15 Jun 2011 14:21:25 EDT

Recently both Al Jazeera and the Wall Street Journal have launched their own versions of wikileaks. However, both have come under scrutiny from the Electronic Frontier Foundation and CNN for their legal disclaimers. The Wall Street Journal legal disclaimer reserves the right “to disclose any information about you to law enforcement authorities” without notice, and reserves the right to disclose information to any "requesting third party,” not only to comply with the law but also to “protect the property or rights of Dow Jones or any affiliated companies” or to "safeguard the interests of others.” Whistleblowing will always threaten the interests of others. The Wall Street Journal disclaimer gives them the right to disclose your personal information for basically any reason they determine, which might cause legal actions to be brought against you.

By uploading to the Wall Street Journal's site you represent that your actions "will not violate any law, or the rights of any person." As a whistleblower this is a very difficult affirmation to make, if not impossible. By its nature whistleblowing is exposing non-public information to the public. Whistleblowing will almost always violate a law or harm the interests of another because a whistleblower is informing the public of failures of another to do what is legal or moral. Even if the information is not stolen, releasing it will probably still violate the rights of another. In order to protect your interests the best way to go about whistleblowing is by obtaining an attorney. The information is more likely to be protected by the attorney client privilege and an attorney's ethical responsibilities, and you may be entitled to compensation for the information.

New FDA warnings about high doses of Zocor

Wed, 15 Jun 2011 13:52:33 EDT

Time Magazine reports the FDA restricted high dosage use of the cholesterol-lowering drug simvastatin (brand name Zocor produced by Merck) because of concerns over serious muscle issues. A similar problem was found in the drug Baycol, which was recalled in 2001. Some experts believe action should have been taken sooner to limit the dosage of Zocor. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation said, “Most knowledgeable lipid experts stopped administering the 80 mg dosage of simvastatin years ago. Unfortunately, once again the FDA has been slow to react to a serious drug safety problem. I’m glad the FDA acted but wish they hadn’t taken so long.”

Read the FDA's June 8, 2011 safety recommendation for dosage here.

Pfizer Fails to Report Adverse Events

Wed, 15 Jun 2011 13:41:11 EDT

Chantix, Pfizer’s drug to assist people in quitting smoking, has recently come under scrutiny again. Chantix has been linked to causing suicides and violent behavior. In 2009 the FDA decided that Chantix should have a black-box warning, which is the strongest possible warning, to inform the public that Chantix may lead to “suicidal thoughts or actions.” Recent studies have further connected Chantix with serious violence and aggressive thoughts. The drug has been banned for pilots and truck drivers who are on Chantix can’t get licensed. France recently decided that it would no longer cover the drug under its national insurance program. The Institute for Safe Medication Practices (ISMP) recently released a report that examined the FDA’s adverse event database and determined that violence was 18 times more likely to be associated with Chantix than the average drug. This time Pfizer isn’t under scrutiny because of the suicides or violence, but because they failed to inform the FDA of adverse events associated with Chantix.
The example is just another in a long line of examples of pharmaceutical companies putting profits ahead of consumer safety. Had Pfizer been up front about the adverse events the FDA may have been able to warn physicians and patients sooner. People can’t make informed decisions when the FDA is being misled. To Pfizer this was just 150 people that died and numerous others that had violent outbursts while they were making money. However, to the families and friends of those people this was something that could have and should have been prevented. Drug companies such as Pfizer make much of their money soon after drugs are approved by the FDA because they are the only ones that can sell them. For Chantix no generic can be made until 2018. These drug companies are incentivized to downplay risks or use questionable reporting methods to ensure the success of their drugs when they first come to market in order to recover the costs of getting a drug approved. Unfortunately the behavior of the drug companies is unlikely to change. We should expect the FDA to work to update regulations to protect consumers though.
The FDA is currently contemplating changing the reporting regulations to require suicides and other serious problems be reported on an expedited schedule, but this change was first proposed in 2003 and still has not been adopted.

Buying Academia

Wed, 15 Jun 2011 08:13:51 EDT

In 1981 FDA created standards for medical-journal ads, requiring the ads to only contain true statements relating to side effects, contraindications, and effectiveness. The ads were also required to contain a fair balance of statements about medication risks and benefits. Between 1997 and 2002, the FDA issued 88 letters to drug companies alleging violations of these restrictions.

Although the FDA has made clear restrictions on Big Pharma advertising in medical journals, these advertisements can provide between 97 and 99 percent of their advertising revenue. There are numerous accounts of controversial and critical articles being turned away by medical journals’ marketing department. Not only do some journals turn away critical articles, some such as Consultant, Geriatrics, and American Family Physician actually have more pages of advertising than articles.

John Abramson, MD, author of Overdosed America: The Broken Promise of American Medicine has called on U.S. medical journals to utilize more skepticism of experts who receive money from the producers of the products they write about. It is estimated that 95 percent of academic-medicine specialists who review patented treatments actually have a financial relationship with Big Pharma.

How do medical journals move away from Big Pharma control when their advertisements are such a large piece of their income? Dr. Abramson suggests journals require primary data for all articles they publish in order to view the article with an informed critical eye.

California Becomes First State to Regulate Diacetyl

Tue, 14 Jun 2011 17:05:35 EDT

In December, 2010, California became the first state in the nation to implement a standard for working with the chemical food additive, diacetyl. Diacetyl is a chemical that is used in many different food flavorings. Those flavorings in turn are used widely across the food production industry. When inhaled, the vapors from diacetyl can cause a sometimes fatal lung disease called bronchiolitis obliterans.

Hundreds of lawsuits across the United States have been filed against the companies that provide the diacetyl to flavor manufacturers and the manufacturers themselves alleging that these companies knew the harmful effects of diacetyl and concealed those effects from workers. Several of these workers have wound up on double-lung transplant lists as a result of their exposure to diacetyl.

The standard, General Industry Safety Orders §5197, would apply to all flavor and food manufacturing facilities that use diacetyl and flavorings that contain 1% or greater concentration of the chemical.

The standard also calls for quality control measures, ventilation standards, require proper personal ventilators be worn by workers. Also, the standard calls for mandatory reporting requirements by companies to state authorities if one of their employees gets sick.

California continues to lead the states and the federal government on this issue. The federal government has consistently declined to regulate diacetyl and the FDA will not change its current GRAS ("generally recognized as safe") designation. California should be commended for its actions regarding diacetyl.

Illinois - Leading the Way in Education Reform

Tue, 14 Jun 2011 16:38:32 EDT

As parents of children currently enrolled in the Illinois Public School System, PTO officers and products of the Illinois Public School system ourselves, we were anxiously awaiting the outcome of negotiations for our very own education reform bill on the heels of the drama experienced by our neighbors in Wisconsin and Ohio.

Nothing could make us more proud than to see Governor Pat Quinn and the Illinois legislature collaborate with the teachers unions and reform groups to draft the most important piece of education reform ever passed in our state. This reform made major changes to our current education system in that teachers can now be dismissed for poor performance, there were major changes made to how teachers earn tenure, how layoff decisions are made, and what is necessary for teachers to strike.

Even though this bill has made some drastic changes, there was no drama. In fact, Jonah Edelman, CEO of Stand for Children, a grassroots public-education advocacy organization stated that this reform bill was "an example of collaboration rather than polarization."

U.S. Secretary of Education Arne Duncan echoed that sentiment when he said "while some states are engaging in noisy and unproductive battles around education reform, Illinois is showing what can happen when adults work through their differences together. This is an example that I hope states across the country will follow."

We are hopeful that the impact of this reform bill will guarantee that our children are taught by the most qualified and effective teachers in the state and we are proud to be an example of what can happen when politics are set aside for the good of our state, and most especially the good of our children.

Tribute to the Greatest Generation

Fri, 10 Jun 2011 10:09:39 EDT

Word came from home that my 98-year young great Aunt Gert was nearing the end of her amazing life. There is no way to describe Gertrude Killgallon Crowley – ex-nun, Marine, teacher, blogger, democrat – in a paragraph (or even a book for that matter), except to say that an entire family rushed to her bedside in Oak Park, IL to partake in a living wake for quite possibly the most incredible woman I will ever have the honor of knowing.

So, on June 7, 2011, it was with a heavy heart that we arrived at Midway Airport in Chicago en route to pay our respects to one of our own personal heros.

To our surprise, we arrived to a heros welcome of a completely different kind that makes us question kharma - how Gert would have loved to see this. And, as of today, I am happy to report that she still can.

Pfizer stops selling an arsenic-containing drug to promote chicken growth

Thu, 09 Jun 2011 16:24:21 EDT

After trace amount of arsenic were found in chickens, Pfizer suspended its sale of the drug. 3-Nitro, also known as roxarsone, is intended to kill intestinal parasites and promote the chickens’ growth. Although the drug is make with organic arsenic, there is building evidence that organic arsenic can turn into inorganic arsenic. Inorganic arsenic is cancer-causing and action on this drug is long overdue.” Pfizer will not restart the sale of 3-Nitro under the FDA has resolved the issues.

Read the rest of this NYTimes article here

New FDA Warnings about high doses of Zocor

Thu, 09 Jun 2011 16:16:38 EDT

Concerns about a side effect of muscle problems, the FDA restricted high dosage use of the cholesterol-lowering drug simvastatin (brand name Zocor produced by Merck). A similar problem was found in the drug Baycol, which was recalled in 2001. Some experts believe action should have been taken sooner to limit the dosage of Zocor. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation said, “Most knowledgeable lipid experts stopped administering the 80 mg dosage of simvastatin years ago. Unfortunately, once again the FDA has been slow to react to a serious drug safety problem. I’m glad the FDA acted but wish they hadn’t taken so long.”

To read more click here.

Are you taking too many meds?

Thu, 02 Jun 2011 13:00:05 EDT

The case of Alesandra Rain is one too often repeated as a result of over medication and a lack of communication between specialists. She was prescribed sleeping pills, heart medication, and various anti-seizure medications. Eventually she was spending more than $900 a month, and taking 12 different types of medications. Alesandra is not unlike many Americans who have been victims of targeted marketing efforts that lead them to believe that there is a pill to cure just about anything that ails them.

Michael Wincor, an associate professor of clinical pharmacy, psychiatry and the behavior sciences at the University of Southern California says, “When you’re on more than 20 drugs all at the same time, you’d want to question whether or not that’s really necessary.” Wincor encourages individuals to take responsibility in tracking their prescriptions by keeping a list of all current prescriptions and making any physician aware of the list before beginning a new medication. In addition, he encourages patients to get more information about a drug through websites like Medications.com and Askapatient.com before beginning a new treatment regimen.

Alesandra’s story does have a happy ending. After enrolling in a drug rehab facility that helps victims of substance abuse, Alesandra was able to diminish the impact that pharmaceutical drugs had on her daily life and she now takes no drugs. In addition, Alesandra is now an advocate for others that find themselves in a similar situation – she runs a company called Point of Return which educates individuals about the effects of prescription drugs and helps people slowly quit taking highly addictive varieties of prescription drugs.

North Carolina House Approves BIll Shielding Pharma Companies from Liability

Wed, 01 Jun 2011 13:55:25 EDT

On Wednesday the North Carolina house voted to protect pharmaceutical companies from product liability for FDA approved drugs. The vote is part of a Republican plan to limit liability for North Carolina businesses. Now the only way a drug company will be held liable for their FDA approved defective products is if a judge or a jurys convinced that the drug was not safe and effective despite FDA approval. Attorney General Roy Cooper is worried about the future implications of this bill. "We continue to be concerned that this law could be a loss for taxpayers and consumers. It's difficult to understand why the legislature would make it harder for North Carolina to take action against drug companies that hurt patients or deceive the government, especially when other states don't have these obstacles," Cooper said in a statement after the vote.

FDA Warns Not to Feed Simply Thick to Premature Infants

Fri, 20 May 2011 13:27:57 EDT

The FDA warns parents, caregivers and health care providers not to feed premature infants SimplyThick to infants born before 37 weeks gestation because it may case a life-threatening condition.

SimplyThick is a brand of thickening agent – available to consumers and medical centers – to help manage swallowing difficulties.It is often added to breast milk and infant formula to help premature babies swallow their food and keep it down, without spitting up. The product can be purchased from distributors and local pharmacies throughout the United States.

This warning comes after reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies. To date, the FDA is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with either breast milk or infant formula products.

The FDA will continue to investigate the link between SimplyThick and the illness and deaths.

Brazilian Blowout under Fire by Congress

Thu, 19 May 2011 05:08:33 EDT

We would like to applaud the efforts this week of several members of Congress, led by Jan Schakowsky, who have written a letter to the FDA asking them to suspend the sale of the popular hair product - Brazilian Blowout. Despite the manufacturers claims to the contrary, studies have shown that Brazilian Blowout contains unhealthy levels of formaldehyde. The members of Congress will also propose legislation to strengthen the ability of the FDA to regulate what goes into cosmetic products.

Regulation seems to have taken on a negative meaning these days. But it is proper and responsible regulation that can help keep us safe, and in this instance prevent many fine people in the hair care industry from developing cancer or other respiratory disease as a result of their exposure to a known carcinogen, formaldehyde.

The cosmetics industry is virtually unregulated, and as representative Schakowsky points out, the story of Brazilian Blowout is a great example of why this has to end.

We all have the right to know what we are exposing ourselves to, and at what levels. Unfortunately, for the past several years, while Brazilian Blowout has become such a popular hair treatment, and the makers and distributors have been making money, the workers that are providing the treatment are getting sick. Not only should the rules be changed, but also the manufacturers should be held responsible for the injuries they have caused.

Lazy Cakes, Kush Cakes, and Lulla Pies - Wake up, Congress, this isn't Willie Wonka's World...

Wed, 18 May 2011 08:40:33 EDT

Melatonin-filled brownies such as Lazy Cakes, Kush Cakes and Lulla Pies have come to the attention of Congress and have prompted Senator Dick Durbin (D-IL) to write to the FDA that, because these cakes are marketed as dietary supplements, they do not require approval by the FDA for use as additives in food. Durbin asked the FDA to clarify its authority to regulate foods that contain additives, such as baked goods that contain high doses of melatonin.

Melatonin is a hormone produced naturally by the body. Standard doses in the Unites States (where it is available over the counter) and in Europe (where a prescription is typically required) range from 0.3 mg to 3 mg.

These brownies contain nearly 8 milligrams of the supplemental sleep aid, so one piece has significantly more than the usual amount prescribed for adults—and who has only one brownie?

Under proper labeling, these cakes may be appropriate for adults, and it would be their own choice to eat them. However, the fact is that a non-descript brownie is likely to fall into the hands of people that could be harmed by the high dosage of melatonin such as children and pregnant women.

Group of Parents and Lawyers Urge Congress to review the Vaccine Injury Compensation Program

Tue, 10 May 2011 12:08:27 EDT

Today, several remarkable families spoke out about their personal struggles starting with the vaccination of their healthy infants and following them through the administrative forum created by Congress meant to compensate them as they struggle to care for their autistic children.
These families all reiterate that they are not against immunization as a public policy, but, want to make sure that the public is made aware of the risks of immunization and that Congress takes action to investigate the Vaccine Injury Compensation Program (VICP), which they state, is not meeting its stated goals.
Congress created VICP as part of its 1986 National Childhood Vaccine Injury Act. Congress passed this legislation to achieve several objectives: (1) To create the infrastructure for a national immunization program; (2) to insulate industry and the medical profession from liability; (3) to establish a program to compensate the injured; and (4) to promote safer vaccines.
At the press conference today, it was stated that the only goal that has been achieved was the insulation of the pharmaceutical industry from liability – as all victims are compensated through the Vaccine Injury Trust Fund which is funded through an excise tax of $.75 imposed on the sale of every vaccine. The victims of these injuries are capped in their damages, if they are compensated at all (of the 13,755 claims filed to date, 2,621 awards have been paid). There is no later review of the cases, and it is very hard to anticipate the changing needs of a child that will live needing a life-time of care.

Persistent Pulmonary Hypertension (PPHN) and SSRIs

Sun, 08 May 2011 09:04:43 EDT

Persistent pulmonary hypertension (PPHN) is a serious and life-threatening lung condition that occurs soon after the birth of a newborn. Infants born to mothers who took selective serotonin inhibitors (SSRIs) after the 20th week of pregnancy are 6 times more likely to have PPHN, according to a February 2006 study in the New England Journal of Medicine.

What happens to a newborn with PPHN?

Newborn babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. Babies that have PPHN often need intensive medical care, and the condition can lead to marked developmental delays and can also be fatal.

What is the risk?

About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth. However, in the case of a mother’s use of SSRI after the 20th week of pregnancy, this percentage increases 6 times.

Brazilian Blowout Gets Hazard Alert by OSHA

Wed, 13 Apr 2011 12:02:01 EDT

The Occupational Safety and Health Administration (OSHA) has issued a Hazard Alert for anyone using or working with Brazilian Blowout hair straightening products.

Read the Huffington Post Article here.

Read the OSHA Alert here.

Mixed Results for Roche Accutane Case

Sat, 09 Apr 2011 11:06:50 EDT

After hearing evidence for more than six weeks, a seven-member jury awarded $2 million in damages to one Accutane plaintiff, but, two other plaintiff's in Greenblatt v. Hoffman-La Roche, including actor James Marshall, received nothing.

The jury verdict is consisten with the results in all prior Accutane trials: Every jury considering the issue has concluded that Accutane can cause IBD and that Roche's warning was inadequate.

Read the entire story here.

Join an Ulcerative Colitis Support Group

Sat, 02 Apr 2011 09:24:36 EDT

Ulcerative colitis can be a challenge to live with — both physically and emotionally. Colitis symptoms such as diarrhea, gas, abdominal cramps, and an urgent need to have a bowel movement can cause a mix of feelings, including anxiety, fear, frustration, anger, and depression. Everyday Health offers a list of support groups that may help deal with these feelings.

Excercising with Ulcerative Colitis

Sat, 02 Apr 2011 09:21:31 EDT

If you are living with ulcerative colitis, regular exercise can help you stay healthy, as well as reduce stress, which helps you better cope when colitis flares occur. However, you may have to modify your exercise routine when symptoms like diarrhea and abdominal cramps are active.

Bayer announces study which clarifies the increased risk of blood clots when using the Pill

Thu, 31 Mar 2011 09:46:44 EDT

Bayer announces the results of a large study which warns women about the increased of blood clots when using combination oral contraceptives like Yaz, Yasmin and Ocella. The two higher risk time frames are:

1.) During the first year of use, with the largest risk of blood clot occurring in the first six months.
2.) Increase risk when the Pill is restarted after a four week or greater break.

Read the PR Newswire report on this study here.

Johnson & Johnson's Quality Catastrophe

Thu, 31 Mar 2011 09:40:23 EDT

In December 2010, Johnson & Johnson was ordered to pay $1.1 million in punitive damages and $700,000 in compensatory damages to an 82-year-old man who suffered injuries as a result of the antibiotic Levaquin. The man suffered tendon damage after Johnson & Johnson failed to properly warn of the risk of this injury. There are currentlymore than 2,600 claims nationwide involving Levaquin. In the last year, Johnson & Johnson was involved in at least 11 major recalls, making the Levaquin verdict just another failure for the once trusted company.

Can Mom's Medicine Hurt the Baby?

Tue, 29 Mar 2011 11:19:54 EDT

The list of medications that women shouldn't take in pregnancy keeps getting longer. Earlier this month, the Food and Drug Administration strengthened warnings that expectant mothers who take topiramate (brand name Topamax), for migraines or to control seizures, have an increased risk of giving birth to babies with cleft lips or cleft palates.

...But determining what the impact might be for tens of thousands of medications is a Herculean task. The labels on most medicines have little or no information on how they might affect the mother or the fetus, other than advising to check with her doctor. Physicians are often baffled too, since conclusive data on safety in pregnancy don't exist for the majority of prescription medications.

Read the entire Wall Street Journal article here.

A Few Good Men in Hollywood stand up against Accutane

Fri, 25 Mar 2011 07:38:02 EDT

The premature end of James Marshall’s career, blamed by the actor and musician on Roche Holding AG’s Accutane acne drug, was an “unbelievable tragedy,” former co-star Brian Dennehy said in court.

Dennehy testified on March 10th that “It amazes me that something like this could have happened and could have had such a long-range effect on a career that should have topped.” Denney got to know Marshall during Marshall’s portrayal as U.S. Marine Louden Downey in the 1992 movie “A Few Good Men.”
During a videotaped deposition, Rob Reiner offered that Marshall’s career prospects were “limitless” after co-starring in “A Few Good Men.” Reiner told the jurors that the actor “was incredibly gifted…He jumps off the screen and it’s rare. I thought, you know, here’s another James Dean. He blew me away.”
Following Dennehy and Reiner, Martin Sheen described the “extraordinary” talent of fellow actor James Marshall whom Sheen had known since birth. Sheen said that Marshall changed when his ulcerative colitis followed his movie successes. “There was a very dramatic change in his physicality,” Sheen said. “He was extremely thin. There was a marked difference in his personality. He was not as gregarious or fun-loving or as social as I remembered him. He was withdrawn in a lot of ways.”
After the colon surgery, Sheen said, Marshall “looked very wan, very think and kind of wasted.”
James Marshall seeks at least $11 million in damages from Roche for what he describes as being a “prisoner in my home” since he as to go to the bathroom 20 times some days and can no longer work as an actor.
Roche is expected to begin presenting evidence soon.

Combo-pilling with Topamax

Mon, 28 Feb 2011 11:24:06 EST

Topamax, the drug known to cause severe birth defects, is rising in popularity as ½ of an unapproved drug pairing to help woman lose weight. Topamax is FDA approved to treat migraines and epilepsy, not weight loss. Without FDA approval and tracking of injuries, resulting harm from off-label drug pairings goes undetected. As a result of the pill cocktail containing Topamax patients reported an inability to organize their thoughts or grasp ideas. While some doctors are unconcerned about the future risks of combo-pilling, many experts in obesity-drug research are calling for physicians to stop using Topamax for weight loss.

Plaintiffs describe the severe pain they feel after using Accutane in New Jersey Court room

Tue, 22 Feb 2011 10:11:35 EST

During opening statements, the attorney representing James Marshall, a 44 year old actor best known for his part as U.S. Marine Louden Downey in the 1992 hit movie "A Few Good Men" and two other California residents (Kelley Andrews, a 29 year old account manager and Gillian Gaghan, a 34 year old nursing assistant), described the injuries that caused the plaintiffs to bring lawsuits against Roche Holding as a result of its failure to warn the public about the severe side effects from using Accutane, the second-biggest selling drug.

All three plaintiffs contend that the drug left them struggling to deal with their bodily wastes.
Both Andrews and Marshall battle incontinence while Gaghan has "developed lupus-like symptoms" as a result of taking drugs to deal with her Accutane-linked bowel disease.
Andrews, who took Accutane over a two years starting in 1997, has endured dozens of hospitalizations and surgeries, including the removal of part of her colon and small intestine.
Gaghan, who took the drug for five months in 1998, has daily pain from the resulting inflammatory bowel disease.

Ulcerative Colitis, Crohn's disease and inflammatory bowel disease affects people physically and mentally. TorHoerman Law wishes these three plaintiffs the best and we will keep you apprised of their legal battle as it moves forward in the NJ courts.

OSHA revises National Emphasis Program to focus on protecting workers from exposure to diacetyl and diacetyl substitutes.

Mon, 24 Jan 2011 11:01:09 EST

OSHA revised its National Emphasis Program (NEP) on Microwave Popcorn Processing Plants. The purpose of this revised NEP is to minimize or eliminate worker exposure to the hazards associated with microwave popcorn manufacturing. Specifically, this Direction revises the previous Microwave Popcorn initiative by OSHA to reduce or eliminate exposure to other related diacetyl substitutes.

"It is alarming that workers continue to be at risk of dying from exposure to diacetyl and diacetyl substitutes," said Assistant Secretary of Labor for OSHA, Dr. David Michaels . "Illnesses and death from these chemicals are preventable and this revised directive will help ensure that employers use necessary measures to protect workers from this hazard."

Read the entire OSHA Direction by linking here.

Mesh Devices May Be Reclassified as "High Risk" by FDA

Wed, 05 Jan 2011 11:35:16 EST

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue - specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI). It is made from either porous synthetic material or biologic material.

In September the FDA advisory panel heard from several patients describing life-altering complications from their vaginal mesh surgery. Although the FDA stopped short of pulling vaginal mesh from the market, despite pressure from consumer groups, it now appears that the FDA will make it more difficult for the manufacturers to sell these devices in the future.

According to a post at the FDA.gov website yesterday, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of POP be reclassified from Class II to Class III. Class III devices are considered high risk and would require the devices to get premarket approval with the FDA as well as require the manufacturers to prove the safety and effectiveness of the products on an ongoing basis.

In addition, the FDA will continue to assess the safety and effectiveness of the surgical mesh devices through review of adverse event reports submitted to the agency.

Eric Terry selected for inclusion on the 2011 Illinois Rising Stars list

Mon, 03 Jan 2011 12:54:38 EST

We are very proud to announce that Eric Terry has been selected for inclusion in Super Lawyer's 2011 Illinois Rising Stars list, an honor given to the top 2.5% of lawyers under 40 in Illinois.

The Super Lawyer selection process is a comprehensive, good-faith and detailed attempt to produce a list of lawyers that have attained high peer recognition, meet ethical standards, and have demonstrated some degree of achievement in their field.

Eric is proud to challenge large pharmaceutical corporations when he believes they have acted irresponsibly and put profits ahead of public safety. He has spend the past 7 years representing injured victims all over the country against the massive pharmaceutical industry. Prior to his role as an attorney, Eric spent a decade as a probation officer in Madison County, but, his proudest role is as father of three great kids - Jordan, Anthony and Maggie, who always felt their Dad was a "rising star".

Congratulations Eric, you make all of us at TorHoerman Law proud!!!

Combo-Pilling with Topamax

Sat, 01 Jan 2011 17:00:00 EST

Read the More Magazine Article titled "Are Two Drugs Better than One?" here

CA Attorney General Targets Brazilian Blowout Over Chemical

Wed, 10 Nov 2010 12:07:10 EST

The CA attorney general's office filed a lawsuit today alleging that the company that makes the Brazilian Blowout hair-straightening product failed to warn consumers that its solution contains a cancer-causing chemical, despite company claims that it is "formaldehyde-free."

Tests by Oregon authorities have consistently shown that the solution is made of about eight percent formaldehyde, a level that is hundreds of times higher than accepted amounts.

Oregon OSHA also issued a safety alert for salon owners and customers who use the product. Authorities in Canada also went farther, calling for salon workers to stop using the product.

The attorney general’s case also seeks to force the company to stop selling the product until adequate warnings are applied and the database report is filed. It was filed today in Alameda Superior Court and is embedded below.

Read the CA report here.

Worker Alert!

Mon, 01 Nov 2010 10:54:47 EDT

OSHA issues an alert to workers who breathe diacetyl on the job. Diacetyl is a chemical used to add flavor and aroma to food and other products. Workers who breathe diacetyl on the job have become disabled or have died from severe lung disease.

Find the Worker Alert Here.

OSHA warns that even though a flavoring is considered safe to eat, it does not mean that the flavoring is safe to breathe or handle in occupational settings.

Thu, 14 Oct 2010 11:15:00 EDT

According to OSHA, it is important to understand that although a flavoring is considered safe to eat, it does not mean that the flavoring is also safe to breathe or handle in occupational settings.

The occurrence of severe lung disease amongst workers in workplaces where diacetyl is manufactured and used has led some manufacturers to reduce or eliminate the amount of diacetyl in some kinds of flavorings, foods, and beverages. However, there is growing concern that these diacetyl substitutes also pose health risks for workers and certain combinations of chemical may actually increase the harm.

The principal types of flavorings that use diacetyl are: dairy flavors, brown flavors, some fruit flavors, vanilla, and tea.

OSHA’s Safety and Health Information Bulletin can be found here.

Covidien supports FDA labeling changes for gadolinium-based contrast agents for kidney disease.

Mon, 13 Sep 2010 09:49:15 EDT

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

Wyeth's Ghost in the Medical Machine

Sun, 12 Sep 2010 09:14:57 EDT

A study of documents unsealed in litigation against the pharmaceutical company Wyeth (WYE) show the drug giant paid ghostwriters to insert marketing messages into articles in medical journals, according to researchers at Georgetown University Medical Center in a study published in PLoS Medicine.

“Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” the study says.

Federal Agencies Knew of Diacetyl Dangers and Kept Silent

Sat, 11 Sep 2010 09:21:56 EDT

Federal regulatory agencies have known for years the dangers that diacetyl exposure creates among workers in factories where bags of microwave popcorn are tested. The only agency to have taken any action, the U.S. Environmental Protection Agency (EPA), has kept its study of the chemical's impact on consumers secret except for sharing it with popcorn industry. Now the first case of potential consumer illness from exposure to diacetyl has been documented.

Discovery Rule Exception in Hormone Replacement Cases Ruled A Jury Question

Wed, 01 Sep 2010 07:40:27 EDT

In a decisions that restores 1,000 hormone replacement therapy mass tort cases to the Philadelphia Common Please Court's caseload, the state Superior Court said it is a question of fact, not a question of law, whether the plaintiffs could have known at the time of their diagnoses with breast cancer that the alleged cause of their cancer was their HRT prescriptions.

Roche, FDA Knew About Accutane Side Effects Before Approval

Mon, 23 Aug 2010 09:04:36 EDT

A New Jersey Court of Appeals recently overturned the ruling in the Accutane lawsuit of a woman who suffered from serious gastrointestinal problems as a result of taking the severe acne medication.

While the woman's case awaits retrial, a startling new fact was released during her trial that has put Accutane makers Hoffman-LaRoche in an even hotter seat. A Roche executive admitted that the company was aware of the Accutane side effects as early as 1978.

Despite studies that showed the drug's tendency to cause gastorintestinal disorders in more than 20% of patients treated with Accutane, the U.S. Food and Drug Administration approved the drug for prescription and use in treating severe nodular acne in 1982.

Illinois Worker Wins $30 million verdict in diacetyl popcorn chemical lawsuit

Mon, 16 Aug 2010 07:53:51 EDT

A jury in Chicago has awarded a $30.4 million verdict to a chemical-flavoring plant worker disabled by exposure to diacetyl, an ingredient in butter flavoring used at a Jasper popcorn plant where several workers claimed similar injury. See the entire story here.

FDA Panel Opposes Plan to Tighten Use of Painkillers

Fri, 23 Jul 2010 07:36:49 EDT

An advisory committee for the Food and Drug Administration voted overwhelmingly on Friday to reject a plan proposed by the agency to reduce the misuse and abuse of long-acting painkillers like the drug OxyContin. Read the rest of the story here.

GE's Own Safety Team Urged Company to Restrict MRI Drug

Thu, 15 Apr 2010 14:45:49 EDT

April 2, 2010 - Cook County Circuit Judge Dooling grants an order allowing for punitive damages against GE based on the evidence she reviewed with regards to Robbie Booker v. GE, one of the approximate 500 lawsuits filed by NSF patients against GE. Read the court order here.

New Jersey Superior Court links Roche's Accutane to IBD

Fri, 19 Feb 2010 09:28:56 EST

In another major courtroom verdict linking powerful acne medication Accutane with long-term inflammatory bowel disease (IBD), a nine-person New Jersey jury has found that pharmaceutical maker Hoffman-La Roche Inc. failed to provide an adequate warning of the possible condition to Andrew McCarrell's prescribing physician, which then led to his development of chronic IBD. Mr. McCarrell, who was 23 at the time he took Accutane, developed a severe case of IBD and thereafter had his colon removed. The jury awarded compensatory damages of $25.16 million to Andy, now in his thirties.

TorHoerman Law meets monetary goal for Oasis Women's Center

Wed, 16 Dec 2009 11:48:22 EST

The employee's of TorHoerman Law proudly raised in excess of $1,000 and specifically needed items for the women and children of Oasis Women's Center in Alton, IL. during the busy holiday season. The donation committee will proudly deliver these items on Monday, December 21st to Oasis. After visiting the center, it became clear that there was a large need for basic necessities to help the victims of domestic violence.

Oasis Women's Center is open to private donations and can be reached at (618) 465-1978. TorHoerman Law's donation committee will proudly continue to support the Oasis Women's Center throughout the coming year.

Just When You Thought It Was Safe to Make Popcorn

Thu, 10 Dec 2009 11:43:41 EST

Although most popcorn makers claim to have removed Diacetyl from their microwave popcorn, it now appears that the "new, safer, butter substitutes" used in popcorn and other foods are, in some cases, at least as toxic as what they replaced.

"We've been very clear to flavor manufacturers, food companies and regulators that these so-called substitutes are diacetyl. When diacetyl trimmer is in the presence of heat and water, it will release diacetyl. And butter starter distillate is not a substitute for diacetyl because it contains high concentrations of diacetyl. However, it is considered a natural material, which is a boon to companies that wish market their food items with the "natural" label," said John Hallagan, general counsel for the Flavor and Extract Manufacturers Association.

Doctors and advocates for popcorn lung victims are worried that an unknown number of popcorn lovers may be going undiagnosed because doctors think the problem has been solved.

"Allegedly all of the companies have taken diacetyl out of their popcorn, but that doesn't seem to be the case."

Read the entire story here.

Double Trouble for Pfizer

Tue, 24 Nov 2009 21:16:33 EST

Two juries award more than $103 million to punish Pfizer unit, Wyeth

Connie Barton and Donna Kendall both have something in common: they stood up to  one of the largest and most powerful drug companies in court – and won. Today, in  Philadelphia, PA, these two verdicts against Wyeth (a division of Pfizer) over its hormone therapy drugs (Premarin and Prempro) were released. In each case, the jury awarded these women significant compensatory and punitive damages ranging from more than $34 million to  $78 million. And this is just the tip of the iceberg as Wyeth faces lawsuits from more than 10,000 additional women who also claim that Wyeth’s drugs gave them breast cancer. A third punitive verdict that was awarded in 2007 in the Daniel v. Wyeth case was scheduled to be released today as well. However, Wyeth was granted emergency relief this morning to keep  the third verdict sealed.  

The evidence at these trials showed Wyeth’s unrelenting campaign to make billions of  dollars in profit from these drugs while keeping the truth about the drugs’ dangers secret. President of the Constitutional Law Center explains that this ruling  shows that “Wyeth’s behavior outraged these judges.”  As Michael Richmond, a jury foreperson in a Prempro trial, explains: “Wyeth had no  concern whatsoever for the health of the patients. They were only concerned about their  profits.” These verdicts – with significant punitive awards ‐ confirm the anger of a community  when the truth is learned.  

The Spectre Haunting GE

Thu, 15 Oct 2009 19:50:22 EDT

Omniscan and comparable products contain the potentially toxic metal gadolinium. During MRIs, the metal helps physicians see the brain and other parts of the body. Healthy kidneys filter out gadolinium. But patients with severely impaired kidneys can become victims of NSF, according to the FDA.

NSF starts with painful swelling in the legs and arms. It progresses to lesions in the skin and connective tissues, and it can attack organs, causing death. So far, there is no cure.

Read the entire Business Week article here.

How Three University Medical Centers Handled GE's Omniscan

Wed, 14 Oct 2009 19:57:38 EDT

In 2006, Danish medical authorities began receiving reports that patients with serious kidney problems who underwent a magnetic resonance scan using Omniscan, an injected drug produced by GE Healthcare, had developed a rare, crippling and potentially fatal disease. GE Healthcare disputes that Omniscan causes the disease, nephrogenic systemic fibrosis, or is more dangerous than similar drugs used to obtain vivid MR images. While the company argued against special restrictions on its drug with U.S. regulators, doctors at three prominent U.S. medical centers moved away from Ominscan of their own accord.

Read the entire ProPublica.org feature here.

Selling Sickness: How Drug Ads Changed Health Care

Tue, 13 Oct 2009 20:28:08 EDT

Today, drug companies spend $4 billion a year on ads to consumers. In 1997, the FDA rules governing pharmaceutical advertising changed, and now companies can name both the drug and what it's for, while only naming the most significant potential side effects. Then, the number of ads really exploded. The Nielsen Co. estimates that there's an average of 80 drug ads every hour of every day on American television. And those ads clearly produce results:

"Something like a third of consumers who've seen a drug ad have talked to their doctor about it," says Julie Donohue, a professor of public health at the University of Pittsburgh who is considered a leading expert on this subject.

"About two-thirds of those have asked for a prescription. And the majority of people who ask for a prescription have that request honored."

Whether the increase in the number of prescription drugs taken is good or bad for patient health is an open question. There's evidence on both sides. What's not up for debate is this: By taking their case to patients instead of doctors, drug companies increased the amount of money we spend on medicine in America.

Health Concerns Over Popular Contraceptives

Sat, 26 Sep 2009 19:41:59 EDT

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention. But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.

Read the entire New York Times Article here.

Pfizer Pays $2.3 Billion to Settle Marketing Case

Wed, 02 Sep 2009 09:18:46 EDT

In the largest fine ever levied for fraud in the Medicare and Medicaid programs, the pharmaceutical giant, Pfizer Inc. will pay a $2.3 billion settlement over the company's illegal marketing of its now-withdrawn painkiller, Bextra. Read the NY Times article here.

Women Should Take Safest Birth-Control Pill, Researchers Say

Thu, 13 Aug 2009 09:23:44 EDT

Doctors should prescribe the birth-control pills that are the least liekely to cause blood clots, according to a study of more than 3,000 women published today in the British Medical Journal. Oral contraceptives containing levonorgestrel and a low does of estrogen, such as Bayer's Microgynon 30, were associated with the lowest risk of blood clots.

Bayer's Yasmin, Yaz and Ocella contain drospirenone which is found to increase the risk of blood clots and thrombosis.

TorHoerman Law Announces New Offices

Wed, 12 Aug 2009 11:47:15 EDT

The staff and attorneys at TorHoerman Law LLC are excited to announce the opening of our new offices on July 1, 2009.

FDA Advises Consumers Not to Use Certain Zicam Products

Tue, 16 Jun 2009 18:36:26 EDT

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. The products are: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (a discontinued product).

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

Read the rest of the FDA warning here.

FDA requires new physician labels for Levaquin

Thu, 30 Apr 2009 10:41:57 EDT

The FDA requires new safety information with the use of Levaquin, particularly the increased risks of tendonitis and tendon rupture. Read about the new requirements here.

Online Age Quiz Is a Window for Drug Makers

Wed, 25 Mar 2009 20:13:08 EDT

While few people would fill out a detailed questionnaire about their health and hand it over to a drug company looking for suggestions for new medications, that is essentially what RealAge is doing. Read the full story here.

A Birth Control Pill That Promised Too Much

Wed, 11 Feb 2009 09:12:43 EST

The Food and Drug Administration and the attorneys general of 27 states have required Bayer to spend at least $20 million on an advertising campaign intended to clarify deceptive consumer drug advertising for its top-selling oral contraception pill, Yaz. In 2008, Yaz was the best-selling oral contraception pill in the U.S. with sales of $616 million and an 18% market share according to IMS Health Regulators say that the ads which aimed to make Yaz the "go-to drug" for women under the age of 35 overstated the drug's ability to improve women's moods and clear up acne, while playing down its potential health risks.

Bayer Removes Remaining Stock of Trasylol

Wed, 14 May 2008 10:53:38 EDT

Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician's stock. Read Full FDA Announcement here.

Popcorn ingredient casues lung disease: U.S. Study

Thu, 13 Mar 2008 11:35:53 EDT

Tests on mice show that diacetyl, a component of artificial butter flavoring, can cause a condition known as lymphocytic bronchiolitis, said the team at the National Institute of Environemental Health Sciences, part of the National Institutes of Health.

The condition can lead to obliterative bronchiolitis -- or "popcorn lung" -- a rare and debilitating disease seen in workers at microwave popcorn packaging plants and at least one consumer.

Read the rest of the Reuters article here.

FDA Requests Marketing Suspension of Trasylol

Mon, 05 Nov 2007 15:04:10 EST

The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.Read the full FDA report here.

The FDA requests a "Black Box Warning" for the Manufacturers of Gadolinium

Wed, 23 May 2007 14:46:35 EDT

The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI)...

The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). Read the full FDA warning.

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

Fri, 30 Mar 2007 10:31:46 EDT

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States. Read entire FDA Announcement here.

St. Louis Nuclear Half-Lies - RiverFront Times, August 13, 2003

Wed, 13 Aug 2003 08:09:04 EDT

Although this River Front Times article concentrates on injuries incurred by Mallinkrodt workers exposed to toxic uranium exposure, the data and history of uranium in St. Louis relating to the wartime effort is well done.