Expert Witness Links Implant Directly to Metal Poisoning

DePuy ASR hip implants are composed of metals like cobalt and chromium, which, if they make their way into an implant recipient’s blood stream, can cause problems ranging from local tissue damage to severe and systemic central nervous system and cellular malfunctions. Exposure to high levels of cobalt and chromium, Dr. Harrison explained, can actually change the way cells and even genes function.

According to Dr. Harrison, doctors and scientists have known since as far back as the 1970s that metal implant components have the potential to cause metal poisoning, which is known formally as metallosis. That the DePuy ASR caused him to suffer this devastating condition is one of plaintiff Loren Kransky major allegations in his lawsuit, which is the first of over 10,000 others against DePuy to reach trial.

Contact RLG Now for a Free DePuy Lawsuit Evaluation

The Rottenstein Law Group watches all state and federal DePuy cases closely in order to provide current and prospective clients with prompt case updates. Nearly ten thousand ASR implant recipients have already filed lawsuits all around the United States; however, thousands of others might essentially be sitting on a ticking time bomb hip as new estimates indicate the global failure rate of the devices could be as high as 40 percent.

If you received a DePuy ASR hip, you should speak to a qualified attorney as soon as possible to discuss your eligibility to file a lawsuit because you might be able to recover full medical costs, lost earnings, pain and suffering, and other damages. The Rottenstein Law Group invites you discuss the details of your situation with one of our attorneys right away. Together, we have over 25 years of collective experience fighting large corporations and helping injured clients obtain the compensation they deserve. Our consultations are free for all prospective clients. Just fill out this form or call 1-877-619-5087.

Report: DePuy Deviated From Risk Assessment Protocol

After presenting the report to the jury, attorneys for Kransky called DePuy compliance manager Jimmy Smith to the witness stand to speak about the company’s normal engineering and testing standards. Asked whether DePuy should have done more to ensure the implant was safe before putting it on the market in 2003, Smith said point blank, “They could have done it better.”

Kransky’s attorneys also put DePuy engineer Graham Isaac on the stand to speak about the company’s risk assessment process in greater detail, and Isaac admitted that his employers had only tested the ASR’s stability and robustness and by applying force to it from one angle.

Contact RLG Now for a Free DePuy Lawsuit Evaluation

Plaintiff Loren Kransky’s DePuy trial is now in its third week in Los Angeles County Superior Court, and attorneys and other industry insiders are watching the case very closely. Since Kransky’s suit is the first of more than 10,000 others to be adjudicated, the outcome will be a strong predictor of how many of the other pending cases will play out.

The Rottenstein Law Group watches all state and federal DePuy cases closely in order to provide current and prospective clients prompt updates and important news every step of the way. If you suffered complications from a DePuy hip implant, you should speak to one of our attorneys as soon as possible to discuss your eligibility to file a lawsuit. You could be entitled to compensation for medical expenses, lost income, and even pain and suffering. Even if your implant device has not yet failed or caused you any complications, you should act now to preserve your rights before it’s too late. The Rottenstein Law Group invites you discuss the details of your situation with one of our experienced litigators right away. Together, we have over 25 years of collective experience fighting large corporations and helping injured clients obtain the compensation they deserve. Our consultations are 100 percent free. Just fill out this form or call 1-877-619-5087.

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Implant Lasted Only Five Years

The recalled DePuy ASR hip replacement implants were expected to have a 15-20 year lifespan, but the plaintiff’s implant lasted only five years. Her original hip replacement surgery took place in 2007, and in May 2012, she had to undergo a painful revision surgery to correct the implant’s failure.

According to the lawsuit, the woman required the revision surgery due to pain, device locking, and the condition known as metallosis, which is caused when metal debris shed from an all-metal hip implant and enters the bloodstream. The lawsuit alleges that the woman suffered injuries from both the implantation and removal of the ASR device.

Ceramic and Plastic Hip Implants Safer For Use, According to Recent FDA/Medical Device Industry Hearing

A recent hearing held in Washington D.C. between FDA officials and prominent individuals from the medical device industry concluded that metal-on-metal hip replacement devices need to be reconfigured using other materials such as polyethylene and ceramic. While the metal hip implant systems can be beneficial to patients in some cases, statistics show that combinations of ceramic-on-ceramic, metal-on-polyethylene, and ceramic-on-polyethylene are now being used in up to 85 percent of hip and knee replacement surgeries, according to a July 13, 2012 article that appeared on the Web sits Plastics Today. Use of all-metal hip implants has decreased to a scant one percent.

Contact The Rottenstein Law Group If You’ve Suffered Harm From Your Hip Replacement

The Rottenstein Law Group has over 25 years of collective experience helping individuals who have been injured by defective medical devices and dangerous prescriptions drugs. If you have been implanted with a recalled hip replacement device and are experiencing symptoms of failure, RLG can help you sue DePuy for compensation. If you’d like a free, confidential consultation with an attorney, click on this link or call 1-877-619-5087 and a lawyer from the Rottenstein Law Group will reach out to you as soon as possible.

For more information on the DePuy recall, download this free brochure.

Click Here to Download RLG’s DePuy ASR Recall Brochure

Mere weeks after the U.S. Food and Drug Administration (FDA) concluded its advisory committee meeting that discouraged use of all-metal hip replacements, another study revealed serious problems with the devices when used in total hip replacement procedures. It found that most metal-on-metal hip replacement failures occur within the first two years of implantation, and they fail for some reasons more than others. The full text of the study can be found in the July 2012 issue of the medical journal Orthopedics.

‘Aseptic Acetabular Loosening’ Most Common Cause of Failure

Using a sample of 80 patients who received a metal-on-metal hip replacement that had to be revised, the authors noted that 78 percent of the revision procedures occurred within two years of the initial implantation and 92.5 percent within the first three years. The researchers also noted that “13% of patients experienced significant localized soft tissue reactions,” meaning damage caused by metal ions shed by the implants’ components. Compared to other causes, the most common reason for implant failure was “aseptic acetabular loosening,” or loosening of the hip cup unrelated to infection. The researchers calculated that 45 of the 80 revision procedures were attributed to this cause, and they attributed failures to some devices more than others, with the second most (four) going to DePuy’s ASR Hip Resurfacing System and another two to the DePuy Pinnacle hip cup.

Here is the study’s list of causes of metal-on-metal hip replacement failure:

• Aseptic acetabular loosening (45/80)
• Infection (10/80)
• Metal hypersensitivity (5/80)
• Failed resurfacing (5/80)
• Fracture (4/80)
• Loose stems (3/80)
• Dislodged liner (3/80)
• Iliopsoas Impingement (2/80)
• Seizing (1/80)
• Cup malposition (1/80)
• Femoral stem fracture (1/80)

The researchers used their findings to create a diagnostic flow chart for orthopedists to refer to if their patients’ hip replacements were showing problems, and citing the DePuy recall and other hip implant problems, they urged the need for a national artificial joint registry. The study can be found in the following link, but before clicking on it, readers should know it contains graphic images of hip replacement surgeries.

RLG Represents ASR Recipients

The Orthopedics study shows once again the dangers inherent to metal-on-metal hip replacements, including those created by DePuy Orthopaedics. If you received one of DePuy’s ASR devices and believe it injured you, it’s important to know that the amount of compensation from a hip replacement lawsuit might be greater than what the manufacturer will offer you via its recall reimbursement program. For a free, confidential consultation with a lawyer from the Rottenstein Law Group, click on this link or call 1-877-619-5087.

At least 165 patients in the Sheffield area are living with “problematic metal hip joints” in addition to 181 patients in Rotherham, and another 164 in Chesterfield. Thirty-four patients have filed lawsuits against DePuy International, and six more have filed complaints against other companies. The plaintiffs include one 35 year-old woman who had to have her all-metal hip removed and replaced last year due to high levels of chromium and cobalt in her blood.

An attorney for the plaintiffs stated, “More than 10,000 people received this type of device, but we still don’t know the full extent as many problems may not yet have developed. Anyone who thinks they may be affected should contact their surgeon or GP.”

The Medicines and Healthcare Products Regulatory Agency in the U.K. recalled metal-on-metal hip implants last year, after fears they could cause “bone and muscle problems, loss of mobility, nausea and long-term disability.”

Recent U.S. Hearing Explored the Use of Alternative Hip Replacement Materials

A recent hearing held in Washington D.C. between FDA officials and prominent individuals from the medical device industry concluded that metal-on-metal hip replacement devices need to be reconfigured using other materials such as polyethylene and ceramic. While the metal hip implant systems can be beneficial to patients in some cases, statistics show that combinations of ceramic-on-ceramic, metal-on-polyethylene, and ceramic-on-polyethylene are now being used in up to 85 percent of hip and knee replacement surgeries, according to a July 13, 2012 article that appeared on the Web sits Plastics Today. Use of all-metal hip implants has decreased to a scant one percent.

RLG Attorneys Can Help If You’ve Been Injured By Your Artificial Hip

The Rottenstein Law Group has over 25 years of collective experience helping individuals who have been injured by defective medical devices and dangerous prescriptions drugs. If you have been implanted with a recalled hip replacement device and are experiencing symptoms of failure, we can help you sue DePuy for compensation. If you’d like a free, confidential consultation with one of our attorneys, click on this link or call 1-877-619-5087 and a lawyer from the Rottenstein Law Group will reach out to you as soon as possible.

For more information on the DePuy recall, download this free brochure.

Metal-on-Metal Hips Differ, Supposedly Have Advantages

In contrast to the uniformly negative reaction at the FDA committee meeting, a DePuy spokesperson and at least one orthopedic expert defended all-metal hips. According to medicalxpress.com, the DePuy representative, Mindy Tinsley, said, “DePuy believes that no single bearing surface meets the needs of all patients, and metal-on-metal implants provide the potential benefit of greater function and a lower risk of dislocation for some patients.” The article further quoted Tinsley, saying, “[A]ll metal-on-metal implants are not alike and they should not be grouped together if problems arise.”

These remarks are not too surprising. Some people benefit from metal-on-metal hip replacements without serious adverse consequences, but overall, they do no better than other types of hip replacements according to a study published in the British Medical Journal. Indeed, the case is worse for DePuy’s ASR than most other types of devices, for the National Joint Registry of England and Wales determined that 29 percent of ASR devices fail after six years in recipients.

Surprisingly, even an orthopedic expert made comments that can be interpreted as critical of the committee. Former vice president of the American Academy of Orthopaedic Surgeons Dr. Joshua Jacobs said, “[M]etal-on-metal devices are not all the same. You have to go down to the individual product to fully understand the result. When you lump metal-on-metal together you miss a lot of important differences.” Hopefully, the FDA’s 2011 call for postmarket information from all-metal hip implant manufacturers will result in data that will help regulators meaningfully distinguish between different devices as Dr. Jacobs desires. However, the British Medical Journal‘s findings still stand: All-metal hip devices generally do no better than other devices and they require revision more often.

RLG Represents DePuy ASR Recipients

Regardless of what any one orthopedist says, the data speak for themselves: The DePuy ASR Acetabular System and ASR Hip Resurfacing System fail at higher-than-expected rates, and many recipients have filed lawsuits against the manufacturer and its parent, Johnson & Johnson. If you received one of these devices, the Rottenstein Law Group is offering free, confidential consultations, and to speak with a lawyer, just click on this link or call 1-877-619-5087.

For more information download this free DePuy ASR brochure.

Company Ceases Global Production, Citing “Potential Trend” in follow-up Data

The company decided to cease global production of the devices after it noticed a “potential trend” in its follow-up data.

One of Stryker’s press releases notes some disturbing data regarding the use of metal-on-metal hip implants: “In vivo production of metal debris from implants has been the subject of much scrutiny recently. Metal on metal bearings, for example, produce small (20-80nm diameter) metallic wear debris whenever motion is present,” the release noted. “Elevated blood serum metal ion levels (it is believed these metal ions are produced by corrosion of the wear debris in the case of metal on metal joints) and metal hypersensitivity resulting in an adverse local tissue reaction may occur with metal-metal articular surface bearings, causing premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation.”

Additionally, Stryker’s hip reconstruction vice president and general manager, Stuart Simpson, commented, “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action.”

Stryker Recall Broadens Definition of “Metal-on-Metal” Hip Implants

The Stryker metal-on-metal hip implants differ from those manufactured by DePuy and other companies in that they are not a ball-and-socket design. The Rejuvenate Modular and ABG II models utilize a two-part modular neck system that has proven to be just as detrimental to patient health as the ball-and-socket design. The Stryker components can rub against one another during normal wear-and-tear just as the ball-and-socket components can, causing metal debris to shed onto surrounding tissues and potentially enter the bloodstream.

Shortly after the Stryker recall was made public, the U.S. Food and Drug Administration (FDA) held a two-day meeting to evaluate the concerns surrounding problematic metal-on-metal hip implants.  A panel of 18 experts evaluated safety issues with hip implants manufactured and sold by DePuy, and Zimmer, with Stryker now added to the list. Now, any hip replacement with metal components, regardless of design, has the potential to cause harm to patients who are implanted with the devices.

Explore Your Legal Options If You’ve Been Injured By Your Artificial Hip

The Rottenstein Law Group has over 25 years of collective experience helping individuals who have been injured by defective medical devices and dangerous prescriptions drugs. If you have been implanted with a recalled hip replacement device and are experiencing symptoms of failure, we can help you sue DePuy for compensation. If you’d like a free, confidential consultation with one of our attorneys, click on this link or call 1-877-619-5087 and a lawyer from the Rottenstein Law Group will reach out to you as soon as possible.

For more information on the DePuy recall, download this free brochure.

Click Here to Download This Free Brochure

One reason the DePuy hip recall occurred is that artificial joint registries outside the United State provided regulators with data on the effectiveness of the DePuy ASR hip series. The U.S., however, did not have such a registry, and as a result, the ASR stayed on the U.S. market longer than it did in other countries. Aside from creating a U.S. device registry, one idea, endorsed by Rochelle Rottenstein, principal attorney for the Rottenstein Law Group, is to require medical device implants to contain a unique device identifier (UDI). On July 3, 2012, the U.S. Food and Drug Administration (FDA) proposed a regulatory rule that would create such a medical device identification system.

Patients’ Personally Identifiable Information would Be Protected

The FDA bases its authority to enact the rule on legislation recently passed by Congress. As for the substance of the rule, the agency claims it has been working with patients’ advocates, consumer groups, the medical device industry, and it has even conducted four pilot studies on the idea. The proposed rule is 165 pages long and is partly based on existing industry standards. It can be found here (PDF).

According to the FDA’s press release, a UDI would include two items:

• “a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and
• a production identifier, which includes the current production information for a device.”

The FDA hopes to phase in the UDI based on the affected devices’ risk factors. Low-risk and over-the-counter devices would be mostly exempt. The UDI information would be available in a publically available database, and most importantly of all: No patient information will be stored there.

RLG Advocates for Recipients of DePuy ASR Devices

If the UDI rule goes through, it will greatly benefit recipients of medical devices, but for those who already received a recalled DePuy ASR, the rule is only a moral victory. If you have a recalled ASR hip, and you have not already contacted a lawyer, do not try to take on DePuy alone because the amount of compensation from a DePuy lawsuit might be greater than what it’s willing to offer you. Click on this link or call 1-877-619-5087 and a lawyer from the Rottenstein Law Group will reach out to you as soon as possible and give you a free, confidential consultation.

‘Few Reasons to Continue Using’ the Devices

The 18-person panel unsurprisingly discouraged orthopedists from implanting metal-on-metal devices in their patients, stating, “There are few reasons to continue using metal-on-metal hip implants amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.”

Although the committee did not broach the topic of a widespread hip replacement recall, one physician, Dr. William Rohr, commented, “I do not use metal-on-metal hips, and I can see no reason to do so.”

For more information on the DePuy ASR recall, click here to download this free brochure.

Committee Outlines Patient Guidelines for FDA

In late February 2012, the British government created a set of guidelines advising physicians how they should monitor their hip replacement patients going forward. The FDA advisory committee made similar recommendations: Recipients with pain and other symptoms should undergo regular x-ray screenings and blood tests, and for recipients without symptoms x-rays alone will suffice. The physicians on the panel noted that there were no generally available diagnostic kits for medical laboratories to use to test metal-on-metal hip recipients for cobalt or chromium poisoning. The advisory committee’s recommendations are not as rigid as those in place in foreign countries.

Sorting Recipients Prioritized

The experts on the committee observed that all-metal hip devices differ in design and how they affect recipients. Injured recipients tend to share common traits. For instance, women and overweight people report pain more often than other recipients. As a result, the advisory committee stressed the need for more research, which could take many years. Diana Zuckerman, who is the president of the National Research Center for Women & Families said, “Keeping these metal-on-metal hips on the market for the next five to 10 years while research is ongoing is not ethical … If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”

RLG Advocates for DePuy ASR Recipients

The DePuy ASR recall has revealed the flaws associated with all-metal hip replacements, but the FDA won’t be able to produce data on how badly the hips affect people for quite some time. Consequently, if you received a DePuy ASR hip replacement and you believe it injured you, waiting for the FDA to reach its conclusions will do you little good, and the amount of compensation from a DePuy lawsuit might be greater than what the company is willing to offer you via its recall reimbursement program. The Rottenstein Law Group wants to help you through this process, and all you need to do is click on this link or call 1-877-619-5087, and one of our recall lawyers will give you a free, confidential consultation as soon as possible.