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The U.S. Food and Drug Administration (FDA) is set to hold a two-day meeting this week to scrutinize the safety of metal-on-metal hip implants after numerous reports from patients that these medical devices are failing earlier than expected. According to a news report in The Associated Press, the FDA has received more than 16,800 adverse event reports about metal hips between 2000 and 2011. A number of patients reported that these implants caused pain and swelling and sometimes required the removal of the devices.

For many years, almost all orthopedic implants were manufactured by plastic or ceramic. However, in the last decade or so, some surgeons viewed metal implants more favorably. Lab tests at the time suggested that these metal devices would be more resistant to wear and tear, reduce the chances of dislocation and delay the need for revision surgeries. As it turned out, the opposite occurred.

Increasing Failure Rates

In March, British experts urged doctors to stop using metal-on-metal hip replacements such as those manufactured by DePuy, a subsidiary of Johnson & Johnson. A careful analysis showed that 6 percent of patients with DePuy hip implants and other similar medical devices had to be replaced in less than five years compared with just 2 percent for those with ceramic or plastic joints. On August 26, 2010, DePuy Orthopaedics shocked their consumers with a defective product recall of their ASR XL Acetabular System and the ASR Hip Resurfacing System.

British regulators are recommending that those who have these metal implants get annual blood tests to ensure that no dangerous metals are seeping into their bloodstream as the components deteriorate or rub against each other. Approximately 500,000 patients have received these implants in the United States, but the FDA has released no such warnings. FDA scientists want to consider all available information before making any recommendations. During this week’s meeting, the FDA is expected to ask a panel of experts to recommend the best practices for monitoring patients with the devices. That includes blood tests, lab tests and medical imaging.

Lives Devastated

As the FDA takes its time, unsuspecting patients are suffering the consequences. One patient, 48-year-old Mary Weaver, who had both her hips replaced with Johnson & Johnson’s metal implants in 2007 and 2008, had to have these defective products removed in 2011 due to increasing pain and elevated metal levels in her blood. She not only had to endure the pain of additional surgeries and the medical expenses, but also lost her job due to the time needed to undergo these surgeries. Weaver is not alone. There are thousands of others like her.

Seeking Compensation for your Losses

If you or a loved one needs to pursue compensation from Johnson & Johnson or other companies that manufacture these and other defective medical devices, you will need an experienced California personal injury lawyer who has fought against these manufacturing giants and has a track record of holding negligent corporations accountable. The best product liability law firms always offer a free consultation and comprehensive case evaluation to injured victims and their families.

New Research Indicates Implant Recipients May Face Increased Cancer Risk

Those who have received DePuy Orthopedics’ ASR Hip Resurfacing System, or an all-metal version of DePuy’s Pinnacle Acetabular Cup System should be aware of new research out of Britain indicating that patients with such devices face an increased risk of developing cancer. A study, conducted by scientists at the University of Bristol, found that 1 in 5 patients fitted with an all-metal hip implant experienced changes to cells in the bladder that could be precursors of cancer, according to a report published by The Sunday Telegraph on February 4, 2011.

Since the August 2010 worldwide recall of the DePuy ASR Hip Resurfacing System and the DePuy ASR Acetabular System 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it.

According to The Sunday Telegraph report, researchers at Bristol University examined data on 72 patients who had been implanted with a metal-on-metal hip replacement device. They found that 17 patients had experienced genetic damage to the cells of their bladder, while three patients had developed full-blown cancer. The report also said, the researchers are concerned that the genetic damage seen in the study could be a precursor to the formation of cancer as the result of cell mutation.

U.K. health regulators were preparing to issue new guidance regarding metal-on-metal hip implants amid concerns that the shedding of metal debris into patients’ blood streams could lead to “systemic toxicity,” and could put the nervous system, heart and lungs at risk of being slowly poisoned.

If you have received a defective hip replacement using this product, contact Bisnar | Chase right away at 800.561.4887.

BISNAR | CHASE has learned that even after the U.S. Food and Drug Administration rejected the sale of Depuy Hip Replacements in this country over safety concerns, the health care products giant Johnson & Johnson continued to market the artificial hip in Europe and elsewhere overseas.

During that same period, the company also continued to sell a related model in the U.S. That version passed inspection by using a regulatory loophole not requiring a similar safety review.

It is not known how many people overseas received the replacement hip after the U.S. agency declined approval in 2009, nor the number who received the similar implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that reviewing experts declare was faulty in design.

Amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates, the DePuy orthopedic division of Johnson & Johnson, started citing declining sales as the culprit and began phasing out both models of the defective Dupuy device.  The unit is formally known as an “articular surface replacement device”, or ASR.

Facing a renewed application process that would probably have taken a year or more, DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.

There is no suggestion that Johnson & Johnson ever broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there. The agency can reject approving a device for various reasons, including cases where it is seeking only small amount of added data.

However, the bottom line for both the company and consumers is that the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. The firm recently took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants. The F.D.A. has received thousands of complaints about the ASR, virtually all of them involving patients who had to undergo replacement operation just a few years after getting the device. In Britain, the units were all recalled recently as the failure rates skyrocketed.

If you or someone you know had a Depuy hip replacement, contact one of our Depuy lawyers immediately for a free consultation. We are currently representing a number of injured victims who have suffered from failed Depuy hips. To claim your free consultation please call 800.561.4887 or visit BestAttorney.com.

When the Depuy Orthopaedic hip device was found to have a higher-than-average failure rate, no one anticipated the wave of metal-on-metal devices that would be put under the microscope. Several studies have since shown that metal on metal hip replacement devices contribute to serious health complications that can lead to painful revision surgeries and permanent health problems. The metal on metal hip failure attorneys at Bisnar and Chase are working towards providing financial compensation for patients who have suffered as a result of these defective products as well as help prevent manufactures from creating defective products in the first place. Read the rest »

At Bisnar and Chase we take great pride in providing an exceptional experience for our clients, inside and outside the courtroom. Victims of the defective Depuy ASR Unit are looking for attorneys who have experience helping victims with similar injuries to their own, but also want an attorney who gives them a personal experience. Our Depuy recall lawyers in California know how to win; we have recovered hundreds of millions of dollars for over 6,000 clients and have had great success taking Fortune 500 companies to court. We know how to help our clients recover on a personal level as well. Suffering injuries as a result of a defective medical device is a difficult tragedy to overcome and obtaining maximum compensation for you injuries will require attorneys with experience and expertise. Read the rest »

Johnson & Johnson, the manufacturers responsible for the defective DePuy hip implant, have their hands full this week. BISNAR | CHASE, some of the top rated personal injury lawyers in California, have filed a products liability lawsuit that could potentially cost these negligent manufacturers millions, not to mention the ripple effect of having yet another of their products proven to be defective.

In a press release issued earlier today, Johnson and Johnson has been named as one of several defendants in a case alleging that the defendants designed, distributed, manufactured, sold and marketed a prosthetic hip implant device known as the “ASR SYSTEM,” that was ultimately defective. Due to the alleged defects, the plaintiff Kenneth Eichler has suffered dangerous and painful complications, will be forced to undergo painful revision surgeries, and may have lifelong problems. Read the rest »