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On August 26, 2010, Depuy Orthopedics, a division of Johnson & Johnson, announced a recall of approximately 93,000 DePuy ASR hip replacement implants, specifically the ASR XL Acetabular System and the ASR Hip Resurfacing System. DePuy has not recalled its Pinnacle Acetabular Cup System, even though it suffers from the same design flaws and has had similar complication rates.
Both ASR systems have an unusually high early failure rate — studies have shown 21% of the hip implants have to be replaced within 4 years after implantation, and half have to be replaced within 6 years, compared to 12% to 15% at 5 years for other devices — and both involve dangerous metal-on-metal bearings that can degrade under normal wear-and-tear, releasing metal shavings and flakes into the bloodstream, as well as toxic chemicals like cobalt and chromium.
Neither of the DePuy ASR hip implant systems were properly tested. Instead, DePuy obtained used the Food and Drug Administration’s “510(k) clearance” — a safety loophole that the Institute of Medicine has recommended be eliminated. DePuy Orthopedics nonetheless remains legally responsible for the safety of its own products, and hundreds of negligence lawsuits have already been filed against DePuy alleging the company did not adequately design or test the ASR systems.
The FDA recommends that patients who might have recalled hip implants watch for symptoms like “hip/groin pain, local swelling, numbness or changes in your ability to walk,” and warns about the potential complications these defective medical devices can cause, including:
Metal-on-metal hip implants, like other types of hip implants, are known to have adverse events including infection and joint dislocation. There are some case reports of the metal particles causing a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant and failure of the device, as well as some of the symptoms described above. In addition, some metal ions from the implant may enter into the bloodstream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart and thyroid gland.
In January 2013, the FDA (finally) issued an updated safety communication warning “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants” and recommending orthopaedic surgeons “select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system.”
DePuy offers “reimbursement” for patient’s out-of-pocket costs through Broadspire, but this “reimbursement” is only a fraction of the compensation to which patients implanted with one of these recalled hip replacements might be able to receive through a civil lawsuit, settlement or jury verdict. Back in August 2011 I wrote about problems with the Broadspire process, and my concern that the process could deceive patients into missing the relevant statute of limitation for filing their claim. (See my article, “DePuy Tricks Hip Recall Patients Into Losing Legal Rights.”)
Over 10,000 lawsuits have been filed against Johnson & Johnson and DePuy Orthopedics, and as of January 2013 the company was attempting to negotiate a $2 billion settlement. That number is consistent with the average hip lawsuit settlements so far, which have been about $200,000 each. The federal court in Ohio overseeing the DePuy ASR hip lawsuits has scheduled an initial round of “bellwether” jury trials to begin this year, to help set a framework for those settlement negotiations. The federal court in Texas overseeing the DePuy Pinnacle cup lawsuits has not set a schedule for those trials yet, because more work needs to be done in the “discovery” phase of the litigation.
If you have had hip implant surgery after July 2003, and either know you received a DePuy ASR or DePuy Pinnacle hip replacement or are unsure which brand and model hip implant you received, use the form below to contact our hip replacement recall attorneys for a confidential, no-fee consultation about a DePuy hip replacement lawsuit.
You can also read my latest articles on the DePuy recall, Medical Implant Manufacturers Lobby For Even More Special Legal Treatment, and Subrogation, Where Much Of The Hip Implant Settlement Money Will Go.