January 25, 2013 — The first two “bellwether trials” have been selected from more than 7,000 federal lawsuits currently pending against DePuy Orthopedics, the maker of the recalled ASR hip implant. The plaintiff, Ann McCracken, is a 57 year-old single mother and business owner from Rochester, New York, who was implanted with the DePuy ASR XL Acetabular System in 2009, one year before its official recall. McCracken’s lawsuit is scheduled for trial on July 8, 2013. In her lawsuit, McCracken alleges that DePuy knew or should have known that the product was defective, but failed to adequately warn her or her surgeon about the devastating risks.
McCracken alleges that the ASR has caused her to suffer permanent injuries. She required two revision surgeries in 2011, including one surgery to address a double hip dislocation. The third surgery left her with debilitating decreased range of motion. She may require more surgeries.
When DePuy initially marketed the ASR, they claimed that the metal-on-metal hip implant was more durable, and therefore ideal for younger, more active patients. Unfortunately, data from a British joint registry linked to ASR XL to a 13% five-year failure rate, and DePuy initiated a recall in 2010. In 2011, according a court documents unsealed last week in a state court trial in California, an internal analysis from DePuy linked the ASR to a 37% five-year failure rate.
The California state court trial has also revealed that DePuy was aware of problems with the ASR in 2008, two years before the recall, and one year before McCracken was implanted with the device. Documents show that officials at DePuy knew about clinical trials that found “extreme” levels of metal ions in ASR patients. Although this complication is one of the first symptoms that a metal hip implant is failing, the company decided to gradually phase out the ASR.
Many lawsuits also allege that DePuy did not test the ASR hip implant adequately before it was marketed, sold, and implanted in about 93,000 people worldwide. In fact, the U.S. Food and Drug Administration (FDA) approved the ASR under an approval process called a 510(k) application. This allows manufacturers of “substantially equivalent” new devices to avoid a rigorous pre-market approval process that includes expensive, time-consuming clinical trials.
The federal litigation is currently centralized in the U.S. District Court for the Northern District of Ohio before Judge David A. Katz, involving more than 7,000 lawsuits. An additional 2,000 lawsuits are currently pending in state court in California.
Do I have a Defective Hip Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting defective hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a hip implant side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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