The first federal trial over DePuy Orthopaedics’ metal-on-metal hip replacement device is scheduled to begin on September 9 in Cleveland. The DePuy ASR XL device is the subject of some 10,000 lawsuits nationwide.
The case, brought by a Rochester, New York woman, will be the first bellwether case of nearly 8,000 suits in a multidistrict litigation before U.S. District Judge David Katz, the National Law Journal reports. The plaintiff claims that a dislocation of her DePuy ASR XL hip implant forced her to undergo surgery to remove and replace the device.
The first two state court verdicts in DePuy cases came earlier this year. In March, in Los Angeles County Superior Court, a jury awarded $8.3 million to a retired prison guard who had a DePuy hip implanted in 2007. The jury rejected the plaintiff’s bid for punitive damages and DePuy has appealed the verdict. In April, a Chicago jury found in DePuy’s favor in the case of an Illinois nurse who had the device implanted in 2008 but claimed she was forced to have it replaced three years later.
DePuy pulled the ASR XL device from the market 2010, but plaintiffs allege the company was aware of the device’s problems long before that and failed to warn doctors, according to the National Law Journal. Pain, swelling, grinding or clicking in the hip, difficulty walking, damage to the bone and surrounding tissue, and a high metal content in the bloodstream are among the problems alleged in lawsuits.
In 2011, the U.S. Food & Drug Administration (FDA), which regulates medical devices, ordered 21 manufacturers of metal-on-metal hip implants to reassess the safety of their products. The agency is also reconsidering the 510(k) approval process, through which these hip implants were brought to market. The FDA is expected to amend the approval process so that implantable devices must undergo clinical testing before they are allowed on the market.
More than 93,000 ASR devices have been implanted in patients worldwide. DePuy also faces more than 4,000 lawsuits over its Pinnacle hip device, and similar litigation has been filed against manufacturers of other metal-on-metal hip devices.