Lessons from the Stryker Hip Replacement Recall
People often look to precedents to predict the future. In situations like DePuy Orthopaedics’ ASR XL Acetabular Hip System and ASR Hip Resurfacing System, knowing what preceded the DePuy recall can be of great help. By now, everyone should know that these two DePuy devices can fail in close to 50% of recipients after six years, a remarkable failure rate. The problems are caused by the metal-on-metal components grinding together. This weakens the implant and releases metal ions, cobalt and chromium, into the surrounding tissues and bloodstream, causing many health ailments. After years on the market, in August 2010, DePuy finally issued a worldwide recall of the devices that included 37,000 within and 93,000 outside of the United States. The recall has triggered roughly 1,000 DePuy ASR hip replacement lawsuits.
Those considering joining the litigation against the Johnson & Johnson subsidiary may want to know the outcome of a previous hip replacement recall, one initiated by Stryker Corp., manufacturer of two ceramic hip replacement devices, the Stryker Acetabular Cup and Styker Trident Hemispherical Cup. Between 2005 and 2007, numerous Stryker hip replacement recipients filed complaints with the U.S. Food and Drug Administration (FDA). These mainly revolved around “squeaking” sounds in the implants and bacterial infections occurring in implanted areas. One study showed that 7% of implants squeaked. The problems were traced to a manufacturing plant in New Jersey that lacked adequate quality controls, and the FDA sent Stryker two warning letters about the problem. In January 2008, Stryker initiated the hip replacement recall. Then it spent $50 million on improving quality control measures. Nevertheless people whose hip implants failed or who suffered a staph infection sued the company. In February 2011, the U.S. Court of Appeals for the Fifth Circuit held that the dismissal of the lawsuits was proper because the Stryker devices were approved by the FDA outside the 510(k) premarket approval process. Some Stryker hip replacement lawsuits may be ongoing in Canada and elsewhere.
Ultimately, the Stryker recall isn’t really comparable to the DePuy hip replacement recall. Primarily, the types of implant differ (ceramic vs. metal-on-metal), but more importantly, the approval process wasn’t the same. Unlike the Stryker implants, DePuy’s ASR series were approved via the fast-track 510(k) premarket approval process, meaning the DePuy lawsuits ought to go forward, much to the benefit of DePuy recipients.
If you received one of DePuy’s recalled hip replacements and you have not yet contacted a hip replacement lawyers about your case, you should do so as soon as possible. You may be entitled to compensation from DePuy. The Rottenstein Law Group is currently giving free, confidential consultations to people like you, and all you need to do for one of our attorneys to contact you is click on this link. or complete our contact form to the right.