What You Need to Know About the DePuy ASR Recall
The DePuy Pinnacle hip implant gained FDA approval in 2000, and five years later the DePuy ASR received FDA approval based on the contention by DePuy that it was substantially equivalent in design to the Pinnacle. Under the FDA’s 510(k) approval process, this was sufficient to approve the ASR even though the Pinnacle had already had some issues of its own. DePuy Orthotics and Johnson & Johnson—the parent company of DePuy—made the decision to recall the ASR in 2010 after the FDA began receiving adverse reports of the implant in 2008. Like many other metal-on-metal hip implants, the cobalt and chromium construction which was meant to allow the hip implants to last as long as twenty years were, instead, leading to hip implant failure and extremely serious health symptoms.
Over three hundred complaints had been received regarding the ASR; most of those people were required to undergo hip revision surgery to remove the ASR and replace it with a ceramic or polyethylene hip device.At the time of the recall, Johnson & Johnson stated that the ASR had exhibited a higher than expected failure rate. While the “normal” failure rate of a hip implant is between three and five percent, at the time of the ASR recall failure rates were reaching 12% and above.
Symptoms of a Defective Hip Implant
The DePuy metal-on-metal ASR hip implant—like many other all-metal models—have been found to create friction between the metal components whenever the recipient engages in physical activity. In turn, this friction creates metal shear which sends microscopic metal ions into the body. In some cases these cobalt and chromium ions will land nearby, in the surrounding hip tissues. The metals will cause inflammation which in turn leads to tissue destruction and death as well as bone loss and pseudo-tumors—tumors filled with pockets of fluid. The recipient will likely suffer significant pain and as the tissues disintegrate, the implant may begin to loosen and eventually fail. When this occurs, revision surgery is necessary.
When the cobalt and chromium ions enter into the bloodstream, they can cause symptoms of heavy metal poisoning and toxicity. Gastrointestinal disorders, problems with the cardiovascular, neurological and renal systems, vision and hearing loss, DNA disruption, skin disorders, breathing problems, depression, anxiety, irritability, the formation of cancerous cells in some cases and even seizures in severe cases can all occur as the levels of cobalt and chromium continue to build. Those with a DePuy ASR hip implant should have their levels of cobalt and chromium tested regularly and should also undergo any further tests their doctor feels necessary including x-rays, bone scans and MRIs.
How DePuy ASR Attorneys Can Help
Johnson & Johnson continues to bear the substantial cost of the ASR recall; both companies currently face thousands of DePuy ASR recall lawsuits most of which have been consolidated in a multi-district litigation which is currently underway in the Northern District of Ohio. It is believed that over 8,000 lawsuits have been filed against DePuy and Johnson and Johnson and attorneys expect there will be more to follow. The first lawsuit in the federal litigation is scheduled for May, 2013, with the second federal trial set for July of 2013. Many people have been helped by lawyers who specialize in these trials however the time may be short for many as the statute of limitations continues to run.