On May 6, 2011, the U.S. Food and Drug Administration (“FDA”) sent requests to Johnson & Johnson and 20 other medical device manufacturers, including Zimmer and Stryker, requesting that they conduct post-market studies involving hip replacement implants and their respective failure rates.  According to the FDA mandate, manufacturers of metal-on-metal hip implants will have to conduct studies of patients who received the implants to determine whether the hip replacements are shedding metal debris into patients’ bloodstreams.  The FDA is primarily concerned with the potential risk of patients’ sustaining chromium and cobalt poisoning.  A spokeswoman for the FDA stated that the “agency is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems . . . [but] there is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic events.”

Prior FDA Actions Related to Artificial Hips

Although this latest action is the broadest use of the FDA’s regulatory authority, it is not the first time that the FDA has reacted to the nationwide controversy surrounding metal-on-metal implants.  Although the FDA was not involved in DePuy’s voluntary recall of its ASR hip products in August 2010, recently the FDA has taken a more active role in dealing with the resulting aftermath.  In February 2011, the FDA created a new website dedicated to educating consumers and health care providers on the risks associated with metal-on-metal implants.  In April 2011, the FDA appeared at a Senate hearing and was forced to vigorously defend its widely criticized fast-tracking 510(k) process that allows medical devices into the marketplace without having to undergo clinical trials or inspection.  These recent events may have been the catalyst for this latest action by the FDA.

DePuy ASR Hip Lawsuit

If you or a loved one has experienced any problems, including cobalt poisoning, as a result of a DePuy ASR hip replacement implant, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.  Contact one of our lawyers today for a free and confidential DePuy ASR hip replacement implant lawsuit evaluation.  The lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients.  In addition to being staunch advocates for your claim, our DePuy ASR hip replacement implant injury lawyers also provide personal attention to guide you through the complex litigation process.

Published November 17, 2011 by