Product News and Recalls

Lawyers worried about regulatory change for hip implants

The leading plaintiff trial lawyers association has expressed concerns to the U.S. Food and Drug Administration that a proposed regulatory change might prevent people injured by faulty all-metal hip implants from suing the manufacturers for damages.

The implants in question, such as those manufactured by Johnson & Johnson’s DePuy Orthopaedics subsidiary, have both a ball and a socket coated in a combination of cobalt and chromium. They were developed to be more durable than implants featuring a plastic socket with a ball made from metal or ceramic.

But as a Reuters story notes, numerous studies show that the all-metal hip implants can shed toxic debris, potentially damaging bone and soft tissue. One study shows that nearly half break down and need replacement within six years. The DePuy model was recalled in 2010, but the company still faces thousands of lawsuits.

Under current regulations, the all-metal models are approved under a process that requires manufacturers only to show that their designs are similar to devices already on the market.

According to Reuters, the FDA has issued a proposed rule requiring manufacturers to go through a more rigorous safety review process to continue selling the implants or to bring new ones to market.

The American Association for Justice has submitted a letter to the FDA, expressing support for the change in principle. But the organization’s concern, according to Reuters, is that the change may prevent injured patients from filing lawsuits.

You should consult with a doctor if you have any ongoing symptoms or health concerns from a DePuy hip implant. If your DePuy hip is causing pain or required revision surgery, you should also consult with a DePuy hip lawyer to discuss your legal rights.

See more information on hip replacement here:

http://newsandinsight.thomsonreuters.com/Legal/News/2013/05_-_May/Plaintiff_group_weighs_in_on_FDA_process_for_metal_hip_implants/