House Democrats Urge Republicans to Examine Metal-on-Metal Hip Safety

As a growing number of lawsuits filed against Johnson & Johnson by injured metal-on-metal hip recipients fuel speculation that there may be a DePuy Pinnacle recall, metal hips in general are facing greater scrutiny due to their unique health risks. The issue has even gained the attention of lawmakers, as Democrats in the House of Representatives last week sent a letter to Republican leaders asking them to investigate the safety of metal hips in addition to the federal regulatory process that brought some of them to market.

Waxman Leads Energy and Commerce Committee Democrats In Call to Action

Representative Henry Waxman of California and three other House Democrats sent a letter to Republican members of the Committee on Energy and Commerce on October 12, 2011 requesting that they examine metal-on-metal hips and brain stents. Both types of medical devices are notable because they have demonstrated high failure rates and were approved by the Food & Drug Administration (FDA) through processes that Waxman and his colleagues feel may be ineffective.

Obtaining FDA permission to market a medical device requires that manufacturers subject new products to a premarket approval process that typically involves clinical trials. But in the case of certain brain stents and metal-on-metal hips, the manufacturers avoided that process, resulting in what the Democratic committee members describe as, “major health problems.”

The Wingspan Stent System was approved by the FDA in August 2005 through the humanitarian device exemption (HDE) application, which allows a medical device to forego the rigors of the premarket approval process. According to recent data, nearly 15% of patients who received a stent after suffering a stroke had a stroke or died within 30 days (compared to 5.8% of patients without a stent).

The other device targeted by Democrats in their letter to Republicans is metal-on-metal replacement hip replacements. Many all-metal hips have been cleared through the 510(k) premarket approval process, which doesn’t require clinical data for a new device if it is demonstrated to be “substantially equivalent” to one or more already on the market. According to the Democrats’ letter, 175 metal-on-metal hip replacements received 510(k) approval by the end of 2010 and the FDA has received more than 5,000 complaints about metal hips. Two metal hip systems have been voluntarily recalled.

DePuy Pinnacle Cleared Through 510(k) Process

One of hip systems that received 510(k) clearance is the DePuy Pinnacle. While not every Pinnacle hip has all-metal components, those that do could shed metal particles and cause pain, device loosening, and even the need for a second hip replacement operation. In May 2011, a federal mass tort was created by the Judicial Panel on Multidistrict Litigation to deal with legal claims against DePuy over faulty Pinnacle hips. More than 500 DePuy Pinnacle lawsuits are now contained within the multidistrict litigation.

Speak With RLG About a Possible DePuy Pinnacle Lawsuit

If you received a metal-on-metal Pinnacle hip replacement and believe it injured you, you may be eligible for compensation from DePuy. The Rottenstein Law Group, a firm representing injured consumers, is offering free case reviews for Pinnacle recipients. To speak with an attorney, fill out this contact form. An attorney will promptly be in touch with you.