FDA to Convene Meetings in June to Review and Discuss Metal on Metal Hips

Fda (Photo credit: Wikipedia)

The Food and Drug Administration will hold a two-day meeting in June to discuss growing safety concerns about metal-on-metal hip replacements, which recent studies suggest are more likely to fail than traditional plastic hips.

Metal hip joints have been under scrutiny due to reports of pain and swelling that have sometimes required removal. In 2010, Johnson & Johnson recalled roughly 93,000 implants. The FDA already asked device companies to conduct additional follow-up studies to monitor problems with the implants.

The agency says it will hold a two-day meeting beginning June 27 to consider whether more rigorous testing standards are needed.

Earlier this month, British experts said doctors should stop using metal hip joints because data show they have to fixed or replaced more often than older implants.

DePuy Pinnacle MDL Update

Our firm has four of the first Pinnacle cases filed in the DePuy Pinnacle MDL and anticipates filing more in the coming months. We are seeing rapid failures of the device due to high cobalt levels in blood tests. Excessive levels of cobalt in the blood stream is a sign of metallosis, which can cause rashes, soft-tissue damage, peripheral neuropathy and pseudo-tumors.

The DePuy Pinnacle cases have been consolidated in the U.S. District Court for the Northern District of Texas under Judge James E. Kinkeade. Judge Kinkeade is currently presiding over at least one of the cases, and the Panel determined his current caseload will accommodate the litigation. There are approximately 57 DePuy Pinnacle hip lawsuits currently pending in federal courts nationwide and that number is expected to rise over the next few months.

DePuy is a subsidiary of Johnson & Johnson, one of the largest corporations in the world. DePuy recalled the ASR XL Acetabular hip system last August, after researchers found 13 percent of patients needed a repeat operation to fix problems with the implant. The company took a $280 million charge in the fourth quarter to pay for the recall. The company faces more than 500 lawsuits by patients who had the hip implants, most of which are consolidated in a separate MDL dealing only with ASR hips. There has been no recall of the DePuy Pinnacle hip.

Johnson & Johnson’s DePuy Orthopaedics division, a maker of artificial prosthetics such as hips and knees, has struggled with product recalls and lawsuits over faulty implants lately. It was announced earlier this year that the worldwide president would leave the company in March. The executive, David Floyd, has been president of the unit since 2007. He is leaving to pursue interests outside the company, a spokesman on behalf of the company, Lorie Gawreluk, said, declining to be more specific.

Our firm is currently investigating claims for those people who have been implanted with the DePuy hip replacement devices, both ASR and Pinnacles. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.