FDA Meeting To Review Metal Hip Implants Slated For June
Bernstein Liebhard LLP reports that on March 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced that an advisory panel will convene on June 27-28 to conduct an expert review of metal hip implants. Prompted by growing safety concerns stemming from the August 2010 DePuy ASR hip recall as well as mounting evidence concluding that metal hip implants fail at higher rates than hip replacement systems that use other materials, a team of scientists, researchers, patients and medical providers will meet to discuss whether to issue a recommendation that new pre-market testing standards and review requirements should be imposed before a medical device can be sold in the United States. Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health stated, “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations.”
FDA Meeting Will Evaluate Nature And Severity Of Problems Associated With Metal Hip Implants
According to Reuters, the FDA meeting will focus on “failure rates, metal ion testing, imaging methods, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems.” Yesterday’s announcement of the upcoming FDA meeting on metal hip implants follows a May 2011 order from the agency requiring medical device manufacturers of metal-on-metal hip implants to collect more safety data.
In August 2010, after receiving data from the National Joint Registry of England and Wales that 1 out of every 8 patients (12%-13%) who received its metal-on-metal ASR hip implants had to undergo revision surgery within five years of implant, DePuy Orthopaedics, a subsidiary of Johnson & Johnson issued a worldwide voluntary recall of all variations of its ASR hip implants. An estimated 93,000 individuals worldwide were affected. In January 2012, Johnson & Johnson announced it would take a $3 billion charge to cover the costs associated with the ASR hip recall.
FDA Review Of Metal Hip Implants Coincides With Mounting Litigation
In light of this latest development, Bernstein Liebhard LLP partner Felecia L. Stern, who is representing clients that received metal hip implants, commented “I am hopeful that the outcome of the FDA meeting will result in a recommendation that the agency impose more stringent regulations in order for medical devices to receive market clearance. Unfortunately, any changes in the medical device approval process come too late to help the 37,000 Americans who were implanted with the recalled ASR hip, many of whom have been forced to undergo painful and dangerous revision surgery. Often too overwhelmed by their own medical problems to engage in activism, I know many of our clients are heartened that Consumers Reports and others have helped pressure the FDA to review these processes.”
The DePuy hip replacement lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals who have been implanted with metal-on-metal hip implants manufactured by DePuy in the following actions: In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio and In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), which is currently underway in the U.S. District Court for the Northern District of Texas. The lawsuits allege that the ASR hip replacement and the metal-on-metal Pinnacle hip replacement systems were defectively designed. The firm is also investigating cases concerning another metal-on-metal hip implant manufactured by Wright Medical Technology, Inc. Lawsuits involving this hip replacement were recently consolidated in In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (“MDL No. 2329”), which is pending in the U.S. District Court for the Northern District of Georgia. Similar to the DePuy litigations, the Wright Medical hip lawsuits allege that the metal-on-metal Wright Conserve hip replacement systems were defectively designed.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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