The NEJM article helps make the case for the new regulations the FDA recently proposed for metal-on-metal hip implants.
New York, New York (PRWEB) January 22, 2013
The high revision rates that prompted the DePuy ASR hip recall may have been discovered by clinical trials, Bernstein Liebhard LLP reports. According to a Perspective Article published this month in the New England Journal of Medicine (NEJM), the DePuy ASR XL Acetabular Cup System was cleared for sale by the U.S. Food & Drug Administration (FDA) in July 2008 under the agency’s 510(K) approval program, which does not require a clinical study. The authors assert that a clinical trial might have identified the high revision rate of the ASR, which became evident within just nine months when it was compared with all other total conventional hip prostheses in the Australian Joint Registry.*
“The NEJM article helps make the case for the new regulations the FDA recently proposed for metal-on-metal hip implants,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free legal evaluations to victims of metal-on-metal hip implant complications.
DePuy ASR Hip Recall
The DePuy ASR hip recall was issued in August 2010, after the devices were found to have an unacceptably high failure rate. According to the NEJM, the DePuy ASR hip, like many other metal-on-metal hip implants currently on the market, was approved under the 510(K) program, which does not require that a device undergo human tests if a manufacturer can show it is substantially equivalent to a product previously approved by the FDA. On January 17, 2013, the FDA proposed an order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications. This would make the devices ineligible for 510(K) clearance, and require manufacturers to submit data showing the devices are safe and effective before they could continue selling existing ones or obtain approval for new metal-on-metal designs.**
Bloomberg.com recently reported that Johnson & Johnson and its DePuy Orthopaedics unit are facing more than 10,000 claims stemming from the DePuy ASR hip recall. Most of those lawsuits are pending in a multidistrict litigation underway in the U.S. District Court, Northern District of Ohio. The first trial in the federal DePuy ASR hip litigation will begin on May 6, 2013, while the second will begin on July 8, 2013. (In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197). ***
DePuy is involved in a second multidistrict litigation underway in U.S. District Court, Northern District of Texas, involving a metal-on-metal version of the Pinnacle Hip Replacement System http://www.consumerinjurylawyers.com/depuy-pinnacle-hip-replacement/ . Court documents indicate that the first trial in that proceeding is scheduled for September 2014. Bernstein Liebhard LLP partner, Jeffrey Grand, serves on the Plaintiffs’ Steering Committee in the federal DePuy Pinnacle litigation. (In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation - MDL No. 2244).
Bernstein Liebhard LLP is offering free lawsuit consultations to anyone allegedly injured as a result of the DePuy ASR hip and the all-metal Pinnacle device. A wealth of information regarding metal-on-metal hip implants is available on Bernstein Liebhard LLP’s website. For additional information, please contact one of our attorneys by calling 877-779-1414.
About Bernstein Liebhard
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 10 consecutive years.
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Bernstein Liebhard LLP