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FDA Proposes Order to Close So-Called “Loophole” for Approval of Metal-on-Metal Devices

As a result of the mounting evidence demonstrating early failure and severe injuries associated with metal-on-metal devices, the FDA has issued a proposed order that would now require metal-on-metal (MoM) hip implant manufacturers to submit premarket approval applications whereby the manufacturers must prove device safety and efficacy prior to the time the devices are placed on the market. This move was made by the FDA in order to close the “loophole” in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, where metal-on-metal hip devices are approved under the FDA’s 510(k) approval process. Under the 510(k) process, hip implant manufacturers were able to bypass clinical testing if their device was found to be “substantially similar” to a device that was already approved by the FDA. Under the new guidelines issued by the FDA for the approval of metal-on-metal implants, any metal-on-metal implant must now undergo rigorous, comprehensive clinical testing prior to being introduced on the market.

Recently, the FDA has also decided to examine the potential link between corrosion and metal-on-metal hip implants. According to Health Point Capital, the FDA will embark on a new study to better understand the link between the devices’ wear and corrosion, as well as other potential links associated with clinical outcomes. The study will take approximately 2 years to complete and will examine approximately 250 metal-on-metal hip devices that have been explanted – or removed – from patients during revision surgery. The FDA will utilize the American Society for Testing and Materials (ASTM) protocol for corrosion testing in order to analyze the explanted devices. In deciding to embark on this new study, the FDA revealed a “renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements.” The objective of the study will be to publish a peer-reviewed journal article to shed light on the ties between wear and corrosion and relevant factors to consider, such as the length of time the device was implanted, device head size, materials, modularity and lateral offset. This study will further help “develop test methodologies and special controls for preclinical studies of total hip implants.”

One metal-on-metal hip implant that has become the subject of litigation is the DePuy ASR™. Since the withdrawal of the DePuy ASR™ hip device from the market in August 2010, thousands of lawsuits have been filed against its manufacturers, including DePuy and Johnson & Johnson, alleging injuries to persons who had the defective device implanted. Plaintiffs continue to file lawsuits, with the majority of them currently pending in federal court as part of the Multidistrict Litigation In re:  DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL 2197) before The Honorable Judge David A. Katz in the Northern District of Ohio. Judge Katz is currently managing nearly 8,000 DePuy ASR™ hip replacement lawsuits that were consolidated in 2010 and are currently pending in MDL 2197. The first bellwether trial in MDL 2197 is scheduled to begin in Toledo, Ohio on September 9, 2013. The Plaintiff in the first bellwether trial has recently designated 95 potential witnesses for the upcoming trial, including surgeons, company employees and product designers.

If you or a loved one has experienced complications with a DePuy ASR™ hip device, including additional surgeries to remove and/or replace the device, please contact the experienced attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

 

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