Last Wednesday, an Indiana federal judge declined to dismiss a lawsuit against Biomet, Inc. over its defective metal-on-metal hip implants. The suit is part of the multidistrict litigation against Biomet, which was consolidated and transferred to the Northern District of Indiana in October of last year.
US District Judge Robert Miller, Jr. ruled that Biomet is not preempted by federal law just because it was approved for use in a clinical investigation, according to Law360. In the case of plaintiff Leslie Caccia, who was implanted with a faulty Biomet M2a-Magnum that caused bone and tissue damage and required multiple revision surgeries, Biomet, Inc. argued that their defective device was preempted by the Food, Drug and Cosmetic Act’s Medical Device Amendments.
Biomet’s M2a-Magnum was approved by the Food and Drug Administration (FDA) through a clinical investigation known as an “investigational device exemption” or IDE. Mr. Caccia did not participate in the study, and Judge Miller felt that the FDA’s approval of a device for use in an IDE was limited to the study.
Biomet is one of several recent multidistrict litigations against manufacturers of metal-on-metal hip implant devices that have caused adverse health effects in patients, including, Cobalt and Chromium poisoning, pseudo-tumors, and tissue necrosis, often resulting in permanent damage and the need for revision surgeries in many cases.
“According to the product webpage, Biomet’s M2a-MagnumTM Metal-on-Metal Hip is the one of the greatest medical innovations of recent times,” said Daniel Nigh, a DePuy and Stryker hip recall attorney with the Levin, Papantonio law firm.
“Ah, but be certain to read the fine print at the bottom of the page: ‘Bench test results are not necessarily indicative of clinical performance,’” he continued. “Like the Stryker hip implant and several other hip replacement products from other manufacturers, Biomet’s M2a-MagnumTM received expedited approval through the now-infamous 510 (k) process, by which the Food and Drug Administration gives manufacturers a pass on safety testing if the product in question is ‘substantially similar’ to a product that has already been approved and is currently on the market.”