Biomet Metal-on-Metal Hip Implant Lawsuit to Proceed, Judge Rules

Qmed Staff

September 4, 2013

2 Min Read
Biomet Metal-on-Metal Hip Implant Lawsuit to Proceed, Judge Rules

A lawsuit against Biomet will proceed, according to Law360. In the lawsuit, the company is accused of selling faulty metal hip implants. As of now, Biomet faces a significant number of lawsuits related to its metal-on-metal hip implants.

In the notice, US District Judge Robert Miller, Jr. declined to dismiss the lawsuit on the grounds that the company is not preempted by federal law, even though tits metal-on-metal hip implant was cleared for use in a clinical study.

In the lawsuit, patient Lesie Caccia alleges health issues related to the implant of a Biomet M2a-Magnum. According to the lawsuit, Caccia alleges that the device caused tissue and bone damage. These health issues required multiple corrective surgeries.

In its defense, Biomet argues that the device was preempted by the Medical Device Amendments of the Food, Drug and Cosmetic Act.

The M2a-Magnum by Biomet received an investigational device exemption (IDE) from FDA regulators. According to Caccia, he didn't participate in the study. Based on this, the federal judge ruled that the FDA approval of the device limited its use to the study.

Biomet and other metal-on-metal hip implant manufacturers face a number of lawsuits. These lawsuits allege that the devices cauld health issues like chromium poisoning, cobalt poisoning, tissue necrosis and pseudotumors. Several of the lawsuits allege that the metal-on-metal hip implants cause lasting, permanent damage.

"Bench test results are not necessarily indicative of clinical performance," notes one attorney. "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."

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