Biomet Hip Implants Update: Investigational Device Exemption

Leslie Caccia and his wife Allison are the lead plaintiffs in a multi-district lawsuit currently pending in the Federal Court in the Northern District of Indiana as part of a massive lawsuit against artificial hip implant maker, Biomet.

The couple claims that Mr. Caccia’s Biomet M2A-Magnum artificial hip implant is defective because it failed prematurely, and he has developed metal poisoning. Mr. Caccia underwent several revision surgeries after his Biomet ReCap Femoral Resurfacing System and M2A-Magnum metal-on-metal hip replacement system prematurely failed.

Our Biomet hip implant lawyers are currently investigating claims on behalf of victims across Florida and the United States who have undergone implant surgery with a Biomet M2A Magnum or other device. For a free legal consultation regarding your potential Biomet claim, please email me, Spencer Aronfeld, or call our office today at 1-866-597-4529.

What is the Biomet M2A-Magnum Hip?

Much like the Stryker Rejuvenate hip implant, the Biomet M2A-Magnum is also a metal-on-metal artificial hip replacement system. Patients implanted with it have also experienced premature hip failure and developed metallosis, or metal poisoning, due to microscopic debris being released into the body’s soft tissues as a result of the components grinding against each other. This can occur during normal daily activity such as walking, standing, or sitting.

The Biomet M2A Magnum is a metal-on-metal artificial hip replacement system, a design which is associated with premature hip failure, according to some experts. To date, unlike Stryker, Biomet had not issued a warning or recall regarding its hip implants.

Biomet Lawsuit Update

Last month, Judge Robert L. Miller, Jr.–the federal judge presiding over all of the product liability claims involving the Biomet M2A-Magnum metal-on-metal hip replacement system in the Northern District of Indiana–was asked by Biomet’s lawyers to dismiss the Caccias’ and all other plaintiffs’ pending cases based on the principle of federal preemption, a legal theory that states that implant makers cannot be sued for design defects if their product was approved by the FDA.

Biomet Hip Implants Injuries: Motion Denied by Judge Miller

Judge Miller denied the motion and found that even though the FDA approved Biomet’s ReCap System under an investigational device exemption (IDE)–a process that allows products to be approved for use during specific clinical trials intended to determine the product’s safety and effectiveness–Mr. Caccia’s use of Biomet’s ReCap System occurred outside such controlled study, with no proper monitoring, record keeping, or FDA oversight. Judge Miller said, “I’m not persuaded that a manufacturer that obtains IDE status for a device to be used in a controlled investigational setting is, during the time the study is being conducted, exempt from the liability for use of that device outside the clinical trial.”

587 Biomet Magnum Lawsuits and Climbing

Currently there are nearly 600 Biomet cases centralized and consolidated before Judge Miller in Indiana. This action includes Biomet victims from across the country. We anticipate that the number of claimants who have been injured by Biomet hips will continue to increase as more and more of these devices fail.

Our office is currently representing victims across the country in both the Stryker Hip Implant litigation as well as the De Puy Pinnacle cases. We are experienced in handling the complex medical and engineering issues that are common in these types of cases. I am a Board Certified Civil Trial Lawyer, and I understand the devastating effect that these hip implants can have on a person’s life.

If you have had a Biomet, Stryker, or De Puy hip implant, please contact our office today for a free initial legal consultation regarding your potential claim, by calling 1-866-597-4529 or 305-441-0440.