Metal-on-metal hip device lawyers at Pintas & Mullins Law Firm affirm that a federal judge in Indiana recently declined Biomet’s motion to dismiss claims by a plaintiff implanted and injured by a defective M2A Magnum hip device.
The plaintiff, Leslie Caccia, suffered extensive bone and tissue damage after being implanted with the M2A-Magnum hip replacement system, requiring several revision surgeries. Litigation surrounding this Biomet hip device was recently consolidated in Indiana, one of several multi-district litigations (MDL) across the country dealing with all-metal hip devices.
Biomet attempted to argue that the plaintiff’s claims were preempted by the FDA’s Medical Device Amendments, which were enacted in 1976 establishing separate regulatory classes for medical devices. The M2A-Magnum was approved by the FDA after clinical investigations to confirm its safety and effectiveness. This is known as an investigational device exemption, or IDE Approval Process.
Caccia, however, did not participate in this clinical investigation, which was the final nail in Biomet’s coffin regarding its motion to dismiss. The judge stated that he was not persuaded that Biomet was exempt from liability just because it obtained IDE status for the M2A device to be used to in a controlled investigational setting. Biomet’s claims were indeed far-fetched, unpersuasive, and unreasonable, and the judge’s ruling should apply to other M2A-Magnum plaintiffs who were implanted with the device under similar circumstances.
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There are other MDLs currently pending for four other metal-on-metal hip implants: DePuy’s Pinnacle and ASR, Wright Medical’s Conserve, and Zimmer’s Durom Cup. Cases are consolidated into MDLs when all plaintiffs share similar claims or factual questions. In the Biomet cases, all plaintiffs shared concerns about the Magnum’s design, manufacture, marketing, and performance. They also share common injuries from the device’s defects.
In 2010, sales of Biomet’s hip implants exceeded $312 million, making up about 12% of the total U.S. hip implant market. Although it has enjoyed much success, its M2A Magnum and Stanmore and Exceed ABT devices with metal liners have had their share of problems caused by the metal-on-metal components.
When hip implant products are made from all-metal components, they rub against each other during daily activities, oftentimes releasing metal particles into the bloodstream. This release of metal alloys can cause metallosis, or metal toxicity, causing soft tissue and bone damage and necessitating expensive and painful revision surgeries.
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Biomet manufactures the widest range of metal-on-metal hip devise in the industry; between 1999 and 2009, more than 110,000 M2A devices were implanted in the U.S. The Magnum device was approved in 2004, and is now one of Biomet’s best sellers. The product is coated with titanium alloy, and the inside is made of cobalt chromium alloy.
More than 450 adverse events have been voluntarily reported to the FDA over M2A Magnum devices, including reports of device failure and fracture, pain and metallosis. In addition to tissue and bone death, metallosis can also cause tissue discoloration, pockets of internal fluid, groin pain, and device loosening leading to dislocation and fracture. The metal particles can also pass through the bloodstream and infiltrate other organs, causing a range of complications.
Biomet M2A Magnum lawyers at Pintas & Mullins Law Firm affirm that there are about 300 lawsuits currently pending against Biomet over its dangerous hip devices. We are currently investigating, accepting and representing clients who were implanted with a Biomet all-metal device, or similar devices made by DePuy, Stryker, Smith & Nephew, Wright, and Zimmer. If you were implanted with a metal-on-metal device and suffered an injury, contact one of our skilled lawyers today for a free legal consultation.