Biomet, Agrees to $56 Million Metal Hip Device SettlementFeb 4, 2014
Medical device maker, Biomet Inc., agreed to a settlement over a multidistrict litigation (MDL) that involves two of its metal-on-metal hip devices. The settlement amount is for at least $56 million.
The federal judge overseeing the case approved the settlement in two parts, according to Law360. The settlement resolves an MDL that was organized in Indiana and involving two Biomet metal hip device implants: the Biomet M2a-38 and the M2a-Magnum hip implant. The litigation involved allegations that Biomet manufactured a defective metal implant device.
Although Biomet continues to dispute the allegations that are the basis of thousands of federal lawsuits, the device maker agreed to fund an account to be used to issue payments to what the settlement described as “qualified plaintiffs,” according to Law360. The agreement was approved by U.S. District Judge Robert L. Miller Jr.
The settlement defines a “qualified plaintiff” as a plaintiff involved in the MDL who received a Biomet M2a-38 or M2a-Magnum hip implant and who later required that metal hip device to be “revised” which, according to the settlement agreement, means that the device was removed or repaired. Each qualified individual will receive a base payment of $200,000; however, there are variations to the amount, Law360 reported. Variations are based on an array of court-approved conditions, according to the settlement.
This settlement resolves the MDL, which Biomet has been fighting as far back as October 2012, Law360 reported, citing court records, and was approved in two parts. The first part involves Biomet funding an escrow account with $50 million. The account will pay individuals who were harmed by the Biomet M2a-38 or M2a-Magnum implant. The second part of the settlement involves a common benefit settlement agreement.
Various device makers have recalled their metal hip device components, including Johnson & Johnson unit DePuy Orthopaedics Inc. and Smith & Nephew PLC. DePuy, Wright Medical Technology Inc., and Biomet are also involved in MDLs involving their metal hip devices, according to Law360. Last November, Johnson & Johnson agreed to pay a $2.5 billion settlement meant to resolve about 8,000 lawsuits brought over its hip devices.
Biomet competitor, Stryker Corp., settled four lawsuits brought over claims concerning defective hip implant devices. The lawsuits were brought over allegations that defective hip implants allegedly led to injuries. Those lawsuits have been consolidated in New Jersey court, according to a December court order, Law360 writes. In that case, the parties agreed to enter into mediation in April to resolve more than 500 lawsuits that were coordinated in a multicounty litigation involving allegations involving Stryker's Rejuvenate and ABG II modular-neck stems.
The U.S. Food and Drug Administration (FDA) placed the metal hip class of medical devices under increased scrutiny as reports of high failure rates and the devices’ tendency to release high concentrations of metallic debris into patients’ bloodstream and tissue were being received. On January 17, 2013, the FDA issued new patient guidelines, instructing physicians to regularly test symptomatic patients implanted with metal-on-metal devices via physical examinations, diagnostic imaging, and metal ion testing.