Biomet Inc., the medical device maker that manufactures the M2a-38 and the M2a-Magnum hip implants, just agreed to a $56 million settlement to end a multidistrict litigation (MDL) organized in 2012.
The settlement has been constructed in two parts, according to Law360, and resolves an MDL that was organized in Indiana and involves the two Biomet metal hip device implants. Litigation involved allegations that Biomet manufactured defective metal implant devices and are the foundation for thousands of federal lawsuits.
Biomet has been fighting the MDL since October 2012, Law360 reported, citing court records, but Biomet did agree to fund an account to be used to issue payments to people who are described in the settlement as “qualified plaintiffs,” according to Law360. U.S. District Judge Robert L. Miller Jr. approved the settlement agreement.
The first part of the settlement involves Biomet funding an escrow account with $50 million to pay individuals harmed by the Biomet M2a-38 or M2a-Magnum implants. The settlement’s second part involves a common benefit settlement agreement. Under that portion of the settlement agreement, Biomet will pay $6 million to the plaintiffs’ attorneys, the agreement indicates, according to Law360.
A “qualified plaintiff,” according to the settlement, is a plaintiff who is involved in the MDL and who received a Biomet M2a-38 or M2a-Magnum hip implant and later had to have that metal hip device “revised.” According to the settlement agreement, a revised device is one in which device removal or repair were required. Each qualified individual will receive a base payment of $200,000, and there are variations to that amount based on an array of court-approved conditions, according to the settlement, Law360 reported.
Meanwhile, a number of other device makers have recalled their metal hip device components, including Johnson & Johnson’s DePuy Orthopaedics Inc. unit and Smith & Nephew PLC. DePuy, Wright Medical Technology Inc., and Biomet are involved in MDLs involving their metal hip devices, wrote Law360. Also, last November, Johnson & Johnson agreed to pay a $2.5 billion settlement meant to resolve about 8,000 lawsuits brought over its metal hips.
Biomet competitor, Stryker Corp., also settled four lawsuits that involved claims over defective hip implant devices. Lawsuits allegations involved claims these hip implants led to injuries. The lawsuits were consolidated in New Jersey court, according to a December court order, Law360 writes. The parties agreed to enter into mediation in April to resolve more than 500 lawsuits that had been coordinated in a multicounty litigation 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.