Biomet’s Preemption Bid Denied

An Indiana federal judge just denied Biomet Inc.’s request to dismiss a lawsuit that is part of a multidistrict litigation (MDL) brought over its allegedly defective metal-on-metal hip implant device, the M2a Magnum. Biomet must now proceed to trial.

The plaintiff alleges that the defective M2a Magnum hip replacement system caused him bone and tissue damage and led him to have to undergo a number of revision surgeries to remove the defective device. This October, the M2a Magnum MDL was centralized for pre-trial processing in Indiana and is just one of a number of MDLs that have been coordinated over metal-on-metal hip implants, Law360 noted.

U.S. District Judge Robert Miller Jr. rejected Biomet’s dismissal motion. The judge found that the action was not preempted by federal law just because the metal-on-metal hip device involved was approved for use in a clinical investigation, according to Law360.

Biomet argued that the plaintiff’s claims are, in fact, pre-empted by the Food, Drug and Cosmetic Act’s Medical Device Amendments, stating that the M2a Magnum received U.S. Food and Drug Administration (FDA) approval under a clinical investigation to determine its safety and efficacy, a so-called “investigational device exemption” (IDE), study, according to Law360. The plaintiff was not involved in the study, a distinction Judge Miller deemed disastrous to Biomet’s motion, noting that the agency’s clearance of a device for use in an IDE study is limited to that study.

“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 liability for use of that device outside the clinical trial,” the judge said, according to Law360. MassDevice.com pointed out that preemption is a controversial rule put in place to protect device makers from lawsuits over FDA-cleared products.

About 600 lawsuits have been brought against Biomet over alleged M2a Magnum him implant device failures. MassDevice.com noted that, despite mounting personal injury lawsuits brought over the Biomet device, the device maker has not called for a recall, pointing out that Johnson & Johnson’s subsidiary, DePuy Orthopaedics, initiated a recall of 93,000 metal-on-metal ASR devices in 2010.

Many metal-on-metal hip devices have been recalled worldwide as injury reports and lawsuits involving these devices mount. The FDA placed this class of medical device 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.

Recent data from Canada suggests that people implanted with metal-on-metal hips are likelier to need to undergo revision surgery within five years of implantation, according to a CBC News report that cited a Canadian Institutes for Health Information study that found that people implanted with these devices experience a 5.9 percent increased likelihood of having to undergo device replacement within five years of original implantation. People who received metal-on-plastic implants experienced a 2.7 percent increased rate.

The all-metal implant design was not as successful as device makers had expected, CBC News reported. Under the body’s weight during activities such as walking, the implant’s metal parts rub against each other. This rubbing causes metal particles to shed into surrounding tissue and bloodstream, which can lead to metallosis (metal poisoning). Metallosis has been associated with bone and tissue damage, pseudotumors, and the need for premature revision surgery.