Judge Denies Biomet's Preemption BidSep 3, 2013
An Indiana federal judge recently denied the request to dismiss a lawsuit that is part of a multidistrict litigation (MDL) brought against Biomet Inc. over its allegedly defective metal-on-metal hip implant device, the M2a Magnum. Biomet will proceed to trial in the matter.
The plaintiff in this case alleges that the defective M2a Magnum hip replacement system caused him bone and tissue damage and forced him to undergo a number of revision surgeries to remove and replace the defective device. The M2a Magnum MDL was centralized for pre-trial processing in Indiana this October and is just one of a number of MDLs coordinated over metal-on-metal hip implants, Law360 noted.
U.S. District Judge Robert Miller Jr. rejected Biomet’s dismissal motion, finding that the action was not preempted by federal law simply 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 preempted by the Food, Drug and Cosmetic Act’s Medical Device Amendments and stated that the M2a Magnum had received U.S. Food and Drug Administration (FDA) approval under a clinical investigation to determine its safety and efficacy, known as the so-called “investigational device exemption” (IDE), study, according to Law360. The plaintiff was not involved in the study, a distinction that Judge Miller deemed to be catastrophic 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 preemption is a controversial rule meant to protect device makers from lawsuits involving FDA-cleared products.
Some 600 lawsuits have been brought against Biomet over alleged M2a Magnum hip implant device failures. Meanwhile, MassDevice.com noted that despite mounting personal injury lawsuits involving the Biomet device, the device maker has not called for a recall similar to the recall Johnson & Johnson’s subsidiary, DePuy Orthopaedics, initiated on its metal-on-metal ASR device.
Many metal-on-metal hip devices have been recalled worldwide as reports of injuries and lawsuits involving these devices mounted. The FDA placed this entire class of medical device under increased scrutiny following reports of high failure rates and the devices’ tendency to release high concentrations of metallic debris into patients’ bloodstream and tissue. The FDA released new guidelines on January 17, 2013 for patients implanted with metal-on-metal devices and advised that physical examinations, diagnostic imaging, and metal ion testing in symptomatic patients be conducted on a regular basis.
New data from Canada suggests that people implanted with metal-on-metal hips are likelier to require revision surgery within five years of implantation, according to a CBC News report citing a Canadian Institutes for Health Information study that revealed that people implanted with these devices face a 5.9 percent increased likelihood of having to undergo device replacement within five years of original implantation. In comparison, people who received metal-on-plastic implants experienced a 2.7 percent increased rate.
The all-metal implant design was not as successful as expected, CBC News reported. Under the body’s weight during typical activities, such as walking, the implant’s metal parts rub against each other. This causes metal particles to shed into the person’s surrounding tissue and bloodstream, which can lead to metallosis (metal poisoning), bone and tissue damage, pseudotumors, and the need for premature revision surgery.