An Indiana federal judge just refused 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 devices; in this case, the M2a Magnum.
U.S. District Judge Robert Miller Jr. rejected Biomet’s dismissal motion in a plaintiff suit finding that the ruling is 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. The plaintiff in this case alleges that he was implanted with a defective M2a Magnum hip replacement system that caused him bone and tissue damage and caused him to have to undergo a number of revision surgeries to remove the defective device.
This lawsuit is part of the M2a Magnum MDL centralized in Indiana this October. This is just one of a number of MDLs coordinated over metal-on-metal hip implants, Law360 noted.
Biomet argued that the plaintiff’s claims are pre-empted by the Food, Drug and Cosmetic Act’s Medical Device Amendments because the device involved 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, which was a distinction that Judge Miller deemed disastrous to the device maker’s motion, noting that the agency’s approval of a device for use in an IDE study is limited to the 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.
Many metal-on-metal hip devices have been recalled worldwide and reports of injuries and lawsuits involving these devices continues to mount. The FDA has placed this class of medical device under scrutiny following reports of high failure rates and the devices’ propensity to release high concentrations of metallic debris into the patients’ bloodstream. On January 17, 2013, the FDA released new guidelines for patients implanted with all-metal devices and advised that physical examinations, diagnostic imaging, and metal ion testing in symptomatic patients be routinely conducted.
New data from Canada suggests that people implanted with all-metal hips are likelier to undergo revision surgery within five years of implantation, according to a CBC News report. The Canadian Institutes for Health Information study revealed that people who have received metal-on-metal implants face a 5.9 percent increased likelihood of having to undergo device replacement within five years of original implantation; this, in comparison to a 2.7 percent rate among people who received metal-on-plastic implants.
The all-metal implant design did not work as expected, CBC News reported. In fact, under the body’s weight during daily activity—such as walking—the implant’s metal parts rub against each other. This rubbing causes metal particles to shed into the person’s surrounding tissue and bloodstream, causing bone and tissue damage due to metallosis (metal poisoning), as well as pseudotumors and the need for early revision surgery.