The federal court overseeing hundreds of hip replacement lawsuits filed against Zimmer-Biomet, Inc. has rejected the company’s bid to dismiss many of those claims.
According to documents pending in the U.S. District Court, Northern District of Indiana, the company had filed two motions for summary judgment: One in relation to claims involving its Taper, ReCap and metal-on-polyethylene devices, and another seeking dismissal of certain allegations in jurisdictions that recognize “state-of-the-art” defenses.
U.S. District Judge Robert L. Miller Jr. denied the motions on February 8th, characterizing the bids as “head-scratching.”
Regarding state-of-the-art defenses, Judge Miller asserted that examining the law in 19 different states would “indefensibly slow the process in this docket.”
“Time in this court is better spent on other matters, with application of state law left to the transferor courts, which more often than not are located in the state whose law provides the rule of decision,” he wrote.
Judge Miller denied the motion related to the Taper, ReCap and metal-on-polyethylene devices on its merits.
Around 420 hip replacement lawsuits remain pending against Zimmer-Biomet in the multidistrict litigation underway in the Northern District of Indiana. However, the proceeding at one time included more than 2,700 cases, the majority of which involved Biomet’s M2a line of metal-on-metal hip devices.
Biomet agreed settle a large number of M2a claims in February 2014, just a few months before the company was acquired by Zimmer. The settlement ultimately cost Biomet $56 million and provided a base award of $200,000 to individuals who had “received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was revised more than 180 days after it was implanted”
Plaintiffs who filed a lawsuit by April 15, 2017 were eligible to participate in the Biomet hip settlement program.
Metal-on-metal hip replacements, such as those included in Biomet’s M2a product line, consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys. Implants in this class were cleared via the U.S. Food & Drug Administration’s (FDA) 510(k) program, which allows a device to come to market without human clinical trials if it is “substantially equivalent” in design to a previously approved product.
The FDA began investigating metal-on-metal hips in February 2011, amid reports that many patients were experiencing premature failure of their devices.
In a January 2013 Safety Communication, the agency confirmed that all-metal hips were prone to shed dangerous amounts of toxic metal ions into the joint surrounding the device, as well as the blood stream, resulting in serious complications and early failure. Patient with metal-on-metal hips were urged to seek medical attention if they experienced any issues with their artificial hip, while doctors were advised to consider metal ion blood testing and imaging for symptomatic patients.
In 2016, the FDA finalized new regulations that, among other things, banned medical device makers from utilizing the 510(k) program to bring metal-on-metal hips to market.