A Colorado woman who suffered metal poisoning and other complications after hip replacement with a Biomet M2a metal-on-metal hip replacement device has filed a lawsuit alleging the device is defective and was responsible for her injuries. The woman needed additional surgery to replace the failed device.
The woman underwent total replacement of her right hip on August 23, 2004; her doctor implanted the Biomet M2a-Taper Device. According to the complaint, she subsequently suffered from increasingly debilitating pain, discomfort, soreness, dysfunction, and unequal leg lengths. Eventually, her doctor diagnosed severe soft tissue metallosis of the right hip, and she needed revision surgery to replace the failed device.
Parker Waichman LLP filed the lawsuit on the woman’s behalf on March 28, 2014 in the U.S. District Court for the Northern District of Indiana (case no. 3:14CV642). The case is part of the multidistrict litigation (MDL) before Judge Robert L. Miller, Jr. (MDL no. 3:12-md-2391).
The M2a-Taper Device’s ball and cup are made entirely of metal. Manufacturers developed and marketed metal-on-metal devices with the claim that they would last longer than implants made with a combination of materials, metal on plastic, for example. But the lawsuit alleges that metal-on-metal hip implants have not lived up to the claims and they can release metal particles into surrounding tissues and the bloodstream during normal movement, damaging bone and tissue. The lawsuit alleges that Biomet was aware of the device’s defects but continued to advertise the device as safe and superior, despite the fact that metal-on-metal devices were under scrutiny for high failure rates. The lawsuit alleges the defendants concealed the defects of the device for financial gain and never warned patients or their doctors about the risks.
The U.S. Food and Drug Administration (FDA) has received numerous complaints involving metal-on-metal hip implants since 2006. In January 2013, the agency issued a safety communication about metal-on-metal hip devices, along with new guidelines for monitoring recipients of all-metal hips. Symptomatic patients should undergo physical exams, diagnostic imaging, and blood metal ion testing, the FDA advises. Because of widespread problems with metal-on-metal hips and other implantable medical devices, the FDA is considering changes to the approval process so that every implantable medical device would have to undergo clinical testing before reaching the market.