A lawsuit filed on behalf of a Pennsylvania man who alleges that his metal-on-metal DePuy Pinnacle hip implant caused a variety of complications, including pain, weakness, and elevated chromium and cobalt levels in his blood.
According to the complaint, the Pinnacle hip device, which was implanted in March 2010, is of defective design; the plaintiff alleges the Pinnacle is responsible for the complications he has suffered. The lawsuit also alleges that the defendants were aware of the device’s potential risks but failed to disclose them to the plaintiff, his doctor, or the public. The complaint notes that more than 1,300 adverse event reports involving the Pinnacle hip have been filed with the U.S. Food and Drug Administration (FDA). Had the defendants revealed the risks, the plaintiff says he would not have consented to having the Pinnacle hip implanted, according to the lawsuit. DePuy Orthopaedics, Inc. and Johnson & Johnson are the defendants.
The lawsuit also alleges that the Pinnacle hip’s all-metal design is flawed. Many believe that chromium and cobalt particles are shed into the bloodstream when the device’s metal parts rub against each other during normal movement, such as walking. In January 2013, U.S. Food and Drug Administration (FDA) issued a Safety Alert describing the risks. In addition, the agency issued new guidelines for metal-on-metal hip recipients, advising that symptomatic patients undergo physical exams, diagnostic imaging, and blood metal ion testing. The FDA is also considering stricter guidelines for clearance of medical devices, including clinical testing for all devices rather than the current 510(k) process, which allows a device to reach the market if it is shown to be comparable to a previously approved device.
The lawsuit was filed in October on behalf of the defendant by Parker Waichman LLP in the U.S. District Court for the Northern District of Texas (Case No. 3:13-cv-04219-K) as part of the DePuy Pinnacle multidistrict litigation (MDL No. 3:11-md-02244).