DePuy Pinnacle Hip injuries prompted filing of a lawsuit that alleges the controversial implant is defective and resulted in the need for revision surgery. The lawsuit also alleges that the DePuy Pinnacle is similar in its defects to the recalled DePuy ASR metal-on-metal implant that has been the subject of nearly 11,000 lawsuits.
Both devices have been accused of allegedly releasing toxic levels of the metals cobalt and chromium into patents’ bloodstreams, which led to pain, device loosening, and the need for complex and painful revision surgery. In this case, brought by a North Carolina woman, the lawsuit was filed by national law firm, Parker Waichman LLP on March 19th in the U.S. District Court for the Northern District of Texas (Docket: 3:13-cv-1171). There, it is one of many cases pending in the multidistrict litigation (MDL) entitled In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation (MDL No. 3:11-md-02244). DePuy Orthopaedics, Inc. and Johnson & Johnson have been named as defendants.
The complaint states that the woman was implanted with the DePuy Pinnacle hip implant on her right side on May 3, 2010. She then suffered from a number of injuries and complications that were allegedly due to the defects of the metal-on-metal Pinnacle, including extreme pain, discomfort, and component loosening, which led to her having to undergo revision surgery to remove and replace the Pinnacle. The lawsuit also alleges that these damages resulted from the defective design of the Pinnacle implant, and that Johnson & Johnson and DePuy concealed the known defects of the device.
The lawsuit also indicates that the woman would never have agreed to be implanted with the Pinnacle had she been aware of its high failure rate and other known risks. She is suing for lost wages; past, present, and future physical and mental pain and suffering; and past, present, and future medical expenses. Also, according to the lawsuit, the Pinnacle hip device is a metal-on-metal device when used with the metal acetabular liner, known as the “Ultamet,” and alleges that the Pinnacle has similar defects to the DePuy ASR, which was recalled in 2010 over its high failure rate. Allegedly, the Pinnacle is defective in nature over its release of toxic ions into patients bodies.
The lawsuit points out, the DePuy Pinnacle and other metal-on-metal hip implants were approved through the 510(k) route. This process exempts the need for clinical safety tests as long as manufacturers can argue that the device is similar enough to a previously approved product. As we’ve explained, following the outcry over the ASR and other all-metal devices, such as the Pinnacle, the U.S. Food and Drug Administration (FDA) is now trying to impose stricter regulations for metal hip makers. The agency has proposed that the devices go through pre-market approval, rather than the fast-tracked 510(k); the proposed process would require manufacturers to conduct clinical tests for safety and efficacy before obtaining approval.
Most Pinnacle lawsuits center on the overarching problem seen in many metal-on-metal hip implant devices—a defect that puts recipients at serious risk of permanent injuries such as tissue and organ damage. Like other metal-on-metal hip implants, the DePuy Pinnacle model is prone to disperse tiny metal fragments through normal wear-and-tear of the device, which causes an accumulation of the toxic metals cobalt and chromium in a recipient’s body. Should this issue remain undetected, the patient could be placed at risk for dangerous complications, including pseudo-tumors in the muscle, tissue death, and organ damage.
People who’ve received the Pinnacle hip implant have also reported pain and inflammation at the site of the implant, popping and squeaks from that area, and complete device failure. Although the Pinnacle and other metal-on-metal implants were touted as an option for younger recipients because they’re allegedly designed to last longer than traditional implants, the opposite has proven true.