In a lawsuit filed on December 16, a Rhode Island couple alleges that the husband’s DePuy Pinnacle hip implant device caused complications including extreme pain and weakness, and elevated chromium and cobalt levels in his bloodstream.
According to the complaint, the man received the Pinnacle hip implant, known as the Pinnacle Acetabular Cup System, on his right side in February 2005. The suit alleges he suffered injuries and complications because of the device’s defective design.
The lawsuit also alleges that defendants, DePuy Orthopaedics and Johnson & Johnson, knew of the potential risks associated with the now-recalled Pinnacle device, but did not disclose this information to the couple, their physician, or the public. The couple claims that if the defendants had disclosed the risks, the man would not have agreed to the Pinnacle hip device in his hip replacement procedure. The complaint notes that over 1,300 adverse event reports have been filed with the U.S. Food and Drug Administration (FDA) over Pinnacle device failures or complications, including hip dislocation, bone fracture, joint infection, local nerve damage, metallosis, numbness/weakness, device loosening and breakage, difference in leg lengths, and bone loss. Some implant recipients have needed revision surgery to remove and replace a failed hip.
The complaint alleges that the Pinnacle device is flawed and, because of this, the metal components shed chromium and cobalt particles within the body when the metal parts of the hip device rub against each other, even during normal activities, such as walking. The couple alleges that the defendants are aware that Pinnacle devices may lead to metallosis and biologic toxicity, and that the devices are associated with premature and high failure rates.
The FDA issued a Safety Alert in January 2013 acknowledging these risks and also issued new guidelines for metal-on-metal hip recipients. The FDA advises symptomatic all-metal hip implant patients to undergo physical examinations, diagnostic imaging testing, and blood metal ion testing.
The FDA has also proposed that medical device manufacturers be subject to stricter guidelines for device approval. The proposal seeks to have device manufacturers prove a device’s safety and efficacy through so-called pre-market clearance, which involves clinical testing. The current 510(k) clearance route allows a device to be brought to market if the manufacturer shows the product is comparable to a previously approved device.
The lawsuit was filed by national law, firm Parker Waichman LLP, in the U.S. District Court for the Northern District of Texas (Case No. 3:13-cv-04891-K) as part of the DePuy Pinnacle multidistrict litigation (MDL No. 3:11-md-02244).