Meanwhile, the U.S. Food and Drug Administration (FDA) recently issued new guidelines for metal-on-metal hip implants such as the DePuy Pinnacle; the agency is also looking to tighten regulations on how these devices are approved.
According to the complaint, the Virginia woman received the DePuy Pinnacle hip implant on her left side in 2010. Thereafter, she suffered a number of injuries and damages, allegedly due to the defective and harmful nature of the Pinnacle device. The woman is suing for past, present, and future physical and mental pain and suffering along with past, present, and future medical expenses and lost wages.
The lawsuit was filed on January 18, 2013 in the U.S. District Court for the Northern District of Texas (Case No. 3:13-cv-00254-K). The suit has been filed into 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 lawsuit also alleges that DePuy and Johnson & Johnson were aware of the defects associated with the DePuy Pinnacle, but concealed this knowledge from the plaintiff.
Recently, the FDA proposed stricter regulations for the approval and sale of metal-on-metal hip implants such as the DePuy Pinnacle. Currently, the devices go through the 510(k) process, which is a fast-tracked regulatory process that permits devices to be sold without any clinical testing for safety or efficacy as long as the product is deemed “substantially equivalent” to a prior device. The new regulations would require manufacturers to conduct clinical safety tests before seeking approval for the implant.
The lawsuit also alleges that if the defendants had conducted clinical safety tests before selling the device, they would have discovered that the Pinnacle’s defects lead to metallosis, biological toxicity, and an early and high failure rate due to the release of metal particles from the device when the surfaces of the implant rub together.
The FDA has also recently issued new guidelines for patients with metal-on-metal hip implants. The agency has recommended yearly physicals and routine radiographs, along with diagnostic imaging such as CT scans or MRI. For the first time, the FDA is also recommending that symptomatic patients be considered for metal ion testing.
From a legal standpoint, these changes are an important step in attempting to hold manufacturers responsible for dangers associated with their products.