Recently, the U.S. Food and Drug Administration (FDA) proposed stricter regulations for the approval and sale of metal-on-metal hip implants such as the DePuy Pinnacle.
(PRWEB) January 22, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit alleging the DePuy Pinnacle hip implant is defective and caused substantial injuries in a Virginia woman. The suit 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). It has been filed into the multidistrict litigation 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.
According to the Complaint, the Plaintiff 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 device. She 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 alleges that the Defendants were aware of the defects associated with the DePuy Pinnacle but concealed this knowledge from the Plaintiff.
Recently, the U.S. Food and Drug Administration (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 permits devices to be sold without any clinical testing for safety or efficacy as long as the product is deemed “substantially equivalent” to a previous device. The new regulations would require manufacturers to conduct clinical safety tests before seeking approval for the implant.
The lawsuit alleges that if the Defendants had conducted clinical safety tests before selling the device, they would have discovered that the Pinnacle leads 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.
Parker Waichman LLP continues to offer free legal consultations to victims of DePuy Pinnacle and other metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with an all-metal DePuy Pinnacle Hip Implant or other metal-on-metal hip replacement device, please contact their office by visiting the firm's DePuy Pinnacle hip implant lawsuits page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney