New York, New York (PRWEB) December 18, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a Rhode Island couple; the male Plaintiff was implanted with a DePuy Pinnacle hip. The lawsuit was filed on December 16, 2013 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). DePuy Orthopaedics, Inc. and Johnson & Johnson are the Defendants.
According to the Complaint, the male Plaintiff was implanted with a Pinnacle hip, known as the Pinnacle Acetabular Cup System, on his right side, on or about February 7, 2005. The lawsuit alleges that the Pinnacle device’s defective design caused the male Plaintiff complications that include, among other injuries, extreme pain, weakness, and elevated chromium and cobalt levels in his bloodstream. The suit also seeks compensation for loss of services and loss of consortium on behalf of his spouse.
The lawsuit alleges that the Defendants knew about the potential for these risks associated with the Pinnacle device, yet neglected to disclose information on these risks to the Plaintiffs, their physician, or the public. The Plaintiffs allege 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. The lawsuit also alleges that the defendants are aware that the all-metal Pinnacle devices may lead to metallosis, biologic toxicity, and a high failure rate in people who are implanted with the hip devices.
The Plaintiffs allege that, had the Defendants not concealed the Pinnacle device’s known defects and complications, early failure rate, and unreasonable risks, the male Plaintiff would not have consented to have been implanted with the Pinnacle device in his total hip arthroplasty procedure.
The lawsuit also alleges that the Pinnacle device is flawed because its all-metal construction causes chromium and cobalt particles to shed within the body. Meanwhile, the FDA issued a Safety Alert on January 17, 2013 that acknowledged these risks and also issued new guidelines for metal-on-metal hip recipients. The guidelines advise that symptomatic all-metal hip implant patients undergo physical examinations, diagnostic imaging testing, and blood metal ion testing. The FDA also proposed that manufacturers of these devices be subject to new, stricter guidelines that mandate they prove device safety and efficacy through so-called “pre-market approval,” or clinical testing. The prevailing clearance route—the 510(k)—simply requires device makers show that their products are comparable to a previously approved device that has been released to the market.
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 have experienced premature failure of your implant, or other health problems associated with the Pinnacle or other metal-on-metal hip replacement device, please contact its office by visiting the firm's DePuy Pinnacle hip implant lawsuits page at yourlawyer.com. Free case evaluations are also available by calling 1-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney