...the lack of clinical testing for metal-on-metal hips has been a growing concern among hip patients and healthcare professionals, so much so that the U.S. Food and Drug Administration (FDA) is now proposing stricter regulations to approve the devices.
(PRWEB) January 23, 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 Virginia man who suffered substantial injuries, allegedly due to the DePuy Pinnacle hip implant. 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-00251-K), where thousands of other lawsuits are 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.
According to the Complaint, the Plaintiff was implanted with the DePuy Pinnacle hip implant in his left hip in March 2008. Thereafter, he suffered from extreme pain, resulting in the need for future revision surgery. The lawsuit alleges that the Plaintiff’s injuries are a direct result of the Defendants’ wrongful or negligent actions. Allegedly, the hip makers concealed the high number of defects related to the device, placing the Plaintiff and other consumers at risk. The suit alleges that if the Plaintiff was adequately informed of these risks he would never have agreed to have the hip implanted. The Plaintiff is suing for past, present and future physical and mental pain and suffering along with past, present and future medical expenses and other expenses related to a new lifestyle.
The lawsuit alleges that the DePuy Pinnacle is defective in its metal-on-metal design and can cause a number of serious complications when metal ions are released from the implant into the body, including metallosis, pseudotumors, infection, inflammation, severe pain or discomfort, death of surrounding tissue and bone loss and lack of mobility. The suit also alleges that the Defendants would have known about these defects if they had bothered to test the device before seeking approval.
In fact, the lack of clinical testing for metal-on-metal hips has been a growing concern among hip patients and healthcare professionals, so much so that the U.S. Food and Drug Administration (FDA) is now proposing stricter regulations to approve the devices. The new regulations would require hip makers to conduct clinical tests for safety and efficacy before selling metal-on-metal hip implants. Currently, the implants go through the 510(k) route, which exempts the need for clinical testing as long as the device is similar enough to a previously approved product.
The FDA also recently warned that metal-on-metal hip implants can release metal ions when a patient walks or runs. This metallic debris is released into the blood stream and tissue surrounding the implant, which can lead to an adverse local tissue reaction in which bone and soft tissues are damaged. The agency has recommended metal ion testing for symptomatic patients. Routine physical examinations and diagnostic imaging such as CT scans were also advised. The FDA advised patients to speak with their doctor if they experience pain, swelling or sounds coming from the hip such as popping, clicking or squeaking.
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