According to Complaint, Plaintiff Suffered Two Dislocations Within a Month of Receiving a Metal-on-Metal DePuy Pinnacle Hip Implant in His Left Hip. Plaintiff Claims the Metal-on-Metal Pinnacle Hip Replacement Was Not Sufficiently Tested by the Defendants, and was Never Approved by the FDA as Being Safe or Effective for the Products’ Intended Purpose.
The nationwide law firm of Wright & Schulte LLC, which represents the victims of defective medical devices, has filed a lawsuit on behalf of a Cincinnati, Ohio, man who suffered two hip dislocations within a month of undergoing total hip replacement surgery on his left hip with DePuy Orthopaedics’ metal-on-metal Pinnacle hip replacement device. The lawsuit, which was filed on August 12, 2012, is just one of hundreds of similar claims pending in IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation (MDL 2244), currently underway in U.S. District Court, Northern District of Texas (Case No. 3:12-cv-03143-D).
According to the Complaint, the Plaintiff received a DePuy Pinnacle hip implant in his left hip on August 29, 2006. He experienced his first dislocation on September 18, 2006, forcing him to undergo a closed reduction procedure. On September 29, 2006, he experienced a second dislocation. Among other things, the lawsuit alleges the Plaintiff faces possible metal poisoning, bone loss, chronic pain, a decrease in his quality of life and other serious medical problems. As a result, he will be forced to undergo painful, complex and risky surgeries (known as a “revision surgery”) to remove and replace the metal-on-metal components that are defective.
According to the lawsuit, the Pinnacle implant the Plaintiff received was different from most hip replacement devices, which use a polyethylene plastic acetabular liner, in that it uses a metal acetabular liner. The complaint alleges this design was not sufficiently tested by the Defendants, and was never approved by the U.S. Food & Drug Administration (FDA) as being safe or effective for its intended purpose. Among other things, the lawsuit points out that the Pinnacle device implanted in the Plaintiff was approved via the FDA’s 510(k) process, which allows device manufacturers to bypass the agency’s rigorous premarket approval process if the device is “substantially equivalent” to another previously-approved product. As a result, the Pinnacle implant was not required to undergo clinical trials.
The lawsuit further alleges the Pinnacle device the Plaintiff received is similar in design to the metal-on-metal ASR and ASR XL hip implant, which DePuy recalled in August 2010, and should have been recalled as well. The Plaintiff asserts that the metal-on-metal Pinnacle hip replacement suffers from one or more similar design or manufacturing defects that cause excessive amounts of cobalt and chromium to wear from the implant. These cobalt and chromium fragments prompt the body to react by rejecting the hip implant, manifesting with symptoms that include dislocation and pain. This metal reaction often causes fluids to accumulate and soft tissues and bone to die in the area surrounding the implant, according to the Complaint.
It is estimated that some 500,000 people in the U.S. have been implanted with metal-on-metal hip replacement devices over the past decade. According to a report from The New York Times, data now indicates that all-metal hip implants are more likely to fail than devices made from other materials. In May 2011, the FDA ordered five producers of metal-on-metal hips to undertake studies to assess the safety of metal-on-metal hip implants. This past summer, an FDA advisory panel recommended that patients with metal-on-metal hip implants should be regularly monitored via imaging tests and blood screening to ensure that the devices are not failing or shedding dangerous levels of metal ions.
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Wright & Schulte LLC, a personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged, and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free case evaluations are available through www.yourlegalhelp.com, or call 1-800-399-0795.
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