A woman implanted with bilateral DePuy Pinnacle hip devices alleges, in a lawsuit she brought against the device maker, that metal hips are flawed.
Allegations also include that the DePuy Pinnacle hip implant’s metal-on-metal design is defective, causing numerous complications, including the need for early revision surgery to remove and replace the hip implants.
Metal-on-metal hip implants, as a class, have become the subject of safety concerns in the orthopedic community. These devices were approved using the fast-tracked 510(k) approval route, which bypassed clinical testing. Now, studies reveal that metal hip replacements tend to fail more often than other implants.
The hip implants were created for greater durability and longevity and with the intention that the seemingly stronger components would be far superior over their more traditional counterparts constructed with plastic or ceramic elements. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries.
According to the complaint, the plaintiff was implanted with a Pinnacle hip on her left side in January 2007; another Pinnacle hip was implanted on her right side in December 2008. The lawsuit alleges that the implants caused complications, including extreme pain, weakness, and elevated chromium and cobalt levels in her bloodstream. The symptoms were said to have become so severe that she had to undergo revision surgery to correct these problems.
The litigation also alleges that the defendants were aware of the potential for these risks but failed to disclose them to the plaintiff, her doctor, or the public and that the Pinnacle is flawed because the metal-on-metal design causes the shedding of chromium and cobalt particles, which are then released into the body. The plaintiff is suing for, among other things, pain and suffering, emotional distress, and economic loss due to lost wages and medical expenses.
On January 17, the U.S. Food and Drug Administration (FDA) issued a Safety Alert acknowledging these risks, issuing new guidelines for all-metal hip patients. The agency advised that people implanted with all-metal devices undergo physical exams, diagnostics imaging, and metal-ion testing, when necessary. In that same alert, the FDA also proposed new, stricter guidelines that would require manufacturers prove that their devices are safe and effective through clinical testing; this method is referred to as “premarket approval.”
National law firm, Parker Waichman LLP, filed the lawsuit on March 25th in the U.S. District Court for the Northern District of Texas (Case No. 3:13-cv-01247-K) as part of the DePuy Pinnacle multidistrict litigation (MDL No. 3:11-md-02244). DePuy Orthopaedics, Inc. and Johnson & Johnson have been named as defendants.