A Pennsylvania resident claims that DePuy Orthopaedics (DePuy) and Johnson & Johnson failed to adequately warn consumers about the risks and severity of side effects of the DePuy Pinnacle hip implant.

Plaintiff Howard M. has filed a complaint against DePuy and Johnson & Johnson, claiming he sustained severe complications, causing him to be permanently disabled as a direct result of DePuy and Johnson & Johnson’s defective manufacturing and marketing of the Pinnacle hip replacement system.

Howard underwent a total hip replacement procedure on his right hip in January 2009 and left hip in October 2009. He received the Pinnacle Hip Implant metal insert for both surgeries, according to the DePuy hip lawsuit. Shortly after, he allegedly began suffering debilitating pain as well as metallosis, the release of toxic metal ions into his tissue and bloodstream, and was forced to undergo premature hip revision surgery on his left hip to replace the Pinnacle hip implant.

Howard alleges in the DePuy hip lawsuit that the manufacturers took no steps to test the Pinnacle hip replacement system or they would have discovered that it leads to metallosis and other hip replacement complications before releasing it on the market. Instead, the Pinnacle hip implant was certified to be sold on the basis of DePuy’s claim that it was “substantially equivalent” to other older metal-on-metal hip implant devices without conducting clinical trials to review the hip implant’s safety.

DePuy Expedites Pinnacle Hip Implant Approval

The DePuy Pinnacle hip replacement system received FDA approval through the expedited 510(k) process, which only requires a manufacturer to show that its medical device is substantially similar to devices already available on the market. Manufacturers are able to bypass rigorous pretrial testing and FDA inspection.

If DePuy had been required to undergo the standard approval process, it is probable that the severe hip replacement complications stemming from the metal-on-metal hip implants would have been detected and the implants would not have been cleared for patient use.

Pinnacle Hip Implant Lawsuits

J&J’s DePuy division faces more than 6,000 federal multidistrict-litigation lawsuits from former Pinnacle hip recipients who claim injuries that include metal poisoning in their blood. According to the Pinnacle hip lawsuits, patients say the metal-on-metal hip replacement system was defective because pieces rubbed together, causing metal to leach.

The coordinated litigation over Pinnacle metal-on-metal hip implants pending is also known as MDL No. 2244.  The MDL was established in May of 2011. As of June 2014, more than 6,400 individual lawsuits have been filed in the national multi-district litigation proceedings that are pending before Judge Kinkeade in federal court in Dallas, Texas.

The DePuy Metal Hip Replacement Lawsuit filed by Howard M. is Case No. 3:14-cv-03251-K (MDL No. 2244) in the United States District Court Northern District of Texas.