DePuy Pinnacle Recall Should Have been Issued Years Ago: Lawsuit

According to allegations raised in a DePuy Pinnacle hip lawsuit filed earlier this month by a Pennsylvania woman, the manufacturer of the implant used during her hip replacement has known for some time that it was a defective and dangerous device, and should have removed it from the market years ago. 

The complaint was filed on April 5 by Anna Maria Sillman in The U.S. District Court for the District of New Jersey against DePuy Orthopaedics, Inc., Johnson & Johnson and the designer of the metal-on-metal hip replacement.

The DePuy Pinnacle hip system was introduced in 2001, with some variations containing a metal liner instead of a polyethylene liner, which can result in microscopic metal particles being shed into the body as the metal parts of the hip replacement rub against each other. This can lead to inflammation, swelling, loosening of the parts and ultimately may cause the hip replacement to fail, resulting in the need for hip revision surgery.

According to allegations raised in the complaint, the defendants had received hundreds of adverse event reports of DePuy Pinnacle hip problems before Sillman had her hip system implanted. Sillman argues that based on information available to the manufacturers, a DePuy Pinnacle hip recall should have been issued before January 2004.

A growing number of people throughout the United States have filed a similar DePuy Pinnacle recall lawsuit against Johnson & Johnson and their DePuy Orthopaedics subsidiary, arguing that the implant should have been removed from the market.

The companies did issue a recall for the DePuy ASR hip replacement system in August 2010, due to problems that are similar to what has been reported in connection with the Pinnacle hip. The DePuy ASR was approved by the FDA in 2005 as a “substantially equivalent” design to the DePuy Pinnacle. Post-marketing data provided at the time of that recall indicated that the DePuy ASR failure rate was about 12-13%, but some estimates suggest that nearly half of the recalled ASR hip replacements may lead to problems within six years.

Over the past year, concerns about metal-on-metal hip replacements have been growing. In October, the American Academy of Orthopaedic Surgeons (AAOS) issued a warning about potential problems with metal on-metal hip replacements, indicating that patients and the medical community should be aware that pain months after hip replacement surgery may be a sign of metal-on-metal hip cobalt toxicity. In addition, the FDA launched a new website in February to provide information about the risks associated with metal-on-metal hip replacements.

As a result of the growing number of DePuy Pinnacle lawsuits that have been filed in federal district courts throughout the United States by individuals who have experienced problems with their hip replacement, a motion was filed last month to consolidate the DePuy Pinnacle litigation before on judge for coordinated handling. The DePuy ASR hip recall litigation is already consolidated as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Ohio before U.S. District Judge David A. Katz.