DePuy Orthopaedics Inc. (DePuy), a unit of Johnson & Johnson (acquired in 1998) which describes itself as the first commercial orthopedics company in the United States, produces several hip replacement systems marketed to physicians in the United States and abroad. More than 7,000 complaints have been filed in the current mass tort action regarding the metal-on-metal Pinnacle Acetabular Cup System (Pinnacle device), although no Pinnacle device recall has occurred to date. The Pinnacle device and pending claims are similar to the ongoing litigation against DePuy regarding its ASR™ XL Acetabular Hip System (ASR) and ASR™ Hip Resurfacing System.
The U.S. Food and Drug Administration (FDA) approved the Pinnacle device metal liner 510(k) application, based on a similar DePuy product previously approved. The metal liner is intended to reduce friction between and improve the fit of the ball-and-socket features that comprise DePuy hip implant devices. The Pinnacle device design differs from the ASR metal-on-metal construction in that it is available in several versions for surgeons to select based on individual patient needs: ceramic-on-polyethylene, ceramic-on-ceramic, metal-on-polyethylene, ceramic-on-metal, and metal-on-metal. Two of these designs include an interface of different metals. One design involves a titanium, porous acetabular shell with a chrome/cobalt acetabular insert, which design includes a large “crevice” between the different metal surfaces and substantially increases product corrosion. Also of concern is the chrome/cobalt acetabular insert contact with the chrome/cobalt femoral head. The FDA has expressed concern over the risk of danger to patients when both surfaces are made of the same metal. A third area of concern is where the chrome/cobalt femoral head connects with the titanium femoral stem, where motion and friction at the connection site significantly increases the risk of Pinnacle device failure due to “metallosis” resulting from corrosion of the metal, a condition in which metal particle debris is released into the blood with damage resulting to the tissue surrounding the implant.
Problems that have been reported when a metal liner is used with the Pinnacle device include:
Depuy stopped selling the metal-on-metal version of the Pinnacle device in August 2013 after the FDA stated it would require device makers to submit new versions of the hip implant for pre-market approval.
The Pinnacle device MDL was established in the Northern District of Texas U.S. District Court (U.S. District Judge Ed Kinkeade) in May 2011 (DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244). The court has designated ten cases to be prepared for trial in 2015, following an October 2014 defense verdict in the first Pinnacle device case that went to trial. In the related ASR proceedings, Johnson & Johnson agreed to pay $2.5 billion in November 2013 to settle 7,500 of the ASR cases. The ASR settlement agreement provides a $250,000 base award to U.S. citizens and residents who are more than 180 days from their hip replacement surgery, and prior to August 31, 2013, had to undergo revision surgery to remove the faulty ASR product.