In re DePuy Orthopaedics ASR and Pinnacle Hip Implant Litigation Lawsuit

In re DePuy Orthopaedics ASR and Pinnacle Hip Implant Litigation

Product and manufacturer

The litigation concerned two orthopaedic devices made by DePuy Orthopaedics, Inc., the orthopaedic division of Johnson & Johnson: the ASR XL Acetabular System, a metal-on-metal hip resurfacing implant, and the Pinnacle Acetabular Cup System, a component used in hip replacement surgery. The ASR system was used in hip resurfacing and total hip replacement procedures, and approximately 93,000 patients worldwide received the implant before it was withdrawn.

Defect and harm

Clinical data and registry reporting indicated an unacceptably high early failure rate for the ASR implant, on the order of one patient in eight within five years of implantation. Identified failure modes included component loosening, component malalignment, infection, fracture of the bone, dislocation, and metal sensitivity or pain. Additional complications associated with the system included elevated metal ion levels in the blood, bone staining, necrosis, swelling, and nerve, tissue, or muscle damage. Even where a failing implant was removed, it could leave behind metallic fragments that might not be discovered for years. In 2010 DePuy recalled the ASR XL Acetabular System and subsequently phased the product out of the market; the company had issued warnings to doctors and patients about the elevated early failure rate before the recall was made, and it later characterized its earlier public statements about a recall as having been inaccurate.

Litigation course

Patients who required revision surgery filed products-liability claims against DePuy in state and federal courts across the United States. The ASR cases were centralized as In re DePuy Orthopaedics ASR and Pinnacle Hip Implant Litigation, docket 1:10-md-2197, in the United States District Court for the Northern District of Ohio, before MDL transferee Judge Jeffrey J. Helmick; the consolidated docket was filed on September 3, 2010. Cases involving the Pinnacle acetabular cup system were centralized separately in the United States District Court for the Northern District of Texas, before Judge James E. Kinkeade, where they proceeded through a series of bellwether trials drawn from plaintiffs in different states. Outside the United States, related class proceedings were brought in Australia against the DePuy and Johnson & Johnson entities, alleging defective design and failure to warn.

Outcome

In 2013 Johnson & Johnson announced a global settlement of the ASR action, under which the company agreed to resolve the claims of patients who had received the recalled implant, while continuing to deny wrongdoing. The matter is accordingly recorded as resolved in 2013 by settlement. The Pinnacle litigation continued after that resolution, with further bellwether trials conducted in the following years.

The MDL remains formally open for residual matters.