Texas federal Judge Ed Kinkeade has refused to delay the scheduled September trial in the ongoing multidistrict litigation involving DePuy Orthopaedics Pinnacle metal-on-metal (MoM) hip implants.
DePuy Orthopaedics requested the delay after a March trial resulted in a $502 million award to five plaintiffs who alleged serious injuries from DePuy Pinnacle hip devices. DePuy wanted the September trial delayed until the appeal of the March verdict had been decided but Judge Kinkeade ruled that the September trial would go forward.
The five plaintiffs in the March case had been chosen as representative cases from among thousands of lawsuits filed against DePuy Orthopaedics. These five hip recipients alleged that Pinnacle hip replacement devices caused painful complications including difficulty standing or walking; loosening of the hip implant; pain radiating to the groin and back; tissue death; bone and soft tissue damage; and metal poisoning. The devices shed metal ions into the bloodstream when the metal ball rubs against the metal cup during normal movement.
When metal-on-metal (MoM) hip devices came to market, surgeons and patients had high expectations for a device that would last longer than older designs and offer greater range of motion. With increasing numbers of people undergoing hip replacement at earlier ages in order to maintain an active life style, doctors were looking for longer-lasting hip devices. Hip implants typically last about 15 years, so younger hip replacement patients face the prospect of needing two or even three hip replacements in their life time. MoM hips not only failed to meet expectations but they have been associated with high early failure rates and painful complications.
Many MoM hip recipients have needed to have revision surgery within a few years of the original surgery to remove and replace failed implants. Revision surgery is often more difficult and less successful than the original surgery because the failed implant has caused bone and tissue damage. In 2010, DePuy recalled the similar ASR metal-on-metal hip but the company, a subsidiary of Johnson & Johnson, has never recalled the Pinnacle hips. In 2013, the company began a settlement program to resolve the legal claims brought by ASR recipients.
A number of expert witnesses testified at the Dallas trial, including Dr. Bernard Morrey, a joint replacement surgeon who has taught at the Mayo Clinic for more than 30 years. Dr. Morrey said he has never used MoM hips for his patients. Other expert testimony came from toxicologists and surgeons involved in the design of DePuy hip. Timothy Ulatowski, a Food and Drug Administration regulatory consultant with 37 years at the FDA testified. Many of the lawsuits criticized the 510(k) device approval process that allows devices to receive approval without clinical testing if they are considered substantially equivalent to a device already on the market. But critics note that even small changes in design and materials can have major impact on a device’s performance and durability and therefor all devices should be subject to clinical testing. The FDA is expected to make changes that would require a stricter approval process before metal-on-metal hips are approved.