Federal Judge Ed Kinkeade of the U.S. District Court for the Northern District of Texas has ruled that the September trial in the ongoing multidistrict litigation involving DePuy Orthopaedics’ Pinnacle metal-on-metal (MoM) hip implants can go forward.
DePuy requested a delay for the September trial, after a March trial ended in a $500 million award to five plaintiffs who alleged they suffered injuries from DePuy Pinnacle hip devices. The five plaintiffs were chosen as representative of thousands of others who filed lawsuits against DePuy Orthopaedics.
The five plaintiffs alleged that their Pinnacle hip replacement devices caused painful complications, including difficulty standing or walking; loosening of the hip implant; groin and back pain; tissue death; bone and soft tissue damage; and metal poisoning.
When metal-on-metal hip devices came to market, they were expected to be more durable than older hip designs and therefore a better choice for younger, more active patients who wanted to maintain an active life style. Hip implants of older design typically last about 15 years, so people having hip replacement at younger ages find themselves facing the prospect of having to undergo hip replacement two or even three times. Surgeons and patients were looking for hip devices that would last longer, but metal-on-metal hip implants did not live up to those expectations.
Metal-on-metal hips implants like the DePuy Pinnacle hip have been associated with high early failure rates and complications. The devices shed metal debris into the bloodstream when the surfaces of the implant rub together during normal movement. Many recipients have had to undergo additional surgery—revision surgery—to remove and replace failed implants within a few years of the original surgery. Revision surgery is often more difficult and less successful than the original surgery because of bone and tissue damage. DePuy recalled its similar ASR metal-on-metal hip in 2010 but DePuy has never recalled the Pinnacle hips. In 2013 the company set up a settlement program to resolve the legal claims of ASR recipients.
Among the expert witnesses who testified at the Dallas trial was implant surgeon Dr. Bernard Morrey. Dr. Morrey, a well-regarded joint replacement surgeon, has taught at the Mayo Clinic for more than 30 years. Dr. Morrey told the jury he has never used MoM hips for his patients.
Toxicologists and surgeons involved in the design of DePuy hip also testified, as did Timothy Ulatowski, an FDA regulatory consultant who spent 37 years at the FDA. Many lawsuits have assailed the device approval process that did not require clinical testing for many metal-on-metal hips. Instead, these devices used the streamlined 510(k) approval process that allows a manufacturer to avoid clinical testing if a device is 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 the device and all devices should be subject to stricter requirements. The FDA is expected to make changes that would require a stricter approval process before metal-on-metal hips are approved.