Texas Judge Rejects Delay for September DePuy Hip Implant TrialJul 25, 2016
Federal Judge Ed Kinkeade of the U.S. District Court for the Northern District of Texas will not grant a delay in the 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 ended in a $500 million award to five plaintiffs who alleged they suffered injuries from DePuy Pinnacle hip devices. DePuy wanted the September trial delayed until the appeal of the March verdict has been resolved.
The five plaintiffs in the Dallas case were chosen as representative cases from among thousands of lawsuits filed against DePuy Orthopaedics. The five hip recipients alleged that their Pinnacle hip replacement devices caused painful complications. They reported difficulty standing or walking; loosening of the hip implant; groin and back pain; tissue death; bone and soft tissue damage; and metal poisoning.
Metal-on-metal (MoM) hip devices came to market with the promise that they would last longer than older hip designs and therefore be a better choice for younger, more active patients seeking to maintain an active life style. Hip implants typically last about 15 years, so younger people undergoing hip replacement face the prospect of two even three hip replacements in their life time. Surgeons and patients were looking for a hip device that would last longer, but MoM hips did not live up to 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 their 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.