In a lawsuit being tried in U.S. District Court in Dallas, Texas, an attorney said Johnson & Johnson knew in 2001 of concerns about metal poisoning with the DePuy Pinnacle artificial hip.
Dr. Thomas Schmalzreid, a doctor who consulted with DePuy on the development of the hip, told the company in February 2001 that implant patients should be tested to determine whether they had metal debris in their bloodstreams, Bloomberg News reports. In an internal memo, DePuy officials Schmalzried warned about the possible release of metal ions as the parts of the hip rubbed against each other during normal activity. He called this a “major issue for metal-on-metal hips.” Andrew Ekdahl, former president of DePuy and now chairman of J&J’s DePuy Synthes unit, denied that company officials considered reducing marketing efforts because of these concerns.
More than 6,000 cases have been filed over the Pinnacle hips; this is the first case to go before a jury. Montana graphic artist Kathleen Herlihy-Paoli sued the company over her two hip implants. Her suit alleges that because of faulty design the Pinnacle hip produced cobalt and chromium debris that leached into her body. A resulting infection necessitated the removal and replacement of both hips, according to Bloomberg News. Reports filed with the Food and Drug Administration (FDA), indicate that recipients of metal-on-metal hip implants have suffered a variety of complications including hip dislocation, bone fracture, infection, nerve damage, metallosis, numbness/weakness, device loosening, difference in leg lengths, and bone loss. Many have needed additional surgery to replace the implants.
Herlihy-Paoli’s attorney said 2012 company files show the Pinnacle hips had a 15 percent failure rate five years after implantation, where the company expected a 5 percent rate. Further, the attorney said, the company misled the public in a 2007 marketing brochure in which DePuy claimed 99.9 percent of the devices were “still in use after five years,” Bloomberg News reports. The attorney said company files indicate that Connecticut orthopedic surgeon Dr. John Irving repeatedly contacted DePuy about high failure rates with the Pinnacle metal hips, saying he considered it “borderline unethical” to market the hips until the issues were resolved.