J&J Knew of Metal Poisoning Concern with Hip Implants in 2001, Attorney SaysSep 10, 2014
Testimony in the first case to go to trial over the DePuy Pinnacle artificial hip indicates that the company knew as early as 2001 the metal-on-metal hip implant might generate debris that could cause metal poisoning.
A doctor who consulted with Johnson & Johnson’s DePuy unit told the company in February 2001 that implant patients needed testing to determine whether they had metal debris in their bloodstreams, Bloomberg News reports. In an internal memo, DePuy officials said Dr. Thomas Schmalzried warned that the potential release of metal ions as the parts of the hip rub against each other during normal activity was a “major issue for metal-on-metal hips.” Andrew Ekdahl, former president of DePuy and now chairman of J&J’s DePuy Synthes global orthopedics business, denied that officials considered cutting marketing efforts over Schmalzried’s concerns.
A Montana woman, Kathleen Herlihy-Paoli, is suing the company over her two hip implants. This is the first of more than 6,000 cases over the Pinnacle hips to go before a jury. In reports filed with the Food and Drug Administration (FDA), recipients of metal-on-metal hip implants say the devices caused complications including hip dislocation, bone fracture, infection, nerve damage, metallosis, numbness/weakness, device loosening, difference in leg lengths, and bone loss. Herlihy-Paoli alleges that because of faulty design the Pinnacle hip produced cobalt and chromium debris that leached into her body, causing an infection that necessitated the removal and replacement of both hips.
Her attorney said that internal files from 2012 showed DePuy officials found the metal Pinnacle hips had a 15 percent failure rate five years after implantation, where the expected failure rate was 5 percent. The attorney said the company misled the public in a 2007 marketing brochure, which said 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 officials about high failure rates with the Pinnacle metal hips. He said he considered it “borderline unethical” to market the hips until the issues were resolved.