January 30, 2013 — Bloomberg reports that expert witness testimony was presented this week at the first trial in the DePuy ASR hip implant litigation. George Samaras, a consultant to Johnson & Johnson’s DePuy Orthopedics unit, testified that the ASR hip implant produced 16-times more metal debris (chromium and cobalt) than a previous DePuy hip implant. Samaras alleges that the ASR failed DePuy’s own safety tests, but instead of re-designing the implant to fix the problem, the company instead changed the criteria in the test.
The metal-on-metal design of the DePuy ASR was based on the DePuy Pinnacle hip implant. When DePuy received approval for the ASR, they argued that it was “substantially equivalent” to the Pinnacle. Instead of conducting rigorous clinical trials and submitting the results to the FDA, DePuy evaluated the ASR on their own tests that required the ASR to perform at least as well as the Pinnacle.
According to Samaras, the biomedical engineers who conducted the ASR safety tests changed the criteria to ensure the ASR would pass.
Another expert witness, Magnus Flett, worked for the design team at DePuy in charge of overseeing the metal cup portion of the hip implant. He testified that DePuy chose not to re-design the ASR — despite the metal debris issues — for financial and business reasons. He also testified that the rate of revision surgery was 8-times higher for the ASR than the Pinnacle. However, DePuy did not warn surgeons about this substantial increased risk between the two implants.
An epidemiologist from Dartmouth Medical School, Dr. John Barton, also presented testimony regarding data from an Australian joint registry study, which linked the ASR XL to a 44% seven-year failure rate, and a 22% five-year failure rate. Documents unsealed last week reveal that DePuy estimated the five-year failure rate at 36%, though this information was not disclosed publicly.
The testimony was presented in a trial on behalf of Loren Kransky, a man who was implanted with the ASR in 2007. Within a few years, he began suffering from debilitating pain, and doctors found “very alarming” elevated levels of chromium and cobalt in his bloodstream. He underwent surgery to remove and replace the implant in 2012.
Attorneys for DePuy have argued that Kransky’s metallosis is not due to the defective hip implant, but rather his other underlying health conditions. Kransky is currently dying of cancer, and his lawsuit was chosen for the first trial because attorneys were concerned he would not survive to see his case justly resolved.
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