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1/29/2013 7:15:06 AM
Johnson & Johnson (JNJ) failed its own safety test in designing an all-metal hip implant and then changed the protocol instead of fixing the flaw, a witness testified in the first of 10,000 lawsuits to go to trial. George Samaras, a consultant, testified yesterday for Loren Kransky, who is suing J&J for defective design and failure to warn over an ASR XL hip he had replaced last year. J&J recalled 93,000 ASR hips in 2010 after saying 12 percent failed within five years. Another witness yesterday said Australian data last year showed the hip failed at a 44 percent rate after seven years. Analysts say the lawsuits could cost J&J billions of dollars. Samaras told jurors in state court in Los Angeles that J&J’s DePuy unit failed the safety standard it set up for the ASR hip cup, in which a metal ball atop the femur rotates. He cited an internal document showing the ASR produced 16 times more chromium and cobalt debris in the body than another DePuy product. While DePuy’s review standards said the ASR should have failed, the company said it passed, Samaras said. “It’s horrible practice,” said Samaras, a biomedical engineer who runs a consulting firm near Pueblo, Colorado. “That’s not what good engineers do. You are playing games with what the requirements for the device are.” The company denies Kransky’s claims, including failure to warn, defective design and negligent recall. In his opening statement, Alexander Calfo, a lawyer for J&J, said the ASR was properly designed. He said claims by Kransky, 65, of elevated metal levels in his body can be traced to his many other health problems, including diabetes, coronary artery disease, high blood pressure, kidney disease, strokes and cancer. Design Criteria: Samaras said DePuy’s original design criteria said the ASR had to be at least as good as predecessor devices at the company. When that failed, DePuy found other devices for comparisons that put the ASR in a more favorable light, he said. “They changed the test,” Samaras said. “They didn’t do what they were supposed to do, which is change the design.” Samaras appeared before John Baron, an epidemiologist at Dartmouth Medical School testified that Australian national registry data showed that the ASR XL failed at a rate of 22 percent after five years and 44 percent after seven years.
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