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Depuy Employees Admit to Poor Testing and Doctors’ Complaints

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

By: Charles Lee

DePuy, a subsidiary of the world’s largest health-care product seller, Johnson & Johnson (JNJ), has been brought to trial in California and soon in many other states. Lost trials will cost the healthcare giant billions of dollars. With a frightening 10,000 lawsuits filed, according to Bloomberg, these suits have taken form to challenge J&J of its design inadequacies of the ASR hip. Just like any daunting surgical operation, persons who have failed hips are medically required to undergo a replacement surgery known as a revision.

Graham Issac, a DePuy engineer based in Leeds, England was questioned in the Kransky trial on the inconsistencies of the hip designs. Evidence was revealed that DePuy had only performed laboratory testing on one of ten ASR cups which all have different diameters. “It was very difficult to test this device,” Isaac said. “It would have been costly and time-consuming to recalibrate simulator machinery and conduct tests on all sizes.” Kelly, attorney for Loren Kransky asked, “Because it was difficult, did you consider not selling them?” Lawyers for Kransky are also litigating that DePuy have been needless in taking shortcuts on design and have pointed out the irresponsibility in releasing a product prior to human testing.

European surgeons reported unexpected problems of pain in patients who had been given an ASR. A surgeon from Northern Ireland, David Beverland, who eventually discontinued the use of ASR, had even noticed an ASR failure rate at approximately 17 percent with a fellow British surgeon, Antoni Nargol. “This ASR problem has been the worst problem I have had in my surgical career — it has been a real nightmare — I am still seeing at least one patient for revision at every problem clinic,” Beverland wrote. Furthermore, according to Graham Issac’s testimony, DePuy did not have a definitive idea on the levels of metal ions that are to be deemed safe in a human body, even though DePuy had marketed and indeed sold unsafe levels of metal ions that lie inside the ASR. “We don’t know and nobody knows,” Isaac said. “We aim to test as much as we can to show the product is safe. We do what we believe is necessary to assure the safety of the product.”

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