January 30, 2013 — Bloomberg has reported on testimony presented this week in a trial involving the DePuy ASR hip implant. Officials at Johnson & Johnson’s DePuy Orthopedics unit knew that the ASR failed the company’s own safety tests, but instead of fixing the problem, they changed the testing criteria. The testimony was presented by George Samaras, a consultant who saw internal documents that showed the ASR released 16-times more chromium and cobalt debris than another DePuy hip implant.
DePuy designed the ASR hip implant as a successor to the Pinnacle hip implant. Because DePuy argued the ASR was “substantially equivalent” to the Pinnacle, they did not need to submit clinical data to the FDA before gaining approval for the product. Instead, the company conducted their own tests which required the ASR to perform at least as well as other metal hip implants.
When the DePuy ASR failed to meet expectations in the company’s own safety tests, the biomedical engineers who ran the test changed the criteria to ensure the ASR passed, according to Samaras.
Magnus Flett, a leader who oversaw a design team overseeing the metal hip implant cups, alleged that DePuy did not redesign the ASR cup due to financial and business reasons. He testified that the company did not bother to warn surgeons that the ASR was linked to an 8-fold increased risk of revisions surgery than the Pinnacle.
Another witness in the trial was Dr. John Barton, an epidemiologist from Dartmouth Medical School. He presented evidence from an Australian joint registry linking the ASR XL to a 22% failure-rate after five years and a 44% failure-rate after seven years. Last week, documents were unsealed that showed DePuy estimated the ASR five-year failure-rate at about 37%.
The lawsuit has been brought on behalf of Loren Kransky, a retired prison guard who was first implanted with the ASR in 2007 and required revision surgery in 2012. His doctors said that he hd “very alarming” levels of chromium and cobalt as a result of his defective hip implant.
Lawyers for DePuy have argued that the elevated levels of metal in Kransky’s body are not due to the hip implant, but rather other health problems are to blame. Kransky’s lawsuit was chosen for the first trial because he is dying of cancer. He also suffers from diabetes, coronary artery disease, high blood pressure, kidney problems, and strokes.
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