01222017Headline:

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Greg Webb
Greg Webb
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Early DePuy ASR Failure Data Not Disclosed

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Critical design flaws in the DePuy Articular Surface Replacement (ASR), the replacement hip joint, marketed by Johnson & Johnson (J&J) were kept under wraps by the Company, according to “internal documents disclosed during a trial related to the device’s failure.” The New York Times reported that information related to the hip joint’s design flaws was kept from physicians, as well as patients, even while doctors complained about the device’s tendency to shed metal debris after implantation. J&J (DePuy’s) records indicate the design of the hip joint components caused wear and shedding of metallic particles into the surrounding body tissue.

While results of J&J’s own 2007 tests comparing the ASR’s ability to perform to another company’s hip implant were disappointing, the ASR continued to be marketed. J&J ’s leadership maintained the hip joint was still working well as physicians began complaining that the implant was failing too soon in patients, causing additional surgeries to have to be performed.

The ASR hip implant was installed in 93,000 patients worldwide. Meier’s article estimates one third of the implants were placed in U.S. patients. On January 25, documents were presented in the first ASR-related lawsuit to go to jury trial in Los Angeles Superior Court. Since the resurfacing version of the ASR was introduced a decade ago, many surgeons have avoided that class of device because their “components can grind together” with deleterious results. (The New York Times, 1/25/13)

According to the New York Times article, DePuy officials did not release information to physicians that the DePuy hip joint “did not match the wear rate of an all-metal hip implant made by the company.” (The New York Times, 1/25/13) Still, a DePuy lawyer, Alexander Calfo, maintains that DePuy acted ethically, while Michael A. Kelly, representing plaintiff Loren Kransky, stressed that the “company executives’ concerns for profits exceeded their worries about patients.” With at least 10,000 lawsuits in the United States related to the ASR hip implant, all eyes will be focused on the outcome of this particular trial.