As we have detailed in various blog posts over the recent months, a subsidiary of Johnson & Johnson, DuPuy Orthopaedics, has been under fire for selling medical devices, including the ASR XL Acetabular Hip Replacement System, that have been deemed unsafe or defective.
That hip replacement product, marketed as ASR, began to show problems in patients as early as 2007, although the product was not pulled until 2009, with a major recall occurring in 2010. Now, word is that Johnson & Johnson continued to market the product overseas, even after the FDA rejected its sale in the U.S. due to safety concerns.
Though the product was implanted in approximately 93,000 patients, including in Alabama, and was noted in databases of orthopedic patients to be failing at distriburingly high rates, Johnson & Johnson apparently continued its quest to sell the product.
According to a recent New York Times article, the FDA told Johnson & Johnson back in August 2009 that the company's efforts to get approval in the U.S. to sell the product outside the country were "inadequate." DuPuy reportedly admitted receiving the letter, but it's not clear if or when it disclosed that information to its investors, not to mention doctors or patients.
While the action was not illegal, the revelation that DuPuy continued marketing the ASR product might only further damage its reputation, and continued financial problems may continue to plague it. Potentially thousands of patients have suffered the negative effects of the product, and it's estimated that 5,000 lawsuits have been filed in relation to the defective implants.
Source: New York Times, "Hip implant U.S. rejected was sold overseas," Barry Meier, Feb. 14, 2012




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