January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
It is not surprising that as time passes we are learning more and more about how DePuy and Johnson & Johnson put profits over patients.
First, it was the recall of the ASR XL Hip System. Next, we learned that DePuy and Johnson & Johnson sold medical devices that were misbranded or sold without proper FDA approval. Now, The New York Times reports that DePuy and Johnson & Johnson sold the ASR Hip Resurfacing System overseas after the FDA rejected the hip system for lack of safety and efficacy.
The article indicates that the FDA told Johnson & Johnson and DePuy in August 2009 that company data submitted to gain approval in the U.S. to sell the DePuy ASR Hip Resurfacing System was inadequate to determine the devices’ safety and effectiveness. The FDA issued a non-approval letter for the device. However, the companies continued to market and sell the device overseas. The device’s sister model, the ASR XL Hip System continued to be marketed and sold in the U.S. until the recall in August 2010.