Johnson & Johnson continued to sell an ill-designed artificial hip overseas even after the FDA deemed it unsafe—and used a regulatory loophole to sell a related model with the same design issue in the US, the New York Times reports. The FDA sent Johnson & Johnson a non-approval letter on the implants, which were marketed under the name ASR, in August 2009. But Johnson & Johnson never disclosed that letter, instead announcing in November 2009 that it would phase out the ASR over declining sales.
Johnson & Johnson started selling the ASR abroad in 2003, but the FDA demanded more clinical testing to sell it here. In the meantime, the company submitted a variant device through a less-stringent regulatory pathway, while continuing to sell the original device in Europe. Both devices suffered from a faulty, all-metal hip cup. None of this is illegal, but the revelation may hurt Johnson & Johnson in the roughly 5,000 lawsuits it faces over the device, which it formally recalled in August 2010.