Johnson & Johnson’s DePuy unit continued to market a hip implant in various locations overseas, including Europe, after the Food and Drug Administration (FDA) had rejected its sale in the United States in 2009. The company also continued to sell a related model, using a loophole to gain its FDA approval, here in the US. The two medical devices were used in about 93,000 patients worldwide, one third of those were used in patients in the US. It is not clear how many patients overseas received the implant after the FDA decided not to approve it in 2009 or how many US patients received the closely linked device that was being sold here.

Both models of the implant, known as articular surface replacement devices (ASR), were based on the same all metal hip socket cup component that experts say was faulty in design. DePuy developed the version of the ASR that was sold overseas for use in a new hip replacement procedure called resurfacing. Because this was a new procedure, the FDA required the company to conduct clinical studies before approving the sale of the device in the US; consequently, DePuy began to sell the implant abroad in 2003. In 2005, while clinical studies on the resurfacing version of the device were still under way, DePuy developed a second ASR with the same problematic all metal hip socket cup for use in traditional hip replacement surgery.  Since this version resembled implants already on the market it was approved for sale in the US without being required to undergo any clinical trials.

In August 2009, the FDA sent the company a letter saying that the clinical studies submitted for the resurfacing ASR’s approval were not adequate and that more studies would need to be done. The DePuy unit began phasing out sales of both models of the device three months later in November 2009 and withdrew its application to the FDA for the resurfacing version’s approval.  The company insisted that the devices were safe and continued to market them both in the US and abroad but in August 2010 both products were formally recalled amid reports that the devices were prematurely failing at high rates.

If you or someone you know has been implanted with one of these defective devices, you should immediately seek advice from a personal injury lawyer that is experienced in handling cases involving the DePuy hip implant recall. For a free consultation with such an attorney, complete the form to the left or call 212-566-1000. Based in New York City, Sullivan & Brill, LLP represents clients throughout the United States, as well as in Manhattan, Brooklyn, Queens, Bronx, Staten Island, Nassau County, Suffolk County, Westchester County and other upstate New York counties.