Earlier this week, we began an in-depth look into the convoluted process by which Johnson & Johnson and its unit DePuy Orthopaedics sought FDA approval for its articular surface replacement devices, or ASRs. Initially, the FDA rejected the medical product, stating that additional clinical study was necessary to determine whether the product was safe.
While those studies were underway in the U.S., Johnson sought approval for a different version of the ASR that was based on the same metal hip cup that is used in traditional joint replacement surgery. Because that version of the ASR was similar to hip replacement products that were already on the market, it reportedly fell under the FDA’s 501(k) loophole and was approved.
However, the ASR soon proved to be faulty, with patients reporting injuries and ailments that resulted from the joint’s metal parts rubbing against one another and releasing metal byproducts into the bloodstream. Johnson began phasing out both versions of the product in 2009 and formally recalled them in late 2010.
Because FDA regulations do not require companies to notify agencies in other countries of FDA rejections, Johnson successfully sold the faulty ASR products in other countries for several years following its failure to gain approval in the U.S. It is unknown how many people around the world have been harmed by the hip replacements.
Currently, about 5,000 product liability blog posts are pending against Johnson in relation to the faulty hip replacements.
If you have been injured as a result of a faulty joint replacement product, please contact Breslin & Breslin for a free consultation.
Source: New York Times, “Hip Implant U.S. Rejected Was Sold Overseas,” Barry Meier, Feb. 14, 2012