According to a recent New York Times article, Johnson & Johnson continued to market an artificial hip replacement in Europe, despite the Food and Drug Administration (FDA) rejecting its sale in the United States, based on safety concerns. The company also continued to sell a similarly designed device in the United States, the articular surface replacement (ASR) device, which had not been required to undergo a similar safety review. Both models utilized an all-metal hip socket that experts have allegedly concluded was faulty in design.
The FDA advised Johnson & Johnson in August 2009, that the company studies and clinical data submitted to gain approval to market the model in the United States, which was already being sold in Europe, were inconclusive to determine the device’s safety and effectiveness. Based on a review of publicly available documents, it appears that Johnson & Johnson did not discuss the advisory letter from the FDA in its financial reports or with analysts. Interestingly, it was only a few months after receiving this confidential correspondence from the FDA that Johnson & Johnson began to officially phase out the ASR models. As we have previously reported, Johnson & Johnson formally recalled the ASR models in August 2010, based on the premature failure rate.
There is no allegation that Johnson & Johnson broke the law by its failure to disclose the FDA’s decisions to the European markets. However, some commentators suggest that the rejection by the FDA further supports the allegation that Johnson & Johnson was aware of the flawed design in the ASR, but continued to market it in the United States. In January 2012, the company took a $3 billion charge, mostly related to anticipated medical and legal expenses associated with the 2010 recall and subsequent litigation.
If you have had a hip replacement, which used the DePuy ASR or Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.