New York Times Article Points Out That DePuy Knew About The Cobalt and Chromium Toxic Problems Well Before They Pulled It From The Market
The law firm of Levin, Papantonio, et al. finds it interesting that Johnson & Johnson execs began phasing out the DePuy ASR hip implant in 2009, mere weeks after the F.D.A. sent the company a request for additional safety data on the implant, according to New York Times article, “Hip Device Phaseout Followed F.D.A. Data Request.” It seems the F.D.A. had begun to discover information about ASR patients’ concerning levels of metal ions, specifically, cobalt and chromium. There had also been reports that the ASR was performing poorly in comparison to DePuy Orthopaedic’s data.
Cobalt and chromium toxicity due to metal-on-metal wear has been shown to cause soft tissue damage in and around the hip. Also known as “Metallosis,” the dispersed, toxic debris builds up and either causes necrosis, or death, of soft tissues or may trigger an inflammatory process, which can lead to pseudo-tumors. Other effects include metal-stained joint fluid, joint fluid build-up, and progressive bone loss, due to metal ions entering the bones. Symptoms can become as severe as a cracked acetabulum or eating away of the abductor muscle. While many patients experience severe pain, it is also possible for patients who feel no pain to be suffering from tissue damage or pseudo-tumors. The premature failure of the ASR hip implant has not only caused all these negative, debilitating side-effects and more, but has also necessitated many revision surgeries.
The worst part may be that although the company must have been aware of the issues with their product, they did not issue a recall or pull the product from the market. In fact, only weeks after receiving the F.D.A.’s request for safety information, DePuy initiated a plan to phase out the ASR implant, an action they attributed to slowing product sales and not for reasons related to the safety of their product. At the same time, they continued to sell their remaining stock of defective products, which would be implanted in patients worldwide.
Ultimately patients may suffer irreversible damage, and the longer patients wait to have the ASR revised, the more permanent and damaging the effects can become. Ben Gordon and Daniel Nigh, attorneys with the Levin, Papantonio law firm, are continuing to take new clients and are actively pursuing litigation against DePuy and Johnson & Johnson, Inc.