DePuy’s ASR hip replacement systems have been at the forefront of medical device news since its recall became inevitable, but the history of the device dates back to 2004, when the U.S. Food and Drug Administration (FDA) first approved it for sale. It is important, however, to note that the ASR was approved through the FDA’s controversial Section 510(k) approval process, which requires absolutely no pre-market testing. Access to this method of FDA approval allowed DePuy to push the product through the FDA’s regulatory scheme at a fraction of the cost based solely on its “substantial similarity” to an already-approved device.
In 2007, the problems with the ASR became clear to those familiar with the device and it was pulled from the Australian market. By mid-2008, the FDA reportedly had received hundreds of complaints regarding problems with the ASR, mostly that the product had loosened or dislocated, causing debilitating pain in the sufferer’s everyday life. More recently, a New York Times report highlighted another potential issue with the ASR—metal toxicity, a condition that results from the metal components of the hip replacement device grinding against each other and shedding bits of poisonous metal into the sufferer’s blood stream and surrounding soft tissue.
Despite having enough evidence to pull the ASR from the Australian market in 2007, and receiving hundreds of complaints regarding the device in the United States as early as 2008, DePuy did not publicly acknowledge the problems in the United States until March of 2010. Still, revealing at that time that 12% of patients that received the ASR in hip replacement surgery required painful revision surgery within just a few years of having the device implanted was not enough for DePuy to pull the product from the market immediately and protect its consumers. It was not until three months later that DePuy voluntarily recalled the ASR.
Since the DePuy ASR recall, plaintiffs all over the world have filed ASR lawsuits against the medical device manufacturer. On November 18th, a hearing was held in front of the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the cases into one multidistrict litigation (MDL) in the interest of efficiency. In early December, the JPML approved the assigned it to the U.S. District Court for the Northern District of Ohio.
If you are one of the roughly 93,000 people who received an ASR hip replacement system, it is important that you take prompt steps to protect your legal rights. ASR litigation has progressed quickly and Johnson & Johnson, DePuy’s parent company, has reserved $922 million to pay litigation costs related to the ASR recall. Therefore you need a law firm like the Rottenstein Law Group that is capable and well experienced in defending the rights of individuals against negligent corporations like DePuy to help guide you through the recovery process. For a free consultation with RLG, please fill out this brief contact form.