DePuy Orthopaedics Ignored Warnings about its Defective Hip Replacement Devices From as Far Back as 2005
(March 21, 2011, New York, NY) Evidence is mounting against DePuy Orthopaedics and its use of a U.S. Food and Drug Administration (FDA) regulatory loophole to gain approval of their metal-on-metal hip replacement devices. The Rottenstein Law Group has learned that complaints about the ASR XL Acetabular System, and ASR Hip Resurfacing System date back to 2005, five years before the company decided to recall the devices from worldwide markets.
Orthopaedists and hip replacement recipients began registering complaints about the DePuy devices, citing symptoms such as difficulty walking, elevated levels of metals in the bloodstream, and tissue inflammation. Instances of hip fractures and hip replacement device failures were also reported, but since there is no official artificial joint registry in the United States, DePuy was remiss in addressing these issues until much later. However, documentation did exist courtesy of joint registries in countries abroad. Those reports indicated a failure rate of approximately one in eight, about five years after implantation. The normal life span of a hip replacement is supposed to average about fifteen years. DePuy withdrew its hip replacement devices from the Australian market in 2009, but a worldwide recall was not issued until August, 2010.
DePuy was able to make use of a regulatory loophole, the “510(k) preapproval process”, which allows companies to market their medical devices based on a product being “substantially equivalent” to other products already on the market. The ASR hip replacement devices proved to be substantially different in that their structure required bone to grow around the implant, instead of being held in place by screws. No extensive clinical trials were conducted in order to prove product safety. As a result, the implants began to fail, seriously injuring recipients. It is believed there are over 90,000 individuals at risk because of this regulatory provision.
The Rottenstein Law Group has a dedicated group of hip replacement lawyers advocating on behalf of persons injured by the DePuy hip recall. It is important for patients to consult with their physicians in order to determine whether or not they are at risk of hip replacement failure. Once a medical assessment has been performed, patients are advised to consult with a hip replacement lawyer to help him or her obtain fair and just compensation for their injuries and suffering. The Rottenstein Law Group has set up a Web site to help keep patients informed about the latest developments in the DePuy hip replacement lawsuit.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.
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