Johnson & Johnson Email Shows Company Executives Knew of ASR Hip Implants' Failures
Published: Feb 24, 2012
On Tuesday, the New York Times published an August 21, 2009 internal e-mail sent by Pamela Plouhar, DePuy Orthopaedics’ Vice President for Worldwide Clinical Affairs, to three company executives, including then-president David Floyd, regarding a communication from the U.S. Food and Drug Administration (FDA) concerning the company’s now embattled ASR hip replacement device. The Times has drawn the conclusion that the content of the internal DePuy Orthopaedics e-mail “contrast[s] with statements made in recent years by the company, which continued to market the device in Europe (and a related model in the United States) before announcing a recall in 2010”
DePuy issued a statement on Tuesday, which accompanies the text of the e-mail in the Times piece. “The ASR Hip Resurfacing System was not ‘rejected’ by the U.S. Food and Drug Administration (FDA), nor did the company inappropriately sell it in other countries.” The gist of the statement is that DePuy’s decision not to pursue further the ability to market in the U.S. its ASR Resurfacing System was based not on the FDA’s non-approval of the device, but rather on “the declining demand for hip resurfacing.”
In August, 2010, the U.S. Food and Drug Administration (FDA) requested a recall of DePuy’s ASR hip replacement systems, due to an unacceptably high rate of failure. The devices were failing an estimated 12% within five years of initial implantation. The FDA based its approval of the ASR devices on their similarity to the Pinnacle systems, which were already for sale, and in widespread use. Currently, the FDA is receiving complaints about the older Pinnacle systems; to date, there have been more than 1,300 reports citing that the device loosens and causes severe pain when the recipient engages in simple movements and normal, everyday activities. Another serious side effect of the Pinnacle systems was reported by the New York Times in December, claiming that metal can flake off the device and embed itself into the surrounding tissue, putting the recipient at risk of developing metal poisoning. At least one plaintiff has already filed a lawsuit claiming this very issue with his Pinnacle hip replacement system.
The Rottenstein Law Group is advising anyone with a friend or relative who has undergone a hip replacement procedure to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer. The Rottenstein Law Group lawyers have a total of more than 25 years of experience fighting for the rights of clients who have suffered harm due to the negligence of powerful corporations. Affected individuals can also stay apprised of the latest developments in the DePuy Orthopaedics ASR situation by visiting the firm’s DePuy Lawsuit Information Center . The site is equipped with easy-to-use social media features which will enable users to spread the word about DePuy hip replacement device failures.
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.