Rottenstein Law Group Skeptical of Proposed FDA Device Review Arrangement
(New York, NY, February 13, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the surgical implantation of hip replacement devices manufactured and sold by DePuy Orthopaedics and other companies, has some reservations about a reported proposed new arrangement for the evaluation of medical devices by the U.S. Food and Drug Administration (FDA).
According to a recent Bloomberg Businessweek report, over the next five years, medical device manufacturers will pay twice as much to the FDA for “faster and more predictable evaluations.”
“The pact with the Food and Drug Administration, which must be authorized by Congress, replaces one that cost Medtronic Inc., Johnson & Johnson and other companies $295 million over the last five years, and expires on Sept. 30,” the Bloomberg article states. “The industry and the FDA have been negotiating the new agreement for more than a year. The FDA has said it will use any added money agreed to by the two sides to increase evaluation staff.”
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 Pinnacle situation by visiting the DePuy Hip Replacement Recall Information Center. The site is equipped with easy-to-use social media features which will enable users to spread the word about DePuy Pinnacle 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.
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