Rottenstein Law Group Alarmed by Report of Widespread Conspiracy to Keep Hip Resurfacing Patients Uninformed About Dangers
(New York, NY, March 5, 2012) The Rottenstein Law Group, which represents clients with claims of injury stemming from DePuy Orthopaedics’ ASR hip resurfacing system, is dismayed by a report from Britain exposing concerted efforts to keep the public uninformed about the dangers of metal hip replacement devices.
In a feature article published on February 28, the British peer-reviewed medical journal, BMJ asserted that “[h]undreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices.” BMJ writer Deborah Cohen suggests, “Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been an uncontrolled experiment.”
In 1990, the BMJ article reports, the World Health Organization International Agency for the Research on Cancer “released a monograph listing hexavalent chromium as a proved carcinogen; trivalent chromium a potential carcinogen; and cobalt ions a probable carcinogen.” But only recently after the early failure of thousands of hip implants, “have tests from the London Implant Retrieval Centre, a centre that tests prostheses, confirmed that trivalent chromium is the ion being released [by metal-on-metal hip implants].”
In the United States, Cohen notes, the U.S. Food and Drug Administration (FDA) considered the parts of metal-on-metal total hip replacements to be “like other heads, cups and stems already in use.” As a result, the devices were cleared for sale through a process that did not require rigorous testing or clinical studies normally required for new medical devices to be approved for use.
The BMJ article quotes Michael Carome, deputy director of the not-for-profit consumer advocacy group, Public Citizen’s Health Research Group: “This is one very large uncontrolled experiment exposing millions of patients to an unknown risk. We will only find out about the safety of these devices after large numbers of people have already been exposed.”
In addition, just hours before the BMJ report was published, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued an advisory to surgeons, telling them that patients who have received metal-on-metal hip implants should have annual checkups for life, according to a press release.
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.
The Rottenstein Law Group is advising anyone with a friend or relative who has undergone a hip resurfacing 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. The firm maintains a DePuy Settlements Information Center, which 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.
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