Last month, U.S. congressmen Edward Markey (D-Massachusetts), Henry Waxman (D-California) and Jan Schakowsky (D-Illinois), introduced legislation — the Safety Of Untested and New Devices Act of 2012, dubbed SOUND Devices Act — that would give the FDA more authority to reject a manufacturer's application for a new device if it was based on a similar product that was recalled.
Guest said any new law should also require rigorous testing of the devices upfront and a national registry that would track device performance over time. Raising manufacturers' user fees that fund FDA could help fund a registry, he said.
Some 93,000 people have been implanted with DePuy's ASR hip system worldwide and J&J faces more than 2,000 lawsuits in state and federal court.
When clients call, they are livid when they find out how (the device) was approved. They say 'I don't understand how this was able to get on the market in the first place,'" said attorney Felecia Stern of Bernstein Liebhard LLP, a New York law firm handling more than 200 cases against J&J over the ASR hip. However, these patients, she said, are usually too overwhelmed by medical problems to get involved in activism.
Carol Kochhar-Bryant, a 62-year-old professor and senior associate dean at the Graduate School of Education and Human Development at George Washington University, was one recipient of the Consumer Reports' email blast.
She had the ASR implanted in 2009. The joint failed after a couple of years and she said it left her with high chromium and cobalt levels in her bloodstream, a condition known as metallosis that some experts fear could cause cancer and other serious problems. She continued to have pain and recently underwent a second, more extensive surgery to scrape out metal shavings embedded in the surrounding tissues of her hip and replace the entire ball and socket with a new device.
I was assuming there was a much more rigorous process," she said, referring to the approval process of her hip replacement. "I did not quiz my doctors on how these things come to the market. They gave me a lot of pamphlets on it. I went back to look to see what adverse events were listed, but there's nothing in there."
Katie Ayers, 42, also had the ASR hip implanted when she was 36 years old. Blood tests revealed that she also had elevated levels of cobalt and chromium, and she decided to have the device replaced with a J&J ceramic implant.
Ayers is suing J&J and testified before Congress last year. Kochhar-Bryant said she has not yet decided on legal action.
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