Medical Device Safety Act of 2009

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The Senate Health, Education, Labor and Pensions Committee heard testimony last week from medical experts concerning the proposed Medical Device Safety Act of 2009. If the Act becomes law, it would restore many of the patient rights lost in the 2008 Supreme Court ruling in Riegel v. Medtronic. In an 8-1 ruling, the nation’s highest court exempted medical device manufacturers from civil lawsuits in state courts if the medical device in question had been previously approved by the FDA. The Supreme Court’s pre-emption ruling was a setback to those who’ve been injured by defective medical devices. One of the key supporters of the Medical Device Safety Act is Dr. William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Maisel also chairs the FDA’s Circulatory Advisory Committee. In his testimony before the Senate committee, Maisel told the Senators that FDA approval of a medical device does not guarantee its safety. Furthermore, Maisel argued, the FDA is not capable of monitoring every medical device that is on the market. The legislation has received letters of support from AARP, the Center for Justice and Democracy, Consumer Federation of America, the Consumers Union, and the National Association of Consumer Advocates. It is endorsed by National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL – The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families.

Kevin Dugan
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