Several legal groups, including the American Bar Association, are voicing their support for passage of the Medical Device Safety Act of 2009, which was introduced on March 5 in the wake of the U.S. Supreme Court's decision in Wyeth v. Levine, No. 06-1249.
Last year, the Supreme Court found that products liability claims against medical device manufacturer Medtronic were pre-empted by the Medical Device Amendments to the federal Food, Drug and Cosmetic Act. Riegel v. Medtronic, 128 S. Ct. 999 (2008). But on March 4, the Supreme Court ruled that federal law governing warnings on prescription drug labels does not pre-empt state claims asserting that pharmaceutical companies failed to warn of risks associated with the medication.
The ruling in Wyeth v. Levine has emboldened some consumer groups and plaintiff's' attorney organizations, such as the American Association for Justice and the Alliance for Justice, to push for passage of the Medical Device Safety Act, which was introduced in both houses by Senator Edward Kennedy, D-Mass., the chairman of the Senate Committee on Health, Education, Labor and Pensions, and U.S. Representative Frank Pallone Jr., D-N.J., the chairman of the House Committee on Energy and Commerce's Subcommittee on Health.
In March, more than 20 consumer, health, women's advocacy and legal groups sent letters to Kennedy, Pallone and Representative Henry Waxman, D-Calif., the chairman of the House Energy and Commerce Committee, urging legislators to pass the Medical Device Safety Act.
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One of the legal groups, the Center for Justice & Democracy, which is a consumer organization focused on the courts, recently released a report on defective heart devices and implants. "These are the very type of patients whose rights have been wiped out as a result of the Supreme Court's decision last year, which is what Congress now needs to fix," said Joanne Doroshow, executive director of the Center for Justice and Democracy, which is based in New York.
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