Foes and advocates of changing liability laws for certain medical devices squared off Tuesday in a hearing before the Senate Health, Education, Labor and Pensions committee. The groups debated whether Congress should try to reverse an eight-to-one US Supreme Court decision handed down in February 2008 in Riegel v. Medtronic, Inc, which held that the Medical Devices Amendment of 1976 allows the most risky medical devices – those that gain approval from the Food and Drug Administration in the pre-market approval process – to gain immunity from liability lawsuits in state courts. Sen. Tom Harkin (D-IA) said the decision has meant complete immunity from lawsuits for corporations that endanger consumers with unsafe devices. However, William Maisel, a cardiologist at Beth Israel Deaconess Medical Center and founder of the Medical Device Safety Institute said that a manufacturer must demonstrate reasonable assurance of safety and effectiveness to gain FDA approval.

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