On Tuesday, Aug. 4, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing on protecting patients from defective medical devices. The principle element of the hearing was to debate the bill S 540: Medical Device Safety Act of 2009 “To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.”

The Medical Device Safety Act would reverse the February 2008 U.S. Supreme Court ruling in Riegel vs. Medtronic Inc. that gave legal immunity to manufacturers of defective medical devices that had been FDA-approved under the premarket approval (PMA) process. The justices ruled that the preemption provision of the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act overrides state law for tort (wrongdoing for which action for damages may be brought) claims concerning PMA medical devices.

“In enacting legislation on medical devices, Congress never intended that the FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers,” stated Senator Edward M. Kennedy in response to the Riegel vs. Medtronic Inc. ruling on Feb. 20, 2008.

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