US Supreme Court Holds Medical Devices Exempt from Liability in Riegel v. Medtronic
In the case Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that the manufacturer of the medical device could not be sued under state law when the device causes an injury. What this means for patients is that it is now harder to file an Illinois product liability lawsuit against a maker of medical device that is FDA approved.
FDA recall video of the leads used in Medtronics pacemakers.
In its decision the Supreme Court relied on the Medical Device Amendments of 1976 (MDA) which holds that a state cannot establish regulations that are different than established by the FDA, or that are in addition to the federal requirements. Nor can state regulations supersede those laid out by the FDA regarding safety and effectiveness.
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