Guide To Preemption of State-Law Claims Against Class III PMA Medical Devices

摘要

Complex and technologically advanced medical devices extend or improve the quality of life of countless Americans. However, if defective in design or manufacture, or if inaccurately labeled, such life-saving devices can turn deadly or cause significant personal pain and injury. Although medical device manufacturers bear primary responsibility for the safety of their products, federal legislation and regulations obligate the Food and Drug Administration (FDA) to provide reasonable assurance that medical devices are safe and effective for their intended use. Both federal and state courts place considerable faith in the ability of FDA to live up to its enormous responsibilities in this area. The scheme of federal regulation impacts whether common law product liability suits may be brought against device manufacturers. Depending on the circumstances, a common law action involving a Class III device subject to premarket approval (PMA) may be preempted by federal law and thereby subject to early dismissal.