A medical device was granted pre-market approval by the Food and Drug Administration (FDA), which studied the device's design, method of manufacture and proposed label. Manufacturers may not change these characteristics after approval is obtained, without further proceedings. However, this case involves whether a private lawsuit in state court may challenge the design, manufacture or labeling of the device, or whether such a suit is preempted by ยง 360k(a) of the Medical Device Amendments to the Food, Drug and Cosmetic Act. That section preempts any state "requirement" that "relates to the safety or effectiveness" of a medical device and "is different from, or in addition to, any requirement applicable under" the MDA.
The plaintiff alleged injuries from the malfunction of a balloon catheter, and the defendant argued that the FDA's grant of pre-market approval established federal requirements that preempted state tort liability, since such liability would be a state requirement different from or in addition to the federal requirements.
The Supreme Court ruled 2/21/08 that FDA premarket approval does establish a requirement under federal law, and it preempts the suit under state law. It found that the New York law suit raised claims that rely on requirements that are "different from, or in addition to" the federal requirements and that relate to the safety or effectiveness of the approved device. State common-law liability is premised on the existence of a legal duty, and constitutes a "requirement." Justice Scalia's opinion notes that a "State tort law that requires a manufacturer's catheters to be safer, but hence less effective, than a model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect." He suggested that tort law, applied by juries, is "less deserving of preservation" than statutory law or regulations, because juries, unlike federal or state officials, do not take into account the benefits of a particular product design along with its risks.
It is clear that Congress can decide to preempt litigation under state common law in order to promote the development and marketing of products whose risks and benefits must be assessed. Allowing such assessment to be made every time there's a new lawsuit would overturn the considered judgment of the federal government.