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Two Supreme Court decisions in the past three years� Geier v. American Honda Motor Co. and Buckman Co. v. Plaintiffs’ Legal Committee�have created a compelling case for federal implied pre-emption of failure-to-warn claims against makers of prescription drugs. The cases support the conclusion that such claims are pre-empted by the Food and Drug Administration (FDA)’s regulation of the prescribing information, or “labeling,” of such drugs. One can reach the same conclusion for medical devices despite an earlier case, Medtronic Inc. v. Lohr, holding that failure-to-warn claims against a medical device manufacturer were not expressly pre-empted by the Food, Drug and Cosmetic Act. The federal pre-emption issue may soon come to a head at the 9th U.S. Circuit Court of Appeals in Motus v. Pfizer Inc. The FDA argued as an amicus that plaintiffs’ failure-to-warn claims against the manufacturer of a prescription drug should be pre-empted by the FDA’s approval of the label under the act. Regardless of how Motus is decided, there remains an important public policy question: Should the FDA adopt a regulation that pre-empts failure-to-warn claims across the board? FDA’s taking action not new Pre-empting state law, even in the absence of any explicit congressional authorization, is nothing new for the FDA; it adopted a regulation pre-empting any state discovery order that would require disclosure of the identity of the physician or other person submitting a voluntary adverse-event report on a drug or device. No specific grant of statutory authority supports this pre-emptive regulation; the Supreme Court has recognized the FDA’s authority to adopt pre-emptive regulations even in the absence of explicit congressional authority. Having the authority, should the FDA adopt a regulation pre-empting state law failure-to- warn claims? Yes, for two reasons. In the wake of Geier (2000) and Buckman (2001), the law plainly supports such pre-emption. In Geier, the court held that a products liability claim that a car should have been equipped with an air bag was pre-empted by implication under a federal safety regulation, even though, prior to this case, the federal agency had never argued that the regulation had a pre-emptive effect. The regulation in Geier plainly permitted the car to be fitted with an air bag, so the defendant could have installed an air bag in the plaintiff’s car while still complying with the regulation. Still, the court held that the plaintiff’s products liability claim was pre-empted because it would interfere with the congressional objectives behind the safety regulation. In Buckman, the plaintiff claimed that the manufacturer of a medical device had made misrepresentations to the FDA in the course of securing clearance of the device, leading to the plaintiff’s injury. The court held that the FDA could look out for itself and that permitting “fraud on the FDA” claims would “inevitably conflict with the FDA’s responsibility to police fraud.” The plaintiffs’ claim, therefore, was pre-empted. In many failure-to-warn cases, plaintiffs try to explain away the FDA’s approval of the labeling by arguing that the manufacturer failed to provide the FDA with full information on the risks of the drug or device. Buckman, though, should be interpreted as cutting off that escape route; any claim that the FDA had less than full information is a matter for the FDA to deal with, not a court or a jury. We need national uniformity. Geier and Buckman will eventually lead courts to find failure-to-warn claims pre-empted, although, like many Supreme Court decisions, it may take years to trickle down to trial courts. The scope of claims that are pre-empted will be a subject of conflict among the courts, especially because Congress, in amending the Food, Drug and Cosmetic Act in 1962, recognized that state law in direct and positive conflict with those amendments could be invalidated. This statutory savings clause has not been interpreted yet by the courts. It is intolerable for the constitutional effect of FDA approval of labeling to vary from state to state and circuit to circuit. Litigants and courts are entitled to expect the FDA to state its views on pre-emption, not just in amicus briefs, but also in notices of proposed rule-making, or at least as statements of policy. The FDA should include medical devices in the sweep of its regulation. The high court held in Medtronic that the express pre-emption provision for medical devices in the drug act does not apply in many products liability cases. Yet Geier and Buckman held that the presence of an express pre-emption provision does not “bar the ordinary working of conflict pre-emption principles.” In other words, a case still may be pre-empted if “ordinary” implied pre-emption principles lead to that result; surely they do so with devices cleared or approved by the FDA. Failure-to-warn claims against manufacturers of prescription drugs and medical devices conflict with the FDA’s labeling approval and these claims should be pre-empted by regulation. James Dabney Miller is a partner in the Washington office of Atlanta’s King & Spalding.

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