Also known as: federal preemption · preemption doctrine · preemption · Supremacy Clause preemption
Written by attorneys — see sources below.
A constitutional principle by which valid federal law supersedes conflicting state law under the Supremacy Clause. Federal statutes or regulations displace state measures when Congress expressly so provides, when federal law occupies the field, or when state law stands as an obstacle to federal objectives.
Felix Franco sought to open a sports betting parlor in his home state after the legislature authorized limited licensing. State officials refused the license under a federal statute barring states from permitting such schemes. The court held that the federal measure did not validly preempt the state law because it directed state legislative action rather than regulating private conduct.
Farah Fox sued a pacemaker manufacturer after the device failed and caused injury. She alleged a state common-law design defect. The court dismissed the claim because federal premarket approval standards for the specific device displaced the state tort standard.
Charles Riegel underwent coronary angioplasty in 1996 shortly after suffering a myocardial infarction. His right coronary artery was diffusely diseased and heavily calcified. Riegel's doctor inserted an Evergreen Balloon Catheter manufactured by Medtronic, Inc. into the artery in an attempt to dilate it. The catheter had received premarket approval from the FDA in 1994, with changes to its label receiving supplemental approvals in 1995 and 1996. The device's labeling stated that use was contraindicated for patients with diffuse or calcified stenoses and warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Riegel's doctor inflated the catheter five times to a pressure of ten atmospheres, and on its fifth inflation the catheter ruptured. Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery. In April 1999 Riegel and his wife Donna brought suit in the United States District Court for the Northern District of New York. Their complaint alleged that Medtronic's catheter was designed, labeled, and manufactured in a manner that violated New York common law and that these defects caused Riegel to suffer severe and permanent injuries. The complaint raised claims of strict liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter. The District Court held that the MDA pre-empted Riegel's claims of strict liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter. It also held that the MDA pre-empted a negligent manufacturing claim insofar as it was not premised on the theory that Medtronic violated federal law. The court concluded that the MDA pre-empted Donna Riegel's claim for loss of consortium to the extent it was derivative of the pre-empted claims. The District Court later granted summary judgment to Medtronic on the remaining claims. The United States Court of Appeals for the Second Circuit affirmed these dismissals. The Riegels petitioned for certiorari. The Supreme Court granted review to resolve a conflict among the Courts of Appeals regarding the scope of the MDA's pre-emption provision. Charles Riegel having died, Donna Riegel is now petitioner on her own behalf and as administrator of her husband's estate.
View caseFrederick Ferguson was injured in a car crash and claimed the manufacturer should have installed a different airbag system under state tort law. The court found the federal safety standard created an obstacle to the state claim and therefore preempted it.
In 1987, petitioner Alexis Geier, then four months old, was a passenger in a 1987 Honda Accord that crashed into a tree. The car was equipped with manual shoulder and lap belts but had no airbag. The lap and shoulder belt did not prevent Alexis from striking her head on the dashboard, and she suffered serious injuries as a result. Alexis and her parents sued the car's manufacturer, American Honda Motor Company, Inc., and its American distributor, Honda of America Manufacturing, Inc., in the United States District Court for the District of Columbia. They claimed that American Honda had designed its car negligently and defectively because it lacked a driver's side airbag. American Honda moved for summary judgment on the ground that the National Traffic and Motor Vehicle Safety Act of 1966 and FMVSS 208 preempted the lawsuit. The District Court dismissed the lawsuit. The Court of Appeals for the District of Columbia Circuit affirmed the dismissal. The Supreme Court granted certiorari to decide whether the Act or the safety standard preempts a no-airbag lawsuit. FMVSS 208, promulgated under the Act, required auto manufacturers to equip some but not all of their 1987 and later model vehicles with passive restraints. The standard required manufacturers to equip 10 percent of their 1987 vehicles, 25 percent of their 1988 vehicles, 40 percent of their 1989 vehicles, and 100 percent of their 1990 and later vehicles with one of several different passive restraint systems, including airbags, automatic safety belts, or other passive restraints providing at least the same level of crash protection.
View caseFelicity French alleged that a medical device caused harm because its labeling failed to warn of a known risk under state law. The court permitted the claim to proceed because the federal approval process did not impose device-specific requirements that would displace the state warning obligation.
In 1976, Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in response to concerns over defective devices such as the Dalkon Shield intrauterine contraceptive. The amendments established a regulatory framework classifying devices into three classes based on risk, with Class III devices like pacemakers requiring premarket approval unless they qualified for an exemption. In October 1982, Medtronic, Inc. notified the FDA that its Model 4011 pacemaker lead was substantially equivalent to pre-1976 devices, and the FDA cleared it for marketing under the §510(k) process. In 1982, Lora Lohr underwent surgery in Florida to receive a Medtronic pacemaker equipped with the Model 4011 lead. Five years later, on December 30, 1990, the device failed, allegedly causing a complete heart block that required emergency surgery; her physician attributed the failure to a defect in the lead. Lohr and her husband subsequently filed suit in Florida state court in 1993, asserting claims for negligent design, negligent manufacture, failure to warn, and strict liability based on an unreasonably dangerous product. Medtronic removed the action to the United States District Court for the Middle District of Florida. The district court initially denied Medtronic's motion for summary judgment but later dismissed the entire complaint after the Eleventh Circuit's decision in a related case, concluding that the claims were preempted by the MDA. On appeal, the Court of Appeals for the Eleventh Circuit affirmed in part and reversed in part, holding that the design defect claims were not preempted while the manufacturing and failure-to-warn claims were preempted by general federal regulations. The Lohrs and Medtronic both petitioned for certiorari, and the Supreme Court granted review to address the conflict among the circuits regarding the preemptive scope of the MDA's preemption provision. The case was argued on April 23, 1996, and decided on June 26, 1996.
View caseFrank Fisher sued a defense contractor after a helicopter part failed during a training exercise. The court applied federal preemption to bar the state tort claim because the government had approved the precise design specifications.
On April 5, 1983, David A. Boyle, a United States Marine helicopter copilot, was killed when the CH-53D Sea Stallion helicopter he was flying crashed into the ocean off the coast of Virginia Beach, Virginia, during a training exercise. Boyle and one other crew member were trapped inside the sinking helicopter and drowned, while three others escaped. His father, the petitioner, brought a diversity action against the helicopter's manufacturer, respondent United Technologies Corporation (Sikorsky Division), in the United States District Court for the Eastern District of Virginia. The petitioner alleged under Virginia tort law that the manufacturer had defectively designed the copilot's emergency escape system because the hatch opened outward rather than inward and its release mechanism was obstructed. The petitioner also alleged that the manufacturer had negligently failed to warn the Navy of dangers in the escape hatch and system. The jury returned a general verdict in the petitioner's favor and awarded $725,000. The District Court denied the manufacturer's motion for judgment notwithstanding the verdict. The Court of Appeals for the Fourth Circuit reversed and remanded with directions to enter judgment for the manufacturer. It held that the state-law tort action was barred by the government contractor defense it had recognized in McKay v. Rockwell International Corp., under which a contractor is not liable for design defects if the United States approved reasonably precise specifications, the equipment conformed to those specifications, and the supplier warned the United States about dangers known to the supplier but not to the United States. The court concluded that the evidence was insufficient as a matter of law to establish a violation of the third condition. The Supreme Court granted certiorari to consider the propriety of the government contractor defense and to resolve a conflict among the Courts of Appeals. The case reached the Court after the Fourth Circuit's 1986 decision in 792 F.2d 413, following the 1983 crash and the subsequent district court trial.
View caseFerrum Metals stored grain at a facility subject to both federal and state inspection rules. When state officials attempted to enforce additional licensing requirements, the court held that federal law occupied the field and preempted the state measures.
Respondents Santa Fe Elevator Corp. and other entities operated public grain warehouses in Illinois under licenses issued by the Secretary of Agriculture pursuant to the United States Warehouse Act. The Rice partnership, an owner, shipper, and dealer in grain, served as one of their customers, while the Illinois Commerce Commission held regulatory jurisdiction over public grain warehouses under state law. In 1944 Rice filed a complaint with the Illinois Commerce Commission alleging that respondents maintained unjust and unreasonable rates, discriminated in storage rates in favor of the federal government, operated in dual conflicting positions as warehousemen and grain dealers, failed to provide reasonable and adequate facilities, issued securities and entered affiliate contracts without prior approval, operated without a state license, abandoned service without consent, failed to file and publish rate schedules, and mixed public grain with inferior grades. Respondents moved to dismiss the complaint on the ground that the federal Warehouse Act superseded state authority. The Commission denied the motion and set the matter for hearing. Respondents then filed suits in federal district court seeking to enjoin further Commission proceedings and any enforcement actions by the Illinois Attorney General. The district court granted petitioners' motions to dismiss the suits. The Circuit Court of Appeals reversed. The Supreme Court granted certiorari because of the public importance of the questions presented. The United States Warehouse Act was enacted in 1916 and originally made federal regulation subservient to state warehouse laws, including by requiring bonds conditioned on compliance with state obligations. Congress amended the Act in 1931 to delete the state-law bond requirement and to provide that the Secretary's power, jurisdiction, and authority shall be exclusive for persons holding federal licenses. The complaint also raised three additional matters not expressly addressed in the federal Act. These were failure to obtain prior Commission approval for management, construction, and financial contracts with affiliates. They also included failure to obtain approval for contracts and leases with other public utilities. Finally they included failure to obtain approval for issuance of long-term securities.
View caseFederal preemption displaces state law that conflicts with or obstructs federal objectives. The anti-commandeering doctrine prevents Congress from ordering states to enact or enforce federal regulatory programs. A federal statute that targets only state legislative action rather than private conduct is analyzed under anti-commandeering rather than preemption.
Supporting sources
Field preemption occurs when Congress intends federal regulation to be exclusive in a given area. Courts infer this intent from a pervasive federal scheme or from the need for national uniformity. State measures in that area are then displaced even if they do not directly conflict with federal commands.
Supporting sources
A state requirement that delays or conditions entry into a federally regulated market can still be preempted if it obstructs federal objectives. Courts examine whether the state action creates an actual barrier rather than waiting for hypothetical future approvals.
Supporting sources
Yes. Federal statutes or regulations that set specific standards for product design or warnings can preempt state tort actions that would impose different or additional requirements.
Supporting sources
…approval, and that the FDA had previously considered and rejected stronger warnings about the IV-push method. We reject Wyeth’s preemption arguments. The history of the FDA’s regulation of drug labeling demonstrates that Congress did not intend for the FDA’s approvals to preempt state-law failure-to-warn claims. When the FDA…