518 U.S. 470 (1996)
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.1
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.2 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.3
In 1982, Lora Lohr underwent surgery in Florida to receive a Medtronic pacemaker equipped with the Model 4011 lead.4 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.5 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.6
Medtronic removed the action to the United States District Court for the Middle District of Florida.7 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.8 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.9
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.10 The case was argued on April 23, 1996, and decided on June 26, 1996.11
Whether the Medical Device Amendments of 1976 preempt state common-law negligence and strict liability claims against the manufacturer of an allegedly defective medical device?12
The MDA's express preemption provision in 21 U.S.C. § 360k(a) prohibits states from establishing or continuing any requirement that is different from or in addition to a federal requirement applicable to the device.13 The provision must be read narrowly in light of the presumption against preemption of traditional state police powers in the field of health and safety.14 It must also be read alongside the statute's saving clause in § 360k(b).15
No. The Supreme Court determined that the Lohrs' common-law claims are not preempted by the MDA.16 The pacemaker lead was cleared through the §510(k) process, which does not impose specific federal requirements on the design or manufacture of the device.17 The claims for negligent design, manufacture, and failure to warn are based on general state common-law duties that do not conflict with any specific federal mandate.18
The MDA does not preempt the Lohrs' common-law claims.19
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Justice Breyer filed a concurring opinion. He agreed that the Lohrs' claims are not preempted.20 Breyer emphasized that the MDA will sometimes preempt a state-law tort claim when a specific federal requirement conflicts with the state requirement on which the claim is based.21
He stressed that the preemption provision must be read in light of the statute's basic purpose to protect consumers from unsafe products and the statute's saving clause.22 Breyer also noted the presumption against preemption and the requirement that the statute's language be read narrowly.23 The regulation is a reasonable interpretation of the statute and is valid.24
The Lohrs' claims are not preempted because the FDA has not imposed a specific federal requirement that conflicts with the state requirements on which the claims are based.25
Whether the FDA's premarket notification process for substantially equivalent devices imposes requirements that preempt design defect claims?26
No. The FDA's substantial equivalence determination under §510(k) is not a finding that the device is safe and effective but merely that it is as safe and effective as a predicate device already on the market.29 The process is a back door that allows manufacturers to market devices that have never been reviewed by the FDA for safety and effectiveness.30 The Lohrs' design claims are not the subject of any specific federal requirement and therefore are not preempted.31
The §510(k) process does not impose requirements that preempt design defect claims.32
Whether general federal manufacturing practice and labeling regulations preempt state common-law claims for negligent manufacturing and failure to warn?33
No. The general good manufacturing practices and labeling regulations apply to a host of different devices and do not constitute specific counterpart regulations applicable to the particular device. The state common-law duties to use due care in manufacturing and to warn of dangers are general obligations that do not threaten to interfere with specific federal interests.36 The Lohrs' manufacturing and failure-to-warn claims therefore escape preemption.37
General federal manufacturing practice and labeling regulations do not preempt the state common-law claims for negligent manufacturing and failure to warn.38
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Joined by The Chief Justice, Justice Scalia, And Justice Thomas
Justice O’Connor filed an opinion concurring in part and dissenting in part.39 She agreed with the Court that the MDA does not preempt all common-law claims.40 O’Connor disagreed with the Court's conclusion that the Lohrs' design claims are not preempted.41
In her view, the MDA preempts the Lohrs' design claims but not their claims for negligent manufacturing or failure to warn.42 She reasoned that the general federal requirements do not impose device-specific mandates that conflict with the state common-law duties at issue in those claims.43
Whether state common-law duties constitute requirements subject to preemption under the MDA's express preemption provision?44
Yes. State common-law duties can constitute requirements within the meaning of § 360k(a).47 They are preempted only when they impose obligations that are different from or in addition to specific federal requirements applicable to the device. On these facts, however, the Lohrs' claims rest on general duties that do not conflict with any specific federal requirement established by the MDA or FDA regulations.48
The generality of both the federal rules and the state duties places the claims outside the category of requirements that Congress intended to preempt.49
State common-law duties constitute requirements subject to preemption only when they differ from specific federal requirements.50
Related opinions on this issue
Justice Breyer agreed that common-law tort actions can impose requirements capable of preemption under the MDA when they conflict with specific federal rules.51 He explained that the statute's language supports reading the term requirement to include tort actions because state regulation can be as effectively exerted through an award of damages as through preventive relief.52 Breyer stressed that the preemption provision must be read narrowly in light of the presumption against preemption and the statute's purpose to protect consumers from unsafe products.53
He found no such conflict here because the FDA had not imposed device-specific requirements on the pacemaker lead that would conflict with the state duties at issue.54