The Lohrs alleged injuries from a surgically implanted Medtronic pacemaker system after a component (a lead) failed, requiring emergency medical intervention and replacement surgery. Medtronic's pacemaker had entered the market via the FDA's §510(k) clearance process, which permits marketing upon a determination of "substantial equivalence" to pre-1976 (pre-MDA) devices rather than the more stringent premarket approval (PMA) process. The Lohrs filed Florida common-law claims including negligent design, negligent manufacturing, and failure to warn, contending the device was unsafe and inadequately labeled. Medtronic argued that §360k(a) of the MDA expressly preempted these state claims because the FDA had regulated the device and its labeling. The district court largely agreed and dismissed on preemption grounds. The Eleventh Circuit reversed, holding the claims were not preempted. The Supreme Court granted certiorari to define the scope of preemption under the MDA for §510(k)-cleared devices.
Does 21 U.S.C. § 360k(a) of the Medical Device Amendments preempt state common-law claims (such as negligent design, negligent manufacturing, and failure to warn) against a medical device manufacturer when the device was cleared through the FDA's §510(k) substantial equivalence process rather than the PMA process?
Under the MDA's express preemption clause, 21 U.S.C. § 360k(a), a state may not establish or continue in effect any requirement with respect to a medical device that is different from, or in addition to, federal requirements and that relates to the device's safety or effectiveness. Preemption applies only if: (1) the FDA has established specific federal requirements applicable to the particular device, and (2) the state-law duty would impose a requirement different from, or in addition to, those federal requirements. State-law claims that parallel federal requirements (i.e., impose duties "equal to, or substantially identical to," federal obligations) are not preempted. The §510(k) process, which turns on substantial equivalence rather than a device-specific safety/effectiveness approval, generally does not impose device-specific federal requirements that trigger preemption.
State common-law claims challenging the design, manufacture, and labeling of a §510(k)-cleared medical device are not categorically preempted. Design-defect and failure-to-warn claims were not preempted because §510(k) clearance does not impose device-specific federal requirements, and any manufacturing or labeling claims that parallel federal requirements may proceed. The Court affirmed in part, reversed in part, and remanded for consideration of whether any particular claims would impose requirements different from, or in addition to, applicable federal obligations.
Text and structure of §360k(a). The Court emphasized that preemption under §360k(a) requires the existence of federal "requirements" specific to the device at issue. Relying on the FDA's regulation, 21 C.F.R. § 808.1(d), the Court read the statute to preempt only where the federal government has established device-specific requirements, not merely general obligations such as Good Manufacturing Practices (GMPs) or general labeling rules. This interpretation respects the presumption against preemption, especially in areas of traditional state concern like health and safety. Nature of the §510(k) pathway. The Court distinguished §510(k) clearance from PMA approval. The former turns on substantial equivalence to preexisting devices and does not reflect a device-specific, safety-and-effectiveness determination imposing detailed, bespoke requirements on the device. Because §510(k) generally lacks such device-specific mandates, it does not by itself create the sort of federal requirements that could displace broad categories of state common-law duties. Common-law duties as "requirements." The Justices generally accepted that state common-law duties can constitute "requirements" for preemption purposes, but concluded that in this case there were no device-specific federal requirements with which Florida tort duties would conflict. Moreover, the FDA's own regulation recognizes that state obligations "equal to, or substantially identical to" federal requirements are not preempted—establishing the modern notion of parallel claims. Application to the Lohrs' claims. The negligent design and failure-to-warn claims were not preempted because no device-specific federal design or labeling requirements had been imposed via §510(k). The negligent manufacturing claim could proceed to the extent it alleged violations parallel to federal manufacturing requirements (e.g., departures from FDA's quality system regulations or GMPs). However, any state claim that would impose obligations different from, or in addition to, applicable federal requirements would be preempted. Because the record did not definitively resolve whether particular theories were parallel or added to federal obligations, the Court remanded for claim-by-claim analysis. Concurring and dissenting views. A partial dissent would have found broader preemption—particularly for failure-to-warn—reasoning that FDA's general labeling regulations suffice as federal requirements. A separate concurrence agreed that state tort law can constitute a "requirement," but concluded that, here, §510(k) did not impose device-specific requirements. The controlling opinions thus converged on a narrow conception of express preemption for §510(k)-cleared devices and endorsed the availability of parallel state-law claims.
Lohr is the cornerstone of medical-device preemption jurisprudence for §510(k)-cleared products. It preserves state tort remedies by holding that §510(k) clearance generally does not trigger broad express preemption and by recognizing the viability of parallel claims. For practitioners, it establishes a roadmap: plaintiffs may plead state duties that mirror federal requirements (e.g., alleging violations of FDA regulations), while defendants may invoke preemption against state rules that would add to or differ from federal obligations. For students, Lohr is essential background to later Supreme Court cases: Buckman (2001), which found implied preemption of fraud-on-the-FDA claims, and Riegel (2008), which held that PMA-approved devices are broadly protected by express preemption, thereby sharpening the contrast with §510(k)-cleared devices.
Medtronic v. Lohr marks a pivotal moment in delineating the reach of federal preemption in medical-device litigation. By emphasizing that §510(k) clearance does not typically impose device-specific requirements and by validating parallel state-law claims, the Court preserved a meaningful role for state tort law in deterring unsafe devices and compensating injured patients.