Medtronic, Inc. v. Lohr
518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)
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Rule of Law:
The Medical Device Amendments of 1976 (MDA) do not preempt state common-law tort claims unless the claims impose requirements that are "different from, or in addition to," specific federal requirements applicable to the particular medical device at issue. General federal manufacturing and labeling regulations, as well as the FDA's § 510(k) "substantial equivalence" review process, are not specific federal requirements that preempt general state common-law duties.
Facts:
- Lora Lohr was dependent on a pacemaker for the proper functioning of her heart.
- In 1987, Lohr was implanted with a pacemaker manufactured by Medtronic, Inc., which included a Model 4011 pacemaker lead.
- Medtronic had marketed the Model 4011 lead after receiving a letter from the Food and Drug Administration (FDA) finding it was "substantially equivalent" to devices on the market before 1976, which allowed it to bypass the more rigorous premarket approval (PMA) process.
- On December 30, 1990, Lohr's pacemaker failed.
- The failure allegedly caused Lohr to suffer a "complete heart block," which required emergency surgery.
- Lohr's physician concluded that a defect in the Medtronic pacemaker lead was the likely cause of the failure.
Procedural Posture:
- Lora Lohr and her husband sued Medtronic, Inc. in a Florida state court, alleging negligence and strict liability.
- Medtronic removed the case to the U.S. District Court for the Middle District of Florida based on diversity jurisdiction.
- Medtronic filed a motion for summary judgment, arguing the claims were preempted by the MDA, 21 U.S.C. § 360k(a).
- The District Court, after initially denying the motion, reconsidered its ruling and dismissed the Lohrs' complaint in its entirety.
- The Lohrs, as appellants, appealed to the U.S. Court of Appeals for the Eleventh Circuit.
- The Court of Appeals affirmed in part and reversed in part, holding that the negligent design claims were not preempted, but the negligent manufacturing and failure-to-warn claims were preempted.
- Both Medtronic, as petitioner, and the Lohrs, as cross-petitioners, sought and were granted a writ of certiorari from the U.S. Supreme Court.
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Issue:
Does the Medical Device Amendments of 1976 (MDA), 21 U.S.C. § 360k(a), preempt state common-law negligence and strict liability claims against the manufacturer of a medical device that was cleared for marketing through the FDA's § 510(k) 'substantial equivalence' process?
Opinions:
Majority - Justice Stevens
No. The Medical Device Amendments of 1976 do not preempt the Lohrs' state common-law claims because the federal regulations applicable to the device are not the type of specific requirements that trigger preemption under the statute. Based on the presumption against preemption of state police powers, the Court held that Congress did not intend to grant medical device manufacturers blanket immunity from liability. The Court reasoned that the § 510(k) 'substantial equivalence' review is focused on equivalence to pre-1976 devices, not on safety or efficacy, and thus imposes no specific federal design 'requirement.' Similarly, the FDA’s general Good Manufacturing Practices and labeling rules are not specific to any particular device and therefore do not preempt general state common-law duties of care. Finally, state-law claims that a manufacturer violated federal regulations are not preempted because they do not impose any requirement 'different from, or in addition to,' federal law; they merely provide a state remedy for conduct that already violates federal requirements.
Concurring - Justice Breyer
No. While state tort actions can impose 'requirements' and thus can be preempted by the MDA, the claims in this case are not preempted. The MDA's preemption provision is ambiguous, which means courts should give weight to the FDA's interpretation. The FDA's regulations state that preemption occurs only when there are 'specific' federal requirements applicable to a 'particular device.' The federal requirements at issue here, such as the § 510(k) process and general manufacturing regulations, are not 'specific' in the sense intended by the FDA's rule. Therefore, under the agency's reasonable interpretation, these general federal rules do not have preemptive effect over the Lohrs' state tort claims.
Concurring-in-part-and-dissenting-in-part - Justice O'Connor
No, with respect to the design and parallel claims, but yes, with respect to the manufacturing and labeling claims. State common-law actions impose 'requirements' within the meaning of § 360k, and they are preempted if they differ from or add to 'any' federal requirement, without a need for specificity. The design claim is not preempted because the § 510(k) process does not impose any 'requirement' on the device's design. Claims alleging a violation of federal law are also not preempted because they enforce, rather than add to, federal requirements. However, the FDA's Good Manufacturing Practices and labeling regulations are extensive and comprehensive federal requirements, so state common-law claims for negligent manufacturing and failure to warn would impose different or additional requirements and are therefore preempted.
Analysis:
This decision significantly limited the preemptive scope of the MDA, preserving a pathway for state tort litigation against manufacturers of medical devices, particularly those marketed through the less-rigorous § 510(k) process. By establishing that only specific, device-related federal requirements can preempt state law, the Court created a high bar for manufacturers asserting a preemption defense. The ruling drew a critical distinction between devices cleared under § 510(k) and those approved via the comprehensive Premarket Approval (PMA) process, suggesting that preemption would be a stronger argument for the latter. This distinction has shaped medical device litigation for decades, encouraging plaintiffs to focus on claims that federal regulations are general in nature or that the manufacturer violated those regulations.
