Facts
- Medtronic manufactured an implantable cardiac pacemaker and lead categorized as a Class III medical device.
- The pacemaker entered the market through the FDA’s § 510(k) “substantial equivalence” process rather than full Premarket Approval (PMA).
- Lora Lohr received the pacemaker; roughly three years later it failed due to an alleged defect in the lead, requiring emergency surgery.
- Lohr and her husband sued Medtronic under Florida common law, alleging negligence and strict products liability, including negligent design, negligent manufacture, and failure to warn.
- Medtronic argued the claims were expressly preempted by the Medical Device Amendments’ preemption clause, 21 U.S.C. § 360k(a).
- The federal district court dismissed all claims as preempted.
- The Eleventh Circuit held the negligent design claim was not preempted but found the manufacturing-defect and failure-to-warn claims preempted.
- The Supreme Court granted certiorari to decide the scope of § 360k(a) preemption for these claims.
Issues
- Whether 21 U.S.C. § 360k(a) expressly preempts state common-law claims against a manufacturer of a Class III device cleared through § 510(k).
- Whether § 510(k) clearance constitutes federal “requirements” that can preempt state design-defect duties.
- Whether state manufacturing-defect and failure-to-warn claims impose “requirements” that are “different from, or in addition to” applicable federal requirements, or instead run in parallel to them.
Decision
- The Supreme Court reversed in part and affirmed in part the Eleventh Circuit and remanded.
- The Court held that § 360k(a) did not preempt the Lohrs’ design-defect claim (unanimous).
- The Court also held that § 360k(a) did not preempt the manufacturing-defect and failure-to-warn claims (5–4).
- Justice Stevens announced the judgment of the Court; Justice O’Connor (joined by three Justices) would have found broader preemption.
Legal Principles
- Because regulation of health and safety is traditionally a state function, courts presume Congress did not displace state authority absent a clear and manifest purpose.
- Section 360k(a) preempts only state “requirements” that (1) are different from, or in addition to, applicable federal requirements and (2) relate to device safety or effectiveness.
- For devices cleared via § 510(k), the federal review generally reflects substantial equivalence to an existing device rather than device-specific safety-and-effectiveness requirements comparable to PMA.
- State tort duties are not preempted where the federal scheme does not impose device-specific requirements that the state rule would contradict.
- State claims may proceed when they function as “parallel” claims—i.e., they seek to enforce duties that match, rather than add to or differ from, federal manufacturing or labeling obligations.
Conclusion
The Court held that the MDA’s express preemption clause did not bar Florida common-law claims arising from injuries allegedly caused by a § 510(k)-cleared Class III pacemaker, because § 510(k) clearance did not impose device-specific requirements displacing state design duties and the manufacturing and warning theories could operate in parallel to federal requirements.