## Facts

- Charles Riegel underwent coronary angioplasty in which physicians used Medtronic’s Evergreen Balloon Catheter, a Class III medical device that had received FDA premarket approval (PMA).
- During inflation, the catheter burst, causing serious complications.
- Charles and Donna Riegel sued Medtronic under New York common law, alleging the catheter was defectively designed, labeled, and manufactured.
- The complaint asserted strict liability, breach of implied warranty, and negligence (including design, testing, inspection, distribution, labeling, marketing, and sale), plus a negligent manufacturing theory not premised on violation of federal law.
- The district court granted summary judgment for Medtronic, holding the Medical Device Amendments’ (MDA) express preemption clause, 21 U.S.C. § 360k(a), barred the claims (including the manufacturing claim to the extent it was not tied to federal violations).
- The Second Circuit affirmed.

## Issues

1. Whether FDA PMA for a Class III medical device imposes federal “requirements” applicable to the device under 21 U.S.C. § 360k(a).
2. Whether state common-law duties enforced through damages actions constitute state “requirements” under § 360k(a).
3. Whether New York common-law claims challenging the safety or effectiveness of a PMA-approved device are preempted because they would impose requirements “different from, or in addition to” federal requirements.

## Decision

- The Supreme Court affirmed, holding 8–1 that § 360k(a) bars state common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received FDA PMA.
- The Court held PMA imposes device-specific federal requirements governing the approved design, labeling, and manufacturing specifications.
- The Court held common-law tort duties function as state “requirements” for purposes of § 360k(a).
- The Court concluded the Riegels’ claims were preempted insofar as they would require design, warnings, or manufacturing standards different from, or additional to, those approved through PMA.
- The Court recognized that claims paralleling federal requirements (e.g., alleging deviation from PMA specifications) are not necessarily barred, but the claims before it were treated as imposing additional or different duties.
- Justice Stevens concurred in part and in the judgment; Justice Ginsburg dissented.

## Legal Principles

- Under 21 U.S.C. § 360k(a), states may not impose requirements relating to a device’s safety or effectiveness that are different from, or in addition to, federal requirements applicable to the device.
- FDA PMA for a Class III device creates device-specific federal requirements within the meaning of § 360k(a).
- State common-law duties enforced through damages liability can constitute state “requirements” subject to express preemption.
- Design-defect, failure-to-warn, and similar claims targeting a PMA-approved device’s approved design, labeling, or specifications are preempted when they would alter the federally approved requirements.
- State-law claims that genuinely parallel federal requirements (rather than add to them) may survive preemption, depending on pleading and proof.

## Conclusion

The Court held that the MDA’s express preemption clause generally bars state-law damages actions that challenge the safety or effectiveness of an FDA PMA-approved Class III medical device by imposing requirements different from, or in addition to, the device-specific federal requirements established through PMA.


Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)