## Facts

- Winston Dillon underwent lumbar spinal-fusion surgery in which his surgeon used Medtronic’s Infuse Bone Graft, an FDA premarket approved (Class III) medical device.
- The FDA approval covered only a specific labeled use (single-level anterior lumbar interbody fusion using an approved cage).
- The Dillons alleged the surgeon used Infuse off-label and that Medtronic unlawfully promoted off-label uses through marketing and sponsored materials.
- They alleged Winston Dillon suffered excessive bone growth and related complications requiring additional treatment; Teresa Dillon asserted derivative claims.
- The complaint asserted Kentucky state-law claims including negligence, strict products liability, breach of warranty, and fraud/misrepresentation theories tied to alleged misstatements or omissions about risks associated with off-label use.
- Medtronic removed the case to federal court, asserting federal-question jurisdiction based on preemption under the Medical Device Amendments (MDA) to the FDCA.
- Plaintiffs moved to remand, arguing their claims arose under state law and that preemption is a defense that does not create federal jurisdiction.

## Issues

1. Whether asserted express or implied MDA/FDCA preemption of state-law claims creates federal-question jurisdiction supporting removal under 28 U.S.C. § 1331.
2. Whether the MDA “completely preempts” the asserted state-law claims or otherwise makes them arise under federal law because they necessarily raise a substantial, disputed federal issue.

## Decision

- The court granted plaintiffs’ motion to remand.
- The court held it lacked federal-question jurisdiction because the complaint pleaded only state-law causes of action.
- The court ruled that MDA/FDCA preemption, even if ultimately valid, operates as a defense and does not satisfy the well-pleaded complaint rule.
- The court rejected complete preemption because the FDCA/MDA does not provide a private right of action that replaces state remedies.
- The court also found the state-law claims did not necessarily turn on resolution of a substantial, disputed federal issue sufficient to confer § 1331 jurisdiction.

## Legal Principles

- Federal-question jurisdiction generally exists only when a federal issue appears on the face of the plaintiff’s well-pleaded complaint; anticipated federal defenses do not confer jurisdiction.
- Ordinary (defensive) preemption under the MDA differs from complete preemption; complete preemption requires both displacement of state law and a federal cause of action.
- The FDCA/MDA does not create a private damages remedy for consumers; enforcement authority rests with the government.
- A state-law tort or warranty claim does not “arise under” federal law merely because federal device regulation forms part of the background or because compliance with FDA requirements may be disputed.

## Conclusion

The court remanded the case to state court because the plaintiffs pleaded only state-law claims, and Medtronic’s reliance on MDA/FDCA preemption—without a substitute federal cause of action—could not establish federal-question jurisdiction or justify removal.


Dillon v. Medtronic, Inc., 992 F. Supp. 2d 751 (E.D. Ky. 2014)