## Facts

- Parents from Canada and Scotland sued Merrell Dow Pharmaceuticals in Ohio state court, alleging birth defects from mothers’ ingestion of Bendectin during pregnancy.
- Plaintiffs pleaded only state-law causes of action (including negligence, breach of warranty, strict liability, fraud, and gross negligence).
- One count alleged Bendectin was “misbranded” under the Federal Food, Drug, and Cosmetic Act (FDCA) due to inadequate warnings.
- The FDCA allegation was used to support state negligence theories (as a rebuttable presumption/standard of care and alleged proximate cause), not as an independent federal claim.
- Merrell Dow removed to federal court, asserting federal-question jurisdiction under 28 U.S.C. § 1331 based on the embedded FDCA issue.
- The district court denied remand and dismissed on forum non conveniens grounds.
- The Sixth Circuit reversed, holding removal improper because the FDCA creates no private right of action and the claims did not arise under federal law.

## Issues

1. Whether state-law tort claims that incorporate an FDCA “misbranding” violation as an element arise under federal law for purposes of 28 U.S.C. § 1331 when Congress provided no private federal cause of action for FDCA violations.
2. Whether the embedded federal issue was sufficiently substantial to support removal to federal court.

## Decision

- The Supreme Court affirmed the Sixth Circuit and held that the actions did not arise under federal law.
- A federal statutory violation pleaded only as an element of a state cause of action does not create § 1331 jurisdiction when Congress has not authorized a private federal remedy for that statutory violation.
- The cases were therefore improperly removed.

## Legal Principles

- Federal-question jurisdiction under § 1331 generally must appear on the face of the plaintiff’s well-pleaded complaint; state-created claims do not become federal claims merely because they reference or incorporate federal standards.
- The absence of a congressionally authorized private federal cause of action is strong evidence that Congress did not intend the embedded federal issue to trigger original federal jurisdiction.
- The mere presence of a federal issue within a state-law claim is insufficient, by itself, to confer federal jurisdiction; courts consider the effect on the federal-state allocation of judicial responsibilities.
- Asserted federal interests in uniform interpretation of a federal statute, and the novelty of a federal statutory question, do not alone supply § 1331 jurisdiction where Congress withheld a private federal remedy.

## Conclusion

Because the plaintiffs’ claims were state-law causes of action and the FDCA “misbranding” allegation functioned only as a state-law element without a federal private remedy, the embedded federal issue was not enough to create federal-question jurisdiction, making removal improper.


Merrell Dow Pharmaceuticals Inc. v. Thompson, 478 U.S. 804 (1986)