478 U.S. 804 (1986)
The Thompson respondents, residents of Canada, and the MacTavishes, residents of Scotland, filed virtually identical complaints against Merrell Dow Pharmaceuticals Inc., a corporation that manufactures and distributes the drug Bendectin, in the Court of Common Pleas in Hamilton County, Ohio.1
Each complaint alleged that a child was born with multiple deformities as a result of the mother's ingestion of Bendectin during pregnancy.2 In five of the six counts, the recovery of substantial damages was requested on common-law theories of negligence, breach of warranty, strict liability, fraud, and gross negligence.3 In Count IV, respondents alleged that the drug Bendectin was misbranded in violation of the Federal Food, Drug, and Cosmetic Act because its labeling did not provide adequate warning that its use was potentially dangerous, that the violation of the FDCA in the promotion of Bendectin constituted a rebuttable presumption of negligence, and that the violation of said federal statutes directly and proximately caused the injuries suffered by the two infants.4
Merrell Dow filed a timely petition for removal from the state court to the Federal District Court alleging that the action was founded, in part, on an alleged claim arising under the laws of the United States.5 After removal, the two cases were consolidated. Respondents filed a motion to remand to the state forum on the ground that the federal court lacked subject-matter jurisdiction.6 The District Court denied the motion to remand and granted Merrell Dow's motion to dismiss on forum non conveniens grounds.7
The Court of Appeals for the Sixth Circuit reversed the District Court's denial of remand.8 The Supreme Court granted certiorari to review the jurisdictional issue.9
Whether the incorporation of a federal standard in a state-law private action, when Congress has intended that there not be a federal private action for violations of that federal standard, makes the action one "arising under the Constitution, laws, or treaties of the United States," 28 U.S.C. § 1331?10
A complaint alleging a violation of a federal statute as an element of a state cause of action, when Congress has determined that there should be no private, federal cause of action for the violation, does not state a claim arising under the Constitution, laws, or treaties of the United States within the meaning of 28 U.S.C. § 1331.11
No. The Thompson respondents and the MacTavishes filed complaints in Ohio state court. The complaints asserted five common-law counts plus Count IV. In Count IV, respondents incorporated the FDCA solely to create a rebuttable presumption of negligence and to allege proximate cause under state tort law. Because the parties assumed Congress intended no private federal remedy for FDCA violations, the federal element in the state cause of action is not sufficiently substantial to support original jurisdiction under section 1331.12
Merrell Dow's removal petition therefore failed.13 The District Court's denial of the remand motion was erroneous, and the Court of Appeals correctly directed return of the cases to state court.14
The incorporation of the federal standard in the state-law private action does not make the action one arising under federal law for purposes of 28 U.S.C. § 1331.15
Related opinions on this issue
Justice Brennan dissented on the ground that federal-question jurisdiction exists under the rule of Smith v. Kansas City Title & Trust Co. because respondents' right to relief necessarily depends upon construction of the FDCA.16 He maintained that the assumption of no private federal cause of action does not logically preclude section 1331 jurisdiction over a state claim that treats an FDCA violation as negligence per se.17 Brennan emphasized that the FDCA enforcement scheme assigns final interpretive authority to federal courts through seizure, injunction, and criminal proceedings, making it consistent with congressional intent for those same courts to adjudicate state-law claims that turn on the meaning of the Act.18
He concluded that denying jurisdiction would undermine rather than advance the policies underlying both the FDCA and the grant of federal-question jurisdiction.19