In the case of Merrell Dow Pharmaceuticals Inc. v. Thompson et al., 1985, the U.S Supreme Court ruled that a violation of a federal statute as an element of a state cause of action did not automatically confer jurisdiction to federal courts under 28 U.S.C §1331 (federal question jurisdiction). The plaintiffs alleged that their children were born with birth defects due to ingestion during pregnancy of Bendectin, a drug manufactured by Merrell Dow Pharmaceuticals. They claimed this violated the Federal Food, Drug and Cosmetic Act (FDCA), which was incorporated into Ohio’s product liability law - thus forming part of their state-law claim for damages. However, since Congress had intended FDCA violations be enforced exclusively by the Federal Government rather than private individuals through civil litigation in federal court, it was determined there was no subject matter jurisdiction for these claims in federal court.

In the dissenting opinion for Merrell Dow Pharmaceuticals Inc. v. Thompson et al., Justice Brennan, joined by Justices Marshall and Blackmun, argued that federal jurisdiction should be recognized in this case because it involved a substantial question of federal law - namely, whether or not the drug Bendectin was misbranded under Federal Food, Drug and Cosmetic Act (FDCA). The majority's decision to deny federal jurisdiction based on Congress' silence about private rights of action under FDCA was seen as an overly narrow interpretation by the dissenters. They believed that such silence did not necessarily mean Congress intended to preclude all forms of private enforcement or recourse in cases involving violations of FDCA standards. Furthermore, they contended that denying federal jurisdiction could potentially undermine uniformity in decisions related to federally regulated areas like pharmaceuticals.