[2] The Thompsons, residents of Canada, and the MacTavishes, residents of Scotland, filed virtually identical complaints against Merrell Dow Pharmaceuticals in the Court of Common Pleas in Hamilton County, Ohio, claiming negligence, fraud, breach of warranty, and misbranding in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

The mother in each family had taken the drug Bendectin during pregnancy which they claimed caused harm to their children including birth defects.

The United States Court of Appeals for the Sixth Circuit reversed claiming that the FDCA did not create or imply a private right to sue for injury resulting in no federal subject matter jurisdiction.

"[6] Smith Test (Quoting from the dissent): "The general rule is that where it appears from the bill or statement of the plaintiff that the right to relief depends upon the construction or application of the Constitution or laws of the United States, and that such federal claim is not merely colorable, and rests upon a reasonable foundation, the District Court has jurisdiction [478 U.S. 804, 820] under [the statute granting federal question jurisdiction].

The Court clarified the issue in Grable & Sons Metal Products, Inc. v. Darue Engineering & Mfg.,[8] saying that the absence of a right of action is relevant evidence of congressional intent, but does not necessarily decide the question in all cases.