Abbott Laboratories v. Gardner

Brief Fact Summary. The Petitioners, Abbot Laboratories (Petitioners), sought declaratory judgment on the 1962 amendment to the Federal Food, Drug, and Cosmetic Act (the Act) that required prescription drug manufacturers to print the “established name” of the drug on labels and other printed materials that referred to the drug.

Synopsis of Rule of Law. Declaratory judgment is appropriate when the issues are fit for judicial decision, and there is undue hardship to the parties if such consideration were withheld.

Facts. The amended Act required pharmaceutical manufacturers to display the “established name” (to be established by the Secretary of Health, Education, and Welfare) in type at least half as large as that used for any proprietary name or other designation for the drug on all printed materials referring to the drug. A group of 37 drug manufacturers (representing more than 90% of the nation’s prescription drug suppliers) brought this suit, alleging the Commissioner exceeded his authority by requiring the use of the established name every time the trade name was used in all printed matter relating to the drug.

Issue. Have appellants brought an action ripe for judicial review?

Held. Yes. Reversed and remanded.
The Supreme Court of the United States (Supreme Court) found the challenge appropriate at the current time, as all parties agreed that the issue was purely legal. The issue was, did the Commissioner properly construe the statute by requiring the establish name to be used every time the trade name is?
The Supreme Court also found undue hardship on the parties involved in postponing a judicial decision. The companies would have to spend a large amount of money changing typefaces and printing new materials, or large penalties if they refuse to make the changes and a court determines the Commissioner was proper his construction of the regulation.

Discussion. The general guidelines of Abbott Laboratories continue to apply in ripeness cases. Note that the concrete nature of the question (did the Commissioner overreach his statutory authority?) allowed the issue to be fit for judicial decision by an Article III court.