ArtIII.S2.C1.7.3 Abbott Laboratories Trilogy and Ripeness

Article III, Section 2, Clause 1:

The judicial Power shall extend to all Cases, in Law and Equity, arising under this Constitution, the Laws of the United States, and Treaties made, or which shall be made, under their Authority;—to all Cases affecting Ambassadors, other public Ministers and Consuls;—to all Cases of admiralty and maritime Jurisdiction; to Controversies to which the United States shall be a Party;—to Controversies between two or more States; between a State and Citizens of another State, between Citizens of different States,—between Citizens of the same State claiming Lands under Grants of different States, and between a State, or the Citizens thereof, and foreign States, Citizens or Subjects.

The Supreme Court refined the ripeness doctrine in three opinions known as the “Abbott Laboratories trilogy.” 1 Each of these three cases involved pre-enforcement challenges to regulations promulgated by the Commissioner of Food and Drugs.2 The Supreme Court concluded that some of those pre-enforcement challenges were ripe for adjudication, but others were not.3

The Court first explained that the ripeness doctrine serves two purposes.4 First, the doctrine mitigates the risk that courts will “entangl[e] themselves in abstract disagreements over administrative policies” by adjudicating claims prematurely.5 Second, the doctrine shields administrative agencies from judicial interference until they finalize their decision.6

The Court then articulated a two-factor test for determining whether a particular controversy is ripe: the court must evaluate both (1) “the fitness of the issues for judicial decision” and (2) “the hardship to the parties of withholding court consideration.” 7 Under the first factor, cases that present purely legal issues are particularly likely to be fit for judicial resolution.8 By contrast, where it would be easier to resolve a challenge to an administrative action in the context of a specific attempt to enforce the agency’s regulations than in the context of a pre-enforcement challenge, the challenge is less likely to be ripe.9 As to the “hardship” factor, the Court explained that, where an administrative regulation threatens noncompliant parties with “an immediate and substantial impact” 10 —such as the “seizure of goods, heavy fines, adverse publicity, [or] possible criminal liability” 11 —a pre-enforcement challenge to that regulation is especially likely to be ripe. The Court, opined that courts ordinarily must entertain challenges to regulations that threaten regulated entities with serious penalties if they fail to modify their behavior.12

See Abbott Labs. v. Gardner, 387 U.S. 136 (1967), abrogated on other grounds by Califano v. Sanders, 430 U.S. 99 (1977); Gardner v. Toilet Goods Ass’n, 387 U.S. 167 (1967); Toilet Goods Ass’n, Inc. v. Gardner, 387 U.S. 158 (1967). back
Abbott Labs., 387 U.S. at 138, 153–54; Gardner, 387 U.S. at 168; Toilet Goods Ass’n, 387 U.S. at 159–60. back
Compare Gardner, 387 U.S. at 170 ( “[R]espondents’ challenge to these regulations is ripe for judicial review.” ), with Toilet Goods Ass’n, 387 U.S. at 161 ( “[T]he controversy is not presently ripe for adjudication.” ). back
Abbott Labs., 387 U.S. at 148. back
Id. back
Id. at 148–49 (explaining that the ripeness doctrine “protect[s] the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties” ). back
Id. at 149. back
Id. back
See Gardner v. Toilet Goods Ass’n, 387 U.S. 167, 171 (1967) (assessing whether “consideration of the underlying legal issues would necessarily be facilitated if they were raised in the context of a specific attempt to enforce the regulations” ). back
Id. See also Abbott Labs., 387 U.S. at 152 ( “This is also a case in which the impact of the regulations upon the petitioners is sufficiently direct and immediate as to render the issue appropriate for judicial review at this stage.” ). back
Gardner, 387 U.S. at 165. back
Abbott Labs., 387 U.S. at 153 ( “[W]here a regulation requires an immediate and significant change in the plaintiffs’ conduct of their affairs with serious penalties attached to noncompliance, access to the courts . . . must be permitted, absent a statutory bar or some other unusual circumstance . . . .” ). back