Abbott Labs. v. Gardner, 387 U.S. 136 

Supreme Court of the United States

1967

Chapter

1

Title

The Federal Judiciary Power

Page

69

Topic

Ripeness and Mootness

Quick Notes

Basic Rationale of Ripeness

o         The basic rationale of the ripeness doctrine is to prevent the courts, through avoidance of premature adjudication, (1) from entangling themselves in abstract disagreements over administrative policies, and also (2) to protect the agencies from judicial interference until an administrative decision has been formalized and its (3) effects felt in a concrete way by the challenging parties.

Book Name

Constitutional Law : Chemerinkski

Issue

o         Whether the statute was properly construed by the Commissioner to require the established name of the drug to be used every time the proprietary name is employed?  No.

Procedure

District

o         The District Court granted the relief sought

Circuit

o         United States Court of Appeals for the Third Circuit reversed without reaching the merits, holding that there could be no pre-enforcement review of the regulations.

Supreme

o         The judgment dismissing petitioners' complaint was reversed, and the case was remanded

Facts

Discussion

Key Phrases

Rules

Pl Abbott Labs

Df Gardner

Party Description

o          In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act to require manufacturers of prescription drugs to print the "established name" of the drug "prominently and in type at least half as large as that used thereon for any proprietary name or designation for such  drug," on labels and other printed material.

Purpose

o         The underlying purpose of the 1962 amendment was to bring to the attention of doctors and patients the fact that many of the drugs sold under familiar trade names are actually identical to drugs sold under their "established" or less familiar trade names at significantly lower prices.

Group of 37 individual drug manufacturers bring action

o         The present action was brought by a group of 37 individual drug manufacturers and by the Pharmaceutical Manufacturers Association, of which all the petitioner companies are members, and which includes manufacturers of more than 90% of the Nation's supply of prescription drugs.

Claim Commissioner Exceeded his Authority

o         They challenged the regulations on the ground that the Commissioner exceeded his authority under the statute by promulgating an order requiring labels, advertisements, and other printed matter relating to prescription drugs to designate the established name of the particular drug involved every time its trade name is used anywhere in such material.

Injunctive and Declaratory judgment are discretionary

o         Injunctive and declaratory judgment remedies are discretionary, and courts traditionally have been reluctant to apply them to administrative determinations unless these arise in the context of a controversy "ripe" for judicial resolution.

Basic Rationale of Ripeness

o         The basic rationale of the ripeness doctrine is to prevent the courts, through avoidance of premature adjudication, (1) from entangling themselves in abstract disagreements over administrative policies, and also (2) to protect the agencies from judicial interference until an administrative decision has been formalized and its (3) effects felt in a concrete way by the challenging parties.

Courts Ripeness Evaluation

1.      Fitness of the issues for judicial decision

2.     The hardship to the parties of withholding court consideration.

Courts Fitness of the issues

o         We believe the issues presented are appropriate for judicial resolution.

Court States Issue

o         Whether the statute was properly construed by the Commissioner to require the established name of the drug to be used every time the proprietary name is employed?

Impact or regulations

o         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.

Puts petitioners in a dilemma

o         Its promulgation puts petitioners in a dilemma that it was the very purpose of the Declaratory Judgment Act to ameliorate [improve].

District Court Findings

o    "Either they must comply with the every time requirement and incur the costs of changing over their promotional material and labeling or they must follow their present course and risk prosecution."

o    Immediate compliance with their terms was expected.

o    If petitioners wish to comply they must change all their labels, advertisements, and promotional materials;

o    They must destroy stocks of printed matter; and they must invest heavily in new printing type and new supplies.

o     The alternative to compliance would risk serious criminal and civil penalties for the unlawful distribution of "misbranded" drugs.

Court Holding

o         Reversed and remanded

Rules

Injunctive and Declaratory judgment are discretionary

o         Injunctive and declaratory judgment remedies are discretionary, and courts traditionally have been reluctant to apply them to administrative determinations unless these arise in the context of a controversy "ripe" for judicial resolution.

Basic Rationale of Ripeness

o         The basic rationale of the ripeness doctrine is to prevent the courts, through avoidance of premature adjudication, (1) from entangling themselves in abstract disagreements over administrative policies, and also (2) to protect the agencies from judicial interference until an administrative decision has been formalized and its (3) effects felt in a concrete way by the challenging parties.

Courts Ripeness Evaluation

1.      Fitness of the issues for judicial decision

2.     The hardship to the parties of withholding court consideration.

Class Notes