Abbott Laboratories v.

Gardner case brief

PROCEDURAL HISTORY: Petitioner drug manufacturers appealed a judgment from the United States Court of Appeals for the
Third Circuit, which held that pre-enforcement review of rules was precluded under the Federal Food, Drug, and Cosmetic Act,
21 U.S.C.S. 301 et seq., and no case or controversy existed such that no relief was available under the Administrative
Procedure
Act,
5
U.S.C.S.

701-704,
or
the
Declaratory
Judgment
Act,
28
U.S.C.S

2201.
FACTS:
-Petitioners appealed a judgment, which dismissed their complaint that challenged regulations issued by the Commissioner of
Food and Drugs. Petitioners argued that the Commissioner had exceeded his authority under the Federal Food, Drug, and
Cosmetic Act (Act), 21 U.S.C.S. 301 et seq., by requiring labels, advertisements, and other printed matter to designate the
established
name
of
a
drug
every
time
its
trade
name
was
used.
-The dismissal was based on a holding that pre-enforcement review of rules was precluded by the Act, and because no case or
controversy existed and no relief was available under the Administrative Procedure Act or the Declaratory Judgment Act.
HOLDING:
-The Supreme Court held there was no explicit statutory preclusion of pre-enforcement review and no persuasive reason to
conclude
Congress
intended
to
preclude
such
review.
ANALYSIS:
-The Court held that the controversy was ripe for adjudication where the legal issues presented were fit for judicial resolution
and the challenged provisions of the Act imposed an immediate change in petitioners' conduct, with serious penalties for
noncompliance.
Accordingly,
judgment
dismissing
petitioners'
complaint
was
reversed.
CONCLUSION: The judgment dismissing petitioners' complaint was reversed, and the case was remanded, where there was no
explicit statutory preclusion of, and no persuasive reason, to conclude Congress intended to preclude pre-enforcement review,
and the controversy was ripe for adjudication.