Abbott Laboratories v. Gardner 387 U.S. 136 (1967)
Drug companies (like Abbott)
were worried about generic drugs taking their market share. They made a
point of only advertising drugs by their brand name, and not mentioning
the generic name in order to establish brand loyalty.
Even doctors tended not to
know the generic name of a drug, so always wrote prescriptions for the
Congress amended the Food
and Drug Cosmetic Act (FDCA) (21 U.S.C. §301) to require all products to contain the name
of the generic drug on their labels. The Food and Drug Agency (FDA)
issued a regulation interpreting the FDCA to require that manufacturers put the generic
name of the drug in parentheses every time they mention their brand name
on the label.
Abbott (and 36 other drug
companies) sued, claiming that there was nothing in the FDCA to require an 'every time' format. Therefore,
FDA was operating ultra vires (aka in excess of statutory
Abbott took this action as
soon as the regulation was announced. They hadn't even started changing
their labels, and the FDA had not taken any enforcement actions against
any companies yet.
Abbott argued that they
preferred to not get sued, and that if they had to change all their
labels it would be expensive, so let's just get the lawsuit out of the
The Trial Court found for
Abbott and granted an injunction. FDA appealed.
The Trial Court found that
the scope of the Statute was not broad enough to encompass FDA's
The Appellate Court reversed.
The Appellate Court found
that the suit was not ripe because
there was no actual case or controversy. It was too early to sue because
no one had suffered any harm yet.
The US Supreme Court reversed
and allowed the suit to proceed.
The US Supreme Court found
that the case was indeed ripe.
The Court came up with a two-part balancing test for ripeness:
Whether the issue presented
to the court is 'fit' for review.
Aka the legal fitness
test, which asks whether the court
has the information and skills necessary to adjudicate the case.
Whether withholding review
would impose a substantial hardship on the party seeking review.
Will the party have to
comply with a rule it believes invalid?
Is there a risk of
enforcement action and the inherent penalties for failure to comply?
In this case, the Court found
that the issue was 'fit' because it was only about the law and did not
require any subject matter expertise. In addition, Abbott could suffer a
hardship if the issue was not adjudicated promptly.
Exactly what would count as
a 'hardship' was left pretty vague.
This case established the
precedent of pre-enforcement review
Today, most Statutes
actually require a suit to be
brought within a limited time after a rule is promulgated. Once
enforcement begins it is too late!