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 brand name.
  • 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 authority).
    • 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 way now.
  • 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 regulation.
  • The Appellate Court reversed. Abbott appealed.
    • 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 of rulemaking.
    • 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!