Abbott Laboratories v. Gardner
 | |
| Abbott Laboratories v. Gardner | |
| Reference: 387 U.S. 136 | |
| Term: 1966 | |
| Important Dates | |
| Argued: January 16, 1967 Decided: May 22, 1967 | |
| Outcome | |
| Third Circuit Court of Appeals reversed and remanded | |
| Majority | |
| Hugo Black • William Douglas • John Harlan II • Potter Stewart • Byron White | |
| Dissenting | |
| Thomas Clark • Abraham Fortas • Chief Justice Earl Warren | |
Abbott Laboratories v. Gardner is a case decided on May 22, 1967, by the United States Supreme Court holding that pre-enforcement review of administrative agency actions is appropriate when it is not prohibited by law or inconsistent with the intent of Congress. The case concerned drug labeling and advertising regulations issued by the Food and Drug Administration. The court reversed the ruling of the United States Court of Appeals for the 3rd Circuit, holding that the Federal Food, Drug, and Cosmetic Act did not prevent pre-enforcement review of the regulations in question. The court also held that the case satisfied the ripeness doctrine because it presented a case or controversy fit for judicial resolution.[1][2][3][4]
Why it matters: This case established that pre-enforcement review of administrative agency actions is appropriate when it is not expressly prohibited by law or inconsistent with the intent of Congress. Furthermore, the majority developed a two-part test used to determine when administrative actions present an actual case or controversy fit for judicial resolution. The test asks whether the agency decision in question is final and whether withholding judicial review would result in hardship for the parties involved.
Background
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In 1962, Congress enacted an amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) requiring prescription drug manufacturers to print the established or generic name of a drug alongside any proprietary or brand name used on labels and other printed material. The amendment tasked the Commissioner of Food and Drugs, the head of the Food and Drug Administration (FDA), with promulgating regulations to implement this requirement. The regulations issued by the FDA required drug manufacturers to print the established drug name every time a proprietary name was used.[2][1]
According to a summary of the original lawsuit included in the majority opinion written by Justice John Harlan II:[2]
| “ | 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. 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.[5] | ” |
| —Justice John Harlan II, majority opinion in Abbott Laboratories v. Gardner (1967)[2] | ||
A federal district court ruled against the government, granting declaratory and injunctive relief and holding that the statute did not permit the commissioner's interpretation. The Third Circuit Court of Appeals reversed, holding, according to the syllabus of the Supreme Court's decision, "that pre-enforcement review of the regulations was unauthorized and beyond the jurisdiction of the District Court, and that no 'actual case or controversy' existed." The group of pharmaceutical manufacturers and their association appealed the decision to the Supreme Court.[2][1]
Oral argument
Oral argument was held on January 16, 1967. The case was decided on May 22, 1967.[1]
Decision
The Supreme Court decided 5-3 that the Federal Food, Drug, and Cosmetic Act did not forbid pre-enforcement review of regulations related to prescription drug labeling and advertising, and further that the case presented "a controversy 'ripe' for judicial resolution." The Supreme Court reversed the decision of the Third Circuit Court of Appeals and remanded the case to that court for reconsideration. Justice John Harlan II delivered the opinion of the court, joined by Justices Hugo Black, William Douglas, Potter Stewart, and Byron White. Justices Thomas Clark and Abraham Fortas and Chief Justice Earl Warren dissented. Justice William Brennan did not take part in considering or deciding the case.[1]
Opinions
Opinion of the court
Writing for the court, Justice John Harlan II first considered whether or not the Federal Food, Drug, and Cosmetic Act forbid pre-enforcement judicial review of the disputed FDA regulations; Harlan concluded that it did not:[2]
| “ | The first question we consider is whether Congress, by the Federal Food, Drug, and Cosmetic Act, intended to forbid pre-enforcement review of this sort of regulation promulgated by the Commissioner. The question is phrased in terms of "prohibition", rather than "authorization," because a survey of our cases shows that judicial review of a final agency action by an aggrieved person will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress. ... We conclude that nothing in the Food, Drug, and Cosmetic Act itself precludes this action.[5] | ” |
| —Justice John Harlan II, majority opinion in Abbott Laboratories v. Gardner (1967)[2] | ||
Then, Justice Harlan argued that the case satisfied the ripeness doctrine because it presented an issue fit for judicial resolution. Harlan used a two-part inquiry to assess the fitness of this case for judicial review:[2]
| “ | The 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. ... The problem is best seen in a two-fold aspect, requiring us to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration. As to the former factor, we believe the issues presented are appropriate for judicial resolution at this time. ... 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.[5] | ” |
| —Justice John Harlan II, majority opinion in Abbott Laboratories v. Gardner (1967)[2] | ||
The Supreme Court reversed the decision of the Third Circuit Court of Appeals and remanded the case to that court for reconsideration.[2]
Dissenting opinions
Justice Abraham Fortas authored a dissenting opinion joined by Chief Justice Earl Warren and Justice Thomas Clark. According to Oyez, a Supreme Court archive maintained by the Cornell Legal Information Institute, Fortas argued the following in his opinion:[1]
| “ | He wrote that courts have jurisdiction over challenges to administrative action only when there is a specific statutory provision, when the agency acts unconstitutionally, or when it acts without jurisdiction. Justice Fortas feared that the majority's ruling would give federal district judges a 'roving commission to halt the regulatory process.' He reviewed the legislative history of the FFDCA and found that Congress had consistently reserved judicial review for specific situations not including the present case.[5] | ” |
| —Oyez, Abbott Laboratories v. Gardner[1] | ||
According to Oyez, "Justice Clark wrote a separate dissent arguing that the commissioner was right to prevent drug manufacturers from misleading the public about the content of their proprietary drugs."[1]
Impact
The Supreme Court's decision in Abbott Laboratories v. Gardner established that pre-enforcement review of administrative agency actions is appropriate when it is not expressly prohibited by law or inconsistent with the intent of Congress. Furthermore, the majority opinion by Justice John Harlan II developed a two-part inquiry used to determine when administrative actions present an actual case or controversy fit for judicial resolution, a principle of judicial review known as the ripeness doctrine. The test developed in Abbott asks whether or not the agency decision in question is final, and then considers whether or not withholding judicial review would result in hardship for the parties involved.[4][3]
In a 2008 article, law professor Aaron-Andrew P. Bruhl described the impact of this case in the following way:[3]
| “ | Abbott Labs v. Gardner, 387 U.S. 136 (1967) is a leading Supreme Court case dealing with the 'ripeness doctrine,' which prevents courts from ruling on matters that have not yet developed into a form that is appropriate for judicial resolution. In the federal courts, the ripeness doctrine derives in part from Article Ill of the Constitution, which gives the federal courts jurisdiction over 'cases and controversies' but not over abstract questions or hypothetical disputes. Although ripeness concerns can arise in many contexts, one recurring issue—and the one at the heart of the Abbott Labs litigation—is whether a person can seek a review of an administrative regulation before the administrative agency attempts to enforce it. ...
|
” |
| —Aaron-Andrew P. Bruhl, "Abbott Labs v. Gardner, 387 U.S. 136 (1967)" (2008)[3] | ||
See also
- Rulemaking
- Administrative law
- Article III, United States Constitution
- Supreme Court of the United States
- History of the Supreme Court
External links
- Full text of case syllabus and majority opinion (Justia)
- Supreme Court of the United States
- Search Google News for this topic
Footnotes
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 Oyez, "Abbott Laboratories v. Gardner," accessed October 30, 2017
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 Justia, "Abbott Laboratories v. Gardner," accessed November 1, 2017
- ↑ 3.0 3.1 3.2 3.3 William & Mary Law School Scholarship Repository, "Abbott Labs v. Gardner, 387 U.S. 136 (1967)," 2008
- ↑ 4.0 4.1 Casebriefs, "Abbott Laboratories v. Gardner," November 10, 2017
- ↑ 5.0 5.1 5.2 5.3 5.4 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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