United States v. Article of Drug . . . Bacto-Unidisk
22 L. Ed. 2d 726, 1969 U.S. LEXIS 3274, 394 U.S. 784 (1969)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
An article is a "drug" under the Federal Food, Drug, and Cosmetic Act if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, regardless of whether it is directly administered to a patient. The Act's definitions are to be construed broadly to effectuate its remedial purpose of protecting public health.
Facts:
- Difco Laboratories, Inc. manufactured antibiotic sensitivity discs under the trade name "Bacto-Unidisk."
- These discs are small, round paper discs impregnated with specific antibiotics.
- In a laboratory setting, the discs are placed on a culture medium where a sample from a patient's infection is grown.
- The resulting reaction helps a physician determine which antibiotic will be effective in treating the patient's specific infection.
- The discs are used exclusively in laboratory work and never come into direct contact with the patient's body.
- The Secretary of Health, Education, and Welfare promulgated regulations requiring pre-market clearance and batch-testing certification for these discs, citing numerous complaints about their unreliability and potency.
- Difco Laboratories marketed the discs without complying with the certification regulations.
Procedural Posture:
- The United States government initiated an in rem seizure proceeding in the U.S. District Court for the Eastern District of Michigan against a shipment of Bacto-Unidisk.
- The government, as plaintiff, alleged the discs were uncertified "drugs" and therefore misbranded.
- The District Court held that the discs were not drugs under the Act and ruled the seizure was improper, finding in favor of the product/claimant.
- The United States (appellant) appealed to the U.S. Court of Appeals for the Sixth Circuit.
- The Court of Appeals affirmed the District Court's judgment, finding the discs were not drugs.
- The United States successfully petitioned the U.S. Supreme Court for a writ of certiorari.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Does an antibiotic sensitivity disc, an article used in laboratories to help determine the appropriate antibiotic to treat a patient but which never comes into contact with the patient's body, fall within the statutory definition of a "drug" under the Federal Food, Drug, and Cosmetic Act?
Opinions:
Majority - Mr. Chief Justice Warren
Yes, an antibiotic sensitivity disc falls within the statutory definition of a 'drug' under the Federal Food, Drug, and Cosmetic Act. A literal reading of the statute's definition of 'drug'—'articles intended for use in the... cure, mitigation, [or] treatment' of disease—clearly applies to the discs as they play a role in selecting appropriate treatment. The legislative history of the 1938 Act demonstrates Congress's clear intent to define 'drug' more broadly than its strict medical definition. The parallel 'device' category was created for semantic reasons to avoid the incongruity of classifying purely mechanical items like crutches or electric belts as drugs, not to create a loophole for diagnostic aids like the discs. Given the Act's remedial purpose to protect public health, the statute must be given a liberal construction, and it was reasonable for the Secretary to regulate the discs to ensure the safety and efficacy of the certified antibiotics they are used to select.
Dissenting - Mr. Justice Douglas
No, an antibiotic sensitivity disc does not fall within the statutory definition of a 'drug.' The disc is a 'device' as defined in § 201(h) of the Act, not a 'drug' as defined in § 201(g).
Analysis:
This decision significantly broadened the regulatory scope of the Food and Drug Administration (FDA) by affirming that the statutory definition of 'drug' is not limited by common medical understanding or the method of administration. By prioritizing legislative intent and the statute's overall remedial purpose, the Court established that items used indirectly in treatment, such as diagnostic aids, can be regulated as drugs. This precedent empowers the FDA to regulate a wide range of products that play a role in patient care, even if they never physically contact the patient, based on their intended use and impact on public health.
