United States v. An Article of Drug . . . Bacto-Unidisk

PETITIONER: United States
RESPONDENT: An Article of Drug . . . Bacto-Unidisk
LOCATION: Stanley's Home

DOCKET NO.: 343
DECIDED BY: Warren Court (1967-1969)
LOWER COURT: United States Court of Appeals for the Sixth Circuit

CITATION: 394 US 784 (1969)
ARGUED: Jan 23, 1969
DECIDED: Apr 28, 1969

Facts of the case

Question

Media for United States v. An Article of Drug . . . Bacto-Unidisk

Audio Transcription for Oral Argument - January 23, 1969 in United States v. An Article of Drug . . . Bacto-Unidisk

Earl Warren:

Number 343, United States versus an Article of Drug.

Mr. Wallace.

Lawrence G. Wallace:

Mr. Chief Justice and may it please the Court.

This case is here on a writ of certiorari to the United States Court of Appeals for the Sixth Circuit and it is an in rem seizure proceeding brought by the Government against an interstate shipment of five cases of antibiotic sensitivity discs bearing the trade name Bacto-Unidisk.

Counsel have asked the clerk to distribute a sample of the seized article to each member of the Court.

The Government's libel alleged that the shipment violated Section 502 (l) of the Federal Food, Drug, and Cosmetic Act in that the Bacto-Unidisk was a drug within the meaning of the Act was composed in part of specified antibiotics and was neither certified nor exempted from certification pursuant to Section 507 of the Act.

And the amended answer by the claimant, Difco Laboratories, the manufacturer of the Bacto-Unidisk admits that the article is composed in part of the specified antibiotics and has neither been certified nor exempted from certification.

The claimant's denial that the shipment violated the Act was based solely on the contention that the antibiotics certification requirements of the statute are inapplicable because the Bacto-Unidisk is not a drug within the meaning of the statute.

And the only issue in this case therefore is whether sensitivity testing discs such as the Bacto-Unidisk are drugs within the definition in Section 201 (g) of the Act which appears on page 2 of our brief.

This issue arises because Section 507 of the Act imposes the batch-testing certification requirement only on antibiotic drugs.

And these are to find in Section 507 by reference to the general term of drug which in turn is defined for purposes of the entire Act in Section 201 (g).

William O. Douglas:

Where is that 507?

Lawrence G. Wallace:

507 may appears on page 3 of our brief; that is the batch-testing requirement for antibiotic drugs.

And in the middle of page 4, the definition of antibiotic drugs is in terms of drug and that brings into play the general definition of drug in the statute as a whole.

William O. Douglas:

As I see 507, it talks about batches and drugs.

Lawrence G. Wallace:

That refers to production batches of --

William O. Douglas:

Where the certification of batches of drug.

Lawrence G. Wallace:

That is correct.

Each production batch has to be certified by taking a sample from that production batch in testing it to see that it has the proper characteristics of identity, strength, potency, etcetera, to assure its safety and efficacy of use, and that has to be done before that production batch of an antibiotic drug can be disseminated for use.

Now, the manner in which the Bacto-Unidisk and similar products are used in the course of antibiotic therapy is described in the opinion and findings of the District Court and in the printed enclosure which the claimant includes in each carton of Bacto-Unidisk and which appears in the record, and to which I shall refer later.

The discs are used in a screening test which in the words of the District Court serves as a guide to a medical doctor in his determination of the choice of antibiotic to prescribe for the patient.

This is accomplished by first drawing from the patient a specimen of affected body fluid which contains the infecting microorganism that is causing his illness.

Typically, this specimen is then taken to the hospital or other clinical laboratory and placed upon a culture medium in a small glass dish so called Petri dish where it is incubated for a period of hours to assure that the mature colonies of the principle infecting organism can be isolated from the specimen for use in the sensitivity test.

This so-called islet of the infecting microorganism is then applied upon a second culture medium in another Petri dish and the dry paper sensitivity discs, each of which has been impregnated with a certain quantity of a particular antibiotic are placed upon the surface of this freshly inoculated culture.

During the ensuing incubation period of 6 to 18 hours, the antibiotics disseminate outward forming circular zones around each of the small impregnated discs.

Can this be brought back by -- (Inaudible)

Lawrence G. Wallace:

I don't know the answer to that.

They cannot be bought until after they have been certified.

They cannot be marketed to anyone.

And as a practical matter, they're used only in clinical laboratories.