United States v. Rutherford

PETITIONER: United States
RESPONDENT: Rutherford
LOCATION: Adult Store

DOCKET NO.: 78-605
DECIDED BY: Burger Court (1975-1981)
LOWER COURT: United States Court of Appeals for the Tenth Circuit

CITATION: 442 US 544 (1979)
ARGUED: Apr 25, 1979
DECIDED: Jun 18, 1979

ADVOCATES:
Kenneth Ray Coe - for respondents
Wade H. McCree, Jr. - for petitioners

Facts of the case

Question

Media for United States v. Rutherford

Audio Transcription for Oral Argument - April 25, 1979 in United States v. Rutherford

Warren E. Burger:

We'll hear arguments next in United States against Rutherford.

Mr. Solicitor General.

Wade H. McCree, Jr.:

Mr. Chief Justice and may it please the Court.

This case concerns a drug or group of drugs variously referred to in the record a Laetrile with a “capital L”, laetrile with the “lowercase l”, amygdalin and Vitamin B17.

Part of the problem with this case is the difficulty of distinguishing just which drug is referred to in a particular context.

Generically, this drug or group of drugs comprised a compound known as a cyanogenetic glucoside.

I understand glucoside to be one of a group of organic compounds found in the kernels and seeds of most fruit that hydrolyzed or breakdown to yield glucose which is a sugar, and in the case of a cyanogenic glucoside, hydrogen cyanide as well which of course is a poison.

Amygdalin is the name of a cyanogenic glucoside that is frequently used interchangeably with Laetrile either with the “capital L” or “small case l.”

One other definition might be useful, one of the chemical definitions of Laetrile or proper definitions of Laetrile has been -- was made in the administered of record as laevo-mandelonitrile-beta-glucuronoside.

I say all of that to suggest the origin of the name Laetrile.

Laevo is the first part which means left as I understand it from the Latin and mandelonitrile is the chemical and if we take lae from leavo and the trile from mandelonitrile, we have Laetrile, and this is the drug with which we are concerned today.

The left business, the Laevo is in contrast to dextro which would be the right rotation and it refers to the way these two drugs show up in polarized light.

The proponents of this drug Laetrile contends that it is a cancer cure and in some instances, a cancer preventive.

The process is change from time to time, but in short it appears to be the following.

It is the theory of the proponents that Laetrile releases hydrocyanic acid, which of course is a poison, and it does so in the presence of an enzyme that allegedly occurs in greater concentration in malignant cells than it does in normal cells.

And therefore, the malignant cells are destroyed by the action of this chemical.

The case comes before us is a consequence of a curious proceeding.

The Federal Food, Drug And Cosmetic Act prohibits the introduction of any new drug as defined in the statute into interstate commerce unless a new drug application, an NDA supported by appropriate evidence of the drug's safety and effectiveness has been approve by the Commissioner of the Food and Drug Administration who is the Secretary of Health, Education, and Welfare's designate, or unless the drug is exempted from the approval requirements by one of the Acts two grandfather provisions, one in 1938 and the other in 1962, both of which are still operative.

Because Laetrile had not been established as being entitled to grandfather status or is having meant the statutory requirements for approval as a new drug, the Food and Drug Administration brought a series of civil and criminal proceedings to prevent the introduction of Laetrile under various names into interstate commerce.

In March 1975, respondents brought a suit in the United States District Court for the Western District of Oklahoma to enjoin the Government from interfering with the sale and distribution to patient suffering from cancer of a substance known as B17, Laetrile and amygdalin.

The District --

Potter Stewart:

What was the status of the respondent?

What was their -- what conferred upon them standing to bring this suit?

Wade H. McCree, Jr.:

That's a question for which I haven't good answer if the Court please of the Government raise the question of the jurisdiction of the court and their standing, but it was decided adversely to the Government and it its present posture, we suggest that on a remand, there probably was jurisdiction.

But at this stage, I cannot answer you Mr. Justice Stewart.

Potter Stewart:

Are these -- the respondents' alleged in their complaint that they want to use it or that they move?

Wade H. McCree, Jr.:

They alleged that they wish to use it.

Potter Stewart:

They are not producers or sellers?

Wade H. McCree, Jr.:

They are not producers.

They alleged that they were patients suffering from cancer and that they were terminally ill cancer patients and they were later certified as a class consisting of terminally ill cancer patients and they wish access to the drug for their therapy to be administered to them by their physicians.