Rutherford v. U.S., 77-2049

• Decision Date: 08 August 1978
• Docket Number: No. 77-2049,77-2049
• Citation: 582 F.2d 1234
• Parties: Glen L. RUTHERFORD, Individually and on behalf of a class composed of terminally ill cancer patients, Plaintiffs, Appellees, v. UNITED STATES of America, Joseph A. Califano, Secretary of Health, Education and Welfare, Donald Kennedy, Commissioner of the Food and Drug Administration, et al., Defendants, Appellants.
• Court: U.S. Court of Appeals — Tenth Circuit

Page 1234

582 F.2d 1234

Glen L. RUTHERFORD, Individually and on behalf of a class composed of terminally ill cancer patients Plaintiffs, Appellees, v. UNITED STATES of America, Joseph A. Califano, Secretary of Health, Education and Welfare, Donald Kennedy Commissioner of the Food and Drug Administration, et al Defendants, Appellants.

No. 77-2049.

United States Court of Appeals Tenth Circuit.

Argued and Submitted Jan. 26, 1978.

Decided July 10, 1978.

Rehearing Denied Aug. 8, 1978.

Barry Grossman, Atty., Dept. of Justice, Washington, D. C. (John H. Shenefield, Asst. Atty. Gen., Catherine G. O'Sullivan, Atty., Dept. of Justice, Peter L. De La Cruz, Atty., Dept. of Justice, Washington, D. C., of counsel, Richard M. Cooper, Chief Counsel, Eugene M. Pfeifer, Associate Chief Counsel for Enforcement, Rockville, Md., and Arnold I. Friede, Asst. Chief Counsel for Enforcement, Food and Drug Div., Dept. of Health, Education and Welfare, Washington, D. C., with him on the brief), for appellants.

Kenneth R. Coe, of Looney, Nichols, Johnson & Hayes, Oklahoma City, Okl., for appellees.

Charles F. Wheatley, Jr., William T. Miller, Grace Powers Monaco, Robert A. O'Neil, of Wheatley & Miller, Washington, D. C., on the brief for amicus American Cancer Society.

Before SETH, Chief Judge, and BARRETT and McKAY, Circuit Judges.

SETH, Chief Judge.

The Government appellants seek review of a district court holding which set aside a determination of the Commission of Food and Drugs that Laetrile, a controversial cancer drug, is a "new drug" within the meaning of the Federal Food, Drug, and Cosmetic Act ("the Act"), 21 U.S.C. § 301 Et seq., and thus excludable from interstate commerce due to the absence of an approved new drug application.

The central question here is whether the plaintiffs, A class of terminally ill cancer patients, should be allowed to acquire Laetrile for their own use intravenously despite the Act's requirements that "safety" and "effectiveness" be established for the approval of a "new drug." We conclude as a matter of law that the "safety" and "effectiveness" terms used in the statute have no reasonable application to terminally ill cancer patients, and have no established meaning when considered in that context.

This case is before us for the second time. For a summary of the facts, See Rutherford v. United States, 542 F.2d 1137 (10th Cir.), and Rutherford v. United States, 438 F.Supp. 1287 (D.C.). In Rutherford v. United States, 542 F.2d 1137 (10th Cir.), we held that an adequate administrative record had not been developed by the Commissioner to justify classifying Laetrile as a new drug. We remanded and said:

". . . To support its determination the FDA in the case at bar would have to present substantial evidence to support the proposition that Laetrile is not generally recognized among qualified experts as 'safe and effective,' and that Laetrile is not grandfathered by either of the exemptions discussed above."

We also upheld a preliminary injunction granted by the district court with prevented the FDA from interfering with a cancer patient's personal use of the drug.

On remand, the Commissioner compiled some 5,500 pages of written submissions and held two days of oral hearings before making a determination. This was apparently a rule-making proceeding under section 701 of the Act, 21 U.S.C. § 371. The unsworn material compiled by the agency represents diverse views but does not appear to be the typical record which should be formulated to support an agency determination which is dealing with issues of scientific and medical expertise or in response to our remand. However, we fully realize difficulties in making a record when the proponents of a drug are a group of individuals and not the typical drug manufacturer who conducted extensive laboratory tests and assembled a mass of scientific data. The FDA was considering what may be regarded as a folk medicine with no established or organized proponents. This was difficult to do within the structure of the agency.

After consideration of the record on remand, the Commissioner announced that: (1) Laetrile is not generally recognized by qualified experts as a safe and effective cancer drug; and (2) Laetrile is not exempt from the premarket approval requirement for new drugs by virtue of the "grandfather" provisions of the Act. Distribution of Laetrile in interstate commerce, the Commissioner concluded, is thus illegal and subject to regulatory activity by the Food and Drug Administration.

The district court reviewed the administrative record and concluded that the decision of the Commissioner was "arbitrary and capricious" with regard to the 1962 grandfather exemption. The district court also held that the...