Rutherford v. U.S.

• Decision Date: 19 February 1980
• Docket Number: No. 77-2049,77-2049
• Citation: 616 F.2d 455
• 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 455

616 F.2d 455

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.

Feb. 19, 1980.

Rehearing Denied April 28, 1980.

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

Kenneth Ray Coe of Hunt, Thomas, Dawson & Gile, Oklahoma City, Okl. (Kirkpatrick W. Dilling of Dilling, Dilling & Gronek, Chicago, Ill., Dennis M. Gronek and Robert E. Armstrong, Chicago, Ill., of counsel, with him on brief on remand), for plaintiffs-appellees.

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

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

SETH, Chief Judge.

The case was remanded by the Supreme Court by United States v. Rutherford, 544 U.S. 442, 99 S.Ct. 2470, 61 L.Ed.2d 68, with a reversal of our Rutherford v. United States, 582 F.2d 1234 (10th Cir.).

We had held that there was no measure or standard to permit the application of the "effective" requirement in the statute as to Laetrile as a cancer treatment by injection with a doctor's recommendation for the terminally ill patient.

The Supreme Court in its opinion held that the "effectiveness" provision of the Act did apply regardless of whether the patient was terminally ill or not. The Court also refers to those persons who have in the past (since 1907) advanced "simple and painless cures for cancer, including, lineaments of turpentine, mustard, oil, eggs, and ammonia; peatmoss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and 'Fountain of Youth' mixtures of spices, oil, and suet." The "effectiveness" of Laetrile as a treatment is to be demonstrated, and to be applied to those for whom no cure is presently available.

Thus there can be no exceptions for the terminally ill; the "effectiveness" standard is so established, and we so recognize. The issues on remand are thus the application of the grandfather clauses in the two statutes, and the constitutional right of privacy. On remand we considered the issues on the basis of the original oral arguments and briefs, and on the briefs filed after remand.

We held in Rutherford v. United States, 542 F.2d 1137 (10th Cir.), that the FDA had the power to declare a substance a "new drug," citing Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207. We also there noted that in Weinberger the Court stated that such an order was reviewable. In Rutherford, we also stated:

"However, the FDA has made an administrative determination that Laetrile is a new drug and this places the plaintiff in a position in which he has to admit that it is a new drug in order to get the FDA to move. As a result he could not be heard to say that they have not effectively stymied the use of this drug. The FDA has done this without citing any facts whatsoever, merely a conclusion, . . . ."

Under these circumstances we also held:

"We are unable, however, to see how the FDA can escape the obligation of producing an administrative record to support its determination of the first and more fundamental issue that Laetrile is a new drug, for it is not a new drug merely because they say it is. Moreover, such a conclusory ruling precludes effective review under 5 U.S.C. Section 706(2)."

Also: "It seems obvious that there cannot be a court review unless there is a decent record made." The case was thus remanded to the trial court on the new drug issue for further proceedings. Hearings by the FDA were thereafter directed by the trial court.

The FDA thereafter held what it refers to as rule-making hearings and received mostly unsworn statements although some affidavits were received. This "record" of several thousand pages of such statements then went to the trial court and ultimately we reviewed it for our Rutherford v. United States, 582 F.2d 1234 (10th Cir.), and made some charitable remarks about it in the opinion. It must, however, be stated that our review of such a record does not necessarily mean that a similar record will again be reviewed by this court.

But as to the remaining issues, the trial court held that the petitioners had a right "to be let alone," or a constitutional right of privacy to permit them, as terminally ill cancer patients, to take whatever treatment they wished regardless of whether the FDA regarded the medication as "effective" or "safe."

It would serve no useful purpose to review the series of Supreme Court opinions treating the privacy issue. These include Whalen v. Roe, 429 U.S. 589, 97 S.Ct. 869, 51 L.Ed.2d 64; Planned Parenthood of Missouri v. Danforth, 428 U.S. 52, 96 S.Ct. 2831, 49 L.Ed.2d 788; Paris Adult Theatre I v. Slaton, 413 U.S. 49, 93 S.Ct. 2628, 37 L.Ed.2d 446; Roe v. Wade, 410 U.S. 113, 93...