Rutherford v. American Medical Association, 15847

• Decision Date: 23 June 1967
• Docket Number: 15930.,No. 15847,15847
• Parties: Dr. F. Allen RUTHERFORD, Edward J. Cronley, Vera Mae Jeffries, Dorothy Williams, C. R. Easter, Chester Plonski, and Sally Ranich et al., Appellants, v. AMERICAN MEDICAL ASSOCIATION et al., Appellees.
• Court: U.S. Court of Appeals — Seventh Circuit

379 F.2d 641 (1967)

Dr. F. Allen RUTHERFORD, Edward J. Cronley, Vera Mae Jeffries, Dorothy Williams, C. R. Easter, Chester Plonski, and Sally Ranich et al., Appellants, v. AMERICAN MEDICAL ASSOCIATION et al., Appellees.

Nos. 15847, 15930.

United States Court of Appeals Seventh Circuit.

June 23, 1967.

Edward J. Cronley, Amityville, N. Y., pro se.

Frank O. Walther, Haverford, Pa., John A. Hyde, Robert Elliott, Chicago, Ill., for appellants.

Edward V. Hanrahan, U. S. Atty., Roger J. Balla, James J. Kelly and John Peter Lulinski, Asst. U. S. Attys., of counsel, for other appellees.

Karl F. Nygren, Bernard Harrold, Elsie C. Spears, of Kirkland, Ellis, Hodson, Chaffetz & Masters, Chicago, Ill., for American Medical Ass'n.

Prentice H. Marshall, John C. Tucker, Chicago, Ill., James J. Costello, Urbana, Ill., for Board of Trustees of University of Illinois, George D. Stoddard, Warren G. Cole, and Danely Slaughter.

Before HASTINGS, Chief Judge, DUFFY, Senior Circuit Judge, and SCHNACKENBERG, Circuit Judge.

HASTINGS, Chief Judge.

This is an appeal from the district court's dismissal on all counts, of plaintiffs' suit for a permanent injunction against defendants, requiring them to cease interfering, in any way, with the national distribution of an alleged cancer drug, Krebiozen.

Jurisdiction in the case was asserted to arise from issues of constitutional import and from the civil rights statutes, 42 U.S.C.A. §§ 1983, 1984, 1985.

Plaintiffs are Dr. Allen Rutherford and a number of cancer patients who have been treated for their disease by the use of Krebiozen.

The mammoth amended complaint — 243 pages, excluding exhibits — which contained eight counts, is difficult to characterize. Most of the complaint is general, irrelevant, vituperative, scandalous and conclusory. Its burden, presumably set down in the hope of establishing a conspiracy of medical and health organizations and institutions, is a full frontal attack on defendants, the American Medical Association, the American Cancer Society, the medical profession generally, the Board of Trustees of the University of Illinois, the Federal Food and Drug Administration (FDA), a number of employees of the foregoing and various individual defendants.

The objective of this attack is to show that the medical profession, with allied parties, purposefully suppresses innovations in medical therapy and that the named defendants have joined in this conspiracy. In essence and sympathetically viewed, the complaint is an outcry of hopeless, suffering cancer victims, who lack the funds required by the recognized cancer therapies and who believe in the ameliorative and curative properties of the now well publicized drug, Krebiozen. Supported by testimonials of Krebiozen's efficacy, they place hope in this drug, but they find it withheld from interstate distribution,¹ and they lay the blame for its unavailability upon the defendants.

Krebiozen is unavailable in interstate commerce. As a new drug, it has not received an approval, required by the Food, Drug and Cosmetic Act, 21 U.S. C.A., § 355,² which would permit its introduction into interstate commerce.

Section 355 of the Act establishes an introduction procedure for new drugs, designed to elicit sufficient scientific information about a drug, including reports on investigations, composition, methods and precautions in manufacture, and samples of the drug, which will permit an intelligent assessment of its safety and efficacy. Section 355(i) provides an alternative procedure for drugs intended solely for investigational use. Compliance with a comprehensive set of regulations promulgated by the Secretary of Health, Education and Welfare is required.

Krebiozen has complied with neither procedure. In 1963, a § 355(i) notice was filed, but was quickly withdrawn. Another notice was filed in 1966, but it did not approach compliance with the regulations. As it now stands, Krebiozen has not been approved, exempted, or denied approval under § 355, and no application with respect to Krebiozen is pending before the FDA.

In a previous case of this kind, we held that an essential element of the plaintiff's case is a showing that under the appropriate standards, Krebiozen would be approved or exempted. Tutoki v. Celebrezze, 7 Cir., 375 F.2d 105 (1967). Since jurisdiction for judicial review of administrative action is statutory in this case, 21 U.S.C.A. § 355(h); cf. A. F. L. v. National Labor Relations Board, 308 U.S. 401, 60 S.Ct. 300, 84 L.Ed. 347 (1940), initial approval or exemption of a drug is within the primary jurisdiction of the FDA. Tutoki, supra. Only after action by the FDA is court review appropriate and provided for by statute. 21 U.S.C.A. § 355(h). Cf. Turkel v. Food and Drug Administration, Dept. of H., E. & W., 6 Cir., 334 F.2d 844 (1964).

Plaintiffs contend, however, that as long as the alleged conspiracy remains unenjoined, it is immaterial whether or not Krebiozen is exempt from Government regulation. In their complaint, plaintiffs have alleged, in effect, that the FDA has systematically attempted to discredit Krebiozen and to prevent its introduction into commerce. It is argued that on a motion to dismiss, we must accept the truth of these allegations.

Accepting their truth arguendo, plaintiffs still have not shown that they have in good faith attempted to comply with the procedures established by Congress for the introduction of new drugs, nor has it been shown that the failure to apply can be attributed solely to the activities of the FDA and the defendants. The fact that compliance might be expensive and burdensome is not unfairness in the procedure, but a consequence of a reasonable Congressional scheme for the introduction of new drugs.

Without an attempted good faith application for approval or exemption, we have no jurisdiction to determine whether the FDA has illegally placed impossible or unreasonable conditions on approval or exemption, or has made requests for information impossible to fulfill, or whether the FDA has been dilatory, biased, or discriminatory. Until someone has attempted to comply with the Act with respect to Krebiozen, plaintiffs' appeal should be to the sponsors of the drug.

Plaintiffs further contend that the Act cannot regulate Krebiozen since, as it is to be distributed free of charge for investigational purposes, it is not in commerce. There is no merit in this argument, for regulation under the Commerce Clause is not limited to articles or activities for which there is a transfer for value. United States v. South-Eastern Underwriters Assn., 322 U.S. 533, 64 S.Ct. 1162, 88 L.Ed. 1440 (1944); Bell v. Porter, 7 Cir., 159 F.2d 117 (1946), cert. den., 330 U.S. 813, 67 S.Ct. 1092, 91 L.Ed. 1267 (1947).

Plaintiffs also contend that Krebiozen is exempt from the requirements of the Act because it is nontoxic. This argument is mistaken, for the new drug provisions of the Act, which prohibit introduction of new drugs without...