Rutherford v. American Medical Ass'n

379 F.2d 641
CourtCourt of Appeals for the Seventh Circuit
DecidedJune 23, 1967
DocketNos. 15847, 15930
StatusPublished
Cited by7 cases

This text of 379 F.2d 641 (Rutherford v. American Medical Ass'n) is published on Counsel Stack Legal Research, covering Court of Appeals for the Seventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Rutherford v. American Medical Ass'n, 379 F.2d 641 (7th Cir. 1967).

Opinion

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 [643]*643in 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, Krebio-zen 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, [644]*644as 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. SouthEastern 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 approval, apply without reservation to all new drugs. Even if Krebiozen is non-toxic as alleged, toxicity is not the sole criterion to be applied by the FDA to new drugs. Effectiveness of the drug as well as its safety and the safety of its manufacturing procedures is a relevant criterion. 21 U.S.C.A. § 355 (d); cf. United States v. Allan Drug Corporation, 10 Cir., 357 F.2d 713 (1966).

Plaintiffs argue that Krebiozen is not a drug, but a biological product not falling within the scope of the Food, Drug and Cosmetic Act. If Krebiozen is a biological product, however, it must meet the more stringent licensing provisions of the Public Health Service Act, 42 U.S.C.A. § 262, which it has not done. Cf. 21 C.F.R. §§ 130.2(a) and 130.3(g).

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Rutherford v. American Medical Association
379 F.2d 641 (Seventh Circuit, 1967)

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379 F.2d 641, Counsel Stack Legal Research, https://law.counselstack.com/opinion/rutherford-v-american-medical-assn-ca7-1967.