Rutherford v. U.S.

Decision Date12 October 1976
Docket NumberNo. 75-1725,75-1725
Citation542 F.2d 1137
PartiesGlen L. RUTHERFORD, Plaintiff Intervenor-Appellee, and Jimmie Stowe and Gene Schneider, Individually and on behalf of a class composed of cancer victims and their spouses, who are responsible for the cost of treatment, Original Plaintiffs-Appellees, v. UNITED STATES of America and David Mathews, Secretary of Health, Education and Welfare, Defendants-Appellants.
CourtU.S. Court of Appeals — Tenth Circuit

Burton J. Johnson, Watts, Looney, Nichols, Johnson & Hayes, Oklahoma City, Okl. (Osborne M. Reynolds, Jr., Professor of Law, University of Oklahoma College of Law, Norman, Okl., on the brief), for plaintiffs-appellees.

Barry Grossman, Atty., Dept. of Justice (Richard A. Merrill, Chief Counsel, Rockville, Md., and J. H. Geller, Associate Chief Counsel, Food and Drug Div., Dept. of Health, Education and Welfare, Washington, D. C., of counsel; John E. Green, Acting U. S. Atty., and William S. Price, Asst. U. S. Atty., Oklahoma City, Okl., Thomas E. Kauper, Asst. Atty. Gen., and Carl D. Lawson and Catherine G. O'Sullivan, Attys., Dept. of Justice, Washington, D. C., on the brief), for defendants-appellants.

Before HOLLOWAY, McWILLIAMS and DOYLE, Circuit Judges.

WILLIAM E. DOYLE, Circuit Judge.

The Department of Health, Education and Welfare here seeks review and reversal of a judgment of the District Court for the Western District of Oklahoma which temporarily enjoined the Department, and particularly the Food and Drug Administration, from preventing appellee Rutherford from obtaining a supply of a controversial cancer drug called Laetrile for his own use. An order was issued on behalf of Rutherford which allowed him to purchase and transport in commerce a six months' supply of Laetrile and accompanying drugs. In the course of this order the trial court found that Laetrile was not toxic and further found that if properly administered it would "effect relief from cancer disease to the satisfaction of many who are privileged to use the same." The court also ruled that the FDA was required under the law to approve or disapprove Laetrile as a cancer treatment and that it had neglected its duty in this regard. The judge also held that the new drug application requirements contained in the Food and Drug Act, Section 505(b), 21 U.S.C. Section 355(b), violated the Fifth Amendment due process clause in that they prescribed expensive procedures which could not be carried out by persons in the position of Rutherford. 1

The government seeks reversal on statutory grounds:

First, that it (FDA) has no duty to approve a new drug unless a so-called new drug application is submitted to it.

Second, that it is not empowered to determine the safety and efficiency of Laetrile.

Third, that the court exceeded its authority in issuing the injunction, the effect of which was to block the enforcement of an Act of Congress without convening a three-judge court, 28 U.S.C. Sections 2282 and 2284.

We need not review the judge's ruling that Laetrile is an effective treatment for cancer or that Laetrile is not toxic or that the new drug application provision is unconstitutional. We confine ourselves to the issue whether the so-called new drug procedure constitutes, as H.E.W. contends, the only legal route that is available for testing the drug for harmfulness or harmlessness. So considered, we are of the opinion that the question whether this is a new drug presents a mixed question of fact and law which should be fully tried. As it is, the FDA's record is grossly inadequate and consists merely of a conclusory affidavit of an official of the FDA which in effect declares that it is a new drug because the FDA says it is and thus is subject to all of the statutory vagaries of such a designation.


As we view it, the reason that the Food and Drug Administration is anxious to classify Laetrile as a new drug is so as to bring it within the new drug certification procedures of the Food, Drug and Cosmetics Act. Section 505(a) of the Act, 21 U.S.C. Section 355(a). This provision bars the introduction into interstate commerce of a new drug without an approved new drug application having been filed pursuant to the Act just cited. The Secretary is required to review the application within a specified period on the criteria of safety and effectiveness as demonstrated by "adequate and well-controlled investigations." Such an application is reviewable directly in the court of appeals. The plaintiff-appellee's position on this is that Laetrile escapes the clutches of this Act by being a food rather than a drug, or even if it is a drug it is not a new drug.


It is unnecessary to linger and dwell on the subject whether it is a food or a drug inasmuch as this is not determinative. Appellee argues that it is in the nature of a diet supplement or a vitamin, but the cases recognize that even if a substance is also a food it may be subjected to the requirements of the Act if it is used in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals. 2 Intended use is an important aspect in the determination whether it is a drug. See Hanson v. United States, 417 F.Supp. 30 (D.Minn.1976).

Unquestionably Laetrile is intended at least as a treatment for cancer, so the likelihood that Rutherford can demonstrate that it is not a drug at all appears slim. Hence if this were the only issue to sustain the injunction it would be unnecessary to proceed further.


Rutherford vigorously argues that even if it is a drug it is not a new one, and therefore, it is exempt from the thicket which results from seeking to comply with Section 505(a) of the Act. A new drug is defined in Section 201(p) of the Act, 21 U.S.C. Section 321(p) as follows:

(p) The term "new drug" means

(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to the enactment of this chapter it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or

(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

Essentially, then, a new drug is a substance which may or may not be generally recognized by scientific experts as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling thereof. A substance is not regarded as a new drug if at any time prior to 1962, the date of the New Drug Amendment in question, it was subject to the Act of June 30, 1906, as amended. The effect of this definition is that there is a twofold grandfather clause exemption which is capable of removing Laetrile from the new drug category even if it is not recognized by the experts as being safe and effective which, by the way, does not say that it is unsafe and ineffective. The first of these grandfather exemptions comes from transitional provisions attached to the 1962 Amendments to the Food, Drug and Cosmetic Act of 1938. The second grandfather exemption arises from provisions attached to the 1938 Act when it superseded the original Food and Drug Act of 1906.

1. Whether the Transitional Provisions Between the 1938 and 1962 Acts Applies

Prior to the 1962 Amendment the only prerequisite for a drug to avoid classification as a new drug was recognition that it was safe. But the 1962 Amendment added the requirement of "effectiveness." See Act of October 10, 1962, Pub.L. 87-781, Section 102(a)(1). One of the transitional provisions enacted in 1962 was as follows:

In the case of any drug which, on the day immediately preceding the enactment date (October 10, 1962), (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force (21 U.S.C. Section 321(p)), and (C) was not covered by an effective (new drug) application under 505 of that Act (21 U.S.C. Section 355), the amendments to section 201(p) made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.

Pub.L. 87-781, Section 107(c)(4), reprinted at 21 U.S.C. Section 321 note.

The effect of this is that if on October 9, 1962, Laetrile was "marketed before 1962 for exactly the same uses for which it is presently being sold and was generally recognized by qualified experts as safe for those uses, it is exempt under this grandfather clause from the test of general recognition by experts as being both safe and effective for its claimed uses." Tyler Pharmacal Distributors, Inc. v. United States Dep't of HEW, 408 F.2d 95, 99 (7th Cir. 1969). See also United States v. Allan Drug Corp., 357 F.2d 713, 717 (10th Cir.), cert. denied, 385 U.S. 899, 87 S.Ct. 203, 17 L.Ed.2d 131 (1966). The present record does not reveal how Laetrile was marketed before the passage of the 1962 Amendment nor does it tell us whether it was recognized as safe. We are mindful, of course, that the cause was not tried on its merits and hence these questions were not considered on preliminary...

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