Rutherford v. United States

• Decision Date: 05 December 1977
• Docket Number: No. CIV-75-0218-B.,CIV-75-0218-B.
• Citation: 438 F. Supp. 1287
• Parties: Glen L. RUTHERFORD, Individually and on behalf of a class composed of terminally ill cancer patients, Plaintiffs, 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.
• Court: U.S. District Court — Western District of Oklahoma

438 F. Supp. 1287

Glen L. RUTHERFORD, Individually and on behalf of a class composed of terminally ill cancer patients, Plaintiffs, 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.

No. CIV-75-0218-B.

United States District Court, W. D. Oklahoma.

December 5, 1977.

COPYRIGHT MATERIAL OMITTED

Burton J. Johnson and Kenneth R. Coe of Looney, Nichols, Johnson & Hayes, Oklahoma City, Okl., for plaintiff class.

Paul Ragan, Associate Chief Counsel for Enforcement, Eugene M. Pfeifer, Associate Chief Counsel for Radiological Health, and Arnold I. Friede, Asst. Chief Counsel for Radiological Health, Food and Drug Administration, Rockville, Md., John E. Green, Acting U. S. Atty., and William S. Price, Asst. U. S. Atty., W. D. Okl., Oklahoma City, Okl., Julian C. Green, U. S. Customs Service, Houston, Tex., for defendants.

OPINION

BOHANON, District Judge.

The plaintiffs seek judicial review of the Food and Drug Administration's (FDA's) determination that the substance commonly called Laetrile 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 excludable from interstate commerce due to the absence of an approved new drug application on its behalf. (21 U.S.C. § 355).

On July 29, 1977, the Commissioner of Food and Drugs 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 pre-market 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. Commissioner's Decision (R 523 at 1).¹

Plaintiffs challenge such administrative decision and urge that Laetrile is not a "drug," that in any event it is not a "new drug," and that FDA's enforcement procedures against the interstate transportation and use of the substance violate plaintiffs' constitutional rights.

I STANDARD OF REVIEW

FDA possesses jurisdiction to initially determine whether a substance is a "new drug" within the Act's meaning, Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 627, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973), but such determination is reviewable by the district court under the Administrative Procedure Act, 5 U.S.C. § 701 et seq., Weinberger, supra. To be affirmed, the administrative decision must not be arbitrary, capricious or abusive of agency discretion.² Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971). The court in its review must consider whether the decision was based upon a consideration of the relevant factors and whether there has been a clear error of judgment.³ Citizens to Preserve Overton Park v. Volpe, supra.

While the standard of review is narrow, and the court is not empowered to substitute its judgment for that of the agency, nonetheless, the reviewing court possesses a responsibility "to engage in a substantial inquiry," and "his inquiry into the facts is to be searching and careful . . .."⁴ Citizens to Preserve Overton Park v. Volpe, supra at 415-16, 91 S.Ct. at 824. Although the agency's decision is entitled to a presumption of regularity, this does not preclude a thorough, probing, indepth review. Citizens to Preserve Overton Park v. Volpe, supra at 415, 91 S.Ct. 814.

Meaningful judicial review requires determining that an agency's course of action flowed from a proper interpretation of the relevant law and a proper application of that law to facts sufficiently well developed by agency inquiry as to reflect the truth of the matter in controversy. The court should intervene where it appears from a combination of danger signals, that the agency really has not taken a "hard look" at the salient problems, and has not genuinely engaged in reasoned decision-making.⁵ Greater Boston Television Corporation v. F.C.C., 143 U.S.App.D.C. 383, 393, 444 F.2d 841, 851 (1970).

The exercise of discretionary authority requires a decision based upon adequate information; to act without collecting necessary facts is abusive of discretion. Xytex Corporation v. Schliemann, 382 F.Supp. 50, 53 (D.Colo.1974).

After collecting the facts, the appropriate legal standards must be applied.⁶ If administrative construction of a statute is clearly wrong, it is the court's duty to correct.⁷ R. V. McGinnis Theatres and Pay T.V. v. Video Independent Theaters, 386 F.2d 592, 594 (10th Cir. 1967), cert. denied, 390 U.S. 1014, 88 S.Ct. 1265, 20 L.Ed.2d 163 (1968). Administrative regulations must be consistent with the statute's purposes and reasonably adapted to carry out those purposes. Greyhound Corporation v. United States, 221 F.Supp. 440, 444 (N.D.Ill.1963).

Having reviewed the Decision of the Commissioner of Food and Drugs on Laetrile, dated July 29, 1977, (42 Fed.Reg. 39768-39806 (1977)), and the entire administrative record upon which that decision was based, and the pleadings and briefs, the court concludes that such decision is arbitrary, capricious, that it represents an abuse of discretion and is not in accordance with law. Consequently, it must be set aside and vacated. 5 U.S.C. § 706(2).

ISSUES

The following issues are presented:

1. Is Laetrile a drug?

2. Is Laetrile a "new drug" within the meaning of § 201(p) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 321(p) in that it 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 in the cure, mitigation, treatment, or prevention of cancer in man, and in that it is not "grandfathered" by one of the Act's provisions applicable to those drugs marketed before the current "new drug" statutory provision became effective?

3. Is the agency action in question violative of plaintiffs' constitutional rights?

II NEW DRUG ISSUE

FDA asserts authority to preclude Laetrile's importation or interstate transportation on the basis that it is a "new drug" within the Act's meaning. "No person shall introduce or deliver for introduction into interstate commerce any new drug," unless an application on its behalf has been approved. 21 U.S.C. § 355(a). It is conceded that no such application in regard to Laetrile has been approved, but plaintiffs challenge the Commissioner's categorization of Laetrile as a "new drug."

Plaintiffs initially question the determination that Laetrile is a drug, contending instead that it is a vitamin or food. "Drug" is defined to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals . . .." 21 U.S.C. § 321(g)(1)(B). The court need not rule whether Laetrile is a food or a vitamin, since, in any event, its well-recognized use in the treatment of cancer renders it a drug within the context of the statutory definition.⁸

III THE "GENERALLY RECOGNIZED . . . AS SAFE AND EFFECTIVE" ISSUE

If Laetrile's composition is such that it is generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use in the treatment of cancer, it is not a "new drug" within the Act's meaning and not subject to the asserted FDA regulation. 21 U.S.C. § 321(p)(1).

Unquestionably, the administrative record in this case reveals a substantial and well-developed controversy among medical professionals and other scientists as to the efficacy of Laetrile.

Advocates of Laetrile's use in cancer treatment include many highly educated and prominent doctors and scientists⁹ whose familiarity and practical experience with the substance vastly exceeds that of their detractors. To deem such advocacy "quackery" distorts the serious issues posed by Laetrile's prominence and requires disregarding considerable expertise mustered on the drug's behalf.

While the record reveals an impressive consensus among the nation's large medical and cancer-fighting institutions as to Laetrile's ineffectualness, a disconcerting dearth of actual experience with the substance by such detractors is revealed.

Special problems, medical, legal and philosophical, arise when applying the "generally recognized as safe and effective" standards of the Act to drugs employed in the treatment of cancer. There are many thousands of terminally ill cancer patients each year whose diseases have progressed to a point where, for them, no drug exists which can fairly be termed "generally recognized as safe and effective." These are the persons who have been told they are beyond help and have been sent home to die. Should further treatment of these people be precluded by the Act? Certainly not. Individuals for whom no orthodox cure is available surely are entitled to select a health-care approach with which they feel compatible.¹⁰

Nonetheless, while Laetrile's use in cancer treatment is widespread, its efficacy may, for statutory purposes, be inadequately documented. A drug can be "generally recognized" by experts as effective for intended use within the meaning of the Act only when that expert concensus is founded upon "substantial evidence" as defined in § 505(d), 21 U.S.C. § 355(d). Weinberger v. Hynson, Westcott & Dunning, supra, 412 U.S. at 632, 93 S.Ct. 2469.¹¹

The current debate is fierce. The issue appears largely unresolved as to Laetrile's true effectiveness, in large part because FDA has prevented adequate testing on humans. Nevertheless, the evidence of record does not render the Commissioner's conclusion that Laetrile is not "generally recognized as safe and effective" arbitrary and capricious.

Significantly, however, a drug not recognized as safe and effective still "shall not be deemed to be a `new drug' if at any...