192 F.2d 62 (9th Cir. 1951), 12665, United States v. El-O-Pathic Pharmacy

Docket Nº:12665.
Citation:192 F.2d 62
Case Date:June 18, 1951
Court:United States Courts of Appeals, Court of Appeals for the Ninth Circuit

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192 F.2d 62 (9th Cir. 1951)







No. 12665.

United States Court of Appeals, Ninth Circuit.

June 18, 1951

Stay of Mandate Denied July 3, 1951.

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Ernest A. Tolin, U.S. Atty., Clyde C. Downing, Asst. U.S. Atty., George E. Danielson, Asst. U.S. Atty., Los Angeles, Cal. (Arthur A. Dickerman, Atty., U.S. Food & Drug Administration, Federal Security Agency, Washington, D.C., of counsel), for appellant.

Eugene M. Elson, Los Angeles, Cal., for appellees.

Before HEALY, McALLISTER (sitting by special designation), and ORR, Circuit Judges.

McALLISTER, Circuit Judge.

This is an appeal from an order of the district court denying permanent injunctions in consolidated cases in which the government sought to restrain appellees from introducing certain allegedly misbranded drugs, known as hormones, into interstate commerce, and, further, to enjoin them from causing any acts to be done with respect to such drugs that would result in their being allegedly misbranded in intrastate commerce, in claimed violation of the Federal Food, Drug, and Cosmetic Act of 1938, as amended, Title 21 U.S.C.A.§ 301 et seq. 1

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The government's complaint asking for injunctions in the district court thus specified two types of prohibited acts which it alleged appellees violated; and the circumstances giving rise to such complaint are as follows: It appears that the hormones in question are manufactured by pharmaceutical corporations in the eastern part of the United States and shipped to appellees in California with labeling that states, in part, 'Caution: To be dispensed only by or on the prescription of a physician.' Thereafter, the appellees relabel the drugs to eliminate this prescription statement; and the new labeling, it was claimed, caused the drugs to become misbranded within the meaning of the statute. 21 U.S.C.A. § 352(a), (f)(1), (f)(2), (j). When appellees distributed these relabeled drugs in interstate commerce, it was alleged that they violated that section of the statute which prohibits the introduction of misbranded drugs into interstate commerce, 21 U.S.C.A. § 331(a); and when they distributed such relabeled drugs in intrastate commerce, it was claimed that they violated that section of the statute which prohibits the doing of acts with respect to the labeling of drugs while they are held for sale after shipment, in interstate commerce, if such acts result in the drugs being misbranded, 21 U.S.C.A. § 331(k).

On appeal, the government contends that the hormones, introduced into interstate commerce, distributed, and sold by appellees, were misbranded, in violation of the statute, in that they did not bear adequate directions for use; that they were dangerous to health when taken as directed; and that they did not bear adequate warnings against use in those pathological conditions where their use might be dangerous to health; all in violation of the statute. Title 21 U.S.C.A. § 352(a), (f)(1), (f)(2), (j).

The district court held that the warnings on the cartons containing the drugs were sufficient in that they stated that the hormones were for use by adult males deficient in male hormone when small dosages are prescribed or recommended by a physician for palliative relief of such symptoms; that the maintenance dosage could be extended from three to six months under supervision of a physician; that before taking, the hormone, a physician should be consulted, since the hormone would not aid or relieve symptoms not associated with male hormone deficiency; and that children and young adults must not use the hormone except under constant, direct supervision of a physician. Remarking that the government wanted the drugs in question to be sold only upon the prescription of a physician, the court concluded that the question as to what effects would follow from the administration of the drugs was in dispute; that the doctors could not agree on the subject; that the government had not sustained the burden of proof; and the court, accordingly, dismissed the case.

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It is the claim of the government that it has sustained the burden of proving that the hormones in this case are inherently dangerous; that they are not safe and efficacious for use except under the supervision of a physician; that they are not suitable for self-medication, since a layman could not know when they should be used and when they should not be used; that adequate directions for unsupervised lay use can not be written; and that such drugs, if sold legally in interstate commerce, must be dispensed only upon prescription of a physician, in accordance with the regulations of the Federal Security Administrator. 2 The government further contends that the proofs disclose that the drugs in question failed to bear adequate directions for use, in that they are offered to the public as efficacious remedies for many conditions which are not mentioned in the labeling or directions for use.

To these contentions, appellees reply that the statute in question is not susceptible of an interpretation that the Administrator, provided for therein, is empowered to determine what drugs may be sold only on prescription; that the labeling of appellees' drugs bears adequate directions for use and warnings within the meaning of the statute; that the drugs are not dangerous to health, within the meaning of the statute; that the findings of the district court are sustained by substantial evidence; and that, since they are not clearly erroneous, they must be accepted on appeal, and the judgment affirmed. Rule 52(a), Federal Rules of Civil Procedure, 28 U.S.C.A.

The evidence in the district court consisted of a stipulated written record. It comprised the pleadings, affidavits, and a transcript of proceedings in the trial of a criminal case in which appellees were found guilty by the district court, sitting without a jury, of the offense of distributing misbranded male and female sex hormone drugs. The convictions were, essentially, based upon the conclusions and findings of the district court that the hormones were dangerous to health and that the labeling claims which appellees therein made for their hormones were false and misleading. The district court stated, in the criminal case, that it was convinced, beyond a reasonable doubt, that indiscriminate distribution or dispensation for use of the hormones carried not only a potential but an actual danger of injury to some persons; that the leaflets and circulars enclosed in the packages by which deliveries of sales were made, were designed to create a belief that many persons were deficient in their natural testosterone, and that, by supplementing it with the drug called by various names, a synthetic testosterone, much benefit could be derived by the user; and that the court was convinced from the evidence that these drugs did not, other than within a restricted class of cases, produce many or any of the alleviatory and beneficial effects that the labeling given them by the defendants indicated, and encouraged readers to believe they would generally produce. Appellees did not file appeals in the criminal case, but paid the fines imposed upon them.

After the convictions in the criminal case, a different judge was assigned to try the injunction cases now before us. The evidence in these consolidated cases, here on review, consisted of the record in the prior criminal case. No additional witnesses were produced and no oral testimony was submitted. While giving due consideration to the trial court's findings, to which they are justly entitled, and with reluctance to reverse them unless well persuaded, nevertheless, under such circumstances, they do not have the weight we would otherwise be obliged to concede to them, and the scope of review is de novo; for this court is in as good a position as the trial court was to appraise the evidence. Equitable Life Assur. Soc. of the United States v. Irelan, 9 Cir., 123 F.2d 462. See Stork Restaurant, Inc. v. Sahati, 9 Cir., 166 F.2d 348; Murphey v. United States, 9 Cir., 179 F.2d 743; Orvis v. Higgins, 2 Cir., 180 F.2d 537; Blackner, et al. v. McDermott, 10 Cir., 176 F.2d 498; and while, under Rule 52(a) of the Federal Rules of Civil Procedure, findings of fact in actions

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tried without a jury may not be set aside unless clearly erroneous, nevertheless a finding is 'clearly erroneous' when, although there is evidence to support it, the reviewing court, on the entire evidence, is left with the definite and firm conviction that a mistake has been committed; United States v. U.S. Gypsum Co., 333 U.S. 364, 394, 68 S.Ct. 525, 92 L.Ed. 746.

For an understanding of the issues involved, an outline of the nature, use, and effect of hormones, as disclosed by the evidence, may be helpful.

The drugs here involved are male and female sex hormones. A hormone is medically defined as a chemical substance originating in an organ, gland, or part of the body, which is conveyed through the blood to another part of the body, stimulating it to increased functional activity, and increased secretion.

The principal drug in question is testosterone, which is a male sex hormone. This hormone is generated by the reproductive organs of the normal adult male. Male sex hormones are also known as androgens, and female sex hormones, as estrogens. They are not only generated in the reproductive organs; the hormones, in this case, are prepared from extracts of animal tissues and fluids, as well as made synthetically by complex chemical fusions that have the qualities of natural hormones.

Leaders of the medical profession in America, practitioners, professors of medicine, as well as...

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