United States v. Hoxsey Cancer Clinic

• Decision Date: 10 September 1952
• Docket Number: No. 13645.,13645.
• Citation: 198 F.2d 273
• Parties: UNITED STATES v. HOXSEY CANCER CLINIC et al.
• Court: U.S. Court of Appeals — Fifth Circuit

198 F.2d 273 (1952)

UNITED STATES v. HOXSEY CANCER CLINIC et al.

No. 13645.

United States Court of Appeals Fifth Circuit.

July 31, 1952.

Rehearing Denied September 10, 1952.

William W. Goodrich, Acting Asst. Gen. Counsel, Food & Drug Division, Washington, D. C., James M. McInerney, Asst. Atty. Gen., Frank B. Potter, U. S. Atty., Fort Worth, Tex., Vincent A. Kleinfeld, Atty., Dept. of Justice, Washington, D. C., Bernard D. Levinson and Joseph L. Maguire, Attys., Federal Security Agency, Washington, D. C., of counsel, for appellant.

Herbert K. Hyde, Oklahoma City, Okl., James H. Martin, Dallas, Tex., for appellees.

Before HUTCHESON, Chief Judge, and RUSSELL and RIVES, Circuit Judges.

RUSSELL, Circuit Judge.

Proceeding under the provisions of the Federal Food, Drug and Cosmetic Act,¹ and relying particularly upon its provisions defining labeling,² prohibiting introduction into interstate commerce of any drug that is misbranded,³ and deeming a drug misbranded "If its labeling is false or misleading in any particular",⁴ the United States sought in the trial Court the injunctive relief provided by the Act⁵ to prevent the Hoxsey Cancer Clinic, and Harry M. Hoxsey, from introducing or delivering for introduction into interstate commerce bottles of brownish-black, and pink, colored liquids intended for use in the treatment and cure of cancer in man. It is alleged that the drugs, which are distributed and dispatched to physicians, practitioners, and other persons, by defendants are misbranded, because their labeling, specifically a booklet accompanying them, contains "general and specific statements which represent and suggest that said drugs are efficacious in the treatment, mitigation and cure of cancer in man, which statements are false and misleading since said drugs are not efficacious in the treatment, mitigation and cure of cancer in man." Two substantially similar booklets are involved, though it appears that one is no longer used.

For the establishment of its claims of general false and misleading statements, the Government relies upon the import and effect of statements made in an address, captioned: "Theory and Application of the Hoxsey Method of Treating Cancer," by "J. B. Durkee, D. O., Medical Director of the Hoxsey Cancer Clinic, Dallas, Texas, before the Second Annual Convention of the National Medical Society October 17, 1947 held at Royal Palms Hotel, Los Angeles, Calif.", reprinted in the booklets, as well as other statements and representations of the booklets which represent that the Hoxsey medicines are effective in the cure, mitigation, or treatment of internal cancer.

The claim of specific misrepresentations is predicated upon the contention that a division of the contents of the booklet, which includes the listing of individuals with their post office address and statement of the portion of the body on which the cancer appeared, reprint of proceedings and testimony of patients thereupon given, "before and after" treatment photographs and comment thereon, and the invitation to write to the individuals listed "requesting first hand testimony regarding our treatment" when read in conjunction with the statement "`we wish only to present the facts and records of results and benefits received by those who have taken our treatment' * * * leaves the clear representation that the persons named were cured of cancer by the Hoxsey drugs." The truth is said to be that "any of these specific representations are downright falsehoods."

The defense, in the trial Court by pleading and testimony, and renewed here by argument and brief, challenges each and all of the Government's contentions. The position of the defendants is that, as to the claim of general representations, the contents and statements of the booklets, considered as a whole, expressly deny that the medicines will cure all cases, but only that they cure some, do not cure some, and "relieve some somewhat." As to the specific charges of misbranding, the defendants' argument is mainly that by use of the word "patients" in reference to the individuals listed in the booklet there is removed any idea that such persons have been cured. However, it is further contended that the testimony does show that many of the listed individuals were successfully treated and, in some instances, cured. Underlying the entire argument is the fundamental contention that the medicines in question are efficacious in some instances in the cure and alleviation of cancer, and that they represent a "revolutionary treatment", which is, in many cases, successful. Running through the entire defense is the claim that the medicines and supportive treatments produce a higher percentage of more satisfactory results in the treatment of cancer than is secured by the other methods of treatment more generally employed of either x-ray, surgery, radium, or, in some instances, use of some of the by-products of atomic bomb production. These so-called orthodox methods are criticised as ineffective and in some cases positively harmful, whereas defendants contend their treatment does not have such harmful results and yet secures a higher percentage of cures.

The issues thus arising are still present here and require for their solution determination of what representations, general or specific, the booklets may fairly and reasonably be determined to make in the circumstances to which they relate and to the persons to whom they were made, and whether, as so construed and found, the representations are false and misleading within the terms of the statute. Implicit in the latter, and actually controlling here, is whether the Government maintained either or both of its positions that the medicines in question were not efficacious in the cure of cancer in man, and that, in any event, assuming that its claim of specific representation had been established, it had proved such representation to be false.

The trial Court made findings of fact and entered conclusions of law,⁶ and, upon the ultimate ground that under the testimony as a whole the Government had failed to show the correctness of its charges, concluded that the injunctive relief sought should be denied.

The Government, as appellant here, strenuously insists that the trial Court's findings and conclusions evidence misapprehension of the legal effect of the competent evidence, as well as failure to apply the controlling law. It is urged that the competent evidence in the case presents undisputed proof of the Government's specific charges of misbranding which entitled the Government to a decree in its favor; that the Court's findings were erroneously induced by consideration of, and reliance upon, incompetent testimony from laymen that they had cancer; and that they were cured; and that the controlling finding by the trial Court that the Hoxsey drugs are not falsely represented as cancer cures and that they do cure cancer are clearly erroneous, should be set aside, and the issuance of an injunction directed by this Court. Appellees relying upon the Court's finding that the treatment "cures some, and some it does not cure, and some it relieves somewhat. That respondents do not guarantee to cure", cite it as confirmation of the finding that the representations of the booklet are neither false nor misleading.

Our consideration of the booklets, which concededly constitute the labeling referred to by the statute,⁷ leaves us in no doubt that as concerns the nature and extent of general representation the content and statements of the booklet are intended to, and do, convey the claim that the Hoxsey medicines present a successful cure for cancer in only some cases, but the recitation of their virtues is so emphasized and reiterated as to induce in the mind of one thinking he suffered from cancer a belief that he had an excellent chance to be one of those cases in which the medicine would be successful. The language and entire contents are so hedged about with denials that the treatment is a "cure-all", or effective in all cases, that its true import is only that the medicines are effective in a substantial number of cases. For the purpose of this decision, and in determining the truth of such representations, we will accept the more restricted position, to which the Government is driven, that the precise extent of successful cures is immaterial since, it is contended, that the representation that any cure can be effected by use of the medicines is false and misleading. We think the claim of specific representation that the parties listed and given as references for testimonials is sustained to the extent claimed by the Government. It is difficult to imagine that one thinking himself inflicted with the dire disease of cancer and reading and considering the references to these listed patients, and the testimony there set forth, and which is prefaced as this is⁸ and reiterated by conclusion,⁹ would reach any other conclusion than that the persons listed were cured of cancer by the Hoxsey drugs. It is common knowledge that such is the representation of "testimonial letters as is the usual custom." It is clear that the general representation is that at least the Hoxsey medicines will cure some cancer, and the specific representation is that it has cured the persons listed as patients, and who have testified as to cure, and to whom it is suggested letters be addressed to obtain testimonials to the efficacy of such medicines. The question of whether these representations are false and misleading remains.

In approaching this question we are guided by some well recognized beliefs and experience so universally entertained and accepted by the practically unanimous aggregate of medical science as that contradiction thereof does not raise a substantial issue of fact. Thus, with practical unanimity, those informed and in position to know are of the firm belief that there is only one reliable and accurate means of determining whether what is...