182 F. Supp. 759 | D.N.J. | 1960
This case is before me on continued return of order to show cause why-enforcement of post office fraud order-No. 57004, made November 12, 1959, should not be preliminarily enjoined, and' on defendant’s cross-motion for summary judgment upon plaintiff’s com
The administrative proceedings in the Post Office Department were initiated by complaint of its General Counsel alleging that U. S. Health Club was obtaining remittances of money through the mails by means of false and fraudulent pretenses consisting of representations that the use of Health Club’s products “Super-Coronaid” and “Choless”, as directed by its advertising and labeling, will prevent or alleviate human heart disease by limiting or reducing the cholesterol level in the blood supply, and thus preventing arterial occlusion. In answer to that complaint Health Club denied that it produced, but admitted that it retailed, the products complained of, and denied knowledge or information sufficient to form a belief as to the falsity of the printed labeling material which accompanied the product when it was sold. That answer unqualifiedly denied the charged fraudulent character of the respondent’s claims respecting the product.
The only evidence before the Judicial Officer upon the issues of falsity and fraudulent intent is to be found in the testimony of Dr. Kenneth D. Campbell, a physician employed by the United States Food and Drug Administration with the title of Associate Medical Director of Drugs and Devices, and the written report, dated January 24, 1958, made by the same doctor to Post Office Inspector C. C. Garver, entitled “Report on All Diet Foods Distributors, Inc., 123 East 34th Street, New York, New York, distributing a product known as SuperCoronaid plus Choless as an allegedly effective means for preventing coronary thrombosis.” The Hearing Examiner defined the questions presented as (1) whether the representations complained of are attributable to Health Club; (2) whether failure of respondent to admit or deny the charged falsity of the representations amounted to an admission of that charge under Section 201.8(c) of the Departmental Rules of Practice
Plaintiff did not admit the falsity of the representations complained of. Paragraph 4 of the departmental complaint charged that the representations recited were “false and fraudulent.” The “First” paragraph of respondent’s answer denies the accusation (set forth in the introductory paragraph of the complaint) that respondent “is
In his written report Dr. Campbell states that “the principal constituents of the Super-Coronaid plan to reduce the incidence of coronary artery disease are the so-called essential fatty acids — Iino-leic and linolenic — present in the Super-Coronaid tablets and liquid. Recent developments in the field of nutrition suggest that the administration of unsaturated fatty acids as present in the two Super-Coronaid products may have some value in decreasing the number of cases of coronary thrombosis in our population since apparently these dietary factors bring about some lowering of the cholesterol levels in the blood.” He adds that the supporting data for the theory stated are fragmentary and in some instances conflicting, but that it has been demonstrated that middle-aged sufferers from coronary thrombosis have an elevated level of blood cholesterol which induces the belief that cholesterol may have been the direct cause of the attack. On the other hand, it is also recognized that both the condition and the disease may be manifestations of some unknown pathological process. He reports that “(e)xperimental studies in human subjects with a variety of oils have indicated that activity in relation to lowering the blood cholesterol levels is correlated with the degree of unsaturation of the component fatty acids.” While the pathogenic mechanism and cause or causes of atherosclerosis are unknown, says Dr. Campbell, and it has not been demonstrated that dietary supplements of unsaturated fatty acids will be effective in reducing the cholesterol level of the blood “there are several prominent pharmaceutical firms making various types of unsaturated fatty acid dietary supplements for use by physicians and it appears that they are enjoying a measure of popularity and usage on the basis that, although details of the relationship are not understood, the serum cholesterol level and atherosclerosis in man are probably interrelated.”
On March 18, 1959, the substance of Dr. Campbell’s testimony before the Hearing Examiner, on direct examination, tended to indicate that the consensus of informed medical opinion impelled the conclusion that the representations made respecting the efficacy of respondent’s products for the purposes stated in the labeling and advertising thereof, were false, and that his conclusion of their falsity was in conformity with the “universality of informed medical opinion” on the subject. Upon cross-examination, Dr. Campbell testified that the role of unsaturated fatty acids in the treatment or prevention of arteriosclerosis is under 'study, and that it appears that the addition of small amounts of unsaturated fatty acids (equivalent to the amount contained in the accused products) without any modification of the diet, would be ineffective in lowering the blood cholesterol level. The witness fur
In American School of Magnetic Healing v. McAnnulty, 1902, 187 U.S. 94, at page 104, 23 S.Ct. 33, at page 37, 47 L.Ed. 90, the Supreme Court used the following language in passing upon the sufficiency of a complaint for injunctive relief against a post office fraud order:
“Because the complainants might or did claim to be able to effect cures by reason of working upon and affecting the mental powers of the individual, and directing them towards the accomplishment of a cure of the disease under which he might be suffering, who can say that it is a fraud, or a false pretense or promise within the meaning of these statutes? * * * As the effectiveness of almost any particular treatment of disease is, to a more or less extent, a fruitful source of difference of opinion, even though the great majority may be of one way of thinking, the efficacy of any special method is certainly not a matter for the decision of the Postmaster General within these statutes relative to fraud. Unless the question may be reduced to one of fact as distinguished from mere opinion, we think these statutes cannot be invoked for the purpose of stopping the delivery of mail matter.”
The views expressed in the foregoing quoted language of Mr. Justice Peekham were referred to with approval by the same Court as recently as 1949, in Reilly v. Pinkus, 338 U.S. 269, 70 S.Ct. 110, 94 L.Ed. 63. At page 273, of 338 U.S. at page 113 of 70 S.Ct. the evidence in McAnnulty was characterized as being “no more than ‘opinion’ in a field where imperfect knowledge made proof ‘as of an ordinary fact’ impossible.” In Reilly, despite the finding of conflicting medical opinion as to whether kelp or iodine is valueless as a weight reducer, the Supreme Court held that “the efficacy of the ‘Reducing Plan’ as a whole was misrepresented in respondent’s advertising.” Nevertheless, the Court refused to direct the enforcement of the fraud order under review because of the restrictions upon cross-examination imposed by the agency.
We pass now to the final question, whether upon the evidence before the Hearing Examiner there was a reasonable basis for inference that the respondent intended to deceive by the representations which it made because of the absence of support for those representations in the “universality of scientific belief.” While Dr. Campbell did testify that the efficacy of certain components of plaintiff’s products for the purposes for which they were advertised was the subject of continuing experimentation, without conclusive results, it was his opinion that the use of the products in the dosage quantities prescribed by the advertising was without value, either prophylactic or therapeutic, in achieving the results held out for the products in the accompanying advertising. He based this opinion upon what he stated to be the consensus of informed medical opinion, and the univer
Because the only evidence before the Judicial Officer was the opinion of Dr. Campbell that plaintiff’s product was valueless for the purpose recommended in the dosages prescribed, I find that the fraud order issued by the Judicial Officer lacks the support of substantial evidence. Its enforcement must, therefore, be permanently enjoined. Plaintiff’s motion is granted, and defendant’s cross-motion is denied. Let an appropriate order be entered.
. “(c) Any facts alleged in the complaint which are expressly admitted or not denied in the answer may be considered as proved, and no further evidence in respect of such facts need be adduced at the hearing.”