In the Matter of the Complaints Against

DAMIANA PLUS CAMPBELL and CAMPBELL PHARMACY
(or any variation thereof),
Box 44241 at Van Nuys, California 91412

P.S. Docket No. 6/174

January 11, 1979

William A. Duvall Chief Administrative Law Judge

Daniel S. Greenberg, Esq.,
Law Department
United States Postal Service
Washington, D.C. 20260, for Complainant

Burton C. Jacobson, Esq.,
424 South Beverly Drive,
Beverly Hills, California 90212, for Respondent

Before: William A. Duvall, Chief Administrative Law Judge

INITIAL DECISION^1/

On October 30, 1978, the Consumer Protection Office of the Law Department, United States Postal Service, Complainant, filed a complaint in which it is charged that Damiana Plus, Campbell and Campbell Pharmacy, or any variation thereof, which hereinafter will be referred to collectively as the Respondent, are engaged in conducting a scheme or device for obtaining money or property through the mail by means of false representations within the meaning of Section 3005 of Title 39, United States Code.

The complaint reads in substance as follows:

"That Respondent attracts attention to said scheme by means of matter (hereinafter referred to as the 'advertisements,' typical copies attached as Exhibits A, B, and C) referring to the products described in paragraph II, below:

"That, by means of said advertisements, and in similar matter, Respondent represents, directly or indirectly, by means of affirmative statement, implication, or omission, in substance and effect:

(a) That both 'Damiana Plus' and 'Damiana + 2' will increase the user's ability to attain and sustain an erection.

(b) That both 'Damiana Plus' and 'Damiana + 2' will increase the firmness of the user's erection.

"That said representations are materially false as a matter of fact;

"That by means of requests contained in, or accompanying the advertisements, Respondent seeks to induce readers thereof to remit money or property through the mails to the captioned names and address for said products."

At the opening of the hearing, it was stipulated by counsel for both sides:

(1) that the Respondent does use the advertisements, copies of which are appended hereto as Appendices A, B and C;

(2) that the Respondent does fill orders for the products specified in the complaint and that he fills those orders through the mails; and

(3) that the product consists of damiana, sarsaparilla and ginseng.

The matter came on for hearing on December 13, 1978, in Los Angeles, California, and at this hearing both parties participated in the examination and cross-examination of witnesses and both parties waived the submission of either oral or written proposed findings of fact and conclusions of law. At the conclusion of the taking of the testimony of the witnesses, pursuant to notice previously issued, this initial decision is being issued at this time, at the close of the hearing.

The first witness to testify in this matter was Dr. Jack L. Segal, a medical doctor who is currently an assistant professor of medicine in residence at the University of California at Los Angeles. He is section chief of clinical pharmacology at UCLA-Harbor General Hospital. He is the acting chief of medicine at Long Beach General Hospital, Long Beach, California.

Dr. Segal, in addition to the training that he had in pharmacology in medical school, had two additional years of training in clinical pharmacology, which Dr. Segal defined as the study of medications and drugs in living organisms, particularly human beings, for the purpose of determining whether these drugs will be beneficial when used therapeutically in human beings. It should be pointed out that not all of Dr. Segal's qualifications have been stated in this decision. They appear in greater detail in the record and it is obvious from a consideration of those qualifications that he is extremely well-qualified to testify with regard to matters in the area of medicine that are involved in this proceeding.

Dr. Segal described the physiologic and neurologic and psychologic phenomena that occur when the penis proceeds from the flaccid state to the erect state and then returns to its flaccidity. Because of the nature of the testimony in this proceeding, it is not necessary to dwell at length upon this phase of his testimony.

Dr. Segal testified that when a person consults with a physician and relates a situation in which the patient has difficulty or inability in attaining or maintaining an erection, the prudent doctor takes a complete medical history of the patient and then performs, or has performed, whatever laboratory tests are necessary in order to determine whether there is any physical condition which is responsible for the difficulty experienced by the patient.

If there is no physical or organic condition which would give rise to the condition of the patient, then the problem is of psychogenic origin. It is the testimony of the medical expert that difficulties of the kind which are under consideration in this proceeding are psychogenic in origin in 95 to 98 percent of the cases and that organic conditions cause only from three to five percent of such cases.

If the condition is psychogenic in origin, then the physician recommends consultation with a clinical psychologist or a psychiatrist and the medical doctor, in conjunction with the psychologist or psychiatrist, co-operates in future treatment of the patient.

Dr. Segal indicated that he is familiar with the products which were stipulated as being the constituent parts of the product under consideration, namely, damiana, sarsaparilla and ginseng. All three substances are herbs and these were described and defined in scientific terms in the record.

Damiana has appeared in the scientific literature and specifically mentioned in this connection was the 1965 edition of a work on pharmacognosy by Claus and Tyler, which Dr. Segal described as being one of the standard works in this field. In the 1965 edition, the substance, damiana, was mentioned and it was indicated that this substance might be of interest and that it might be worthwhile to have further studies conducted with respect to this substance in order that its therapeutic value, if any, may be discovered. However, in the 1976 edition of this work -- there is no mention of damiana.

Sarsaparilla was the next product discussed by Dr. Segal. Sarsaparilla is still listed in some scientific reference texts, but it is mentioned principally in connection with the flavoring used in certain effervescent beverages and specific mention was made of root beer. Sarsaparilla was once viewed as a precursor of certain steroids, such as cortisone and some of the hormones. Its relation to the condition under consideration in this particular proceeding is not mentioned or, if so, it is not prominently mentioned.

The third ingredient is ginseng and that has gained some notoriety or stature for providing a multiplicity of benefits for almost every illness afflicting mankind. It is otherwise known as panax, suggesting that it is a panacea for a wide variety of conditions. It derives its name from a Chinese word which means "manlike" and it is a root which, if provided in its natural state and if one uses his imagination sufficiently, may be thought to resemble the shape of a man.

The lay literature says that it is an adaptogen, which means that it is thought to help people to adapt to unusual environments, such as hot or cold. It is thus thought to be beneficial in improving the sexual function of individuals who take it. However, the scientific works contain no such references. It does not appear in the scientific references of today, nor does it appear in the compendia such as the National Formulary or the U. S. Pharmacopeia .

It was the testimony of the medical expert that the product will not increase the user's ability to attain or retain an erection and further, that the product will not increase the firmness of the user's erection. If a positive effect occurs to the user after he has ingested this product, that effect is due to the placebo effect, which is an effect upon the mental attitude and approach of the individual. In other words, for people who are sufficiently suggestible, the inhibiting psychogenic factors preventing the attainment or the maintenance of an erection may be overcome in some individuals under proper circumstances. This result may occur in up to or as much as 30 percent of some populations. If the patient believes sufficiently strongly that he will have a beneficial effect, it is possible, again referring to as much as 30 percent of some populations - not every population - that a favorable result may occur. (Tr. 23) The placebo effect is unpredictable and non-reproducible. (Tr. 22)

The testimony of Dr. Segal with respect to the product being sold by the Respondent is in conformity with the consensus of informed modern medical and scientific opinion.

On cross-examination, Dr. Segal was asked if the fact that the 1965 edition of Claus and Tyler recommended that further studies might well be devoted to damiana, but that no mention was made in the 1976 edition of that work, indicated that the product might have been studied, but no mention was made of the studies in the 1976 edition of the work. The reply to this question was that that would not necessarily follow. Dr. Segal was of the opinion that if the studies had been made, and certainly if the studies had proved that the use of the product was efficacious for the purposes for which it had been sold, that fact would have been mentioned, although if the studies were not made or if they were inconclusive, mention would not necessarily be made in the 1976 edition. On the other hand, if studies had been made and the substance, damiana, had been proved to be inefficacious, that fact probably would have been mentioned.

But on the basis of present information, as it appears in medical literature, it would be speculative to make any conclusions about the conduct of any tests on this product and, if no tests were made, it was because there was not considered sufficient probability of a worthwhile use being found for this product, certainly in connection with its ability to increase one's sexual capabilities. Dr. Segal said, in substance, that none of the constituents has any capability in that direction; therefore, there is no reason to believe that the constituents in combination would produce the desired effect. (Tr. 21)

Dr. Segal did state on cross-examination that people who answer Respondent's ad probably would be motivated along that line and that, as a group, they might have good results in more than the usual 30 or 35 percent. He indicated that such persons may have a good result, but that it is not likely.

Reference was made to a definition in Webster's New International Dictionary with respect to damiana. It developed, however, that the dictionary referred to was a 1928 edition. It is certain that medical science has progressed beyond the state at which it was in 1928 in this as well as in other fields.

The first witness called by Respondent was Mr. Benjamin W. Cannadate, of San Jose, California. Mr. Cannadate testified that he has purchased damiana three times and that he is satisfied with the results. He consulted with a doctor who told him that he had a hormone deficiency, but the doctor did not remedy this deficiency. Later, Mr. Cannadate saw the advertisement and he recalled that, as a young man or a child in Georgia, his parents had used herbs in their treatment of various illness and conditions and he bought the product because he believed it would help him. Mr. Cannadate took the product and he indicated that, in his case, it performed as he had hoped it would. With respect to Mr. Cannadate's testimony, Dr. Segal testified in rebuttal that Mr. Cannadate's experience as a youth and as a young man, or whenever his parents had administered this product to him, had conditioned him so that he would be an ideal subject for the efficacious operation of the placebo effect and that that phenomenon might have been responsible for the fact that Mr. Cannadate was satisfied with the product.

Dr. Segal stated, however, that based upon the very meager testimony of Mr. Cannadate, it would be impossible to state a valid medical opinion as to the cause of Mr. Cannadate's inability to maintain or obtain an erection. Therefore, if Mr. Cannadate recovered, there is no means by which, on the basis of his testimony, his recovery could be attributed to any particular cause.

The next witness for the Respondent was Mr. Fred White Buck, whose function at the Respondent's business is to open the mail, record the orders, and mail products in response to the orders. Respondent receives, in the brief experience of Mr. Buck with the Respondent, about 50 to 60 orders per week for the products, of which from 20 to 25 percent are reorders. Mr. Buck has seen no complaints, nor any requests for refunds from any of Respondent's customers.

The next and final witness for the Respondent was Mr. Irwin Spector, who is the President of the Respondent. He is also in the advertising business and has some other mail order business.

Mr. Spector testified that he is familiar with damiana; that he has been selling it for about a year and a half; but that during this time he has sold no other product containing damiana. (Tr. 45) He confirmed the testimony of Mr. Buck that he has been receiving for some extended period of time, while he has been in the business of selling this product, approximately 50 to 60 orders per week and that his reorders are running to from 20 to 25 percent of these 50 to 60 orders per week. Some reorders may be for as much as a dozen bottles at a time. Mr. Spector says that he has received no complaints and that he has received no requests for refunds.

With respect to the orders and reorders, quite obviously, the orders are the result of the attractiveness of the advertisements of the Respondent. There is no basis in the record for ascribing a particular reason for the reorders, except that perhaps the product being sold by the Respondent is not doing any harm to the persons who use the product. It is not necessarily to be concluded that these persons who reorder are reordering because the ingestion of the product enables them to attain and maintain an erection. In fact, just the contrary may be true. If the product were performing as represented there would not be the need to reorder the product in such quantities. So the fact that there are reorders may be a tribute to the advertising acumen of the Respondent, rather than to his skill in providing a product which performs such marvelous results.

In these proceedings there are three issues which are basically to be resolved. The first issue is does the Respondent advertise and receive orders through the mail? This issue has been resolved by the stipulation. Therefore, the Respondent is engaged in selling this product through the mails.

The next issue is does the Respondent make the representations which are set forth in the complaint? It is not necessary to dwell at length upon this issue because, by comparing the language of the charges in Paragraph 2 of the complaint with the language of the advertisement, it is clear that to the person of ordinary mind, the advertisement does make the representations and convey the impression expressed in the charges. Therefore, the Respondent does make the representations which are set forth in Paragraph 2 of the complaint.

The next issue is whether the representations set forth in the complaint are true or are they materially false as a matter of fact? In effect, there is only one witness in this proceeding who is qualified to testify with respect to the matter under consideration and that is Dr. Segal. The Respondent's witness who was presented to testify with respect to the efficacy of the product for the purpose for which it is being sold was Mr. Cannadate and Mr. Cannadate's testimony, in addition to being purely anecdotal, is so sketchy, and so indefinite, and so brief, as to provide no basis whatsoever for the making of any finding with respect to the efficacy of this product.

The representations in the advertisement are certainly material representations because they relate to an area or a facet of human existence which is very important and which weighs heavily upon the mind of mankind, particularly those individuals whose sexual capabilities are impaired.

There is no competent, credible evidence in this record, and none was offered, which is in opposition to the competent, credible expert testimony adduced by the Complainant. In this connection, reference is made to the case of U. S. Health Club v. Major , 292 F.2d 665, Third Circuit, 1961. It follows, of course, that the representations found to have been made by the Respondent are material representations and they are false as to matters of fact.

In view of the foregoing findings of fact, it is concluded as a matter of law that the Respondent is, as charged, engaged in conducting a scheme or device for obtaining money or property through the mail by means of false representations within the meaning of Section 3005 of Title 39, United States Code.

An order of the type provided for in 39 U. S. Code 3005 in substantially the form attached should be issued against this Respondent.

1/ This decision was rendered orally at the close of the hearing. It has been edited and transcribed for formal issuance.