In the Matter of the Complaints Against BASIC HEALTH AIDS, P. O. Box 517, Canal St. Station at New York, NY 10013 and 17 W. 17th St., 10th Floor at New York, NY 10011 and STARTIME INDUSTRIES INC., P. O. Box 702 Cooper Station at New York City, NY 10003, SKANDIA DISTRIBUTORS and SKANDIA DIST., Box 430, Canal St. Station at New York, NY 10013 and Box 790, Cooper Station at New York, NY 10003 and P.S. Docket No. 6/35; P.S. Docket No. 6/50; P.S. Docket No. 6/50 August 27, 1979 William A. Duvall Chief Administrative Law Judge H. Richard Hefner, Esq. , Law Department United States Postal Service Washington, D.C., for Complainant Herbert Monte Levy, Esq., 9 East 40th Street, New York, NY, for Respondent Before: Rudolf Sobernheim, Administrative Law Judge Decided by: William A. Duvall, Chief Administrative Law Judge 1/
The Consumer Protection Office, Law Department United States Postal Service, (Complainant) filed Complaints in which it is alleged that Skandia Distributors and Skandia Dist., Box 430, Canal St. Station, New York, NY 10013 and at Box 790, Cooper Station, New York, NY 10003; Basic Health Aids, P. O. Box 517, Canal St. Station, New York, NY 10013 and at 17 W. 17th St., 10th Floor, New York, NY 10011; and Startime Industries Inc., P. O. Box 702, Cooper Station, New York City, NY 10003 (hereinafter referred to collectively as "Respondent") are engaged in conducting a scheme for obtaining money through the mails by means of false representations in violation of 39 U. S. Code 3005.
Each Complaint alleges that Respondent attracts attention to its scheme by means of advertisements distributed to the public which are calculated and intended to induce readers thereof to remit sums of money through the mails to Respondent.
The Complaint in the appropriate case (hereafter Skandia Distributors or Startime) alleges that by means of such advertisements Respondent expressly or impliedly represents to the public in substance and effect:
"(a) 'SWEDISH TURN-ON CAPS THE AUTHENTIC SPANISH FLY IMITATION' are an effective aphrodisiac or sexual stimulant.
"(b) 'ERICA NYMPHO DESIRE CREAM' will:
1. Overcome sexual frigidity;
2. Assure sexual conquest by a male; and
3. Assure the female partner of a satisfactory sexual relationship.
"(c) 'ERECTION PILLS' will cause a certain, immediate, long lasting hard erection.
"(d) 'STA-HARD PILLS' are a certain means of achieving, maintaining and prolonging an erection.
"(e) 'IMITATION SPANISH FLY AND GINSENG' is an effective aphrodisiac or sexual stimulant for both men and women.
"(f) 'LITTLE DEVIL STIMULANT TABS' are an effective means of increasing the sexual performance, capacity and pleasure of the user."
"(a) MX-70 CAPSULES are an effective sexual stimulant for men.
"(b) MX-70 CAPSULES will assure a male user of a full, satisfactory sex life.
"(c) FX-70 FEMALE CAPSULES are an effective sexual stimulant for women.
"(d) FX-70 FEMALE CAPSULES will assure a female user of a full, satisfactory sex life."
Complainant charges that the foregoing representations are materially false as matters of fact.
In the Answer to each Complaint, Respondent denies the allegations of the Complaint except for an admission of the dissemination of the advertisements of the products referred to in the Complaint.
A hearing was held in Washington, D.C., and in New York, NY, at which the parties introduced evidence and participated in the examination and cross-examination of witnesses. Since one of the ingredients on which certain of Respondent's Skandia claims are based (Rufous Capsicum Annum) is the same as the ingredient of the products in Startime, it was agreed that to the extent applicable the evidence taken in Skandia with reference to that ingredient would be deemed to apply in Startime. (P.S. Docket No. 6/50, Tr. 8-9) The cases were consolidated by Order of Judge Sobernheim. Both parties have filed post-hearing briefs.
1. Respondent inserts advertisements of the products which are the subject of this case in various publications. 2/ The advertisements are written by Melvin Cooper, principal officer of Respondent, and at his direction they appear in sexually-oriented publications, some of which are owned and published by Cooper. He selects sexually-oriented publications, in part, to absorb some of the ambiance from the other advertisements and, in part, because other types of publications will not accept his advertisements. Test purchases of the products considered herein were conducted by a Postal Inspector, who made remittances of money through the mail and who, in turn, received products from Respondent. Thus, Respondent uses the advertising matter which is calculated to, and does, induce readers thereof to remit money through the mails for the products as advertised. (Tr. 214-215, 217, 219; stipulation and testimony, Tr. 7-52; Comp. Ex. 1-14)
2. The products involved in this proceeding contain the ingredients listed as follows:
Exh. No.
Product Exh. No. of Ad Ingredients on Label
MX-70 & FX-70 A (in Star-Time) Capsicum Compl. Ex. 1,
Resp. Ex. 2,
respectively
Swedish Turn- 1 Capsicum Comp. Ex. 3
on 3/ Caps
Erica Nympho 1 Methyl Comp. Ex. 4
Desire Cream salicylate
(less than
1%) 4/
Erection Pills 6, 14 Saw Palmetto Comp. Ex. 8
Berries,
Capsicum
Sta-Hard Pills 6 Capsicum, Comp. Ex. 9
damiana
Imitation Spanish 6, 14 Capsicum Comp. Ex. 10
Fly & Ginseng & ginseng
Little Devil 11 Caffeine Comp. Ex. 13
Stimulant Tabs 100 mg. per
tablet
3. With respect to the products of Startime Industries Inc. I find, based on Finding of Fact No. 1, supra , that they are advertised in sexually-oriented publications and that the advertisement, itself, in which they are offered for sale has a predominantly sexual appeal. I find, further, that when the advertisement is considered as a whole, it contains the representations that such products are effective sexual stimulants for men, in the case of MX-70, and for women, in the case of FX-70. Sample portions of the advertisement which support this general finding are (App. A):
a. Both products
"NOW YOU CAN HELP
YOUR SEX PROBLEMS]"
"Whether you have no sex life at all and would like to start enjoying the sexual bliss that life has to offer or you just want to perk up a lackluster sexual life, this is a product you should try.*** Everything to gain and nothing to lose."
b. MX-70
"A truly unique scientific preparation designed to parallel the results of authentic Spanish Fly in the male system."
"Initial tests on many men with problems like yours show that they work."
c. FX-70
"WOMEN no matter what your sexual problems, even if you have never experienced orgasm before, now is the time to try
FX-70 FEMALE
AUTHENTIC PLACEBO
SEX POTENCY
CAPSULES"
"This product is completely safe and results of the initial tests were highly satisfactory."
4. With respect to the products of Respondent Skandia Distributors, Skandia Dist., 5/ and Basic Health Aids, (identified herein as "Skandia") which products are "SWEDISH TURN-ON CAPS THE AUTHENTIC SPANISH FLY IMITATION", "ERICA NYMPHO DESIRE CREAM", "ERECTION PILLS", "STA-HARD PILLS", "IMITATION SPANISH FLY AND GINSENG", and "LITTLE DEVIL STIMULANT TABS", I find, based upon Finding of Fact No. 1, supra , that the publications in which they are advertised are sexually-oriented publications, and that the advertisements, themselves, in which
such products are offered for sale have a predominantly sexual orientation and appeal. I find, further, that when each advertisement is considered as a whole, Respondent makes (with one exception which later will be specified) the representations that are set forth in the Complaint.
5. With respect to "SWEDISH TURN-ON CAPS THE AUTHENTIC SPANISH FLY IMITATION", I find that Respondent Skandia makes the representation alleged in the Complaint, based on Finding of Fact No. 4, supra , and on the following sample excerpts from the advertisement for the product (App. B):
"A unique combination of imported ingredients specially formulated to work on the same basic principle as real Spanish Fly."
"It causes a mild irritation in the urethral tract and will induce real sexual excitement."
6. With respect to "ERICA NYMPHO DESIRE CREAM", I find that Respondent Skandia makes the representations set forth in Paragraph II (b) 1 and 3 of the Complaint, based on Finding of Fact No. 4, supra , and based, also, on the following sample excerpts from the advertisement for that product (App. B):
"GUARANTEED TO HEAT UP EVEN THE MOST FRIGID"
"Will create the desire again and again and again."
I find that Respondent does not make, with respect to "ERICA NYMPHO DESIRE CREAM" the representation set forth in Paragraph II (b) 2 of the Complaint and the Complaint is dismissed as to that charge.
7. With respect to "ERECTION PILLS", I find that Respondent Skandia makes the representation set forth in Paragraph II (c) of the Complaint, based on Finding of Fact No. 4, supra , and based, also, on the following sample excerpts from the advertisement for that product (App. C and E):
"For a Stiff Erection That Will Astound You and Delight Your Partner"
"Results Are Immediate and Long Lasting"
8. With respect to "STA-HARD PILLS", I find that Respondent Skandia makes the representation set forth in Paragraph II (d) of the Complaint, based on Finding of Fact No. 4, supra , and based, also, on the following sample excerpts from the advertisement for that product (App. C):
"Not Getting It Up Lately? STA-HARD PILLS
For A Terrific Rise - Erection Supreme"
"Effects will last for hours."
9. With respect to "IMITATION SPANISH FLY AND GINSENG", I find that Respondent Skandia makes the representation alleged in Paragraph II (e) of the Complaint, based on Finding of Fact No. 4, supra , and based, also, on the following sample excerpts from the advertisement for that product (App. C and E):
"Guaranteed To Make Her Hot
IMITATION SPANISH FLY AND GINSENG
Do You Measure Up? You Can. Unbelievable in Their Effect"
"Ginseng is sometimes called 'The Turn-On Root'.
To quote S. Steingold '...if you think you have been turned on before, you ain't seen nothing yet'."
10. With respect to "LITTLE DEVIL STIMULANT TABS", I find that Respondent Skandia makes the representation alleged in Paragraph II (f) of the Complaint, based on Finding of Fact No. 4, supra , and based, also, on the following sample excerpts from the advertisement for that product (App. D):
"SEX LIFE BELOW PAR?
Feeling tired, sluggish and unable to perform? Try LITTLE DEVIL STIMULANT TABS"
"If you are feeling sluggish, tired and worn out and performing your marital pleasures in a general lackluster manner, the stimulating qualities of Little Devil Stimulant Tablets may be just what the doctor has ordered."
11. The representations heretofore found to have been made by Respondent are material because they are statements which by their nature would, and do, cause persons to order Respondent's products.
12. Complainant relied on the testimony of two medical doctors to support its charge that the representations made by Respondent are false. These witnesses, in the order in which they testified, were Vincent F. Cordaro, M.D. and Robert F. Hotchkiss, M.D.
13. a. Dr. Cordaro is a physician licensed in 1943 by the State of Massachusetts to engage in the practice of medicine. He was in general medical practice until 1951. During his medical education he took courses in urology and during his internship and his practice he had occasion to examine and treat patients for conditions of the genito-urinary tract and for various sexual dysfunctions. He entered the Air Force as a Captain in the Medical Corps in 1951 where he remained until 1953, later entering training for the speciality of anesthesiology which he completed in 1955. He continued part time general practice until his anesthesiological practice required his entire time. While in the Air Force and part time general practice he also had occasion to diagnose and treat persons who had sexual dysfunctions. In 1968, he became a Medical Officer of the Food and Drug Administration where he reviewed matters relating to new drugs and devices. Since 1971, he has been assigned as liaison with the Complainant to provide medical evaluation of new products, drugs, devices, diets, foods and other matters being investigated under 39 U. S. Code 3005. In connection with the last assignment, he consults with his colleagues at the Food and Drug Administration and with practitioners and specialists in appropriate fields related to materials submitted to him by Complainant. In addition, he consults various scientific writings in particular areas of medicine involved in matters under investigation. (Tr. 60-64)
b. In the male, the most common cause of sexual dysfunction is advancing age. In the younger male the most common sexual dysfunction is premature ejaculation. In the case of females, the unstimulated female is the female who is referred to as being "frigid". Another cause of sexual dysfunction in the female is dyspareunia, or the experiencing of pain in sexual intercourse. Most cases of sexual dysfunction, except those which are the normal concomitants of aging, are psychological in origin (Tr. 71-72) and may be alleviated by psychiatric treatment. (Tr. 138)
c. The term "aphrodisiac" is used to mean a substance, function, chemical, drug or food which purports to increase or restore waning sexual function. While certain of the ingredients listed above as being present in Respondent's products (Rufous Capsicum Annum, or red pepper; methyl salicylate, or wintergreen) are used to some extent as counter-irritants, no listed ingredient is recognized as possessing an intrinsic aphrodisiac capability. In earlier times, such substances as Saw Palmetto berries, damiana and ginseng were regarded as aphrodisiacs, but they no longer are, and for some time have not been so regarded by the medical profession. (Tr. 74, 78, 82, 84, 85, 86) Caffeine is a mild central nervous stimulant which may make one more alert and help to keep one awake. It does not provide energy and is not a sexual stimulant. (Tr. 88-90) These views are in accord with the consensus of informed medical opinion.
d. Dr. Cordaro agrees that a beneficial result might occur to some persons from the use of one or more of the products involved in this case by operation of the placebo effect, which is the psychological reaction to the use, under certain conditions, of any product, drug, food or device. As many as 35 - 50 per cent of people to whom placebos have been given without their knowledge have reported a positive reaction in terms of the conditions for which they were being treated. If persons are told that they are being given placebos more than 50 - 70 per cent will not have a positive reaction. Of the latter group, those who report a favorable effect would be a very low number. (Tr. 147-148)
14. a. The final witness for Complainant was Dr. Robert F. Hotchkiss, Professor Emeritus in urology 6/ at New York University. Dr. Hotchkiss received his B.S. degree (1924) and his M.D. degree (1928) at the University of Michigan. After a year's internship in surgery at the Royal Victoria Hospital, McGill University, Montreal, Canada, he received a combined medical and surgical residency at Bellevue Hospital, Cornell Medical College, New York, followed by four years as a resident in urology at the latter hospital. He became an attending physician on the staff of the Department of Urology at New York Hospital and, later, on the staff of Bellevue Hospital with the New York University Medical School. After four years of service in the Navy during World War II, he became the Director of the Cornell Division of Urology at Bellevue. Two years later was invited to, and did, become Professor and Chairman of the Department of Urology at New York University Medical College at Bellevue. In 1974, he retired from active practice and became Professor Emeritus. Dr. Hotchkiss belongs to a number of professional societies, he has written and published scientific articles and he has conducted and participated in (1) experiments and (2) seminars in this country and in Europe relating to sexual functions. (Tr. 251-253)
b. Dr. Hotchkiss searched the U. S. Pharmacopeia in regard to the ingredients of all of Respondent's products involved in this case. Rufous Capsicum Annum, Saw Palmetto berries, Damiana, and ginseng no longer are listed in that reference work. Methyl salicylate and caffeine are listed in the Pharmacopeia. Methyl salicylate is categorized as a local irritant and a flavoring agent, and it is primarily for external use. Caffeine is a central nervous system stimulant. Dr. Hotchkiss has not used any of the ingredients in Respondent's products in connection with the treatment of sexual problems of his patients. He knows of no physician who has used those substances for such purposes. The fact that the substances in question are (1) no longer listed in the Pharmacopeia or (2) not credited with any efficacy in the treatment of sexual dysfunctions is convincing evidence that such substances will not accomplish beneficial results for persons with such dysfunctions.
c. The Pharmacopeia attempts to list all substances which are useful for medical purposes. Mention of the substances capsicum, damiana, ginseng, and Saw Palmetto berries were, in 1924 or earlier, carried in that compendium. They had been used by the medical profession and in this manner they were tested. If these substances had been found to be useful, that usage would have survived. The fact that mention of these substances has been discontinued indicates that experience has shown that they were not medically useful. It is unlikely that double-blind tests ever will be done on these substances because there is no indication that they will be found to be useful. The expenditure of time and money necessary to conduct double-blind testing of these substances for the purposes for which they are being sold by this Respondent would be an unworthy undertaking. (Tr. 257-264-A) 7/
d. The pioneering work of early physicians, and the respect due the conclusions formed on the basis of this practical testing, were put in the proper, and the generally accepted, perspective in the following question and answer between Complainant's Counsel and Dr. Hotchkiss:
"Q You heard Dr. Davis' testimony concerning the fact that in the absence of controlled double-blind studies relative to these substances, he could not express an opinion concerning whether they would or would not enhance sexuality; do you agree with that?
"A I would differ with his opinion on that score. I think that they have been tested by our forefathers in the past years and if they were useful, it would have survived the usage. Now, I don't think anyone will ever do a double-blind test on any of these because there is no indication that they are apt to be useful. Double-blind tests are only done when you hope that you can come up with a product that has some clinical usage." (Tr. 260)
15. a. Respondent's first witness was Dr. Arthur K. Shapiro. Dr. Shapiro received his Bachelor degree at the City College of New York and the M.D. degree at the University of Chicago, respectively, in 1951 and 1955. In 1955-56, he interned at Wayne County General Hospital, followed by psychiatric residency, the first two years of which were at Massachusetts Mental Health Center at Harvard Medical School, and with the last year, 1958-'59, at Jacobi Hospital, Albert Einstein Medical College. Dr. Shapiro is Board certified in neurology and psychiatry. He is in private practice but he maintains an association with academic institutions where he has taught a number of subjects in psychiatry, as well as conducted research primarily into the placebo effect of therapy, or into the nature of therapy as the major research effort. Secondly, he conducts research into a condition known as the de la Tourette syndrome - a condition involving involuntary body movements and vocal emissions.
b. From 1960 to 1966 Dr. Shapiro was on the staff of the Montefiore Medical Center in the Department of Psychiatry where he was head of the Veterans Administration Contract Clinic, with responsibility for the supervision and teaching of residents and engaged in research into the placebo effect of treatment. From 1966 until 1977 he was at Payne-Whitney Psychiatric Clinic, Cornell University Medical College at New York Hospital where he was Director of a laboratory devoted to the study of the therapeutic process. While at the latter institution he was Clinical Professor of Psychiatry, Clinical Professor of Pharmacology, and a Graduate of the School of Medical Sciences. (Tr. 163-167)
c. Dr. Shapiro's major area of research interest, and one in which he has written about 75 articles, is the placebo. He defines the placebo as "any therapeutic procedure, or any part of any therapeutic procedure, which is presumably given with the attempt to help a patient by a healer, or is given by a healer without the presumed intention to help, but unknown to the healer, he gives with a belief that it will help but, objectively, the treatment is without specific effect upon the symptom, the condition, the syndrome, or the patient's complaints." (Tr. 167-8)
d. As a teacher of psycho-pharmacology, Dr. Shapiro would say that 95 per cent of psycho-pharmacologic agents, although they have been well demonstrated to have specific effects, are used in dosages or circumstances or periods of time where there is no specific effect. If one uses a drug at a dosage which is too small to cause a therapeutic effect and there is a therapeutic effect, that is a placebo effect. (Tr. 169)
e. When asked for the number of percentage of persons sending in orders for Respondent's products involved in this proceeding who would receive a beneficial effect, Dr. Shapiro stated that he would not be able to answer. Based on his review of the percentage of placebo effects that occurred in numbers of studies, he concludes that the percentage of persons receiving a placebo effect can vary from as low as six per cent up to 100 per cent. These results depend upon the condition for which the therapy is given, how the study is conducted, and other factors. If a person does not believe that something will help, he probably will not take the product. Or, if such a disbeliever does take the product, he probably would not respond, or he would respond less. (Tr. 173) If a person has hope and belief in a product, he may or may not get a placebo effect. If he has neither such hope nor such belief, he will not get a placebo effect. (Tr. 172-176) In a study which Dr. Shapiro reviewed, the investigator reported that in a test to determine the effect of a placebo in terms of relief from post-operative pain, of the 1000 patients who were the subjects of the study, 36 per cent received a beneficial placebo effect. In Dr. Shapiro's opinion, that figure is too low, but it nevertheless was the result produced by the study. (Tr. 199)
f. Dr. Shapiro can not say that in pharmacology there is a class of drugs that have been demonstrated to be specific aphrodisiacs. (Tr. 184) He has treated patients suffering from different degrees of sexual dysfunction, but prior to his preparation for the hearing in this proceeding, he had heard of Rufous Capsicum Annum, but he did not know what it was and he does not prescribe this substance for any of his patients. He had never prescribed Saw Palmetto berries for any of his patients, he did not know of it, and he had not read about or seen it. He does not use ginseng or damiana in his practice. (Tr. 186-188) He is of the opinion that the doctor-patient relationship is important in dealing with sexual dysfunctions. (Tr. 191) There is possible danger to the patient if treatment for sexual dysfunction is delayed. (Tr. 205)
16. a. The last medical witness called by Respondent was Dr. Joseph E. Davis, a 1953 graduate of New York Medical College who served his internship at St. Vincent's Hospital in 1953 and 1954. He was a surgical resident at Flower Fifth Avenue Hospital, 1954-'55; U. S. Army Medical Corps 1955-'57; he had a urology residency at Bellevue Hospital, Cornell Division, 1957 to 1960. Since 1960 he has been in private practice and, in addition, he has been Attending Urologist at Polyclinic, Columbus and Flower Fifth Avenue Hospitals. He is now Professor and Chairman of the Department of Urology at the New York Medical College. Dr. Davis is a member of the New York County, State and American Medical Associations, the American Urological Association, International Urological Society, American Fertility Society, and he was President of the Association for Voluntary Sterilization between 1971 and 1977. He is Board certified in urology, he has written a number of publications which cover the span of urology, and he has had several governmental grants dealing with work in the reversal of male sterilization. (Tr. 223-225)
b. With reference to this proceeding Dr. Davis has read some newspaper articles and some advertising material in various health stores which aid him in forming an opinion on the question of whether ginseng would have an aphrodisiac effect, but he has no knowledge based on any scientific literature. (Tr. 232-253) He could not tell, in the absence of double-blind experimentation, whether damiana would be efficacious when used as an aphrodisiac. His answer would be the same if he were asked the same question, but about Saw Palmetto berries. He has had no occasion in his practice to use any of these substances. (Tr. 235) He has used caffeine and methyl salicylate but not in the treatment of patients suffering from sexual dysfunction. (Tr. 236) At one point Dr. Davis gave it as his feeling that "***the stimulation of sexual desire is something which is a very individual thing and that some patients may, by merely reading advertising material like this or using these agents or placebo agents, find that which will then allow them to have the appropriate sexual desire. So, I don't see how this can be called true advertising or false advertising.***" (Tr. 241) Thus, Dr. Davis has added his endorsement of Respondent's theory of this case that if Respondent's preparations produce the results claimed by Respondent, and on the basis of which they are sold, it will be due to the placebo effect.
c. Dr. Davis's views on the medical truth or falsity of the claims made by this Respondent, and which are under scrutiny in this case, are expressed in his affidavit submitted after the hearing, as follows:
* * * *
"8) I am aware that Dr. Hotchkiss has testified, since I was present at his testimony, to the effect that he opposes the sale of these products as a fraud upon the public, but the judgment that he expressed is clearly a social, not a medical judgment, for simply stated, no scientist or doctor knows whether any of these products work or not. Dr. Hotchkiss apparently thinks that the sale of these products, or the advertising for them, should be prohibited unless and until it is proven that the products work; my own feeling is that in the absence of scientific proof, one cannot say that any of the advertisements, or any of the representations therein, are false. Therefore, since our society prohibits only false statements in advertising, I would reach the diametrically opposite conclusion of Dr. Hotchkiss, and would make the social judgment that these advertisements should be allowed to stand, in the complete absence of any proof of falsity in them.***"
d. Dr. Davis holds in low esteem, and regards as of little consequence, the knowledge accumulated over the years by the medical profession through testing in the crucible of experience the substances under consideration in this case. (See F.F. 14d., supra )
The position of the Respondent in this case, reduced to its essence, is that the products he is selling may produce beneficial results for some people because of the placebo effect.
It was stated by Dr. Cordaro that 35 - 50 percent of the population may be susceptible to the placebo effect under appropriate conditions. (F.F. 13d., supra ) This testimony was not contradicted by Respondent's witness, Dr. Shapiro. At one point Dr. Shapiro said that in some studies positive placebo results occurred in a range of from six to 100 per cent, while in another large, scientific test, 36 per cent of the participants obtained beneficial results due to the placebo effect. (F.F. 15e., supra )
The question now becomes: are the chances of the occurrence of these rates of assistance to that segment of the public buying Respondent's products sufficient to establish that Respondent is truthfully representing his products in the advertising matter which has been examined in this proceeding? It must be kept in mind that the purchasers do not have the benefit of the doctor/ patient relationship; they may have sexual dysfunction because of some organic condition which they, themselves, can not diagnose; and the delay of proper treatment caused by relying on Respondent's nostrum may produce serious, perhaps even fatal, consequences.
The foregoing question has been answered recently in decisions relating to cases originating in the Postal Service. 8/
In the Postal Service Decision the Judicial Officer said:
"***From the fact that a doctor may treat a patient with a placebo, where medically indicated, and attain results therefrom it does not follow that a commercial enterprise may sell a product on the basis of false claims of its effectiveness and justify the practice on the theory that the customer may conceivably thereby overcome a possible psychological obstacle. The tool is deception and deception for profit. This the postal false representation law prohibits.***"
In Magistrate Sol Schreiber's Recommendation to the District Court, it is said:
"In this case, it is clear that evidence of a placebo effect of these products would not have altered the outcome of the hearing. Defendants correctly contend that if
products are represented as causing a physical reaction when used, and this representation is false, the fact that they incidentally have a favorable psychological effect does not vitiate the falseness of the representations.
"The use of placebos, if at all, should be properly confined to the province of skilled medical personnel who have examined the troubled individual, ascertained that his problem is not physiological, and determined that a placebo may be of aid. In fact, an article offered by plaintiffs regarding placebos suggests the ethical problems of physicians in prescribing placebos.
'For many doctors, deliberate use of a placebo to treat a patient involves an ethical problem. The placebo will work only if the physician lies to the patient. Indeed, studies have shown that the more conviction he can muster in his deception the more effective the placebo.' 'Potent Non-Drugs....'. supra .
"Thus, the failure to reopen the hearing to take evidence on the placebo issue did not constitute a violation of due process."
The District Court, Judge Leonard B. Sand, adopted the Magistrate's Recommendation. The Court of Appeals for the Second Circuit affirmed the judgment of the District Court.
1. The opinion of doctors which is in consonance with medical knowledge gained over years of experience is entitled to great credence. In Reilly v. Pinkus , 338 U.S. 269 at 274, it is said:
"We do not understand or accept it [the McAnnulty case] as prescribing an inexorable rule that automatically bars reliance of the fact-finding tribunal upon informed medical judgment every time medical witnesses can be produced who blindly adhere to a curative technique thoroughly discredited by reliable scientific experiences." (p. 274)
2. An advertisement must be considered as a whole and its meaning must be determined by the impression it creates upon the mind of the average reader.
"It is not each separate word or a clause here and there of an advertisement which determines its force, but the totality of its contents and the impression of the entire advertisement upon the general populace. *** The ultimate impression upon the reader results not only from the total of what is stated but also from what is reasonably implied." Vibra-Brush Corp. v. Schaffer , U.S.D.C., S.D.N.Y., 152 F. Supp. 461, 465 (1957).
3. Respondent's reliance on his money-back guarantee is misplaced.
"When it appears that an advertiser deliberately induces its patrons to purchase its product in the belief that its value far exceeds its true worth it is sufficient to support a finding that a fraudulent scheme was being conducted. Leach v. Carlile , 1922, 258 U.S. 138, ***. This is so, even where there is a promise to refund the purchase price should the article sold prove unsatisfactory. Farley v. Heininger , 70 App. D.C. 200, 105 F.2d 79, 84, cert. den. 1939, 308 U.S. 587, 60 S. Ct. 110, 84 L. Ed. 491." Borg-Johnson Electronics v. Christenberry , U.S.D.C., S.D.N.Y., 169 F. Supp. 746, 751 (1959)
4. Respondent makes the representations set forth in Paragraph II of each Complaint.
5. The evidence in this proceeding establishes that the representations found to have been made by Respondent are material representations.
6. Respondent's said representations are false in fact.
7. Respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations within the meaning of Section 3005, Title 39, United States Code.
Proposed findings of fact and conclusions of law submitted by the parties have been carefully considered. To the extent indicated herein, those proposed findings of fact and conclusions of law are adopted. Otherwise such proposed findings of fact and conclusions of law are rejected for the reasons stated, or because they are contrary to the evidence, or because of their immateriality.
An order of the type provided by 39 U. S. Code 3005, substantially in the form attached, should be issued against this Respondent.
1/ This case was heard by Administrative Law
Judge Rudolf Sobernheim, who transferred to the Civil
Aeronautics Board before the decision was written.
With the consent of the parties this decision was written
by the undersigned Administrative Law Judge.
2/ Complainant's Exhibits A, 1, 6, 11 and 14 are annexed
hereto,
respectively, as Appendices A, B, C, D and E.
3/ In response to an order for Swedish Turn-on Caps,
Respondent
sent Compl. Ex. 3, Placebo Spanish Fly Capsules. Thus, Respondent
must represent that the two products are substantially the same
and that they are interchangeable insofar as the ingredients and
their effects are concerned. Otherwise, Respondent failed to
deliver the product offered for sale.
4/ Cooper post-hearing affidavit, p. 2, par. no. 5.
5/ Comp. Ex. 5 is a pre-addressed envelope to be used in
submitting re-order of desired products to this name at P.O. Box
430, Canal Street Station, New York, NY 10013.
6/ Urology is a branch of medicine which deals with the
urinary and sexual organs. (Tr. 250)