In the Matter of the Complaint Against MEAD-WILSON PHARMACAL and PENN-BIO PHARMACALS, Caroline Road at Philadelphia, PA 19176 P.S. Docket No. 6/146 May 2, 1979 William A. Duvall Chief Administrative Law Judge Daniel S. Greenberg, Esq. Law Department United States Postal Service Washington, D.C. 20260, for Complainant Charles B. Chernofsky, Esq. and Benjamin F. Kursman, Esq. Weiss, Rothfarb & Chernofsky, 6 East 43rd Street, New York, New York 10017, for Respondent Before: William A. Duvall, Chief Administrative Law Judge
The Complaint in this proceeding was filed on August 22, 1978. In the Complaint it is charged that the Respondent, under the names Mead-Wilson Pharmacal and Penn-Bio Pharmacals, Caroline Road, Philadelphia, PA 19176, 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 39 U. S. Code 3005. It is charged that Respondent attracts attention to the said scheme by means of advertisements (Ex. C-1 and C-2), copies of which are attached to this decision as Appendices A and B.
Complainant charges that by means of advertisements, of which Appendices A and B are typical, Respondent seeks remittances of money through the mails by making, directly or indirectly, by means of affirmative statement, implication or omission, in substance and effect, certain specific representations, which are alleged to be false as to material matters of fact. The specific misrepresentations charged are attached hereto as Appendix C.
By its Answer, filed on September 11, 1978, Respondent, among other things, admitted that the advertisements attached to the Complaint were placed at the direction of the Respondent, but denied any inferences drawn from the remainder of Allegation I, and Respondent denied, also, all charges and inferences drawn from Allegations II and III.
The matter came on for hearing before the undersigned on October 20, 1978, at which hearing counsel for both parties participated in the introduction of evidence and in the examination and cross-examination of witnesses. Post-hearing Proposed Findings of Fact and Conclusions of Law have been filed by Counsel, by each of whom has also been filed a Reply to his opponent's initial filing.
Not including the mailing wrapper, Respondent's product is delivered to the purchaser in a blue and white carton (Ex. C-4(a)), on the outside of which is the following language:
"FULL STOP
Slim-Cubes To Be Used in Conjunction with
The Full Stop Slim-Cubes program
63 CUBES
APPETITE DEPRESSANT
In The Treatment of Obesity (Overweight)
Distributed by Mead-Wilson Pharmacal
Caroline road, Philadelphia, PA 19176
DIRECTIONS -- adults: Take one cube with hot beverage 30
minutes before each meal. Do not exceed 3 cubes a day.
CAUTION: Should not be used by persons with heart or thyroid
diseases, high blood pressure or diabetes except on medical
advice. Each cube contains Phenylpropanolamine Hydrochloride.
25 mgm. WARNING: Keep out of reach of children."
The "Full Stop Slim-Cubes" are small, white, cube-shaped tablets enclosed in a plastic bubble type of container. (Ex. C-4(b)) Accompanying the tablets is an instruction booklet (Ex. C-4(c)). This booklet is approximately 3 3/4 x 4 3/4 inches in size and it contains 28 pages, not including front and back covers. The booklet contains a brief description of the weight loss program, directions to the purchaser, a discussion of the three daily meals, cautions that persons with certain physical conditions should check with their physicians before beginning the program, a question and answer section on matters of interest to obese persons, including a diet outline for a typical day, various food lists, and a program of calisthenics for the purchaser. There are numerous cautions stated in different parts of the booklet, e.g., pp. 1, 19 and 24.
Postal Inspector Olin J. Broadwater investigated this matter, which first came to his attention when he noticed one of Respondent's advertisements (Ex. C-5) that appeared in the January 1978 issue of TV and Movie Screen. (Tr. 114-115) Inspector Broadwater initiated a test purchase of the product through the mail on February 6, 1978 (Tr. 15, Ex. C-6-9), and on March 7, 1978, the product was received via the mail. In the conduct of the business of selling its weight loss program, Respondent does solicit and obtain remittances of money through the mail.
It first must be determined whether the Respondent makes the representations set forth in the charges of the Complaint. To do this, Respondent's advertisements must be considered in the light of the effect such advertisements would most probably have upon the mind of the ordinary reader. Donaldson v. Read Magazine, 333 U.S. 178, 188-9 (1948) As the court said in Vibra Brush Corp. v. Schaffer, 152 F. Supp. 461, 465 (1957):
"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."
At the top of Respondent's advertisement (App. A hereto) 1/ in large type are the following eye-catching messages:
"INCREDIBLE PLAN FOR AUTOMATIC WEIGHT-LOSS]
"Now] Lifetime
Freedom From Fat
"WITH DOCTOR'S AMAZING 'COFFEE-OFF' PROGRAM
"FOR CUP-TO-CUP WEIGHT-LOSS]"
In the right-hand column of the three-column page is a photograph of a trim, slender young woman who is looking admiringly at a cup and saucer she is holding. Beneath the photograph mentioned above is the following message: "JUST 3 CUPS A DAY HELPS MELT FAT AWAY as you sip yourself thin cupful to cupful with Doctor's LIFETIME SLIMNESS program for AUTOMATIC WEIGHT-LOSS]"
Beginning with the second paragraph in the left-hand column there is the following language:
"So effective, you LOSE up to 6 pounds the very first weekend -- LOSE up to 12 pounds of both fluid and fat in just 14 days -- LOSE as much as 20 -- 30 -- 40 POUNDS OR EVEN MORE ... (and never gain it back for the rest of your life), as medical science shows you how to turn ordinary coffee or tea into the most 'DYNAMITE' FAT-MELTING aid you've ever seen in your life.
"LIKE TURNING UP AN INNER FURNACE THAT SHRINKS YOUR BODY'S FAT CELLS - STARTING THE VERY FIRST DAY]
Just 60 seconds from now you are going to discover how to take your morning cup of coffee ... drop in what appears to be an ordinary sugar-cube ... and launch yourself on the most incredible FAT-BURNING SPREE you've ever heard of."
It is reasonable to interpret the above language, as Complainant did in charge II A(1), to mean:
"That the addition of 'FULL-STOP' Slim-Cubes to coffee, tea, or clear bouillon converts said beverage into one which causes the body to burn fat to a greater degree than normally."
In the left-hand column, beneath the picture of a cube-shaped object in a spoon is the following language:
"Most significant of all, as long as you follow this medically proven 'Coffee-Off' lifetime slimness program, you actually become totally immune to fat build-up for the rest of your life -- even if you've been hopelessly overweight for all your adult life.
"The secret is a medically-proven formula, (that to the eye looks just like an ordinary sugar-cube) ... BUT, when activated in coffee or tea ... enters your system and automatically SHUTS OFF YOUR APPETITE -- SHUTS OFF THAT DRIVING URGE FOR FOOD -- SHUTS OFF GNAWING HUNGER for hours at a time] Actually kills your desire, your craving, your appetite for food from meal to meal] So much so in fact, you aren't lured or tempted by even the most mouth-watering food. Not by ice cream ... not by cake ... not even by the most luscious steak. In a nutshell ...
YOU'RE SIMPLY TURNED OFF FOOD FOR HOURS AT A TIME"
The foregoing quotations contain language which can, and undoubtedly do, cause the ordinary reader to believe, as stated in charge II A(2):
"That ingestion of coffee, tea, or clear bouillon in which the 'FULL-STOP' Slim-Cubes have been dissolved will:
(a) prevent the buildup of fat in the user;
(b) eliminate hunger for hours;
(c) eliminate the user's desire for even the most mouth-watering foods;"
Starting with the second sentence of the third paragraph in the left-hand column of Appendix A, the Respondent states:
"Yes, a journey to 'lifetime slimness' so fantastic, that just a few short weeks after using this doctor's amazing 'Coffee-Off' weight-loss program you'll suddenly find yourself 5 -- 10 -- 15 pounds lighter . . . your belt size 1 -- 2 -- 3 notches tighter] Because for the first time in your life you are going to win INSTANT CONTROL over your appetite . . . become its master instead of its slave ... actually SWITCH OFF that maddening urge for food for hours at a time ... as you watch your waistline shrink itself down by as much as a full size in just a single week]
24 HOURS -- up to 2 POUNDS GONE]
48 HOURS -- up to 6 POUNDS GONE]
AND THAT'S JUST THE BEGINNING]"
The average person by whom this advertisement is read would believe that Respondent is assuring him, as Complainant sets forth in charges II A(3) and (4):
"that the following weight losses are typical of losses that may be expected by ingestion of coffee, tea, or clear bouillon in which 'FULL-STOP' Slim-Cubes have been dissolved:
(a) 2 lbs. in 24 hours;
(b) 6 lbs. in 48 hours; and
that the weight losses described in subparagraph (3), supra, will consist primarily of loss of fat."
Weighing Respondent's advertisements as a whole, including not only the statements quoted above but, also, other statements in the advertisement; the context in which the statements appear, such as the use of large type size; the repeated use of the word "fat" throughout the advertisement; the photographs and other features, not the least of which is the reference to the fact that the program being sold was prepared by a medical doctor; it is concluded that the reader of Respondent's advertisement would receive the impression and believe the advertisements to mean:
"That by its failure to disclose that its program places limitations on the foods that may be eaten, coupled with its emphasis on the alleged fat-controlling effects of the 'FULL-STOP' Slim-Cubes, as described in subparagraph A, supra, Respondent misleads prospective purchasers as to the effort required to achieve the promised results"; (Charge II (B))
"That, by seeking remittances based upon the claims made for the 'FULL-STOP' Slim-Cubes, Respondent implies that their use will provide a substantial benefit, over and above anything else sent with said tablets, in effecting the claims charged in subparagraph A, supra." (Charge II (C))
It now must be determined whether the representations found to have been made by Respondent are true or false.
The first witness called by Complainant was Dr. Jack Crowell, M.D. of Washington, D.C., who was graduated in 1951 from the Medical School of George Washington University. After an internship at George Washington University Hospital, residency at the former Mt. Alto Veterans Administration Hospital, Washington, D.C., and a final year of residency at the George Washington University Hospital, he entered private practice in Washington, D.C., in 1955. Dr. Crowell established his own obesity clinic in 1955 and he had this clinic until 1969. He now specializes in metabolic diseases and endocrinology and he is also interested in Air Space medicine. He belongs to numerous medical societies including, the American Medical Association, American Diabetes Association, Air Space Medical Association, and others. (Tr. 7, 8) Approximately 30 per cent of Dr. Crowell's practice now consists of the treatment of patients for obesity. (Tr. 9)
Obesity is caused by eating more than is required to meet one's metabolic needs, with the excess intake over such needs being stored in the body as fat. (Tr. 9) "Hunger" was defined as the desire for food, and that desire is satisfied by eating almost any type of food. "Appetite," on the other hand, is a desire to eat a particular kind of food, and nothing but that kind of food will satisfy one's appetite. People eat for a variety of reasons including boredom, frustration, compulsion and tension. (Tr. 10, 16)
The treatment of a person who wants to lose weight generally begins with the taking of the patient's history, his background, family history, length of time the person has been overweight, what problems he may have in his employment and in his family life, whether he is tense and nervous, and what he does for recreation and exercise. The patient is told of certain fallacies that have been propagated, some results he reasonably can expect, and he is told something about food. The patient is told, also, to keep a food diary. After a short period, the patient returns to the physician's office, and doctor and patient review the diary with a view to finding low-calorie substitutes for the high-caloric foods shown in the diary. (Tr. 11-12; 15-16) Depending upon the individual needs of a patient, pills may be prescribed which may act as hunger suppressants, tranquilizers, diuretics or anti-depressants. (Tr. 18)
Tension eating is often referred to as "nervous eating." It may occur when one is upset about some problem, such as the rent, the performance of one's children in school, or some marital situation. Compulsive eating generally stems from some sense of guilt which is deep-seated in the childhood emotional or psychological background of the patient. Compulsive eating is much more difficult to treat and frequently requires psychiatric treatment. Perhaps 80 per cent of obese people may be classified as tension-eaters, while compulsion eating is not as prevalent as is popularly believed. (Tr. 17)
Dr. Crowell establishes an easy goal, on the order of one pound of weight loss per week, for his patients and then spreads out their visits depending upon whether they have met, or failed to meet, their objective. If the goal is reached, the visits are much less frequent until the desired weight loss has been achieved, at which time the visits may be once a year, or even less frequent. (Tr. 18)
Dr. Crowell does not use appetite or hunger depressants on the first or second visit of the patient, which visits usually occur during the first month of treatment. (Tr. 58) These medications are reserved for such times as the patient may reach a difficult "hump" or "plateau" in his weight loss effort, and the pills serve to assist the patient over such difficulties. These remedies, however, produce, if any, only short-term benefits. (Tr. 20, 21, 74) Hunger suppressants are effective in terms of weight loss in about 20% of the overweight population to whom they are administered because the other 80% are tension, or compulsion, eaters who eat despite the ingestion of hunger suppressants. (Tr. 75-77)
In general, it is not beneficial to give a hunger suppressant to someone who is just starting on a weight-reduction program. Most people at the start of such a program are so motivated that they tend to adhere more closely to whatever they initially are supposed to do. Thus, the likelihood is that they will experience some weight loss and there is no reason or need to give them a hunger suppressant. Later, when the motivation lags, the use of such medication may or may not be helpful, but it would still be effective for only one in five persons. (Tr. 81-83) All patients ultimately develop a tolerance for any program that includes constant, repetitive use of a hunger suppressant day after day for long periods of time. (Tr. 88, 219)
Dr. Crowell stated that the contact resulting from the doctor-patient relationship over a course of treatment is beneficial to the patient who is trying to lose weight. The doctor can individualize the program, and the patient will develop confidence in the doctor and believe that the doctor is competent in the methods he employs. In Respondent's program all persons receive the same product and if it is individualized, the user must individualize it for himself, or seek professional advice. Obviously, the user's aim in purchasing the product is to treat himself without seeking professional advice. (Tr. 88-91)
The exercise portion of Respondent's program would be beneficial, if adhered to, but experience has shown that people generally do not regularly follow such exercise programs. (Tr. 92) Performing exercises may increase or decrease the desire for food depending on the individual. (Tr. 93)
Respondent called as its witness Lester J. Besen, M.D., 1 Sadore Lane, Yonkers, New York. Dr. Besen graduated from New York University College of Medicine in June 1947; he interned at Morrisania City Hospital, 1947-1948, where he was a Resident in Medicine, 1948-49; in private medical practice, 1949-1950. Dr. Besen was in the United States Air Force Medical Corps as a Captain, with a specialty in internal medicine, 1951-1953; he practiced family medicine in Yonkers, 1953-1965. Since 1965, he has limited his practice to the medical treatment of obese patients on a full-time basis. Dr. Besen is employed, in addition, by T & T Diet Research, Inc. by whom the booklet which forms part of Respondent's product is copyrighted. (Tr. 127-128; Ex. R-1; Ex. C-4(c))
Dr. Besen presently belongs to a number of professional societies, academies and associations, including the American Society of Bariatric Physicians. He was licensed to practice medicine in New York - 1949; New Jersey - 1966; Florida - 1970; and he is a Diplomate of the National Board of Medical Examiners. He is affiliated with various hospitals in Yonkers and he is a lecturer on obesity at numerous medical meetings. (Ex. R-1) Since he limited his practice to the medical treatment of obese patients, in 1965, Dr. Besen has seen over 8000 patients. (Tr. 129)
Doctors who wanted to become members of the American Society of Bariatric Physicians once had to submit summaries and records on at least 10 patients with an outline of what occurred at their first visit, and the type of testing performed. Now, the Society requires an on-site inspection, presumably of the doctor's office, his treatment practices and facilities. Dr. Besen states that Bariatric physicians use a system under which the doctor starts at a given date and goes back 100 patients, without regard to the period of time covered. The progress of these patients is followed from the point of the first visit, and the physician's success is based on how many of them lost 20 pounds, 2/how many of them lost 40 pounds, and how many of them had that weight off at the end of a six-months period. Using this system, Dr. Besen said that his success rate is 60 per cent. Using a longer time period than six months, his success rate would be "a little less" than 60 per cent. 3/
In his practice, Dr. Besen uses a booklet he authored, entitled "The Weight-Loss Program," (Ex. R-2) which has substantially the same content as is found in Complainant's Exhibit 4(c), except that Exhibit R-2 has been updated over the years based on Dr. Besen's experience. Dr. Besen personally sees his patients and he does talk with them in the course of his treatment of them. Except in the rare case, one would not expect there to be any personal relationship in connection with Respondent's program. Every one of his more than 8000 patients since 1965 has been given a copy of the version of Exhibit R-2 that was current at the time of their visits to Dr. Besen. (Tr. 130, 144)
Dr. Besen agrees, in essence, with the distinctions made by Dr. Crowell between hunger and appetite, i.e., hunger is evidence of a physiological need, while appetite is a psychological manifestation. To the layman the terms are synonymous. Dr. Besen has found that Phenylpropanolamine Hydrochloride (PPA) cuts down the patients' actual food intake. (Tr. 158)
Dr. Besen agreed with Dr. Crowell that "it takes 3500 calories of excess to put on a pound of fat, and it takes 3500 calories less to take off a pound of fat." (Tr. 159) He reviewed, as a consultant, the advertisement used by Respondent. (Tr. 161) He stated that he was "very careful to make sure that they included the fact that weight loss is fat and fluid, not just fat alone, and I insisted that it be stated right up in the very first line where it is ***." (Tr. 159) Dr. Besen testified, also, that he repeated "again and again to the people writing the ad" that what was being sold was "not just a pill, and it was a program." He wanted the writers "to make it very clear that we are not selling a miracle. There are no miracles. We are selling a program." 4/ (Tr. 162)
Dr. Crowell, it will be recalled, stated that persons would develop a tolerance to almost any hunger suppressant (Tr. 88) but Dr. Besen, at first, disagreed, Dr. Besen stated that he believes that such a pill "is the thing that keeps a patient coming back. It keeps them motivated, and keeping them losing weight is that fact that right up front they have lost some weight because if they do not lose that weight, they have been a failure again, and they have spent years and years being told they are slobs, that they cannot push themselves away from the table, and that they cannot succeed in losing weight." (Tr. 171)
Dr. Besen has seen no patient who: expected to receive a tablet that would burn away fat in and of itself (Tr. 171); expected that some tablet they would take would prevent the build-up of fat; but all of his patients expected to take a tablet and thereby control their hunger for hours. (Tr. 172) According to Dr. Besen a tablet containing PPA (of unspecified amount but presumably in the amount contained in the Full Stop Slim-Cube) would control hunger for hours, and, if taken a half hour before each meal in conjunction with the following of Respondent's diet and exercise programs, would eliminate the user's desire for even the most mouth-watering foods. (Tr. 172)
Dr. Besen stated that the following of his total program of diet, exercise and PPA pills would result in a weight loss (fluid and fat) of up to two pounds within 24 hours, and "'Up to', [six pounds in 48 hours] definitely, depending on the initial weight at the outset." (Tr. 173) He placed great emphasis on the phrase "up to" and there was a corresponding de-emphasis of the figures to which the words "up to" related. (Tr. 173-4) When questioned on direct in respect to the last charge in the Complaint (charge II C), he answered: "[The Full-Stop Slim-Cubes] do [have a substantial benefit] as an appetite suppressant, very definitely." (Tr. 175)
On cross-examination Dr. Besen said that the effectiveness of a hunger suppressant will vary from person to person depending upon the individual responses to the drug. (Tr. 179) Dr. Besen's method of treatment of obese patients differs from Dr. Crowell's method in that, based on the first day's visit Dr. Besen discovers: (1) what the patient eats at breakfast, lunch and dinner; (2) what his snack foods are; and (3) what seems to cause them to eat the wrong type or amount of food. A reduced calorie diet is prescribed, but if it is not completely satisfying, the patient may substitute snack foods. Dr. Besen says that he and Dr. Crowell agree on the last point. (Tr. 209)
Dr. Besen testified that tolerance to PPA develops, but the length of time in which tolerance occurs varies from patient to patient. (Tr. 215) It is possible that one would develop tolerance for PPA in a much shorter time than 90 days. (Tr. 218) "There are people who might get tolerant on the second dose. There are, you know, I do not know, but by and large, in an overall group of people, most of them will go eight, 10, 12 weeks before they become tolerant of the drug." (Tr. 219; see, also, 1st complete par., p. 206, Ex. R-5)
According to Dr. Besen, his "advice to [purchasers of Full-Stop Slim-Cubes pills or programs] is to go to see their own doctor to supervise their diet because everyone should be supervised when they are dieting." (Tr. 223) Yet, when asked if there is any reference in the advertisement or in the booklet to having one's doctor monitor a user's weight loss, the answer was, "No." (Tr. 224)
Dr. Besen stated that he does not treat every patient the same way. He starts all of them out on the basic program which is set forth in Ex. C-4(c) and Ex. R-2. But one of the advantages of going to Dr. Besen and following Ex. R-2, as opposed to buying and following the plan which incorporates Ex. C-4(c), is that Dr. Besen does modify the program in Ex. R-2 according to the patient's response on a one-to-one relationship. (Tr. 250) When he is giving them medication, Dr. Besen requires his patients to see him every week, two weeks or four weeks depending on the individual patient and what other problems he may have. Generally, he sees them every four weeks. (Tr. 267-268) Later, he said that "After the initial visit or two, I may bring them in a couple of days a week the first time, and then it becomes a couple of weeks. Once they are into it, it is every four weeks." (Tr. 279) He estimates that he has more success treating people who are moderately obese than with those who are grossly obese. (Tr. 270-271)
In considering Dr. Besen's testimony, the following facts are relevant. Mead-Wilson Pharmacal and Penn-Bio Pharmacals, according to the order blanks on Appendices A and B, are division of American Consumer, Inc. The booklet describing the program (Ex. C-4(c)), although prepared by Dr. Besen, bears the copyright indicia and the words, "T & T Diet Research, Inc. 1977," at the bottom of the inside of the front cover. The order blank, which is the next-to-the-last page (excluding the cover) at the back of the booklet, directs that orders be sent to Mead-Wilson Pharmacal, or Penn-Bio Pharmacals, and at the bottom of that page Mead-Wilson, or Penn-Bio, is again shown to be a "Div. of American Consumer, Inc."
Dr. Besen stated that "T & T" is a Florida corporation, it is a consultant to American Consumer and to Diet Products, and it is, also, the "provider" of the booklet that goes with the program. (Ex. C-4(c)) Dr. Besen is employed by T & T "to see that the ad is proper and correct, and to upgrade it on any ongoing and continuing basis." (Tr. 224-5) It is not clear whether Dr. Besen is to upgrade the advertising matter, the booklet, or both, but other parts of his testimony indicate that he advises with respect to both the booklet and the advertising matter related to it. (Tr. 224-227)
Before beginning the consideration of the truth or falsity of the individual charges, the general impact of the advertisements as a whole will be examined. As will be pointed out later in more detail, Respondent's witness at the hearing insisted that Respondent's product is a program, or a plan, consisting of an appetite suppressant tablet, a diet system, and an exercise program. The message which the average reader receives is that Respondent's product is some recent medical discovery which, when taken with coffee, tea or bouillon, will enable one to experience large and rapid weight losses. The weight loss produced by ingesting this discovery as directed will last throughout one's lifetime. This discovery is called the Full-Stop Slim-Cube. This coffee additive is described in words and pictures in such a way as to lead one to believe that it, by itself, is the "program" or "plan." Some of the numerous illustrations of the last statement are:
"Think of it] You actually sip your appetite to sleep for hours at a time -- sip yourself slimmer cupful to cupful ***"
"*** turn ordinary coffee or tea into the most 'DYNAMITE' FAT-MELTING aid you've ever seen in your life."
***drop in what appears to be an ordinary sugar-cube ... and launch yourself on the most incredible FAT-BURNING SPREE you've ever heard of."
"The secret is a medically-proven formula (that to the eye looks just like an ordinary sugar-cube)..."
"BEST OF ALL - NO CRAVING, NO SLIDE-BACK - YOU STAY SLIM FOR GOOD ON THIS LIFETIME SLIMNESS PROGRAM]"
These quotations are sufficient to convey the tone of the entire advertisement. Further illustrating this point, it is found that (1) words relating to the medical profession, such as "this doctor's," "medical science," and "medically proven" are used at least 15 times in the advertisement; (2) references such as "fat," "fat-melting" and "fat-burning" are used at least 11 times; and (3) praises of the life-long efficacy of the product in such terms as (a) "LIFETIME CONTROL OF YOUR APPETITE" and (b) "LIFETIME SLIMNESS PROGRAM" are used at least 15 times in the advertisement.
All of the foregoing factors serve to generate in the mind of the average lay reader the belief that here, at last, is something he easily can take which will, without great suffering or will power on his part, enable him to get rid of his excess fat now and keep it off for the rest of his life.
The overpowering type of advertising used by this Respondent would fit precisely into the pattern the Supreme Court had in mind in Donaldson v. Read Magazine, supra, when it said:
"Advertisements as a whole may be completely misleading although every sentence separately considered is literally true. This may be because things are omitted that should be said, or because advertisements are composed or purposefully printed in such way as to mislead. Wiser v. Lawler, 189 U.S. 260, 264; Farley v. Simmons, 99 F.2d 343, 346; see also cases collected in 6 Eng. Rul. Cas. 129-131. That exceptionally acute and sophisticated readers might have been able by penetrating analysis to have deciphered the true nature of the contest's terms is not sufficient to bar findings of fraud by a fact-finding tribunal. Questions of fraud may be determined in the light of the effect advertisements would most probably produce on ordinary minds. Durland v. U. S., 161 U.S. 306-313, 314; Wiser v. Lawler, supra at 264; Oesting v. U.S., 234 F. 304, 307. People have a right to assume that fraudulent advertising traps will not be laid to ensnare them. 'Laws are made to protect the trusting as well as the suspicious.' Federal Trade Commission v. Standard Education Society, 302 U.S. 112, 116." (Emphasis added)
With respect to charge II A(1), Dr. Crowell stated at least twice that the addition of Full-Stop Slim-Cubes to coffee, tea or clear bouillon will not produce a substance which will cause the body to burn fat faster than it otherwise would. (Tr. 36, 39) Dr. Besen's only testimony directly bearing on this aspect of the case occurred when he indicated in response to a question that he had never seen a patient who expected to receive a tablet that would burn away fat in and of itself. (Tr. 171) That question and answer do not really address the issue, and they surely can not by any means be regarded as a refutation of the testimony of Dr. Crowell.
As to whether the ingestion of Respondent's pills as directed with coffee, tea or bouillon will prevent the buildup of fat, eliminate hunger for hours and eliminate desire for the most mouth-watering foods, (charge II A(2)) some discussion is necessary. Each of the pills or tablets contains 25 mg. of PPA. The effectiveness of PPA as an anorexiant is under consideration by a panel of experts at the United States Food and Drug Administration. The Final Report of these experts will state their conclusions on this subject. When the Final Report of this panel is issued, it is subject to review and adoption or rejection, in while or in part, by the Commissioner of the Food and Drug Administration. It is not the function or purpose of this proceeding to act as a forum for the trial of the efficacy, or lack thereof, of PPA.
Keeping the foregoing considerations in mind, it is now stated that for purposes of this proceeding it is immaterial whether PPA is found to be, or not to be, an effective hunger or appetite suppressant. This immateriality derives from the fact that Respondent's advertising material uses language suggesting, and at times openly stating, that the "program" is for lifetime use and benefit. For example, the advertisement contains the following, and similar, language which may be seen at various places throughout Appendix A:
"Now] Lifetime Freedom From Fat"
* * *
"FINAL STEP TO LIFETIME SLIMNESS"
* * *
"LIFETIME VICTORY OVER FAT"
* * *
"totally immune to fat build-up for the rest of your life"
* * * *
"YOU STAY SLIM FOR GOOD ON THIS LIFETIME SLIMNESS PROGRAM]"
* * * *
"LIFETIME CONTROL OF APPETITE"
Dr. Besen testified that he insists that the advertisement writers make it clear that what is being sold is "not just a pill *** it [is] a program." The "program" has three constituent parts, namely: the pills, the diet and the exercise. (Tr. 173)
There is agreement in the expert testimony that persons do develop a tolerance in varying periods of time to drugs used to suppress hunger. For example, when Dr. Crowell was asked whether the suppressants he uses would have a limited period of effectiveness in terms of a number of days, he replied: "Yes. I can't state in terms of a specific number of days. It would vary with the patient, but all of them, ultimately, develop some tolerance to them, and they would lose their effectiveness." (Tr. 88) Speaking specifically of PPA Dr. Besen stated that patients develop tolerance to it, but the length of time varies among patients. (Tr. 215) The longest period of effectiveness for the daily ingestion of three PPA tablets of 25 mgs each was estimated by Dr. Besen when he said: "There are, you know, I do not know, but by and large, in an overall group of people, most of them will go eight, 10, 12 weeks before they become tolerant of the drug." (Tr. 219)
The foregoing evidence in this record supports the following conclusions:
1. If, through the regular procedures established by the Food and Drug Administration, it is eventually determined that PPA is ineffective as an appetite and hunger suppressant, there is no doubt that Respondent has employed misrepresentation to sell this program, the salient point of which, based on its advertisements, is the Full-Stop Slim-Cube which has PPA as its active ingredient.
2. If the Food and Drug Administration Commissioner determines that PPA is an effective appetite or hunger suppressant, it is the uncontroverted testimony of the medical expert for the Respondent that everyone who takes it will develop a tolerance for the drug and it will thereupon lose its effectiveness. Since the product inevitably loses its effectiveness in a period measurable in weeks, it is a misrepresentation to sell such a pill as an integral and necessary part of a "lifetime" program.
Accordingly, undisputed expert medical testimony in this record by Respondent's own witness is to the effect that Respondent's pills will not, if taken as directed, continue for a "lifetime" to prevent fat buildup; to eliminate hunger for hours, and to eliminate desire for the most mouth-watering food. With respect to mouth-watering food, even Dr. Besen said that there are some patients whose desire for such food would not be affected. (Tr. 283)
Charges II A(3) and (4) may be considered together. These charges are, in sum, that Respondent represents that persons taking Respondent's product may reasonably expect to lose 2 pounds in 24 hours and 6 pounds in 48 hours and that the losses will consist primarily of fat.
When obese persons, which is the type of person at whom Appendices A and B are directed, read Respondent's advertisement, they must be filled with hope that they finally have found the solution to their weight problem. The Stay-Slim cube has been glowingly described as the "secret" to the new "medically-proven formula" and as the means to "LIFETIME CONTROL OF YOUR APPETITE" in such a way as to cause the reader to expect out-of-the-ordinary results. When he reads the words:
"24 HOURS -- up to 2 POUNDS GONE]
48 HOURS -- up to 6 POUNDS GONE]
AND THAT'S JUST THE BEGINNING]",
his eye, his mind and his heart focus on the maxima. He pictures himself as having the figure he used to have, he is filled with determination, and he has been lulled into supreme confidence that he has found the "LIFETIME" answer to his problem. And this is precisely the state of mind Respondent hoped to engender. Otherwise, why are only the words "up to" in small-case type?
In order for the individual to lose 2 pounds in 24 hours or 6 pounds in 48 hours, he must be markedly overweight. (Tr. 98) An average person who is 25 percent overweight seldom will lose that much. (Tr. 96) The foregoing statements by Dr. Crowell were not disputed by Dr. Besen. It is obvious, therefore, that the maximum weight loss represented for either the 24 or the 48 hour period can be achieved only by the more extremely overweight.
With respect to the composition of the weight loss, it will be recalled that Dr. Besen testified that he insisted that the writers state clearly that the loss consists of both fat and fluid. (Tr. 159) Careful examination of the advertisement shows, however, that while reference to loss of fat is explicitly mentioned at least 11 times, there is only one reference to the loss of fluid. This mention, rather than being "stated right up in the very first line where it is," (Tr. 159) is stated in the second paragraph of the body of the advertisement. And even this statement is not a model of clarity. The statement reads:
"So effective, you LOSE up to 6 pounds the very first
weekend -- LOSE up to 12 pounds of both fluid and fat in just
14 days -- LOSE as much as 20 -- 30 -- 40 POUNDS OR EVEN MORE
... (and never gain it back for the rest of your life)."
The reference to "both fluid and fat" is not made in connection with the 6 pound loss over the weekend, but in connection with the 12 pound loss in 14 days. Furthermore, will there be in 14 days a 12 pound loss of fluid accompanied by a 12 pound loss of fat, or will there be a 12 pound loss of fat and fluid combined? The phrase reasonably may be interpreted more than one way.
In summary, the evidence in this proceeding concerning charges II A(3) and (4) is to the effect that losses of weight of 2 pounds in 24 hours and 6 pounds in 48 hours, will be achieved only by the more greatly obese persons, and that such losses, if they occur, will consist primarily of fluid. (Tr. 52, 260) The medical experts were in agreement on the above facts. Therefore, the representations contained in charges II A(3) and (4) of the Complaint are false.
With respect to the charge stated in charge II B of the Complaint, there is no suggestion in the advertisement that a restricted caloric diet is part of the "LIFETIME SLIMNESS PROGRAM." To the contrary, it is stated that the "secret" of the program is the "medically-proven formula" that "looks just like an ordinary sugar-cube." In addition, it is stated that this "medically-proven concept" combines "both a doctor's scientific development and his full-satisfaction eating program***." It is not until one receives the product that it becomes clear that a caloric intake restriction must become part of the way of life of the purchaser.
As the Court said in G. J. Howard Co. v. Cassidy, 162 F. Supp. 568, 572, U.S.D.C., D.C.N.Y. (1958):
"It is the net impression which the advertisement is likely to make upon purchasers to whom it is directed which is important, and even if an advertisement is so worded as not to make an express misrepresentation, if it is artfully designed to mislead those responding to it the mail fraud statutes are applicable."
Section 3005 of Title 39, United States Code, no longer is a "fraud" statute, but the comments made by the Court are just as applicable to a case involving misrepresentation.
There remains charge II C of the Complaint to be considered. Since the "FULL-STOP Slim-Cubes" are but one, albeit the main one, of the three components of Respondent's so-called "LIFETIME SLIMNESS PROGRAM," and since the effectiveness of this part of the program is of but limited duration, it is a misrepresentation to indicate that those tablets will provide for the user a substantial benefit, over and above anything else sent with the tablets, in effecting the claims set forth in charge II C of the Complaint. In Borg-Johnson Electronics v. Christenberry, U.S.D.C., S.D.N.Y., 169 F. Supp. 746, 751, (1959) District Judge, now Chief Circuit Judge, Kaufman said:
"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, 308 U.S. 587, 60 S. Ct. 110, 84 L.Ed. 491."
This statement by the Court applies in its totality to the representations forming the basis of charge II C of the Complaint in this proceeding.
The evidence in this proceeding leads to the following findings of fact:
1. Respondent, under the names Mead-Wilson Pharmacal and Penn-Bio Pharmacals, Caroline Road, Philadelphia, Pennsylvania 19176, is engaged in a scheme for obtaining money or property through the mails;
2. In the conduct of the aforesaid scheme, Respondent advertises in various publications;
3. In its advertisements, Respondent makes material representations which are set forth in paragraph II of the Complaint filed herein; and
4. The representations found to have been made by Respondent are false as to material matters of fact.
Upon the basis of the foregoing findings of fact, it is concluded as a matter of law:
1. This 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 of Title 39, United States Code.
Accordingly, a mail-stop order as provided in 39 U. S. Code 3005, in substantially the form attached, should be issued against this Respondent.
____________________
1/ Only one advertisement is cited, but the language in both
advertisements is substantially the same.
2/ There is no standard, in terms of pounds or per cent the
patient was overweight, against which to measure the weight loss.
3/ Pages numbered 129A and 129B should have the A and B
designations reversed.
4/ Dr. Besen corrected himself to indicate that he is not engaged
in selling.