In the Matter of the Complaint Against

UXBRIDGE PRODUCTS COMPANY

and

UXBRIDGE HEALTH PRODUCTS COMPANY
84 State Street at
Boston, Massachusetts 02109

P.S. Docket No. 2/199;

APPEARANCES:
Daniel S. Greenberg, Esq.
Consumer Protection Office
Law Department
U.S. Postal Service
Washington,D.C. 20260
for Complainant

Sheldon S. Lustigman, Esq.
Bass & Ullman
747 Third Avenue
New York, New York 10017
for Respondents

POSTAL SERVICE DECISION

This is a proceeding by Complainant against Respondents under 39 U.S.C. 3005 which authorizes action against Respondents upon evidence satisfactory to the Postal Service that Respondents are "engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations."

Complainant originally named Uxbridge Products Company as Respondent. At the hearing held herein, Complainant named Uxbridge Health Products Company as an additional Respondent and its motion to amend its complaint accordingly was granted without objection by Respondent (T 10).

Complainant alleges that both Respondents are engaged in a scheme or device violative of 39 U.S.C. 3005 in the sale of "Prostex" and receipt of payment therefor through the mails. Specifically, Complainant alleges in paragraph 2 of the complaint that by use of advertising material Respondents falsely represent, directly or indirectly, by means of affirmative statement, implication or omission, in substance and effect: "(a) That 'Prostex' will relieve male:

1. frequency of urination;

2. urgency to urinate;

3. nocturia;

4. pain and burning during urination;

5. feeling of fullness and pressure in the perineum and bladder;

6. dribbling after urination;

7. abnormal retention;

"(b) That the effects enumerated in subparagraph (a), supra, will be noticeable in 2-4 weeks;

"(c) That the relief of the symptoms enumerated in subparagraph (a), supra, will be prolonged even after the use of 'Prostex' is discontinued;"

Copies of the advertising material used by Respondents are attached to the complaint as Exhibits A and B through D. Exhibits B through D are a single document which is hereafter referred to as Exhibit B.

Respondents admit the use of the aforesaid advertising material in the sale of Prostex and the receipt of money, representing the purchase prices paid by purchasers thereof through the mails but deny making any false representations. Respondents also filed a motion to dismiss the complaint on the grounds of res judicata and equitable estoppel to which copies of the adjudications relied on as the basis for the motion were attached. Complainant opposed the motion.

Thereafter Complainant's application in the United States District Court for the District of Massachusetts for a mail detention order under 39 U.S.C. 3007 pending determination of the instant proceeding was denied, based on an agreement of Respondent Uxbridge Products Company to seek an expedited hearing before the Judicial Officer of the U.S. Postal Service as provided in 39 C.F.R. 952.17(a). Such application was orally made and this proceeding thereupon assigned to the undersigned as Acting Judicial Officer. At the same time decision on the motion to dismiss was ordered to be held in abeyance until an adequate record was developed.

The matter was thereafter fully tried before the undersigned, sitting as Acting Judicial Officer. Both parties presented testimonial and documentary evidence and filed posthearing briefs.

FINDINGS OF FACT

1. Respondents are owned by Dr. George Curzon of Cambridge, Massachusetts, a physician acting as a consultant in the health care field and not engaged in medical practice since 1962 (T 37, 47, 49).

2. Respondents are engaged in the sale of Prostex by mail and receive through the mails remittances of monies representing the purchase price for Prostex sold to customers.

3. Respondents became engaged in the sale of Prostex after 1962 (T 47) and receive now many repeat orders for the product with allegedly only 1% or 2% of the purchasers complaining that the product does not work (T 48). Dr. Curzon testified that, before undertaking the sale of Prostex, he consulted with physicians to whom its manufacturer referred him and later with other physicians who informed him that Prostext work (T 47).

4. Respondents buy Prostex from Advanced Laboratories, Inc. which they believe to be a wholly-owned subsidiary of Metabolic Products Corporation with which Advanced Laboratories shares office and manufacturing facilities (T 45-6). Metabolic has also manufactured the product.

5. Prostex is sold by Respondents through advertisements placed in various newspapers, reading as follows (Compl. Ex. A, Ex. 1): MEN: If You

GET UP NIGHTS

GET PROSTEX

Sleep disturbing discomforts such as getting up nights, frequent daily discomfort, dribbling, urgency, and undue retention are now relieved by PROSTEX. This now famous formula is also used by many doctors.

Read the complete fascinating story on how it was discovered and details of its use. Send for free literature today.

UXBRIDGE PRODUCTS COMPANY Dept. 3, 84 State Street, Boston, Ma 02109

6. Those who respond to this advertisement receive through the mails a pamphlet (Compl. Ex. B) informing them about Prostex and offering for sale bottles of 100 and 250 capsules priced respectively at $8.00 and $15.00 per bottle.

(a) The pamphlet, printed in six columns, on two sides of a sheet 3 by 7 1/2 inches in size is entitled "Prostex" with the statement underneath the title:

"A proven scientific formula of pure food substances for relieving the symptoms of benign prostate hypertrophy." followed by the male symbol.

(b) There follow three columns of descriptive matter accompanied by a schematic view of the prostate, bladder and urethra with an introduction to the topic of prostate gland enlargement. The introductory paragraph recommends an annual physical examination, including the prostate, for all men past middle age although the symptoms of prostate enlargement are in many cases only mild.

(i) The main body of the text describes the symptoms of benign prostate hypertrophy, including increased frequency of urination, especially at night, smaller urine stream, pain, hesitation in starting to urinate, pressure in the perineum and bladder and dribbling, all of which may ultimately lead to more serious symptoms.

(ii) The reader is introduced to the alleged medical evidence of the effectiveness of Prostex, said to have been discovered by an alert physician practicing in Boston, Massachusetts, on the staff of a world-renowned medical center and tested on some fifty patients with relief of symptoms experienced in 80% of the cases. A follow-up survey three years later of 100 men, a clinical study in New York, published in two medical journals, and work of another doctor on 40 cases, published in a geriatric journal, are cited as further evidence of effectiveness. It is also stated that all studies found Prostex without side effects and safe.

(iii) Prostext is described as a special scientific combination of the amino acids glycine, alanine and glutamic acid which are naturally found in food and tissue proteins but are

stated to produce special results "in the pure form and in a special combination". Prostext comes as a white powder in gelatin capsules to be taken orally.

(iv) Although admittedly neither the cause of senile non-malignant enlargement of the prostate gland nor the reasons why Prostext gives relief to the distress caused by this ailment are known " C certain medical research workers" are cited as believing that Prostext by its effectiveness against edema causes the swelling of the prostate gland to be reduced. Another explanation is seen in the metabolic action of Prostex and an eminent unnamed urologist allegedly has suggested a semi-hormonal effect of the product.

(c) After this text the purported advantages, administration and dosage of Prostex are taken up in a single column, framed for emphasis.

(i) Again anonymous "experienced" physicians are referred to as stating that "the great majority of cases of Benign Prostatic Hypertrophy may well be amenable to conservative measures." Advantages in the use of Prostext are indicated as: beneficial in most cases; effectively relieving the symptoms of the disease; providing "often dramatic results in cases with high symptom frequency, in 2 to 4 weeks"; safety and compatibility with simultaneous use of vitamins and special diets and medication.

(ii) The dosage is given as two capsules three times daily after meals for three weeks, then half this dosage for at least five more weeks. The prospective purchaser is warned that Prostext may have to be used for as long as a year and that its

effect is gradual and prolonged after discontinuance. It may be used again "if a medical examination indicates that the discomforts are still due to Benign Prostatic Hypertrophy."

(d) The back page of the pamphlet, when folded, urges prospectivepurchasers to check whether their symptoms are caused by cancer of the prostate. They are told, however, that Benign Prostatic Hypertrophy and cancer of the prostate may coexist. Beneath this framed caution the following sentence is printed in heavy letters: "Be sure to consult your Physician."

7. The product label (Compl. Ex. 11), attached to the Prostex bottles states the ingredients without their dosage, the directions for use, and the following CAUTION:

"For symptomatic relief only. (Not intended as a substitute for surgery or as a cure or treatment of cancer or any other disease). Prior examination by your doctor is recommended."

8. Amino acids are the building blocks from which the proteins needed by the human body are formed (T 15). The human body requires about 50 to 56 grams daily in proteins (T 14).

9. Amino acids are divided into those which the human body must ingest by way of food intake and those which the human body can build if food intake does not provide them (T 16).

10. The three amino acids of which Prostex is formed are among the latter (T 17-18). However, among common foods glutamic acid is found in milk, glycine in pork and alanine in corn meal (T 19). A normal diet provides two grams each of glycine and alanine and nine grams of glutamic acid for a total of 13 grams (ibid.).

11. The initial daily six-capsule dose of Prostex provides two grams of the three named amino acids in therin pure form in unknown proportions. The reduced dosage after the first three weeks provides 1 gram or 1/13 of the daily intake from food.

12. The ingestion of Prostex thus slightly increases the body's intake of alanine, glycine and glutamic acid.

13. It was the view of a highly qualified nutritionist, employed by the U.S. Agricultural Research Service in Beltsville, Maryland (T 11), called by Complainant as an expert witness, that the body receives or makes more of these amino acids than it can use (T 26) and that the forms in which they are received, i.e. either through food intake or from materials in the body or through consumption in their pure state by means of Prostex capsules, made no difference (T 26, 30). This nutritionist knew of no general disability in the human body which would prevent its use of amino acids although there may occur biochemical defects in the body preventing it from manufacturing a particular amino acid (T 33).

14. One of Respondents' medical witnesses tended to the view, on the other hand, that as the body ages, it may not be as capable of producing amino acids, such as those making up Prostex, and hence the body must be supplied such amino acids directly (T 201). Though he conceded that he did not know whether it makes a difference if the amino acids in Prostex are ingested in pure form or through food (T 205) he concluded that possibly the absorptive ability of the elderly was reduced

(T 206, 243) and the consumption of pure amino acids helpful.

15. Amino acid therapy in and of itself is not a novelty. In the nineteen-forties it was in use at Massachusetts General Hospital in the treatment of allergies. At that time a patient treated for an allergy with amino acids claimed that during the course of his treatment the symptoms of prostate hypertrophy from which he had suffered had ceased and brought this to the attention of one of the physicians treating him. This was Dr. Julian C. Gant who testified for Respondents in this proceeding and whose testimony is summarized hereafter (T 140-1).

16. At Massachusetts General the amino acid combination which later was manufactured for sale to the public as Prostex was used in the form of capsules apparently made specially for physicians' use. Dr. Gant was instrumental in inducing thereafter Metabolic to manufacture the amino acid formula for commercial use. Metabolic modified the formula by adding glycine for definite biochemical reasons (Resp. Ex. 2, p. 1, note). The product was originally called Prostall and later also sold as Urex and currently as Prostex.

17. Although Prostex has been on the market since about 1950 (T 188) scientific literature on the subject is scant. Of the four studies of Prostex cited in Respondents' pamphlet apparently two only were published. They were introduced in evidence as Respondents' Exhibits 1 and 2. Neither study was published in a journal of wide circulation among urologists (T 99), although of obvious interest to them. One of Respondents' expert medical witnesses cited no other studies and knew of no adverse medical literature (see T 169-70) and Complainant's medical literature and urological journals that there was any discussion of

Prostex or amino acid therapy for benign prostatic hypertrophy (T 100-1).

18. The earlier of these studies was published in March 1958 in the Journal of the Maine Medical Association by Dr. Feinblatt, a former Director of Medicine at Kings County Hospital in Brooklyn, New York, and Dr. Gant, then Medical Director of the Madison Sanitarium and Hospital, Madison College, Tennessee (Resp. Ex. 2). Dr. Feinblatt who is now deceased (T 40) was introduced to Dr. Gant by Metabolic (T 187). Dr. Gant stated in his testimony that his part in the study was to review Dr. Feinblatt's material and to edit the article in major part (T 149). Dr. Gant did not examine any of the patients in the study. Apparently the patients were physically examined by a urologist who palpated their prostate glands through the rectum (Resp. Ex. 2, p. 1, col. 2) and their histories and symptoms were taken by Dr. Feinblatt (T 175). Dr. Gant also participated in no way in the determination of the urologist and of Dr. Feinblatt that the patients studied suffered from benign prostatic hypertrophy. Patients with hardened nodules, indicating possible carcinoma, or other contributory disease were excluded.

Half of the 40 patients were given Prostall and the other half a placebo. At the end of the two-month test 92% of the patients given Prostall were reported to have reduced prostate size, one-third reduced to normal. Various symptoms were relieved in between 70 and 95% of the cases. Those given a placebo found relief of their symptoms in from 4 to 15% of the cases and only 5% showed a reduction in prostate size. The seeming success of Prostall was attributed by the authors to the anti-edematic effectiveness of the alanine, glycine and glutamic acid combination (Resp. Ex. 2, p. 2). While the results of the Feinblatt and Gant study seem to confirm the favorable results claimed by the Prostex advertising material, the study loses much of its value due to the fact that the accuracy of the basic observations cannot be checked or confirmed by any witness who participated in the study. Dr. Gant merely acted as editor and, given his enthusiasm for the product (T 142) and his feeling that he is pioneering a great advance in medicine (T 160, 161, 169-70), his editorial work may well have over-accented the positive aspects of the study at the expense of cautionary observations.

19. Moreover, the selection of a rather out-of-the-way state medical journal by doctors practicing then in New York and Tennessee respectively, is unexplained. The choice was said by Dr. Gant to have been Dr. Feinblatt's (T 170) and Dr. Gant gave no thought to publication in a journal which would have assured wide-spread attention among urologists or other medical specialists (T 171).

20. The second study referred to was published by Dr. Frederic Damrau, a New York City physician, in May 1962 in the Journal of the American Geriatrics Society (Resp. Ex. 1). He made a study of 45 cases to whom Prostall was given for three months. After that period, various symptoms were completely relieved in from 19 to 42% of the patients and reduced in from 43 to 66% of the patients. Patients receiving a placebo had total relief in from 5 to 11% and partial relief in from 5 to 15% of the cases except for one symptom which showed no improvement. The size of the prostate was reduced or increased during the

treatment in both groups only in statistically insignificant numbers (id., p. 428). The presence and degree of prostatic enlargement was determined by rectal palpation according to a code set forth in the study and the diagnosis of benign prostatic hypertrophy was made apparently solely on the basis of prostate enlargement without regard to other possible causes. Dr. Damrau was not called as a witness to explain his methods nor was an effort made, as far as the record shows, to reach him. It is judicially noted that a physician of the author's name is, however, readily located in the Manhattan, New York, telephone directory. The lack of supporting testimony from Dr. Damrau greatly limits the evidentiary value of his study in this proceeding. In addition, as Complainant's medical expert witness testified, the Damrau study cannot be deemed conclusive since it does not convincingly establish that all participating patients actually had benign prostatic hypertrophy.

21. The Gant and Damrau studies confirm each other only partially. While the Gant study showed a substantial proportion of cases in which the size of the prostate was reduced to normal and partial reduction in nearly all cases, no such results were recorded by Dr. Damrau. Moreover, Dr. Gant noted far higher percentages of symptom relief, especially complete relief, than Dr. Damrau found. As an example, Dr. Gant noted complete relief of nocturia in 72% of his cases (Resp. Ex. 2, Table), while Dr. Damrau found such complete relief in only 15% (Resp. Ex. 1, Table 2).

22. The medical testimony proffered by the parties through expert witnesses was sharply conflicting on the ultimate question whether Prostex is truthfully represented effectively relieving the symptoms caused by benign prostatic hypertrophy.

23. (a) Complainant's medical expert is presently professor and chairman of the department of urology at George Washington University in Washington, D.C., a post which he reached after a distinguished medical career (for his curriculum vitae, see Compl. Ex. 13). He is a member of numerous scientific societies in the field of urology and is certified as a specialist in this field. He is the author of numerous presentations and publications in the field of renal diseases and other aspects of urology, including bladder malignancies.

(b) He testified that prostate hypertrophy could be due to numerous causes, such as congenital anomalies (T 68), kidney infections (T 69), infection from venereal disease, congested prostatis resulting from respiratory infections (T 87-88), edema of the bladder neck (T 89), in addition to benign hypertrophy, at issue here (T 65).

(c) He recognized in his testimony that palpation of the prostate was the initial method of examination for diagnosing a case of benign prostatic hypertrophy but stated that it was necessary to assure that at the time of examination the bladder was empty and that additional cystoscopic and X-ray examination might be needed to obtain a complete picture (T 73-76).

(d) According to this witness' testimony the prostate may be enlarged but no symptoms felt and the reverse can also occur (T 82). Moreover, persons suffering from the ailment frequently have temporary remissions as well as exacerbations of their symptoms (T 80-81).

(e) Benign prostatic hypertrophy is either treated by massage in the case of congested prostatitis to release the gland secretions or by surgery. Whether surgery is indicated depends on the severity of the symptoms (T 124). Furthermore, a new hormone drug, called metrogestone, is being tested (T 103, 132). In addition, antibiotics are used to remove the underlying infection if one is present (T 128, 133). The witness was aware of the therapeutical use of amino acids (T 109) but stated that they were used to rehabilitate patients suffering from nutritional deficiencies (T 112), as in anorexia nevrosa or anemia (T 110), and not to treat the illness itself or its symptoms (T 112). Questioned about a 1945 article in the AMA Journal on amino acids he replied that the article represented knowledge as of 30 years ago and should be read in the light of present knowledge on patient rehabilitation (T 110-111).

(f) On the main issue Complainant's medical expert took the view that Prostex would not give relief from the symptoms of benign prostate hypertrophy (T 98). He had never heard of the use of amino acid therapy to this end until he undertook to testify (ibid.). Benign prostate hypertrophy therapy was discussed at a May 1974 meeting of the American Urological Association, but of the two relevant papers read neither mentioned Prostex or amino acid medication (T 101). He also discussed Prostex with Dr. Scott, professor of neurology at Johns Hopkins University and editor of the Journal of Urology who has done a great deal of work on benign prostate hypertrophy and who stated to the witness, on being advised of the content of Prostex, that in 40 years of studies he had not heard of it at

all and that it made no sense to him (T 98). The witness also consulted Dr. Treadwell, professor of biochemistry at George Washington University who was of the view that the use of Prostex or its ingredients made no sense to him (T 99). The witness himself shared the view of his informants (T 122) and saw no significance in feeding amino acids at the rate contained in Prostex to persons suffering from benign prostatic hypertrophy (T 127).

24. Respondents called as their witnesses two practicing physicians, the already mentioned Dr. Gant and a former intern of Dr. Gant (T 143).

(a) Dr. Gant spent many years of practice at Massachusetts General Hospital where he became acquainted, as already stated, with amino acid therapy and "discovered" its effect in reducing or eliminating the symptoms of benign prostatic hypertrophy. He and a colleague thereafter treated some 50 to 60 patients for this ailment with amino acids and became very enthusiastic about their results (T 142). From 1947 to 1954 (T 137) Dr. Gant was director of a hospital in Tennessee (FF 18, supra) and later became Chairman of the Board of another Tennessee hospital (T 140). Since 1954 he has been engaged in the private practice of medicine, in recent years specializing in psychiatry (T 138, 143, 164).

(b) The second medical expert called by Respondents was originally a physiologist who during World War II was trained to become a physician (T 190). He was a resident of Dr. Gant's hospital in Madison College, Tennessee in 1949 (T 192) and thereafter studied surgery in Austria (ibid.). He maintains a

practice in Huntsville, Alabama, as well as in Cave Springs, Georgia, where he took over the practice of a Dr. Norton who primarily treated arthritis with a combination of drugs (T 214, 220).

25. (a) Dr Gant continued to use Prostex in his practice in Tennessee (T 143) and introduced it at the hospitals with which he became connected. He continued to find it successful and from consultations with doctors and from reading hospital records claims to know that it is currently successfully used in these hospitals (T 145, 146). According to him the favorable results of Prostex are usually observed in two weeks (T 147).

(b) The number of cases which he treated or of which he knew from records appears, however, to have been quite limited for an approximately 25-year period.

(c) He agreed that besides palpation other examining techniques, such as the use of a catheter, may be required. He added the doctors at the hospital in Madison College, Tennessee do not use a cystoscope (T 183) since at a smaller hospital every patient could not be as thoroughly examined as in a university hospital (T 174).

(d) While Dr. Gant does not deny that surgery may become necessary to cure a benign prostatic hypertrophy (T 156), the use of Prostex in his view delays or avoids it (T 155-6) or relieves the tension of the symptoms sufficiently so that a patient suffering from other complications may become operable (T 157).

(e) In summary, Dr. Gant sees amino acid therapy as a form of treatment for many illnesses (T 159-160, 167 et seq.)

and its application through Prostex as one of many. He ascribes to the ingestion of amino acids in their pure form a favorable metabolic effect, not limited to benign prostate hypertrophy (T 157) but he concedes that such therapy is not generally recognized by the medical profession and he considers himself as pioneering a non-surgical treatment of the ailment (T 162, 166). He has not tried since 1958 to explain or publicize his therapy (T 162).

26. (a) Respondents' second medical witness testified that he had used Prostex to treat himself for symptoms of benign prostatic hypertrophy and that it kept his symptoms under control as long as he took Prostex but that they came back when he stopped (T 194-6).

(b) He had treated over the last 20 years some 150 to 200 patients for benign prostatic hypertrophy with Prostex or Prostall and relieved their customary symptoms (T 193-4, 221-2) and they no longer needed to use catheters to empty their bladder (T 204).

(c) He stated that palpation was the best form of examination for ascertaining that the prostate enlargement was due to benign hypertrophy (T 197) but conceded that he could not be sure without X-ray or cystoscopic examination (T 231) and relied in the end on his good judgment.

(d) The witness conceded that the cause of benign prostatic hypertrophy was unknown (T 198) and added that in his view the ailment is due to the aging of the body which no longer can produce all needed amino acids (T 201, 203, 234 et seq.). He compared benign prostate enlargement to enlargement of the thyroid gland caused by lack of certain chemicals. He admitted, however, that this theory was not provable (T 243).

27. In rebuttal, Complainant offered to prove through its expert witness in nutrition that he would testify, if recalled, that contrary to the theories advanced on behalf of Respondents and summarized above the aging or aged did not suffer from amino acid deficiencies (T 247).

28. Respondents offered to prove as part of their case through the testimony of the president of Metabolic that many physicians had commented favorably about Prostex to his firm (T 246). The fact is not doubted but such testimonials have little, if any, evidentiary value unless those giving them testify and can be cross-examined as to the basis and strength of their opinions.

29. The instant proceeding is not the first brought by federal authorities in respect of the advertising used to promote the sale of Prostex, Prostall or Urex.

(a) In 1962 the United States brought an action in the U.S. District Court in Massachusetts under the Food and Drug Act (21 U.S.C. 352(a) and (f)) against Metabolic and its president seeking to enjoin interstate trade in Prostall because of misbranding. A permanent injunction was granted since the Court interpreted the literature then issued by the defendants as representing Prostall to the ordinary reader as a substitute for surgery, promosing "prostatic relief without prostatectomy." Thus a patient with serious prostatic disturbance would be led to relieve its symptoms while the disturbance was allowed to proceed to a terminal result.

In reaching this result the District Judge, in summarizing the evidence before him, found Prostall safe to take and without side effects and found further that many doctors, including some testifying in that case for the Government, had observed in patients relief from certain symptoms of prostate disorder, such as those cited in the current Prostex advertising and involved in the instant proceeding.

(b) Two years earlier in 1960 an administrative Post Office proceeding was instituted under 39 U.S.C. 3005 against United Pharmacal Corp., a partly-owned subsidiary of Metabolic (P.O.D. Docket No. 1/162). This proceeding was ended by a stipulation under which United agreed not to advertise Urex or any similar product as being an effective treatment for the malignant enlargement of the prostate and not to solicit remittances through the mails by means of such representation. United further agreed that it would prominently state in its advertising soliciting mail remittances that its product should be used only in the treatment of benign prostate hypertrophy "after proper diagnosis by a physician" (loc. cit., supra, Aff. of Agr., par. 3). United further agreed that the settlement of P.O.D. Docket No. 1/162 should not be a bar to further proceedings under 39 U.S.C. 3005 "if, based upon changed facts and circumstances in the opinion of the General Counsel or his representative shall so warrant" (id., par. 4).

(c) The full text of the foregoing documents is attached to Respondents' motion to dismiss this proceeding. However, no records of the evidence received in the Massachusetts District Court action were available and no evidence as to the record in the 1960 Post Office proceeding was introduced in the present proceeding.

30. Based on the detailed findings of fact made hereinabove and the record as a whole I find:

(a) Hypertrophy of the prostate gland may be caused by several causes: malignant or cancerous growth; infection, especially from veneral or kidney diseases, congested prostatitis; congenital anomalies; otherwise unexplained enlargement of the prostate.

(b) Symptoms of the kind resulting from prostate hypertrophy may also result from causes other than prostate hypertrophy, of which edema of the bladder neck is an example.

(c) Respondents' advertising lumps together all such phenomena except cancerous growth under the designation of benign hypertrophy of the prostate without altering its prospective purchasers to the dangers of infection or the other conditions which may cause it and may require medical attention to avoid dangers to the purchaser's health.

(d) Respondents' advertising warns the prospective purchaser to seek a medical examination for cancer so as to be sure that only "prostate hypertrophy" and not "cancer" causes his difficulties (Compl. Ex. B). This cautionary language is, however, weakened by the statement that benign and malignant enlargement of the prostate may exist simultaneously, emphasis elsewhere "that the great majority of cases of Benign Prostatic Hypertrophy may well be amenable to conservative measures" and

which "often provide dramatic results" (Compl. Ex. B); and the general overall tenor of Respondents' advertising seeking to induce those to whom it is addressed to purchase Prostex as self-medication without reference to what a physician may advise.

(e) By urging prospective purchasers to buy Prostex to relieve their symptoms in all cases of non-cancerous prostate hypertrophy Respondents represent that the use of Prostex to relieve the symptoms of prostate hypertrophy is proper in all non-cancerous cases regardless of the specific cause thereof and of the medical attention which such cause may require.

(f) Respondents' representation as to the effectiveness of Prostex (Compl. Exs. A and B), is materially false in fact since non-cancerous hypertrophies of the prostate due to infection and other mentioned causes require treatment of the infection or other cause if obvious medical complications are to be avoided. See Complaint, par. 2(a).

(g) The representation made in Respondents' advertising that relief of symptoms is noticeable in two to four weeks is false in fact (Compl. Ex. B). The supporting studies, cited by Respondents, whatever otherwise their limitations or weight, extended over two and three months to attain the results reported therein. No evidence but the single bare assertion of Dr. Gant supports the claim that any relief, much less "often" attained "dramatic results," is noticeable in two to four weeks (Compl. Ex. B). See Complaint, par. 2(b).

(h) Respondents further falsely represent that relief of symptoms will be prolonged after use of Prostex is discontinued, or in the language of Respondents' advertising, " is often

experienced" in this manner (Compl. Ex. B). The only evidence on this point is that of Respondents' second medical expert who testified, contrary to the advertising claim, that in his own case the effect of Prostex ceased as soon as he stopped taking it. No reliable evidence to support the language used by Respondents in their advertising was adduced. See Complaint, par. 2(c).

(i) Respondents' representations, found to be false in paragraphs (g) and (h) above, are also materially false. For the promise of rapid and lasting relief without the expense of continued medication in many, even if not in all, cases is a powerful inducement to purchase a product such as Respondents offer. It is plain that these representations are made solely to reinforce the appeal of the product to prospective purchasers.

ON MOTION TO DISMISS

1. Respondents have moved to dismiss the instant proceeding on the ground that the decision in the Metabolic case (FF 26(a)) and the agreement in United Pharmacal (FF 26(b)) are binding on Complainant and prevent an adjudication of the false representation issues raised by the complaint herein.

2. Respondents are correct in pointing out that a judgment involving one Government agency binds all other parts of the Government and that another Government agency may not relitigate the issue previously decided in order to obtain a different result. Sunshine Coal Co. v. Adkins, 310 U.S. 381, 402-403 (1940); Lee v. F.T.C., 113 F2d 583 (8th Cir., 1940). Nor does the application of the doctrine of res judicata require that the parties in the later case be identical with those in the former,

as long as the later litigation can be considered to be between the "same" parties (Sunshine Coal Co. v. Adkins, supra) or involves the same subject matter (Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313 (1971); Gambocz v. Yelencsics, 468 F2d 837 (3d Cir., 1972); Ritchie v. Landau, 475 F2d 151 (2d Cir., 1973).

3. Assuming for purposes of this Postal Service Decision that the Postal Service is treated like any other Government agency as part of the United States (see Butz Engineering Corp. v. United States, Ct. Cl. No. 223-73, decided 19 June 1974) the principles laid down in the cited decisions would appear to bar a retrial of the issues litigated and settled in Metabolic and would in fairness require Complainant to treat Respondents no different than United Pharmacal.

4. Paragraph 4 of the stipulation ini that case indisputably left open further proceedings against United Pharmacal and could hardly, therefore, be deemed to bar them against Respondents. The language of the "if" clause therein is garbled but appears to contemplate the possibility of further proceedings if changed circumstances so warrant. Such circumstances need not involve, as Respondents' counsel intimates, new medical discoveries but are present here in the shift of emphasis to aspects of Respondents' advertising not previously considered or perhaps even present. The rules of privity or res judicata do not bar consideration in subsequent litigation of such new issues. Schuylkill Fuel Co. v. B. & C. Nieberg Realty Corp., 250 N.Y. 304 (1929).

5. None of these questions need, however, be decided here, for it is plain that the issues now raised are not those adjudicated in Metabolic or compromised in United Pharmacal. Hence, the principles of res judicata cannot apply. United States v. R.C.A., 358 U.S. 334, 352 (1959).

6. Metabolic and United Pharmacal raised solely the issue that Prostall and Urex, both alter egos of Prostex, were advertised as a substitute for the removal of a cancerous prostate or as efficacious or of value in its treatment or in the relief of its symptoms.

7. In neither case was the issue litigated or adjudicated whether advertising Prostex to obtain symptom relief was appropriate in all cases of benign prostatic hypertrophy and whether symptom relief was as fast and as permanent as Respondents' advertising now claims. At most, the U.S. District Judge found in Metabolic that Prostex was compounded of safe ingredients and that some doctors testified to its effectiveness. Neither point is disputed. The District Judge in Metabolic concluded that the "greatest claim" which Metabolic could "possibly" make would be effectiveness for symptom relief. But such limited effectiveness was, as appears from Chief Judge Sweeney's findings and opinion, neither litigated nor adjudicated. Substantively, the same appears to be true of United Pharmacal as far as the parties' agreement in that proceeding discloses.

8. Hence, the motion to dismiss must be denied.

CONCLUSIONS OF LAW

1. Respondents are engaged in a scheme or device for obtaining money or property through the mails by means of false representations within the meaning of 39 U.S.C 3005.

2. Respondents' advertisements expressly seek to create the false impressions charged in the complaint of the U.S. Postal Service and will be so understood by the ordinary reader. See Donaldson v. Read Magazine, 333 U.S. 178, 189 (1948).

3. Respondents' representations that its product is suitable for relieving the symptoms of benign prostatic hypertrophy in all cases thereof includes the representation that its use is medically appropriate in all case and the allegations of the complaint are so read. See 39 CFR 952.12(c), first sentence. This and its other representations, going to the effectiveness of Respondents' product, are not in accordance with fact and their falsity misleads prospective mail order purchasers contrary to the intent of 39 U.S.C. 3005. For a similar ruling see Midwest Health Aids, P.S. Docket No. 2/151(1974).

4. In reaching these conclusions it is not necessary to determine whether on the question of the truth or falsity of the representation of whatever effectiveness Prostex may possess scientific evidence or empirical observation of medical practitioners is to be accepted as most probative. It would appear, however, that, whether Prostex is as effective as claimed by Respondents or as ineffective as claimed by Complainant, the phenomenon should be capable of being established by objective tests, free of the manufacturer's bias or of the preconceptions of those who hold strong views as to particular modes of

therapy. On the record here made such tests are completely lacking.

5. Accordingly, in the instant proceeding an order pursuant to 39 U.S.C. 3005 is hereby issued.

12/24/74

Sobernheim, Rudolf