Kurzon v. U.S. Postal Service, 75-1378

• Citation: 539 F.2d 788
• Decision Date: 21 June 1976
• Docket Number: No. 75-1378,75-1378
• Parties: George KURZON d/b/a Uxbridge Products Company, Plaintiff-Appellant, v. UNITED STATES POSTAL SERVICE, Defendant-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals (1st Circuit)

Page 788

539 F.2d 788

George KURZON d/b/a Uxbridge Products Company, Plaintiff-Appellant, v. UNITED STATES POSTAL SERVICE, Defendant-Appellee.

No. 75-1378.

United States Court of Appeals First Circuit.

June 21, 1976.

Sheldon S. Lustigman, New York City, for appellant.

William A. Brown, Boston, Mass., and Morton Hollander, Washington, D.C., for appellee.

Before COFFIN, Chief Judge, McENTEE and CAMPBELL, Circuit Judges.

LEVIN H. CAMPBELL, Circuit Judge.

Appellant Dr. George Kurzon brought this suit in the district court to enjoin enforcement of a mail stop order. Under 39 U.S.C. § 3005 ¹ the Postal Service had determined after formal hearing that appellant was "engaged in a scheme or device for obtaining money or property through the mails by means of false representations . . . "; and had ordered the Boston postmaster to stop all related mail addressed to appellant and to return it stamped, "Return to Sender; Order Issued Against Addressee for Violation of False Representation Law." ² The district court, to which appellant turned under 5 U.S.C. § 703; 28 U.S.C. § 1339; and 39 U.S.C. § 409, denied the injunction. Appellant thereupon filed this appeal.

I

As owner of the Uxbridge Health Products Company and the Uxbridge Products Company, Dr. Kurzon has for some time sold a non-prescription drug product trade-named Prostex through the mail. Prostex is a combination of three amino acids, glycine, alanine and glutamic acid, and is sold as a remedy for the symptoms of benign prostatic hypertrophy (BPH). BPH, according to the evidence before the Postal Service, is a condition of enlargement of the prostate gland in older men that tends to compress the urethra; its symptoms include difficulty in voiding, frequency of urination, urgency to urinate, nocturia, and dribbling after urination.

The Prostex formula has been on the market under various names since 1950, and is apparently still available over the counter in retail pharmacies. ³ The claims made for the drug have, however, undergone a transformation. The early advertising gave the impression that the drug would effectively treat the condition of prostate enlargement, whether benign or malignant. This came to an end in 1960, when the Post Office (as it was then known) complained that the advertising was fraudulent and sought a mail stop order under former 39 U.S.C. §§ 259 & 732 (1952), the precursors of § 3005. The proceedings resulted in a settlement by which United Pharmical Corp., the manufacturer, agreed to disclose in all mailed advertising that the product "should be used only in the treatment of benign prostate hypertrophy after proper diagnosis by a physician."

Two years later this disclosure itself came under attack, this time by the Food and Drug Administration. The FDA charged that the product was misbranded in violation of 21 U.S.C. §§ 331(a) & 352 ⁴ in that its labeling was "false or misleading". In United States v. Metabolic Products Corp., C.A. No. 61-570-S (D.Mass.1962), the district court agreed and enjoined sale of the drug in interstate commerce for as long as its labeling suggested "that the drug is adequate or effective in the treatment of hypertrophy of the prostate in man, or for the prevention of cancer of the prostate in man." The court observed in its opinion that in light of what was then known about the drug the most that could be claimed for it was "that it relieves merely the symptoms which indicate prostate disorder . . . ."

Dr. Kurzon became interested in Prostex following the decision in Metabolic, and claims to have designed Prostex's present labeling and advertising with the decision in mind. The label affixed to the drug's container now states that it is "(f)or relief of symptoms of Benign Prostatic Hypertrophy such as frequency, nocturia, continence of urine, urgency and dribbling. . . . " It cautions that the drug is "(f)or symptomatic relief only" and is not intended "as a cure or treatment of cancer or any other disease."

The advertising is more elaborate. To initiate interest in Prostex, Dr. Kurzon used the following newspaper advertisement:

"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 HEALTH PRODUCTS CO.

Dept. 26, 84 State Street, Boston, Ma 02109"

Those who responded to this advertisement would receive a pamphlet, consisting of a single sheet of paper printed with three columns on each side and folded so that each column fills a single page. The front page, as the pamphlet is folded, introduces Prostex with the following characterization, in large type: "A proven scientific formula of pure food substances for relieving the symptoms of benign prostate hypertrophy." The back page, which bears the address of the Uxbridge Health Products Company and gives the price of the product, prominently displays the following message:

"CAUTION

Of course, before using PROSTEX for relief from symptoms such as frequency, nocturia (getting up nights), continence of urine (abnormal retention), dribbling, and other discomforts, you should make sure through a medical examination that your urinary difficulties are caused only by prostate hypertrophy and not by cancer of the prostate. The cause of either ailment is not known. The one does not cause the other. The two conditions may co-exist."

Following that is the warning, in bold print, "Be sure to consult your Physician".

The four interior pages provide detailed textual and graphic information about Prostex and its effects. The first three of these pages define BPH and its symptoms; describe Prostex and its amino acid composition; recount the "discovery" of the drug's effect on BPH symptoms and the subsequent studies that purported to confirm the discovery; and speculate on possible explanations for Prostex's effectiveness. The last of the interior pages, which is framed for emphasis, highlights the claimed advantages of Prostex:

"Several experienced physicians state that the great majority of cases of Benign Prostatic Hypertrophy may well be amenable to conservative measures. The use of PROSTEX capsules indicates many advantages:

PROSTEX capsules may be used with expected benefit in most cases of Benign Prostatic Hypertrophy.

PROSTEX capsules effectively relieve the urinary frequency, abnormal retention, urgency, nocturia, and dribbling.

PROSTEX capsules often provide dramatic results in cases with high urinary frequency, nocturia, and urgency, in 2 to 4 weeks.

PROSTEX capsules are safe. They are not toxic, cause no side reactions and have no contraindications when eating is allowed.

PROSTEX capsules do not interfere with the simultaneous use of vitamins, special diets or other medications (including insulin)."

On the same page, the claims for early and prolonged relief are qualified as follows:

"Although many persons using PROSTEX receive early benefit, you should not expect immediate help. PROSTEX is composed of pure nutritional factors which, of course, require some time for full performance. The beneficial results are usually gradual over a period of weeks.

After discontinuing use of PROSTEX, prolonged relief of the urinary discomforts is often experienced. In the future, should identical symptoms again occur, PROSTEX may be resumed if a medical examination indicates the discomforts are still due to Benign Prostatic Hypertrophy."

The Postal Service complaint charged that the advertising for Prostex falsely represented the product's effect, thereby inducing mail-order purchases in violation of § 3005. Three representations were singled out as materially false:

"(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 . . . ."

Apart from the advertising materials, the evidence before the Postal Service consisted primarily of the testimony of medical experts for both sides. There was general agreement that BPH is a condition of unexplained enlargement of the prostate in older men whose symptoms are as the advertising for Prostex described; that a number of other conditions including urinary tract infections, congenital anomalies, and cancer of the prostate cause the same or similar symptoms (without necessarily enlarging the prostate); ⁵ and that where the cause of the symptoms is not BPH but some other problem, Prostex is ineffective and medical treatment advisable.

The experts disagreed on the question whether Prostex would relieve the symptoms of BPH. The Government presented the testimony of two witnesses, a nutritionist and a urologist. While neither of the two had tested the drug, their testimony tended to establish that as a matter of sound and current medical theory an amino-acid combination like Prostex could not and would not relieve the symptoms of BPH. On the other side, Dr. Kurzon relied primarily on the testimony of two practicing physicians who testified to their own observations. One of these physicians, Dr. Gant, testified that he had discovered the drug's effect inadvertently while practicing at the Massachusetts General Hospital and had later confirmed in his practice and in a published study that the drug relieved the symptoms of BPH. The other, Dr. Hewitt, who had worked under Dr. Gant at one time, testified to having observed the drug's beneficial effect on BPH symptoms both in himself and in numerous...