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UNITED STATES v. AN ARTICLE OF DRUG

August 2, 1962

UNITED STATES of America, Libelant,
v.
AN ARTICLE OF DRUG, ETC., ACNOTABS, Respondent, and Pannett Products, Inc., Claimant



The opinion of the court was delivered by: SHAW

An action in rem, pursuant to the provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 334, was commenced by Libelant by filing of Libel of Information in the United States District Court for the Southern District of California on June 12, 1961, to accomplish seizure of 219 individually cartoned bottles of a product described as 'Acnotabs' and to obtain a decree of condemnation of the seized product on the ground that it was a drug introduced into interstate commerce and misbranded within the meaning of 21 U.S.C.A. § 352(a). Pannett Products, Inc., a New York corporation, intervened, alleging ownership of the products seized. By stipulation of Libelant and Claimant, the action pending in the Southern District of California was removed for trial to this District.

A second libel, directed against the same product and involving further seizure of additional quantities, was filed in the United States District Court for the Southern District of New York on April 2, 1962. Pannett Products, Inc., intervened in this case as owner and, hence, the same parties and the same product are involved in both cases.

 By Order of this Court dated May 15, 1962, on application of Claimant, Pannett Products, Inc., the action pending in the Southern District of New York was transferred to this District and consolidated with the action pending here. Trial by jury, initially demanded by Claimant, was waived by both parties, and consent to the transfer above mentioned was confirmed at pretrial with agreement of counsel that trial of the consolidated actions would proceed in this District to final adjudication on the merits.

 It was stipulated at pretrial of the consolidated cases that Acnotabs, the subject matter of this litigation, was a drug which had been introduced into interstate commerce by Claimant, and further stipulated that the only issue to be tried was whether the drug, Acnotabs, was misbranded by reason of false and misleading statements in the labeling within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 352(a). By the language of the pertinent statutory provision a drug shall be deemed to be misbranded when labeling is false or misleading in any particular.

 Exhibits G-1, G-2 and G-3 were marked in evidence by consent. G-1 consisted of two pieces of printed matter: (1) a leaflet entitled 'To All Teenagers' and (2) a form of questionnaire attached to a reply card with other printed matter and addressed to Pannett Products, Inc. It was stipulated that this exhibit represented the labeling involved in the California case.

 Exhibit G-2 consisted of four pieces of printed and graphic matter: (1) a leaflet entitled 'To All Teenagers' with a red box on the first page entitled 'Important'; (2) the same form of questionnaire and business reply card as shown on Exhibit G-1; (3) a piece of printed and graphic matter entitled 'Now Stop Pimples Where They Start Inside Your Body.' bearing the picture of a young man holding a mask; (4) a piece of printed and graphic matter entitled 'Now Stop Pimples Where They Start Inside Your Body.' bearing a picture of a young lady holding a mask. It was stipulated that Exhibit G-2 represented the labeling involved in the New York case.

 Exhibit G-3 consists of the label on each bottle of Acnotabs and the label on the retail carton in which the bottle was packaged. It was stipulated that Exhibit G-3 represented the bottle label and the carton label of Acnotabs involved in both the New York and California cases.

 The drug, Acnotabs, is a combination of pancreatin, bile salts, pepsin, and Vitamins A and C. According to the carton and bottle labels (Exhibit G-3 in evidence), there are 72 Acnotab tablets in a bottle. Acnotabs are advertised by the label as a drug which is 'an internal medicine for acne (pimples).' The instructions for dosage, quoted from the carton label in which the individual bottle is packaged, are:

 'Take one tablet three times a day after meals or as directed by your physician. For complete directions, see enclosed folder.'

 The enclosed folder to which reference is made is the leaflet identified in Exhibits G-1 and G-2.

 Acne, referred to medically as 'acne vulgaris,' is a disease of the skin. It is prevalent during adolescence and manifested by oiliness of the skin, blackheads, red pimples, pus pimples, and small boils. The degree of severity varies with the individual case. Some individuals will have a few blackheads; others will have a combination of blackheads and pimples; and still others will suffer from the entire combination of blackheads, pimples and boils; and, within these categories, there are varying degrees of severity. Most people outgrow the susceptibility to this disease after adolescence. Among those afflicted, and during the period of affliction, the disease does not run a uniform course. There are periods of spontaneous improvement followed by spontaneous regression due to natural causes, the precise nature of which is unknown. As stated by the medical experts, the course of the disease during adolescence has its 'ups and downs.'

 In medical terms, a blackhead is a comedone; the red pimple is a papule; the pus pimple is a pustule; and eruptions resembling small boils are described as cysts. The comedone is described as an excessive horny formation at the follicular opening of the skin cell which prevents excretion from reaching the skin surface. Secondary infection creates the papule and the pustule and, in some cases, the final development into a cyst. It seems to be generally conceded by the medical testimony that, without the formation of the comedone, there would be no subsequent development of papules and pustules or, probably, of cysts. Dr. McCarthy, testifying for Libelant, stated that cysts will develop independently of formation of comedones. Dr. Baer testified otherwise. It was further stated in the testimony that, while there would be no papules or pustules without the comedone, it did not follow that papules and pustules would always develop from the comedones. Hence, we have the varying pattern of the manifestations of this skin condition.

 No single prescription or standard method of treatment which has been effective in all cases in any substantial degree has heretofore been discovered by medical science. Various methods of treatment have been tried, with overall minimum effect, consisting generally of diet restriction, external applications to dry the skin, use of vitamins (principally Vitamin A and Vitamin C in combination or Vitamin A alone), antibiotics, hormonal treatment, ultra-violet light radiation, x-ray radiation, and others, depending upon the individual case and the opinion of the individual treating physician. There has been no unanimity of opinion in the medical field as to the efficacy of any one of the known methods of treatment. In fact, Dr. McCarthy, testifying for Libelant, indicated by his testimony that, if any drug could be found which would be 25% Effective, it would be a wonderful discovery.

 Claimant contends that its product, Acnotabs, has been shown to be an effective treatment for acne with results in improvement of the skin condition ranging from a low percentage in some cases up to 100% In others over relatively short periods of time. The medical theory is that Acnotabs combat the formation of the comedone and thereby eliminate the subsequent formation of the papule, pustule, and cyst. Claimant does not base this contention upon any theory of the rationale of change in body chemistry which the drug causes in order to effect the result claimed. In fact, it is conceded that the real underlying cause of the basic disturbances in the human metabolism which create excess production by the oil glands and the horny formation of the comedone is not definitely known to medical science. One of the generally accepted theories is that these disturbances are due to hormonal imbalance. As a corollary, Claimant further admits, by the testimony of the medical experts upon which it relies, that it does not know precisely what occurs in the human metabolism when Acnotabs are taken, but that effectiveness in the elimination of the comedone has been established by clinical testing. Claimant points out, in connection with this, that the same holds true in the field of medical science with respect to many other drugs in common use having beneficial effects in treatment which was discovered only by clinical testing and without knowledge of the rationale of the effect. Claimant relies, therefore, primarily upon the result of studies and clinical tests made by Dr. Shane and Dr. Kelter in the use of this drug in the treatment of patients suffering from acne.

 Dr. Shane, a general practitioner, testified that he used the drug on a number of patients suffering from acne. He kept a record of the progress of these patients, which is set forth on a chart marked G-7 in evidence. The chart shows onset of improvement within one to three weeks after taking Acnotabs. It further shows, as to maximum improvement, that this was achieved over periods ranging generally from three weeks to nine weeks. Results in terms of ultimate improvement are stated in percentages ranging up to 100%. The patients were graded as to the degree of severity of the acne at the ...


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