United States v. 935 Cases More or Less, Each Containing 6 No. 10 Cans Tomato Puree, 136 F.2d 523 (6th Cir.1943). A drug shall be deemed to be misbranded when labeling is false of misleading in any particular. 21 U.S.C.A. § 352(a).
The Court was particularly impressed with the testimony of Dr. Bear and Dr. Kelter. There was nothing in the evidence, in the opinion of the Court, that either was motivated in the testimony given by any interest other than professional integrity. They differed in their ultimate conclusions. This is understandable when the approach is considered. Dr. Baer adhered to the strict line of scientific thinking that findings must be rejected in toto unless they are the product of the maximum objectivity that can be achieved according to recognized scientific methods of study and test. Dr. Kelter was critical of such rigid scientific technique, which he described as outmoded, taking the position that, when a physician treats a patient and observes results, such results cannot be ignored even though there is no rationale in scientific medical theory to account for them. The testimony of each of these doctors is entitled to considerable weight. On the one hand, Dr. Baer's testimony was very persuasive with respect to the weaknesses in the studies conducted by Dr. Shane and Dr. Kelter, particularly so, because of the nature of the disease of acne vulgaris. On the other hand, it is difficult, in the light of the testimony by Dr. Kelter, to conclude that his observations as to improvement of patients treated with Acnotabs are to be ignored entirely. But allowance must be made for the conceivable margin of error that would be inherent in the methods used to develop the factual information upon which the report of the effectiveness of Acnotabs was based. These studies, in the opinion of the Court, had value to the extent of indicating further and more objective clinical testing. In fact, Dr. Kelter testified that his tests are still continuing.
As a consequence, it does not seem to the Court that the results of these clinical studies can be translated into representations that Acnotabs will cure acne or would constitute an adequate effective treatment for the disease. The overall import of the leaflet literature is that the drug is the panacea for acne vulgaris and that quick and effective results, tantamount to cure, can be expected from use of one bottle, excepting in rare cases where probable recurrence of the disease would be in mild form. In conjunction with the printed matter in the label, the graphic matter on Exhibit G-2 showing a young man and a young lady with clear complexions holding a mask with dots resembling pimples suggests that the drug removes the mask of pimples leaving a clean, clear, healthy complexion. The impression is definitely created from the printed and graphic matter of the labeling that one who takes the drug, exclusive of other treatments, may expect that the problem of acne pimples will be eliminated, or at least substantially mitigated, within a relatively short period of time.
It may be that more objective and intensive clinical testing will demonstrate the effectiveness of the drug as a treatment for acne, or the lack of it, in a degree that cannot be determined by the evidence now before the Court. This is not to suggest that the burden of proof herein has been cast upon the Claimant. When Libelant came forth with competent expert medical testimony from which it could be inferred that the representations of Claimant as to the efficacy of its product were not well grounded, it became incumbent upon Claimant to demonstrate otherwise by its proofs. Claimant has not done this to the satisfaction of the Court.
When representations in the labeling of a product go beyond what has been established to be the fact, according to recognized standards in the particular field for the determination thereof, such representations must be considered as false and misleading. Whether the misrepresentation springs directly from the literal import to the average reader of the statements made in the labeling or by calculated innuendo does not matter. Statements in the labeling of a product shipped in interstate commerce which are false and misleading in any sense of common understanding are prohibited. 21 U.S.C.A. § 352(a); United States v. 95 Barrels, etc., Vinegar, 265 U.S. 438, 44 S. Ct. 529, 68 L. Ed. 1094 (1924); V. E. Irons, Inc. v. United States, 244 F.2d 34 (1st Cir.1957), cert. den. 354 U.S. 923, 77 S. Ct. 1383, 1 L. Ed. 2d 1437; Jeffries v. Olesen, 121 F.Supp. 463 (D.C.Cal.1954); United States v. 46 Cartons, etc., 113 F.Supp. 336 (D.C.N.J.1953). In the V. E. Irons case, supra, the Court, commenting upon the nature of representations which constitute mislabeling, stated:
'It must be remembered that a representation may be 'misleading' from the very fact of overemphasis and exaggeration, even though the product in question may be helpful, and in some circumstances useful, though not really indispensable to good health. * * *'
Having considered all of the evidence in the light of the applicable principles of law for evaluation of the probative value thereof together with the Stipulations of fact, the Court makes the following findings of fact:
1. 'Acnotabs' is a drug (hereinafter referred to as 'the drug') owned and shipped in interstate commerce by the Claimant, Pannett Products, Inc.
2. The drug is an internal medication consisting of Vitamin A, Vitamin C, pancreatin, bile salts, and pepsin prepared and recommended for use by Claimant in the treatment of acne vulgaris.
3. The drug is not injurious to health.
4. Clinical studies of the effect of the drug upon patients suffering from acne vulgaris, which were not extensive in scope or conducted with controls to assure maximum objectivity in evaluation of result, indicate that the drug does have some beneficial effects as a medication in the treatment of some cases of acne vulgaris.
5. The overall import of the labeling is that the drug has been thoroughly tested; that it is an adequate effective remedy for acne vulgaris tantamount to a cure; and that a person suffering from acne vulgaris may expect that the problem of acne pimples will be eliminated in a short period of time with recurrence only in rare cases and then in mild form.
6. The drug will not cure acne vulgaris.
7. The drug is not an adequate effective medication for acne vulgaris in the sense that the use of it will assure a blemish-free skin within a short period of time, with recurrence of the disease only in rare cases and then in mild form.
8. The effectiveness of the drug as a treatment for acne vulgaris has not been thoroughly tested.
Accordingly, the Court concludes that it has jurisdiction in the California case and in the New York case and finds that the drug, 'Acnotabs,' was misbranded and was shipped in interstate commerce and that Libelant is entitled to a decree of condemnation pursuant to the provisions of 21 U.S.C.A. § 334. Destruction of the drug does not follow condemnation as a matter of course. 21 U.S.C.A. § 334(d); A. O. Andersen & Co. v. United States, 284 F. 542 (9th Cir.1922). Thus, after entry of the decree and upon payment of the costs of the proceedings and the execution of bond as provided in 21 U.S.C.A. § 334(d), the Court may, upon application and pursuant to an appropriate Order, direct that the drug seized be delivered to the owner to be brought into compliance with the applicable provisions of Chapter 9 of Title 21.
Submit Decree and Order in accordance herewith.