The opinion of the court was delivered by: BRUCHHAUSEN
The libelant instituted this action to condemn a quantity of drugs and advertising material, upon the ground that the drugs were misbranded or mislabeled, in violation of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq.
'The purpose of the law is to protect the public, the vast multitude which includes the ignorant, the unthinking, and the credulous who, when making a purchase, do not stop to analyze. It was enacted to make self-medication safer and more effective, and to require that drugs moving in interstate commerce be properly labeled so that their use as prescribed may not be dangerous to the health of the user.' United States v. 62 Packages, etc., D.C., 48 F.Supp. 878, 887, affirmed 7 Cir., 142 F.2d 107, certiorari denied Raladom v. U.S., 323 U.S. 731, 65 S. Ct. 68, 89 L. Ed. 587.
The term 'labeling' applies to the matter printed or written upon the article itself, and upon the containers or wrappers accompanying it. 21 U.S.C.A. § 321(m). A drug is deemed misbranded 'if its labeling is false or misleading in any particular' also if the labeling fails to include adequate warnings as to its use. 21 U.S.C.A. § 352(a, f).
It is not disputed that the claimant Ira Lichtenstein, doing business as Baldwin Laboratories, conceived the formula for the drugs or tablets in question; that the formula consisted of a mixture of flowers of sulphur, rhubarb root and cream of tartar; that the said claimant engaged Jabert Pharmacal Company, Inc., to manufacture the tablets, and that the said claimant contracted with the claimant Elip Distributing Corporation to market them, including packaging and advertising.
The contention is that in the process of marketing the tablets, the claimants deceived the public in asserting that the tablets would relieve the ailment, known as 'Piles'.
It is interesting to note that the manufacturer made no such assertion. Its label on the gross shipment to the distributors made no mention of such ailment but designated the tablets as 'laxatives'. The distributors did not use that label but prepared a different label, inserted it in each package or vial of 12 tablets, reading, in part:
'Elip Tablets -- A palliative treatment for discomfort and itching of rectal irritation caused by piles.'
The counter display cards contained the statement:
'An internal preparation for the relief of piles. Price $ 2. Elip Reg. U.S.Pat.Off.'
A neon sign in the window of Baldwin Laboratories read: 'Elip for Piles'.
During the trial, the claimants stipulated that the labeling should contain a warning against using the tablets for bleeding piles.
'Elip', the designation used by the claimants in promoting the product is 'pile' spelled backwards.
The three medical experts produced by the Government, expert proctologists, testified that Elip tablets are laxatives and not particularly mild and that the only complete cure for piles is surgery.
The claimant Lichtenstein, a pharmacist, admitted that surgery was the only known complete cure for piles, but denied that Elip was held out as a cure. He said that he conceived the tablet as a mild laxative softening the digested matter passing over the pile ...