United States v. Schlicksup Drug Co.

• Decision Date: 30 July 1962
• Docket Number: Cr. 3670.
• Citation: 206 F. Supp. 801
• Parties: UNITED STATES of America v. SCHLICKSUP DRUG CO., Inc., a corporation, Defendant.
• Court: U.S. District Court — Southern District of Illinois

206 F. Supp. 801

UNITED STATES of America v. SCHLICKSUP DRUG CO., Inc., a corporation, Defendant.

Cr. 3670.

United States District Court S. D. Illinois, N. D.

July 30, 1962.

Edward R. Phelps, U. S. Dist. Atty., Springfield, Ill., Richard E. Eagleton, Asst. U. S. Atty., Peoria, Ill., for plaintiff.

John Cassidy, Cassidy & Cassidy, Peoria, Ill., for defendant.

MERCER, Chief Judge.

This cause coming on to be heard on the government's petition for order to show cause why the Schlicksup Drug Company, Inc., the defendant herein, should not be punished for criminal contempt, and the Court having heard the evidence submitted thereon by the parties hereto, and having examined the written arguments and briefs of counsel, and being now fully advised in the premises, finds as follows:

1. Defendant, Schlicksup Drug Company, Inc., is a corporation under the laws of the State of Illinois, and is and has been continuously since 1951 engaged at Peoria, Illinois, in the District and Division aforesaid, in the business of manufacturing, preparing, packing, distributing, and selling drug products.

2. Defendant has been continuously since 1951 and is now introducing and delivering for introduction and causing to be introduced and delivered for introduction into interstate commerce at Peoria, Illinois, certain of said drug products.

3. On October 21, 1953, this Court entered an order for temporary injunction enjoining defendant from directly or indirectly introducing or causing to be introduced, or delivering or causing to be delivered, for introduction into interstate commerce, at and from Peoria, Illinois, in violation of Section 331(a) of Title 21 U.S.C.A., articles of drugs adulterated within the meaning of Section 351(c) of said Title, because their strength differs from that which they are represented to possess and/or misbranded within the meaning of Section 352(a) of said Title because of false and misleading statements in the labeling of said drug with respect to the quantity of ingredients contained in said article.

4. Said temporary injunction was based on the Court's findings that:

(a) Much of the equipment used by the defendant in the manufacture and preparation of drug products was inadequate, unsuitable, in a poor state of repair, and inaccurate;

(b) There was laxity in the control of the identification, analysis, and formulas in the preparation of the firm's drug products;

(c) The deficiencies found in several finished products which were shipped in interstate commerce resulted from the inadequate manufacturing methods.

5. Said temporary injunction remained in full force and effect throughout the years 1956 and 1957.

6. The president and responsible managerial personnel of the Schlicksup Drug Company, Inc., had complete knowledge of the terms of said injunction from the time of its issuance.

7. Each of the products described in government's petition for order to show cause, to wit, Dapco-S, Double Hyatal, Douchett Powder, Vee-6, and Dumate are articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of diseases in man, or intended to affect the structure or function of the body of man.

8. The above-described products were introduced into interstate commerce by the defendant company between February and November of 1957.

9. The product, "Dapco-S," described in paragraph 3(a) of the government's petition, was 35 percent deficient in the amount of dextroamphetamine sulfate declared on its label when introduced into interstate commerce by defendant.

10. The label on the product, "Double Hyatal," as described in paragraph 3(b) of government's petition, states that each tablet supplies two complete doses. However, when introduced into interstate commerce by defendant, this product would release only one dose while in the human digestive system. The failure of one dose to be released is equivalent to a deficiency of 50 percent of the active ingredients, which the product's label states are contained in each tablet.

11. The product, "Douchett Powder," described in paragraph 3(c) of government's petition, when introduced by defendant into interstate commerce, contained 49 percent less than the amount of dried alum which the product's label stated was contained therein.

12. The product, "Vee-6," described in paragraph 3(d) of government's petition, when introduced into interstate commerce by defendant, was more than 20 percent deficient in the amount of niacinamide which its label stated it contained.

13. The label of the product, "Dumate," described in paragraph 3(e) of government's petition, states that each tablet supplies two complete doses. However, when introduced into interstate commerce by defendant, this product would release only one dose while in the human digestive system. The failure of one dose to be released is equivalent to a deficiency of 50 percent of the active ingredients, which the product's label states are contained in each tablet.

14. The product, "Vee-6," described in paragraph 3(f) of the government's petition, when introduced into interstate commerce by the defendant, was more than 20 percent deficient in the amount of niacinamide which its label stated it contained.

15. The basic criteria employed in establishing control methods by the Schlicksup Company and the consulting firm of Scientific Associates was economic. The specific changes effected were influenced entirely by the cost to the company rather than the desire to make certain that the actual strength and quantity of the drug ingredients was as the label declared them to be.

AND THE COURT adopts the following as its

CONCLUSIONS OF LAW

1. The articles prepared, packaged, and manufactured by the defendant, as described in paragraphs 3(a) through 3(f) of the government's petition, are articles of drugs within the meaning of Section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 321(g)).

2. Defendant's lax and inadequate manufacturing practices have resulted in the production of drugs which are misbranded and adulterated under the terms of the Federal Food, Drug, and Cosmetic Act.

3. That the articles of drug described in paragraphs 3(a) through 3(f) of the government's petition, when introduced into interstate commerce by defendant, were adulterated and misbranded within the meaning of Sections 501(c) and 502 (a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 351(c) and 352(a)).

4. Defendant's failure to eliminate the inadequacies in its manufacturing processes, was deliberate and not inadvertent and said violations are found to have been done wilfully and intentionally.

5. Said introduction into interstate commerce of adulterated and misbranded drug products is a violation of Section 331(a) of Title 21 U.S.C.A. and also a violation of the order for temporary injunction issued by this Court on October 21, 1953.

6. Although I am satisfied that the government need not prove willful intent, I find that the defendant corporation had such intent and, accordingly, is adjudged guilty of criminal contempt of the order for temporary injunction.

I have found that the defendant wilfully, knowingly and intentionally violated the injunction. Defendant has earnestly advanced the argument that there is a necessity that the government prove intent and because of the earnestness of defendant in this regard, I feel constrained to discuss this argument.

In a proceeding for criminal contempt, alleging disobedience of a temporary injunction restraining defendant from delivering into interstate commerce, in violation of 21 U.S.C.A. § 331(a), articles of drugs adulterated within the meaning of 21 U.S.C.A. § 351(c) or misbranded within the meaning of 21 U.S.C.A. § 352 (a), does the government have the burden of proving specific intent to violate the Act and the injunction?

The only pronouncement by any court upon this precise question is a dictum in United States v. Wilson-Williams, Inc., No. 149-6, S.D.N.Y. (1961). There the court said that specific intent is not an element of the government's proof upon a charge of criminal contempt for the violation of an injunction restraining the interstate shipment of misbranded drugs, for the reason that the proof required to sustain a contempt charge should not be greater than that required to sustain a criminal conviction under the Food, Drug, and Cosmetic Act. It would be, the court said, an anomaly to require proof of specific intent in the contempt situation when no such requirement was necessary to prove a criminal violation.

After a review of the precedents, I am convinced that the result suggested by Wilson-Williams is correct for the reasons hereinafter set forth. I do not necessarily agree that the anamoly suggested in that opinion is apt, but I think it must be recognized that, in the matter of the elements of proof required, where the violation of an injunction order may also constitute a substantive crime forbidden by a statute, the contempt partakes of an analogous relationship to the substantive crime.

Certainly, it is not necessary, as defendant seems to suggest, to ignore the statute in the contempt situation. Mr. Justice Frankfurter, speaking for the Court, in United States v. Dotterweich, 320 U.S. 277, at pages 280-281, 64 S.Ct. 134, at page 136, 88 L.Ed. 48, said of the Food, Drug, and Cosmetic Act:

"The prosecution to which Dotterweich was subjected is based on a now familiar type of legislation whereby penalties serve as effective means of regulation. Such legislation dispenses with the conventional requirements for criminal conduct — awareness of some wrongdoing. In the interest of a larger

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