United States v. Schlicksup Drug Co.

206 F. Supp. 801, 1962 U.S. Dist. LEXIS 3792
CourtDistrict Court, S.D. Illinois
DecidedJuly 30, 1962
DocketCr. 3670
StatusPublished
Cited by5 cases

This text of 206 F. Supp. 801 (United States v. Schlicksup Drug Co.) is published on Counsel Stack Legal Research, covering District Court, S.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Schlicksup Drug Co., 206 F. Supp. 801, 1962 U.S. Dist. LEXIS 3792 (S.D. Ill. 1962).

Opinion

MERCER, Chief Judge.

This cause coming on to be heard on the government’s petition for order to show cause why the Sehlicksup 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, Sehlicksup 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.

*803 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) ©f 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, “Du-mate,” 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 *804 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.

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206 F. Supp. 801, 1962 U.S. Dist. LEXIS 3792, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-schlicksup-drug-co-ilsd-1962.