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August 15, 1978

MORTON-NORWICH PRODUCTS, INC., a corporation, trading and doing business as Norwich Pharmacal Company, and James J. Mahoney, Defendants

The opinion of the court was delivered by: MUNSON


This is a criminal action involving three alleged violations of the Federal Food, Drug and Cosmetic Act, Title 21 U.S.C. §§ 301, et seq. Named as defendants in the Indictment are Morton-Norwich Products, Inc., a corporation doing business as Norwich Pharmacal Company, and James J. Mahoney, Vice-President of Operations for Morton-Norwich Products, Inc.

 Indictment Number 75-CR-114, which was handed up on or about September 30, 1975, alleges three violations by both defendants of the Food, Drug and Cosmetic Act, all of which violations involve the interstate shipment of adulterated drugs, in contravention of sections 301(a) and 303 of the Act, 21 U.S.C. §§ 331(a) and 333 respectively. Each count, in turn, alleges adulteration in two separate and distinct senses, one falling within section 501(c), 21 U.S.C. § 351(c), *fn1" in that the purity of the drugs involved differed from that purported, the other coming under section 501(a)(2)(B), 21 U.S.C. § 351(a)(2)(B), *fn2" contending that the drugs were not manufactured, processed, packaged or held in conformity with current good manufacturing practice so as to assure that they would conform to the Food, Drug and Cosmetic Act requirements as to safety, and would have the strength and identity and meet the quality and purity characteristics which they purported to possess (The (a)(2)(B) violation will be referred to simply as CGMP).

 The products involved in the three counts of the Indictment are two lots, numbered 705553 (Counts I and II) and 710749 (Count III), of individually packaged gauze pads impregnated with Furacin (trade name for nitrofurazone), an antibacterial dressing. All of the products involved were manufactured at the defendants' sterile fill facility located in Norwich, New York.

 The gravamen of the charge of adulteration under 21 U.S.C. § 351(c) is that the pads, purported to be sterile according to the labeling found on the foil envelopes in which the pads were to be marketed, were not, in fact, sterile. The charge under 21 U.S.C. § 351(a)(2)(B) relates to several alleged violations of CGMPs, based heavily upon observations made during Food and Drug Administration (FDA) inspections of the defendants' sterile fill facility at Norwich, as well as the actual evidence of product contamination.

 This Court conducted a rather lengthy nonjury trial of this action, commencing on January 13, 1977, and ending on March 18, 1977. Following the trial, the Court reserved decision on the verdict. Since none of the parties requested that the Court make special findings, the general verdict was announced to the parties in open court. See Fed.R.Crim.P. Rule 23(c). To recapitulate, the Court found defendant Morton-Norwich guilty on Counts I and II and not guilty on Count III, and acquitted defendant Mahoney on all three charges.

 Prior to, during, and after the trial, the parties made numerous motions, upon many of which the Court reserved decision. This supplemental Opinion is being rendered in order to deal with those motions, and to hopefully clarify the verdict somewhat for the benefit of the parties.


 Throughout this proceeding, the defendants have attacked, on three grounds, the introduction into evidence of the results of tests performed by FDA analysts on post-shipment specimens of product taken from the two lots in issue. First, they claim that owing to the fact that a sterility test such as involved in this case is necessarily destructive of the product unit tested, and because sterility in a manufacturing situation cannot be guaranteed on an absolute basis, sterility is necessarily a probabilistic concept. The defendants have insisted that their representation of sterility was proper in this case as long as pre-shipment tests, validly conducted by them in accordance with the methods prescribed by the United States Pharmacopoeia (U.S.P.), *fn3" indicated sterility, despite the fact that later tests revealed the presence of contamination in one or more samples of previously untested product. Secondly, the defendants attack the relevance of post-shipment tests with respect to the issue of sterility at the time of shipment. Finally, the defendants have sought to impeach the results of the Government's tests, pointing to several deviations of the methods used from that prescribed by the U.S.P.

 A. Defendants' Representation of Sterility

 In support of their position on this score, the defendants, through various expert witnesses, have proffered definitions of the term "sterility" or "sterile," all of which reject the notion of sterility as being an absolute concept in favor of a definition dependent upon results of probabilistic testing performed upon random samples of the product in accordance with U.S.P. testing methods. Thus, the argument goes, an article is properly labeled as "sterile" if it has passed pre-shipment sterility tests performed pursuant to the U.S.P. method, notwithstanding the fact that some untested product units are in fact contaminated.

 The Court rejects the notion that the term "sterile," as contained within the labeling which accompanies the defendants' product, is susceptible of such a narrow interpretation. This Court is of the opinion that the meaning to be ascribed to labeling which accompanies a product is, like beauty, properly in the eyes of the beholder, rather than the manufacturer. Cf. United States v. Article . . . Consist. of 216 Carton. Bot., 409 F.2d 734 (2d Cir. 1969). *fn4" A customer who utilizes defendants' furacin gauze or batiste pads, whether he be a doctor, a nurse, or a layman, in this Court's estimation, will interpret the representation of sterility to mean the total lack of contamination of the product. To allow the defendants to avoid liability under the Act merely by testing samples of the product, which samples prove negative for contamination, would be to obliterate the standard of absolute liability imposed by the Food, Drug and Cosmetic Act, see United States v. Park, 421 U.S. 658, 95 S. Ct. 1903, 44 L. Ed. 2d 489 (1975); United States v. Dotterweich, 320 U.S. 277, 64 S. Ct. 134, 88 L. Ed. 48 (1943), and subtly inject into the statute an element of scienter, or conscious awareness of guilt. The Court believes that the relevant inquiry under 21 U.S.C. § 351(c) is whether or not the gauze and batiste pads contained in Lots 705553 and 710749 were, in fact, sterile when shipped, utilizing an absolute definition of sterility. *fn5"

 The defendants' motion to exclude the Government's test results upon this basis ...

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