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UNITED STATES v. BEL-MAR LABS.

May 20, 1968

UNITED STATES of America,
v.
BEL-MAR LABORATORIES, INC., a corporation, and Morris Schechter, an individual, Defendants


Mishler, District Judge.


The opinion of the court was delivered by: MISHLER

Memorandum of Decision and Order

MISHLER, District Judge.

 Defendants have been charged under a fourteen count information with having unlawfully introduced or delivered for introduction into interstate commerce various misbranded and adulterated injectable drugs in violation of section 331(a) of title 21, United States Code. *fn1"

 The odd numbered counts of the information contain the allegations that the drugs were adulterated, while the charges of misbranding are set forth in the even numbered counts.

 The government contends that all of the subject drugs were adulterated within the meaning of section 351(a)(2)(B) of title 21, in that "* * * the methods used in, or the facilities or controls used for, * * * [their] manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such * * * [drugs meet] the requirements of this chapter as to safety and * * * [have] the identity and strength, and * * * [meet] the quality and purity characteristics, which * * * [they purport] or * * * [are] represented to possess * * *."

 In addition, the government asserts that the drugs referred to in counts seven, nine and thirteen were also adulterated within the meaning of section 351(c), in that their strength differed from, or their purity or quality fell below, that which they purport or are represented to possess. *fn2"

 The misbranding charges are to the effect that certain allegedly false and misleading statements are contained in the labeling of the subject drugs. Counts two and four charge that certain statements on the ampule labels were inconsistent with statements on the carton labels. *fn3" Count four also complains that the labeling of the particular drug in question lacked adequate directions for the use of a prescription drug, and failed to bear any statement of the route of administration, as required by the regulations of the Food and Drug Administration. *fn4" In counts six, eight, ten and fourteen the alleged misstatements relate to the strengths and qualities of the various drugs. Finally, in count twelve the government maintains that the carton insert did not relate to the drug with which it was used, but rather to a different drug.

 Defendants, in turn, have made the following set of motions: (1) a motion to dismiss various counts of the information, on several grounds, pursuant to Rule 12(b) of the Federal Rules of Criminal Procedure; (2) an application for the convening of a three-judge district court under section 2282 of title 28; (3) a motion for an order permitting defendants to obtain both copies of the government's scientific analyses upon which this proceeding has been based, and representative samples of the allegedly objectionable printed material and drugs, pursuant to Rule 16(a)(2) of the Federal Rules and section 372(b) of title 21; (4) a motion for discovery and inspection of any statements made by defendants that are within the government's possession, custody or control, and of various labels and carton inserts pertinent to the charges of misbranding, pursuant to Rule 16; and (5) a motion for a bill of particulars pursuant to Rule 7(f).

 The motion to dismiss is directed against ten of the fourteen counts of the information, and is based upon several distinct theories, none of which is applicable to all of the challenged counts. First, defendants attack all of the odd numbered counts on the ground that section 351(a)(2)(B), which is the sole statutory predicate for four out of the seven odd numbered counts, is unconstitutional. More specifically, they argue that said section is devoid of any definite, certain or ascertainable standards with which one could determine whether the methods being used in, or the facilities or controls being used for the manufacture, processing, packing or holding of a particular drug conform to, or are being operated or administered in conformity with "current good manufacturing practice." As a result, they contend, the section is too vague, indefinite and uncertain under the fifth amendment, and fails to inform defendants to the nature and cause of the charges based thereon, in violation of the sixth amendment.

 Second, defendants assert that all of the odd numbered counts are defective in that they are merely couched in the language of the statute; they are vague, indefinite and uncertain; and they fail to charge or aver that defendants committed any acts constituting an offense under any federal statute.

 Third, defendants also move to dismiss counts nine, ten, thirteen and fourteen on the ground that said counts fail to allege any facts to show that defendant's drugs do not fall within the permissible variations or exemptions envisaged by section 352(b) of title 21. *fn5" And finally, defendants attack counts eight, ten and fourteen as duplicitous.

 As a concomitant to their challenge to the constitutionality of section 351(a)(2)(B), defendants request the convening of a three-judge court for the stated purpose of securing a permanent injunction restraining the enforcement, operation or execution of said section as against them. *fn6" Injunctive relief is unnecessary in this case, however, since defendants have an adequate available legal remedy with which they may place the pertinent section's constitutionality at issue and, thereby, attempt to prevent its use against them - their pending motion to dismiss the relevant counts of the information. The provision for the convening of a three-judge court and direct appeal to Supreme Court was never intended to apply to all situations where the validity of an act of Congress is drawn into question. See, Flemming v. Nestor, 363 U.S. 603, 607, 80 S. Ct. 1367, 1371, 4 L. Ed. 2d 1435 (1960). Moreover, even assuming that a three-judge court might be called under similar circumstances, this court would still refuse to convene such a panel because, for the reasons hereinafter stated, defendants' claim of unconstitutionality is insubstantial. See, Ex Parte Poresky, 290 U.S. 30, 54 S. Ct. 3, 78 L. Ed. 152 (1933); Utica Mut. Ins. Co. v. Vincent, 375 F.2d 129, 130 (2d Cir.), cert. denied, 389 U.S. 839, 88 S. Ct. 63, 19 L. Ed. 2d 102 (1967).

 It is well settled that a penal statute must fix an ascertainable standard of guilt, and must adequately inform the accused of the nature and cause of the charge against him. See, United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 84 S. Ct. 559, 11 L. Ed. 2d 536 (1964); Boyce Motor Lines v. United States, 342 U.S. 337, 340, 72 S. Ct. 329, 330, 96 L. Ed. 367 (1952); Jordan v. De George, 341 U.S. 223, 231, 71 S. Ct. 703, 707, 95 L. Ed. 886 (1951); United States v. L. Cohen Grocery Co., 255 U.S. 81, 89, 41 S. Ct. 298, 300, 65 L. Ed. 516 (1921); United States v. Woodard, 376 F.2d 136, 140 (7th Cir. 1967).

 While an act of Congress that has been attacked as vague must initially be examined "on its face", United States v. National Dairy Prods. Corp., 372 U.S. 29, 32, 83 S. Ct. 594, 597, 9 L. Ed. 2d 561 (1963), few words possess mathematical precision, and most statutes deal with untold and unforeseen factual variations. Boyce Motor Lines v. United States, supra. Thus, such scrutiny frequently fails to uncover a readily discernible dividing line between validity and invalidity. United States v. National Dairy Prods. Corp., supra.

 In recognition of such factors, the constitution does not require an impossible degree of specificity. Rather "[the] test is whether the language conveys sufficiently definite wording as to the proscribed conduct when measured by common understanding and practices." Jordan v. De George, supra 341 U.S. at 231-232, 71 S. Ct. at 708. Moreover, a strong presumption of validity attaches to an act of Congress, and "* * * statutes are not automatically invalidated as vague simply because difficulty is found in determining whether certain marginal offenses fall within their language." United States v. National Dairy Corp., supra. See also, United States v. Irwin, 354 F.2d 192, 196 (2d Cir. 1965), cert. denied, 383 U.S. 967, 86 S. Ct. 1272, 16 L. Ed. 2d 308 (1966). No more than a reasonable degree of certainty, viewed in light of the conduct charged, can be demanded. United States v. National Dairy Prods. Corp., supra 372 U.S. at 32, 83 S. Ct. at 598; Boyce Motor Lines v. United States, supra 342 U.S. at 340, 72 S. Ct. at 330-331.

 Section 351(a)(2)(B), the particular provision in issue, was enacted as part of the 1962 amendments to the Food, Drug and Cosmetic Act of 1938, *fn7" a piece of legislation that touches "* * * phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection." United States v. Dotter-weich, 320 U.S. 277, 280, 64 S. Ct. 134, 136, 88 L. Ed. 48 (1943). Indeed, in the area of food and drug legislation, Congress has not always chosen to make guilty intent a prerequisite to the imposition of criminal sanctions. See, United States v. Wiesenfeld Warehouse Co., supra 376 U.S. at 91, 84 S. Ct. at 563. Instead, Congress has often determined that the larger good demands that the burden of acting at one's hazard be placed upon persons, who though they might otherwise be innocent, occupy a responsible position relative to a public danger. The reasoning has been that it is preferable to place hardships "* * * upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless." United States v. Dotterweich, supra 320 U.S. at 285, 64 S. Ct. at 138.

 The 1962 amendments were intended to strengthen and broaden the Act by effecting better, safer medicine and a more effective system of enforcement. *fn8" More specifically, the purpose of section 351(a)(2)(B) was to attack commerce in unsafe and unreliable *fn9" drugs in its incipiency by giving the Food and Drug Administration (FDA) "* * * additional authority to require that sound methods, facilities, and controls be used in all phases of drug manufacturing and distribution." *fn10" Thus, under the subject section a drug is deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacture practice to assure that such drug is safe and reliable, regardless of whether the drug actually is deficient in some respect. *fn11"

 The real question posed by defendants' motion to dismiss, therefore, is whether section 351(a)(2)(B) affords them a standard with which they can ascertain whether they are contravening the statutory scheme. See, United States v. L. Cohen Grocery Co., supra 255 U.S. at 92, 41 S. Ct. at 301.

 Defendants rely heavily on two cases in particular, United States v. L. Cohen Grocery, supra and Connally v. General Constr. Co., supra. The former involved section 4 of the Lever Act, *fn12" which proscribed, inter alia, unjust, unreasonable or excessive rates or charges in the handling or dealing in any necessaries. In holding the statute void for vagueness and quashing the indictment, the Supreme Court said that no standard of any sort was afforded thereby, and that the legislation amounted to penalizing and punishing all acts detrimental to the public interest when unjust and unreasonable in the estimation of the court and jury. Indeed, the Court's opinion was buttressed by the conflicting results in the cases then at bar. United States v. L. Cohen Grocery Co., supra 255 U.S. at 89-90, 41 S. Ct. at 300.

 In the latter case, a state statute prohibiting the payment of "* * * less than the current rate of per diem wages in the locality where the work is performed" was declared unconstitutional because of two serious ambiguities: (1) the legislature incorrectly assumed that there actually was such a rate while, in fact, there were many gradations; (2) the term "locality," the Court said, was subject to varying interpretations. Connally v. General Constr. Co., supra 269 U.S. at 393-395, 46 S. Ct. at 128-129, 70 L. Ed. 322.

 Aside from the fact that these cases predated a change in the Court's attitude toward governmental regulation of the economy, both rest upon determinations that under the circumstances the respective statutes afforded no meaningful standards at all. This court concludes that such is not the case with the provision presently under scrutiny, *fn13" and several more recent cases upholding analogous sections of the Food, Drug and Cosmetic Act support this view.

 Two of the cases, Berger v. United States, 200 F.2d 818 (8th Cir. 1952) and Golden Grain Macaroni Co. v. United States, 209 F.2d 166 (9th Cir. 1953), involved the validity of section 342(a)(4) of title 21, *fn14" while two others, United States v. Wiesenfeld Warehouse Co., supra and United States v. Sullivan, 332 ...


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