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136.

Opposition to Defense Motions re Due Process, Vagueness, "Van Liew", and "Minarik" Problems

The defendant, XXXX X. XXXXX, has moved to strike or dismiss portions of the Indictment, and for a bill of particulars. For the reasons set forth in the following memorandum of law, the United States opposes those motions.

I.Introduction

The Indictment charges XXXX with conspiracy, obstruction of administrative proceedings, and distributing adulterated drugs. During times relevant to the Indictment, XXXXX was vice-president for quality assurance at the Prettybig Drug Company, and was responsible for making reports to the Food and Drug Administration ("FDA") concerning the failure of marketed drug products to meet legally-required stability specifications [NOTE: names changed from original]. XXXX also was responsible for stopping the shipment of a drug, and initiating a recall (if appropriate), when the drug failed to meet stability specifications. See Indictment at 3. The Indictment charges that XXXXX concealed from FDA certain stability failures involving the prescription drugs Euthroid, Proloid, Parsidol, and Dilantin,[FN1] and that he caused the distribution in interstate commerce of adulterated Dilantin.

FN1. Euthroid and Proloid are thyroid medications, Parsidol is used to treat parkinsonism, and Dilantin is an anti-seizure drug. See Indictment ¶¶ 6-8.
A.Statutory And Regulatory Context

The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., requires drug manufacturers to obtain approval from FDA prior to marketing prescription drugs. See 21 U.S.C. § 355. Before granting a drug approval, scientists at FDA's headquarters in Rockville, Maryland, undertake an extensive review of the drug's formula and manufacturing processes, and of scientific evidence establishing that the drug is safe and effective for use in the manner recommended in its labeling. A manufacturer's "new drug application" ("NDA"), once approved by FDA, functions like a license, describing particularly the manner in which the drug must be manufactured, and the specifications the drug must meet in order to be sold.

In addition, a precondition for FDA approval of any drug is proof that the drug will be manufactured in conformity with "good manufacturing practice" ("GMP"). Conformity with GMP is also a separate requirement of the FDCA. The FDCA deems a drug to be "adulterated":[FN2]

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 manufacturing practice to assure that such drug meets the requirements of [the FDCA] as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
21 U.S.C. § 351(a)(2)(B). FDA has described certain requirements of GMP in regulations set forth at 21 C.F.R. part 211.

FN2. The FDCA prohibits the interstate distribution of adulterated drugs. 21 U.S.C. § 331(a).
An important aspect both of NDA approval and of GMP is drug stability testing. See 21 C.F.R. §§ 211.137 and 211.166. As part of an NDA approval, FDA sets stability specifications delimiting the ranges of acceptable potencies and/or dissolution characteristics that a drug must meet at set time-intervals following production. Drug manufacturers conduct stability tests according to those specifications to ensure that a drug maintains its potency and dissolution properties throughout its expiration period. For example, the NDA for Dilantin 30 mg requires that the product's dissolution characteristics be tested 3, 6, 9, 12, 18, 24, and 36 months after manufacturing, to support a three-year expiration period for the drug. The prescribed test involves dissolving the drug in water, and measuring the rate of dissolution by assessing the amount of dissolution at 30 minutes, 60 minutes, and 120 minutes.

FDA's role in ensuring drug safety and efficacy does not end when the agency has established specifications in an NDA. Pursuant to statutory mandate, see 21 U.S.C. § 355(e) and (k), the agency continuously monitors the drugs it has approved, to ensure that they are safe and effective, and that they are not adulterated or misbranded. FDA conducts this monitoring principally by reviewing required reports from manufacturers, see 21 C.F.R. § 314.81(b)(1) and (2), and by inspecting manufacturers' facilities. See 21 U.S.C. § 374.

B. The Indictment

Count One of the Indictment ("the Conspiracy Count) charges XXXXX with conspiracy, under 18 U.S.C. § 371. As alleged, the conspiracy had three objects:

1. to violate Title 21, United States Code, Sections 331(a) and 333(a)(2), by introducing adulterated drugs into interstate commerce, with the intent to defraud and mislead;[FN3]
2. to violate Title 18, United States Code, Section 1505, by corruptly endeavoring to influence, obstruct, and impede the due and proper administration of the law under which a pending proceeding was being had before the Food and Drug Administration;
3. to defraud the United States, by using craft, trickery, deceit, and dishonest means to impede, impair, obstruct, and defeat the lawful government functions of the FDA in its administration of the FD&C Act and related regulations.
FN3. It is further alleged as a "manner and means of the conspiracy" that XXXXX and his co-conspirators, "knowing that prescription drugs (including, but not limited to, Euthroid, Proloid, Parsidol, and Dilantin) had stability problems, caused Prettybig Drug to continue to market those drugs and make profits without alerting FDA or consumers."
Counts Two through Four ("the Dilantin Counts") charge that XXXXX, with the intent to defraud and mislead, caused the interstate distribution of adulterated Dilantin, in violation of 21 U.S.C. § 331(a). Count Five ("the Obstruction Count") alleges that XXXXX obstructed FDA proceedings relating to three Dilantin drug products, in violation of 18 U.S.C. § 1505.

II. Counts One Through Four Of The Indictment Are Constitutionally Sufficient
XXXXX contends that Counts One through Four of the Indictment--the Conspiracy Count and the three Dilantin Counts--violate the Indictment, Due Process, and Double Jeopardy Clauses of the Fifth Amendment, the Notice Clause of the Sixth Amendment, and Rule 7(c) of the Federal Rules of Criminal Procedure. As demonstrated below, Counts One through Four fully comply with all legal requirements relevant to the sufficiency of indictments.

In determining the legal sufficiency of an indictment, courts are guided by the following basic principles:

(1) the indictment must contain a statement of the "essential facts constituting the offense charged," (2) it must contain allegations of each element of the offense charged, so that the defendant is given fair notice of the charge that he must defend, and (3) its allegations must be sufficiently distinctive so that an acquittal or conviction on such charges can be pleaded to bar a second prosecution for the same offense.
United States v. Smith, 44 F.3d 1259, 1263 (4th Cir.) (quoting Fed. R. Crim P. 7(c)(1)), cert. denied, 115 S. Ct. 1970 (1995). These criteria reflect the the several constitutional guarantees that XXXXX contends are violated in this case. See United States v. Darby, 37 F.3d 1059, 1063 (4th Cir. 1994), cert. denied, 115 S. Ct. 1826 (1995); United States v. Daniels, 973 F.2d 272, 274 (4th Cir. 1992), cert. denied, 506 U.S. 1086 (1993).

A. The Dilantin Counts Are Sufficient

The Dilantin Counts (Counts Two through Four) allege that XXXXX violated 21 U.S.C. § 331(a) by causing the shipment in interstate commerce of Dilantin that was adulterated because it was not manufactured in conformity with GMP. The three counts are identical in all respects except for the dates of shipment.

"The allegations of an offense are generally sufficient if stated in the words of the statute itself." Smith, 44 F.3d at 1264. That is the situation here: the language of the Dilantin Counts tracks the language of the relevant statutory and regulatory provisions that describe the offenses--viz. 21 U.S.C. §§ 331(a), 333(a)(2), and 351(a)(2)(B); 21 C.F.R. § 211.100. Moreover, each count specifically describes the drug involved, the lot number of the drug, the date of shipment, the place to which the drug was shipped, and the manner in which the drug was adulterated. This is sufficient to provide notice to XXXXX of the nature of the charges against him. See, e.g., United States v. Bel-Mar Laboratories, Inc., 284 F. Supp. 875, 884 (E.D.N.Y. 1968).

XXXXX complains that the Dilantin Counts "in no way apprise [him] of the conduct or omissions--by himself or anyone else--that rendered Lot #68400L of Dilantin criminally 'adulterated.'"[FN4] Def. Memo at 4-5. The Dilantin Counts contain not only sufficient detail to apprise XXXXX of the theory of adulteration, but in fact provide more detail than is legally required.

FNX. XXXXX's challenge to the sufficiency of the Dilantin Counts focuses exclusively on the adequacy of the allegation concerning adulteration. XXXXX also implies, however, that the mens rea of the offenses is inadequately described. See Def. Memo at 3 (noting that mental state of "intent to defraud and mislead" is "not otherwise explained"). This suggestion is without merit. It has been clearly held that an indictment charging offenses under the FDCA need not allege facts establishing the defendant's "intent to defraud and mislead." See United States v. Arlen, 947 F.2d 139, 144-45 (5th Cir. 1991), cert. denied, 503 U.S. 939 (1992).
The theory of adulteration is clearly stated:

[the] drugs were adulterated within the meaning of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with GMP, because the production processes used to manufacture the drugs were inadequately designed to assure that the drugs met the requirements of the FD&C Act as to safety and had the identity, strength, quality, and purity characteristics which they purported to and were represented to possess.[FN5]
FN5. The language in the first underscored section ("the methods . . . with GMP,") tracks exactly the language of the FDCA's GMP requirement, 21 U.S.C. § 351(a)(2)(B). The second underscored section ("the production . . . to possess.") tracks closely the language of an FDA GMP regulation, 21 C.F.R. § 211.100(a). Contrary to XXXXX's assertion, Def. Memo at 12 n.8, the omission of a citation to this regulation is not ground for dismissal of the Dilantin Counts. Fed. R. Crim. P. 7(c)(3).
Pursuant to this allegation, the government will prove at trial that the Dilantin lot in question was adulterated because the process used to manufacture the drug was inadequate to assure that the drug would meet its stability dissolution specifications.

XXXXX's contention that he cannot understand the nature of this charge sufficiently to prepare his defense is pure sophistry. Indeed, XXXXX acknowledges his clear understanding of the charge in a later section of his memorandum, when he contends that the FDCA's GMP requirement is unconstitutional as applied to this case. In that context, he argues that "it was impossible in this case to predict . . . whether the particular process in question was 'inadequately' designed 'to assure' a particular result." Def. Memo at 30. This statement, which concisely describes the Indictment's stated theory of adulteration, belies XXXXX's feigned confusion concerning the adulteration issue.

XXXXX's complaint that "hopeless ambiguities" in the allegations will force him to "guess which of the 'methods' or 'facilities' or 'controls' were the source of the 'adulteration,'" Def. Memo at 9-10, also is without merit. The specific reason why the production processes for Dilantin 30 mg were inadequate to assure that the drug would meet its stability specifications is not an "essential fact" that the government must prove to establish that the Dilantin was adulterated; indeed, the government would be unable to make such proof, for even Prettybig Drug cannot answer the question. The government will prove, simply, that the processes Prettybig Drug used during times relevant to the Indictment were inadequate. The Indictment clearly apprises XXXXX of that allegation.

The sufficiency of the Dilantin Counts is further demonstrated by comparison with analogous indictments that have been upheld in other cases. Two particularly helpful examples can be found in United States v. Smith, supra, and United States v. Lang, 766 F. Supp. 389, 394-96 (D. Md. 1991). Structurally, the charges in those cases--money laundering in Smith, false statements in Lang--are very similar to the Dilantin Counts. The Dilantin Counts allege interstate commerce involving drugs which are adulterated; that is, a core transaction (innocent by itself) that is made criminal because of the nature of the item transacted. Similarly, the money laundering charges in Smith alleged a monetary transaction involving proceeds of a wire fraud; and the false statement charges in Lang alleged submission to a government agency of a document containing false statements.

Smith and Lang hold that an indictment charging offenses of these sorts is sufficient if it provides details about the core transaction of the offense, but need not describe details of the nature of the item transacted. For example, the money laundering charge in Smith stated no details of the wire fraud offense which rendered the "monetary transaction" criminal. The Fourth Circuit nonetheless held that the charge was sufficient:

The core of money laundering, which distinguishes one such offense from another, is the laundering transaction itself. Because the requirement that the funds be illegally derived is not the distinguishing aspect and therefore does not lie at the core of the offense, details about the nature of the unlawful activity underlying the character of the proceeds need not be alleged.
Smith, 44 F.3d at 1265.

Lang reached a like result. In that case, the defendant contended that an indictment charging submission of a false document to the Securities and Exchange Commission was insufficient because it did not specify which parts of the documents were false, and why they were false. Judge Nickerson ruled that the charge was sufficient. "It is the submission of the false document which constitutes the separate crime. While some identification is required, it is not necessary that the indictment itself go into evidentiary matters." Lang, 766 F. Supp. at 396 (quoting United States v. Bernstein, 533 F.2d 775, 786 (2d Cir.), cert. denied, 429 U.S. 998 (1976)).

As already noted, the "adulteration" allegation serves the same function for the Dilantin Counts as the wire fraud allegation served for the money laundering charge in Smith, and allegation of falsity served for the false statements charge in Lang. Thus, as in Smith and Lang, details concerning this component of the charge need not be pleaded. "Because the requirement that the [drugs] be [adulterated] is not the distinguishing aspect and therefore does not lie at the core of the offense, details about the [adulteration] need not be alleged."[FN6] Smith, 44 F.3d at 1265. Because they do describe the theory of adulteration, the Dilantin Counts are not merely sufficient, but they actually provide more information than legally is required.

FN6. In fact, as already explained, the Dilantin Counts describe the theory of adulteration very specifically. Thus, the the Dilantin Counts actually provide greater specificity than the law requires.
Van Liew v. United States, 321 F.2d 664 (5th Cir. 1963), upon which XXXXX heavily relies, does not require a different result. As demonstrated below, Van Liew is distinguishable, both factually and legally, from the instant case.

The defendants in Van Liew were charged by indictment with causing the "economic" adulteration and misbranding of orange juice by diluting the juice with water, sugar, and other ingredients. Id. at 667 and n.1. The Fifth Circuit held that the indictment violated the Fifth Amendment's Indictment Clause because it inadequately described the legal theories of adulteration and misbranding upon which the grand jury had based the charges.

The indictment in Van Liew alleged that the orange juice was adulterated and misbranded "within the meaning of" certain multifaceted provisions of the FDCA (none of which is at issue in this case), but did not explain further how those statutory provisions were violated. In the view of the Fifth Circuit, this resulted in allegations of "a variety of unknown actions." Id. at 670. Whatever the merits of the Fifth Circuit's ruling, it has no application to the Dilantin Counts. As explained above, the Dilantin Counts specifically (and more than adequately, under Fourth Circuit precedent) describe how the Dilantin was adulterated. The Dilantin Counts do not merely allege that the Dilantin was adulterated "within the meaning of" the FDCA. Rather, they explain with particularity that the drug was adulterated because it was not manufactured in conformity with GMP, and further describe the nature of the non-conformity with GMP, tracking the language of the applicable GMP regulation. Thus, Van Liew is wholly inapposite.

Van Liew also is legally distinguishable, in that it appears to conflict with precedent in the Fourth Circuit (and, indeed, has been received unfavorably by other courts, including within the Fifth Circuit itself). Part of the reason XXXXX no doubt finds the Van Liew opinion appealing is its unusual emphasis on the Fifth Amendment's Indictment Clause. Without question, indictment by a grand jury is an important constitutional guaranty. However, the government is unaware of any other decision that has analytically isolated this guaranty in the manner the Fifth Circuit did in Van Liew.[FN7] Rather, as the Fourth Circuit has made clear, courts "ensure that a defendant is afforded his constitutional guarantees under the [Indictment Clause of the] Fifth Amendment" by applying the three-part test quoted earlier from Smith. United States v. Darby, supra, 37 F.3d at 1063.

FN7. In United States v. Staggs, 881 F.2d 1527, 1533-34 & n.8 (10th Cir. 1989) (en banc), cert. denied, 493 U.S. 1020 (1990), the court expressly rejected an analysis similar to that set forth in Van Liew.
The uniqueness of Van Liew, and its antagonism to Fourth Circuit law, are evidenced by how Van Liew has fared in false statements cases similar to Lang. Whereas Lang holds that a false statements charge does not require specification of evidentiary particulars concerning falsity, Van Liew suggests that it does require such specification. Thus, for example, in United States v. Winchester, 407 F. Supp. 261, 276 (D. Del. 1975), the court held that Van Liew supported a holding--inconsistent with Lang--that an indictment must "spell out the specific falsity underlying the false statement charges."

Other courts, reaching results consistent with Lang, have expressly declined to follow Van Liew. In United States v. Clark, 546 F.2d 1130 (5th Cir. 1977), for example, the Fifth Circuit reached a result consistent with Lang, and all but overruled Van Liew by interpreting the case as focusing on double jeopardy considerations, rather than on the grand jury guaranty.[FN8] See id. at 1134-35. Similarly, in United States v. Radetsky, 535 F.2d 556 (10th Cir.), cert. denied, 429 U.S. 820 (1976), the court reached a result consistent with Lang notwithstanding its acknowledgement that Van Liew would support an opposite position. Id. at 564.

FN8. In other opinions, the Fifth Circuit has been similarly dismissive with respect to arguments based on Van Liew. See, e.g., United States v. Graves, 669 F.2d 964, 968 n.3 (5th Cir. 1982).
Van Liew thus clearly should have no impact on this Court's assessment of the validity of the Dilantin Counts. Van Liew is not only factually distinguishable from the instant case, but it also reflects a legal analysis (discredited in its own and other circuits) that is irreconcilable with the law in the Fourth Circuit.

For the reasons stated above, the government therefore requests that the Court deny XXXXX's motion to dismiss the Dilantin Counts.

B.The Conspiracy Count Is Sufficient

XXXXX next challenges that portion of the Conspiracy Count which charges him with conspiring "to violate Title 21, United States Code, Sections 331(a) and 333(a)(2), by introducing adulterated drugs into interstate commerce, with the intent to defraud and mislead." Indictment at 4. XXXXX contends this allegation is insufficient because it fails to specify a theory of adulteration. Like XXXXX's challenge to the Dilantin Counts, this challenge also lacks merit.

If XXXXX is uncertain about the adulteration alleged in the Conspiracy Count, that is only because he refuses to undertake a proper reading of the Indictment. XXXXX overlooks entirely the allegation that it was "part of this conspiracy that the members of the conspiracy, knowing that prescription drugs (including, but not limited to, Euthroid, Proloid, Parsidol, and Dilantin) had stability problems, caused Prettybig Drug to continue to market those drugs and make profits without alerting FDA or consumers." Indictment at 5. It is clear from this allegation that XXXXX is charged with conspiring to ship drugs that were adulterated because they had stability problems.

Furthermore, as XXXXX recognizes, the only three overt acts of the Conspiracy Count that describe drug shipments refer to the same Dilantin drug shipments that are the basis for the Dilantin Counts. There can be no doubt, then, that the Conspiracy Count charges XXXXX with conspiring to commit the same offenses as are alleged in the Dilantin Counts. Although XXXXX obviously understands this, he refuses to accept it, insisting that the Conspiracy Count must stand alone. Def. Memo at 22 n.14. That is not the law in this Circuit, however. Rather, it has been expressly held that the allegations of related substantive counts are relevant in determining the meaning and sufficiency of a conspiracy charge.[FN9] See United States v. Brown, 784 F. Supp. 322, 326 n.9 (E.D. Va. 1992) (citing United States v. Duncan, 598 F.2d 839, 849 & n.5 (4th Cir.), cert. denied, 444 U.S. 871 (1979)).

FN9. United States v. Hooker, 841 F.2d 1225 (4th Cir. 1988) (en banc), cited by XXXXX, holds only that a missing element cannot be read from one count into a another (in the absence of express incorporation). See id. at 1231. Hooker does not prohibit reference to other counts to assist in understanding a charge (such as this one) which states all necessary elements. See United States v. Brown, 784 F. Supp. 322, 324 n.6 (E.D. Va. 1992); see also United States v. Duncan, 598 F.2d 839, 849 n.5 (4th Cir.), cert. denied, 444 U.S. 871 (1979) (allowing reference to other counts, noting "[w]e are not in this case, however, confronted with the complete omission of an essential element of the offense, but at most a non-specific statement of an element clearly identified"). Other circuits similarly allow that, for purposes of determining the sufficiency of one count in an indictment, reference may be made to other counts. See, e.g., United States v. Morris, 18 F.3d 562, 568 (8th Cir. 1994); United States v. Staggs, 881 F.2d 1527, 1531 (10th Cir. 1989) (en banc), cert. denied, 493 U.S. 1020 (1990).
Like his challenge to the Dilantin Counts, XXXXX's complaint about the Conspiracy Count is overly technical, and inconsistent with the law applied in this Circuit.

It is well settled that in an indictment for conspiring to commit an offense--in which the conspiracy is the gist of the crime--it is not necessary to allege with technical precision all the elements essential to the commission of the offense which is the object of the conspiracy, . . . or to state such object with the detail which would be required in an indictment for committing the substantive offense.
Wong Tai v. United States, 273 U.S. 77, 81 (1927) (citations omitted); see also Belvin v. United States, 12 F.2d 548, 550 (4th Cir.), cert. denied, 273 U.S. 706 (1926); United States v. Brown, supra, 784 F. Supp. at 324. As noted above, the Fourth Circuit's decision in Smith suggests that little, if any, detail concerning adulteration is necessary to state a substantive offense under 21 U.S.C. § 331(a). Under the more lenient pleading requirements applicable to object offenses of conspiracies, therefore, the Conspiracy Count clearly is more than sufficient.

III.The FDCA's GMP Requirement Is Not Unconstitutionally Vague As Applied
Complaining that the FDCA's GMP requirement is "too illusive a concept" upon which to rest criminal liability, Def. Memo at 10, XXXXX contends that the GMP requirement is vague as applied in this case. Id. at 24-31. This challenge, too, has no merit.

XXXXX's claim that the GMP requirement is vague as applied "must be examined in the light of the facts of the case at hand." United States v. McAusland, 979 F.2d 970, 975 (4th Cir. 1992) (quoting United States v. Mazurie, 419 U.S. 544, 550 (1975)), cert. denied, 507 U.S. 1003 (1993). Here, the government will present evidence that XXXXX was familiar with the GMP requirement from his long experience as a drug quality assurance officer at Prettybig Drug. By itself, this militates against any unfairness in holding XXXXX responsible for shipping drugs that violated GMP. See United States v. Bel-Mar Laboratories, Inc., 284 F. Supp. 875, 883 (E.D.N.Y. 1968) (upholding GMP requirement against vagueness challenge, and noting that the concept of GMP "is not strange to those in the trade to whom [it] is directed").

Even more compellingly, the government's evidence will show that XXXXX was specifically aware that Dilantin 30 mg violated GMP, and was thus adulterated, in the manner alleged in the Indictment. Through both testimony and documentary evidence, the government will prove that XXXXX knew the Dilantin formulation was inadequate to produce a product that would consistently meet its stability specifications.[FN10] For example, in a memorandum dated September 13, 1990, XXXXX wrote that "a reformulation" of Dilantin 30 mg "is urgently needed" because of "the risk of out-of-spec stability test results." Noting Prettybig Drug's desire to continue marketing the product, XXXXX requested that company scientists work "to achieve a more consistent manufacturing formulation as soon as possible." Similarly, in a memorandum dated March 27, 1990, XXXXX stated that reformulation was necessary "in order to meet current dissolution standards." [Copies of the two documents discussed above are attached to this Memorandum.]

FN10. Stability specifications, which consist of precise quantitative ranges, are the opposite of vague standards.
These statements are compelling proof that XXXXX knew the Dilantin formulation was inadequate to meet the product's specifications, which is precisely what the Indictment's adulteration theory alleges. What is more, XXXXX knew that the inadequacies in the Dilantin formulation created concern for the safety and efficacy of the drug, and thus violated regulatory standards. In the March 27 memorandum, XXXXX wrote: "Continuing with the status quo is not a viable option for a number of reasons, not the least of which is the potential for Class I recall actions for any violation involving antiepileptics." As XXXXX evidently understood, FDA categorizes a recall as "Class I" when "there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death." 21 C.F.R. § 7.3(m)(1). Thus, XXXXX's acknowledgement of the risk that Dilantin would be the subject of a Class I recall evidences his clear recognition that the inadequacies in the drug's formulation violated the GMP requirement that a drug's production processes must be adequate to assure the drug will meet its specifications.

XXXXX's vagueness challenge cannot survive this proof. "Objections to vagueness under the Due Process Clause rest on the lack of notice, and hence may be overcome in any specific case where reasonable persons would know that their conduct is at risk." Maynard v. Cartwright, 486 U.S. 356, 361 (1988); see also Boyce Motor Lines, Inc. v. United States, 342 U.S. 337, 340 (1952) ("Nor is it unfair to require that one who deliberately goes perilously close to an area of proscribed conduct shall take the risk that he may cross the line"). Here, before any of the Dilantin shipments referenced in the Dilantin Counts had occurred, XXXXX knew that the product violated regulatory requirements and might therefore be the subject of a recall. This conclusively refutes XXXXX's claim that the regulatory requirements were vague as applied to him.[FN11] See McAusland, 979 F.2d at 975-76; United States v. Ellen, 961 F.2d 462, 466-67 (4th Cir.), cert. denied, 506 U.S. 875 (1992).

FN11. The scienter the government will prove to convict XXXXX of the Dilantin Counts--an intent to defraud or mislead--also mitigates any vagueness in the GMP requirement. See United States v. Strauss, 999 F.2d 692, 698 (2d Cir. 1993); see also United States v. Hiland, 909 F.2d 1114, 1127 (8th Cir. 1990) (scienter of FDCA offense protects defendant from being convicted for violating rules he didn't understand).
As XXXXX reluctantly acknowledges, Def. Memo at 30 n.22, a consistent line of cases has upheld the GMP requirement against claims of unconstitutional vagueness. See United States v. Jamieson-McKames Pharmaceuticals, Inc., 651 F.2d 532, 545 n.24 (8th Cir. 1981), cert. denied, 455 U.S. 1016 (1982); United States v. Article of Drug . . . "White Quadrisect", 484 F.2d 748 (7th Cir. 1973); United States v. The Kendall Company, 324 F. Supp. 628, 629 (D. Mass. 1971); United States v. Bel-Mar Laboratories, Inc., supra, 284 F. Supp. at 880-84. XXXXX offers no effective challenge to these holdings. Rather, he simply ignores them, contending in favor of a constitutional standard of definiteness that is much stricter than settled doctrine permits.

The Constitution does not require perfect specificity in criminal statutes, but only a reasonable degree of certainty in light of the subject matter.

[M]ost statutes must deal with untold and unforeseen variations in factual situations, and the practical necessities of discharging the business of government inevitably limit the specificity with which legislators can spell out prohibitions. Consequently, no more than a reasonable degree of certainty can be demanded.
Boyce Motor Lines, Inc. v. United States, supra, 342 U.S. at 340. In the regulatory context, extra leeway is allowed because of the expectation that regulated entities will consult relevant legislation in advance of action, and because such entities often have the opportunity to seek administrative clarification on important statutory or regulatory issues. Village of Hoffman Estates v. Flipside, Hoffman Estates, 455 U.S. 489, 498 (1982). This interpretative flexibility is especially appropriate in the context of the FDCA.

[T]he fact that the general public is unable adequately to protect itself in the purchase of food and drugs imposes a high degree of responsibility on those who profit from their manufacture and sale and affects their obligations under regulatory legislation.
United States v. Marcen Laboratories, Inc., 416 F. Supp. 453, 455 (S.D.N.Y.) (upholding FDCA definition of "new drug" against vagueness challenge), aff'd, 556 F.2d 562 (2d Cir. 1976).

In Bel-Mar Laboratories, the court undertook a detailed analysis of the constitutionality of the FDCA's GMP requirement. Comparing the GMP statute with other FDCA provisions that have withstood vagueness attacks, the court found the GMP requirement "at least as definite. . . ." 284 F. Supp. at 882. Moreover, the court noted:

The requisite conditions are not demanded in the abstract, but rather are expressly related to the achievement of a specified goal--the assurance that drugs will be safe and reliable. The fact that the standard may vary in degree does not render it unconstitutional.
Id. at 882-83 (citations omitted). Bel-Mar is persuasive and compelling precedent, which has been followed by several courts. See, e.g., United States v. Jamieson-McKames Pharmaceuticals, Inc., supra, 651 F.2d at 545 n.24; United States v. The Kendall Company, supra, 324 F. Supp. at 629. So far as government counsel is aware, moreover, no information or indictment charging violations of GMP has ever been dismissed on grounds of unconstitutional vagueness.

For the foregoing reasons, XXXXX's vagueness attack against the Dilantin Counts and the portion of the Conspiracy Count which refers to the GMP requirement should be rejected.

IV.The Conspiracy Count Properly Alleges Both A Conspiracy To Defraud And A Conspiracy To Commit Offenses
NOTE: The balance of this memorandum can be found in the Civil Resource Manual at 171Civil Resource Manual at 171.

[updated June 1998] [cited in USAM 4-8.240; Civil Resource Manual 171]