| 21 U.S.C. § 333(a)(2) INCLUDES, BUT IS NOT
LIMITED TO, INTENT TO DEFRAUD OR MISLEAD
THE ULTIMATE CONSUMERS OF MISBRANDED DRUGS
INTENT TO DEFRAUD OR MISLEAD DIRECTED TOWARD THE FDA
SATISFIES THIS ELEMENT OF THE OFFENSE
Any person who commits one of the prohibited acts set forth in 21 U.S.C. § 331 has violated the Federal Food, Drug and Cosmetic Act (FD&C Act). However, any person who commits such an act "with the intent to defraud or mislead" is guilty of a felony and is subject, pursuant to 21 U.S.C. § 333(b)(2), to punishment of up to three year's imprisonment.[FN1] Counts Two, Three, Five, Six, Seven, Eight, and Nine (formerly Ten) of the Indictment in this case charge the Defendants with manufacturing and thereafter introducing into interstate commerce specified misbranded and adulterated drugs - "with the intent to defraud and mislead" - in violation of 21 U.S.C. §§ 331(a) or (k)[FN2] and 333(a)(2). Count Four and Count Ten (formerly Count Eleven) charge that the defendants - "with the intent to defraud or mislead" - failed to maintain accurate batch production records (Count Four) and product complaint records (Count Ten).
FN1. Pursuant to 18 U.S.C. § 3571, the maximum potential fines for violations of the FD&C Act are $250,000. per count for individuals and $500,000. per count for organizations.
FN2. 21 U.S.C. § 331(a) prohibits, inter alia, introducing or delivering for introduction into interstate commerce any drug which is adulterated or misbranded. Under 21 U.S.C. § 351(a) a drug is adulterated if it consists in any part of any filthy substance, or has been held under insanitary conditions whereby it may have been contaminated with filth or if the methods used in its manufacture do not conform to or are not operated or administered in conformity with good manufacturing practices. Under 21 U.S.C. 352(a) a drug is misbranded if its labeling is false or misleading in any particular. This definition of false or misleading includes, but is not limited to, the failure on the labeling to reveal material facts relating to the safety or efficacy of the drug. 21 U.S.C. § 321(n).
A FRAUD DIRECTED AGAINST THE FDA SATISFIES THE MENS REA REQUIREMENTS OF 21 U.S.C. § 333(a)(2) The mens rea element of Section 333(a)(2) - the intent to defraud or mislead - can be established by evidence of intent to defraud the customers of violative products. In addition, however, a seller of violative products acts "with the intent to defraud" as defined by section 333(a)(2) if he or she takes affirmative steps to evade detection by, and thus mislead, regulatory authorities. See, e.g., United States v. Andersen, 45 F.3d 217, 220 (7th Cir. 1995)("The FDA represents the public, and a deliberate attempt to mislead the FDA should be considered as clearly a fraud as are attempts to mislead customers or other individuals."); United States v. Arlen, 947 F.2d 139, 143 (5th Cir. 1991), cert. denied, 112 S.Ct. 1480 (1992); United States v. Cambra, 933 F.2d 752, 755 (9th Cir. 1991); United States v. Bradshaw, 840 F.2d 871, 874 (11th Cir.), cert. denied, 488 U.S. 924 (1988); see also United States v. Mitcheltree, 940 F.2d 1329, 1350-51 (10th Cir. 1991) (adopts the Bradshaw analysis concerning "intent to defraud or mislead" but adds a refinement pertinent to misbranding offenses). Appellate courts have uniformly held that FD&C Act cases involving fraud on regulatory authorities are properly sentenced as felonies under U.S.S.G. ڈF1.1. E.g., Andersen, 45 F.3d at 220; Arlen, 947 F.2d at 143-44, 146-47; Cambra, 933 F.2d at 756.
The plain language of 21 U.S.C. § 333(a)(2) provides for felony treatment for any person who violates a provision of 21 U.S.C. § 331 "with the intent to defraud or mislead." The focus is upon the violator's intent; there is no limitation with respect to whom the violator's intent is directed. Thus, when a person manufactures or distributes misbranded or adulterated drugs in violation of 21 U.S.C. § 331(a) or 331(k) with intent to defraud or mislead either a purchaser of the drugs or any other person or entity (including the FDA), that person is subject to the punishment specified in § 333(a)(2).
Courts have held that schemes to circumvent the requirements of the FD&C Act constitute schemes to defraud the FDA. United States v. Bradshaw, 840 F.2d 871, 874 (11th Cir.) (expressly finding that an illicit steroid distribution scheme amounted to fraud against the FDA and state regulatory authorities), cert. denied, 109 S. Ct. 305 (1988); see also, e.g., Hammerschmidt v. United States, 265 U.S. 182, 188 (1924); Dennis v. United States, 384 U.S. 855, 861 (1966) (holding that an agreement to impair, obstruct or defeat the lawful function of the FDA constitutes a conspiracy to defraud an agency of the United States in violation of 18 U.S.C. § 371). Fraud against the FDA alleged in this indictment includes that the defendants interfered with the agency's governmental function and undermined the agency's important statutory responsibilities by preventing legitimate inspection and by preparing and maintaining false records that were required to be maintained under the FD&C Act.
The starting point of statutory construction is the plain language of the statute itself. Greyhound Corp. v. M[t]. Hood Stages, Inc., 437 U.S. 322, 330 (1978). If the language of the statute is clear, there is no need to look elsewhere. Packard Motor Car Co. v. NLRB, 330 U.S. 485, 492 (1947)." Because the words of § 333(a)(2) are unambiguous, there is no basis for or need to look beyond those words for enlightenment as to the statute's meaning. Caminetti v. United States, 242 U.S. 470, 485 (1917) ("Where the language is plain and admits of no more than one meaning, the duty of interpretation does not arise, and the rules which are to aid doubtful meanings need no discussion.").Nonetheless, a review of judicial decisions construing the FD&C Act and a consideration of the purposes to be served by the Act further support the conclusion that "intent to defraud or mislead" governmental regulatory bodies, and not just the ultimate consumer of misbranded drugs, is punishable as a felony under § 333(a)(2).
Although, to the government's knowledge, prior to the Bradshaw case in 1988, 840 F.2d 871, no written opinion construed the "intent to defraud or mislead" provision of § 333(b) [now codified as 21 U.S.C. § 333(a)(2)], the leading cases interpreting the related provisions of the FDC Act, 21 U.S.C. § 333(a), all concluded that the Act's enforcement provisions are to be liberally construed to effectuate the purposes of the Act.
In United States v. Dotterweich, 320 U.S. 277 (1943), the Court was faced with the question of whether a corporate officer, and not just the corporation itself, could be subject to prosecution and conviction under § 333(a) for introducing misbranded and adulterated drugs into interstate commerce in violation of 21 U.S.C. § 331(a). The Court of Appeals had reversed the conviction of the officer, Dotterweich, relying on an exception to the criminal liability provisions of the Act contained in 21 U.S.C. § 333(c), the so-called "guaranty clause," which insulates from criminal liability a person who introduces a violative product into interstate commerce in reliance upon a guaranty, given by the original supplier of the product, that the product is not adulterated or misbranded. 320 U.S. at 279-80. The Supreme Court rejected the Court of Appeals construction of the guaranty clause as "read[ing] an exception to an important provision safeguarding the public welfare with a liberality which more appropriately belongs to enforcement of the central purpose of the Act." Id. at 284 (emphasis added). The Court said:
The guaranty clause cannot be read in isolation. The Food and Drugs Act of 1906 was an exertion by Congress of its power to keep impure and adulterated food and drugs out of the channels of commerce. By the Act of 1938,[FN3] Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience. The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.
FN3. The Act of 1938, 52 Stat. 1040, 21 U.S.C. §§ 301--392, as amended, is the present FDC Act.
Id. at 280. Based on this analysis of the Act's purposes, the Court reinstated Dotterweich's conviction. In United States v. Sullivan, 332 U.S. 689, 692 (1948), the Supreme Court once again rejected an appellate court's "narrow construction" of the FDC Act and upheld a conviction under the Act's misbranding provisions. The particular FD&C Act provision at issue in Sullivan was 21 U.S.C. § 331(k), which prohibited the doing of any act with respect to a drug, "while such article is held for sale after shipment in interstate commerce," that rendered the drug misbranded. The Supreme Court rejected the appellate court's construction that § 331(k) applied only to acts done by the first person to hold the drug after interstate shipment and not by subsequent intrastate purchasers of the drug who also held it for sale:
[T]he language used by Congress broadly and unqualifiedly prohibits misbranding articles held for sale after shipment in interstate commerce, without regard to how long after the shipment the misbranding occurred, how many intrastate sales had intervened, or who had received the articles at the end of the interstate shipment. Accordingly we find that the conduct of the respondent falls within the literal language of § 331(k).
Id. at 696. The Sullivan Court found ample support for its decision in the purposes underlying the FDC Act:
Given the meaning that we have found the literal language of § 331(k) to have, it is thoroughly consistent with the general aims and purposes of the Act. For the Act as a whole was designed primarily to protect consumers from dangerous products. This Court so recognized in United States v. Dotterweich .... Its purpose was to safeguard the consumer by applying the Act to articles from the moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer.
Id. More recently, in United States v. Park, 421 U.S. 658, 672-73 (1975), the Court reaffirmed the strict liability of corporate officers and agents, as enunciated in Dotterweich, for misdemeanor violations of the FDC Act:
Congress has seen fit to enforce the accountability of responsible corporate agents dealing with products which may affect the health of consumers by penal sanctions cast in rigorous terms, and the obligation of the courts is to give them effect so long as they do not violate the Constitution.
These cited cases are part of a large, uniform body of law which has consistently held that the FDC Act is to be liberally construed to effectuate its public health purposes.
The FDC Act protects consumers from adulterated and misbranded drugs by, inter alia, authorizing agents of FDA to enter and inspect the contents of any premises or vehicle in which drugs are held for or after introduction into interstate commerce to ensure proper storing, handling, and dispensing of drugs. 21 U.S.C. § 374. "Nothing is clearer than that the later legislation [the 1938 Act adopting the criminal provisions of § 333] was designed to enlarge and stiffen the penal net and not to narrow and loosen it." United States v. Dotterweich, 320 U.S. at 282.
Moreover, limiting the Act's felony provision only to cases involving "intentional misconduct intended to deceive the ultimate consumer" would render § 333(a)(2) a nullity with respect to several of the violations prohibited by 21 U.S.C. § 331. Section 331 prohibits not only violative activities that directly impact upon consumers but also activities that would inhibit FDA from fulfilling its regulatory mission. For example, § 331 prohibits refusal to permit access to and copying of records of interstate drug shipments, the failure to maintain records required under the Act such as drug manufacturing and production records and records of adverse drug reactions, refusal to permit entry or inspection of drug facilities by FDA, and the failure to register with FDA as a drug manufacturer. 21 U.S.C. §§ 331(e), (f), & (p).
Section 333(a)(2) applies by its terms to any person who violates any provision of § 331 with intent to defraud or mislead. While since such violations as those just listed do not directly affect the ultimate consumers of drugs (but rather affect FDA's ability effectively to regulate the drug industry and, thereby, to protect consumers), they nevertheless constitute felonies under the FD&C Act. Any alternative interpretation of § 333(a)(2) would read the statute out of existence with respect to whole classes of violations. This would, in part, "render the statute useless, a result inconsistent with the well-established principle of statutory construction requiring that all parts of an act be given effect, if at all possible." In re Hall, 752 F.2d 582, 586 (11th Cir. 1985); Weinberger v. Hynson, Westcott and Dunning, Inc., 412 U.S. 609, 633 (1973) ("well-settled rule of statutory construction that all parts of a statute, if at all possible, are to be given effect" applied to FDC Act's "new drug" definition).
Any contrary reading of the statute § 333(a)(2) would thus be, in reality, a loose reading of the statute that would impose limitations, for the benefit of violators, not present in the plain words or the manifest purposes of the FD&C Act. In analogous settings, courts have declined to read such limitations into otherwise unambiguous statutory language. See Riggs v. United States, 280 F.2d 750, 752 (5th Cir. 1960) (upholding conviction for passing counterfeit currency with intent to defraud even though recipient of currency knew it was counterfeit; "'intent to defraud' required by 18 U.S.C. § 472,[FN4] when, as here, such intent is not restricted by the terms of the indictment or by a bill of particulars to any specified person, may be an 'intent to defraud unknown third persons or the United States itself"); Bachrack v. United States, 75 F.2d 824, 824-25 (5th Cir. 1935) (statute prohibiting possession of counterfeit internal revenue stamps "uses the comprehensive term 'with intent to defraud' for the very purpose of making it immaterial whether the offender intended to defraud the government or some particular individual"); United States v. Cattle King Packing Co., 793 F.2d 232, 237-38 (10th Cir.), cert. denied, 107 S. Ct. 573 (1986) (upholding convictions for violations of Federal Meat Inspection Act, with intent to defraud,[FN3] where defendants attempted to avoid inspection of spoiled meat by federal inspectors).
FN3. The Federal Meat Inspection Act makes any violation a misdemeanor and, modeled on the FDC Act, provides for enhanced felony punishment "if such violation involves intent to defraud." 21 U.S.C. § 676(a).
There is simply no authority for any contrary interpretation of § 333(a)(2).
FN4. 18 U.S.C. § 472 provides, in relevant part, that "[w]hoever, with intent to defraud, passes ... any falsely made, forged, counterfeited, or altered obligation or other security of the United States, shall be fined not more than $5,000 or imprisoned not more than fifteen years, or both."
FRAUD ON THE CONSUMER FIRM's [NOTE: name changed from original] manufacture of adulterated and misbranded drugs for distribution to unknown consumers also defrauded those ultimate consumers of those drugs. See Bradshaw, 840 F.2d at 873-74 n. 4. In addition to being deprived of the FD&C Act's safeguards that are designed to prevent consumers from having drugs in their possession that may be unsafe or ineffective, these individuals also received less than they bargained for. Consumers did not know that drug products they purchased had passed the established expiration date, were made from raw material that was delivered to FIRM in punctured barrels, contained metal fragments, desiccant and other extraneous matter, had been manufactured using unapproved and undocumented manufacturing procedures and that the quality control personal who tested these drugs had been instructed not to record failing test results. Had the ultimate consumers been informed of these facts, those products would, of course, have been unmarketable.
CONCLUSION Intent to defraud or mislead, as defined at 21 U.S.C. § 333(a)(2), can be established by demonstrating a fraud upon either the ultimate consumer of the product, or upon the FDA, or both. In this case the evidence demonstrates that the defendants attempted to defraud and mislead both the ultimate consumer and the FDA.
JAMES B. BURNS
United States Attorney
SUSAN E. COX
Assistance United States Attorney
219 South Dearborn Street
Chicago, Illinois 60604
LAWRENCE G. MCDADE
[cited in USAM 4-8.205]
DEBORAH S. SMOLOVER
Office of Consumer Litigation
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 10044