To the extent intended by Congress and permitted by the Constitution, courts may impose criminal sanctions on individual corporate officers who were in positions of authority to have prevented or corrected wrongdoing within a corporation but failed to do so. That concept, which has come to be known as the responsible corporate officer (RCO) doctrine, was first developed under the Food, Drug & Cosmetic Act of 1938 (FDCA). See United States v. Dotterweich, 320 U.S. 277 (1943); United States v. Park, 421 U.S. 658 (1975); 21 U.S.C. §§ 331(a), 333(a)(1), 352. Under the RCO doctrine, the government is not required to prove that an officer participated in wrongdoing or even knew about it. The RCO concept also exists outside of the FDCA context – principally under environmental laws. See, e.g., United States v. Hanousek, 176 F.3d 116 (9th Cir. 1999) (construing the Clean Water Act to allow conviction of a misdemeanor offense punishable by a prison term not exceeding one year without a showing of mens rea).

Sometimes characterized as imposing a form of strict vicarious liability, and sometimes characterized as requiring a showing of negligence, the RCO doctrine under the FDCA is a powerful weapon for federal prosecutors and (at least indirectly) the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The potential criminal consequences of a FDCA conviction under the RCO doctrine include a term of imprisonment up to 12 months and at least a six figure fine. The potential collateral consequences of such a conviction include, as a practical matter, exclusion by HHS from participation in the medical device and pharmaceutical industries. Given the lack of a mens rea requirement and the potential sanctions involved, the RCO doctrine provides profound leverage to federal prosecutors to resolve cases through plea agreements, stipulated facts, and uncontested proceedings. As a result, it gives great leverage to other federal enforcement agencies, especially HHS in the exercise of its exclusion authority, and stands as a tool for efficiently advancing the broader regulatory goals of the FDA. Whether that approach to law enforcement is fair or appropriate in any given case is another question.

On appeal, the defendant argued that the district court incorrectly defined the term “willful.” The Fifth Circuit agreed: “We have explained that ‘willfulness’ in the context of the criminal contempt statute at a minimum requires a finding of recklessness, which requires more than a finding that an individual ‘reasonably should have known’ that the relevant conduct was prohibited. Thus, the district court clearly erred.” Slip op. at 12. Defense counsel had failed to object in the district court so the Fifth Circuit applied the plain error doctrine and affirmed the conviction.  Id.

The term “willful” in federal criminal practice is used to describe any number of mental states. Although the district court’s conflation of willfulness and negligence in Allen is an extreme example, the Fifth Circuit’s own doctrine in the contempt context – which equates willfulness with recklessness – is itself remarkable. “As a general matter, when used in the criminal context,” the Court stated in Bryan v. United States, 524 U.S. 184, 191 (1998), “a ‘willful’ act is one undertaken with a ‘bad purpose.’” Id. at 191. The use of the term “willful” in a federal criminal statute frequently invites battles over whether Congress intended to require proof that a defendant violated a known legal duty. See, e.g., id. at 196 (holding that the term “willfully” in 18 U.S.C. § 924(a)(1)(D) does not require proof that defendant actually knew of a federal licensing requirement); Ratzlaf v. United States, 510 U.S. 135, 149 (1994) (holding that Congress intended, in 31 U.S.C. § 5322(a), that a jury must conclude that defendant knew that structuring currency transactions was prohibited by law before a conviction for a “willful” violation may occur). The term “willful” is not alone in its lack of repute. The concepts of “specific intent” and “general intent” create similar confusion. See Liparota v. United States, 471 U.S. 419, 433 n.16 (1985) (commenting that a “useful” jury instruction might “eschew use of difficult legal concepts like ‘specific intent’ and ‘general intent’”).

The drafters of the Model Penal Code got it right by banishing the terms “willfully,” “specific intent,” and “general intent.” See Dixon v. United States, 548 U.S. 1, 16 (2006) (noting that Section 2.02(2) of the Model Penal Code does not embrace the term “willfully” but instead defines “purposely,” “knowingly,” “recklessly,” and “negligently”). As Judge Learned Hand, in an exchange with Professor Herbert Wechsler (the reporter for the Model Penal Code), put it: “[Willfully is] an awful word! It is one of the most troublesome words in a statute that I know. If I were to have the index purged, ‘willful’ would lead all the rest in spite of its being at the end of the alphabet.” United States v. Aversa, 984 F.2d 493 (1st. Cir. 1993), vacated sub nom. Donovan v. United States, 510 U.S. 1069 (1994) (quoting American Law Institute, Model Penal Code § 2.20, at 249 n. 47 (1985)).  That Congress and so many judges, after all these decades, have failed to absorb Judge Hand’s message is cause for serious concern.