KATRICE BRIDGES COPELAND
I. INTRODUCTION
The pharmaceutical industry has long been an enforcement headache for the Food and Drug Administration (FDA). In particular, FDA has struggled with enforcing the laws restricting the promotion of drugs. For many years, FDA pursued a strategy of cooperative enforcement with pharmaceutical companies to avoid the collateral consequences of criminal conviction. If a pharmaceutical company is convicted of a felony, it would be automatically excluded from participation in federal health care programs, such as Medicare and Medicaid, for a period of at least five years. Exclusion has been described as a “death sentence” for pharmaceutical manufacturers because it prevents the federal government from reimbursing patients for any drug produced by the excluded pharmaceutical manufacturer (Girard 2009:137). To avoid the potentially devastating consequences of exclusion for patients, FDA opted not to pursue felony criminal charges against pharmaceutical manufacturers that engaged in off-label promotion. Instead, FDA entered into corporate integrity agreements that required the pharmaceutical companies to pay large fines and enact compliance measures designed to prevent the illegal promotional activity from recurring (Copeland 2012). In return, the government agreed not to pursue felony criminal charges or debar the pharmaceutical manufacturers from participation in federal health care programs.
FDA’s approach seemed like a reasonable response to a complicated enforcement problem. The harsh reality, however, was that pharmaceutical companies viewed the fines and compliance measures as nothing more than the cost of doing business. Thus, the corporate integrity agreements were not enough to deter pharmaceutical companies from engaging in illegal promotional activity. As a result, FDA began to see repeat offenders of the pharmaceutical marketing rules.
In March 2010, FDA announced that it intended to use individual misdemeanor prosecutions “to hold responsible corporate officials accountable” (Hamburg 2010). FDA also made it clear that it intended to enhance and make better use of its debarment and disqualification procedures (Hamburg 2010). Thus, the focus shifted from simply pursuing pharmaceutical companies to pursuing misdemeanor criminal charges against individual executives for the misconduct of their subordinates. To support its theory of indirect criminal liability, the government dusted off the responsible corporate officer doctrine. The responsible corporate officer doctrine permits the government to prosecute an executive for a misdemeanor violation of the Federal Food, Drug, and Cosmetic Act (FDCA, 21 USC §§ 301–92), regardless of the officer’s lack of awareness of misconduct if by reason of the officer’s position in the company she had the responsibility and authority either (1) to prevent the misconduct in the first place, or (2) promptly to correct the violation, but failed to do so (United States v. Park 1975:673–74). The government has already successfully obtained guilty pleas based on the responsible corporate officer doctrine (see infra part III.B).
The misdemeanor convictions, however, are not the end of the story. Just as there are collateral consequences that flow from convicting pharmaceutical manufacturers, there are collateral consequences that flow from convicting executives as well. Following a misdemeanor conviction, the government has the discretion to exclude executives from participation in federal health care programs. The baseline period of exclusion is three years but can be increased based on aggravating factors. For an individual, exclusion means that the executive is virtually unemployable in the health care industry because there are only limited circumstances where a company that directly or indirectly receives money from federal health care programs can employ an excluded individual without jeopardizing its own participation in those programs.
Despite its use by FDA as a means to punish pharmaceutical executives, exclusion is not meant to be punitive. The goal is supposed to be to protect the health care system from unscrupulous individuals (67 Fed. Reg. 11,928 (Mar. 18, 2002)). This chapter argues that absent a showing of moral blameworthiness on the part of health care executives who were in charge at the time the misconduct occurred, a period of exclusion longer than the three-year base level for permissive exclusions is a grossly disproportionate remedy.
II. BACKGROUND
FDA regulates the pharmaceutical industry through the FDCA. Violations of the FDCA are considered to be public welfare offenses. Public welfare offenses are a special category of regulatory offenses that involve dangerous activities or materials. Because a reasonable person should be aware of the risks involved with activities proscribed by public welfare offenses, these crimes are an exception to the fundamental requirement that individuals should not be punished unless the government can demonstrate wrongful conduct along with a guilty mind (Liparota v. United States 1985:433).
The responsible corporate officer doctrine, which has only been applied to public welfare offenses, grew from two Supreme Court cases dealing with violations of the FDCA. In the first case, United States v. Dotterweich, the government charged Buffalo Pharmacal Company, Inc. and Joseph H. Dotterweich, the president and general manager of Buffalo Pharmacal Company, with violating the FDCA by shipping misbranded and adulterated drugs in interstate commerce (1943:278). Although Dotterweich was not personally involved in packaging or shipping the drugs, the jury convicted him of violating the FDCA (United States v. Buffalo Pharmacal Co., Inc. 1942:501). The Supreme Court found that Dotterweich was liable under the act because he had a “responsible share” in the shipment of the misbranded and adulterated drugs despite the fact he did not have “consciousness of wrongdoing” (United States v. Dotterweich 1943:284). In the Court’s view, Dotterweich, as an executive in the company, was in a better position than the public to ensure that the drugs met the requirements of the FDCA. Therefore, he had to bear the risk of those laws being violated, not the public (ibid., 284–85).
In the second case, the government charged Acme Markets, Inc. (Acme) and John R. Park, Acme’s chief executive officer, with violating the FDCA by causing adulteration of food (United States v. Park 1974:660). The evidence showed that an FDA inspector found evidence of rodent infestation of food on multiple occasions and sent a letter to Park detailing the violations (ibid., 662–63). In a follow-up inspection, an FDA inspector found that there was still rodent activity in the warehouse (ibid., 662). Park testified that all Acme employees were under his general control but the job of sanitation was handled by somebody else at Acme (ibid., 663). The jury convicted Park.
The Supreme Court upheld Park’s conviction (United States v. Park 1975:667). The Court explained that the government makes a prima facie case by demonstrating that “the defendant had, by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so” (ibid., 673–74). Thus, the burden of complying with the law is placed on “a person otherwise innocent but standing in responsible relation to a public danger” (ibid., 668–69). The Court recognized that there is a defense to liability when it would be “objectively impossible” for the executive to prevent or correct the misconduct (ibid., 673). In the cases following Park, however, the impossibility defense has never been successfully raised.
III. EXCLUSION OF RESPONSIBLE CORPORATE OFFICERS
Pharmaceutical executives face misbranding charges under the FDCA as responsible corporate officers.1 A drug or device is misbranded if its label is false, misleading, or does not contain “adequate directions for use” (21 USC § 352(a), (f)). Misbranding is a misdemeanor offense punishable by less than one year in jail, unless it is undertaken “with the intent to defraud or mislead,” in which case it is a felony punishable by up to three years in jail (21 USC § 333(a)(1), (2)). Following a guilty plea or conviction and sentencing, the executives are faced with the potential collateral consequences, or civil restrictions, of their criminal convictions (Demleitner 1999:154). For health care executives, the most severe collateral consequence of conviction is the Department of Health and Human Services’ (HHS) discretionary authority to exclude the officers from participation in federal health care programs.
A. The Exclusion Authority
The HHS Office of Inspector General (OIG) exercises the exclusion authority. If the OIG excludes an individual or entity from federal health care programs, those programs may not pay for any item or services furnished directly or indirectly by the excluded individual or entity. The OIG has extensive authority to debar individuals and executives for a wide range of offenses. The OIG’s exclusion authority is mandatory in some cases and within the OIG’s discretion in other cases. Exclusion is mandatory if the individual or entity is convicted of a felony offense “relating to” health care fraud (42 USC § 1320a-7(a)(3), (4)). The mandatory exclusion period is a minimum of five years (42 USC § 1320a-7(c)(3)(B)). Exclusion is permissive if the individual or entity is convicted of a misdemeanor offense “relating to” fraud in connection with the delivery of a health care item or service (42 USC § 1320a-7(b)(1), (3)). Permissive exclusions are for a period of three years unless there are mitigating or aggravating circumstances that lengthen or shorten the period of exclusion (42 USC § 1320a-7(c)(3)(D)). While there are base periods of exclusion, there are no outer limits on the OIG’s ability to increase the exclusion period beyond the base period through aggravating factors. In situations where the individual is convicted as a responsible corporate officer, the authority to extend the base period of exclusion is potentially subject to misuse or abuse.
B. The Purdue Pharma Case
A prominent example of the OIG’s use of its broad exclusion authority is the Purdue Pharma case. FDA investigated Purdue Pharma for marketing violations concerning its pain drug OxyContin (Information, United States v. Purdue Frederick Co., Inc. 2007:10). Purdue Pharma supervisors and employees marketed and promoted OxyContin as less addictive than other pain medications (ibid., 5–6, 15). Their own studies, however, demonstrated that those claims were not true (Goldenheim v. Inspector General 2009:6).
After a five-year investigation, the government entered into a global settlement with Purdue Pharma that included a corporate integrity agreement, a fine, and a plea of guilty by Purdue Frederick Company, Inc. (a subsidiary of Purdue Pharma) to felony misbranding with intent to defraud or mislead. In addition, the government charged three Purdue Pharma executives—Michael Friedman (chief executive officer), Howard Udell (chief legal officer), and Paul D. Goldenheim (chief scientific officer)—as responsible corporate officers, with misdemeanor counts of misbranding.2 All three of the executives entered guilty pleas. The district court accepted the plea agreements even though they did not impose prison sentences because there was no “proof of knowledge by the individual defendants of the wrongdoing” (United States v. Purdue Frederick Company, Inc. 2007:576).
Following these convictions, the OIG sent notices to the executives informing them that they would each be excluded from participation in federal health care programs for twenty years. According to the OIG, the exclusion was proper because “the misdemeanor offense[s] relat[ed] to fraud…in connection with the delivery of a health care item or service” (Goldenheim v. Inspector General 2009:7). Because these were permissive exclusions, the base period of exclusion would have been three years.
The executives sought review of the inspector general’s decision. After briefing was complete, the administrative law judge (ALJ) reduced the period of exclusion to fifteen years based on the executives’ cooperation with law enforcement officials (a mitigating factor) (Goldenheim v. Inspector General 2009:7). The executives argued that they had no intent to defraud and that their convictions rested solely on their status as responsible corporate officers rather than their own misconduct (ibid., 2, 13). The ALJ found that the executives’ misbranding offenses were offenses “relating to fraud” because of the relationship between the executives’ conduct and Purdue’s fraudulent misbranding (ibid., 8).
On appeal, the executives argued that their convictions were not related to fraud because they were not convicted of fraudulent conduct. The Departmental Appeals Board (DAB) found that based on the plain language of the exclusion provision, the statute “does not restrict exclusions to only offenses constituting or consisting of fraud, but requires merely that the offense at issue be one ‘relating to’ fraud” (Goldenheim v. Inspector General 2009:10). The DAB found that an offense “relating to” fraud is one that has some “nexus” or “common sense connection” to fraud (ibid., 8). In the DAB’s view, the misdemeanor misbranding offense clearly related to fraud because without Purdue Frederick’s fraudulent misbranding there would not have been any charges against the executives (ibid., 10–12). Thus, the executives’ lack of knowledge concerning or role in the fraudulent conduct was irrelevant (ibid., 13). Ultimately, the DAB upheld the exclusion but reduced it to a period of twelve years because it found that the ALJ relied on an aggravating factor that was not supported by substantial evidence (ibid., 25–26). The executives sought review of the final decision, but the federal district court held that the secretary’s decision was supported by substantial evidence (Friedman v. Sebelius 2010:105). Similarly, the D.C. Circuit found that the convictions related to fraud because the executives’ were in charge when the felony misbranding took place (Friedman v. Sebelius 2012:816). The D.C. Circuit was convinced, however, that the length of exclusion was arbitrary and capricious because it was a significant departure from prior agency decisions and was not sufficiently justified (ibid., 828).
IV. THE MORAL BLAMEWORTHINESS OF RESPONSIBLE CORPORATE OFFICERS
The Purdue Pharma case perfectly illustrates the fundamental problem with imposing significant collateral consequences on individuals convicted as responsible corporate officers—neither their prosecution nor their collateral consequences are based on their intent or conduct. It makes sense to permit the conviction and perhaps even the three-year period of exclusion because with violations of the FDCA, the concern is the protection of society (Morrisette v. United States 1952:257). The Supreme Court has explained that in these cases, the “penalties commonly are relatively small, and conviction does no grave damage to an offender’s reputation” (ibid., 256). Given that violations of the FDCA could potentially lead to serious injury or death, the interests of the public are paramount and outweigh an executive’s lack of intent or moral blameworthiness in a given criminal case. The question becomes whether that justification holds when there are significant and long-lasting collateral consequences that attach to that conviction. This section contends that it does not.
A. Exclusion Is a Harsh Remedy
Exclusion from participation in federal health care programs for a prolonged period of time, while technically a civil penalty, is far harsher than the potential criminal penalty for a misdemeanor misbranding violation. Using the example of the Purdue executives, their criminal penalties included fines, disgorgement, and three years of probation. Even if they had received prison time, it would have been for less than a year. In contrast, the OIG initially wanted to debar the executives for a period of twenty years. Thus, the collateral consequences of their convictions would have lasted seventeen years after their probation ended. The exclusions effectively ended the careers of the Purdue Pharma executives in the health care industry and forever labeled them as untrustworthy criminals.
Professor Gabriel Chin argues that these types of overly restrictive collateral consequences bear a striking resemblance to a form of punishment called “civil death” (Chin 2012:1790). In the nineteenth century, civil death statutes took away the civil and political rights of felons “on the theory that they ceased to exist as legal persons after their conviction” (Labelle 2008:85). Although civil death statutes fell out of favor in the 1960s, they returned in the 1980s and 1990s (Love 2011:770). Federal laws barred people with convictions from public benefits, government employment, and government contracts (ibid., 771). Professor Chin argues that these collateral consequences are the new form of “civil death” (2012:1790). As he explains it, “[f]or many people convicted of crimes, the most severe and long-lasting effect of conviction is not imprisonment or fine. Rather, it is being subjected to collateral consequences…” (ibid., 1791). Further, he argues that “for a person who must work for a living, [the] loss of the right to do business with the government—or work in any regulated industry—could result in exclusion as complete as civil death under the nineteenth-century statutes” (ibid., 1802). It is these collateral consequences of conviction that become the “most important part” of the conviction (ibid., 1806).
There is no question that for health care executives “the most important part” of their conviction is exclusion from participation in federal health care programs. Debarred health care executives cannot contract with the government and have very limited ability to work for any health care company that contracts with the government. The health care industry accounts for approximately 18 percent of the United States’ gross domestic product (Radnofsky 2012). Thus, excluded health care executives are unable to access employment in a large segment of the economy. As Professor Demleitner has argued, exclusion from “vast segments of the labor market…parallels the effect of restrictions on the ex-offender’s right to contract in the nineteenth and early twentieth centuries” (1999:156). Therefore, a long period of exclusion is not just a harsh remedy, it is also the modern day equivalent of “civil death” for health care executives.
B. The Government Should Prove Moral Blameworthiness Before Imposing a Prolonged Period of Exclusion
1. Exclusion Is Being Misused as Criminal Punishment
The collateral consequence of a long period of exclusion is far more devastating than the direct criminal consequences of conviction. Indeed, as Margaret Colgate Love has argued, “collateral consequences are increasingly understood and experienced as criminal punishment, and never-ending punishment at that” (2011:114). To avoid problems of over deterrence, it is important that the sanction fits the crime. Exclusion is not meant to be punitive. As such, it should not be used to transform a misdemeanor offense with minor punishment into a harsh penalty. This section argues that if the OIG wants to impose a period of exclusion greater than the base level of three years, it should be required to demonstrate that the officer is morally blameworthy for the misconduct. Otherwise, the debarment may be seen as unjust criminal punishment instead of a civil sanction.
The purpose of exclusion is essentially risk prevention (67 Fed. Reg. 11,928 (Mar. 18, 2002)). The government needs to be able to safeguard the federal health care programs and their participants from individuals who have defrauded the government or caused some other program-related harm. In that sense, the exclusion is for utilitarian reasons because the excluded individual’s loss from the inability to participate in federal health care programs is outweighed by the need to prevent an untrustworthy individual from harming the program in the future. The problem is that when a responsible corporate officer is excluded, the decision is based on the harm caused by a subordinate. Even if one believes that harsh sanctions are appropriate to encourage health care executives to be more responsible when they supervise their subordinates, there still needs to be proportionality between the harm caused by the executive and the period of exclusion. The critical question becomes how much of the harm should be attributed to the executive for the purpose of setting a period of exclusion. If there is a strong belief that health care executives should face harsher criminal punishment for misbranding, that should be addressed by the legislature. In the absence of that, however, the OIG should not be permitted to use a long period of civil exclusion as a criminal sanction without some showing that the long period of exclusion is proportional to the harm caused by the executive. Thus, if an individual is to be excluded, the exclusion period should be proportional to the harm inflicted by the individual and the potential for future harm by the individual. As Professor Ewald has argued, “[w]hen the punitive elements of a sentence are premised on proportionality, the collateral consequences of conviction should be held to the same standard” (2002:1099).
In the Purdue Pharma case, the prosecutor and judge recognized that the individual executives had no knowledge of or involvement in the misconduct. Accordingly, the executives received three years of probation and paid large fines but did not receive prison time. But, the OIG initially imposed a twenty-year exclusion based on aggravating factors—financial losses to government programs, duration of the offenses, and the impact of those offenses on individuals—that did not relate to the failure of the executives to discover and remedy the misconduct. While exclusion for three years is likely warranted under these circumstances, it is unclear how an extended period of exclusion is warranted without any consideration of factors that relate directly to the failures of the individual executives. It seems that the OIG should exclude an individual based on the risk that the individual poses to federal health care programs. At a minimum, the length of exclusion for the individual should be tied to the wrongdoing and risk that the individual will violate the law in the future.
Thus, while exclusion may not technically be a criminal sanction, its imposition is much more serious than the criminal penalties associated with a misdemeanor misbranding conviction. If the government is going to impose “civil death” on an executive, then the exclusion should either be based on a conviction for the executive’s personal misconduct or the executive’s awareness of or participation in his or her subordinate’s misconduct. Therefore, a responsible corporate officer should not be subjected to a prolonged period of exclusion unless the OIG can demonstrate the executive’s moral blameworthiness for the misconduct.
2. Responsible Corporate Officers Are Not Always Morally Blameworthy for the Actions of Their Subordinates
Responsible corporate officers may be held criminally accountable for the conduct of their subordinates, but criminal accountability does not demonstrate moral blame for the misconduct. Moral blameworthiness is necessary because strict liability public welfare offenses are justified in part by the fact that they have minor sanctions associated with their violation. If the OIG intends to use long periods of exclusion as additional criminal punishment to scare executives into being responsible actors, as they did with the Purdue Pharma executives, then the justification no longer applies. A mere showing that the executive failed to detect and prevent or correct the wrongdoing is not the same as saying that the executive had a hand in the misconduct and is morally blameworthy for it. Moral blameworthiness is not demonstrated simply by virtue of the officer’s position in the company. There needs to be some measure of culpability.
While there are many theories of moral responsibility, this chapter accepts the formulation by Professor Peter Arenella. Professor Arenella explains that in order to assign moral blame to an individual’s conduct, four conditions must exist: “(1) moral agent must be implicated in (2) the breach of a moral norm that (3) fairly obligates the agent’s compliance under circumstances where that (4) breach can be fairly attributed to the agent’s conduct” (Arenella 1992:1518). Responsible corporate officers are certainly moral agents who have the capacity to make moral judgments and take actions in conformity with those judgments. While regulatory offenses such as misbranding under the FDCA may not be based on morality or have moral content, they are morally wrongful in the sense that they are done “in violation of a legal norm” (Green 1997:1575). Therefore, the sole question with respect to responsible corporate officers is whether the breach of a moral norm by a subordinate can be fairly attributed to the officer’s conduct.
As Professor Arenella explains, to satisfy the fair attribution principle, first “there must be a voluntary act as well as causation between a defendant’s act and any resulting harm” (1992:1523). But, the responsible corporate officer doctrine lacks the “traditional requirement…to show a connection between the individual and the particular wrong” (Petrin 2012:299). It does not conform to ordinary notions of causation and blame because the executive is being held accountable for the misconduct of others rather than herself. Professor Stanford Kadish explains that
we are responsible for ourselves and for what our actions cause in the physical world, and we may cause things to happen unintentionally as well as intentionally. However, what other people choose to do as a consequence of what we have done is their action and not ours. Our actions do not cause what they do in the sense that our actions cause events.
—(1985:355)
In many responsible corporate officer cases, the only way to show causation is by omission. As Professor Brickey explains, “proof that the officer had the responsibility and the power to prevent the violation and that he failed to fulfill the duty to do so establishes the required causal link between the officer and the violation” (Brickey 1982:1363). But, the notion that one person causes the actions of another runs counter to our idea that each person is an autonomous actor. “We regard a person’s acts as the products of his choice, not as an inevitable, natural result of a chain of events” (Kadish 1985:333). While causation based on a factual connection between the officer and the violation may be sufficient for a misdemeanor conviction, it is insufficient to show that an action is fairly attributable to an executive.
Second, for an action to be fairly attributable there must be proof of mens rea with respect to the individual’s act or risked harm (Arenella 1992:1523). A finding that a responsible corporate officer is guilty of a strict liability misdemeanor offense, such as misbranding, does not establish culpability because there is no requirement of mens rea. As Professor Brickey makes clear, “while one might well conclude that the [Park] Court’s language…would support the proposition that liability must be predicated upon a finding of minimal culpability or negligence, within the context of the Park opinion the premise is unsound” (1982:1364; emphasis added). There is no explicit mens rea requirement in either the offense of conviction or in the responsible corporate officer doctrine. Therefore, a conviction as a responsible corporate officer does not demonstrate culpability. Some additional showing will be necessary to demonstrate that the wrongdoing can be fairly attributed to the responsible corporate officer’s conduct.
To prove that the actions of subordinates are fairly attributable to the responsible corporate officer, there needs to be some showing that the executive in charge intended for the wrongdoing to occur. As Professor Kadish explains, “[w]e become accountable for the liability created by the actions of others…only when we join in and identify with those actions by intentionally helping or inducing them to do those actions; in other words, by extending our wills to their action” (1985:355). Without some showing of intentionality, through negligence, recklessness, knowledge, or purpose, there can be no finding that the actions of the subordinate are attributable to the executive. Thus, in the ordinary case there would be no showing of moral blameworthiness.
This is not to discount, of course, the fact that it would be difficult to prove the moral blameworthiness of a responsible corporate officer. This is particularly true if the executive is a high level official such as a chief executive officer. It is unlikely that the high level official’s participation in the wrongdoing would be documented. Further, the executive might become aware of misconduct but choose not to intervene. The executive’s discovery of the misconduct and subsequent decision not to get involved may similarly go unmemorialized. In many cases, the prosecutor would have to rely upon circumstantial evidence to prove culpability. While both of these scenarios are realistic in a large corporation, the fact that these situations could occur is not enough to relieve the prosecutor of the burden to prove that the officer is morally blameworthy before imposing the harsh remedy of a long period of exclusion. While the public certainly has an interest in these proceedings just like it does in criminal misdemeanor misbranding cases, the public’s interest no longer outweighs the executive’s interest because the punishment is no longer minor and there is great harm to the executive’s reputation. In short, the justification for holding responsible corporate officers accountable without a showing of moral blameworthiness does not hold up when the executive is facing a career-ending exclusion.
V. CONCLUSION
FDA should be commended for its efforts to raise the stakes in cases of pharmaceutical fraud. Targeting executives who were in charge at the time that misconduct occurred at the pharmaceutical company sends a strong message that FDA does not take violations of the drug marketing rules lightly. It holds the executives accountable and gives them strong incentives to monitor their subordinates. After obtaining a conviction, however, FDA should not impose the collateral consequence of exclusion for more than three years without first demonstrating that the executive is morally blameworthy for the misconduct. While exclusion may be a civil remedy, it is the most damaging remedy that an executive can face. A long period of exclusion could amount to “civil death” that takes away an executive’s livelihood and should not be imposed without sufficient justification.
NOTES
This chapter is adapted from a 2014 law review article of the same name that originally appeared in American Criminal Law Review 51: 799–836.
1. 21 USC § 331(a) (prohibiting “the introduction or delivery for introduction into interstate commerce of any…drug…that is adulterated or misbranded”).
2. Plea Agreement, United States v. Michael Friedman, No. 1:07CR29 (W.D. Va. May 10, 2007); Plea Agreement, United States v. Howard Udell, No. 1:07CR29 (W.D. Va. May 10, 2007); Plea Agreement, United States v. Paul Goldenheim, No. 1:07CR29 (W.D. Va. May 10, 2007); 21 USC § 333(a)(1).
Arenella, Peter. 1992. “Convicting the Morally Blameless: Reassessing the Relationship Between Legal and Moral Accountability.” UCLA Law Review 39:1511–1622.
Brickey, Katheleen F. 1982. “Criminal Liability of Corporate Officers for Strict Liability Offenses—Another View.” Vanderbilt Law Review 35:1337–81.
Chin, Gabriel. 2012. “The New Civil Death: Rethinking Punishment in the Era of Mass Conviction.” University of Pennsylvania Law Review 160:1789–1833.
Copeland, Katrice Bridges. 2012. “Enforcing Integrity.” Indiana Law Journal 87:1033–86.
Demleitner, Nora V. 1999. “Preventing Internal Exile: The Need for Restrictions on Collateral Sentencing Consequences.” Stanford Law and Policy Review 11:153–63.
Ewald, Alec C. 2002. “‘Civil Death’: The Ideological Paradox of Criminal Disenfranchisement Law in the United States.” Wisconsin Law Review 2002:1045–1137.
Friedman v. Sebelius, 755 F. Supp. 2d 98, 105 (D.D.C. 2010).
Friedman v. Sebelius, 686 F.3d 813, 820 (D.C. Cir. 2012).
Girard, Vicki W. 2009. “Punishing Pharmaceutical Companies for Unlawful Promotion of Approved Drugs: Why the False Claims Act Is the Wrong Rx.” Journal of Health Care Law & Policy 12:119–58.
Goldenheim v. Inspector General, DAB No. 2268, at 6 (Dep’t of Health & Human Servs. Aug. 28, 2009) (final admin. review).
Green, Stuart P. 1997. “Why It’s a Crime to Tear the Tag Off of a Mattress: Overcriminalization and the Moral Content of Regulatory Offenses.” Emory Law Journal 46:1533–1615.
Hamburg, Margaret A. 2010. Letter from Hamburg, FDA Commissioner, to Charles E. Grassley, Ranking Member, Senate Committee on Finance.
Information, United States v. Purdue Frederick Company, Inc., No. 1:07CR00029 at 1 (W. D Va. May 10, 2007).
Kadish, Stanford A. 1985. “Complicity, Cause and Blame: A Study in the Interpretation of Doctrine.” California Law Review 73:323–410.
Labelle, Deborah. 2008. “Bringing Human Rights Home to the World of Detention.” Columbia Human Rights Law Review 40:79–133.
Liparota v. United States, 471 U.S. 419, 433 (1985).
Love, Margaret Colgate. 2011. “Paying Their Debt to Society: Forgiveness, Redemption, and the Uniform Collateral Consequences of Conviction Act.” Howard Law Journal 54(3):753–93.
Morissette v. United States, 342 U.S. 246, 274 (1952).
Petrin, Martin. 2012. “Circumscribing the ‘Prosecutor’s Ticket to Tag the Elite’—A Critique of the Responsible Corporate Officer Doctrine.” Temple Law Review 84(2):283–324.
United States v. Buffalo Pharmacal Co., Inc., 131 F.2d 500, 501–2 (2d Cir. 1942), rev’d sub nom. United States v. Dotterweich, 320 U.S. 277 (1943).
United States v. Park, 421 U.S. 658 (1975).
United States v. Purdue Frederick Company, Inc., 495 F. Supp. 2d 569 (W.D. Va. 2007).
