PATRICK O’LEARY
THE FOOD and Drug Administration’s (FDA’s) stated mission is to promote and protect the public health (Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 393(b)). In the agency’s own words, this mission has multiple aspects: “protecting the public health by assuring the safety, efficacy and security of [regulated products],” on the one hand, but also “advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable….” (FDA 2013). One of the key challenges that the agency faces is how to achieve the former goal—guaranteeing product safety and efficacy—with minimal negative impact on the important interests reflected by the latter—viz, industry’s continued ability and incentive to develop and distribute innovative medical products. Further complicating this challenge is the fact that in health care enforcement in particular, regulators must place a premium on deterrence—when the cost of violations can be measured in human lives, making victims whole after the fact is often an impossibility. Although this chapter addresses only one small piece of this complex balancing act, it is a vital and increasingly urgent one, particularly in light of an escalation in enforcement that in recent years has imposed substantial costs and uncertainty on life-sciences firms without achieving meaningful deterrence.
This chapter makes two assertions. The first is that the current federal approach to deterring misconduct in the biomedical industry is broken. Prosecutors’ emphasis on ever-larger monetary settlements and corporate integrity agreements (CIAs) has imposed significant costs on industry without achieving real deterrence, and threats of increased reliance on administrative and criminal sanctions against corporate officers at offending firms have raised practical and philosophical concerns. The second assertion is that our broken system can be fixed using existing enforcement tools—including monetary penalties and compliance programs, criminal prosecution, and administrative exclusion from federal health care programs—but only if they are used intelligently and responsibly. By coordinating and aligning enforcement policies at the various agencies involved and tying enforcement decisions at all of these agencies more directly to the objective of promoting and protecting the public health, I posit that existing tools can be deployed to effectively deter misconduct, ameliorate the flaws of the current regime, and meaningfully address apprehensions relating to the prosecution and exclusion of individuals.
I. THE SYSTEM IS BROKEN
A. The Futility of Escalating Monetary Penalties
According to a report compiled by Public Citizen,1 from 1991 to July 2012, the federal government entered into 104 settlements with pharmaceutical manufacturers for a total of $26.9 billion (Almashat and Wolfe 2012:10). Well over half of that sum was collected in just a three-and-a-half-year period beginning in 2009, a period that saw multiple record-breaking settlements, including a $2.3 billion settlement against Pfizer and a $3 billion settlement against GlaxoSmithKline. Since the report was published, there have been additional large settlements, including a $762 million settlement against Amgen in 2012 and a $2.2 billion settlement against Johnson & Johnson in 2013 (Groeger 2014). Massive settlements like these are generally accompanied by CIAs, agreements imposing broad compliance obligations on firms as a condition of settlement (Copeland 2012:1050–52; Paulhus and Richter 2013). This reliance on ever-larger penalties and more demanding compliance programs reflects a “strategy aimed at financial recovery and organizational reform” (Copeland 2012:1075).
Notwithstanding the headline-making size of settlements and the increasingly comprehensive character of CIAs, the current enforcement approach has struggled to achieve meaningful deterrence (Copeland 2012:1075; Rodwin 2013). The commonly accepted explanation envisions industry as Justice Holmes’s “bad man,” who treats monetary fines as merely the prescribed cost of engaging in proscribed conduct (Holmes 1897:461). The idea is that these firms treat penalties and fines as simply the “cost of doing business” and thus treat the decision to engage in misconduct (or not to take greater steps to prevent it) as an economic one. When the expected revenues from misconduct exceed the risk-adjusted anticipated penalty, it becomes rational to break the rules (Boozang 2012:86–87; Copeland 2012:1064).
Logically, the response for regulators is to try to make misconduct economically unattractive—wrongdoers will be deterred if “the costs of their conduct, multiplied by the probability of their punishment, outweigh the net expected benefits of such conduct” (Baer 2012:629). That is, to deter, we need only increase either the cost of misconduct (by raising penalties) or the likelihood of punishment. Although increased focus from law enforcement and strong compliance programs have improved the likelihood of punishment to an extent, significant increases are ultimately constrained by limited resources and the inherent difficulty of investigating sophisticated organizations. Perhaps for this reason, the government has so far mostly sought additional deterrence by increasing penalties. But this approach suffers from a basic flaw: the evidence suggests that effective monetary penalties would have to be truly massive. Consider the government’s 2009 settlement with Pfizer. The criminal fine in that case—$1.195 billion, which at that time was the largest criminal fine ever imposed—exceeded the profits resulting from the charged conduct by a factor of 1.8. The government explained this massive penalty by arguing that it would “deter such conduct in the future and make sure that the fine is not treated by such companies as merely a cost of doing business” (United States v. Pharmacia & Upjohn Co. 2009). But violations have persisted, and the fact that such settlements have been insufficient to achieve meaningful deterrence suggests that penalties may have to be even larger and exceed firms’ ill-gotten profits by still more significant margins before they can be effective deterrents. At some point, this becomes untenable; penalties large enough to really “hurt” would likely also be large enough to materially endanger a firm’s financial well-being. If that firm makes drugs or devices that lack other readily available sources, then the additional deterrence may come at the expense of public health.2 The same problem prevents regulators from exercising their authority to exclude entire firms from federal health care programs, a punishment so severe it is sometimes referred to as the “death penalty” (Bucy 1995:720). Because firm-wide exclusion could deny access to essential drugs or devices, Boozang (2012:87–88) has characterized life-sciences firms as “too big to nail.”
Faced with the prospect that penalties strong enough to meaningfully deter misconduct would have unacceptable social costs, the agencies principally responsible for enforcement in this area—FDA, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG), and the Department of Justice (DOJ)—have faced a choice: either accept that some firms can afford and will choose to pay the maximum “price” regulators can impose to engage in misconduct, or determine that this misconduct is not just legally wrong but ethically so,3 and find another way to deter it. Their controversial response in recent years has been to “up the ante” (Boozang 2012:89) by employing two powerful enforcement tools: prosecution of individual corporate officers under the Park doctrine and exclusion of these officers from federal health care programs (i.e., from employment in the industry) under OIG’s permissive exclusion authority.
B. Targeting Corporate Officers
In 2010, federal officials began making public statements indicating an increased willingness to pursue enforcement actions targeting individual officers of biomedical firms. These statements came from high-ranking officials at all of the relevant agencies, including FDA Commissioner Margaret Hamburg and Deputy Chief Counsel for Litigation Eric Blumberg, OIG Chief Counsel Lewis Morris, and multiple lawyers from the DOJ’s Consumer Protection Branch (CPB), which has a formal role in coordinating enforcement efforts under the FDCA. What many in industry found most alarming in these comments was the suggestion that the government was increasingly open not only to going after individuals in general but in pursuing at least some of these cases under the strict liability theory known as the Park doctrine.
A few words about the Park doctrine may explain the concern. The most severe individual sanction provided for by the FDCA is criminal prosecution. In fact, the statute creates two different criminal causes of action: a felony and a misdemeanor. The misdemeanor provision is more controversial because under the “responsible corporate officer doctrine” articulated in the seminal Supreme Court cases United States v. Dotterweich (1943) and United States v. Park (1975), individual managers can in principle be held criminally liable for any violation committed at their firm, even if they were unaware of the violation or took reasonable steps to prevent it, so long as they stood in a “responsible relationship” to the violation (i.e., if by reason of their position in the corporation, they had the responsibility and authority either to prevent the violation or to promptly correct it).
The prospect of more aggressive use of Park concerns critics for a number of reasons. On a philosophical level, the main criticism is that the doctrine authorizes criminal prosecution and even incarceration of individuals with no knowledge of, let alone intentions regarding, the underlying misconduct. This objection is as old as the doctrine itself, as Justice Murphy’s oft-quoted dissent in Dotterweich (1943:286) illustrates: “It is a fundamental principle of Anglo-Saxon jurisprudence that guilt is personal and…ought not lightly to be imputed to a citizen who…has no evil intention or consciousness of wrongdoing.” More directly, potential defendants are justifiably concerned about the serious consequences of conviction. Indeed, some commentators have argued that the consequences of a Park conviction are so fundamentally disproportionate to the conduct required for conviction that they raise due process concerns (Breen and Retzinger 2013:109–10).4 The OIG’s willingness to exclude individuals on the basis of Park convictions—a strategy upheld as legal by a divided panel of the D.C. Circuit in Friedman v. Sebelius (2013)—has only exacerbated these concerns. And, though the number of prosecutions and exclusions has in fact remained fairly modest (Savage and Klawiter 2013:32), regulators have to some extent made good on their threats, pursuing a nontrivial number of high-profile Park misdemeanor prosecutions, felony prosecutions, and exclusion actions over the last five years (O’Leary 2013:165–74, discussing cases against Purdue Frederick, Synthes, KV Pharmaceutical, InterMune, and Stryker Biotech).
II. A PROPOSAL FOR REFORM
If the shortcoming of the current enforcement model is that it has proved impossible to impose a strong enough financial penalty to deter misconduct without also imposing unacceptable harm on society in the form of medicines delayed and denied, the objective going forward must be to find ways (practically feasible and philosophically defensible) to raise the stakes for misbehaving firms without imposing costs on the public. Used in a coordinated enforcement framework prioritizing public health, criminal prosecution and exclusion of individuals, including prosecution under the Park doctrine, can be valuable tools in achieving this goal.
A. The Case for Individual Enforcement
There is good reason to believe that enforcement actions targeting individuals are a particularly effective deterrent. Indeed, this conclusion follows from two simple premises. First, we assume that to at least some extent “[s]ystematic management failures and corporate cultures that emphasize profits over safety reflect the values and conduct of individual actors within the organization….[P]eople—not a fictional entity—make the choices and decisions that translate into conduct” (Barrett 2011:313). Second, we assume that individuals will be more motivated by direct harms than indirect ones, and by harms they cannot externalize rather than ones they can. That is, “[p]ersonal accountability, which creates a risk to an individual that he might go to jail [or be excluded] as a result of decisions he makes, can change behavior and drive deterrence” (Barrett 2011:313) in a way that harm to a firm’s bottom line (which might indirectly harm the firm’s employees in the form of reduced compensation or termination) or individual monetary penalties (often subject to indemnification agreements and insurance) cannot. Because “[b]eing named in a pleading, put on trial, forced to make a public apology, required to pay a fine, or serve time in jail, are often expensive, professionally damning and personally humiliating consequences [that] most individuals, including corporate officers, prefer to avoid” (Wise 2002:285–86), we can infer (as regulators clearly have) that corporate officers will be more effectively deterred by the prospect of such consequences.5
Another reason individual liability adds deterrent value over corporate liability alone is that to the extent monetary penalties are tied to the profits earned through misconduct, certain proceeds of misconduct are unlikely to be reflected in these penalties. This could be the case, for example, when the benefits of misconduct accrue over a longer time horizon than the misconduct itself, such as where a firm is able to capture a significant share of a new product market through misconduct. In this scenario, the firm might benefit from the misconduct over the long term even if all of the profits directly attributable to the period of misconduct are nullified through a monetary penalty. Though difficult to reach through monetary penalties, the use of strategic misconduct to gain competitive advantage may be more susceptible to deterrence through individual liability because misconduct calculated to produce long-term benefits is likely to be driven by individual decision makers.
Beyond the deterrent effect of individual liability in general, the strict liability offense under Park offers an additional, important advantage through what might be described as the doctrine’s “burden lowering” effect (Clark 2012:5; Ellis 2013:1007–8; O’Leary 2013:167 n.207). Unlike what Ellis describes as the “vicarious liability perspective” on Park (what I have elsewhere described as the “true strict liability” application of Park (O’Leary 2013:148)), which permits a prosecutor to impute misconduct onto an officer even where there is no reason to believe the officer was “in any way complicit in committing the crime” (Ellis 2013), the burden-lowering aspect of Park makes it easier to obtain a conviction (or plea) where there is reason to believe an officer is culpable. The U.S. Attorney’s Manual expressly embraces this burden lowering conception of Park, noting that while “CPB attempts wherever possible to bring felony charges to deal with fraudulent behavior[,]…[Park] misdemeanor liability can attach to behavior that, due to lack of proof…, may not merit felony prosecution” (U.S. Attorney’s Manual § 4–8.210).
As noted before, the Park doctrine has been the subject of considerable criticism both because of philosophical concerns over the relationship between culpability and criminal punishment and because of concerns involving the interaction of prosecution and the collateral consequence of exclusion. But fears that the Park doctrine will be abused to any great extent, in the sense of prosecutors using it to pursue convictions of individuals who they have no reason to believe possessed any knowledge of wrongdoing, are vastly exaggerated. For one thing, prosecution of such individuals would quickly run up against formidable political and legal obstacles. With respect to political barriers, it is worth observing that, over the years, political opposition to the Park doctrine based on fairness concerns has even come from otherwise staunch advocates of regulatory enforcement, like Senator Ted Kennedy and Secretary Joseph Califano, who led HHS in the Carter administration (O’Leary 2013:151–52). It is hard to believe the pharmaceutical industry has so few friends in Washington today that genuinely abusive use of Park would go unchallenged in Congress and at the highest levels of the executive branch. As for the legal safeguards, courts have from the very beginning expressed doubts about the propriety of imposing criminal sanctions on nonculpable defendants—even the Supreme Court majorities that upheld the doctrine did so only on the belief that “the good sense of prosecutors, the wise guidance of trial judges, and the ultimate judgment of juries must be trusted” (United States v. Dotterweich 1943:285). Indeed, some commentators have argued that in light of changes over the four decades since Park was decided, “it is no stretch to imagine that today’s [responsible corporate officer] doctrine would not pass muster before the Supreme Court, whether before the bench of 1943, 1975, or 2010” (Bragg et al. 2010:534). Similar doubts arguably constrain the OIG’s use of its permissive exclusion authority, which notwithstanding the D.C. Circuit’s opinion in Friedman, stands on tenuous legal footing. In addition to political and legal constraints on the abuse of Park, such use is unlikely for the simple reason that federal prosecutors—who have the ultimate authority over the decision to employ Park in any particular case—have a variety of incentives to “pursue the most egregious types of violations” rather than “conduct that is illegal for reasons that are…cloudy, overly technical, or arcane” (Schiffer and Simon 1995:2532–33).
Concerns about the interaction between Park and OIG exclusion (and between criminal prosecution and exclusion in general) are another matter. There are legitimate reasons to wonder whether the recent emphasis on excluding individual officers as a mechanism of corporate regulation is sound enforcement policy. Not only does OIG’s aggressive use of its permissive exclusion authority in connection with Park convictions raise questions about the appropriate scope of collateral consequences for strict liability crimes (recall that the eponymous Mr. Park, whose case divided the court, received only a $250 fine), but OIG’s use of exclusion has the potential to undermine the effective use of criminal prosecution as a deterrence tool, e.g., by creating a strong disincentive to guilty pleas and cooperation (O’Leary 2013:171–74; Glasner 2011:4). These concerns are serious, and the collateral consequences problem undoubtedly casts a shadow over the otherwise promising role that (conservative) use of corporate officer liability could have in achieving effective deterrence without relying on ballooning corporate monetary penalties. Fortunately, these concerns are not irremediable, as the final portion of this chapter explains.
B. Interagency Coordination and Prioritizing Public Health
Putting aside anxieties about an aggressive expansion of “true strict liability” prosecutions under Park—which for the reasons expressed earlier, is unlikely—a federal enforcement regime that more heavily relies on holding corporate officers personally accountable for their companies’ misconduct would still raise three substantial concerns absent reform. First, there is a plausible concern that case selection may be driven, at least in some instances, by principles not directly tied to protecting the public health. If the ultimate objective of the enforcement regime is to protect the public health, case selection should be ambivalent about the size of potential penalties. There is nothing inherently wrong with prosecuting large firms with deep pockets, but if we justify using harsh penalties by invoking the public welfare, decisions about imposing these penalties should be tied to that idea, not to the potential for treasury and reputation-enhancing settlements. Second, a troubling hallmark of the current framework for case selection, charging, and settlement decisions is its unpredictability and opacity. Each U.S. Attorney’s office has the independent authority to pursue food- and drug-related cases without or in spite of FDA input, and many offices choose to do so using more general criminal statutes instead of health care–specific causes of action.6 This has the effect of (1) creating the possibility for disparate charging and settlement standards for comparable offenses and (2) making it difficult or impossible to track criminal enforcement in this area (O’Leary 2013:153 n.117). Finally, as noted previously, there is a real concern that the OIG’s aggressive approach to permissive exclusion undermines the efficient resolution of criminal proceedings by discouraging defendants from entering plea agreements.
Although these problems with individual enforcement are significant, they can be substantially mitigated through greater coordination between the various agencies responsible for enforcement and through a shared commitment to prioritizing the public health goals underpinning the food and drug laws. By coordination, I mean to propose formal interagency policies guiding decision making in individual cases. The present reality is that criminal prosecutions for FDA-related misconduct—whether charged as a Park misdemeanor, an FDCA felony, or a more general Title 18 offense—are controlled by the DOJ. Although FDA investigates many of these cases, and many arrive in U.S. Attorneys’ offices as a result of FDA referral, others are investigated by different law-enforcement agencies, or arise out of civil False Claims Act actions. In every case, the key decisions—whether to prosecute and on what charges, whether to settle and on what terms—belong to lawyers at the DOJ. Whether those lawyers are specialists in food and drug crimes working at the CPB in Washington or generalists at any of the ninety-three U.S. Attorneys’ offices depends on how a case originates and on what charges it ultimately proceeds. Either way, the consequence is that strategic FDA-related enforcement decisions are routinely made by lawyers at the DOJ, which, unlike FDA or HHS, has no statutory obligation to prioritize public health. Particularly where FDA-related conduct is prosecuted under more general criminal theories—and much of it is, partially because charges like those under the fraud and false-statement statutes are more familiar to generalist prosecutors, more easily explained to jurors, and often comparatively easy to prove—officials from FDA may have at most a minimal role in the prosecution. Moreover, because many cases tried on more general theories (but based on conduct that could be prosecuted under a more specific statute) are not classified as food and drug prosecutions for tracking purposes, there is presently no straightforward way to develop a complete picture of how and how often the DOJ prosecutes this conduct.
Glasner (2011:7) has proposed remedying the FDA-DOJ coordination problem, at least with respect to the decision to proceed under Park, by “establish[ing] DOJ guidelines that reflect FDA guidelines in order to keep the application of the Park doctrine consistent even when…prosecutions are referred to DOJ from whistleblowers outside FDA.” Consistency is obviously of paramount importance with respect to the Park doctrine, but it is also important for enforcement in this area more generally. Consistent but independent written policies, moreover, do not necessarily translate into decision making that reflects the shared values underlying those policies, particularly when the agency whose authorizing statute contributes the values—the public health–oriented FDA—and the agency with final decision-making authority differ. Rather than simply aligning the principles articulated in the agencies’ policy manuals, the agencies could more fully address the concerns expressed above by adopting a binding interagency agreement that (1) formally recognizes that no matter which government agency acts to enforce the food and drug laws, it must do so in a manner that prioritizes public health impacts; (2) sets a uniform policy guiding prosecutors on how to charge (and track) cases where the underlying offense conduct is a violation of the food and drug laws; and (3) gives FDA a formal role in deciding what cases are brought and dropped. As Girard (2009:153) puts it: “If the goals of promoting and protecting the public health under the [FDCA] are truly paramount, FDA should be afforded an early and substantive role in the decision of whether prosecution is warranted.”
The issues raised by exclusion can be addressed in much the same way. The decision whether to seek exclusion in any given case should not be divorced from decisions about whether to prosecute, whether to settle, and on what terms to settle. Whatever the differences between exclusion (technically a tool of incapacitation rather than deterrence, though not used that way) and criminal liability, the ultimate goal of both sanctions is to protect the public, and it makes no sense that two agencies of the same government, pursuing this goal in relation to the same actors for the same conduct, would not coordinate. The OIG must be on the same page with the DOJ and FDA, not only so that the risk of exclusion does not undermine negotiations between these agencies and actual or potential defendants but also so that these agencies can effectively employ the powerful stick that is exclusion in these negotiations in the first instance.
The federal enforcement regime for the biomedical industry is broken. Prosecutors have become addicted to a lightning-strike enforcement approach that emphasizes headline-making billion-dollar settlements despite growing evidence that these massive fines (and the CIAs that accompany them) do not effectively deter the misconduct they punish. With larger fines and firm-wide exclusion substantially off the table due to the social costs of shutting down the developers and suppliers of essential medical products, the most straightforward way to bridge the deterrence gap is by imposing accountability on the individual corporate officers who shape the culture and drive the decision making at these firms. While targeting these individuals using the full range of enforcement tools available—including Park prosecutions and exclusion from federal health care programs—can be an important element of a credible deterrence regime, these forms of enforcement also raise valid concerns. For this reason, it is vital that the agencies applying them coordinate and use their authority responsibly, according to shared principles emphasizing, above all, the public health mission that justifies such authority in the first place.
NOTES
1. Public Citizen is a consumer-rights advocacy group based in Washington, D.C.
2. This concern could theoretically be addressed in part through reforms, like some already being discussed in response to drug shortages, geared toward creating alternate sources for vital products. For example, Copeland (2012:1077–78) suggests that compulsory licensing could be employed in some cases as an intermediate sanction for off-label promotion, which would require the subject firm “to permit another manufacturer to produce and sell the patented drug.”
3. Boozang (2012:91) explains that while “efficient breach of public law” can be seen as ethically acceptable “in the case of matters that are malum prohibitum” this is not the case for acts that are “malum in se.” With the understanding that not all food and drug offenses can be fairly characterized as such, it seems fair to say that from the regulators’ perspective, at least those prohibitions in the FDCA pertaining to safety and efficacy of regulated products are of the sort that cannot be ethically breached for a price.
4. As Baer (2012:632–33) observes, however, the notion “that offenders should be punished proportionally and in relation to their culpability” is really the “core claim” of retributive justice, not deterrence. While by “happy coincidence[]” this notion “bears some resemblance to the concept of ‘marginal deterrence’ in economics,” in fact “[t]he amount of culpability someone bears for a given act may differ in translation from the specific sanction necessary to internalize and optimally deter that same act.”
5. Petrin (2012:312–14) notes, however, that this inference is still just that, given the paucity of empirical evidence about the effectiveness of individual liability for corporate criminality.
6. A wide variety of Title 18 (and other) criminal charges can be used to prosecute conduct that arises in FDA-regulated industry, including mail and wire fraud, obstruction of justice, conspiracy, and violations of the Anti-Kickback Statute (Drake et al. 2013:1177–87; O’Leary 2013:161–62).
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