The Responsible Corporate Officer, the DeCosters, and the Opioid Epidemic: Why Prison Sentences Based on the RCO Doctrine Do Not Violate Due Process.

• Author: Murray, Stacey

1. INTRODUCTION 483 II. BACKGROUND 484 A. The Opioid Epidemic 484 B. 2007 Purdue Pharma Case 486 C. Post-2007 487 D. Looking for Justice 489 III. ANALYSIS 491 A. Responsible Corporate Officer Doctrine 491 B. United States v. DeCoster 493 C. The Erroneous Due Process Arguments in DeCoster 496 1. Strict Liability Crimes Do Not Violate the Due Process Clause 496 2. The RCO Doctrine Is Not Based on Vicarious Liability 497 IV. RECOMMENDATION 498 A. Prosecutors Need Resources 498 B. The Supreme Court Should Uphold the RCO Doctrine If It Is Challenged 499 C. Congress Should Codify the RCO Doctrine 500 V. CONCLUSION 501 I. INTRODUCTION

   The opioid epidemic catapulted corporate criminal wrongdoing to the forefront of public consciousness in an unprecedented way. Now, as society pleads for opioid manufacturers and distributors to recognize how they have caused a public health emergency, prosecutors and the court systems are left to work with the Responsible Corporate Officer (RCO) doctrine--a doctrine on unsteady ground.

   This Note explores the legal arguments raised by opponents of the RCO doctrine and why those arguments are not grounded in law. This Note explains how a recent 8th Circuit case, United States v. DeCoster, (1) addressed the due process issues within the RCO and how the 8th Circuit has made the underpinnings of the doctrine clear. Because of DeCoster, future prosecutors should be able to move forward without threat of the doctrine falling out from underneath of them. Part II lays out how the opioid crisis arose and outlines the first court cases in the early 2000s against Purdue Pharma executives. Part III discusses the doctrine and how the 8th Circuit analyzed due process concerns raised by the defendants. Part III also considers the erroneous arguments the defendants raised and makes the case for the prosecutions of Big Pharma. Finally, Part IV recommends prosecutors move forward with these cases, the Supreme Court uphold the doctrine if challenged, and Congress codify the responsible corporate officer doctrine.

2. BACKGROUND

   1. The Opioid Epidemic

      According to the American Society of Addiction Medicine (ASAM), opioids are "a class of drugs that... interact with opioid receptors on nerve cells in the brain and nervous system to produce pleasurable effects and relieve pain." (2) While pain management may be a central tenant of wellness in the modern era, it has not always been a primary goal of medicine. Until recently, the medical field has treated pain as an "existential experience" and a side effect of aging. (3) In the first parts of the 20th century, healthcare providers used opioids sparingly. (4) Still, in the 1970s and 1980s, specialists recognized opioids often brought great relief to dying cancer patients suffering from intense pain. (5) Starting in the 1980s, there was a push in the medical community to further address the pain itself as a condition worth treating. (6)

      Around this time, the World Health Organization (WHO) created guidelines for treating patients with cancer pain, including opioids as a treatment method. (7) Perhaps more importantly, the WHO recognized pain treatment as a universal human right in these guidelines for the first time. (8) A groundswell focusing on pain management grew as the American Pain Society (APS) campaigned for healthcare providers to recognize pain as the fifth vital sign. (9) The campaign gained legitimacy and by the late 1990s, "it was generally accepted that all patients are entitled to the assessment and treatment of pain...." (10)

      The medical community's assumptions about the addictive nature of opioids have fluctuated greatly since the early 20th century. (11) At least until the 1980s, healthcare providers hesitantly prescribed opioids because of their addictive nature. (12) That assumption unraveled, albeit incorrectly, over the next two decades. (13) In 1980, the New England Journal of Medicine printed a one-paragraph "Letter to the Editor," noting less than one percent of patients treated with narcotics subsequently became addicted. (14) The letter read:

      Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction. (15) That statistic became a widely cited figure in the medical field, and the assumption went without criticism or further review. (16) By 1986, APS concluded opioid maintenance therapy was "safe and humane." (17) While concerns about opioid addiction lingered, those fears were largely put to rest by two studies, but those studies lacked sufficient evidence to support these claims. (18)

      The business opportunity to capitalize on opioid treatment for patient pain grew in tandem with the belief opioids were generally nonaddictive. In 1996, Purdue Pharmaceuticals introduced Oxycontin, a now-infamous actor in the opioid crisis. (19) From 1996, when Purdue first introduced the drug, to 2001, Purdue held more than 40 all-expense-paid conferences for more than 5,000 healthcare providers, where executives trained the healthcare professionals. (20) Purdue's efforts were extraordinary; the company created profiles on individual physicians, detailing their opioid prescribing habits, so they could target doctors prescribing higher levels of opioids for pain management. (21) The company aggressively marketed the drug, spending $200 million in 2001 on these efforts alone. (22) A feature of OxyContin's marketing was a "systematic effort to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer-related pain." (23) From 1999 to 2014, opioid prescriptions grew almost fourfold. (24)

      The crisis has come in three waves, each individually distinct. (25) As the number of opioid prescriptions increased throughout the 1990s, so did the number of deaths related to these prescription overdoses, accounting for the first wave of the crisis. (26) Still, opioid producers continued their aggressive marketing techniques as the new millennium began and the number of opioids "exploded throughout the country." (27) By 2010, the second wave of the epidemic arrived, this time featuring an increase in heroin overdoses. (28)

      Public consciousness of the problem unfolding in communities around the country grew. (29) For instance, in November 2012, the Los Angeles Times published a series on prescription drug overdoses. (30) The third and final wave began in 2013 with drastic increases in deaths from synthetic opioids, such as fentanyl. (31) Amid an ongoing crisis, the federal government officially declared the opioid epidemic to be a public health emergency on October 16, 2017. (32) Currently, public health officials estimate 128 people die in America every day from opioid overdoses. (33)

   2. 2007 Purdue Pharma Case

      While the opioid epidemic is a public health crisis of an unprecedented scale, (34) the associated legal issues began to arise over a decade ago. (35) In 2007, Purdue Pharmaceuticals and three of its executives pled guilty for misleading regulators, doctors, and patients about OxyContin's addictive nature. (36) The company agreed to pay roughly $600 million in fines. (37) The three executives involved in the lawsuit agreed to pay more than $34 million in individual fines after pleading guilty as individuals to misbranding--though they were not implicated on the felony charges. (38) Both the company and its executives acknowledged the company frequently downplayed the drug's addictive nature, stating they "accept responsibility for those past misstatements and regret they were made." (39) None of the executives faced jailtime. (40) One of the prosecutors has since said more serious charges for executives "would [have sent] a message that drug industry officials faced being held to 'a higher standard,'" though executives never saw those charges. (41)

   3. Post-2007

      It is unclear whether these 2007 fines deterred the conduct fueling the latter half of the opioid crisis. Over the five years following the 2007 settlement, (42) the number of OxyContin pills sent to West Virginia outnumbered West Virginia's population 433:1. (43) Between 2006 and 2012, pharmaceutical companies distributed 76 billion oxycodone and hydrocodone pills throughout the United States. (44) In places like Floyd County, Kentucky, there were 163 pills per person distributed every year from 2006 to 2014. (45) In the five years after the Purdue settlement, roughly 100,000 Americans died from opioid overdoses. (46) Given these statistics, members of the public justifiably wonder whether there will be adequate consequences for the actors responsible for the epidemic's unprecedented growth. (47) After all, Purdue admitted wrongdoing in 2007 and still continued to fuel the epidemic.

      States are currently pursuing a wide variety of civil and criminal charges against the various corporations responsible for such over-distribution. (48) Three pharmaceutical distribution companies--McKesson, Cardinal Health, and AmerisourceBergan--have announced a $260 million settlement with two Ohio counties, which allow the companies to avoid a federal trial. (49) Additionally, Purdue Pharmaceuticals settled a case with Oklahoma in March 2019 for $270 million. (50) Purdue Pharma has since filed for bankruptcy. (51) So far, Purdue has avoided a messy public trial.

      Of course, the financial penalties Purdue and its peers now face are important for retribution. The victims of the...