ILLEGITIMATE OVERPRESCRIPTION: HOW BURRAGE V. UNITED STATES IS HINDERING PUNISHMENT OF PHYSICIANS AND BOLSTERING THE OPIOID EPIDEMIC.

• Author: Mcclure, Alyssa M.

INTRODUCTION

When physicians enter the practice of medicine, they swear to follow the principle: "First, do no harm." (1) In 2006, Dr. Dewey MacKay of Utah prescribed prescription opioid medication to patient David Wirick, killing him. In 2013, a jury convicted him of two counts of distributing Schedule II and III controlled substances, the use of which resulted in death. (2) The district court sentenced Dr. MacKay to 240 months of incarceration, (3) based on the penalty enhancement for distributing controlled substances resulting in death under the federal drug trafficking statute. (4)

Dr. MacKay's conduct "went far beyond a 'bad doctor' standard of care" (5): he chronically overscheduled patients, "sometimes seeing 100 patients in [fewer] than eight hours"; conducted no or limited physical examinations of his patients, "with entire [office] visits lasting between two to five minutes"; repeatedly refilled prescriptions early; and "reflexive[ly]" prescribed controlled substances without considering alternative methods of treatment. (6) In total, Dr. MacKay was convicted of thirty-seven counts of unlawful distribution of Schedule II and III controlled substances. (7)

His story is not unique. Dr. Paul Volkman ran a pain clinic in Ohio, where he was convicted of four counts of unlawful distribution of a controlled substance leading to death after four of his patients died of opioid overdoses due to prescriptions he wrote. (8) In fact, from 2003 to 2005, Dr. Volkman dispensed more oxycodone than any other physician in the country. (9) Dr. Stephen Schneider and his wife, nurse Linda Schneider, ran a pain management treatment facility in Kansas, at which, over the course of six years, sixty-eight of their patients died of drug overdoses. (10) Just last November, a grand jury in the Western District of New York returned a 166-count indictment against pain management doctor Eugene Gosy. (11) One hundred forty-four counts accused him of "unlawfully distributing and dispensing controlled substances[ ] other than for a legitimate medical purpose and not in the usual course of professional practice," and a separate count alleged that this conduct resulted in the death of six patients. (12)

As the opioid epidemic in the United States surges, death resulting from physician prescription of controlled substances is becoming more common. With it, criminal prosecution of physicians has increased; the Drug Enforcement Administration (DEA) has reported "a steady rise in successful criminal prosecutions of physicians, from just 15 convictions in 2003 to 43 in 2008." (13) In pursuing these cases, prosecutors utilize 21 U.S.C. [section] 841. Section 841(b) contains a penalty enhancement for cases where distribution of controlled substance(s) in violation of section 841(a) results in death or serious injury. (14) Under this enhancement, the statutory minimum incarceration period is twenty years. (15) Prior to 2014, the causation standard a prosecutor was required to prove to apply this increased penalty enhancement varied across jurisdictions. Some courts held that a contributing-factor standard was appropriate, (16) while others held that a showing of proximate cause was necessary. (17) Subsequently, the Supreme Court, in Burrage v. United States, determined that the penalty enhancement under section 841(b) is not applicable unless the defendant's use of the controlled substance was a "but-for" cause of the death or injury. (18)

Counts one and two in the case of Dr. MacKay alleged violations of 21 U.S.C. [section] 841(a)(1), (19) triggering the potential application of this penalty enhancement. Post-Burrage, Dr. MacKay was resentenced. (20) After declaring the jury instructions insufficient in light of Burrage, the district court vacated Dr. MacKay's enhanced penalty convictions on counts one and two and reduced his sentence from 240 to only thirty-six months. (21) While the Court's decision in Burrage does not wholly prevent the prosecution of physicians for misconduct or fully eliminate consequences for such behavior, it significantly limits the penalties applicable in cases where physician misconduct results in patient death. Because physicians are subject to oversight by the medical community and their patients may sue for malpractice, cases of prosecutorial involvement generally indicate conduct so severe as to justify criminal consequences. Burrage's narrow interpretation of the language in section 841(b) significantly increases prosecutors' burden of proof.

Due to the concerns Burrage raises and its implications for the nation's current opioid crisis, this Note proposes that Congress should broaden the circumstances in which the penalty enhancement of section 841(b) may be applied. Part I of this Note discusses the opioid crisis and the role physicians play in it. Part II explores the section of the Controlled Substances Act used to criminally charge physicians and the exception the Act provides for physicians prescribing opioids within the scope of relevant medical conduct and professional practice. Part III analyzes Burrage v. United States (22) and examines the immediate legal consequences of its holding, flagging issues that Burrage's approach creates in ensuring appropriate punishment for physician violators. Finally, Part IV proposes a legislative amendment that widens the applicability of the twenty-year mandatory minimum penalty enhancement of section 841(b) by broadening the language of the statute to allow for contributing factors. Such a solution is not without concern, and several concerns are addressed here, but the devastation of the opioid crisis must be met with creative lawmaking.

1. THE OPIOID CRISIS

   On October 26, 2017, President Donald Trump declared the United States opioid crisis a national public health emergency. (23) The President's Commission on Combating Drug Addiction and the Opioid Crisis released an interim report (24) in July 2017, which acknowledged the dire state of the epidemic in the United states:

   [H]ere is the grim reality: Americans consume more opioids than any other country in the world. In fact, in 2015, the amount of opioids prescribed in the U.S. was enough for every American to be medicated around the clock for three weeks.... We have an enormous problem that is often not beginning on street corners; it is starting in doctor's offices and hospitals in every state in our nation. (25) Opioids are "[n]atural or synthetic chemicals that interact with opioid receptors on nerve cells in the body and brain, and reduce the intensity of pain signals and feelings of pain." (26) Prescription opioids are prescribed by a physician to treat moderate-to-severe pain (27) and include drugs such as morphine, codeine, oxycodone, hydrocodone, hydromorphone, oxymorphone, methadone, tramadol, and fentanyl. (28) According to the Centers for Disease Control and Prevention ("CDC"), nearly half of all opioid overdose deaths involve a prescription opioid, and in 2013, providers wrote nearly 250,000,000 opioid prescriptions--enough for every adult in the United States to have his "own bottle of pills." (29)

   The current epidemic arose from opioid overuse in the United States. This overuse stemmed from assurances by pharmaceutical companies to the medical community in the late 1990s that patients would not become addicted to prescription opioid painkillers. (30) From 1999 to 2010, "[t]he amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices nearly quadrupled," yet there was no overall change in the level of pain patients reported. (31) Providers prescribed such pain medication in consistently larger quantities and doses, which led to "widespread diversion and misuse of these medications" before it became clear that these drugs are in fact highly addictive. (32) From 1999 to 2016, more than 200,000 people in the United States died from prescription opioid-related overdoses. (33)

   Public health officials have deemed the opioid epidemic "the worst drug crisis in American history." (34) Deaths from prescription opioids "have more than quadrupled since 1999." (35) In 2015, more than 15,000 people died from overdoses involving prescription opioids. (36) In 2016, opioid overdoses killed more people than did guns or car accidents, and "at a pace faster than the H.I.V. epidemic did at its peak." (37) As of November 2017, the CDC estimated that in 2016, more than 64,000 people died of drug overdoses, (38) compared to just over 52,000 in 2015--the largest annual jump ever recorded in the United States. (39) And "there's no sign it's letting up." (40) Current trends indicate that as many as 650,000 people will die over the next decade from opioid overdoses--nearly as many people in ten years as HIV/AIDS killed in forty. (41)

   Prescription opioid abuse remains one of the leading causes of opioid death, (42) as the vast majority of individuals abusing opioids obtain them from a prescription--whether the prescription was written for them or for a family member or friend. (43) As far back as 1984, the Senate, in discussing amendments to the Controlled Substances Act, noted that "[i]t is estimated that 80 to 90 percent of all current diversion occurs at [the practitioner] level." (44) Historically, the legal and academic professions have been reluctant to advocate criminal liability for physicians for improper prescribing, "fearing that such liability would create a chilling effect: physicians would refrain from properly treating patients who legitimately needed certain prescription medications out of fear of criminal sanctions if a patient died from an overdose." (45) But as the opioid epidemic proliferates, killing ninety Americans every day, (46) the argument for protecting misprescribing physicians from criminal prosecution has become less persuasive. This is not to say that all physicians prescribing opioids are doing so unlawfully; in fact, it is likely that the majority adhere to...