CASE PREVIEW

Amid overdose crisis, court will weigh physician intent in “pill mill” prosecutions and more under the Controlled Substances Act

In the midst of a national opioid crisis that claimed more than 100,000 lives in this country over the past year, the Supreme Court will hear a case on Tuesday about the relevance of doctors’ subjective intentions in criminal prosecutions for unlawful distribution of controlled substances. While on the surface, the case, Ruan v. United States, may appear to be an ordinary “pill mill” case, the decision could have a much broader impact on the practice of medicine as well as doctrines of criminal intent.

The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “[e]xcept as authorized by this subchapter.” One of those exceptions is for physicians who operate under the statute’s registration scheme; registered doctors may prescribe controlled substances in accordance with rules promulgated by the attorney general. The rule at issue in this case allows doctors to dispense a controlled substance that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” The question is whether a doctor’s subjective intent — namely, whether she prescribed in good faith — is relevant to applying that standard. Two doctors who were convicted of violating the CSA say subjective intent is critical. The United States, in contrast, argues for an objective standard, on the ground that the act “does not permit a physician to simply decide for himself that any manner or volume of drug distribution is ‘medicine.’”

Dr. Xiulu Ruan, one of the petitioners, was a board-certified interventional pain specialist who the government alleges operated an Alabama “pill mill” — a term used to describe doctors, clinics, or pharmacies that prescribe or dispense high volumes of powerful narcotics inappropriately. Ruan’s clinic, the government says, improperly issued more than 300,000 prescriptions for controlled substances over a four-year period. Ruan is also alleged to have been one of the top prescribers in the nation of a type of fentanyl, an extremely potent synthetic opioid approved to treat breakthrough pain in cancer patients, and to have tied his prescribing practices to his own financial interests, including to manufacturers in whose companies he had purchased stock and to the drugs available in the pharmacy he and his partner owned. The other petitioner, Dr. Shakeel Kahn, is alleged to have sold controlled substances in exchange for cash and even firearms in Arizona and Wyoming, sometimes without performing any exam and documenting the encounters with falsified notes. 

Both doctors vigorously contest the allegations, saying they “at all times” believed in good faith they were prescribing for legitimate medical purposes. Ruan emphasizes the government’s own statements that in many cases he did serve his patients well, while acknowledging the government’s claim that he could have been more careful, e.g., by supervising staff more closely or spotting red flags. The doctors argue, however, that there is a difference between criminal activity and malpractice, and the critical difference, they contest, is the presence of culpable intent. Their appeals center on challenges to their jury instructions, which they argue did not properly emphasize this good-faith component. 

The government argues, in contrast, that the physician must show she has made an “objectively reasonable good-faith effort to learn and comply with medical norms.” The doctors respond that the government’s standard would criminalize innocent mistakes and chill the practice of medicine, including medical innovations that federal law permits doctors to engage in; for instance, the federal government does not generally prevent doctors from prescribing drugs approved by the Food and Drug Administration for unapproved, “off-label” uses. The government responds that its standard will not reach mistakes or off-label prescribing, as long as the physician makes the “honest effort to practice medicine as conventionally understood.”

The briefs run through a litany of legal arguments, ranging from the longstanding background presumption that mens rea — a guilty state of mind — is necessary to establish a crime; to federalism-grounded arguments that the government’s standard works an improper expansion of federal authority into the practice of medicine, the regulation of which is traditionally left to the states; to arguments based on text, legislative history, and precedent. Ruan and Kahn, among other things, train on the words “knowingly or intentionally” in the CSA, as well as the fact that the key phrase in the rule — “an individual practitioner acting in the usual course of his professional practice” — uses the term “his,” which they argue demands an individualized inquiry, not that of the generic reasonable physician. They also argue that Congress, elsewhere in the CSA, meaningfully deviated from the “knowingly or intentionally” language to impose a lower standard for certain actions undertaken “knowingly or recklessly,” thereby showing that Congress knew how to criminalize merely reckless behavior when it wanted to.

The government, in turn, focuses on the structure of the CSA — the words denoting mens rea, “knowingly or intentionally,” come after the exception clause at issue and so, the government argues, do not apply to it. The government also focuses on, among other things, the rule’s use of the word “usual” in the phrase “usual course of his professional practice,” arguing that “usual” connotes the ordinary, objective, everyday norms of medical practice, not doctors effectively deciding for themselves the scope of their own criminal liability. 

While at first glance the case may seem relatively straightforward, it raises issues for health care, regulation, and criminal law that extend beyond the opioid crisis and the dramatic facts presented in these particular prosecutions. As a result, a variety of different bedfellows have filed amicus briefs in support of a clearer culpability standard, some on the side of the doctors, others on the side of neither party, perhaps in the hope that the court will be able to articulate a compromise rule or at least clarify the existing standard.

In the health care context, in addition to the arguments already noted, amici argue that the government’s objective standard criminalizes what should be understood and addressed as mere careless prescribing. The objective standard, they argue, will dangerously chill the practice of medicine in general and have especially detrimental effects on the practice of pain medicine. Medicine, they contend, is by nature iterative, and the science of pain medicine in particular continues to evolve. (As one example, outside commentators have noted that the Centers for Disease Control and Prevention earlier this month issued a draft revision of its opioid-prescribing guidelines that would, among other things, relax dosing caps.) Further, as a result of the opioid crisis and the ensuing increase in regulation and enforcement, amici point out that many physicians have stopped prescribing opioids altogether, or have stopped interacting with patients in populations likely to present issues of pain and substance-use disorder. It has thus become much harder for patients in need to find pain medicine for legitimate chronic pain, including pain caused by cancer and the end-of-life. 

A group of health law professors also focus on novel medical therapies, arguing that doctors need “discretion to deploy their specialized training and expertise to pioneer new treatment approaches that may improve patients’ well-being.” They also doubt the ability of lay juries, confronted with battles of the experts, to fairly judge this scientific landscape and determine when under an objective standard a doctor has done enough to learn and conform her behavior to usual practice. Instead, Ruan and Kahn endorse a standard that “separates physicians operating at the fringes of medical innovation from those who abandon medicine entirely to engage in conventional drug dealing and trafficking.”

In this regard, it is interesting to note that the leading precedent the government relies on is United States v. Moore, an early CSA decision in which the Supreme Court confirmed that “registered physicians can be prosecuted under the CSA when their activities fall outside the usual course of professional practice.” The Moore court affirmed the conviction of a doctor experimenting with novel uses of methadone to treat patients with substance-use disorder. The jury was instructed that it could find guilt if the defendant had not acted in “good faith” with “an honest effort” to comply with “an accepted standard of medical practice.” But Moore aimed to answer the question of whether physician-registrants could be convicted under Section 841 in the first place — it answered that question in the affirmative; the opinion did not delve deeply into the jury instruction. The precedent therefore leaves open some question about how experimental therapies should be treated. The government describes Moore as relevant to only “plainly out-of-bounds” practices, and relies on the case for the proposition that “a doctor cannot claim an innocent mind when he opts to remain ignorant of medical conventions or deems himself above them.”

Other amici focus on mens rea, including a brief from the Chamber of Commerce arguing that a “strong mens rea” requirement that includes “statutory willfulness” is especially important for “complex regulatory schemes,” where there can be confusion about what constitutes wrongdoing, and where there are risks of overdeterrence of beneficial activity. Notably, the Chamber’s argument to thus limit the reach of criminal law extends beyond the CSA; its brief singles out, for instance, some cases in the environmental law context where the Chamber contends a subjective mens rea standard should likewise apply. Others question whether the CSA provides sufficient guidance to prevent the Drug Enforcement Administration or the attorney general, as opposed to Congress, from setting out the contours of criminal liability.

Ruan concludes his brief arguing, as a fallback to his preferred rule, that a doctor “must be acquitted if he honestly tried to meet reasonable professional standards.” The government argues throughout its own brief that the version of the “honest effort” standard it advocates provides the necessary mens rea, contending that a doctor who “makes no reasonable effort to respect professional norms, and thereby elevates his own notions of medical practice to the point where other doctors would not describe them as such, does not have an innocent mind.” It’s possible the court will focus on this potential middle ground to navigate the complexities of this landscape.

In a moment when civil opioid litigation is sprawling  in courts around the country — with cases brought by more than 2,000 local governments pending in the multidistrict federal litigation in Cleveland, hundreds more brought in state courts or by state attorneys general across the country, and the leading manufacturer Purdue Pharma mired in a contested bankruptcy proceeding in New York — there can be no doubt about the extraordinary complexity of using litigation as a response to a public health crisis. And while criminal prosecutions relating to the crisis have garnered fewer headlines, they are still significant. Federal prosecutors have opened criminal probes into six major opioid makers and distributors, and Purdue pleaded guilty to federal charges in October 2020. The outcome of Ruan will almost certainly have an effect on physician behavior and the approach of federal prosecutors to similar questions in the future.