OPINION ANALYSIS

Subjective intent of wrongdoing required to convict doctors under Controlled Substances Act

With a majority opinion that will be one of Justice Stephen Breyer’s last for the Supreme Court, the court on Monday ruled 9-0 that two alleged opioids “pill mill” doctors could not be convicted absent a jury finding that they subjectively believed they were wrongfully dispensing pills. The opinion is a victory for physicians prescribing innovative treatments that they believe serve legitimate medical purposes, and it should assuage concerns about a ruling that could have chilled more doctors from prescribing needed pain treatments. Even in the midst of a historic opioid crisis, and an intensely fractured Supreme Court term, the justices found common ground in longstanding presumptions of criminal law and the core principle of physician discretion.

The case, Ruan v. United States, was a challenge to jury instructions in two prosecutions of doctors accused of prescribing outside the bounds of ordinary medical practice. The Controlled Substances Act makes it unlawful, “except as authorized,” to “knowingly or intentionally” distribute controlled substances. 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 was whether a doctor’s subjective intent in prescribing matters. In arguing a subjective standard is required, the charged doctors and other advocates emphasized longstanding rules about the presumption of mens rea (a guilty state of mind) for criminal offenses. The United States, in contrast, argued 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.’” 

The court ruled for the doctors, with Breyer writing for six justices, and Justice Samuel Alito concurring in the judgment on behalf of himself, Justice Clarence Thomas and, in part, Justice Amy Coney Barrett. Breyer’s opinion makes quick work of grammar-oriented arguments that pervaded oral argument — namely, the contention that, because the phrase “except as authorized” comes before “knowingly and intentionally” in the CSA, no mens rea requirement applies to the exceptions. Referencing a “a longstanding presumption, traceable to the common law, that Congress intends to require a defendant to possess a culpable mental state,” Breyer opined that “we expect, and indeed usually want, doctors to prescribe the medications that their patients need.” A mens rea requirement, the opinion holds, is essential to separate physicians’ “socially beneficial conduct” from criminal conduct.

Alito’s opinion reaches the same result but through a different pathway. He argues that the “except as authorized” provision sets forth an affirmative defense, not an element of the crime. He therefore objects to both the application of a mens rea presumption and also the court’s view that the government bears the burden to prove, beyond a reasonable doubt, that the defendant did not qualify for the statutory exception. Instead, Alito would have left the burden on the defendant to prove that they fell into the exception authorizing dispensation or, in the alternative, apply only a preponderance-of-the-evidence burden to the government. In so doing, Alito relied on precedent from the CSA’s predecessor statute, the Harrison Narcotics Act of 1914, which utilized a “good faith” standard to evaluate physician prescribing.

These differences may prove important for future debates about burdens of persuasion with respect to affirmative defenses, but for purposes of this case, the bottom lines of both opinions were in agreement: A subjective standard, not an objective one, should be applied to doctors who are charged with violations of the CSA’s controlled-substances provision. Alito described this “good faith” requirement as one that makes the relevant standard quite different from mere negligence and malpractice. He wrote: To act in good faith “‘as a physician’ does not invariably mean acting as a good physician, as an objective understanding of the ‘in the course of professional practice’ standard would suggest. A doctor who makes negligent or even reckless mistakes in prescribing drugs is still ‘acting as a doctor’ — he or she is simply acting as a bad doctor. The same cannot be said, however, when a doctor knowingly or purposefully issues a prescription to facilitate addiction and recreational abuse.” Breyer’s majority opinion reaches essentially the same result, but puts a much higher burden on the government.

None of this is to say that the court has let pill mill doctors off the hook. In this case, the government alleged that defendant Dr. Xiulu Ruan’s clinic improperly issued more than 300,000 prescriptions for controlled substances over a four-year period; that he was 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 that he tied his prescribing practices to his own financial interests. The other petitioner, Dr. Shakeel Kahn, is alleged to have sold controlled substances in exchange for cash — and even firearms sometimes — without performing any exam and documenting the encounters with falsified notes.

What the court held is that juries must scrutinize whether charged physicians actually believed their behavior was legitimate rather using an objective standard of a hypothetical reasonable physician. And Breyer was clear that circumstantial evidence might be important to such an inquiry. That may make prosecutions of some outliers difficult, but good government lawyering should smoke out dishonest doctors who are not acting as doctors at all. The cases were remanded for scrutiny of the jury instructions under the clarified standard.