Subjective intent of wrongdoing required to convict doctors under the Controlled Substances Act
By Father R. Gluck
June 28, 2022
at 10.15 a.m.
With a majority opinion that will be one of Justice Stephen Breyer’s last on the Supreme Court, the court on Monday reigned 9-0 that two doctors alleged to be opioid “pill mills” could not be convicted in the absence of a jury finding that they subjectively believed they were wrongfully dispensing pills. The advisory is a victory for doctors prescribing innovative treatments they believe serve legitimate medical purposes, and it should allay concerns about a decision that could have deterred more doctors from prescribing needed pain treatments. Even amid a historic opioid crisis and a wildly fractured Supreme Court tenure, the justices have found common ground in longstanding criminal law presumptions and the fundamental principle of physician discretion.
The case, Ruan v. United States, was a challenge to jury instructions in two suits against physicians accused of prescribing outside the bounds of ordinary medical practice. The Controlled Substances Act makes it illegal, “unless authorized”, to “knowingly or intentionally” distribute controlled substances. One such exception is for physicians who practice under the act’s registration regime; licensed physicians can prescribe controlled substances under rules promulgated by the Attorney General. The rule at issue in this case allows doctors to deliver a controlled substance “delivered for a legitimate medical purpose by an individual practitioner acting within the usual framework of his professional practice”.
The question was whether a physician’s subjective intent in prescribing matters. In arguing that a subjective standard is required, accused physicians and other lawyers have emphasized long-standing rules regarding the presumption of mens rea (a guilty state of mind) for criminal offences. The United States, on the other hand, argued in favor of an objective standard, on the grounds that the law “does not allow a physician to simply decide for himself that any form or volume of dispensation of drugs is a ‘medicine ‘”.
The court ruled for the doctors, with Breyer writing for six justices and Justice Samuel Alito approving the judgment on his behalf, Justice Clarence Thomas and, in part, Justice Amy Coney Barrett. Breyer’s opinion makes quick work of the grammar-driven arguments that have permeated oral argument – namely, the assertion that because the phrase “except as permitted” comes before “knowingly and intentionally” in the CSA, no mens rea requirement applies to exceptions. Referring to “a long-standing presumption, traceable to common law, that Congress intends to require that a defendant possess a culpable mental state,” Breyer opined that “we expect, and in fact want generally, that doctors prescribe the drugs that their patients need. ” According to the opinion, a requirement of mens rea is essential to distinguish the “socially beneficial conduct” of doctors from criminal conduct.
Alito’s opinion leads to the same result but by a different route. He argues that the “except leave” provision sets forth an affirmative defence, not an element of the crime. He therefore objects both to the application of a presumption of mens rea and to the court’s view that the onus is on the government to prove, beyond a reasonable doubt, that the defendant was not eligible for exception provided by law. Instead, Alito would have left the onus on the defendant to prove that it fell within the exception authorizing the waiver or, alternatively, would have imposed only a preponderance of proof burden on the government. In doing so, Alito built on the precedent of the law that preceded the CSA, the Harrison Narcotics Act of 1914, which used a “good faith” standard to assess physician prescribing.
These differences may prove important for future debates about the burdens of persuasion with respect to affirmative defences, but for the purposes of this case, the bottom lines of the two opinions agreed: a subjective, not objective, standard should be applied to physicians who are accused of violating the CSA’s controlled substance provision. Alito described this “good faith” requirement as one that makes the relevant standard very different from mere negligence and malpractice. He wrote: Acting in good faith “’as a physician’ does not invariably mean acting as a good physician, as an objective understanding of the standard ‘in professional practice’ suggests. A doctor who makes negligent or even reckless mistakes in prescribing drugs is still ‘acting like a doctor’ – he is just acting like a bad doctor. However, the same cannot be said when a physician knowingly or deliberately issues a prescription to facilitate addiction and recreational abuse. Breyer’s majority opinion achieves essentially the same result, but imposes a much heavier burden on the government.
None of this is to say the court let the pill factory doctors off the hook. In that case, the government alleged that the clinic of the defendant, Dr. Xiulu Ruan, improperly issued more than 300,000 prescriptions for controlled substances over a four-year period; that he was one of the nation’s top prescribers of a type of fentanyl, an extremely potent synthetic opioid approved to treat breakthrough pain in cancer patients; and that he linked his prescribing practices to his own financial interests. The other petitioner, Dr. Shakeel Kahn, allegedly sold controlled substances in exchange for money – and sometimes even firearms – without performing any examinations and documenting the encounters with falsified notes.
What the court held was that juries must consider whether the doctors charged Actually believed their behavior was legitimate rather than using an objective standard of a hypothetical reasonable physician. And Breyer was clear that circumstantial evidence could be important to such an investigation. This can make it difficult to prosecute some aberrant people, but a good government lawyer should weed out dishonest doctors who aren’t acting as doctors at all. The cases were remanded for consideration of jury instructions under the clarified standard.