The Supreme Court today unanimously sided with two physicians who were convicted of drug trafficking based on opioid prescriptions that federal prosecutors portrayed as medically inappropriate. Six justices said the government is required to prove that a doctor "knowingly or intentionally" exceeded the authorization for medical use of controlled substances. Three justices disagreed with the majority's legal analysis but concluded that a doctor cannot be convicted of drug trafficking if he acted in "good faith."
The decision in Ruan v. United States sends both cases back to the lower courts so they can assess the defendants' arguments that the instructions received by the juries that convicted them misstated the law seriously enough that they are entitled to new trials. But whether or not they prevail on those claims, the ruling represents an important limit on prosecutions that have long had a chilling effect on pain treatment. Physicians who prescribe opioids based on an honest belief that they are practicing good medicine now have less reason to fear that they will nevertheless face federal charges that could send them to prison for decades.
Kate Nicholson, executive director of the National Pain Advocacy Center, is "thrilled with the ruling," which she says "entirely tracked the argument we made in our amicus curiae brief." Under Ruan, she notes in an email, "doctors authorized to prescribe controlled substances can only be convicted for violating the Controlled Substances Act when they intend or know that they are prescribing in an unauthorized manner." That requirement, she says, is especially important for "doctors treating patients in pain, who might otherwise be deterred from meeting the needs of their patients by the fear that disagreement with their medical judgment would subject them to serious criminal liability."
The question for the Court was how to interpret 21 USC 841, a provision of the Controlled Substances Act (CSA). "Except as authorized by this subchapter," Section 841 says, "it shall be unlawful for any person knowingly or intentionally" to "distribute" or "dispense" a controlled substance. The CSA authorizes physicians registered with the Drug Enforcement Administration (DEA) to prescribe controlled substances. But according to a CSA regulation, a valid prescription "must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice."
Xiulu Ruan, a board-certified Alabama pain specialist, was sentenced to 21 years in federal prison for violating Section 841 by prescribing opioid analgesics "outside the usual course of professional medical practice." He was also ordered to pay millions of dollars in restitution and forfeiture. Casper, Wyoming, physician Shakeel Kahn, whose appeal was consolidated with Ruan's, was sentenced to 25 years in prison for the same offense. In both cases, the prosecution argued that the defendants were legally indistinguishable from drug dealers, while the defendants argued that they wrote prescriptions in a good-faith belief that they were medically appropriate.
In Ruan's case, the jurors were instructed that a doctor complies with the CSA when he acts "in good faith as part of his medical treatment of a patient in accordance with the standard of medical practice generally recognized and accepted in the United States." They were also told that a doctor violates Section 841 when his actions "were either not for a legitimate medical purpose or were outside the usual course of professional medical practice."
The U.S. Court of Appeals for the 11th Circuit sustained Ruan's convictions. A doctor's "subjectiv[e] belie[f] that he is meeting a patient's medical needs by prescribing a controlled substance," it said, is not a "complete defense" to charges under Section 841. Quoting an earlier decision, the 11th Circuit said "whether a defendant acts in the usual course of his professional practice must be evaluated based on an objective standard, not a subjective standard."
In Kahn's case, the jurors were told that he should be acquitted if he acted in "good faith," meaning he made "an attempt to act in accordance with what a reasonable physician should believe to be proper medical practice." As the trial court defined it, a finding of "good faith" required the jury to conclude that Kahn "acted in an honest effort to prescribe for patients' medical conditions in accordance with generally recognized and accepted standards of practice."
Kahn's convictions also were sustained on appeal. To prove a CSA violation, the U.S. Court of Appeals for the 10th Circuit said, the government had to show either that Kahn "subjectively knew a prescription was issued not for a legitimate medical purpose" or that he "issued a prescription that was objectively not in the usual course of professional practice."
As the appeals courts saw it, Ruan and Kahn were guilty unless they complied with an "objective" standard of medical care. The implication was that a physician could be convicted of drug trafficking even if he sincerely believed he was doing what a doctor should do.
During oral argument in March, several justices were clearly dismayed by the idea that a doctor could accidentally be guilty of crimes punishable by long prison sentences (up to 20 years per violation and 20 years to life if the offense results in "death or serious bodily injury") and exorbitant fines (up to $1 million per offense). It is therefore not surprising that the Court ended up rejecting that theory, although the fact that every justice saw something wrong with the way such cases have been handled is striking evidence that the government's traditional approach was unjust and seriously misguided.
The majority opinion by Justice Stephen Breyer, which was joined by Chief Justice John Roberts and Justices Sonia Sotomayor, Elena Kagan, Neil Gorsuch, and Brett Kavanaugh, concludes that the phrase "knowingly or intentionally" should be read as applying not only to the act of dispensing a controlled substance but also to a doctor's failure to do so "for a legitimate medical purpose…in the usual course of his professional practice." Although that interpretation may be grammatically problematic, Breyer says, it is consistent with "a longstanding presumption, traceable to the common law, that Congress intends to require a defendant to possess a culpable mental state" in order to be guilty of a crime.
In the context of medical prescriptions, Breyer notes, "it is the fact that the doctor issued an unauthorized prescription that renders his or her conduct wrongful, not the fact of the dispensation itself. In other words, authorization plays a 'crucial' role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct." Breyer says the "language of §841 (which explicitly includes a 'knowingly or intentionally' provision); the crucial role authorization (or lack thereof ) plays in distinguishing morally blameworthy conduct from socially necessary conduct; the serious nature of the crime and its penalties; and the vague, highly general language of the regulation defining the bounds of prescribing authority all support applying normal scienter principles to the 'except as authorized' clause."
The Court therefore concludes that "the statute's 'knowingly or intentionally' mens rea applies to authorization." The implication, it says, is that "once a defendant meets the burden of producing evidence that his or her conduct was 'authorized,' the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner."
Does that mean that anything goes as long as a doctor claims he thought he was complying with the CSA? No, Breyer says, because the government can still "prove knowledge of a lack of authorization through circumstantial evidence."
The government "argues that requiring it to prove that a doctor knowingly or intentionally acted not as authorized will allow bad-apple doctors to escape liability by claiming idiosyncratic views about their prescribing authority." But Breyer notes that "the regulation defining the scope of a doctor's prescribing authority does so by reference to objective criteria such as 'legitimate medical purpose' and 'usual course' of 'professional practice.'"
While merely failing to satisfy those "objective criteria" is not enough to make a doctor guilty of violating Section 841, the extent of the deviation can be viewed as evidence that he knowingly violated the law. "As we have said before," Breyer writes, "'the more unreasonable' a defendant's 'asserted beliefs or misunderstandings are,' especially as measured against objective criteria, 'the more likely the jury…will find that the Government has carried its burden of proving knowledge.'"
In a concurring opinion joined by Justices Clarence Thomas and Amy Coney Barrett, Justice Samuel Alito rejects the argument that the phrase "knowingly or intentionally" applies to exceeding the CSA's authorization for medical use. But he says the Court's cases dealing with the Harrison Narcotics Tax Act, a predecessor to the CSA, indicate that a doctor cannot be convicted of violating Section 841 if he "writes prescriptions 'in good faith.'" Alito therefore joins the majority in concluding that the decisions by the appeals courts should be vacated and that the cases should be sent back "for further proceedings."
Alito also faults the majority for treating lack of authorization as an element of the offense rather than treating authorization as an affirmative defense. In his view, the burden should be on the defendant to prove it is more likely than not that he acted in good faith. The prosecution therefore would not have to disprove that claim beyond a reasonable doubt.
Despite these differences, all of the justices agreed that a doctor's subjective good faith matters. While prosecutors can still introduce testimony indicating that a physician deviated from widely accepted medical practices, the point of such evidence will be to show that the defendant knowingly broke the law, not merely that other doctors would have made different decisions. Given the ongoing medical and scientific debates about how best to treat pain, that distinction is crucial.
"This is the most significant health care decision by the Supreme Court in 50 years," Lynn Webster, a former president of the American Academy of Pain Medicine, says in an email. "It is the first time the Court [has] interpreted the federal Controlled Substances Act and its application to a criminal case involving the good-faith defense in the context of prescribing. The Court correctly decided that a physician has a right to a good-faith defense."
Webster notes that the Court's holding means doctors cannot be convicted merely for departing from "the standard of care" as defined by the government. "This has been an egregious misinterpretation of the CSA," he says. "Physicians have been afraid to prescribe controlled substances even with an appropriate indication for fear of a government expert testifying they believe it is not the standard of care. Standard of care should never be used to determine criminal conduct. That is a civil matter."
Webster says the Court's decision will "rein in the overzealous[ness] and lawlessness" of the DEA and the Justice Department. The decision's beneficiaries, he says, "will be prescribers who are trying in good faith to help people," plus their patients. "This is a monumental decision that will literally save lives," he adds, "because fewer patients will be abandoned by their doctors for fear of losing their freedom."