Supreme Court Establishes a Subjective Mens Rea Burden of Proof Under the Controlled Substances Act

Physicians and other health care workers responsible for dispensing controlled substances in accordance with the Controlled Substances Act¹  will benefit from a recent Supreme Court decision holding that, to prove criminal liability under the act, the government must prove beyond a reasonable doubt a defendant knowingly or intentionally acted in an unauthorized manner when prescribing controlled substances. With recent attention on physician overprescribing in the context of the opioid epidemic, physicians can now practice with a bit less fear that their good-faith prescribing practices will result in a criminal conviction and can instead refocus their attention on serving their patients. Indeed, with an increased burden on prosecutors, the government may (hopefully) focus its attention on only the most problematic cases or prescribers.   

The act, among other things, makes it a federal crime “[e]xcept as authorized” for “any person knowingly or intentionally . . . to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense a controlled substance.”²  Until now, to sustain a conviction under the act, the government need only prove that the prescription at issue was not authorized and that the physician who wrote it did so knowingly or intentionally. Unlike whether the physician actually wrote the prescription, the government need not prove the physician knew the prescription was unauthorized. Consequently, the Department of Justice has tested the boundaries of the act, bringing criminal prosecutions against a multitude of health care professionals.³  Essentially, the approach has meant that in prescribing, even when a physician acted in good faith and honestly believed the controlled substance was needed for a legitimate medical purpose, they were still subject to criminal prosecution if the government proved that the prescription was unauthorized, regardless the physician’s own subjective belief about its medical necessity.  

In Ruan v. United States,⁴  the Supreme Court resolved this issue, holding that the state of mind, the mens rea, required to sustain a criminal conviction must be applied to all elements of the crime, including whether the prescription was authorized.⁵  In short, the government must now prove, beyond a reasonable doubt, a physician knowingly or intentionally dispensed a controlled substance and did so intentionally or knowing that it was unauthorized. Under federal law, for a distribution to be “authorized” it must “be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.”⁶  After Ruan, the government must prove beyond a reasonable doubt that a physician knew they were prescribing, or intended to prescribe, a controlled substance without a legitimate medical reason to do so.

Ruan involved two physicians convicted under the act. Xiulu Ruan was convicted for, among other things, dispensing controlled substances outside the usual course of practice and without a legitimate medical purpose. Essentially, Ruan was convicted of running a “pill mill.” In the second case, Shakeel Kahn was convicted of 18 counts under the act regarding his distribution of controlled substance prescriptions, primarily opioids. The primary issue on appeal was the fact that the district courts did not instruct the jury to consider each physician’s subjective intent and knowledge in prescribing and whether they knew their actions were illegal. The Supreme Court determined that the jury should have been instructed to consider this because the physicians could not be convicted solely on the fact that the prescriptions themselves were not authorized. 

Through its ruling, the Supreme Court has made it more difficult for the government to criminally convict physicians for improper prescribing under the act. The court’s interpretation of the “except as authorized” clause adds a subjective element to the government’s burden in addition to the previously required objective elements. Where previously the government needed only prove beyond a reasonable doubt that a physician knowingly or intentionally dispensed or distributed a controlled substance and that the dispensing or distributing was not authorized, now the government must also prove beyond a reasonable doubt that the physician dispensed or distributed controlled substances and knew that in dispensing or distributing the controlled substance in question they were not authorized to do so.   

While Ruan addressed the conduct of two physicians, the decision appears to be applicable against any “authorized” players in the controlled substances arena. The act is not reserved solely for physicians. Pharmacists, drug manufacturers, and drug distributors are only a few of the players who fall under the act’s jurisdiction and thus may be affected by the court’s decision. The ambiguity in the statute that was present before led the government to pursue cases against these additional health care players in accordance with the act.⁷  With this added element to prove, convictions of these parties may not only become less likely to succeed but also become less likely for the government to pursue.

On its face, Ruan interpreted a federal criminal statute and is thus arguably limited to criminal cases brought under the act. However, given how the act is structured, it remains to be seen whether the decision will influence courts in federal civil cases.⁸  Civil litigation under the act arises under similar factual scenarios as those in criminal cases brought under the act. The provision of the act that governs civil violations provides that “no controlled substance . . . which is a prescription drug . . . may be dispensed without the written prescription of a practitioner.”⁹  However, the same regulation that is used to define what is “authorized” under the criminal provisions of the act are also relied upon in the civil context to define what is a proper prescription. As such, it is fair to ask whether the analysis in Ruan is applicable to civil litigation for improper prescribing. When interpreting the statute in a civil context and relying on the same definition of what is “authorized,” a civil defendant might argue that the same intent or knowledge requirement to prescribe or dispense without authorization in a criminal case would be required to prove a civil violation of the statute. For instance, a pharmacist facing civil claims under the act might, subsequent to Ruan, successfully defend their dispensing practices if they believed (and showed) the targeted prescription was “authorized” and the government was unable to prove the pharmacist knew otherwise. Time will tell how this decision influences the law in adjacent contexts. For now, physicians can focus on providing the best care for their patients a bit less concerned that they will be criminally prosecuted for doing so.      

If you have any questions regarding the content of this alert, please contact Chris Shaw, partner, at cshaw@barclaydamon.com, or another member of the firm’s Health Care Controversies Team or White Collar & Government Investigations Practice Area.

1 21 U.S.C. § 841.

2 21 U.S.C. § 841(a)(1).

3 See U.S. v. Tobin, 676 F.3d 1264, 1279 (11th Cir. 2012) (On appeal from convictions under the act, the court held that the government need only prove that the three physicians and pharmacist defendants acted knowingly and that the dispensed controlled substances were objectively not authorized); but see U.S. v. Hurwitz, 459 F.3d 463, 476 (4th Cir. 2006) (citing U.S. v. Hughes, 895 F.2d 1135, 1141–42 (6th Cir. 1990)) (a conviction under the act of a solo practitioner was overturned because the court failed to instruct the jury to objectively consider whether the physician acted in good faith); U.S. v. Collazo, 982 F.3d 596 (9th Cir. 2020) (in upholding the convictions of gang members convicted under the act, the court held the government had to prove the specific type and quantity of controlled substance involved, but not defendants’ knowledge of, or intent, with respect to the type or quantity).

4 Ruan v. U.S., 2022 U.S. LEXIS 2089 (June 27, 2022).

5 Id.  

6 21 C.F.R § 1306.04(a).

7 See U.S. v. Jones, 825 Fed. Appx. 335 (6th Cir. 2020) (evidence sufficient to convict pharmacist); U.S. v. Lovern 590 F.3d 1095 (10th Cir. 2009) (conviction of pharmacy computer technician reversed).

⁸ The Ruan case is unlikely to have any impact on cases brought in state criminal court for illegally prescribing or dispensing controlled substances. Under New York State law, to sustain a conviction for criminal sale of a prescription for a controlled substance, prosecutors were already required to prove beyond a reasonable doubt the practitioner or pharmacist acted “unlawfully” in prescribing or dispensing, which the law defines to mean “other than in the good faith in the course of his or her professional practice.”  Penal Law § 220.65[1].