Does a doctor who prescribed controlled substances outside of the usual standard of medical care violate federal drug distribution laws if the doctor believed in good faith that he was adhering to standard medical practice?
This case asks the Supreme Court to consider the requirements for criminal conviction under the Controlled Substances Act (“CSA”), 21 U.S.C. Section 841(a)(1). Two physicians, Petitioners Xiulu Ruan and Shakeel Kahn, were convicted of violating the CSA by prescribing medication without legitimate medical purposes. Both physicians brought good-faith defenses, arguing that they did not intentionally or knowingly violate the CSA. The physicians claim that a subjective lack of knowledge or intent is sufficient to maintain innocence under the CSA. At trial, juries were instructed to find the physicians innocent only if the physicians reasonably believed they were in compliance with the law. Respondent United States claims this objective standard is the correct reading of the statute, and Ruan and Kahn claim the objective standard creates an impermissibly low standard for conviction. This case has important implications for the future of medical practice, medical research, and mens rea requirements in criminal law.
Questions as Framed for the Court by the Parties
Whether a physician alleged to have prescribed controlled substances outside the usual course of professional practice may be convicted of unlawful distribution under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, he “reasonably believed” or “subjectively intended” that his prescriptions fall within that course of professional practice
Petitioner Dr. Xiulu Ruan owned and operated a pain clinic and pharmacy with his partner Dr. John Couch. United States v. Ruan, at 1121–22. From January 2011 to May 2015, Ruan and Couch prescribed over 475,000 doses of Transmucosal Immediate-Release Fentanyl Medicines (“TIRFs”), a type of opioid, to patients at rates which often doubled the next highest prescriber in the United States. Id. at 1123. Often, Ruan and Couch signed prescriptions for patients they had never met or had met only once. Id. at 1127.
In 2016, the United States indicted Ruan and Couch for violating 21 U.S.C. Section 841(a)(1), a provision of the Controlled Substances Act (“CSA”), and other offenses based on Section 841(a)(1). Id. at 1120. At trial, the government’s case centered around demonstrating that Ruan and Couch’s prescriptions deviated from the course of standard practice and were not administered for a legitimate medical purpose. Id. at 1127. Ruan and Couch countered that both doctors believed they were prescribing opioids within the usual course of professional practice. Id. After both sides rested, Ruan and Couch requested that the judge instruct the jury that, so long as Ruan and Couch acted in good faith, the doctors did not violate Section 841(a)(1). Id. at 1165. The district-court judge refused and instead instructed the jury that Ruan and Couch could be held criminally liable if the doctors’ practices prescribed controlled substances in such a way that was so out of line with medical practice as to be unrecognizable. Id. at 1166 The jury ultimately found Ruan and Couch guilty of violating Section 841(a)(1) and various offenses for which the Section 841(a)(1) count was a predicate offense. Id.
Ruan and Couch appealed to the United States Court of Appeals for the Eleventh Circuit, arguing that the evidence presented was insufficient to support the convictions and that the district court’s jury instructions were legally erroneous. Id. at 1121. But agreeing with the trial judge’s holding that “good faith” only acts as a defense where a defendant was already acting within standard medical practice, the Eleventh Circuit affirmed the district court’s judgment. Id. at 1169. Ruan and Couch subsequently filed a petition for certiorari, requesting the Supreme Court review the Eleventh’s Circuit’s decision.
Petitioner Dr. Shakeel Kahn owned and operated his own private medical practice in Ft. Mohave, Arizona where he specialized in pain management. United States v. Kahn at 812–13. Kahn regularly prescribed patients with a variety of controlled substances, including opioids. Id. In 2016, the United States charged Kahn with violating Section 841(a)(1) and other related offenses. Id. at 813. Similar to Ruan, the government relied mainly on evidence that Kahn’s practice deviated significantly from standard medical practice. Id. at 815. Like the judge in Ruan, the trial judge instructed the jury that the government can prove Kahn did not act in “good faith” by demonstrating that he dispensed controlled substances outside the usual course of medical practice. Id. at. 813. The jury returned a guilty verdict, and Kahn appealed, contesting among other things the judge’s good-faith instruction. Id. at 826. The United States Court of Appeals for the Tenth Circuit affirmed on appeal. Id. Kahn subsequently filed a petition for certiorari, requesting the Supreme Court review the Tenth Circuit’s decision.
On November 5, 2021, the Supreme Court granted Ruan and Kahn’s respective petitions for certiorari and consolidated the doctors’ cases.
CSA SECTION 841(a)(1)’s KNOWLEDGE REQUIREMENT
Petitioners Ruan and Kahn (“the Physicians”) argue that CSA Section 841(a)(1) contains a knowledge requirement. Brief for Petitioner, Shakeel Kahn at 14. The Physicians contend that under traditional principles of statutory interpretation, a culpable mental state is required for criminal convictions unless Congress clearly indicates otherwise. Id. Further, the Physicians state that any mens rea, or mental state, requirement listed for one element of a crime applies to all material elements of the crime without a clear congressional statement to the contrary. Brief for Petitioner, Xiulu Ruan at 17-18. The Physicians note that the CSA explicitly states that “knowingly or intentionally” providing controlled substances to people violates the statute. Id. The Physicians conclude that the knowledge or intent requirement therefore applies to all material elements of a CSA crime. Id. Therefore, the government must prove that a physician knowingly or intentionally provided illegitimate medication to convict the physician under the statute. Brief for Kahn at 27.
The Physicians argue that the text, structure, and history of the CSA indicate that knowledge or intent is required for conviction. Brief for Ruan at 17. The Physicians note that the CSA has no mental state requirement for actions that result in civil penalties or misdemeanor convictions. Id. at 23. Therefore, the Physicians assert, Congress must have intended to require a mental state for any harsher penalties, such as those the Physicians face. Id. Finally, the Physicians highlight that in previous cases under the CSA’s predecessor law (the Harrison Narcotics Act), the Court assumed that knowledge or intent was required to convict any defendant, even though the Harrison Narcotics Act had less explicit mental state requirements than the CSA. Id. at 26–28. The Physicians state that the CSA’s more explicit reference to mental states shows that Congress intended to affirmatively support a mental state requirement for convictions under the statute. Id. The Physicians conclude that they cannot be convicted under the CSA because they did not knowingly or intentionally violate the statute. Id.
Respondent United States argues that under correct statutory interpretation principles, the knowledge and intent requirements do not apply to violations of the statute. Brief for Respondent, United States at 24–25. The United States contends that any mental state requirements apply to the text following, but not preceding, such requirements. Id. The United States notes that in the text of CSA Section 841(a), the knowing and intentionality language comes after the statement “[e]xcept as authorized by this subchapter.” Id. at 20. The United States concludes that under the correct interpretation of this section, physicians are only exempt from liability if “authorized” by the statute, meaning if they follow generally accepted medical practice. Id. Therefore, according to the United States, Physicians’ argument that they did not knowingly or intentionally violate the statute is without merit. Id.
The United States asserts that its interpretation makes the most sense, because ignorance or mistakes regarding laws are generally not valid defenses in criminal proceedings. Id. at 25. The United States claims that the Physicians’ argument requires ignoring this general principle. Id. The United States argues that this is because the Physicians’ knowledge in this case relates to legal knowledge, the CSA’s requirements, and not factual knowledge. Id. The United States thus posits that the statute would be inconsistent with general principles of criminal law if it required knowingly violating the CSA. Id. The United States therefore argues the Physicians’ interpretation is inconsistent with both statutory interpretation and general principles of criminal law. Id. The United States concludes that the statute does not require proof of either knowledge or intent for conviction. Id. at 30. Hence, the United States notes that under the correct legal standard, a physician may be convicted under the statute if the physician fails to make “objectively honest or good-faith effort[s] to act as a reasonable doctor would.” Id.
SUBJECTIVE OR OBJECTIVE STANDARD FOR THE GOOD-FAITH DEFENSE
The Physicians argue that their “good faith” defense should be judged on a subjective standard. Brief for Ruan at 30-31. The Physicians contend that only a subjective standard is compatible with the statute’s knowledge and intent requirement. Id. The Physicians state that an objective standard for the good-faith defense creates a negligence standard for conviction. Id. at 33. The Physicians first note that this is inconsistent with the rest of the statute, which imposes only civil liabilities for acting recklessly, which is a “higher” requirement than negligence. Id. at 23–24. The Physicians next argue that negligence is not a high enough standard for criminal convictions, because criminal law seeks to punish those who knowingly commit wrongs. Id. The Physicians argue that someone acting negligently does not have this awareness. Id. The Physicians conclude that an objective standard is reasonable for civil liability, but not for criminal convictions which carry higher penalties and prison time. Brief for Kahn at 30-31.
The United States contends that the Court has already considered, and rejected, a subjective standard for the good-faith defense. Brief for United States at 26–28. The United States notes that in a previous case relating to physician wrongdoing, United States v. Moore, the Court applied an objective good-faith standard. Id. at 30. The United States contends that in Moore, the Court explicitly rejected applying anything but an objective standard. Id. at 28. The United States further argues that an objective standard is consistent with the history of the CSA, which shows that Congress intended to strengthen patient protections compared to the previous laws under the Harrison-Narcotics Act. Id. at 31. The United States claims that applying a subjective standard to the good-faith defense permits physicians to escape criminal liability even when they act outside the bounds of normal medical practice. Id. at 32. The United States asserts that this understanding would also protect physicians that refuse to conform to legal requirements. Id. at 33. The United States concludes that such a subjective standard is undesirable because it would “upset existing legal understandings” and “expand the notion of good faith beyond plausible limits.” Id.
JURY INSTRUCTIONS ON THE GOOD-FAITH DEFENSE
The Physicians claim that the jury instructions in their respective trials used the wrong good-faith defense language and also negated the good-faith defense altogether. Id. at 49. The Physicians contend that their respective juries were instructed that the Physicians were innocent only if the Physicians acted in good faith as judged against a reasonable physician acting in their position. Brief for Kahn at 10. The Petitioners argue that this incorrectly applies an objective, rather than subjective, standard to the defense. Id. The Physicians further argue that the jury instructions then removed the good-faith defense altogether. Brief for Ruan at 49. The Physicians state that the jury was instructed to find the Physicians guilty simply if the Physicians deviated from professional norms. Id. at 48. The Physicians contend that this instruction removes the good-faith defense altogether because the instruction allows a jury to convict any physician that commits regular malpractice. Id. at 48–49. The Physicians assert that in Cheek v. United States, the Court vacated a conviction because jury instructions on the good-faith defense used objective language when the required mens rea for the crime was willfulness. Brief for Kahn at 29–30. The Physicians conclude that the same result is appropriate in this case because the jury instructions resulted in impermissibly low standards for conviction. Id. at 29.
The United States asserts that the courts provided correct jury instructions in the Physicians’ cases. Brief for Respondent at 44. The United States first states that the juries were given instructions that are consistent with the correct legal standard. Id. The United States claims that the district courts permissibly denied the Physicians’ respective proposed jury instructions. Id. at 44–45. Next, the United States argues that the jury instructions included multiple references to “good faith” and therefore, even if certain parts of the instructions did not mention good faith, the jury understood good faith to be part of the overall instructions. Id. at 44–45. Finally, the United States argues that any jury instruction defects were “harmless” and did not change the outcome of either trial. Id. at 47–48. Therefore, the United States claims, the Physicians do not deserve new trials because the jury instructions were neither erroneous, nor outcome-determinative. Id. at 48–49.
EFFECT ON MEDICAL RESEARCH AND PRACTICE
Professors of health law and policy (“the Professors”), in support of Ruan, argue that the petitioners’ proposed good-faith defense to criminal liability is necessary to allow medical research to flourish. Brief for Amici Curiae Professors of Health Law and Policy, in Support of Petitioner at 14. According to the Professors, without a good-faith defense Section 841(a)(1) would likely criminalize a physician using experimental treatment methods, adopted only by a minority of physicians. Id. However, the Professors posit that medical innovation requires doctors to do exactly that, or else the medical field will not grow or evolve. Id. at 15–16
Further, the Professors contend that without such a defense, Section 841(a)(1) would disincentivize physicians from prescribing controlled substances to patients that need them. Id. at 14–15. Compassion and Choices (“Compassion”), also in support of Ruan, adds that if physicians are discouraged from prescribing controlled substances, end-of-life medical care would particularly suffer. Brief for Amicus Curiae Compassion & Choices, in Support of Petitioner at 9. Compassion asserts that other end-of-life patients require controlled substances to deal with pain and using pain medication in this way is sometimes considered an “off-label” use. Id. Compassion warns that a doctor would risk criminal liability under Section 841(a)(1) by making such prescriptions. Id.
The United States counters that the Professors’ dire predictions about a chilling effect on the medical profession are unfounded. Brief for Respondents, United States of America at 41. The United States contends that Section 841(a)(1) recognizes the practice of medicine is not absolutely homogenous because the analysis under the statute is not a determination of many accepted medical practices in the community. Id. The United States concludes that a physician could still follow the practice of a minority subgroup of experimental physicians so long as by doing so the physician’s actions are still recognizable to the medical community. Id. at 43
Additionally, the United States argues that adopting its interpretation of Section 841(a)(1) would not cause physicians to under-prescribe controlled substances to those in need. Id. at 42. By the United States’ account, a physician can still prescribe a controlled substance for off-label purposes without violating Section 841(a)(1) so long as the physician is adhering to some recognized form of medical practice. Id. at 43. The United States clarifies that simply prescribing a controlled substance for an off-label use does not necessarily rise to the level of unrecognizable medical practice. Id.
MEDICAL MALPRACTICE AND FEDERALISM
The Cato Institute (“Cato”), in support of Ruan, argues that without a good-faith defense, Section 841(a)(1) would absorb state malpractice law. Brief for Amicus Curiae the Cato Institute, in Support of Petitioners at 14–15. In addition, Cato highlights that four circuits have explicitly noted that without a good-faith defense, a doctor who merely committed malpractice may be found guilty under Section 841(a)(1). Id. at 15–16. Finally, Cato adds that states are better equipped than the federal government to regulate malpractice, as the public tends to hold States accountable for the human harms of poor medical care. Id. at 17.
In response, the United States counters that even without a good-faith defense, a gap still remains between Section 841(a)(1) and state malpractice law. Brief for Respondents, United States of America at 41. In support of this assertion, the United States highlights that a physician is liable for malpractice in Alabama when the physician fails to conform to proper standards of medical care, causing an actual injury. Id. at 42. The United States argues that a physician could then be liable for malpractice under Alabama law without violating Section 841(a)(1) so long as the physician fell short of the standard by mere negligence. Id.
- Brendan Pierson, SCOTUS to Weigh Good Faith Defense in Illicit Prescription Cases, Reuters (Nov. 5, 2021)
- Adam Lidgett, Feds Urge High Court to Back Doctors’ Opioid Convictions, Law360 (Jan. 20, 2022)
- Alexandra Hussey, SCOTUS to Examine “Good Faith” Defense in Criminal Opioid Prescription Cases, ReedSmith (Nov. 10, 2021)