Introduction
Next week, the Supreme Court will hear oral argument in a pair of cases that may reshape the landscape of legitimate prescribing under the Controlled Substances Act (“CSA” or “the Act”). In companion cases Ruan v. United States and Kahn v. United States, the Court is expected to resolve a circuit split over the availability and scope of acting in “good faith” as a defense for medical practitioners charged with unlawfully distributing narcotics under the CSA.
Let’s start with the Act. The CSA makes distribution of controlled substances a federal crime. The Supreme Court, through its 1975 decision in United States v. Moore, took an expansive view of the Act and held that “registered physicians can be prosecuted under [the CSA] when their activities fall outside the usual course of professional practice.”[1] Since then, lower courts have largely agreed on the elements required to support a medical practitioner’s conviction for unlawfully distributing controlled substances: (1) the practitioner knowingly and intentionally, (2) distributed or dispensed a controlled substance, (3) not for a legitimate medical purpose and outside of the usual course of professional medical practice.[2]
Courts disagree, however, over whether and under what circumstances good faith provides a defense for practitioners under the CSA. At least three different approaches to the defense exist among the circuits. And it is not uncommon for courts within an individual circuit to vary in their application of the circuit’s approach.
In many ways, the Supreme Court laid the foundation for next week’s arguments back in 1975. In Moore, the Court opened the door to good faith as a defense by positively referencing a good faith instruction given by the district court.[3] Since then, however, the Court has remained silent regarding the availability and scope of the defense. Now, nearly 50 years later, the Supreme Court will address for the first time what role, if any, a practitioner’s good faith in prescribing controlled substances plays in prosecutions under § 841.
The Cases Before the Supreme Court
In Ruan v. United States, the defendants were board-certified pain management doctors who co-owned pain management clinics and a pharmacy in Mobile, Alabama. At trial, the defendants asked the court to instruct the jury that a doctor dispensing or distributing a controlled substance in good faith must be found not guilty. The requested jury instruction defined “good faith” as “good intentions and the honest exercise of professional judgment . . . in accordance with what he reasonably believed to be proper medical practice.”[4] The district court rejected this proposed jury instruction, and on appeal the Eleventh Circuit upheld the ruling. The issue, as the Eleventh Circuit explained, was that defendants’ proposed instruction inappropriately included a subjective standard. According to the Eleventh Circuit, good faith is only a defense to a CSA violation if the defendants’ conduct “also was in accordance with the standards of medical practice generally recognized and accepted in the United States.”[5]
In Kahn v. United States, a doctor who operated pain management clinics in Arizona and Wyoming was convicted of drug trafficking and money laundering. The doctor argued that the district court erred by instructing the jury that any exercise of good faith by the doctor must be reasonable. The Tenth Circuit affirmed, holding that § 841 requires proof that the doctor “either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.”[6] The court reasoned that any argument of good faith must be buttressed by objectively reasonable behavior.
The Circuit Split
The approaches taken by the circuits to a good faith defense in this context can be divided into three general categories, though variations exist within these categories and even within individual circuits: (1) conduct-based approach; (2) objective approach; and (3) subjective approach.[7]
1. Conduct-Based Approach
Ruan and Kahn both are examples of the conduct-based approach to the good faith defense. The Tenth and Eleventh Circuits limit the availability of the good faith defense to instances where the practitioner’s conduct does not objectively fall outside of the usual course of professional practice. The Fifth Circuit similarly has applied the conduct-based approach, affirming an instruction that charged jurors to in part consider whether “from an objective standpoint . . . the drugs were dispensed in the usual course of a professional practice.”[8] By focusing on the conduct of the practitioner, as opposed to his or her state of mind when engaging in that conduct, these circuits effectively do not offer a good faith defense and impose a strict liability regime for prescribing that is found to have occurred outside of the usual course of professional practice.
2. Objective Approach to Good Faith
The Second, Fourth, Sixth, and Eighth Circuits have each adopted an objective belief approach. A practitioner distributing or dispensing controlled substances in these circuits does not violate the CSA if he or she reasonably believes that his or her actions were for a legitimate medical purpose within the usual course of professional medical practice. In contrast to the conduct-based approach, a practitioner’s objectively reasonable belief that his or her actions were legitimate and medically sound is sufficient to avoid criminal liability, regardless of whether the practitioner’s conduct was not objectively reasonable and within the usual course of professional practice. In other words, the focus is on whether the practitioner’s belief, and not his or her conduct taken in the light of prevailing medical standards, was objectively reasonable.[9]
3. Subjective Approach to Good Faith
Finally, the First, Seventh, and Ninth Circuits have applied a subjective belief approach. In these circuits, the good faith defense to prosecution under § 841 may be available when the practitioner possesses a sincere, subjective belief that he or she distributed a controlled substance for a legitimate medical purpose in the usual course of his or her professional medical practice. For example, in United States v. Sabean, the First Circuit upheld the district court’s jury instruction that “‘a sincere effort to act in accordance with proper medical practice,’ even if flawed, could not undergird a guilty verdict so long as the defendant had acted in ‘good faith.’”[10] Although the focus is on the practitioner’s own subjective belief—and not that of a reasonable doctor under similar circumstances—the practitioner’s belief must nevertheless be “sincere.”
Conclusion
Notably, the issue is coming to the court through two cases involving egregious misconduct. In Ruan, the evidence demonstrated that the doctors received kickbacks from pharmaceutical companies, prescribed medically unnecessary controlled substances without performing any medical exams, lied to insurance companies to facilitate a high volume of prescriptions, and improperly used their own pharmacy to fill prescriptions. And in Kahn the doctor regularly prescribed and dispensed large quantities of opioids in exchange for cash and personal property, including firearms.
Most unlawful prescribing investigations, however, are far less clear cut. In light of the opioid epidemic, practitioners have understandably faced increased oversight and scrutiny from state and federal law enforcement authorities over the last several years. Often, the prescribing of a controlled substance to a patient in the first instance will clearly be justified. The investigation instead will focus on the quantities and combinations of drugs prescribed, the duration of the prescriptions and other factors. Under these circumstances, relying on the practitioner’s good faith is often necessary to defend his or her exercise of medical judgment.
The questions before the Court are complex. During oral arguments, the Justices will likely attempt to untangle the dividing lines between the approaches offered by the circuit courts and work to identify a rule that is clear and suited for consistent application. In doing so, they will have to grapple with the appropriate role for the criminal justice system to play in regulating the medical profession.
We will continue to monitor developments in this area following oral arguments and the Court’s decision.
[1] United States v. Moore, 423 U.S. 122, 124 (1975).
[2] 21 U.S.C. § 841(a)(1); 21 C.F.R. § 1306.04(a). See also United States v. Chube II, 538 F.3d 693, 697–98 (7th Cir. 2008); United States v. Hurwitz, 459 F.3d 463, 475 (4th Cir. 2006); United States v. Vamos, 797 F.2d 1146, 1151–52 (2d Cir. 1986); United States v. Hayes, 794 F.2d 1348, 1351–52 (9th Cir. 1986).
[3] Moore, 423 U.S. at 138–39, 142 n.20 (referencing in dicta instructions given by the trial court that “the jury . . . had to find ‘beyond a reasonable doubt that a physician, who knowingly or intentionally, did dispense or distribute [a controlled substance] by prescription, did so other than in good faith . . . in the usual course of a professional practice and in accordance with a standard of medical practice generally recognized and accepted in the United States’” and that the defendant “could not be convicted if he merely made ‘an honest effort’ to prescribe . . . in compliance with an accepted standard of medical practice.”).
[4] United States v. Ruan, 966 F.3d 1101, 1165 (11th Cir. 2020).
[5] Id. at 1167 (approving the district court’s instruction that “told the jury that good faith was a defense to a [CSA] violation as long as the [defendants’] conduct also was in accordance with the standards of medical practice generally recognized and accepted in the United States . . .”).
[6] United States v. Kahn, 989 F.3d 806, 825 (10th Cir. 2021).
[7] The approaches described herein largely track the patterns described in the Petition for Certiorari in Kahn. See Petition for Cert. at 9, Kahn v. United States, No. 21-5261 (July 26, 2021).
[8] United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986) (finding the district court properly rejected a subjective instruction and noting that “[o]ne person’s treatment methods do not alone constitute a medical practice”).
[9] See, e.g., United States v. Hurwitz, 459 F.3d 463, 479 (4th Cir. 2006) (“[I]n a § 841 prosecution against a doctor, the inquiry into the doctor’s good faith in treating his patients . . . must be an objective one . . . .”); United States v. Vamos, 797 F.2d 1146, 1153 (2d Cir. 1986) (“[A]n instruction that the jury should use an objective standard of reasonableness in deciding whether a practitioner acted in accord with what he believed to be proper medical practice is not improper.”); United States v. Voorhies, 663 F.2d 30, 34 (6th Cir. 1981) (upholding the district court’s instruction defining good faith as “good intentions and honest exercise of best professional judgment as to a patient’s medical needs. It connotes an observance of conduct in accordance with what the physician should reasonably believe to be proper medical practice”).
[10] 885 F.3d 27, 44–46 (1st Cir. 2018) (affirming the defendant’s conviction for tax evasion, unlawful distribution of controlled substances, and health care fraud); see also United States v. Kohli, 847 F.3d 483, 489, 494 (7th Cir. 2017) (upholding jury instruction that “[t]he [d]efendant may not be convicted if he merely made an honest effort to treat his patients in compliance with an accepted standard of practical practice . . . . Good faith in this context means good intentions and the honest exercise of good professional judgment as to the patient’s medical needs”); and United States v. Feingold, 454 F.3d 1001, 1006–08 (9th Cir. 2006) (upholding jury instruction that “[g]ood faith . . . involves [a practitioner’s] sincerity in attempting to conduct himself in accordance with a standard of medical practice generally recognized and accepted in the country. Thus, good faith in this context means an honest effort to prescribe for a patient’s condition . . .”).
