Subjective Knowledge of Unauthorized Conduct Required for Conviction under 21 U.S.C. § 841

Introduction

The Fourth Circuit’s decision in United States v. George P. Naum, III, 20-4133 (4th Cir. Apr. 11, 2025) applies and amplifies the Supreme Court’s scienter holding in Ruan v. United States, 597 U.S. 450 (2022), in the context of medical-practice prosecutions under 21 U.S.C. § 841(a)(1). Dr. Naum, an osteopathic physician licensed in West Virginia, was convicted for conspiring with and aiding a nurse who prescribed suboxone without proper supervision or authorization. On appeal, he argued that the district court’s jury instructions failed to require the government to prove that he subjectively knew his conduct was unauthorized. The Fourth Circuit agreed that the instructions mischaracterized Ruan’s mens rea rule, but under plain-error review, concluded that Naum did not carry his burden to show a reasonable probability of a different outcome had the jury been properly instructed. This case clarifies how post-Ruan prosecutions under § 841 must handle the subjective knowledge element when charging “unauthorized” or “outside the bounds of professional practice.”

Summary of the Judgment

The Fourth Circuit affirmed Dr. Naum’s convictions for one count of conspiracy under 21 U.S.C. § 846 and four counts of aiding and abetting distribution of controlled substances outside professional practice under § 841(a). The court held:

The jury instructions misstated federal law after Ruan by failing to require proof that Naum knew his conduct was outside the bounds of professional practice.
Naum did not invoke invited error because Ruan was decided after his trial.
Because Naum did not preserve his Ruan objection at the jury‐charge conference, plain‐error review applies.
Although the instructional error was “clear and obvious,” Naum failed to show the error affected his substantial rights or undermined the fairness of the trial.
The convictions were therefore affirmed.

Analysis

Precedents Cited

Ruan v. United States, 597 U.S. 450 (2022): Held that § 841(a)(1)’s “knowingly or intentionally” mens rea applies both to distribution of controlled substances and to proof that the distribution was unauthorized. A defendant must have subjective awareness that his conduct was not properly authorized.
United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006): Prior Fourth Circuit decision describing § 841’s elements in medical prosecutions—distribution “not for legitimate medical purposes in the usual course of professional medical practice.”
United States v. Smithers, 92 F.4th 237 (4th Cir. 2024): Applied Ruan to jury instructions, holding that a disjunctive instruction (“without a legitimate medical purpose or beyond the bounds of practice”) fails to preserve the required subjective mens rea absent an instruction that the defendant knew his conduct was unauthorized.
United States v. Olano, 507 U.S. 725 (1993): Established the plain‐error standard for preserved and unpreserved errors under Federal Rule of Criminal Procedure 52.

Legal Reasoning

1. Ruan’s Dual-Mens Rea Requirement. The court began by reiterating Ruan’s core holding: to secure a § 841(a)(1) conviction, the government must prove beyond a reasonable doubt both that the defendant knowingly distributed a controlled substance and that he “knew or intended that his conduct was unauthorized.” 597 U.S. at 457. Prior to Ruan, Fourth Circuit precedent had used an objective standard—“not for a legitimate medical purpose” or “beyond the bounds of professional practice”—without requiring proof of subjective knowledge.

2. Jury Instruction Error. At trial, the district court instructed the jury that it must find only that Dr. Naum “knowingly” distributed suboxone and that his actions were “outside the bounds of professional medical practice.” The charge did not tell jurors they must also find he knew his actions were unauthorized. The Fourth Circuit held this omission “misstates the law after Ruan” and is “clear and obvious.”

3. Preservation and Standard of Review. The government argued the invited‐error doctrine barred Naum’s challenge, because he had requested the same instructions. The Fourth Circuit declined to apply invited error when the law changed after trial. However, because Naum did not explicitly object to the instructions at the charge conference, the error was unpreserved, warranting plain‐error review under Rule 52(b).

4. Plain Error Analysis. Under plain‐error review, Naum bore the burden to show (a) error, (b) that is clear and obvious, (c) affecting substantial rights (i.e., a reasonable probability of a different result), and (d) that correction is necessary to preserve the fairness or integrity of proceedings. While the court found error and obviousness, Naum failed to demonstrate a reasonable probability that the verdict would have been different had the jury been told to find his subjective knowledge of unauthorized conduct. The voluminous record evidence established he knew Jackson was prescribing and changing dosages without authorization, yet he signed off on charts to keep patients from overdosing. Thus, his substantial‐rights argument and any claim of serious unfairness collapsed.

Impact

This decision confirms that after Ruan, every § 841(a)(1) prosecution—especially those premised on “unauthorized” medical practice—must include a jury instruction requiring proof that the defendant subjectively knew his conduct fell outside legal or professional bounds. Failure to do so is a reversible error in future cases if preserved, and a plain error if not preserved. The case also sharpens the interplay between objective misconduct (medical practice regulations) and subjective mens rea in controlled‐substances law. Trial courts should revise standard instructions and charge conferences to focus squarely on the dual scienter requirement.

Complex Concepts Simplified

Mens Rea (Scienter): The mental state a defendant must have to be guilty. Here, it means knowing both that a substance is controlled and that the distribution is unauthorized.
“Outside the Bounds of Professional Medical Practice”: A legal phrase describing distribution not conforming to accepted medical standards. Post-Ruan, the government must prove the defendant subjectively knew the conduct was outside those bounds.
Plain‐Error Review: An appellate standard for unpreserved errors. The defendant must show (1) a clear or obvious error, (2) affecting substantial rights (reasonable probability of a different outcome), and (3) that failure to correct it would seriously compromise fairness or integrity.
Invited Error Doctrine: A rule that a party cannot litigate an error on appeal when it requested or agreed to the very error at trial. Here, the Fourth Circuit declined to apply it because the controlling law changed after trial.

Conclusion

United States v. Naum reaffirms and refines the principle established in Ruan: to convict under 21 U.S.C. § 841(a)(1) for unauthorized distribution, the government must prove the defendant’s subjective knowledge that his conduct was unauthorized. Although the Fourth Circuit found the district court’s jury instructions plainly erroneous in omitting that requirement, it upheld Dr. Naum’s convictions because the record overwhelmingly showed he knew of the unauthorized prescribing yet signed patient charts anyway. Going forward, this decision places trial courts and litigators on notice to explicitly frame jury instructions around the dual scienter requirement—knowledge of distribution and knowledge of lack of authorization—to safeguard convictions from reversible error.