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Fourth Circuit Vacates Where Instructions Failed to Inform Jury That Mens Rea of ‘Knowingly or Intentionally’ Applies to ‘Except as Authorized’ in 21 U.S.C. § 841(a)(1)

by Douglas Ankney


The U.S. Court of Appeals for the Fourth Circuit vacated the convictions of Dr. Joel Smithers because the instructions failed to inform the jury that the mens rea of “knowingly or intentionally” of 21 U.S.C. § 841(a)(1) applied to that statute’s “except as authorized” provision.

Smithers was charged with 861 counts related to his opioid-prescription practices – one count of possession of a controlled substance with intent to distribute, in violation of §§ 841(a)(1) and (b)(1)(C); one count of maintaining a place for the purpose of unlawful distribution in violation of 21 U.S.C. § 856; and 859 counts of unlawful dispensing and distributing of a controlled substance in violation of § 841(a)(1).

At Smithers’ trial, the parties proposed differing instructions related to § 841(a)(1). In pertinent part, the statute reads: “Except as authorized ..., it [is] unlawful for any person knowingly or intentionally ... to manufacture, distribute, or dispense ... a controlled substance.” The parties’ dispute concerned the definition of “[e]xcept as authorized.” The Government requested it be defined in the disjunctive – that the medications were prescribed “without a legitimate medical purpose or beyond the bounds of medical practice.” In contrasat, Smithers requested the instruction be in the conjunctive – “without a legitimate medical purpose and beyond the bounds of medical practice.” The District Court sided with the Government. The jury convicted Smithers on all counts. He was ultimately sentenced to an aggregate term of 480 months’ imprisonment, and he timely appealed.

While Smithers’ appeal was pending, the U.S. Supreme Court granted certiorari in Kahn v. United States, No. 21-5261 (2021), to determine whether jury instructions presenting the unlawful-dispensing charge in the disjunctive (as opposed to the conjunctive) were proper. Smithers’ appeal was held in abeyance until the issue was addressed in the consolidated case of Ruan v. United States, 597 U.S. 450 (2022).

Ruan, while not directly addressing the disjunctive versus conjunctive issue, held that the “knowingly or intentionally” terms of § 841(a)(1) applies to that statute’s “except as authorized” provision. And a prescription is only “authorized” when issued “for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04.

The Fourth Circuit asked for supplemental briefing post-Ruan. Smithers then “more directly” argued that the jury “instructions improperly stated an objective mens rea standard.” He objected to the disjunctive language (i.e., “without a legitimate medical purpose or beyond the bounds of medical practice”) in Instructions 15, 19, and 20 that he argued “(1) failed to state that Smithers could only be convicted if he knew that his conduct was unauthorized and (2) created a strict liability offense by phrasing the mens rea requirements in the disjunctive.”

The Court observed the “key issue is ‘whether the instructions, construed as a whole, and in light of the whole record, adequately informed the jury of the controlling legal principles without misleading or confusing the jury to the prejudice of the objecting party.’” Noel v. Artson, 641 F.3d 580 (4th Cir. 2011).

The District Court had also given a “good-faith” instruction which stated, in pertinent part: “‘Good faith’ means that the physician acted with good intentions in the honest belief that he was attempting to act in accord with the standards of medical practice generally recognized and accepted in the medical profession. This is an objective test, and not a subjective one. In other words, a physician cannot substitute his views of what is good medical practice in place of generally accepted norms simply because he believes it proper.”

The Court, quoting from Ruan, stated “that words like ‘good faith,’ ‘objectively,’ ‘reasonable,’ or ‘honest effort’ appear nowhere in the statute and would ‘turn a defendant’s criminal liability on the mental state of a hypothetical ‘reasonable’ doctor, rather than on the mental state of the defendant himself or herself.’” The Court explained that by stating the terms in the disjunctive it was possible for the jury to find Smithers guilty if the jury believed he acted outside of the “objective standard” of “the bounds of medical practice.” But Ruan held that the statute requires proof that a defendant “knowingly and intentionally” acted beyond the bounds of medical practice. In other words, the question for the jury was not whether Smithers acted beyond an objective standard but whether he so acted with the mens rea of “knowingly and intentionally.” Consequently, the Court determined that the instructions, as a whole, failed to adequately inform the jury of the controlling legal principles.

The Court further determined that the error was not harmless. An error is harmless where the Court can conclude, beyond a reasonable doubt, that the “jury verdict would have been the same absent the error.” Neder v. United States, 527 U.S. 1 (1999). Smithers testified at trial regarding the medical histories, accidents, pain, and suffering of each patient for whom the Government had presented evidence. It was possible that a juror who had been properly instructed as to the mens rea requirement would have found that, while Smithers’ conduct didn’t meet an objective standard, subjectively Smithers believed his conduct was within the bounds of medical practice, the Court concluded.

Accordingly, the Court vacated Smithers’ convictions and remanded to the District Court for proceedings consistent with its opinion. See: United States v. Smithers, 92 F.4th 237 (4th Cir. 2024).

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United States v. Smithers



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