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SCOTUS Announces Government Must Prove Physicians in § 841 Prosecutions ‘Knowingly and Intentionally’ Exceeded Their Authorization to Prescribe Controlled Substances, Such as Opioids

by Harold Hempstead

The Supreme Court of the United States (“SCOTUS”) held that 28 U.S.C. § 841’s “knowingly or intentionally” mens rea requirement applies to the “except as authorized” clause in criminal prosecutions against physicians, meaning that the Government must prove beyond a reasonable doubt that the defendant-physician had the subjective intent of knowingly or intending to issue a prescription for a controlled substance that is not authorized by statute. 

Xiulu Ruan and Shakeel Kahn (together, “Doctors”), who were both physicians registered with the DEA to prescribe controlled substances, were charged and tried for allegedly violating the “provision of the Controlled Substance Act, codified at 21 U.S.C. § 841, [which] makes it a federal crime, except as authorized, ... for any person knowingly or intentionally ... to manufacture, distribute, or dispense ... a controlled substance such as opioids 84 Stat. 1260, 21 U.S.C. § 841(a).”

Both Doctors argued at their separate trials that they wrote their prescriptions in “good faith” in accordance with 21 CFR § 1306.04(a), which states that a prescription is authorized when it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” The Doctors also argued that even if their prescriptions did not comply with this regulation, they did not subjectively knowingly or intentionally deviate from it, while the Government argued that they objectively did so.

The U.S. District Court for the Southern District of Alabama rejected Ruan’s request for a jury instruction requiring the Government “to prove that he subjectively knew that his prescriptions fell outside of the scope of his prescribing authority” in favor of an objective standard. Hence, the District Court instructed “the jury that a doctor acts lawfully when he prescribes ‘in good faith as part of his medical treatment of a patient in accordance with the standard of medical practice generally recognized and accepted in the ... [U.S.].’” It also instructed that a doctor violates § 841 when “the doctor’s actions were either not for a legitimate medical purpose or were outside the usual course of professional medical practice.”

The U.S. Court of Appeals for the Eleventh Circuit affirmed Ruan’s convictions, stating that whether “a defendant acts in the usual course of his professional practice must be evaluated based on an objective standard, not subjective standard.”

Similarly, the U.S. District Court for the District of Wyoming disagreed with Kahn on how the jury should be instructed on mens rea. That court instructed the jury that it should acquit “if it found that Kahn acted in ‘good faith,’ defined as ‘an attempt to act in accordance with what a reasonable physician should believe to be the proper medical practice.’” The District Court also stated that a finding of “good faith” had to be based on Kahn acting “in an honest effort to prescribe for patients’ medical conditions in accordance with generally recognized and accepted standards of practice.”

The U.S. Court of Appeals for the Tenth Circuit affirmed Kahn’s convictions, ruling that a conviction under § 841 requires the Government to prove that a defendant-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.”

SCOTUS granted both Doctors’ petitions for certiorari and consolidated them “to consider what mens rea applies to § 841’s authorization exception,” i.e., “is it sufficient for the Government to prove that a prescription was in fact not authorized, or must the Government prove that the doctor knew or intended that the prescription was unauthorized?”

The Court held in favor of the latter interpretation of the statute requiring a subjective mens rea and announced: “This means that once a defendant meets the burden of producing evidence that his or her conduct was ‘authorized,’ [to write prescription for controlled substance] the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.” 

The Court started its analysis by discussing the general principles regarding culpable mental state known as “scienter,” i.e., the requisite knowledge required to hold a person criminally responsible for his actions. See Rehaif v. United States, 139 S. Ct. 2191 (2019). In general, when interpreting criminal statutes, there’s a presumption “that Congress intends to require a defendant to possess a culpable mental state.” Id. The Court explained that when a statute contains a general scienter provision, terms such as “knowingly” apply to both the words immediately following them as well as other statutory terms that “separate wrongful from innocent acts.” Id.

Turning to the present case, the Court observed that § 841 contains a general scienter provision and then provided the following four reasons as to why the “knowingly or intentionally” mens rea provision applies to the “except as authorized” clause in § 841.

(1) The SCOTUS’ history of applying the presumption of scienter supports “[a]pplying § 841’s ‘knowingly or intentionally’ mens rea to the ... [except as authorized] clause thus helps advance the purpose of scienter” by helping separate criminal from noncriminal acts, see X-Citement Video, 513 U.S. 64 (1994);

(2) What “plays a ‘crucial’ role in” determining whether a doctor violated § 841 or whether he engaged in innocent “socially beneficial conduct” hinges on whether the doctor “issued an unauthorized prescription ... not the fact of the dispensation itself” since prescriptions generally benefit society, see id.;

(3) Imposing the mens rea provision to the authorization clause helps reduce the risk of the innocent being found guilty as a result of the ambiguity in the regulatory language that defines what constitutes an authorized prescription, see Gonzales v. Oregon, 546 U.S. 243 (2006); and

(4) The severity of the penalties for violation of § 841 – 20 years to life imprisonment and fines up to $1 million – is not associated with statutory provisions that typically fall outside the ordinary scienter requirements, e.g., minor regulatory or public welfare offenses carrying only minor penalties. See Staples v. United States, 511 U.S. 600 (1994).

The Court instructed that 21 U.S.C. § 885requires that once a defendant in an§ 841prosecution produces evidence of his authorization to distribute controlled substances, the burden shifts back to the Government to “prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an authorized manner.”

Thus, the Court ruled that both Courts of Appeals “evaluated the jury instructions under an incorrect understanding of § 841’s scienter requirements.”

Accordingly, the Court vacated the judgments of both of the Courts of Appeals and remanded the cases for further proceedings consistent with its opinion. See: Ruan v. United States, 142 S. Ct. 2370 (2022).

Writer’s note: Lynn Webster, a former president of the American Academy of Pain Medicine, said that physicians who try in good faith to help their patients no longer have to worry about being convicted of violating § 841 based on what some government expert testifies is the objective “standard of care.”

Webster described the Court’s ruling as “the most significant health care decision by the Supreme Court in 50 years ... [it] will rein in the overzealousness and lawlessness of the DEA and Justice Department ... [and it] is a monumental decision that will literally save lives ... because fewer patients will be abandoned by their doctors for fear of losing their freedom.”  

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