In a brush-back pitch to DOJ opioid initiatives, the U.S. Supreme Court this past June issued an important decision clarifying the mental state the government must establish to convict a licensed medical professional of illegal drug distribution under the federal Controlled Substances Act (“CSA”). No longer can a doctor be convicted of such a crime based on objectively unreasonable prescribing practices alone. The government now must show that the medical professional subjectively, knowingly, and intentionally prescribed a controlled substance with no legitimate medical purpose. While unlikely to materially impact the number of DOJ opioid prosecutions, the case will no doubt inform charging decisions in marginal cases and will support important defense arguments at trial.

In Ruan v. United States, the Supreme Court overturned the convictions of two physicians for violating the CSA, holding that to convict a licensed doctor of illegal distribution of a controlled substance, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally prescribed a substance regulated by the Controlled Substances Act that was not for a legitimate medical purpose.

Ruan involved the consolidated appeal of criminal convictions of medical doctors Ziulu Ruan and Shakeel Kahn, who were convicted for distributing drugs in violation of 21 U.S.C. § 841, and each sentenced to more than 20 years’ imprisonment. Section 841 makes it a crime to, “[e]xcept as authorized . . . knowingly and intentionally . . . distribute, or dispense . . . a controlled substance.” Federal regulation authorizes controlled substance prescriptions that are “issued for a legitimate medical purposed by an individual practitioner acting in the usual course of his professional practice.” 21 CFR s 1306.04(a).

At the trials of Drs. Ruan and Kahn, jury instructions on the meaning of Section 841’s “except as authorized” clause were contested. Both juries were told that they should not convict if the doctor acted in “good faith.” Dr. Ruan’s jury was told that “good faith” meant providing treatment “in accordance with the standard of medical practice generally recognized and accepted in the United States.” Dr. Kahn’s jury was told that “good faith” meant “an attempt to act in accordance with what a reasonable physician should believe to be proper medical practice.” In affirming Dr. Ruan’s conviction, the Eleventh Circuit held that a doctor’s subjective belief that he is meeting the patient’s need was not a “complete defense,” and whether he adhered to the “usual course of his professional practice” is evaluated using an objective standard. As to Dr. Kahn, the Tenth Circuit similarly held that a conviction could stand despite the “authorized” clause if the government proved that the “prescription was objectively not in the usual course of professional practice.” Neither Circuit imposed a mental state—or mens rea—requirement on the “except as authorized” clause of Section 841. Rather, both Circuits endorsed a rule that would allow conviction where a prescription was in fact unauthorized, even if the prescribing physician believed that it was for a legitimate medical purpose.

The Supreme Court held that the trial court erroneously failed to apply a mens rea requirement to the “except as authorized” clause. Citing the fundamental goal of criminal laws to punish only conscious wrongdoing, the “general intent” mens rea requirement set forth in Section 841, the “ambiguous” terms of the federal regulation, and the steep penalties that flow from violation of the statute, the Supreme Court opted to impose a “strong scienter requirement” on that clause. In doing so, the Court rejected the government’s argument that the “except as authorized” clause was more like an exception to the rule and, consistent with another Title 21 provision governing pleading standards, the government need not refute every such “exemption or exception.”

The government also proposed a hybrid standard of “objectively reasonably good faith effort” to evaluate whether a physician’s prescribing behavior was “authorized.” While appealing to the dissent authored by Justice Samuel Alito and joined by Justices Clarence Thomas and Amy Coney Barrett, which promoted a “good faith” standard without further clarification, the majority of the Supreme Court rejected that argument, too.

The dissent also argued the “except as authorized” clause was not an element of the statute at all, but rather an “affirmative defense” undeserving of the presumption that mens rea even applies. Unpersuaded, the majority found the “except as authorized” clause to be “sufficiently like an element” to “warrant similar legal treatment,” and held that a showing of the “knowingly and intentionally” mental state was required to satisfy conviction under the clause.

The Court’s decision directly overruled holdings of the Tenth and Eleventh Circuits, and indirectly overruled other courts that had sustained convictions for prescribing controlled substances that were in fact unauthorized under federal regulations, even if the doctor subjectively believed the prescription was authorized, or for a legitimate medical purpose.

Today, DOJ prosecutors—particularly pursuing cases in the opioid space—must do more than show that no reasonable doctor would have written the prescriptions at issue. Under Ruan, DOJ now must show that the defendant physicians wrote the prescriptions knowing that they lacked a legitimate medical purpose. In opioid prosecutions, which have increased and will continue to increase along with the media around physician and opioid manufacturing cases, expert testimony that a defendant physician’s prescribing practice was within the realm of reasonable medical care will present a high hurdle for the DOJ. But prosecutors will still summon the same trial-tested circumstantial evidence to prove a medical professional’s subjective intent in opioid cases, such as quantities prescribed, patient characteristics, examination time, medical records (or lack thereof), medical necessity, adherence to distributor agreements, the disregard of patient “red flags,” and the prescriber’s financial practices.

As for Drs. Ruan and Kahn, the Tenth and Eleventh Circuits will now decide whether the outcome under the new standard would have been the same; that is, whether the jury instruction error was “harmless.”

While it is not clear whether the Ruan case will materially impact DOJ charging decisions going forward, DOJ’s enforcement efforts in the opioid space are not expected to wane any time soon. At most, the Ruan decision will influence DOJ declinations in marginal cases. Ruan will fortify defense arguments where prescribing or distribution practices, particularly those that were arguably consistent with a reasonable medical purpose, and will leave the government with the burden to establish, not just that the defendant’s prescribing practices fell short of professional standards, but that the defendant intended to prescribe without any legitimate medical purpose.

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