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It Is Now Harder to Convict Physicians for Allegedly Improper Prescriptions

By: Matthew R. Palmer-Ball & Alexa J. Elder

A ruling this week from the U.S. Supreme Court will transform the U.S Department of Justice’s (“DOJ”) widespread prosecutions of physicians it views as improperly prescribing narcotics to patients, shifting the ground in favor of physician defendants.  In Ruan v. United States, Nos. 20–1410 and 21–5261, — S. Ct. —-, 2022 WL 2295024, *3 (June 27, 2022), the Court held that, for a physician to be convicted of illegally prescribing narcotics under the Controlled Substances Act, the government must prove beyond a reasonable doubt that the doctor “knew that he or she was acting in an unauthorized manner, or intended to do so.”  The holding simultaneously made it easier for physicians to mount a defense at trial and created a new component to the government’s evidentiary burden. 

In Ruan, juries in two separate trials convicted two different doctors for dispensing drugs in ways that were not “authorized,” id. at *3–4, i.e., overprescribing narcotics.  The statutory framework for both prosecutions began with a provision of the Controlled Substances Act:

Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally–

(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or

(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.

21 U.S.C. § 841(a) (emphasis added).  From there, a doctor’s prescription would be “authorized” if it was “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(a) (2021).

In Ruan, the Court held that the statute’s “knowingly and intentionally” requirement applied to its “[e]xcept as authorized” proviso.  Id. at *3.  Procedurally, the Court explained that, once a defendant physician produces evidence at trial that her conduct was “authorized,” the burden then shifts to the government to “prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”  Id. at *5.  Therefore, as long as a defendant physician makes some evidentiary showing that the prescription was authorized—and keep in mind that this showing does not need to meet the high bar of “beyond a reasonable doubt”—then the government has an additional legal standard to prove, which it arguably did not have to prove before Ruan, and must do so beyond a reasonable doubt.

In both trials considered in Ruan, the physicians sought to defend themselves by showing that they had dispensed narcotics via “valid” prescriptions.  Id. at *4.  Under Ruan’s holding, that evidentiary showing should have put the burden back on the government to prove that the defendants knew their prescriptions were not “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

This holding is noteworthy because, as the concurring opinion points out, the “[e]xcept as authorized” proviso is not an element of the offense, id. at *11 (J. Alito concurring), and the government generally has the burden of proving only the offense elements by the high standard of “beyond a reasonable doubt.”  It is also noteworthy because, again as the concurring opinion highlights, the Court chose not to treat the “[e]xcept as authorized” proviso as an affirmative defense, which would have shifted the burden to defendants to prove beyond a reasonable doubt that their prescriptions were authorized.  Id. at *11–12. 

In reaching its holding, the Court rejected several notions.  First, the Court declined to allow a doctor to be convicted simply for writing an objectively unauthorized prescription—the doctor must have known the prescription was unauthorized.  Id. at *3.  Second, the Court refused to grant the government’s request for a good-faith standard, i.e., requiring the government to “prov[e] beyond a reasonable doubt that the defendant did not even make an objectively reasonable attempt to ascertain and act within the bounds of professional medicine” when prescribing the narcotics.  Id. at *8.  Lastly, the Court was not swayed that its ruling might allow doctors to “escape liability by claiming idiosyncratic views about their prescribing authority” because, by the Court’s reasoning, the government is able to use a doctor’s idiosyncrasies against her.  Id. (stating “the more unreasonable a defendant’s asserted beliefs or misunderstandings are, especially as measured against objective criteria, the more likely the jury will find that the Government has carried its burden of proving knowledge”) (quotation marks and citation omitted).

Ruan’s direct consequences are clear, but its indirect implications remain to be seen.  On one hand, Ruan will certainly affect improper-prescription cases at trial.  Physician defendants can now mount a de facto defense by making a simple evidentiary showing, and the government will then have an additional standard, if not technically an element, to prove at trial beyond a reasonable doubt.  On the other hand, only time will tell whether this decision may weaken DOJ’s approach to these prosecutions more broadly, with the possibility that having to convince juries of an arguably vague standard—“issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice”—will discourage the government from prosecuting these cases and simultaneously bolster defendants’ negotiating positions in plea bargaining.

Matthew R. Palmer-Ball

Matt Palmer-Ball is a seasoned trial attorney and former federal prosecutor. He concentrates his practice in the areas of complex commercial litigation, white collar crime, and internal and government investigations. Prior to joining Wyatt, Matt served as a Trial Attorney with the U.S. Department of Justice’s Public Integrity Section and as an Assistant U.S. Attorney for the District of Columbia. Read more.

Alexa J. Elder

Alexa Elder is a member of the firm’s Litigation & Dispute Resolution team. She assists with the representation of a broad range of clients in a variety of cases, including appellate practice, constitutional law and commercial litigation. Read more.

Alexa J. Elder
Alexa Elder is a member of the firm’s Litigation & Dispute Resolution team. She assists with the representation of a broad range of clients in a variety of cases, including appellate practice, constitutional law and commercial litigation. Read More
Matthew R. Palmer-Ball
Matt Palmer-Ball is a seasoned trial attorney and former federal prosecutor. As co-leader of the firm’s White Collar Defense practice, he concentrates his practice in the areas of complex commercial litigation, white collar crime, and internal and government investigations. Prior to joining Wyatt, Matt served as a Trial Attorney with the U.S. Department of Justice’s Public Integrity Section and as an Assistant U.S. Attorney for the District of Columbia. In those roles, he tried three... Read More