Supreme Court requires more proof in controlled substances prescribing cases

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The majority concluded that the mental intent requirement does indeed apply not only to the conduct in issuing a prescription but also to a prescriber’s awareness of whether the prescription is authorized.

On June 27, the United States Supreme Court held (6-3) in Xiulu Ruan v. United States, and the companion case of Shakeel Kahn v. United States,[1] that in prosecutions under the Controlled Substances Act (“CSA”), the government can sustain a conviction only by proving beyond a reasonable doubt that a defendant prescriber issued a controlled substance prescription knowing or intending to do so without authorization. The issue arises in the context of Title 21 of the United States Code, Section 841(a), which states that, “[e]xcept as authorized . . . it shall be unlawful for any person knowingly or intentionally . . . to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance.” 21 U.S.C. § 841(a) (emphasis added).A related regulation states that “[a] prescription for a controlled substance to be effective must be 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).

The question before the Court was whether the so-called mens rea requirement (i.e., the mental intent requirement of “knowing” or “intentional” conduct) applies only to the action (i.e., the manufacture, distribution, or dispensing) or whether it also applies to the prescriber’s awareness of the authorization for issuing the prescription.The majority concluded that the mental intent requirement does indeed apply not only to the conduct in issuing a prescription but also to a prescriber’s awareness of whether the prescription is authorized.In other words, in future prosecutions of prescribers, the U.S. Department of Justice will now be required to prove that a prescription was not issued “for a legitimate medical purpose” and “in the usual course of . . . professional practice” by proving the prescriber issued the prescription knowing or intending that the prescription would be issued without authorization.And in such prosecutions it will no longer be sufficient for federal prosecutors to prove that no reasonable physician could have believed the prescription was appropriate; instead, the prosecution will have to prove that the particular prescriber subjectively believed the prescription was inappropriate.

Under prior case law, the prosecution could merely rely upon an objective standard to prove that a prescriber was not acting in “good faith,” “reasonably,” or with “honest effort” in issuing a prescription.But as the Court pointed out, this came much too close to a standard of negligence, which is routinely used in civil cases, but is generally insufficient in most criminal cases, where the mental intent element typically requires proof of a higher state of awareness, such as knowledge and intent.Or, as the Court put it, the government’s preferred good faith reasonableness or “honest effort” standard “would turn a defendant’s criminal liability on the mental state of a hypothetical ‘reasonable’ doctor, not on the mental state of the defendant himself or herself.”[2]Consequently, rather than prove the objective standard of what a reasonable prescriber would or should have known to be the case, the government must now satisfy a harder subjective standard—that is, proof of what the particular prescriber actually knew or intended regarding his or her authority to issue the prescription.Naturally, this all makes the task of prosecutors harder; the task of defense counsel correspondingly easier.

The case against Drs. Xiulu Ruan and Shakeel Kahn arose from their convictions for dispensing controlled substances not “as authorized.” The Court ruled the jury instructions in the doctors’ respective trials (which did not require jurors to consider whether the physicians subjectively believed they were prescribing in good faith) were wrong based upon its analysis of the statute.That analysis led the Court to conclude that proof of a prescriber’s intent applies to the authorization to issue the prescription for several reasons, including:(1) the language of the statute; (2) the fact that criminal law typically requires proof of elevated intent; (3) the fact that the authorizing language in the statute is critically important to the distinction between blameworthy conduct meriting prosecution (i.e., improper prescribing not for a proper medical purpose and outside the usual course of professional practice) and blameless conduct that is socially beneficial (i.e., prescribing for a proper medical purpose in the usual course of professional practice); (4) the very serious implications of a conviction (which include lengthy prison sentences and substantial fines); and (5) the vagueness of the associated regulatory language in § 1306.04(a).

Justice Samuel Alito authored a concurring opinion, which Justice Clarence Thomas joined and Justice Amy Coney Barrett joined in part. Justice Alito opined that the “except as authorized” language in the statute is not an element of the offense the government is required to prove; rather it is an affirmative defense a defendant can raise.Consequently, the intent element adopted by the majority is inapplicable to the authorization of the prescription.Justice Alito would instead have required proof that the physician merely acted in good faith in issuing the prescription.

In our roles both as a former federal prosecutors who has prosecuted opioid diversion, and as defense counsel who regularly represent prescribers under investigation, we have had front-row seats both to the challenges of appropriate prescribing, and to the effects of improper prescribing.As the statistics and recent government enforcement announcements make clear, the opioid epidemic has hardly ceased.[3]Physicians should continue to consult appropriate federal and state prescribing guidance, and seek legal counsel when appropriate.

[1] 597 U.S. __ (2022).

[2] Slip Op. at 13.

[3] According to the Center for Disease Control and Prevention (“CDC”), more than 11.5 million Americans, aged 12 or older, reported misusing prescription opioids in 2016. See Centers for Disease Control and Prevention, About CDC’s Opioid Prescribing Guideline, (June 30, 2022) The over prescribing of opioid drugs by health care professionals is a leading cause of the crisis. Initiatives to contain and eliminate the widespread illegal distribution of opioids focus upon both health care fraud and prosecution of drug diversion offenses. Recently, the DOJ’s Criminal Division announced the formation of the New England Prescription Opioid (“NEPO”) Strike Force to identify and investigate health care fraud schemes and prosecute individuals involved in the illegal distribution of prescription opioids and other prescribed controlled substances.See Press Release, U.S. Dep’t of Justice, “Justice Department’s Criminal Division Creates New England Prescription Opioid Strike Force to Focus on Illegal Opioid Prescriptions,” available at (last visited June 30, 2022).

Saul Ewing Arnstein & Lehr attorneys regularly counsel physicians and health care professionals with respect to prescribing issues and defend clients with regard to federal and state investigations related to these activities.

Bruce D. Armon, a Partner in the Healthcare Practice at Saul Ewing Arnstein & Lehr, counsels clients on how federal and state health care laws affect health care businesses and providers.

Justin C. Danilewitz, a Partner in the White Collar and Government Enforcement Practice at Saul Ewing Arnstein & Lehr, and former Assistant U.S. Attorney, represents physicians and practice groups in government investigations.

Athira Sivan, an Associate in the Healthcare Practice at Saul Ewing Arnstein & Lehr, represents organizations and health care businesses on corporate matters.