On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United States, the Supreme Court overturned two doctors’ convictions under the Controlled Substances Act, ruling that the trial courts improperly applied lowered burdens of proof proposed by the U.S. Department of Justice (DOJ).

Supreme Court: DOJ Must Prove that Doctors Knowingly or Intentionally Dispensed Opioids Without Authorization in Criminal Cases

Specifically, the doctors were convicted under 21 U.S.C. Section 841. This law makes it a federal crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . [to] dispense . . . a controlled substance.” 21 C.F.R. Section 1306.04(a) grants authorization for registered doctors to dispense prescribed controlled substances—provided that the prescription is, “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of [the practitioner’s] professional practice.”

At the trial level, the DOJ secured a conviction in each of the underlying cases by relying, in part, on 21 U.S.C. Section 885. Subsection (a)(1) of this law states:

“It shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceedings under this subchapter, and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.”

Based on this language, the DOJ argued that the requirement to prove that a doctor acted “knowingly and intentionally” under Section 841 does not apply to the element of authorization. In other words, the DOJ sought—successfully at the trial level—to prosecute without evidence that the defendant doctors knowingly or intentionally prescribed numerous opioid prescriptions without authorization under 21 C.F.R. Section 1306.04(a) (i.e., due to the drugs not being used for legitimate medical purposes). However, this is not what Section 885 is intended to do. As the Supreme Court explains in Ruan v. United States:

“Section 885 simply absolves the Government of having to allege, in an indictment, the inapplicability of every statutory exception in each Controlled Substances Act prosecution. Section 885 also shifts the burden of production—but not the burden of persuasion—regarding statutory exceptions to the defendant.”

In Ruan, the DOJ also sought to impose a reduced standard for determining whether dispensing opioids without authorization rises to the level of a criminal offense under the Controlled Substances Act. The Supreme Court rejected this effort as well. Explaining the Court’s reasoning, Justice Breyer writes:

“Resisting the ‘knowingly or intentionally’ standard, the Government instead [argues] we should read the statute as implicitly containing an ‘objectively reasonable good-faith effort’ or ‘objective honest-effort standard.’ . . . That is to say, once a defendant meets his or her burden of production [to establish authorization to prescribe], the Government can convict ‘by proving 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.’”

The Opinion then goes on to bluntly state, “We are not convinced.”

In rejecting the government’s effort to impose a “good-faith effort” or “objective honest-effort” standard in opioid prescription cases, the Supreme Court relied on four primary justifications:

• The Presumption of Scienter – There is a presumption of scienter (or a requirement for a culpable mental state) in criminal proceedings at the federal level. Justice Breyer writes, “The presumption of scienter applies even when a statute does not include a scienter provision, and when a statute does ‘includ[e] a general scienter provision,’ ‘the presumption applies with equal or greater force’ to the scope of that provision.”
• The Plain Language of the Statute – As the Supreme Court notes, the plain language of Section 841 does not contain the “good-faith effort” or “objective honest-effort” standards that the federal government sought to impose at the trial level. Instead the statute “uses the familiar mens rea words ‘knowingly and intentionally,’” so these are the standards that should apply.
• The Government’s Attempt to Shift Focus from the Doctor’s Actual Mental State to a Hypothetical Standard – The Supreme Court notes that the Government’s standards would shift the focus of criminal prosecution under Section 841 from the defendant doctors’ actual mental state to, “the mental state of a hypothetical ‘reasonable’ doctor.” While this standard is often applied in civil medical malpractice litigation, using this standard under Section 841 would be inconsistent with fundamental principles of criminal jurisprudence.
• Rejection of Analogous Suggestions in Prior Cases – Justice Breyer also writes that the Court has “rejected analogous suggestions in other criminal contexts.” He then gives the example of Elonis v. United States, 575 U.S. 723 (2015), in which the Court held that “[h]aving liability turn on whether a ‘reasonable person’ regards [a] communication as a threat—regardless of what the defendant thinks—reduces culpability on the all-important element of the crime to negligence,” and further emphasized that it has, “long been reluctant to infer that a negligence standard was intended in criminal statutes.”

In short, the Supreme Court resoundingly rejected the DOJ’s efforts to prosecute doctors for routinely prescribing controlled substances or medically-unnecessary opioids without evidence that the doctors either knew or intended to issue the prescriptions despite this lack of medical necessity. Ultimately, the Supreme Court concluded:

“[Section] 841’s ‘knowingly or intentionally’ mens rea applies to the ‘except as authorized’ clause. This means that in a §841 prosecution in which a defendant meets his burden of production under §885 [to establish that the 21 C.F.R. Section 1306.04(a) authorization applies], the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”

What Are the Implications for Doctors Who Have Been Convicted (and Who are Facing Prosecution) Under Section 841?

For other doctors who have been convicted under Section 841—and for those who are currently facing prosecution under Section 841—the Supreme Court’s decision in Ruan v. United States could have significant implications. The Supreme Court’s decision effectively creates a presumption of lawfulness whenever a doctor dispenses a prescribed medication “for a legitimate medical purpose” and when “acting in the usual course of [the practitioner’s] professional practice.” In particular, doctors who have been convicted or are currently facing prosecution based on the DOJ’s proposed “good-faith effort” or “objective honest-effort” standard under Section 841 appear to have clear grounds to challenge this approach.

With that said, Ruan v. United States is not a “get out of jail free” card for doctors who have been convicted during the opioid epidemic—this is true even for those convicted under the DOJ’s now-defunct “good-faith effort” and “objective honest-effort” standards.

“The Supreme Court’s decision in Ruan V. United States could significantly impact the prosecutions and convictions of many doctors targeted during the nation’s opioid crisis. While there is no question that some doctors have criminally contributed to the crisis, those who are innocent deserve justice. Fortunately, Ruan now provides these innocent doctors a second chance.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

The DOJ can still prosecute cases based on the standards that the Supreme Court affirmed. If DOJ prosecutors can prove that a doctor knowingly or intentionally prescribed opioids without evidence of medical necessity (or outside of the normal course of the doctor’s practice), then it can still secure a conviction under Section 841. While 21 C.F.R. Section 1306.04(a) provides a limited shield for doctors who meet their burden of production under Section 885, it is still entirely possible that the DOJ could have adequate evidence of knowledge or intent as a result of a DEA investigation or other federal inquiry to prove guilt beyond a reasonable doubt.

As a result, whether on appeal or remand, the DOJ may argue that allowing the jury to consider the “good-faith effort” and “objective honest-effort” standards amounts to nothing more than harmless error. If the evidence presented at trial was still sufficient for the jury to conclude that the defendant-doctor knowingly or intentionally dispensed medically-unnecessary opioids, then the DOJ may assert—and the court could agree—that the defendant’s conviction should stand. Thus, in addition to raising the Supreme Court’s decision in Ruan v. United States, convicted doctors may also need to proactively address the question of whether the prosecution’s evidence establishes the requisite knowledge or intent to support a conviction—the implications of Ruan v. United States notwithstanding.

Even so, any doctor who has been convicted of illegally dispensing opioids or who is currently facing charges under the Controlled Substances Act would be well-served to seek legal advice in light of the Supreme Court’s recent holding. As more doctors appeal their convictions (hundreds have been convicted under Section 841 during the opioid epidemic), we will likely gain a clearer picture of how the federal courts will judge the impact of Ruan v. United States in jurisdictions across the country.