The U.S. Supreme Court Just Overturned Two Doctors’ Opioid Convictions. What Does This Mean for You?
In a notable decision for doctors who prescribe opioid medications to their patients, the U.S. Supreme Court recently overturned the convictions of two doctors who were charged with illegally dispensing opioids—potentially filling hundreds of thousands of unlawful prescriptions between 2011 and 2015. The Supreme Court’s decision in Ruan v. United States is important not only for the doctors involved, but potentially for numerous other doctors who have been convicted of unlawfully dispensing opioids and who are currently facing charges under the Controlled Substances Act.
Doctors Have Been a Prime Target for the DOJ During the Opioid Epidemic
While the U.S. Department of Justice’s (DOJ) efforts to target opioid manufacturers have received widespread media attention, the DOJ’s efforts to target doctors have received relatively little coverage. But, the DOJ has secured the convictions of hundreds of doctors under the Controlled Substances Act in recent years—and many of these doctors are still sitting in federal prisons.
What Does the Controlled Substances Act Say about Opioid Prescriptions?
The Controlled Substances Act does not address opioid prescriptions directly. Instead, the DOJ has been targeting doctors under the Controlled Substances Act’s general prohibition on dispensing controlled substances without authorization. This prohibition appears in 21 U.S.C. Section 841, which states in pertinent part:
For doctors, the key language that allows them to dispense opioid prescriptions to patients is, “Except as authorized.” As the Supreme Court explained in Ruan v. United States, this language brings into play 21 C.F.R. Section 1306.04(a), which states in part:
This language, the Supreme Court stated (and other courts have stated as well), creates an “authorization” for doctors to prescribe opioids consistent with Section 1306.04(a).
Reading Section 841 of the Controlled Substances Act and 21 C.F.R. Section 1306.04(a) together, it is clear that doctors can only face criminal prosecution if they knowingly or intentionally dispense opioids (or other controlled substances) without the authorization implicitly granted for prescriptions issued “for a legitimate medical purpose” and in the usual course of a doctor’s medical practice.
What Did the DOJ Argue?
In Ruan v. United States, the DOJ argued that its obligation to prove that a doctor acted “knowingly or intentionally” does not apply to the “authorization” provision of Section 841. The DOJ sought to prosecute (and did so successfully in multiple cases) without relying on evidence that defendant-doctors knowingly or intentionally dispensed opioids without a legitimate medical purpose. Instead, the DOJ argued, the “knowingly and intentionally” standard only applies to the question of whether the doctor “dispense[d] . . . a controlled substance” (using the relevant language from Section 841).
As for the question of authorization, the DOJ argued that a different, lower, standard should apply. Specifically, the DOJ asserted (again, successfully in multiple cases) that whether a doctor violated Section 841 with respect to authorization should be judged based on a “good-faith effort” or “objective honest-effort” standard.
What Did the Supreme Court Decide?
In Ruan v. United States, the Supreme Court rejected the DOJ’s approach on both counts. It identified several flaws with the DOJ’s arguments; and, as a result, it reversed the doctors’ convictions in both underlying cases, remanding them for further proceedings. The Supreme Court’s holdings in Ruan v. United States include:
1. The “Presumption of Scienter” in Federal Criminal Cases Applies to Prosecutions Under Section 841 of the Controlled Substances Act
The Supreme Court affirmed that there is a “presumption of scienter” in federal criminal cases. This means that it is presumed that federal criminal statutes require proof of a criminal state of mind—which typically means proof that the defendant acted knowingly or intentionally. Specifically, the Court stated in Ruan v. United States that, “[t]he 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.”
Since Section 841 includes the language “knowingly or intentionally,” it is entitled to the strongest presumption that the obligation to prove scienter applies to all elements of the offense. Under Section 841, this includes the element of prescribing opioids and other controlled substances without the authorization granted under 21 C.F.R. Section 1306.04(a).
2. The “Plain Language” of Section 841 Requires the DOJ to Prove Knowledge or Intent
The Supreme Court also based its decision, in part, on the “plain language” of Section 841. In other words, simply reading the statute makes clear that the DOJ must prove knowledge or intent in order to secure a conviction. In addition to referencing the language that is in Section 841, it also took time to point out that the DOJ’s proposed “good-faith effort” or “objective honest-effort” standards do not appear in the statutory language.
3. The DOJ’s Proposed “Good-Faith Effort” and “Objective Honest-Effort” Standards Would Shift the Focus Away from Doctors’ Actual Mental States
Mental state (or “scienter”) is a key element of criminal culpability (scienter often is not required in civil enforcement proceedings), and the DOJ cannot avoid its burden to prove a doctor’s mental state beyond a reasonable doubt. As the Supreme Court explained, adopting the DOJ’s proposed “good-faith effort” and “objective honest-effort” standards would shift the focus away from doctors’ actual mental states to what a hypothetical doctor would have thought under similar circumstances.
But, as the Supreme Court pointed out, what other doctors might think is not relevant to determining whether a particular doctor acted criminally. To prove that a doctor illegally dispensed opioids in violation of Section 841, the DOJ must prove not simply that the doctor knowingly or intentionally dispensed opioids, but also that the doctor knowingly or intentionally did so without a legitimate medical purpose or outside of the scope of the doctor’s normal practice.
4. The Supreme Court has Already Rejected the DOJ’s Efforts to Lower the Standard for Criminal Culpability in Prior Cases
Finally, the Supreme Court noted that it has “rejected analogous suggestions [from the DOJ] in other criminal contexts.” Effectively, the Court held, the DOJ’s proposed “good-faith effort” and “objective honest-effort” standards would allow doctors to be convicted based on mere evidence of negligence. In rejecting the DOJ’s arguments, the Court emphasized that it has, “long been reluctant to infer that a negligence standard was intended in criminal statutes.”
What Does This Mean for Doctors Convicted During the Opioid Crisis?
So, what does the Supreme Court’s decision in Ruan v. United States mean for doctors convicted during the opioid crisis?
Simply put, it means that many of these doctors may have grounds to file an appeal. Effectively, the Supreme Court’s decision creates a presumption that a doctor complies with the law whenever the doctor prescribes an opioid medication “for a legitimate medical purpose” and when “acting in the usual course of [the practitioner’s] professional practice.” For a conviction under Section 841 to be valid, it must be based on evidence that the doctor knowingly or intentionally violated either or both of these requirements. If a doctor’s current conviction is based merely on evidence of a lack of “good-faith effort” or “objective honest-effort” to determine whether an opioid prescription was medically necessary, this is not a valid basis for the doctor’s conviction—and the conviction should not stand.
In light of the Supreme Court’s decision in Ruan v. United States, doctors who have been convicted of illegally dispensing opioids during the nation’s opioid epidemic should consult with a lawyer to determine if they now have grounds to file an appeal.
What Does This Mean for Doctors Who Have Criminal Cases Pending?
For doctors who have criminal cases pending under Section 841 of the Controlled Substances Act, the Supreme Court’s decision in Ruan v. United States could mean that they have new defenses at their disposal. If the DOJ is basing its prosecution on evidence that you failed to use “good-faith effort” or “objective honest-effort” to determine whether an opioid prescription was medically necessary, this is no longer an adequate justification for a criminal conviction. Depending on the current status of your case, you may have grounds to file a motion to dismiss, or you may have strong new defenses that you can assert at trial. If warranted by the facts at hand, now may be a good time to target plea negotiations as well.
Discuss Your Case with a Federal Healthcare Defense Lawyer at Oberheiden P.C.
If you have questions about what the Supreme Court’s decision in Ruan v. United States means for you as a doctor facing criminal charges for illegally dispensing opioid medications, we encourage you to contact us promptly. Call 888-680-1745 or get in touch online to discuss your case with a senior lawyer at Oberheiden P.C. as soon as possible.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.