Supreme Court Clarifies That Medical Providers Cannot Be Convicted Of Illegal Drug Distribution If Prosecutors Do Not Prove the Intent To Issue Unauthorized Scripts

By Aloke S. Chakravarty and Nicolas A. Misuraca

In Justice Breyer’s final opinion from the bench in a 9-0 decision, the United States Supreme Court clarified that for a physician to be criminally convicted of distributing a controlled substance, the Department of Justice must prove that a physician intended to dispense a controlled substance for an inappropriate purpose when he raises an affirmative defense that such prescription was authorized. The case is Ruan v. United States, available here.

It is a crime for any person, except as authorized, to knowingly or intentionally dispense a controlled substance. 21 U.S.C. § 841(a). Two doctors, Xiulu Ruan and Shakeel Kahn, were both separately convicted for allegedly running “pill mills” under this statute and sentenced to decades in federal prison.

It is an affirmative defense to this charge if the defendant can show they were authorized to dispense the controlled substances. During their trials, the doctors presented evidence showing they were practicing physicians who had valid licenses to prescribe controlled substances and were therefore issuing authorized prescriptions. As an affirmative defense, the burden to disprove this authorization then shifted to the Government. In both cases, relying on the prevailing jury instructions, the Government met its burden, which did NOT require that the doctors know their prescriptions were improperly issued.

The jury instructions used required only that the Government show the doctors prescribed controlled substances in a manner outside the objective standard of medical practice to be “unauthorized.” In effect, the instructions did not require a showing that the doctors intended to issue a bad prescription, which would capture conduct that might otherwise be a mistake or error. The prevailing instructions were influenced by a Federal Drug Administration regulation that said a doctor’s prescription is authorized when it is issued “for a legitimate medical purpose…acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a) (2021).

The Court held the required mental state in the charging statute, knowingly or intentionally, like many criminal statutes, also applies to the except as authorized language. This means the objective, negligence-like hurdle applied in the trial courts was erroneous because it did not require the Government to show that a doctor knew or intended to issue unauthorized prescriptions. Under the new decision, once a defendant doctor meets their burden of production to show that they can legally issue the prescription, the burden shifts back to the Government that must show—beyond a reasonable doubt—a doctor prescribed controlled substances in a manner they actually knew was unauthorized.

Justice Alito, writing in concurrence, reached the same result, but diverged from the majority opinion in two major ways. First, he complained that it is an “innovation” to apply a mens rea to an affirmative defense. He pointed out that mens rea is applied to elements of an offense, not to an affirmative defense. Secondly, he took issue with the requirement that the Government must rebut the authorization affirmative defense beyond a reasonable doubt. He complained applying this higher standard to an affirmative defense was concocted “out of thin air” because the usual rule is the lower by a preponderance of the evidence.

The concurrence predicted this “innovation” could be applied to a multitude of affirmative defenses potentially leading to confusion and disruption among prosecutors, defense attorneys and lower courts.

The implications of this opinion remain to be seen, but the Supreme Court has clarified that a strong mens rea requirement helps reduce the risk of “over-deterrence,” i.e., punishing conduct that lies close to, but on the permissible side of, the criminal line. For many criminal charges, including financial crimes and allegations of corporate fraud, proving that an individual intended to do something they knew to be wrong can be a challenge for the Government. We should expect to see this criminal decision cited in other prosecutions where an affirmative defense is raised. Only time will tell whether Justice Alito’s concerns materialize.  The Department of Justice will surely continue to bring such prosecutions and will attempt to gather evidence that disproves any foreseeable affirmative defense.