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Ruan Is A Victory for Liberty

In Ruan, the Court checked the government’s power of prosecution. 

(Steve Heap/Shutterstock)

The Supreme Court has ended its 2021-2022 term and left the republic with much to digest. While Ruan v. United States may not be the most well-known or controversial case, the legal outcome and the warning it carries should not go unnoticed. 

As everyone knows, doctors may prescribe controlled substances that are otherwise generally unlawful for persons to distribute. The statute at issue makes it a federal crime “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” Therefore, this federal criminal statute could be used to prosecute doctors only if the doctor is not authorized to distribute or dispense the controlled substance.


Per federal regulation, doctors are only authorized to prescribe controlled substances for a legitimate medical purpose in the ordinary course of the doctor’s professional practice. In Ruan, two doctors were convicted under the statute for dispensing controlled substances not “as authorized.” The essential question was what standard to use to determine whether the doctors were acting as authorized.

To understand the issue in this case, we must briefly summarize via example two important concepts in criminal law: the difference between elements of a crime and an affirmative defense to a crime, and the concept of a culpable mens rea or criminal mental state. 

The common law elements of murder were “killing another human being with malice aforethought,” and the typical burden of proof for criminal prosecution is that one has committed each of those elements beyond a reasonable doubt. So, to be convicted of common-law murder, the prosecution would have to prove beyond a reasonable doubt that the defendant 1) killed another human being 2) with malice and 3) “aforethought,” or in a premeditated way. 

Proving the elements of a crime is the prosecution’s burden. This is distinct from an affirmative defense, such as self-defense in a murder case. If someone is accused of murder but claims he acted in self-defense, the burden is on the defendant to prove that he acted in self-defense. “Not in self-defense” is not an element of the crime, so it is not the prosecution’s job to prove beyond a reasonable doubt that the killing was not in self-defense.

The mens rea requirement simply means that the government must prove that a criminal defendant had a guilty mental state when he committed the criminal act. Generally, criminal law requires that a person committed the crime knowingly or intentionally; sometimes recklessly suffices. As the Ruan majority points out, our criminal law is meant to “punish the vicious will” and with few exceptions “wrongdoing must be conscious to be criminal” (internal quotations omitted).


The majority opinion in Ruan grapples with the above concepts, particularly how the phrase “except as authorized” fits into the federal crime of distribution of a controlled substance. Is an unauthorized distribution an element of the crime that the prosecutor must prove beyond a reasonable doubt? Is an authorized distribution an affirmative defense that the accused doctor must prove? If a doctor claims he was authorized, does the “knowingly or intentionally” mental state apply to the unauthorized-use portion of the statute? 

The majority opinion reads the “except as authorized” clause as something of a hybrid between an element and an affirmative defense. It is a defense in that it is initially up to the defendant to claim he was authorized. But once the defendant gives evidence that he was authorized, it is up to the prosecution to prove beyond a reasonable doubt that the defendant was not authorized. Further, the majority opinion applies the “knowingly or intentionally” clause to the authorization clause, so that the prosecution must prove that the doctor knowingly or intentionally acted without authorization. 

This is the case, despite the fact that this reading is grammatically incorrect. The “knowingly or intentionally” language comes after the “except as authorized” clause and does not modify that part of the sentence. Regardless, the Court held that once a defendant doctor raises the issue that he was authorized to prescribe a controlled substance, the prosecution must prove beyond a reasonable doubt that the doctor knowingly or intentionally acted in an unauthorized manner.

If your reaction to the above analysis is that it seems to get to the right answer while being a bit convoluted, Justices Alito, Thomas, and Barrett agree with you. Justice Alito’s concurrence in the Ruan case agrees that the criminal statute was incorrectly applied to the two doctors. But he is rightfully concerned that the majority opinion has created “a new hybrid that has some characteristics of an element and some characteristics of an affirmative defense. The consequences of this innovation are hard to foresee, but the result may well be confusion and disruption.” He writes that this innovation is not only novel and potentially problematic, but is also “entirely unnecessary.” 

Justice Alito refers back to the Harrison Act, which was the precursor to the current statute. The standard for whether a doctor was acting in the course of professional practice and thus was authorized to dispense the controlled substance was whether he was acting within his “bona fide medical practice.” Bona fide simply means good faith, which goes to the subjective mental state of the doctor. Therefore, the concurrence agrees that applying an objective standard of what a reasonable doctor would do in the circumstances is inappropriate. 

Justice Alito cites a different section of the Controlled Substances Act to show that the prosecution is not required to prove from the beginning that each possible defense to a criminal charge is inapplicable. He believes that same logic should apply here, making the “except as authorized” provision an affirmative defense, not an element of the crime. The outcome of the concurring opinion is simple and logical. If a doctor prescribes a controlled substance and believes he is acting in good faith to do his work as a doctor, he can raise that defense, and this criminal statute should not apply to him. If the prosecution disagrees, they must prove it is more likely than not that the doctor was not acting subjectively in good faith.

I invite you to consider two brief takeaways from this reflection on the Ruan case. First, statutory analysis is hard work. Both sides of this decision make interesting points about proper interpretation of the text. It is notable that there are committed originalist/textualist conservative justices on both sides of this opinion. 

Those who see everything in the public square through a political or policy lens should stop and realize the reality of the work these judges are doing. Yes, sometimes the Supreme Court is dealing with social-policy issues (see Dobbs) that are not enumerated in the Constitution, and then it can appear that policy preferences are leaking into judicial decisions. But in most cases, most judges are trying in good faith to interpret the legal text as written. We can thank Justice Scalia for pushing the Court in that direction: even Justice Kagan admitted that, thanks to Justice Scalia’s work on the court, “we’re all textualists now.”

Second, putting statutory analysis aside, the effect of the Ruan decision may not grab public attention like abortion or religious liberty. But the issue it raises and answers is quite important. The majority opinion held that when federal prosecutors charge a doctor with criminal distribution of a controlled substance, the prosecution must prove beyond a reasonable doubt that the doctor acted knowingly or intentionally outside the legitimate scope of his medical practice. This is a good check on the power of government prosecution. 

The government’s argument in this case was to apply an objective standard of what a reasonable doctor should have done. This is a dangerous precedent to set in criminal law. Criminal law is meant to punish criminally guilty conduct. The government’s interpretation would make it quite possible to charge doctors with federal felony charges when a doctor acts in good faith but made an objectively bad judgment about who should be prescribed a particular medication. Professionals of all kinds should shudder at the thought that we could be criminally charged because the government says we did not act in a way that a reasonable person in our profession would act. Being sued for civil negligence is one thing, but this kind of “what would a reasonable person have done in that situation?” analysis should play no part in the process of charging people with serious crimes. 

While cases like this don’t make headlines like Dobbs and Bruen, we must be vigilant about their implications. People should be punished criminally only when they commit a criminal act with a criminal state of mind. The federal government’s attempt to lower those standards was a subtle but frightening overreach. While it is debatable whether the majority opinion in Ruan was a perfect interpretation of the statute, the general result was a victory for American liberty.


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