A bottle of pills is tipped on its side, spilling onto a glass-top desk with stethoscope and clip board in the background - doctors prescribing opioids concept

In June, the U.S. Supreme Court issued a unanimous opinion in favor of two doctors accused of overprescribing opioids, raising the standard of proof the government must meet to secure a conviction in “pill mill” cases. The case defines the standard that the government must prove to secure a conviction for unlawful distribution of a controlled substance and resolves a split in the circuit courts regarding the mental state required to convict a doctor accused of overprescribing opioids.

Ruan v. United States Requires Knowledge that Prescription Would Be Abused

In Ruan v. United States, the Court held that to secure a conviction for a violation of the Controlled Substances Act, the government must prove, beyond a reasonable doubt, that a doctor knew that a prescription for a controlled substance would be abused.

The decision stems from two separate cases in which prosecutors claimed that the defendant doctors were not prescribing opioids for legitimate medical purposes. The defendant doctors, Xiulu Ruan and Shakeel Khan, both had licenses to prescribe controlled substances. They were separately charged with running “pill mill” operations. Dr. Ruan was convicted and sentenced to 20 years in prison, while Dr. Khan was sentenced to 25 years in prison. The sentences were separately upheld by appellate courts.

Dr. Ruan’s practice was based in Mobile, Alabama, where he was charged with running a “massive pill mill” operation, while Dr. Khan was charged with running a conspiracy to distribute a large quantity of opioids in Wyoming.

In both cases, prosecutors argued that the defendant doctors were not prescribing opioids for a legitimate medical purpose. In response, the physicians claimed that they were and that, even if they were not, they did not knowingly or intentionally deviate from the standard. In each case, the trial court did not allow the jury to consider whether the doctor was acting as a physician should.

On appeal to the Supreme Court, the justices unanimously found that the physicians could not be convicted solely on proof that the prescriptions were not authorized and that the government must prove beyond a reasonable doubt that the defendants knew or intended that the prescriptions would be abused.

Prosecutors Must Prove Intent Under the Controlled Substances Act

Prior to the decision in Ruan, prosecutors would try to prove a violation of the Controlled Substances Act by showing that a physician deviated from a normal or recommended practice. But in the wake of Ruan, prosecutors will need to prove that the doctors knew or intended that their prescriptions would be abused.

Under the Controlled Substances Act, it is illegal to “knowingly or intentionally…manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense a controlled substance.” To avoid criminal liability, the prescription must “be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

The Act recognizes an exemption for prescribers. Once a defendant doctor has shown that they are entitled to this exemption, the government must prove that the defendant knowingly or intentionally acted in an unauthorized manner by prescribing a controlled substance.

Previously, prosecutors needed to prove different levels of intent depending on the circuit in which the physician practiced. For example, in the First and Ninth Circuits, a prescriber could only be convicted if the prosecution proved the prescriber’s subjective “intent to act as a pusher rather than a medical professional.” In the Second Circuit, a prescriber could rely on an objectively reasonable belief that they were acting in the normal course of professional practice. In the Tenth and Eleventh Circuits, a prescriber’s subjective intent was irrelevant.

Ruan resolved the circuit split and adopted the standard that a prescriber could only be convicted in cases where the physician intended to act as a pusher. The ruling reaffirms the Court’s 1975 decision in U.S. v. Moore, where it required that “physicians be allowed reasonable discretion in treating patients and testing new theories.”

Prosecutions Likely to Continue, but with a Focus on More Egregious Cases

Ruan continues a recent trend of pushing back against extensions of federal power over the practice of medicine. While the federal government has pledged to continue to fight the opioid crisis, the public health interest in preventing opioid prescription abuse needs to be balanced against the need to give doctors the latitude to exercise independent professional judgment in their practice.

There is significant public pressure to stem the opioid crisis, and it is unlikely that the Department of Justice will cease prosecuting these cases anytime soon. But doctors can take solace in the additional protections afforded by the Ruan decision.

Nonetheless, doctors should protect themselves by adopting best practices and if they face criminal charges for an alleged violation of the Controlled Substances Act. Physicians should avoid prescribing opioids in a way that gives the appearance that they are motivated by financial concerns and should take steps to ensure that prescriptions are being used by patients and not being sold on the black market. They should monitor patients for signs of abuse, watch for red flags, warn patients before prescribing opioids, and maintain thorough records about prescriptions. Finally, doctors should take care not to rely on others, such as nurse practitioners, to write prescriptions, unless writing prescriptions for opioids falls within their scope of practice under state law.

The Controlled Substances Act is aimed at prosecuting drug dealers, not doctors. While Ruan provides additional protections, any criminal charges must be taken seriously as the consequences can be severe.

Hope Lefeber Defends Doctors Against “Pill Mill” Charges

If you are under investigation for illegally prescribing opioids or other “pill mill” charges, you need an experienced federal defender on your side. For more than 30 years, Hope Lefeber has been defending people charged with federal drug crimes. She is highly respected by her colleagues and has earned a reputation as a fierce defender of her clients’ rights. Ms. Lefeber is meticulous in her preparation and carefully investigates every piece of evidence the government will use to convict you. She frequently works with forensic consultants, investigators, and other experts to identify inconsistencies in the government’s case.

If your livelihood is at stake and you are facing the prospect of a criminal conviction, you need a fierce and tenacious criminal defense lawyer on your side. Hope Lefeber should be your first call.

To learn more about Hope Lefeber and how she can help, contact us today to schedule a confidential consultation to discuss your situation.