Amicus Brief

Ruan v United States Decision

On June 27, 2022, the United States Supreme Court unanimously ruled to vacate the decision of a lower court to convict Xiulu Ruan M.D. for violating the federal Controlled Substances Act (CSA).  My coauthors and I had submitted an Amicus Brief in support of the petitioners which we hope contributed to the Court decision.  This was the most important case involving the prescribing of controlled substances before the Court in more than 50 years.

At issue was whether a healthcare practitioner can be convicted under the CSA for violating the standard of care. To be legal, a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of one’s professional practice. In contrast, standard of care typically determines civil liability in medical malpractice cases. However, in keeping with a heavy focus on prescription opioid supply-reduction efforts, the Department of Justice (DOJ) and its sub agency the Drug Enforcement Administration (DEA) has confounded the two standards in their zeal to aggressively investigate, raid, and prosecute practitioners.

Over the past 50 years, how the CSA is interpreted and applied has evolved. The legislative intent of the CSA in 1970 was to curb drug abuse, in itself a flawed goal. At the time the law was created most public health officials and policy makers believed drug misuse was volitional and those who misused drugs were social deviants.  Punishment was aimed at deterrence, and the problem was viewed as legal, not medical. Obviously, now we can see that this reductionist view was not only naïve but counterproductive. Because the CSA is a drug trafficking statute, penalties for convictions can be steep.

Congress authorized the DEA to enforce the CSA but did not give the DEA authority to regulate the practice of medicine.  Regardless, the CSA has been weaponized and is being used to prosecute physicians for prescribing medications in good faith. The CSA became the federal tool to use legislative means to practice medicine, even though the practice of medicine is regulated by the states, not the federal government.

To underscore the intent of the law in 1983, associate chief counsel of the DEA wrote the following about one part of the CSA:

“Acts of prescribing or dispensing of controlled substances which are done within the course of the registrant’s professional practice are, for purposes of the Controlled Substance Act, lawful.  It matters not that such acts might constitute terrible medicine or malpractice.  They may reflect the grossest form of medical misconduct or negligence.  They are nevertheless legal.” Source: Stone SE. The investigation and prosecution of professional practice cases under the Controlled Substances Act. Drug Enforcement. Spring 1983;10(1):21-28.

Yet ambiguous language in the CSA allowed the DEA to exceed the authority intended by Congress. An example is charging physicians for violation of the CSA for not following practice guidelines, particularly the 2016 Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain. This guideline spurred much scientific debate, has required clarification and serious revision, and was never intended to serve as a standard of care in legal proceedings.

When duly licensed medical professionals land in federal court on criminal drug charges, judges must grapple with the flawed and ambiguous provisions of the CSA when attempting to explain to the jury what actions constitute illegal conduct. For example, in the November 2022 trial for California physician Thomas Keller, the jury sent a note to the judge asking, “Can you provide a definition of the ‘usual course of professional practice’ as it pertains to the medical profession?” The judge replied, “I can only refer you back to the evidence that came to trial.” Judges’ inabilities to define key terms leave juries to decipher their meanings, the interpretations of which are heavily influenced by the prosecution, despite no legal or medical consensus on the terms’ meanings.

The Court’s decision in Ruan pointed to the concept of intent or mens rea— a guilty mind. For criminal charges, it is not legally sufficient for prosecutors to prove that a defendant broke a law; they must also prove beyond a reasonable doubt that the defendant knew his or her conduct was illegal and proceeded anyway.

Mens rea is fundamental to U.S. criminal law, even when it is not explicitly so stated in a statute. A large question before the Supreme Court was to what degree intent (mens rea) and knowledge of the practitioner are relevant for conviction of prescribing without a legitimate medical purpose and not in the usual course of a professional practice.

The recent Supreme Court decision exposes the DEA’s and the DOJ’s approach to policing doctors through the CSA as flawed and unlawful. Through expansion of its regulatory authority due to the “vague language” of the CSA, the DOJ has exercised unrestrained prosecutorial power.

The DOJ and DEA are not authorized to determine the scope and bounds of a physician’s professional practice. It is my hope that Congress will return the authority to police irresponsible practitioners to state regulatory bodies and ensure that the DOJ and DEA only undertake enforcement authority that has been duly and clearly authorized – and limited – by Congress. Following the Supreme Court’s firm stance against overreach in Ruan paired with its reinforcement of the mens rea requirement, the DOJ’s and the DEA’s influence over the practice of medicine must stop.

Webster - amicus