Xiulu Ruan, a board-certified Alabama pain specialist, was sentenced to 21 years in federal prison for prescribing opioid analgesics “outside the usual course of professional medical practice.” According to the appeals court that upheld his conviction, it did not matter whether he sincerely believed he was doing what a physician is supposed to do.
That ruling, which is the focus of a case the Supreme Court heard on Tuesday, conflates negligence with criminal liability, invites the Drug Enforcement Administration to usurp state medical regulators and encourages prosecutions that have a chilling effect on pain treatment. If it is allowed to stand, doctors who already face intense pressure to curtail opioid prescriptions will be even more inclined to elevate drug control above pain control.
Ruan’s trial featured the usual battle of experts. Defense witnesses portrayed him as a conscientious physician doing his best to serve patients in dire need, while prosecution witnesses portrayed him as careless and blind to “red flags” indicating abuse or diversion of the drugs he prescribed.
Some of this disagreement stemmed from dueling interpretations of Ruan’s practices and lapses. Some of it stemmed from ongoing debates on issues such as the risks and benefits of long-term opioid therapy for chronic pain and, more generally, how to balance patients’ needs against the government’s demand that physicians prevent misuse of pain medication.
That demand puts doctors in a difficult position since pain cannot be objectively verified. If they trust their patients, some people will take advantage of that trust; if they reflexively treat their patients with suspicion, some people will suffer needlessly from pain that could have been relieved safely and effectively.
The threat of regulatory sanctions and malpractice lawsuits already forces clinicians to weigh the risk to their licenses and livelihoods if they make questionable prescribing decisions. The threat of criminal prosecution ups the ante because it means that doctors also can lose their liberty if they make decisions that the DEA, a law enforcement agency with no medical expertise, views as medically inappropriate.
Criminal penalties traditionally are reserved for people who knowingly break the law. But the U.S. Court of Appeals for the 11th Circuit has held that a physician’s “good faith belief that he dispensed a controlled substance in the usual course of his professional practice is irrelevant” to the question of whether he violated the Controlled Substances Act.
Based on that reading of the law, the 11th Circuit rejected Ruan’s argument that he was entitled to a jury instruction precluding a guilty verdict if the evidence indicated that he honestly thought his prescriptions were “for a legitimate medical purpose” and that he was “acting in the usual course of his professional practice,” as required by CSA regulations. As the appeals court saw it, Ruan could be sent to prison for decades even if he unintentionally fell short of those ambiguous standards.
Doctors defending themselves against CSA charges in other circuits face obstacles that are nearly as daunting. In a case that was consolidated with Ruan’s, the trial court told the jury that good faith “connotes an attempt to act in accordance with what a reasonable physician should believe to be proper medical practice.”
While that standard might make sense in a malpractice lawsuit, it falls short of the culpability that is usually required for a criminal conviction. Worse, when the U.S. Court of Appeals for the 10th Circuit considered the same case, it held that good faith, however defined, does not matter in deciding whether a prescription was written in “the usual course of professional practice,” which must be determined “objectively.”
As two health law professors note in a brief supporting Ruan’s appeal, uncertainty about which practices may provoke federal prosecution hurts patients as well as physicians. It provides yet another reason to turn away or abandon patients who already are suffering from the indiscriminate crackdown on pain medication, sacrificing their welfare on the altar of the war on drugs.
