Publisher Health

For years, Dr. Xiulu Ruan was one of the nation’s top prescribers of quick-release fentanyl drugs. The medicines were approved only for severe breakthrough pain in cancer patients, but Dr. Ruan dispensed them almost exclusively for more common ailments: neck aches, back and joint pain. According to the Department of Justice, he and his partner wrote almost 300,000 prescriptions for controlled substances from 2011 to 2015, filled through the doctors’ own pharmacy in Mobile, Ala. Dr. Ruan often signed prescriptions without seeing patients, prosecutors said.

Dr. Ruan has been serving a 21-year sentence in federal prison, convicted in 2017 for illegally prescribing opioids and related financial crimes. To collect millions of dollars in fines, the government seized houses, beach condos and bank accounts belonging to him and his business partner, as well as 23 luxury cars, such as Bentleys, Lamborghinis and Ferraris.

On Tuesday, lawyers both for Dr. Ruan and for Dr. Shakeel Kahn, who is serving 25 years on charges related to pill mill clinics in Arizona and Wyoming will argue before the Supreme Court of the United States that the criminal standard the physicians faced is applied inconsistently among the federal circuits. In asking that the doctors’ convictions be overturned, they want the court to establish a uniform standard that permits doctors to raise a “good faith” defense. Juries could then consider whether doctors subjectively believed they were using their best medical judgment.

The likelihood of these two doctors being set free is small, legal experts believe, but the court’s decision on the broader legal questions could have significant implications for the latitude doctors can take in prescribing potentially addictive painkillers and other restricted medications.

The cases confront an uneasy relationship between law and medicine. In an era when overdose deaths are soaring, how should the law balance letting physicians exercise their best judgment with stopping egregious outliers?

At issue is the reading of the language of the Controlled Substances Act of 1970. The act permits doctors and pharmacists to dispense certain drugs such as opioids and amphetamines, categorized by their potential for abuse and medical value, even as it prohibits everyone else from doing so. It says that a prescription for one of these medications “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

Prosecutors, through the office of the U.S. Solicitor General, argue that the criminal standard in the act is straightforward and well-established, with a baked-in good-faith defense that affords doctors ample leeway. Even if the Supreme Court were to adopt a new framework and order that the doctors be retried, they argue, a jury could not conclude that the doctors were relying on their good-faith medical judgment.

The evidence, they wrote, “overwhelmingly demonstrated that petitioners acted as drug dealers disguised as medical professionals, dispensing addictive drugs that endangered their patients simply to line their own pockets.”

Lawyers for the government and the doctors declined to comment or did not respond to requests to do so.

For many in medicine, the case is not about whether Drs. Ruan and Kahn were bad doctors.

“It’s about all the other doctors in the country who intend to do the right thing, but are dealing with difficult cases,” said Dr. Stefan Kertesz, a professor of medicine at the Heersink School of Medicine at the University of Alabama at Birmingham and an addiction researcher. “Are we all at risk of criminal investigation based on making decisions that involve difficult medical trade-offs?”

Some legal experts say they presume that the court picked two cases from different circuits in order to examine legal distinctions and disjunctions, and that it may well emerge with a clarifying rule. But it is difficult to predict how the justices will rule, they say, because the issues do not fit tidily into liberal and conservative boxes.

The cases are being argued during a period when investigations of prescribing habits have increased, in an effort to curb the rise in overdose deaths that began more than 20 years ago, as prescription painkillers became readily available. Authorities saw doctors as a significant source of the problem.

State regulators imposed an array of punishments for excessive prescribing, such as fines, license revocation and imprisonment. In recent years, the prescribing of opioids fell sharply. Even so, overdoses and deaths hit a record last year. A majority of those deaths were not from prescribed opioids but from illegal ones.

Some studies see a connection between the drop in prescriptions and the rise in overdose deaths. An article published recently in The New England Journal of Medicine reported that high-dose chronic pain patients who were abruptly dismissed from doctors’ practices have experienced surges in emergency room visits, addiction to illegal drugs and even suicide.

To what extent has the increased surveillance of doctors led to an overcorrection in prescribing? A 2019 survey in the journal Pain of 452 primary care clinics in nine states found that nearly half would not prescribe opioids to new primary care patients who said they were already being prescribed the painkillers.

Dr. Samer Narouze, president of the American Society of Regional Anesthesia and Pain Medicine, said that he knew of doctors who had lost licenses or were jailed, and that it could be hard to understand the basis on which different sanctions were meted out. In the current risk-averse, litigious climate, his hospital’s opioid oversight committee has, on occasion, sought legal counsel before making decisions in difficult cases involving the drugs, said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.

The outcome of the Supreme Court cases is also being closely monitored by representatives of chronic pain patients.

“We definitely want to catch doctors who are behaving like large-scale drug pushers,” said Kate Nicholson, executive director of the National Pain Advocacy Center, which filed a brief arguing that fear of criminal prosecution deterred doctors from using good medical judgment to treat pain.

“Our issue is the chilling effect the current standards have on good doctors, who fear that even when they are exercising their best medical judgment, they will be subjected to oversight and enforcement,” said Ms. Nicholson, a former government disability rights lawyer who was bedridden for 18 years and relied on high-dose opioids.

Some years ago, she moved to Colorado to start post-surgical rehabilitation and needed to find a doctor to help her safely wean off opioids. But her new doctor, she said, told her that he had stopped prescribing opioids and that “you won’t find anyone else in this area willing to, either.”

Yet other patients, whose opioid addictions were initiated by doctors’ prescriptions, still want to see prescribers more tightly reined in and punished. Dr. Kahn based his rates on the number of pills prescribed; his brother, the office manager, would meet patients in parking lots to exchange the doctor’s signed prescriptions for cash, prosecutors said. Two days after a young patient paid him $1250, she died of an overdose of oxycodone.

The Supreme Court’s analysis of the Ruan and Kahn cases will likely involve a close reading of Congress’s text and a discussion about canons of criminal law.

In the last 15 years, as federal agents raided pill mills and prosecutions increased, the language around “legitimate medical purpose” and “professional practice” has been interpreted differently by different federal appellate courts. Those readings direct how a judge instructs a jury on what it must find to convict or acquit the prescriber.

In a brief asking for a clear legal standard, health-law and policy professors argue that several appeals courts — including the U. S. Court of Appeals for the 11th Circuit, which upheld Dr. Ruan’s conviction, and the U. S. Court of Appeals for the 10th Circuit, which upheld Dr. Kahn’s — permit doctors to be convicted if they deviate from accepted medical practice, without a jury also having to find that the doctor did so “without a legitimate medical purpose.” That standard, they say, lacks a critical component of criminal law: intent.

That element, the professors wrote, distinguishes well-meaning, possibly negligent doctors from criminal ones. Without the requirement of intent, the Controlled Substances Act “has been weaponized against practitioners in reaction to the overdose crisis,” they said. Prosecutions have increased, they said, while the standards for conviction have “steadily eroded.”

The professors argue that this broad standard can ensnare doctors who determine that an individual patient requires a prescription of opioids that exceeds conventional limits. Doctors who prescribe medications off-label, a common practice, could also fall under that standard.

Conversely, other circuits require that prosecutors prove beyond a reasonable doubt that doctors knew not only that they were deviating from accepted medical practice but also, and crucially, that they were prescribing without a legitimate purpose.

But how far can a good-faith defense be stretched? Does it suffice for doctors to simply argue that they believed the prescriptions served a legitimate medical purpose?

“Good faith,” then, would seem to be a subjective standard; “legitimate medical purpose,” an objective one. If so, the two would inherently be in conflict.

Prosecutors argue that at the very least, doctors must show they made reasonable efforts to learn the medical norms upon which they based their good-faith judgment. A mistake in understanding those norms, they say, would not rise to the level of criminal conduct.

Recently, the Centers for Disease Control and Prevention took steps to give physicians more leeway in prescribing opioids. In a draft of the new recommendations, the agency bluntly states that prescribers should almost always seek alternative pain therapies rather than opioids. But it also says that doctors can rely on their best medical judgment, especially when treating “legacy” patients — typically, chronic pain patients who are already on high opioid doses.

The good-faith argument shouldn’t be read as a “get out of jail free” card, said Kelly Dineen, who teaches health law at Creighton University School of Law in Nebraska and who is a co-author of the health-law professors’ brief. “The jury still has to assess their credibility,” she said. “But doctors should be allowed to bring that defense.”

Sheelagh McNeill contributed research.