Supreme Court Rules in Favor of Doctors Appealing Opioid Convictions

By Pat Anson, PNN Editor

In a precedent setting case, the U.S. Supreme Court has ruled in favor of two doctors who were convicted of prescribing high doses of opioid pain medication outside the usual standard of medical care. The ruling could potentially impact dozens of past and future cases in which doctors are accused of “overprescribing” opioids to their patients.

In their combined appeals, lawyers for Dr. Xiulu Ruan and Dr. Shakeel Kahn argued that jurors were not properly instructed that doctors are allowed to prescribe opioids under the Controlled Substances Act (CSA), as long as they act in good faith and with a medical purpose.

Unlike recent rulings which saw the high court bitterly divided over abortion and gun control, the justices ruled unanimously 9 to 0 in favor of the doctors, with some quibbling over the legal reasons.

Writing for the majority, Justice Stephen Breyer said government prosecutors failed to “prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner" under the CSA.

In a concurring opinion, Justice Samuel Alito drew a finer line, saying doctors could still be prosecuted under the CSA if they knowingly acted in a way “foreign to medicine — such as facilitating addiction or recreational drug abuse.”

The high court’s ruling does not overturn the convictions of Ruan and Kahn. Instead, the cases are remanded back to lower courts for review, where charges against the doctors could be dismissed or new trials ordered.

‘Monumental Decision’

Pain patients and their advocates cheered the high court ruling, saying it could have a sweeping impact on pain management in the United States. Fearing prosecution by the DEA or state medical boards, many doctors have stopped prescribing opioids, tapered patients to lower doses, or simply stopped treating pain.  

“This is a monumental decision that will literally save lives because fewer patients will be abandoned by their doctors for fear of losing their freedom,” said Lynn Webster, MD, a Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript.  “Physicians have been afraid to prescribe controlled substances even with an appropriate indication for fear of a government expert testifying they believe it is not the standard of care.  

“The Court’s decision will affect not only Ruan and all healthcare professionals with authority to prescribe any controlled substances, but millions of patients now and in the decades to come.”  

"I would say (the ruling) directly challenges many past convictions of doctors that were tainted by improper instructions to juries or anti-opioid biases by judges,” said patient advocate Red Lawhern, PhD. “It may also make future convictions more difficult given that the decision forces DEA and other law enforcement authorities to demonstrate beyond reasonable doubt that prescribers knew their practices exceeded accepted medical standards." 

“There remain other issues to be decided, but this decision was the right one for pain physicians and patients.  It affirmed the higher standard for the government to prove doctors acted with criminal intent,” said Kristen Ogden, a patient advocate and caregiver for her husband, who is disabled by intractable pain.

Complicating the cases of Ruan and Kahn is that they were both convicted of crimes outside of the CSA.

Ruan, who practiced in Alabama, prescribed Subsys to many of his patients, an expensive and potent fentanyl spray that was only approved by the FDA for breakthrough cancer pain. Ruan was also convicted of taking kickbacks from Insys Therapeutics, the maker of Subsys. He was sentenced to 21 years in prison.    

Kahn, who practiced in Wyoming and Arizona, was convicted of prescribing excessive amounts of oxycodone and running a criminal enterprise that resulted in the death of a patient. He is serving a sentence of 25 years.

Supreme Court Hears Arguments in Key Opioid Prescribing Case

By Pat Anson, PNN Editor

The U.S. Supreme Court heard oral arguments today in the case of two doctors appealing their convictions for criminal violations of the Controlled Substances Act (CSA) -- a case that could have a significant impact on opioid prescribing nationwide.

Dr. Xiulu Ruan and Dr. Shakeel Kahn were sentenced to lengthy prison terms for prescribing high doses of opioid medication to patients, including one who died from an overdose. Their combined appeals focus on whether jurors were properly instructed that doctors are allowed to prescribe opioids outside the usual standard of medical care, as long as they act in good faith and with a medical purpose.

“It is important for me to be clear that my client didn’t get that instruction,” said attorney Saul Robbins, who represents Ruan. “His jury was told if he was outside the bounds of medicine, you may convict him. Full stop. No good faith, no ‘knowingly or intentionally,’ none of that.”

Kahn’s lawyer told the high court that a strict interpretation of the CSA was having a chilling effect on many doctors, who worry about their “medical morals” being policed by the Drug Enforcement Administration.

“I think that raises the real risk the DEA becomes the de facto national medical board. That’s never been authorized,” said attorney Beau Brindley.

Much of the 90-minute hearing focused on legal semantics and whether the CSA gives doctors the discretion to prescribe medications as they see fit. Some of the court’s most conservative justices asked the toughest questions of a Department of Justice attorney who argued against the doctors’ appeals.

“Many things disturb me about some of the arguments. One is the ungrammatical reading of the statute itself,” said Justice Neal Gorsuch, who openly speculated that Ruan and Kahn could not only be entitled to new trials, but the indictments against them could be dismissed.  

Justice Brett Kavanaugh said the CSA was too vague.

“The problem here, the core as I see it, is the statute says ‘except as authorized’ and the regs (regulations) say ‘legitimate medical purpose.’ That’s very vague language in my estimation,” said Kavanaugh. “Write more specific regs if you have the problem that you’re talking about. But ‘legitimate medical purpose’ is a very vague thing on which reasonable people can disagree.

“There are going to be close calls on what the evidence shows objectively was legitimate. And so, if you’re on the wrong side of the close call as the doctor, you go to prison for 20 years.”

“I don’t think that’s going to be the case for doctors who make innocent mistakes,” replied Eric Feigin, a U.S. deputy solicitor general. “We do not think a doctor can be convicted for something that other doctors would recognize as within the boundaries of medicine.”

It could take several months for the Supreme Court to make a ruling on the case. The high court will not determine whether the doctors are guilty or innocent, but will decide if they were lawfully prosecuted and if new trials are needed. Complicating the appeals of both doctors is that they were also convicted of crimes outside of the CSA.

Ruan, who practiced in Alabama, often gave patients Subsys, an expensive and potent fentanyl spray made by Insys Therapeutics that was only approved by the FDA for breakthrough cancer pain. Ruan prescribed Subsys “off label” to patients who didn’t have cancer, a practice that led to several other doctors being targeted by the DEA. Ruan was also convicted of taking kickbacks from Insys. He was sentenced to 21 years in prison.    

Kahn, who practiced in Wyoming and Arizona, was convicted of prescribing excessive amounts of oxycodone and running a criminal enterprise that resulted in the death of a patient. He is serving a sentence of 25 years.

Supreme Court Case May Decide Future of Opioid Prescribing

By Pat Anson, PNN Editor

Over a dozen patient and physician advocacy groups have filed legal briefs with the U.S. Supreme Court in support of two doctors appealing their convictions for criminal violations of the Controlled Substances Act.

The nation’s high court has consolidated the cases of Dr. Xiulu Ruan of Alabama and Dr. Shakeel Kahn, who practiced in Wyoming and Arizona. Both doctors were sentenced to lengthy prison terms after being convicted on a variety of charges – including the prescribing of high doses of opioid pain medication to patients “outside the usual course of professional practice.”

Oral arguments will be heard by the Supreme Court on March 1, with a decision expected later in 2022. Monday was the deadline for interested parties to file “amicus curiae” briefs on the case, which could have a significant impact on opioid prescribing practices nationwide if the appeals are successful. Many doctors have stopped or reduced their prescribing of opioids because they fear being prosecuted under the Controlled Substances Act (CSA).

“It is no exaggeration to say that CSA prosecutions of physicians have already impaired the treatment of chronic pain,” Ruan’s attorneys said in their appeal. “In response to the opioid crisis, fear of prosecution has increasingly prompted pain management doctors to avoid or reduce opioid prescriptions, even when those decisions leave chronic pain patients without recourse.”

A successful appeal would mean Ruan and Kahn could ask for new trials, along with dozens of other doctors convicted of similar charges under the CSA.

“It will also avoid what I see as the chilling effect that it’s had on lots of doctors who are not doing anything even remotely suspicious, but are afraid that they are going to get caught because they prescribe a higher dose, and so they’re dropping people from care or tapering them,” said Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC).

NPAC, along with other advocacy groups and the U.S. Chamber of Commerce, are asking the high court to clearly state how the practice of medicine should be regulated under the CSA. Some argued it is best left to state medical boards, not federal prosecutors or law enforcement.

“Patients with pain, addiction, or both desperately need appropriate care and treatment. If practitioners are held strictly liable under (the CSA), patient abandonment will become ever more common as practitioners act to avoid scrutiny,” Jennifer Oliva and Kelly Dineen, professors of health law and policy, said in their brief. “Progress in medical care in these areas can only recover if the regulation of medical practice is returned to the province of the states except in narrow circumstances.”

‘Good Faith’ Practice

At issue in the Ruan/Kahn case is what constitutes the “standard of care” and “usual course of professional practice” under the CSA. Doctors traditionally have been given wide latitude in determining what’s appropriate for a patient, as long as they act in “good faith” with a medical purpose. But that laissez-faire approach came to an end as the overdose crisis intensified and doctors came under more scrutiny for their opioid prescribing practices. 

“No other country criminalizes physician behavior like the federal prosecutors have done in the US. This is especially the case as these prosecutions are all based on a whim with an ‘expert’ opinion rendered by a hired government expert and orchestrated by a new generation of overzealous and unchecked federal prosecutors pointing fingers at wealthy doctors as greedy drug pushers and fraudsters,” Physicians Against Abuse argued in its brief.

“Doctors are just a ‘sitting duck’ for these federal prosecutors who raid medical offices and unlike the career drug pusher on the streets who gets caught and charged with one or two counts, federal prosecutors pile up count after count because doctors are required to keep records and those records are used against them in these out of control prosecutions against physicians.”  

Pain Clinic ‘Factory’

Complicating Ruan’s appeal is that he often gave patients Subsys, an expensive and potent fentanyl spray that was only approved by the FDA for breakthrough cancer pain. Ruan prescribed Subsys “off label” to patients who didn’t have cancer, which made him an easy target for federal prosecutors who were building a massive fraud and bribery case against Insys Therapeutics, the manufacturer of Subsys.

In his new book, “The Hard Sell: Crime and Punishment at an Opioid Startup,” author Evan Hughes depicts Ruan as a greedy and ruthless physician who was more interested in acquiring luxury cars and Insys stock than he was in treating patients. According to Hughes, Ruan and his business partner ran their pain clinic and adjoining pharmacy like a factory.

“Instead of collecting a mere $200 or so for an office visit, Couch and Ruan treated each patient as a profit center, an opportunity to bill for tests and procedures in-house, or to refer out to some other provider who would cut them in on the business. They reinvested to grow their factory, buying new machines that added lucrative capabilities,” Hughes wrote.

In addition to the charges against him under the CSA, Ruan was convicted of taking kickbacks from Insys in exchange for prescribing “massive quantities” of Subsys. Ruan was one of the top prescribers of Subsys in the United States.

Kahn was convicted of more than 20 counts involving excess prescribing of oxycodone and other controlled substances, and running a criminal enterprise that resulted in the death of a patient. When federal agents raided his properties in Wyoming and Arizona, they found firearms and over $1 million in cash.

Advocates hope the Supreme Court will overlook the seedier aspects of both cases and rule in a way that clearly defines the rights of doctors under the CSA to prescribe medications they deem appropriate.

“I think our biggest concern is having the correct standard moving forward so that doctors have space to practice medicine appropriately and patients stop suffering,” Nicholson told PNN. “My guess is that they’ll do something to clarify, but how objectively or subjectively they go, I think that’s anyone’s guess.”