Why the Ruan Case Won’t Protect Doctors From Prosecution

By Dr. Joseph Parker

Doctors trying to save lives and help pain patients are regularly being sent to prison for prescribing opioids. And despite last year’s Supreme Court ruling in the Ruan case, that’s not changing.  Here’s why. 

First, it’s important to know what you are up against.  When the US federal government goes after a doctor or anyone else, they face a streamlined conviction machine.  Since the time of Ronald Reagan (who I voted for), the rights of an American citizen to challenge the charges against them or try to overturn an unjust conviction have been eroded. 

Then came President Bill Clinton (I voted for him too), who signed into law the Antiterrorism and Effective Death Penalty Act, doing more to ensure that the government can imprison the innocent than any other president since the Civil War.

At the founding of this nation, it was recognized that governments are prone to lock up people they don’t like, finding some legal pretext to justify their actions.  To guard against this, the Constitution and Bill of Rights were adopted to limit the powers of the federal government. 

Originally, there was only one federal crime: an act of treason. This crime was much more limited than the British version had been, when wandering over onto the King’s hunting grounds was considered treason. In the American version, you had to wage war against the United States or give aid and comfort to its enemies during a time of war. 

Then John Adams, the second president of the United States, made sedition a federal crime. Since then, so many federal laws have been added that government itself cannot tell you exactly how many or what they are.

That’s not counting all of the rules and regulations enforced by federal law enforcement, as if they were the law.  Locked up is locked up, after all.  Today the land of the free incarcerates more of its citizens than any other nation.  Not only that, but the sentences have become draconian. 

There is no nation on earth today where the liberty of a citizen has less value than in America.  The US incarcerates an average of 629 people for every 100,000 citizens. The next closest nations are Rwanda, Turkmenistan, El Salvador and Cuba. China and Russia don’t even make the Top 10.

Believe it or not, there are 37 states in the US that beat Cuba’s incarceration rate of 510 prisoners, with Louisiana coming in at a mind numbing 1,341. 

All of those inmates did not end up in prison by accident.  Looking at 2020 numbers, there were about 1,879 criminal cases heard in federal court.  Of those, about 90% of the accused plead guilty without even going to trial. Is that because the US government is absolutely right 90% of the time?  I am cautiously skeptical. Only 0.04% of cases -- 4 out of 1,000 – resulted in acquittal.  Those are not good odds. 

In Ruan v. United States, Dr. Xiulu Ruan appealed his conviction for prescribing opioids in an “unauthorized manner.” In a stunning unanimous verdict, the Supreme Court justices repeated what they said in 1925 in Linder v. United States, and then again in 2006 in Gonzales v. Oregon:  the federal government cannot dictate the practice of medicine and a doctor can only be prosecuted if they knew what they were doing was wrong.

As has happened in the past, US law enforcement doesn’t let something like a Supreme Court ruling slow them down.  They are completely ignoring the Ruan ruling by arguing something called “willful blindness.” What was the doctor willfully blind to?  To whatever opinion the government’s expert witness feels like arguing is the “usual practice of medicine” and “a legitimate medical purpose.”

Even though the Supreme Court made clear that only individual states can regulate the practice of medicine, the government’s hired expert does not have to come from your state or even be familiar with your state’s laws regarding the practice of medicine.

In effect, the DEA argues that there is a national practice of medicine that must be followed.  Where do they draw these medical practice standards when there is no such thing as a federal medical license?  From medical textbooks like the "Principles and Practices of Pain Medicine"?  No.  From the teachings of national medical organizations like the American Academy of Pain Medicine or the American Society of Addiction Medicine?  No again. 

The teachings from those sources are not allowed in court, unless you can get one of the original authors to come testify for you.  And sometimes, not even then.  The chapter on avoiding addiction in pain management from the above textbook was written by Dr. Alan Wartenberg.  Despite his advanced years, Dr. Wartenberg came to my trial to testify for me.  But he was not allowed to be considered as an expert in pain medicine, because he was “only” an addiction specialist. 

This is nothing compared to what happened to Dr. William Bauer of Ohio.  A dozen pharmacists, doctors, and scientists were willing to testify on his behalf, and all of them were disqualified by the court.  But the government’s “experts” in pain medicine can testify about almost anything, including addiction and even chronic cough.

The government does not convict you by proving you are guilty, they convict you by smearing you publicly long before you get to trial, and then making sure that the jury does not have access to the truth, by disqualifying experts, withholding favorable evidence, allowing false testimony, and making false statements to the jury. 

And remember, Dr. Ruan “won” at the Supreme Court. But he’s still in prison. 

Good luck and be prepared.  Ruan will not save you.

Joseph Parker, MD, is Chief Science Officer and Operations Officer at Advanced Research Concepts, a company developing solutions to the challenges of space travel and space-related medical issues.  In clinical practice, Dr. Parker specialized in emergency medicine and served as Director of Emergency Medicine at two hospitals. Prior to that, he had a distinguished career in the U.S. Marines and Air Force. 

In 2022, a federal jury convicted Dr. Parker on two counts of unlawful opioid prescribing. He has filed an appeal as he awaits sentencing.

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.”