SCOTUS Sides with Physicians in Opiate Opinion – Ruan v. United States

Leading up to Ruan – 46 years of silence

Over the last 46 years of silence from the Supreme Court on the issue of unlawful prescribing, the Federal Government and Circuit Courts have taken some strange turns. The standard levied against physicians charged with unlawfully prescribing controlled substances shifted from one in which the benefit of the doubt rested with the prescriber to one in which evolving “objective” standards, such as the CDC Guidelines and state medical board regulations, became an ad hoc standard of care. As the scope of permissible conduct began to narrow, federal prosecutions ramped up and courtrooms across this country became filled with allegations that a physician “failed to do a physical exam” “ignored an inconsistent urine drug test” or didn’t respond to signs of addiction and diversion.

This shift had a profound impact on pain in America. Primary care physicians ceased prescribing, emergency rooms minimized pain complaints and discharged patients in excruciating pain. The epidemic of untreated pain was thrust upon pain management providers who were ill-equipped to handle the millions of Americans suffering with chronic pain. The “deterrent” effect so often sought in federal sentencing had tremendous blowback when coupled with the vague and shifting standards for permissible conduct.

We all watched and waited as the cases of Ruan v. United States, Khan v. United States and Naum v. United States trickled up to the Supreme Court with the hope that the high court would decide once and for all what exactly a physician must do to violate 21 U.S.C. 841(a).

The Supreme Court Rejects “Objective” Good Faith

At 10:30 in the morning on June 27th, 2022 as I sat listening to jury instructions in a six-week federal trial involving opiate prescribing, the Supreme Court gave us our answer. And it was unanimous:

Section 841’s “knowingly or intentionally” mens read applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his or her conduct was “authorized” the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.

Let's break this down for those that don’t speak Breyer-ese.

Every criminal statute must have an intent component. In most instances, other than strict liability offenses (i.e. speeding) you must approach the crime with a guilty mind. You must know your conduct is wrongful. The same is true for unlawful prescribing. A physician only becomes a criminal when he or she intentionally prescribes a controlled substance medication without a legitimate medical need and outside the usual course of professional practice.

In order to increase the chances of conviction of a physician charged with unlawfully prescribing, over the last 20 years, Federal Prosecutors have attempted to water down this standard. They did this by claiming that the statute required adherence to objective standards of medicine. The only problem with this, and experts agree, “objective” standards for the practice of pain management are non-existent and available standards are shifting, unclear, and generally contain a caveat that they should not be applied as rigid rules but rather guidelines for conduct (i.e. the CDC Guidelines).

In a final blow to physicians facing serious jail time for unlawful prescribing, some Circuits stripped physicians of an exception to these rigid guidelines that would allow them to escape conviction if they reasonably believed they were acting in furtherance of the “good faith” treatment of a patient.

And this was the battleground in Ruan v. United States. Dr. Ruan wanted the jury instructed that he cannot be convicted if he reasonably believed he was acting in furtherance in the “good faith” treatment of a patient. The Government responded that “good faith” is not an element of the offense and the “good faith” violation of objective standards is not “good faith” at all.

Struggling to determine if this “good faith” exception – which is found nowhere in the federal statute – should be “objective” or “subjective” the Supreme Court did what every good textualist should do – they went back to the statute.

Re-Affiriming the Standards in Physician Prosecutions

Justice Breyer authored the unanimous decision of the court and Justice Breyer did an amazing job clearing up the mess that has been created by a wide range of conflicting decisions over the last 46 years.

Plainly, he stated that, first the physician must show that he was authorized to prescribe controlled substances. This is as simple as showing a DEA registration to the jury to prove that he or she had permission to prescribe. Next the Government must show that he knowingly and intentionally violated this standard. This means that the physician must know that he unlawfully prescribed – a violation of an “objective standard” is insufficient to meet this knowledge requirement.

Practically speaking, it is insufficient to simply state that the physician should have known or should have followed “objective” standards in the practice of medicine. Rather he must knowingly prescribe for a non-medical purpose outside the usual course of professional practice. He must knowingly abandon the practice of medicine and willingly become an unlawful drug pusher.

Justice Breyer believes that “a strong scienter (intent) requirement helps to diminish the risk of “over deterrence” i.e. punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line”. This passage is an obvious nod to the pain population and physician advocates in the United States that rose to speak up against the “overdeterrant” effect of prior interpretations.

So then how does the government go about proving violation of the criminal standard in prescribing prosecutions?

Justice Breyer gives us a roadmap. He states that the government can prove knowledge of a lack of authorization through circumstantial evidence. And the regulation defining the scope of a doctors prescribing authority does so by reference to objective criteria such as “legitimate medical purpose” and “usual course of professional practice.” Therefore, the Government must show what reasonable conduct looks like in the practice of medicine and show that a physician departed so far below it that he must have known that his conduct was unauthorized and not for a “legitimate medical purpose”.

So what Happens with Dr. Ruan, Dr. Khan and Physicians Facing federal charges?

Dr. Ruan and Khan’s convictions were vacated and remanded back to the Circuit court of appeals for the court to determine if the instructions given in their cases followed this new precedent. Justice Breyer believes that they likely did not but is giving the Circuit Courts the opportunity to interpret and apply this standard against instructions already given. Pending that decision, they will either get a new trial or have another visit in front of the Supreme Court.

As for other physicians, there are two categories: (1) those that have been convicted, and (2) those that are facing trial.

For the first category, their counsel must exhaust appellate remedies by arguing that their jury was improperly instructed under this new standard. They must show that they were faced with an “objective” standard which violates the express wording of Justice Breyer’s opinion. Those that received an “objective good faith instruction” will likely fair the best on appeal. An objective good faith standard is clearly inappropriate and failed to properly instruct the jury on the applicable intent for a violation of 21 U.S.C. 841.

Those facing trial must utilize this decision to craft jury instructions that plainly stated that the Government must prove that the physician “knowingly” and “intentionally” prescribed outside the usual course of professional practice and for other than a legitimate medical purpose. The trial strategy has also changed dramatically. Justice Breyer invited the Government to try to construct an “objective” standard during its case. They most certainly will try to do this utilizing their expert to construct a set of objective criteria that the expert deems appropriate i.e. “physician exams”, discharging patients with inconsistent urine drug screens, addressing “red flags” and prescribing within a certain range of morphine milligram equivalents.

The defense must then respond with appropriate expert testimony breaking down this objective standard and showing that the physician believed his conduct was reasonable given his training, education, experience, and history of treating his patient population. In trial, I put a large emphasis on my client’s education and training during direct examination of my client. Building the defendant up to seem as a reasonable person who made reasonable decisions helps greatly to rebut the contention that he/she abandoned the practice of medicine and engaged in “drug trafficking”. You must also show that the selection of the cases shown by the government constitutes the most difficult patients wherein the physician had to make difficult prescribing decisions. This, juxtaposed with his/her patient population of normal everyday patients will be helpful to show that this doctor generally made good decisions.

Sometimes, a trial judge will try to tell me that patients outside the indictment are irrelevant. The Ruan opinion strengthens the argument that this is vitally important. A physician should be given reasonable latitude to show the jury the vast number of patients who received detailed physical exams, reduced quantities of opiates etc. This can be done with statistical sampling and extrapolation.

If you need help with this feel free to reach out, I can help create graphs and charts of billing and prescribing data that will make sense for the jury.

If you are facing trial or have been convicted of an unlawful prescribing offense or you are an attorney for a physician accused of unlawful prescribing, don’t hesitate to contact me for a review of your case and your jury instructions to determine if you may get relief from the Supreme Court’s decision in Ruan v. United States.

A copy of the opinion can be accessed here