The Supreme Court Set to Determine “GOOD FAITH” in Physician Opioid PRescribing - United STates v. Ruan.

Overview - United States v. Ruan and “Good Faith”

The Supreme Court will decide the first cases regarding opioid prescribing since 1975: United States v Ruan and United States v. Kahn and likely United States v. Naum and determine if a physicians prosecuted by the federal government can be convicted for violating an objective standard of care. Oral argument in Ruan is set for March 1st 2022. United States v. Ruan cuts at the heart of opioid prescribing federal prosecutions. Ruan appeals to the Supreme Court because the trial court prevented him from asserting the defense of “good faith”. Instead, the Court determined that he could be convicted for prescribing outside the course of professional practice regardless of his “good faith”. The Defense has filed its brief in United States v. Ruan . In it, Ruan argues that the the controlled substance act text and structure must permit physicians to argue that they prescribed in “good faith” for a legitimate medical purpose. Ruan believes that the “good faith” standard permits a physician to argue that his subjective belief that an opioid was prescribed for a legitimate medical purpose is sufficient. But then in the alternative, at a bare minimum an “objective good faith” belief is sufficient.

Given that Ruan was denied any “good faith” instruction, a finding by the Supreme Court that a “good faith” instruction is required will result in reversal of his convictions and a re-trial of all three physicians impacted by the ruling.

The decision in the Ruan case also hinges on important questions pending before the Supreme Court in the case of United States v. Naum. If a physician is permitted to argue “subjective” “good faith” then even medical decisions that don’t comport with a nationally recognized standard of practice would be permitted. If he is not permitted to argue “subjective” “good faith” then his prescribing decisions will be strictly judged under an “objective” standard making the physician’s personal belief about the necessity of treatment irrelevant. The government will certainly argue that no “good faith” instruction is required because removing the requirement for a good faith instruction would permit the government to lower its burden and convict more physicians for unlawfully prescribing. Physician conduct would be judged under whatever standard the government expert elected to provide on the witness stand and government documents such as the hotly contested CDC Guidelines will continue to be used as a basis for prosecution.

Amicus Briefs are In

On December 27, 2021 multiple parties filed amicus briefs on behalf of petitioner including the Center for U.S. Policy represented by Ronald W. Chapman II and authored by Dr. Stephen Ziegler, associate professor emeritus at Purdue University, Lynn Webster a chronic pain advocate and notable author and speaker, and Michael Barnes, ESQ former confidential counsel to President George W. Bush in the White House Office of National Drug Control Policy.

You can read the Amicus Brief filed by the Center for U.S. Policy here. The brief authored by the Center for U.S. Policy lays out a clear path for the court to take in deciding United States v. Ruan which will stop the terrible impact federal prosecutions have had on the chronic pain population while ensuring that physicians who abuse their authority are brought to justice.

Other notable organizations filed Amicus Briefs in the case include Compassion & Choices, an end of life non-profit, the Pacific Legal Foundation, a brief authored by Professors of Health Law and Policy, the National Pain Advocacy Center, and the United States Chamber of Commerce. All available here.

To learn more about the history of United States Drug Laws read this article

Controlled substance Prescribing Prosecutions

The primary United States drug law is the Controlled Substances Act (CSA). The CSA makes it unlawful for any person knowingly or intentionally manufacture, distribute or dispense a controlled substance. In order to lawfully prescribe a physician must obtain a registration issued by the attorney general who delegate this power to the Drug Enforcement Administration. In order to lawfully prescribe a physician must also comply with the DEA’s regulations which require a prescription to be issued “in the course of professional practice” “for a legitimate medical purpose”. If a physician violates these rules she can be subject to criminal, administrative or civil prosecution - and sometimes all three. When a physician faces prosecution for unlawfully prescribing, nearly all courts have permitted the physician to argue that a prescription was written “in good faith” for the legitimate treatment of a patient. Recently, the 11th Circuit removed this protection and issued a decision stating that the “good faith” belief of a physician is irrelevant. Without this protection, physicians could be subject for prosecution if their prescribing falls outside of professional norms. Proponents of more narrow interpretations of this section argue that this development would chill medical progress, disrupt the doctor-patient relationship and criminalize prescriptions whenever a lay jury is persuaded that the physician exceeded the “usual” practice of medicine.

“Expert Testimony” and “Red Flags”

To meet its burden, federal prosecutors call medical experts to testify and often these experts take issue with the physician’s prescribing and their failure to spot “red flags” of diversion. These “red flags” of diversion include “doctor shopping”, inconsistent urine drug screens, requesting high doses of medication, living far from their prescriber or pharmacy. There are many more behaviors that the DEA considers “red flags”. The problem is that these same behaviors are also exhibited by legitimate patients suffering from untreated pain. Government “experts” also testify to the “standard of care” for prescribing but this standard is usually a standard created ad hoc by the physician and there is very little agreement in the pain management community as to the proper pain treatment of a patient. “Experts” fault doctors for lack of adequate record keeping and will consider a treatment not pursued unless it’s thoroughly included in the medical record. This expert testimony usually sounds in malpractice and holds a physician to a very high standard to defend her conduct. Without the ability to argue that the physician prescribed in “good faith” federal juries can convict if they believe the standard of the “medical expert” and they believe that the physician departed from this standard - regardless of the medical need for the patient.

Practical effect of Opioid Prosecutions United STates v. Naum

A few years ago, I spent over a month in Northern West Virginia defending a doctor accused of unlawfully prescribing Opiates — specifically Suboxone. A family practice physician running a small clinic in Northern Ohio and West Virginia Dr. George Naum wanted to help patients suffering from the opioid epidemic by providing medication assisted treatment. In small rural communities this service was needed to help those suffering from addiction begin their recovery and start getting their life back together. Dr. Naum joined a practice and began working with a nurse to treat this vulnerable patient population.

Fast forward a few years and Dr. Naum found himself in the middle of a federal investigation for, of all things, unlawfully prescribing opiates. The practice was not a pill mill. It was a treatment center. The practice was not prescribing high power narcotics to patients seeking opiates or unlawful purposes but rather a place where people recovering from addiction sought treatment. Unfortunately for Dr. Naum, federal prosecutors not trained in the complexity of healthcare law and medical treatment failed to understand the difference.

To make matters worse, the standards for prosecuting physicians became convoluted over time by federal appellate court decisions that failed to recognize sometimes Doctors are required to make tough calls in the wake of the opioid epidemic. Knowing that Dr. Naum had done nothing wrong we proceeded to trial and were quick to learn that both the prosecutor and the judge stacked the case against us by making a critical error in interpreting Controlled Substance Prescribing laws.

Decided in 1975 the landmark case of United States v. Moore was the first case that determined that the weight of the federal government’s drug trafficking laws could be applied against physicians. To be convicted, a doctor must have abandoned the practice of medicine, ceased acting as a physician, and engaged in drug trafficking as conventionally understood i.e., running a “pill mill”. Since United States v. Moore circuits have widely spilt in their interpretation of the standard necessary to convict a Defendant. In the Fourth Circuit courts determined that a physician could be convicted of drug trafficking if he or she prescribed a medication “beyond the bounds of professional medical treatment”. The Circuit court interpreted this to mean that any doctor who prescribes outside of “professionally recognized norms” may be convicted of Drug Trafficking.

The Court in Dr. Naum’s case determined that Dr. Naum could be convicted if he stepped outside of professional norms for prescribing Suboxone regardless of whether the patients had a legitimate medical need for the treatment. Given that it’s nearly impossible for every doctor to follow the myriad of rules and regulations applied explicitly and in an ad hoc fashion Dr. Naum was convicted. Nearly every practitioner without a robust compliance program and a team of compliance professionals would be. Dr. Naum appealed, all the way to the Supreme Court of the United States.

Meeting Dr. Naum at the Supreme Court was the case of Xiulu Ruan. Dr. Ruan was a board-certified interventional pain management specialist in Mobile Alabama. He owned the practice along with his partner John Patrick couch, whom I am also representing before the Supreme Court. Drs Couch and Ruan were indicted in 2016 for unlawfully prescribing drugs. Just as in Naum, the prosecutors acknowledged that the patients, by in large, needed the medications prescribed but they prosecuted them anyway for falling outside of professional norms. The Government elicited testimony from three experts who testified at length that both doctors prescribed medication “outside the standard of care” and “outside the usual course of practice”. Back in 1975 such testimony would not be sufficient to support a criminal conviction. Today its much different. The standard has been sufficiently eroded to achieve convictions against doctors making tough judgment calls in the pain management field.

The Legal Standard Has Changed

In all three cases, medical “experts” brought by the government faulted the physicians for: ignoring “red flags”, not conducting a thorough examination, using opiates as a first line of treatment, not abandoning patients who presented inconsistent urine drug screens. The practice of opening up a physician’s medical records and heavily criticizing care based on an unenumerated list of “red flags” or professional norms is something that has sent a lot of innocent doctors to the slammer. Moreover, each physician, Naum, Ruan, and Couch, called experts of their own who were well credentialed and supported the care provided. None of these cases presented the sort of rampant “pill mill” evidence commonly seen in prosecutions of this nature in the early 2000's.

Similarly, to Naum, Ruan and Couch were the victims of a judicial decision that drastically changed the standard for conviction presented to the jury and stacked all odds against them. In Ruan and Couch the trial court refused to provide a commonly provided instruction that informed the jury that prescriptions written by the doctors “in the good faith treatment of a patient” are lawful. Without the benefit of the “good faith” defense, minor differences between the standard set forth by government experts and the prescribing practices of Ruan and Couch became criminal, just as in Naum.

Ruan and Couch requested the following instruction:

“Good faith in this context means good intentions and the honest exercise of professional judgment as to the patient’s needs. It means that the Defendant acted in accordance with what he reasonably believed to be proper medical practice”

This instruction was a mainstay in opioid prosecutions until a few years ago when the government elected to take the position that the instruction was not a valid statement of the law. The government argued that “good faith” was “subjective” and the standard should be an objective one. The court ruled that a physician cannot save his conduct if he failed to adhere to professional norms but subjectively believed that his prescriptions were legitimate.

All three physicians sought the review of the high court to change the state of law for good. All three physicians sought to stop the prosecution of physicians for what amounted to allegations of mere malpractice and revert to the standard set in 1975 by United States v. Moore.

On November 5, 2021 the Supreme Court agreed to hear the appeal of Ruan v. United States and consolidated the case with a very similar case Kahn v. United States. Naum v. United States is still pending before the court and may be taken up later if the decision in Ruan does not dispense with the issues in his case.

The Supreme Court’s Decision

Ruan will be set for oral argument on March 1, 2022 and the Justices have elected to decide the very narrow issue of whether the “good faith” defense to opiate prescribing is a valid defense and whether an instruction must be given to the jury. The Court will likely opine on whether a physician’s subjective “good faith” is a relevant consideration for a jury in opioid prosecutions. If the Court determines that “subjective good faith” is relevant, doctors making tough decisions during medical treatment of a patient will get a break. If the Court determines that it is not, doctors will be beholden to the rigid, ever changing, and often unenumerated standards often used by physicians in opioid prosecutions.

While the ruling may be narrowly applied to the issue of “good faith” it will require an analysis of the state of the standard for prescribing opiates and the ruling will have wide ranging implications for all doctors prescribing controlled substances to patients and how they must document their prescriptions to avoid federal scrutiny for their prescribing decisions.

What this Means for Pain Practices

The Court’s decision will either strengthen existing opioid prescribing laws and enable prosecutors to use them against physicians who merely deviate from the “standard of care”, or it will sway to the benefit of prescribers allowing them the benefit of a jury instruction that makes judgment calls made in “good faith” a defense. Regardless, all prescribers should be watching this case and read the court’s dicta very carefully to ensure that their practices stay compliant with the current interpretation of federal regulations in this field.

Link to Petitioner’s Brief Here: Petitioner’s Brief United States v. Ruan

The Government’s Brief Here: Government’s Brief United States v. Ruan