Post-Ruan World: Unlawful Distribution | Health Care Fraud Blog

A Post-Ruan World: Unlawful Distribution of Opioids

unlawful distribution opioids

Doctors, and other medical professionals, serve as the gatekeeper for various medication in the United States.  The government largely allows the doctors and patients to decide on a course of treatment, including the medications that are necessary to achieve the goals.  It would be a rare occurrence for the government to stop a doctor from prescribing medication when the doctor has determined the benefits outweigh the risks.  This is true for antibiotics, anti-depressants, cholesterol medications, and many others with known side effects.

While doctors and patients are normally free to make their own medical decisions, privacy is discarded when a medical professional begins prescribing substances that have addictive qualities.  Addictive medications with a role in the black market receive even greater scrutiny.  When a doctor prescribes an opioid for pain, Xanax for anxiety, or another controlled substance, they are running the risk of falling on government radars.  The more prescriptions that appear under a professional’s registration number, the more likely the government is to review the medical decisions for a particular physician and clinic.

The government’s ratoinale for this oversight is linked directly to the illicit market for specific controlled substances.  It is well-known there is a high demand for opiates on the street.  The same is true for Xanax, muscle relaxers (Soma), and Fentanyl.   These particular drugs make up a multi-million dollar drug trade conducted on the streets of every city and town across the country.

These particular drugs are highly regulated and produced by large corporations.  The drugs hit the streets in one of three ways: 1) legitimate processes, 2) the illicit drug trade predominantly sourced in Mexico, and 3) theft from pharmacies.  Our focus here is on the first route; legitimate processes to move the product from the manufacturers to the streets.  The legitimate route requires a drug dealer to pass through two bottle necks for distribution – a valid prescription from a physician and a pharmacy to distribute the drugs.  If doctors refused to write the prescriptions and/or pharmacies refused to fill them, we would see a substantial reduction in supply of these narcotics in the black market.

This reality has led many doctors to refuse to write these specific prescriptions for their patients.  This decision is not linked to a cost-benefit analysis for the patient, but rather, a risk assessment for the physician.  Put differently, many professionals would rather quit prescribing any drug with street value than assist their patients with specific issues.

The government’s view of the prescription drug problem in America is not wrong.  A large amount of opiates, anti-anxiety meds, and muscle relaxers get on the street through legitimate processes.  There are doctors that prescribe these medications as a cog in the drug dealing narrative.  There are pharmacies that fill prescriptions they know are not valid.  The issue is not the narrative.  It is the assumption that all physicians who prescribe these drugs are part of that process.  That latter narrative is false, and it results in select doctors being lumped in with the truly nefarious actors.

In this post, we will use this background to dive into the fine lines between criminal and legitimate conduct under current federal criminal statutes.  We will do this by reviewing the elements of unlawful distribution and the role of the Supreme Court’s decision in Xiulu Ruan v. United States in that analysis.

21 U.S.C. § 841 – Unlawful Distribution of a Controlled Substance

Doctors and pharmacies charged for the illegal distribution of scheduled substances will be charged (at least in one count) under 21 U.S.C. § 841 – “except as authorized, it is a criminal act to knowingly or intentionally distribute or dispense a controlled substance.”  Under § 841, it is a criminal act to distribute or dispense controlled substances unless the prescription is authorized.  The prescription is authorized if it is 1) issued by a doctor for a legitimate medical purpose and 2) issued in the normal course of professional practice.  If any authorization element is not met, the prescription is not authorized and criminality can be tied to the particular transaction.

Acting within the normal course of professional practice is a difficult concept that likely deserves its own series of blogs.  But for our purposes, understand there are a host of federal regulations which guide a physician’s practice.  A violation of any one of those regulations can serve as the basis to meet the overarching “normal course of practice” element.  For example, there is a regulation that states doctors must issue a prescription on the same day it is signed.  If a doctor signs 100 prescriptions on May 8, 2023, and his nurse practitioner issues them on April 9, 2023, the regulation has been violated.  That violation has been seen as sufficient to support a conviction under § 841.

Issuing prescriptions for a legitimate medical purpose is nearly as opaque as the “normal course” element above.  Whether a certain drug is a legitimate way to treat a certain ailment is a subjective decision made by physicians across the country every single day.  Some doctors believe there are zero patients where the benefit of a month supply of hydrocodone outweighs the risks.  There are other doctors that believe it is effective and legitimate to treat long term pain patients with opiates as long as the doctor is monitoring their addiction.  Though  this element is far from as concrete as “causing death” in a murder case, the parameters are well understood.  It requires a fight over the science and an attorney who can tie the science into the doctors medical practice.

Under § 841, the trial has always included a battle of experts.  The two parties argue over whether the prescriptions were a product of legitimate medical practices, and thus, authorized under federal law.  The doctor had an advantage in that fight as the burden of proof lies with the government.  However, the perceived advantage is normally very little assistance at trial.  The jury wants to, and often does, decide these cases on what they believe is true, not what they believe beyond a reasonable doubt.

This common elemental fight in § 841 cases changed in 2022 following the Supreme Court’s seminal decision in Ruan.

Knowledge under Ruan

The Doctor or medical professional must KNOW the prescription was not authorized

In 2022, the Supreme Court granted certiorari in Xiulu Ruan v. United States.  The question before the Court was whether the mens rea elements (knowingly or intentionally) applied to the “except as authorized” language in the statute.  Put differently, whether the government had to prove the professional knew the prescriptions were 1) not for a legitimate medical purpose and 2) not done in the normal course of professional practice.

After analyzing historic precedent, the Supreme Court ruled the mens rea terms had to apply to the authorization elements  to create a clear line between criminal and other improper conduct.  Applying the mens rea solely to the act of dispensation or distribution meant the government could prove criminal conduct because they disagreed with the doctor’s choice of treatment.  Pre-Ruan, the government only needed to prove the defendant intentionally and knowingly distributed a scheduled substance.  If that prescription later turned out to be unauthorized, the criminal elements were met.

Historically, United States law has been hesitant to create criminal conduct on subjective decisions between a professional and their clients.  Criminal activity should be relegated to those persons who know their conduct is outside the bounds of federal regulation and choose to act anyways.  It should never be a criminal act to write a prescription for a patient where the physician or other medical professional believes it is appropriate.  The Ruan logic has already been applied to medical necessity cases; where the government must prove the physician knew the procedure was not medically necessary to obtain a criminal conviction.

The Ruan decision is huge for unlawful distribution defense.  Now, the defensive theory can be built around the doctor’s own practices instead of a mud slinging match between experts on the effectiveness of Xanax, opiates or other scheduled substance at treating a particular subsect of patients. The question following Ruan is not whether the prescription was in fact authorized under federal regulations.  The question is solely whether the defendant knew the prescriptions violated federal law when they were issued.

This new stance brings a physician’s treatment procedures to the forefront of the criminal prosecution.  An example likely highlights this best. Let’s assume a physician is treating a patient at his clinic in Dallas, Texas.  This patient has been prescribed oxycodone 30s for two years by another doctor.  The patient takes three pills per day.  The physician reviews the patients medical charts, drug tests the patient, and requests X-rays to confirm any ailments that may be causing the underlying pain.  After this review, the physician determines the benefits of continued opiate use outweigh the risks.  The physician prescribes the patient a thirty-day supply of hydrocodone 10s, and asks the patient to taper down from the oxycodone 30 milligram dose.

This patient relationship continues for a year.  The physician is effective in tapering the patient from their exceedingly high dosage of the controlled substance with limited withdrawal symptoms.  The goal is to get the patient to a place where they can discontinue opiate use and still manage their pain, or alternatively, effectively manage their pain with the lowest dosage possible.

The above story, with one patient, likely never hits government radars.  The DOJ strike force is unlikely to ever hear about this mystery physician and his one pain patient.  However, if the physician chooses to scale this practice and treat numerous opiate dependent pain patients at his clinic, his risk of government contact will sky rocket.  The government is constantly checking the PMP database to isolate those physicians who are outliers in their schedule II prescription practice.

If done at scale, this physician could, and likely would, get indicted for unlawful distribution of a controlled substance in violation of 21 U.S.C. § 841.  Before Ruan, the case would come down to one simple question – were the prescriptions for a legitimate medical purpose and written during the ordinary course of medical practice.  If they were not, the elements of § 841 would be met.  The trial would come down to multiple experts arguing whether it is legitimate to treat these patients with hydrocodone 10.  The government would call their long standing expert with the VA.  He would testify it is not legitimate to treat any patient with an opiate for longer than a week or two.   The defense expert would challenge that theory diving into the nuances of addiction and pain treatment for long term, pain patients.  The jury would decide if they believed the prescriptions were written for a legitimate purpose.

After Ruan, the issues do not entirely change.  However, the way a litigator can challenge the government does.  Let’s take the exact facts laid out above.  The new question no longer centers around the science and the appropriate use of opiates in pain treatment. The science is now a peripheral matter that is useful in so far as it impacts the reasonableness of the physician’s decisions. The jury can find that opiates should not be used as the physician prescribed them, but still believe the physician genuinely believed he was helping his patients.  As long as the physician was following all technical prescription regulations for schedule II substances, his/her belief his treatments were proper is enough to set him free from the prosecution.

The Ruan decision served to take some power away from the Department of Justice.  Before Ruan, DOJ was free to go after any physician writing monthly prescriptions for opiates.  Their expert would always disagree with such a practice.  Post-Ruan, the government should only attack the physicians who are clearly writing schedule II prescriptions for the sole purpose of financial gain.  If a doctor has a legitimate treatment protocol, backed by any expert studies, there is a defense built into the “except as authorized” language.

The Real Impact of Ruan

In practice, Ruan will likely play a bigger role in charging and investigatve decisions than trial practice.  The government gets to choose who they bring to trial in any criminal case; holding the ultimate power to not indict or dismiss.  The Ruan decision should cool their ferocity when looking at doctors that do not fit the classic “pill mill” profile.  However, the classic pill mills will continue to fall on the wrong side of an indictment, and their cases will likely not benefit from the decision in Ruan.  Ruan only protects those physicians who are actually treating certain patients in a way the government deems unacceptable.  The clinics that continue to write prescriptions for cash without seeing the patient will still be susceptible to government contact. Ruan provides no safety net for those classic cases.