Waiting on Ruan

Insights from White Collar Criminal Defense Attorneys Trusted Nationwide

Waiting on Ruan

Late June or Early July?

The hotly anticipated SCOTUS ruling that will greatly impact prescribers, patients and dispensers of controlled substances is right around the corner. In United States v. Ruan, the Supreme Court will determine whether physicians may avail themselves of the “good faith” defense when prosecuted for prescribing decisions and whether that “good faith” must be subjective or objective.

Court watchers anticipate a decision in late June but occasionally the Court dips into July to finish up its term. The leaked abortion decision and subsequent investigation of SCOTUS law clerks may have an impact that delays this vital ruling.

Federal district courts and circuit courts are eagerly awaiting a decision in Ruan and many have taken the extreme step of adjourning cases pending the outcome of the SCOTUS ruling.

Interesting SCOTUS Developments

Reading the tea leaves is nearly impossible here but there are a few interesting developments in the Supreme Court this term that may give us some insight into the Court’s leanings. The first is the rejection of the recent SCOTUS bid by Insys Therapeutics Inc. founder John Kapoor and another former executive of the drugmaker to overturn their convictions for conspiring to bribe doctors to prescribe addictive opioids and defraud insurers into paying for them.

The jury found Insys executives guilty of participating in a wide-ranging scheme to bribe doctors nationwide by retaining them to act as speakers. In a petition filed in January with the Supreme Court the executives argued that a non-physician cannot be convicted of agreeing with a doctor to illegally distribute drugs if the doctor believed he or she was acting in good faith.

Its unsurprising that the Court rejected this petition on June 13th but what is interesting is that it was relisted on June 6th. What’s even more interesting is the rather fact intensive 15-page brief the Government filed opposing cert. The brief in opposition was filed in April after the Solicitor General filed motions for extension of time in February and March. This means that it was filed after oral argument on Ruan and Khan suggesting that the Solicitor General wanted to see the outcome of oral argument before taking a position. While Kapoor’s petition was ultimately denied, the Court’s treatment of another similar petition on its docket gives us more juicy details on the pending decision.

Naum v. United States

In Naum v. United States, petitioner, a physician also convicted of violating the Controlled Substance Act, filed a petition before the petitions in Khan and Ruan arguing that his conviction cannot stand because the trial court severed the standard required to convict a physician and determined that he could be convicted simply for deviating from objective standards such as state licensing regulations and SAMHSA guidelines. The court relisted his petition five times before deciding to hold it pending the outcome in Ruan and Khan. Kapoor was relisted and denied in June, Naum was relisted and a decision is still pending. With a Court very interested in clearing its docket by the end of June it's reasonable to conclude that by holding on to the Naum case and not denying cert some favorable treatment is on the horizon.

Either way, we will find out soon enough. But for those waiting on a SCOTUS decision that is a model of clarity and clearly instructs physicians on their legal limits in prescribing opioids – don’t hold your breath. Regardless of how the Court decides this important issue federal district and circuit courts will be wrangling with the impact of Naum, Khan, and Ruan for the foreseeable future. Medical boards and federal investigators will take time to digest the decision and make appropriate modifications to their regulations and procedures.

About the Author

Ronald Chapman II is the founder of Chapman, Dowling & Mallek and a top-rated Michigan federal criminal defense attorney who represents clients in federal courts nationwide. His practice is focused on defending individuals and organizations in complex federal prosecutions, including white-collar criminal matters and healthcare fraud investigations.

Throughout his career, Mr. Chapman has helped clients avoid more than $550 million in potential penalties, primarily in cases involving physicians, healthcare providers, executives, and professionals facing federal charges. He is widely recognized for his work as a Michigan healthcare fraud defense attorney, as well as for his results in white collar criminal defense in Michigan, where cases often involve parallel civil, regulatory, and criminal exposure.

Ronald Chapman II Federal criminal defense Attorney
2 Comments
rlamartini rlamartini June 19, 2022

This really needs to be good news for the plight of pain patients and their doctors who are in a desperate situation due to the ongoing unjust war on pain management by the DEA/DOJ.

Reply
Robert Schubring Robert Schubring June 20, 2022

The basic flaw in all these arguments is that they ignore the threshold issue of jurisdiction. Profound scientific discoveries in 1985-87 rendered obsolete and factually false, the Government's position on its jurisdiction of controlled substances under the Harrison Act. That Act presumed all opioids to enter the US from foreign nations and therefore be within federal jurisdiction under the Commerce Clause. The Harrison Act was absorbed into the Controlled Substances Act, drawing its claim of constitutional jurisdiction from the same exact theory: that Congress could broadly invade state powers to regulate public safety and morality by asserting an interstate commerce power, safe in the belief that not one picogram of opioids ever formed naturally within the US.

The profound discoveries at NIDA in 1985-87 revealed that the opiate Morphine is naturally secreted in the human adrenal gland by metabolism of food, particularly the amino acid tyrosine found in beans, sharp cheeses, meats, soy sauce, and dark beer. More importantly, it is now known that morphine and dopamine act as hormones, regulating the human sleep cycle. Endorphins, which are peptides of morphine and amino acids, occupy sites on nerve receptors that process and prioritize pain. Thus the hundreds of milligrams of morphine made daily by the adrenal glands of every human alive, totally vacate DEA's claim of jurisdiction over all opioids. Most of the opioids in daily use, are used by 100% of the population, and form inside our bodies by natural means. Since the act of digesting a meal in no way requires interstate commerce, the commerce clause is not an absolute source of authority over opioid presence in the body nor its effects, Worse yet, Congress has stepped into a giant bear trap of its own creation, by invading state authority over keeping the domestic tranquility and deciding matters of public morality. It has second guessed what state drug policy should be. And it based all of that on deeply flawed science now thoroughly debunked, as it's basis of jurisdiction, by assuming all opioids to be imported. The growing body of science disproving federal jurisdiction over the morality of opioid use, demands that the early cases considering the constitutionality of the Harrison Act be reviewed de novo in line with the factual findings.

I strongly expect that something similar to another overreach case will emerge. In Roe v Wade, an overly broad Texas statute claimed jurisdiction of "potential children" (defined HOW?), granting police the power to nose into any medical procedure involving a female between puberty and menopause, in case it somehow affected the viability of some future pregnancy. The obvious solution was to invoke the individual right to self-defense found in the Second Amendment and the right to be secure from unreasonable search set forth in the Fourth and tell Texas that it's statute was overbroad. It is noteworthy that today's SCOTUS shows no sign of overturning the Roe ruling as it relates to self-defense and the right to own one's person, property, papers and effects...what's being scrapped is an attempt to legislate when children acquire the right to survive, a matter entirely outside the powers of Congress and within the power of states.

I suspect that a challenge to the constitutionality of the Harrison Act would end in bifurcation. We would get from SCOTUS a ruling upholding a federal power to restrict drug smuggling and regulate drugs sold in interstate commerce...and we would lose federal jurisdiction of addicts and addiction.

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