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.

If you aren’t familiar with the issues in Ruan read this and this.

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 its 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.