Can You Be Held Liable for Prescribing Opioids in Good Faith?

https://www.medpagetoday.com/opinion/second-opinions/97904

The Supreme Court is considering this question in Ruan v. United States

Earlier this month, the Supreme Court heard oral arguments in a case that will impact how doctors can treat patients where opioids are involved. The threshold question in Ruan v. United States, which came to the Supreme Court from the U.S. Court of Appeals for the Eleventh Circuit, is when the care a doctor provides patients crosses the line into a criminal act where the doctor is prescribing opioids.

Xiulu Ruan, MD, practiced medicine as a board‐certified pain specialist in Alabama, and was indicted in 2016 for unlawful distribution of opioids. The jury in the trial court convicted Ruan and other physicians in his practice based on a ruling that did not allow doctors to claim a defense of “good‐faith” where they honestly prescribed opioids under the belief that it was the right thing to do medically. Once the case reached the Eleventh Circuit on appeal, Ruan was essentially doomed, as that federal appellate circuit does not recognize a good-faith defense in cases such as this. He lost and appealed to the Supreme Court on a writ of certiorari, a court process to seek judicial review of a decision from a lower court.

John Brennan, JD, a New Jersey criminal defense lawyer, explains that the heart of the question presented to the Court in this case is what is and isn’t reasonable medical judgment:

“The argument of the doctors involved in the case was that the Supreme Court should look at the good faith of the doctors prescribing opioids. In a situation where a doctor genuinely believes that writing an opioid prescription falls within their normal course of practice, that this should not be viewed as a criminal act and they shouldn’t be convicted of unlawful distribution under the Controlled Substances Act.”

In the recent oral arguments, the Supreme Court Justices seemed to be leaning towards overturning the Eleventh Circuit and siding with the convicted doctors. However, the notion of reasonable belief and subjective intention are going to be difficult to agree upon because they can be a little slippery.

Three Justices — Brett Kavanaugh, Neil Gorsuch, and Chief Justice John Roberts — each expressed concerns for doctors who would be on the wrong side of a close professional judgment call, pointing out that doing so could result in decades in prison. When Justice Clarence Thomas asked whether the standards regulators set forth on this issue were insufficiently clear, counsel for Ruan replied that the elements of knowingly and intentionally misprescribing are left to states and administrative boards, as there is no clear federal guidance on this issue.

For the Justices, this will essentially come down to a question of reasonable professional practice, which can be difficult to pin down in medicine. At least from the nature and tone of the questioning at the oral argument, the Justices seem unwilling to look at the Controlled Substances Act in as restrictive a manner as the Eleventh Circuit did. While pinning down a reasonable good-faith defense is going to be a real challenge for the Court, the outcome here relies upon it, as does intelligent and balanced enforcement of the Controlled Substances Act.

The importance of this case and the underlying issue — the opioid crisis — cannot be overstated. A recent position paper by the American Medical Association made it clear that the nation’s opioid and drug overdose epidemic continues to worsen with metrics far beyond earlier projections. The ruling in this case could impact its trajectory.

While both the Alabama Federal Court jury and the Eleventh Circuit convicted Ruan for violating provisions of the Controlled Substances Act, among other laws, the larger question goes far beyond the wrongdoing of any doctor who may have been motivated to prescribe opioids for financial gain.

Simply put, a doctor’s ability to practice medicine properly would be limited by an inability to make judgment calls. If doctors fear huge penalties for honest mistakes, they will err on the side of not treating. So, if the Court’s ruling sets forth an overly restrictive policy aimed at the small number of physicians motivated by their own self-interest, it may be patients in pain who suffer in the long run.

Will the Supreme Court overturn the Eleventh Circuit here? In my opinion, they absolutely need to. While ensuring the availability of opioids may seem counterintuitive in a national opioid crisis, this is neither the legal nor medical issue presented in this case. Having the Controlled Substances Act without a good‐faith defense makes no sense from a legal or practical perspective. If the Supreme Court doesn’t overturn the Eleventh Circuit, they are essentially saying the binary between good doctors and those who run illegal pill mills is always crystal clear.

We can still be against pill mill doctors but agree that, in all jurisdictions, doctors need the legal ability to follow their best medical judgment to prescribe or not to prescribe as they see fit. If doctors are overly fearful of the legal consequences of perceived misprescribing — which may be the result of the current ruling in the Eleventh Circuit — patients in chronic pain will suffer unnecessarily. Beyond being fundamentally unfair, it is also a specious medical argument for any court to hold that physicians should still be convicted for unlawful distribution of controlled substances if they sincerely believe they were prescribing the drugs under acceptable standards of practice.

Filed under: General Problems