Last week, in an otherwise unremarkable order list, the Supreme Court remanded a case involving a "pill mill" doctor to a lower court for further consideration, in a move that could impact previous precedent-setting decisions on prescribing liability.
The ultimate decision in the case, (Santos), will have important implications for care.
Details of the Cases
Counsel for Medardo Queg Santos, MD, filed a writ of certiorari -- a petition for review -- with the Supreme Court earlier this year. The counsel argued that if the court were to decide that "pill mill" doctors could not be convicted absent a jury finding that they subjectively believed the doctor was wrongfully dispensing pills, then Santos should be cleared of his conviction.
I wrote about a similar case, , back in March, the day after the Supreme Court heard oral arguments.
In Ruan, the Supreme Court upheld a federal law making it illegal for doctors to prescribe opioids to patients without a legitimate medical purpose, but held, in a 9-0 ruling, that Xiulu Ruan, MD, the "pill mill" doctor in question, indeed had a good faith defense. He was, however, convicted for unauthorized distribution of controlled substances.
The historical context in which Ruan was charged was part of a push by the federal government to crack down on so-called "pill mills" or "opioid mills," which are clinics where doctors prescribe opioids to patients without conducting any real examination, often with no regard for their long-term health or safety.
As for Santos, given that he had a pending application for certiorari in front of the Supreme Court and given the decision in Ruan, it should be a fait accompli that he and his conviction should have a similar fate.
Not so fast.
As I mentioned at the outset, last week the Supreme Court vacated the judgment against Santos and remanded the case to the 11th Circuit. I don't believe that "further consideration" is going to result in the 11th Circuit simply aligning Santos with Ruan.
My theory is that Santos may again be considered by the Supreme Court after the 11th Circuit's decision. This is because the Supreme Court might have seen something factually interesting in Santos that presents the Ruan issues in a different light. In other words, the settled law of Ruan might not be so settled, even after a 9-0 decision.
This could have serious implications for physician practice and care.
The Broader Context
What has changed in the short time since the Ruan case faced the Supreme Court is that the opioid epidemic has . This puts pill mills and the doctors who fuel them firmly in the crosshairs of the media and the law.
This zeitgeist speaks to the presented to the Supreme Court in Santos, which mirrors that in Ruan:
Whether, if a physician's good faith is a complete defense to a prosecution for prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.
The issue with "good faith" is that it's simultaneously fact-based and subjective. Ten cases presenting 10 different fact sets are going to have some commonalities but also some critical differences. Of course, this is the case with Santos and Ruan.
In the recent ruling, the federal trial court found Santos (as well as a co-defendant) guilty of three counts of illegally distributing and dispensing controlled substances for no legitimate medical reason (similarly to Ruan's conviction). However, unlike Ruan, Santos was also found guilty of conspiracy to distribute and dispense controlled substances outside the normal course of his professional practice.
Testimony at trial, which led to Santos' conviction, spoke to his abuse of the system. Santos was director of a cash-only pain management clinic in Tampa, and over a 3-year period he and his co-defendant allegedly spent very little time with their patients and took little to no medical history or documentation. After this cursory medical attention, they allegedly prescribed what the trial court decided were excessive amounts of controlled substances, including morphine, oxycodone, hydrocodone, methadone, and more.
So, it was no surprise that the trial court found Santos guilty of these charges. This is not dissimilar to what happened at the trial court in Ruan's case.
It's critically important to understand that the 11th Circuit is a superb example of how a U.S. president can reshape a court. As Bloomberg Law recently highlighted, Trump nominees dominate the 11th Circuit Court of Appeals. Over "got their posts through Trump's aggressive remaking of the U.S. judiciary."
Simply put, the 11th Circuit is a perfect venue to re-examine and realign Ruan.
As we examine this today, it's worth considering whether the Supreme Court remanded this to the 11th Circuit because they see a factual basis for overturning Santos' conviction (and aligning the decision with Ruan) or whether the Supreme Court sees a way for the 11th Circuit to distinguish this case from Ruan. In this latter instance, the 11th Circuit would, again, affirm the District Court's decision and essentially take a bite out of Ruan.
Implications for Physician Practice
If the Santos decision holds, the implications for physician practice and care are immediate. Every bite that gets taken out of the Supreme Court's decision in Ruan takes agency away from doctors to practice medicine as they see fit, using their best judgment and good faith as their north stars. But court decisions impact medical practice, and there is no denying that court decisions are influenced by the times we live in.
Ruan was one of Justice Stephen Breyer's final decisions on the Supreme Court. While last term's Supreme Court ruled that even doctors in a pill mill could be convicted only if a trial court jury found that they subjectively believed they were wrongfully dispensing pills, by the time Santos is decided by the 11th Circuit, close to a year will have passed since the Ruan decision.
As long as the U.S. government continues to crack down on illegal opioid production and distribution and opioid-related overdoses continue to rise, legislatures and courts will drive new regulation aimed at curbing opioid distribution and use.
In that context, doctors need to ask themselves whether they believe the scrutiny of their dispensing practices is the same, better, or worse than it was in March when the oral argument in Ruan was heard. They need to be responsive to the signals courts are sending about the good faith defense in Ruan and to keep a close eye on the impact of the upcoming Santos decision.
an experienced medical malpractice lawyer, observes that: "The Supreme Court's decision in Ruan essentially established a rebuttable presumption that prescriptions from doctors are legitimate. The holding requires the government to prove, beyond a reasonable doubt, that an individual doctor 'knowingly or intentionally' acted in an unauthorized manner, which established an extremely high bar for prosecutors to meet in criminal cases."
Ultimately, these cases present an ultimately more important question for doctors to consider:
Can it ever be good faith (and medically justifiable) for a physician to prescribe controlled substances without a legitimate medical purpose or outside the usual course of professional practice?
Reframing the question in this way makes the correct answer obvious, as it would to the 11th Circuit and the Supreme Court if they undertake a similar exercise.
The "good faith" standard is invariably subjective and a subjective standard should never operate as an absolute defense when assessing physician conduct. Why? Because a subjective good faith standard erodes patient safety.
For example, it's not a valid defense in a traditional malpractice case for a doctor to say, "Well, I tried my best." While that may be true, the real issue is whether the doctor's care complied with the accepted standard of care. This is why objective standards are necessary to ensure safety, and allowing subjective defense will erode any culture of safety.
So, were I advising the Supreme Court in Santos, I would suggest that the standard of care remains the same: the care that a reasonably prudent physician would provide under the same or similar circumstances. By this logic, Santos should not be of much concern to physicians as it will not alter the standard of care in their practice area. Convictions should remain limited to the "pill mill" line of cases.
But, as last term's Supreme Court reminded us again and again, nothing they do is predictable, and while not every decision defies logic, some of their more controversial ones clearly test its elasticity.
is the chief legal analyst for and the editor of . He has taught entrepreneurship at McGill University and the University of Pennsylvania, and was elected to Fastcase 50, recognizing the top 50 legal innovators in the world.