Thread by @national_pain

The US Supreme Court Oral Argument in Ruan and Kahn: Speed Limits, Grammar Teachers, Vulnerable Patients, and more. #SCOTUS #MedTwitter #Opioids #Pain #OUD

A long🧵🧵🧵

1/ The issue in these cases is when a medical provider who prescribes controlled medications like opioids for pain or an opioid use disorder (but also meds for seizure disorder, depression, ADHD, etc.) can be held criminally liable for drug distribution.

2/ In simple terms, it comes down to when a doctor is acting as a drug dealer versus as a clinician. But the devil is in the details re: how the relevant statute (Controlled Substances Act) and regulation are interpreted.

3/ These cases came to the Supreme Court because at least one circuit eliminated the criminal intent requirement for doctors altogether. Intent is how we typically distinguish serious criminal from non-criminal conduct (even though the latter might be ‘wrong’ in a civil case).

4/ @national_pain argued that the government has a legitimate right to prevent drug diversion but sufficient room needs to be left for doctors to practice medicine, per an earlier Supreme Court case in US v. Moore.

5/ Our concern: when the standard overly deters – as when doctors can be held liable without criminal intent for a felony – there is a chilling effect on care in which good doctors stop seeing patients who require these medications out of fear of prosecution.

6/ And as the Chief Justice made clear during the argument to the attorney for the government – the facts of the cases do not matter at the Supreme Court level. All that the Court is concerned about is proper legal interpretation of the statutory scheme.

7/ First – the CSA is a statute that prohibits knowing or intentional drug distribution “except as authorized” and that is where doctors – who have a specific authorization to prescribe—
come in.

8/ That “except as” language refers to a regulation. The regulation authorizes a healthcare provider to prescribe for a legitimate medical purpose in the usual course of his professional practice.

9/ Justices Alito and Breyer who each had different grammar teachers –took differing views of whether the “knowing and intentional” language in the statute applies to the exception/authorization. (We think it does).

10/ Justice Thomas raised the concern that we rarely have authorizations for registration (as in this regulation) attach to serious criminal penalties like they do here. Usually, you just lose your license vs spending 20 years in prison.

11/ Justice Barrett noted that the exception in this statutory/regulatory scheme was pretty circular. Others like Justices Kavanaugh and Gorsuch seemed to agree that the intent applies to the exception.

12/ On the grammar question – textual interpretations usually rely on what an ordinary person would think the language means (not necessarily a battle of evolving grammar rules) credit: @DebbieHellman.

13/ @national_pain argued that the intent spelled out in the statute is read most sensibly as applying to the exception and there is #SCOTUS precedent that supports that view.

14/ The Chief Justice posed the hypothetical of a speed limit for which people are liable regardless of intent – if you go over 55 in a 55, while you genuinely believed you were going 40 – doesn’t matter. His question: does intent matter here at all?

15/ Speed limits are one of the few places we don’t require intent. But the CSA does. Plus, speed limit violations are generally lesser offenses and there is a bright line rule – 55, super clear – not a vaguer standard, as is the case here, being enforced.

16/There seemed to be a fair amount of consensus that what the 11th Circuit did – which was to eliminate any intent requirement – is problematic. But just what the intent requirement should be & how objective or subjective it is was up for debate.

17/ Where the Justices seemed to differ is whether to use knowing or intentional from the statute or to focus on the words in the exception: like legitimate medical purpose (which has both subjective (purpose) and objective (legitimate) words.

18/ Justices Alito (and probably the Chief Justice) seemed to focus on the later, while more of the Justices seemed to favor the former. BUT THIS IS READING TEA LEAVES, because sometimes a Justice is just trying to clarify a party’s position rather than telegraphing her view.

19/ To complicate things further-- the case law often uses the short-hand of “good faith” to refer to intent, but good faith is nowhere in the statute or regulation.

20/ Our view: objective good intent is an oxymoron – rather there are two questions: 1) what meaning to give to legitimate medical purpose and usual professional course & 2) what intent of the prescriber had in doing both.

21/ Here is where it gets complicated. Some Justices worried that allowing too much subjectivity means the idiosyncratic view of a clinician—however extreme—excuses them of liability. Others think those lines will be drawn when a jury considers the credibility.

22 /The Justices then lobbed and received hypos to elucidate the right balance. One slippery slope from the government was the suggestion that doctor selling drugs on the street might be perceived as having a legitimate purpose because we know many experience pain.

23/ That is where Justice Sotomayer’s question about whether “the usual course of professional practice” adds anything comes in: the usual course is not selling scrips on the street. Both legitimate medical purpose and usual course of his professional practice matter.

24/ @national_pain’s brief offered four hypotheticals. We distinguished two categories of criminally liable actors – the drug pusher & aberrant physician, from two non-criminally liable – the out-of-date physician & the potential pioneer.

25/ The drug pusher neither knows or intends to practice medicine - the doctor who sells prescriptions at a premium. The aberrant physician who prescribes for a purpose other than to promote healing also knows his prescribing departs from accepted goals of medicine

26/ But the doctor who is just out-of-date and departs from standards of care is not criminally liable under the CSA (although he may negligent) nor is the pioneer who intends to promote healing and is adopting a new treatment not yet fully used by her peers.

27/ To be clear, even the government supported some intent requirement – what it called an objective “honest belief” standard – or an “extreme objectively grounded” intent standard.

28/When pressed for details about what this means, counsel said some very specific things like: How the prescriptions were written, how many times PDMPs were checked etc.

29/ This points up a problem we raised in our brief: when the standards for appropriate prescribing are in flux (case in point, the CDC just issued a new draft guideline w/ significant changes from 2016) – what determines legitimate or usual?

30/ In short, it looks like the Court will articulate a standard that requires some criminal intent – but how they define that intent and where they draw the subjective/objective/whose burden is it to prove (lots of Qs on that) line is where the rubber will meet the road.