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A Unanimous SCOTUS Lifts The Fear Of Prosecution For Physicians Prescribing Pain Medication In Good Faith

A Unanimous SCOTUS Lifts The Fear Of Prosecution For Physicians Prescribing Pain Medication In Good Faith

Instilling fear of jail time and financial ruin in the hearts of doctors for good faith prescription of pain medication is not the way to go. As recognized by all 9 SCOTUS justices.

What a week in SCOTUS news! While the media has chosen to focus almost exclusively on you- know-what, there is another medical holding that merits coverage.  In the consolidated cases of Ruan v. United States and Kahn v. United States, the Court delivered a 9-0 opinion, written by Justice Breyer, taking the feet of the law off of the necks of doctors who prescribe drugs to treat pain in their patients.

Drs. Ruan and Kahn were convicted under a provision of the Controlled Substances Act (codified at 21 U. S. C. §841) which makes it a federal crime to prescribe a controlled substance, “except as authorized.” A prescription is only authorized when it is a prescribed “for a legitimate medical purpose… acting in the usual course of his professional practice.”

The Department of Justice portrayed the doctors as pseudo drug dealers operating “pill mills.” At trial, Dr. Ruan asked for a jury instruction that would have required the State to prove that he subjectively knew that his prescriptions fell outside the scope of his prescribing authority, but that request was rejected.

Instead, the District Court instructed the jury that a doctor acts lawfully when he prescribes “in good faith as part of his medical treatment of a patient in accordance with the standard of medical practice generally recognized and accepted in the United States.”  The court further instructed the jury that a doctor violates §841 when “the doctor’s actions were either not for a legitimate medical purpose or were outside the usual course of professional medical practice.”  Following his conviction, Dr. Ruan was sentenced to over 20 years in prison and was ordered to pay millions in restitution and forfeiture.  Dr. Kahn was sentenced to over 25 years in prison.

The question before the Supreme Court was what state of mind the government has to prove in order to convict a doctor for dispensing controlled substances not as authorized.  The Court held as follows:

“We now hold that §841’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause. This means that once a defendant meets the burden of producing evidence that his or her conduct was “authorized,” the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”

Mens rea or guilty mind is defined by Black’s Law Dictionary as the state of mind that the prosecution, to secure a conviction, must prove that a defendant had when committing a crime.

If a prosecutor decides to go after a doctor who prescribed pain meds to a patient, said prosecutor needs to prove beyond a reasonable doubt that the doctor knew he or she was acting in an unauthorized manner or intended to do so.  So without the mens rea to dispense prescriptions for an illegitimate purpose outside of the course of usual professional practice, a doctor cannot be convicted.

The Court began its analysis with the general principle that a defendant must have scienter, or a “culpable mental state” in order to be guilty of a crime.  It acknowledged that “we expect, and indeed usually want, doctors to prescribe the medications that their patients need.  In §841 prosecutions, then, it is the fact that the doctor issued an unauthorized prescription that renders his or her conduct wrongful, not the fact of the dispensation itself. In other words, authorization plays a “crucial” role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct…Applying §841’s “knowingly or intentionally” mens rea to the authorization clause thus “helps advance the purpose of scienter, for it helps to separate wrongful from innocent acts.”

This was critical per the Court because “[a] strong scienter requirement helps to diminish the risk of “overdeterrence,” i.e., punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.”  The severe penalties that §841 carries, namely the potential for life imprisonment and fines up to $1 million, was additional evidence that the Court pointed to in furtherance of a strong scienter requirement.

The concurrence was authored by Justice Alito, and joined by Justice Thomas as well as partially by Justice Barrett, and advocates for a simpler standard, namely whether the doctor wrote the prescription(s) in “good faith.”  The Justices accuse the holding of suffering from “an obvious conceptual mistake,” confusing the mens rea requirement for an element of the offense instead of as an affirmative defense.

There is undoubtedly a staggering drug problem in this country.  Tragically, too many Americans and their families have suffered.

Provisional data from CDC’s National Center for Health Statistics indicate that there were an estimated 100,306 drug overdose deaths in the United States during 12-month period ending in April 2021, an increase of 28.5% from the 78,056 deaths during the same period the year before.

Here are the visuals.

But as recognized by all 9 justices on the Court, instilling fear of jail time and financial ruin in the hearts of doctors is not going to solve the drug abuse problem.  The proper course of medical treatment should be decided by doctors and their patients, without the overbearing control of the Feds’s power-hungry prosecutors.

Throughout the opioid crisis, doctors have increasingly faced “the idea of criminalization of physician conduct,” Nelson said, creating “a climate of fear” around prescribing.  Now, attorneys say the Supreme Court has eased constraints on doctors, allowing them to use their best judgment in filling prescriptions for patients. This decision gives physicians “a day to celebrate,” Nelson said. As they’re “prescribing in good faith,” doctors “don’t have to be worried about criminal prosecution.”

A huge range of patients need these meds.  It’s a “‘major win for patients with chronic pain, and also a major win for patients with opioid use disorder as well as a whole range of conditions for which the medically appropriate care includes controlled substances,” such as ADHD and anxiety, said Kelly Dineen, director of the health law program at Creighton University, who authored a brief in the case.  This is also going to help ensure that the dying are treated compassionately not denied the medications they need to lessen suffering at the end of their life.

Perhaps the most significant takeaway from this case is that the ruling makes sense!  It was practical! And it was unanimous!  It is considered a “win” for both doctors and patients!  Does this mean there is hope, after all?

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Comments

The Gentle Grizzly | June 30, 2022 at 6:01 pm

About time!

Now. Where do the doctors go to get back their money, their dignity, their reputations, and their lives?

    mbecker908 in reply to The Gentle Grizzly. | June 30, 2022 at 7:00 pm

    The doctors in question in this particular action were dumping pain meds like the cartel. A case can be made for the SCOTUS decision, but these guys are as bad or worse than the people selling fentanyl-laced heroin on the corner.

      Dathurtz in reply to mbecker908. | June 30, 2022 at 7:48 pm

      Yeah, I am not sympathetic to these particular drug dealers.

      It doesn’t seem the hardest matter to allow doctors to give appropriate treatment to their patients while simultaneously prosecuting drug dealers posing as doctors.

      SDN in reply to mbecker908. | July 1, 2022 at 6:44 am

      Yeah? Were you on the jury.?

      Speaking as someone who actually has chronic pain, and whose spouse has osteoarthritis in every joint, if you object to this ruling you have to also support gun control for legal gun owners even though they aren’t the problem.

        willford2 in reply to SDN. | July 1, 2022 at 8:20 am

        I HOPE fools like YOU need bunches of pain meds in the near future and YOU CANT GET THEM. BECAUSE a bureaucrate somewhere says you dont need them! You “POMPOUS @$$e$”

          willford2 in reply to willford2. | July 1, 2022 at 8:22 am

          that was for dathurtz

          billi in reply to willford2. | July 1, 2022 at 9:49 am

          I agree. Suddenly docs were under the thumb of the Gov and wary of prescribing pain meds for chronic conditions, even though the quality of their life deteriorates to staying in the rocker, physically and emotionally worn out with coping.

        mbecker908 in reply to SDN. | July 1, 2022 at 12:08 pm

        You jackass, read the indictment.

        There are responsible doctors who prescribe appropriately for chronic pain. And there are tons of doctors whose practice consists of writing scripts and that is exactly what this indictment charged.

      Char Char Binks in reply to mbecker908. | July 1, 2022 at 7:35 am

      How do you distinguish between prescribing fentanyl to patients in need and “dumping pain meds like the cartel”? This seems like moral panic.

        mbecker908 in reply to Char Char Binks. | July 1, 2022 at 12:11 pm

        Look at their script counts. There are lots of doctors whose practice consists of writing scripts. Like these guys.

        It’s not a “moral panic” at all. Just so happens the #1 cause of death for 18-45yo is fentanyl overdose. Most of them started on pain meds.

henrybowman | June 30, 2022 at 6:10 pm

The women looked. The Organisms stood in a knot, staring at the sky.
“Look at the sky!”
The women looked; the frosted glass was cracking, breaking, curling aside.
“The blue! The blue sky of old times!”
A terribly bright light burnt down, seared their eyes. The rays warmed their naked backs.
“The sun,” they said in awed voices. “The sun has come back to Earth.”
The shrouded sky was gone; the sun rode in a sea of blue. The ground below churned, cracked, heaved, solidified. They felt the obsidian harden under their feet; its color shifted to glossy black. The Earth, the sun, the galaxy, had departed the region of freedom; the other time with its restrictions and logic was once more with them.
“This is Old Earth,” cried Finn. “We are Men of Old Earth! The land is once again ours!”

–JACK VANCE

As a matter of practicality wouldn’t it be simpler to use state and federal regulations to monitor dispensing? If a particular pharmacy in a low population, rural county suddenly begins filling RX for an opioid at 100 times the previous rate that should be a trigger for a review. Same Physician writing the RX? The Physician just lost a big divorce settlement? That sort of combination of factors leads one to conclude that it’s worth asking some questions.

Outside that sort of situation some poor bastard with chronic pain shouldn’t get hassled because the docs and pharmacists are scared. We need to ensure our systems come much closer to common sense. This ruling brings us part of the way.

    rutvet83 in reply to CommoChief. | June 30, 2022 at 9:00 pm

    There actually is a system in place, at least in Texas. Having worked years in a Free Standing ER I can state from experience. The physician had access to a system where he or she could look up a patient and see what they had been prescribed, how much and where it was prescribed from and by whom. The system was run by the Dept of Public Service. It saved my physicians from running into this problem and kept the “doctor shoppers” from getting more (at least from us). I’m not sure if anything is in place here in Alabama. My last job was the Corrections Department ( a whole ‘nuther animal).

      CommoChief in reply to rutvet83. | July 1, 2022 at 7:15 am

      That seems reasonable. What I meant was a more macro view so any sudden spike in RX or a complete mismatch in RX v population should be monitored all the way through the chain.

      Doc checks the patient, Pharmacy checks the Doc, supplier/ manufacturer checks the pharmacy. State and Fed check all and each other. The goal being to provide care to patients while restricting blatant pill mill operations. Using a regulatory action v a criminal proceeding.

      SeiteiSouther in reply to rutvet83. | July 1, 2022 at 10:43 am

      It’s actually a good system, and we have it in Louisiana, too. Unfortunately, it’s been legalproofed to the point that trying to get impeachable documentation of drug seeking behavior against plaintiffs is impossible.

The_Mew_Cat | June 30, 2022 at 7:14 pm

It seems to me the SCOTUS ruling isn’t all that different from the instructions the jury actually got. They clarified the law, yes, but if the jury thought these guys were guilty originally they are almost sure to do so when they are tried again.

“the doctor’s actions were either not for a legitimate medical purpose or were outside the usual course of professional medical practice.” is not that different from ” it is the fact that the doctor issued an unauthorized prescription that renders his or her conduct wrongful, not the fact of the dispensation itself. In other words, authorization plays a “crucial” role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct”

I don’t think a real jury sees that much difference. If the jury was convinced beyond reasonable doubt that the doctor was feeding the illegal drug trade in the first trial, they are sure to make the same decision when the case is retried.

    healthguyfsu in reply to The_Mew_Cat. | July 1, 2022 at 1:21 pm

    Doctors are not the DEA, that’s the difference.

    Your average joe family doctor doesn’t deserve to be threatened with feet to the fire just for trying to help someone with a legitimate pain management condition. That needs to be delineated and clarified, even with small nuances.

      The_Mew_Cat in reply to healthguyfsu. | July 1, 2022 at 6:03 pm

      He will be still threatened the same. The real issue is how much will a real jury, which is not composed of lawyers or doctors, get the tiny nuances in the law explained by the Supreme Court. The jury will either think he is guilty or he isn’t and will rule accordingly.

The Gentle Grizzly | June 30, 2022 at 7:21 pm

I’m just nasty enough to hope some overzealous DAs, showboater LEOs like Arpaio, and other nasties, got VERY tightly controlled pain meds when in the hospital.

steve_gosney | June 30, 2022 at 7:23 pm

s a public defender, I am ecstatic about the decision. I doubt we will have many physician clients in the public defender’s office, but the language in the case is helpful in other areas. For example, in Florida if you have a prescription and are charged, the burden of proof is on YOU to prove that you actually have it, rather than the State have to prove you do not. That means even if you present your prescription into evidence at trial, the jury can still convict, and there are minimum mandatories for even small amounts of prescription drugs. Of course, your not so humble commenter presaged SCOTUS by at least a year! Look up Gosney, Steven, Florida’s Prove Yourself Innocent Absurdity: Florida’s Prescription Drug Affirmative Defense (September 7, 2021). 8 Stetson J. Advoc. & L. 97 (2021), https://www2.stetson.edu/advocacy-journal/floridas-prove-yourself-innocent-absurdity-floridas-prescription-drug-affirmative-defense/ , Available at SSRN: https://ssrn.com/abstract=3919088

nordic prince | June 30, 2022 at 7:27 pm

Too bad they don’t apply the same reasoning to doctors who prescribe HQ or ivermectin for “off label” uses.

100k overdoses this year vs 78k a year ago. I think this is a ploy to say we have a drug problem. How many of those are prescription drugs vs street drugs. We know St. George died of an overdose. The problem may not lie with the doctors, but with illegal drugs coming over the border. Stop the flow of illegal drugs, stop the overdoses.

    Dathurtz in reply to rutvet83. | June 30, 2022 at 8:21 pm

    I personally know 3 people that have overdosed and died. All three began their addiction journey at a doctor’s office. They ended their journey on a variety of street drugs.

      artichoke in reply to Dathurtz. | June 30, 2022 at 10:45 pm

      I personally know of a case (although I don’t know the patient personally) of a girl who had surgery to remove a diseased intestine, and some alternative plumbing was installed in its place. She was very sick and it was extremely invasive surgery, needless to say.

      She was admitted to the hospital to recover, but without pain meds.

      Doctors are scared to death of prescribing obviously needed pain meds. Maybe that will change now.

        ThePrimordialOrderedPair in reply to artichoke. | July 1, 2022 at 12:23 am

        The real and terrible TORTURE that hospitals inflict on so many patients is unreal. It is so endemic that it has become part of the whole culture among doctors and nurses, And it is torture – not fake torture like the left loves to scream about, but true torture. People like to dismiss the whole issue with the argument that nurses must not get emotionally involved and be distant from patients but anyone who has spent time in a hospital with serious pain knows that it goes much deeper than just the staff keeping an emotional distance. There has been a certain culture of torture that has arisen in the profession.

        if you go to a hospital in pain, you can almost be assured to have to endure that severe pain every so often while you’re in there and no one really cares how much you scream or moan or ring the buzzer for help. The more you ring the more intent they become on ignoring you.

        Dathurtz in reply to artichoke. | July 1, 2022 at 7:11 am

        I hate that. This doean’t seem like the most difficult problem in the world to solve.

    henrybowman in reply to rutvet83. | June 30, 2022 at 8:45 pm

    There will never be a supply-side solution to the black market. Never.

      CommoChief in reply to henrybowman. | July 1, 2022 at 9:45 am

      There’s one but it’s dark and evil; simultaneously lace every illicit drug with a lethal dose of fentanyl. In this example the supply side kills off 100% of the customer base Dark and evil but effective.

    ThePrimordialOrderedPair in reply to rutvet83. | July 1, 2022 at 12:29 am

    A lot of these “overdoses” are not people who intended on taking those drugs but people who thought they were buying something else and got pills laced with fentanyl. But anyone who has ever had an interest in recreational drugs knows that trusting that what you get is what you’re paying for is always an issue. People who buy drugs online from sketchy sites or buy pills from people they don’t know are taking undue risks … and many of them are paying for it.

I usually get a 30 pill (10 day) supply of oxycodone from the VA once a year. Normally it lasts most of the year. If I get a pain that keeps me from either functioning or sleeping that the Walmart equivalent of Excedrin doesn’t take care of- I’ll pop one. Rarely do I need two in a day. Comes free because the pains come from service connected disabilities.

The doctors I see don’t have a problem prescribing it to me- because I get it ONCE a year. My regular doctor knows I get it from them. And I don’t ask him to prescribe it. Would be nice if I could keep a 30 day supply on hand just in case- but 10 days seems to be the max they’re write it for.

The libertarian-adjacent side of me says GOOD

If all prosecutors were able and interested in differentiating between somewhat naive docs who believe what they are told and see, when they see someone acting as if in pain, and those who prescribe knowing it is being abused or diverted for cash on the street, then such a ruling would not be necessary.
But that can one assumed of prosecutors, and it is a mixed up message when the increase in deaths is more from street fentanyl.
The tug of war in the medical profession between those who say chronic and cancer pain are inadequately treated and those who say too many controlled substances are prescribed predates my med school days in the early 80’s. The likely truth is that both are correct, some people could benefit who aren’t being treated adequately, and overall too many are being prescribed.
One problem in the medical system as a whole, in decades past it was easier to give a small amount of medication and see someone back in a week to check progress, rather than “since my schedule is too full here is a 30 day supply”.

    gonzotx in reply to MDP. | June 30, 2022 at 10:19 pm

    I have really bad asthma attacks about once every 5 years, I literally broke 2 ribs with non stop coughing. Forget the little tessalon P
    Anyway, I was on the road to perdition with the asthma this past year amd I asked my PCP, who knew about my situation, it I could have some cough med with a narcotic in it to stop the 24/7 coughing. . I have gone to this man for 20 years and never asked him for any pain medication
    He was shocked and appalled .
    He’s a very good Dr but I must say I thought he was nuts.

Albigensian | June 30, 2022 at 9:59 pm

Proposed general principle: it’s better that 100 junkies OD than that one patient who badly needs adequate pain relief is unable to obtain it.

ThePrimordialOrderedPair | July 1, 2022 at 12:17 am

opioid use disorder

What the hell kind of medical euphemism is that?? Is “addiction” not allowed any more?

Good decision by the SCOTUS on this one. People with serious, chronic pain have been tortured by the state and the medical establishment for some time, now. It is awful the way doctors put patients through hell, for no good reason. Evil, even. And those who thought up those rules ought to suffer the consequences of their own rules in the same way that they have caused the pain and torture of so many defenseless patients.

And it’s not as if it is difficult to know who are the criminal doctors running scrip factories and selling drugs, basically, for the street. But the establishment is too corrupt and too inept and too stupid to put those people in jail, so instead they make insane rules that harm all of the innocent people (while the scrip factories figure ways around and keep the business going, anyway).

Some people are a lot more susceptible to opioid addition than others. The problem is a drug regulation regime that doesn’t recognize this and forces all of us to pay for their problems.

Fat_Freddys_Cat | July 1, 2022 at 8:48 am

This is a good ruling, alas too late for my late Mother who spent the last years of her life in agonizing pain because the doctor was too scared to give her sufficient pain meds.

What kind of a standard is “good faith”? How does one establish whether a prescription is ordered in “good faith” or not?

    MDP in reply to Q. | July 1, 2022 at 2:29 pm

    In concept, the idea is that if a person comes into the doctors office using a cane, walking as if in pain, has a scar on his back for surgery, and says he has needed narcotics for pain control since Toradol was limited to 5 days, a doctor can prescribe narcotics without concern of getting busted, even if the “patient” is found selling them to an undercover DEA agent.
    On the other hand, if the doc keeps writing scripts because the person says the dog ate his prescription for the third time this week, more scrutiny of the docs practice is easily warranted.
    Now, the details of that are vague and where some judgment by the prosecutor with consideration of more than just his/her conviction total.