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Bitter Pills

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WORLD Radio - Bitter Pills

The federal government and two pain management physicians argue about the meaning of the text in the Controlled Substances Act.


JENNY ROUGH, CO-HOST: Dr. E lives and works in Nashville, Tennessee. He keeps long work hours and says he’s a tad O-C-D … especially when he’s keenly interested in a research project. Like the human back.

MICHAEL EASLEY: So, from the base of your skull down to your tailbone, your spinal cord runs.

Dr. E stuffs his brain full of facts…

EASLEY: It’s a column. It’s like a cord. But as it goes down your back, there are hundreds of thousands of nerve fibers that come out of your spinal cord to make your body work.

And facts…

EASLEY: The spinal column is conducting all this information for your life, respiration, your blood pressure, your organ function, your brain stem function…

And more facts!

EASLEY: Your vertebrae are bones. In between each vertebrae is a disc. Think of a disc as a car tire on its side. In that car tire, instead of air, it’s filled with a gelatinous material… 

Dr. E isn’t a medical doctor, by the way. He’s a doctor of ministry. His name is Michael Easley, and he’s the pastor of Stonebridge Bible Church. He’s been married to his wife for over 40 years. Raised four kids, and now has young grandkids. He also hosts the podcast “Ask Dr. E,” where he fields theological questions about life, death, and faith.

So why the intense interest in the spinal column? Well, he lives with chronic back pain … 50 million Americans live with some sort of chronic pain. For him, it was degenerative disc disease … and he’s lived with it for more than 20 years.

EASLEY: I’m laying on the couch in this contorted position trying to decompress the area. I was in so much pain. I would never do it, but I understand why now someone would jump off a highway and kill themself to deal with pain…I had a piece of bone and lamin fragment that were jamming against a nerve root in my back.

In 2003, he had surgery. It offered relief—at first. But the pain returned. His pain management doctor kept upping the dose of his medication … as was common at the time.

EASLEY: I was on massive doses of opioids to the point that I was no longer allowed to drive. I was on Oxycontin, on the highest dose you could get, prescription, and then I took hydrocodone, all under a doctor’s prescriptions. I was disoriented. I had a fog in front of my life. And I was still in pain.

So with the assistance of another doctor … he decided to get off opioids completely. In the years since, he’s had four additional surgeries on his back and neck. Now he takes a low dose opioid two times a day. He says daily pain management is very complicated.

EASLEY: So you’re trying to calm the pain down so your body can heal. Opioids are wonderful if used in this application. The problem with opioids are when you continue upping the dose or when a person starts using them for euphoric effect…

Chasing after that euphoria has led to an opioid crisis not only in this country but around the world. According to the U.S. Department of Health and Human Services, 75 percent of drug overdose deaths in 2020 involved opioids. Some from prescription drugs. Most from counterfeit opioids chewed or smoked or injected for a quick high. In recent years, the government has brought criminal charges against doctors for over-prescribing opioids and contributing to the crisis. This past term, two of those cases ended up at the Supreme Court.

THEME: I Clarence Thomas...I Sonya Sotomayor...I Stephen Breyer, I Amy Coney Barrett…do solemnly swear, I Brett M. Kavanaugh do solemnly swear, do solemnly swear, do solemnly swear, that I will administer justice, without respect to persons, that I will support and defend the constitution of the United States, and that I will well and faithfully discharge the duties of the office on which I’m about to enter, so help me God…[APPLAUSE]

JR: Welcome to Legal Docket, I’m Jenny Rough.

MARY REICHARD, CO-HOST: And I’m Mary Reichard. This podcast is from the creative team at WORLD Radio.

MARSHALL: The honorable Chief Justice and the associate justices of the Supreme Court of the United States. Oyez! Oyez! Oyez!

MR: Come with us inside the world of the Supreme Court as we talk to the people involved and think deeply about the most recent term’s disputes and decisions—and how they make a difference to your life.

MARSHALL: All persons having business before the honorable Supreme Court...

JR: Today, a case of two doctors accused of running a “pill mill.”

MARSHALL: God save the United States and this honorable court.

[UNDERWRITING BREAK] Support for the Legal Docket podcast comes from listeners like you. Additional support comes from Samaritan ministries, a biblical and affordable solution to healthcare, connecting more than 280,000 Christians across the nation who help pay one another’s medical bills. More at Samaritan Ministries.org /worldpodcasts.

JR: A lot of healthcare litigation these days involves opioids.

MR: Many cities, counties, and tribal authorities have filed suit in federal and state court against the entire opioid industry: drug manufacturers, distributors, pharmacies. The claims range from public nuisance to actual harm from the fatal overdoses. Such as the increased costs of police and paramedics. That’s the private, civil side.

JR: And on the criminal side … the federal government is charging individual doctors with overprescribing opioids. Shaun Clarke is a defense lawyer in New Orleans who specializes in both civil and criminal healthcare cases.

SHAUN CLARKE: I think they both illustrate what a tragic situation exists in this country.

MR: It was in the 1990s that Clarke says the number of prescription opioids began to increase. Doctors gave them as pain relievers for their ability to block the brain’s sensation of pain.

CLARKE: The idea was put forward, and probably legitimately…I mean, pain was under treated in this country. That patients who were in pain were not getting the treatment they needed. And so there was a real change in the standard of care among physicians.

And that real change, by 2010, turned into an exponential increase in prescriptions for opioids.

CLARKE: Many of them would be prescribed by what are called pill-mill doctors, writing illegitimate prescriptions just solely because a patient comes in and says, you know, my ear aches.

The pill mill case we cover today arises under a federal narcotics law aimed at drug abuse: the Controlled Substances Act.

CLARKE: Let me quote the statute…under the law, any person knowingly, intentionally who manufactures, distributes, or dispenses a controlled substance, such as opioids, commits a crime.

JR: So a general crime of knowingly and intentionally dispensing drugs.

JOEL JOHNSON: My name is Joel Johnson, I’m an associate professor of law at the Pepperdine Caruso School of Law, and I just started in that capacity in August of 2022.

JR: Before that, Johnson worked at the Department of Justice in the criminal appellate section. He says the Act regulates both the legitimate and illegitimate traffic of drugs.

JOHNSON: So in other words, it regulates not only drugs that are considered to have no legitimate purpose, like heroin, cocaine. But also any potentially dangerous drug that does have some legitimate medical purpose, such as prescription drugs. So this statute is used a lot in federal drug prosecutions. Usually as a basis for charging illegal drug manufacturers and distributors. So if you’ve watched Breaking Bad for example, this would be one of the federal statutes that could’ve been used to charge Walter White for cooking meth.

BREAKING BAD CLIP: Why are you here? / I was curious…methamphetamine?…A lot of money in it, huh? / Look I don’t know what you’re doing here, Mr. White. / You know the business. And I know the chemistry. I’m thinking maybe you and I could partner up. / You want to cook crystal meth? You and me? / That’s right.

MR: So, that’s a TV series, Breaking Bad. But what about drugs with a legitimate purpose, like a doctor’s prescription? Healthcare lawyer Shaun Clarke says there’s an introductory phrase in the provision that carves out an exception. There’s a clause in there … 

CLARKE: ...that says "except as authorized," i.e., if you are authorized, are you a physician who is authorized to write prescriptions? Well, then it's not a crime to do so.

It’s not a crime if doctors write prescriptions in compliance with DEA regulations—the Drug Enforcement Administration. Those regulations put meat on the bones of the statute. Joel Johnson explains.

JOHNSON: There's a DEA regulation that's relevant here that limits the scope of a physician's authorization by making clear that a physician's prescription for a controlled substance "must be issued for a legitimate medical purpose in the usual course of the physician's professional practice."

MR: Let’s stop right here: 17 really crucial words … two key ideas … legitimate medical purpose is one, and usual course of professional practice is the other. So a doctor who writes a prescription for opioids must do it for a legitimate medical purpose … in the usual course of his professional practice. A lot to unpack there. But we’ll have to return to it.

JR: First, we need to meet the doctors involved in today’s case: Xiulu Ruan and Shakeel Kahn. Dr. Ruan worked as a board-certified pain specialist in Alabama. Dr. Kahn worked as a pain specialist in Arizona and Wyoming. The federal government charged each of them with violating the Controlled Substances Act. Said they didn’t meet the standard of the authorized exception.

In Dr. Ruan’s case, the government alleges he over-prescribed oxycodone and morphine, and an expensive and potent version of fentanyl. A drug that had been approved for breakthrough pain in adult cancer patients for whom other opioids no longer worked. Almost 9 in 10 of Dr. Ruan’s clients didn’t even have cancer, but according to the government, he was the highest prescriber in the state by more than double. He also purchased over $1 million of stock in the company that manufactured that breakthrough drug.

MR: In 2014, the DEA started investigating. One agent who acted as a patient said he easily obtained a prescription for opioids from the clinic. Yet no one asked him about his pain levels. The office visit lasted less than one minute.

The government made similar allegations against the other doctor, Shakeel Kahn. Prosecutors claimed that Dr. Kahn excessively prescribed opioids without proper monitoring. And that he falsified records. For example: His notes said he’d seen patients when he actually hadn’t, and that he’d collected urine samples when he hadn’t. Urine samples are important to confirm the patients were taking the meds and not dealing them to others on the streets. He often operated on a cash-only basis, except when he took firearms as a form of payment.

At one point, Dr. Kahn began to require patients to sign a form stating that he wasn’t a drug dealer; that the patient wasn’t an addict; and the patient would pay him a fine of $100,000 if someone brought a lawsuit against him related to that patient’s treatment. He gave one patient a mix of potent drugs and two days later, she overdosed. Fatal.

JR: At trial, juries convicted both doctors. Healthcare lawyer Clarke again:

CLARKE: In a nutshell, they were two doctors in two different areas of the country who were convicted of prescribing controlled substances, opioids, outside the proper course of medical practice.

JR: There’s that phrase again … outside the usual course of medical practice. Dr. Ruan got 20 years in prison, Dr. Kahn 25. The doctors claim that the trial court judge made an error when instructing the jury about the criminal charges. Remember the introductory clause in the Controlled Substances Act, “Except as authorized”

CLARKE: What was at issue in both these cases is what exactly does that phrase “except as authorized” mean?

JR: And more specifically, how does “except as authorized” relate to the language about knowledge and intent.

MR: Ruan and Kahn argue that in order for the jury to find them guilty … jurors first had to determine that they had the intent to prescribe for illegitimate purposes. Intent. That’s the key.

CLARKE: In both cases, the doctors … both asserted that the jury should be given instructions, saying that “except as authorized” means that they have to have been shown to have knowingly and intentionally act understanding that the prescriptions were not authorized. And so the question became is that defined by an objective standard or subjective standard.

JR: "Objective standard"--meaning, would a hypothetical reasonable doctor think the prescription was unauthorized. Outside the usual course of medical practice. "Subjective standard"--meaning, did Drs. Ruan and Kahn think it was unauthorized. Did they personally have the knowledge and intent to prescribe outside the usual course of medical practice? In legalese, that subjective intent is called mens rea. Joel Johnson, the Department of Justice attorney-turned law professor, explains the significance.

JOHNSON: Mens rea means essentially guilty mind. And it’s typically a requirement for any criminal conviction. The basic idea—there’s really a philosophical or moral notion that we as a society think that only those who have a guilty mind in addition to a guilty act are appropriately subjected to criminal punishment.

MR: The doctors said the trial court failed to properly instruct the jury. The jurors never heard that the law required them to determine whether the doctors had a subjective guilty mind … and the doctors argued without that mens rea finding, the jury couldn’t rightly hand down guilty verdicts. So the doctors appealed. But lost.

And the doctors appealed again—to the US Supreme Court, which agreed to hear the cases together as one. Lawrence Robbins argued on behalf of Dr. Ruan at the Supreme Court, March first, this year.

LAWRENCE ROBBINS: The argument we are making today takes the "knowingly" and "intentionally" language in the statute and asks, to what elements does that apply? We contend that it applies to the "except as authorized" language in the statute.

MR: So first and foremost: The plain text of the statute makes it a crime for a person knowingly and intentionally to dispense opioids. And Robbins argues that that same knowledge and intent should apply to the exception… apply to the introductory phrase except as authorized.

JR: Yeah. He’s saying that if the doctor acted in good faith or personally believed his prescription was legitimate, he can’t be convicted. He didn’t have subjective knowledge or intent to write an illegitimate prescription. That’s the argument. But Chief Justice John Roberts questioned whether the guilty mind really matters here. He used this hypothetical:

CHIEF JUSTICE JOHN ROBERTS: What if you're driving along the highway and you're pulled over for speeding and the officer tells you, “Look, it was 55 miles an hour.” You get a ticket. And you say, “Oh, no, I thought it was 70 miles per hour?” You still get the ticket, right?

ROBBINS: Of course.

JR: Roberts took it a step further. You know the speed limit is 55. But you think in good faith it should be 70!

ROBERTS: You say, you know, this is in the middle of Montana, I think it should be 70…You'd still get a ticket, right?

ROBBINS: Yes, you would.

MR: Robbins agreed a doctor can’t just pick whatever rules he likes. But he also categorized a narcotics crime differently than a traffic infraction.

ROBBINS: Speeding is the classic case of a regulatory offense. You don't get to defend the traffic violation based on your state of mind. But, when you're talking about sending doctors or anybody for that matter to jail for mandatory minimums of decades in prison, this is not a regulatory offense.

MR: There’s a difference in the law between a regulatory offense and what’s known as true crimes. Illegal moral and social conduct. Here’s Joel Johnson again:

JOHNSON: The court has previously made clear in earlier cases that…mens rea does not apply to certain statutory provisions. And those are statutory provisions that carry only minor penalties…The main goal isn’t to severely punish the behavior. So laws against speeding would actually be an example of this type of law, right? There’s some pretty low-level penalty imposed against the speeder, but it’s not a severe penalty like prison time.

JR: The Controlled Substances Act does come with severe penalties like prison time. Some doctors get life in prison. The doctors here got decades. Michele Zumwalt lives in Sacramento, California, and offers insight into the consequences of drug crimes. In 2011, she took a job as a law enforcement chaplain.

MICHELE ZUMWALT: One of the things a law enforcement chaplain will do…is death notifications as part of it. … When I first started, it was: car accident, overdose, shooting. It was kind of a mix.

JR: But within a few years, it was kind of not a mix: the death notifications were too common.

ZUMWALT: It was really overdose, overdose, car accident, overdose, overdose, suicide, overdose, overdose. It was a lot more overdose.

MR: One argument against punishing doctors so severely is that it isn’t prescription opioids that typically lead to overdose death. Criminal defense attorney Shaun Clarke.

CLARKE: Right now, the biggest issue is not whether doctors are improperly prescribing properly manufactured and distributed opioids. The problem now is largely counterfeit opioids, containing fentanyl. Frankly, even the slightest misapplication or miscalculation of the amount of the dosage is the difference between a high and death.

MR: Michele Zumwalt’s daughter is a second year medical student. The two of them started a nonprofit called Hope Again Recovery. They give talks together. Zumwalt’s daughter uses a salt shaker to demonstrate to high school students that a few grains of fentanyl can be deadly.

JR: Dr. E, the pastor who you heard from at the beginning of this episode, put it this way:

EASLEY: Remember how they used to teach us about drinking in high school? You know, a 12-ounce beer is the same as 5 ounces of wine, is the same as 1 ounce of hard liquor? So, a full vial of opioid versus half a vile of heroin versus four grains of sand or salt of fentanyl. That’s how powerful this stuff is. So you can bring fentanyl in a Bic pen and sell oh, easily $5,000 or $6,000 worth of fentanyl on the street.

JR: Zumwalt agrees that the drug crisis in our country is tied to synthetic opioids sold on the street. Chemically made instead of natural opiates found in the opium poppy.

ZUMWALT: Which are oftentimes even cheaper than a 6-pack of beer. The problem is, it’s poison. There is poison on our streets. I was talking to a director of a large recovery home the other day, and he was saying that a lot of people are coming in that have never taken fentanyl to their knowledge, and they’re testing positive for fentanyl. So, there’s fentanyl in everything, marijuana. And all kinds of things that people think they’re not taking it and they are.

MR: The Centers for Disease Control says over four of every five opioid overdose deaths are due to those synthetic street drugs. And yet?

ZUMWALT: Seventy-five percent of them started with a prescription pad.

MR: Zumwalt knows about that from personal experience. In college, she started suffering with migraines. Doctors prescribed meds.

ZUMWALT: They were prescription narcotics. Opiates mostly. I loved them immediately. I felt good, and I felt better.

JR: Zumwalt spiraled into addiction. She says meds were so easy to get, she would simply show up at a hospital and say she had a headache. She told the doctors she could tolerate high doses. Until one day, she couldn’t. In October 2003, she took a dose that almost proved lethal.

ZUMWALT: What happened in the hospital is I had this experience where…if you’ve ever touched a person that has died, how their body is like stone, like rock, and it feels real cold. That’s what happened. I felt like a rock, and I couldn’t move at all and my breathing was real labored like it was this deep rattle. And I knew beyond any doubt that I was dying in that hospital. And I started begging God. I will never do this again. Please let me live. Please. Please. Please. They rushed me into ICU, and I could hear them saying, “We’re losing her.”…And I felt this love like I have never felt. Like God was just like it’s okay. You’re not going to get this. Just come on. And after probably about 45 minutes, I started feeling tingling in my hands and I knew that He was going to let me live.

JR: Shortly after that tingling, though, she suffered a stroke. And her recovery wasn’t easy. She’s been sober now for 19 years.

ZUMWALT: Americans are four percent of the world’s population, and we’re taking about 80 percent of the world’s prescription narcotics. So we have a massive problem here that is uniquely ours, you know, American…It doesn’t have to be this way. We can change the way, we’re stopping people from getting hooked on them and we can also help people that already are.

MR: All that to demonstrate the doctors’ position that drug offenses are not so cut-and-dried as traffic infractions are. Ergo, courts should adopt the higher standard. Require a jury to find the doctor wasn’t acting in good faith.

JR: Back to oral argument. Dr. Ruan’s lawyer argued just that. But Justice Samuel Alito returned to the basics.

JUSTICE SAMUEL ALITO: We're interpreting a statute, so we should start by looking at what the statute says. And it says, "Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally to" do a variety of things.

JR: Manufacture, distribute, or dispense opioids.

ALITO: As a matter of language, do the adverbs "knowingly" or "intentionally" modify the introductory clause "except as authorized by this subchapter"?

ROBBINS: The answer is yes, Justice Alito, and I'd be happy to explain why I think so.

ALITO: Well, I think my old English teacher would say no, you've gotten that answer wrong.

MR: Much of oral argument sounded like a grammar lesson.

ALITO: I don’t mean to be disputatious, but I d on’t accept the proposition that they don’t—as grammar is best understood, I think they do modify the predicate language.

MR: Justice Alito wasn’t convinced.

ALITO: The problem is what an adverb can modify. It can only modify a verb, and "except as authorized" is not a verb.

MR: Alito was stating the other side’s argument: the government’s. The adverbs knowingly and intentionally can only modify the verbs that follow: manufacture, distribute, or dispense opioids. And cannot modify the introductory clause, except as authorized. But Justice Breyer jumped into the debate to disagree.

JUSTICE STEPHEN BREYER: I had a different English teacher.

ROBBINS: I’m sorry, your honor?

BREYER: Ms. Chichester. I had a different English teacher, Ms. Chichester, who told us an adverb could modify a verb, an adjective, or another adverb.

JR: Let’s take a step back for a moment. This might seem like pointless quibbling. Super technical grammar questions far removed from pain management and drug prescriptions. But words matter. And the words of the Controlled Substances Act have broad implications. I called up a word nerd to help me out.

MELINDA MAHAND: My name is Melinda Mahand. I live in Franklin, Tennessee. And I’m academic dean and also honors senior English and literature teacher at Franklin Classical School.

JR: First question: Do adverbs modify only verbs? Or also adjectives and other adverbs? Team Alito? Or Team Breyer?

MAHAND: The prefix on the word, ad, A-D, is a Latin prefix, and it means to or toward, so an adverb typically points to or toward a verb.

MR: Team Alito off to a good start!

MAHAND: But sometimes it does modify an adjective or another adverb.

MR: Ooo, Team Breyer pulls ahead.

JR: But what’s the answer to the debate at oral argument? Do the adverbs “knowingly and intentionally” extend back to the introductory clause, “except as authorized?” If so, then a doctor who over-prescribed opioids would only be guilty if he knowingly and intentionally prescribed outside the usual course of medical practice.

MAHAND: This is a bit of a challenge, and I’m not a lawyer or a judge. But I’ll tell you what I think is happening, and I’ll tell you what I believe should be the correct diagramming of this sentence.

MR: Mahand says the phrase except as authorized is a subordinate conjunction. Everything else in the sentence is subordinate, or of lesser importance, to it.

MAHAND: It rules supreme. You can kind of imagine a subordinate conjunction it has a crown on. It rules. And everything else is lower than it. Except as authorized by this subchapter is the ruling phrase. And everything else is subordinate to it. Knowingly and intentionally. They cannot go back and modify something that’s in a completely different clause.

MR: So Team Alito wins. Well, at least with this English teacher.

JR:Moving on. Lawrence Robbins, who argued for Dr. Ruan, had a non-grammatical argument for the justices about why the statute’s language should be read in his client’s favor.

It’s a long-standing principle in criminal law that a prosecutor must prove a defendant had a guilty state of mind. Back to mens rea. Courts make the presumption that the principle applies. Here, Robbins uses the word “scienter.” That’s a synonym for mens rea or guilty mind.

ROBBINS: If push really came to shove, I would recur to the point that this Court made that even when it's not the most grammatically satisfying solution, the presumption that scienter extends to any element that separates wrongful from innocent conduct still obtains.

JR: Law professor Johnson explains it like this:

JOHNSON: And it's just a presumption, right? So, sometimes it can be overcome. But the existence of the presumption means that the court will start by presuming that there is mens rea required as to each element.

MR: Next, Beau Brindley took a turn at the lectern. He argued on behalf of the second doctor, Dr. Kahn. Justice Brett Kavanaugh wanted to understand how this would play out in real life. Let’s say there was an objective standard about when a doctor couldn’t prescribe opioids. But the doctor writes a prescription anyway.

JUSTICE BRETT KAVANAUGH: And the way this plays out, tell me if I'm wrong. The doctor may have violated that objective standard but might have legitimately thought that the standard was somewhat different. And, therefore, in those circumstances should not be sent away for 20 years to prison, right?

BEAU BRINDLEY: That’s absolutely right, Justice Kavanaugh.

KAVANAUGH: And your further thought is if the doctor comes in with some outlandish theory about what he or she subjectively believed, the jury will almost certainly disbelieve the doctor's testimony that, oh, I actually thought there was some kind of outlandish idea that was a legitimate medical purpose?

BRINDLEY: Yes. Absolutely. That's absolutely correct.

MR: Justice Alito didn’t let the lawyer get away quite so fast.

ALITO: But what if the jury doesn't disbelieve it? What if the doctor legitimately believes that legitimate medical practice encompasses giving people who are dependent on drugs the drugs they need to satisfy that dependency? That's what the doctor really thinks deep down…The doctor has to be acquitted in your view?

BRINDLEY: … I think that is true.

JR: Lawyer Brindley went on to argue that the government’s standard would prevent doctors from treating patients with genuine pain. Because the doctors are too scared to! They don’t want to end up prosecuted for a crime.

On the one hand, worrying about these extreme examples that are not going to come to fruition fails to take into account the terrible chilling effect that's coming and we see in the amicus briefs from the result of having what turns out to be medical norms policed. And I think that raises the real risk that the DEA becomes a de facto national medical board that's never been authorized.

Deputy solicitor general Eric Feigin argued on behalf of the federal government. He pushed back on the argument that extremes wouldn’t play out in the real world. Sure they would, he said. And if the Supreme Court adopts a stricter standard, the subjective one, Feigin said that would prevent the prosecution of troublesome doctors. Doctors who clearly act outside the scope of professional practice. For example:

ERIC FEIGIN: ​​Number one would just be the irrationally egotistical doctor. And he prescribes substances that any other doctor would say are crazy and lethal. Number two would be the absentee doctor…It's the kind of doctor, and I think you'll see some resemblances to the doctors here, who doesn't follow up on the background of his patients, doesn't make sure they're taking the medications, doesn't even conduct physical exams, doesn't check the database to see who else is prescribing opioids…

MR: Chief Justice Roberts said that shows evidence. But what law stops that kind of conduct? What legal standard should a court use?

ROBERTS: Counsel?

FEIGIN: Yeah.

ROBERTS: …you're saying this is outrageous…But what is it in the statute that separates innocent conduct from unlawful conduct?

MR: Feigin returned to the grammar argument. But Justice Kavanaugh switched topics. Remember the DEA regulation that sits on top of the Controlled Substances Act? The regulation that puts meat on the bones? It says a physician's prescription for opioids "must be issued for a legitimate medical purpose and in the usual course of the physician's medical practice.”

KAVANAUGH: Well, that's very vague language in my estimation, and reasonable people can disagree…"Legitimate medical purpose," don't you agree that's a somewhat vague term?

FEIGIN: No, I don't, Your Honor.

JR: Feigin said it’s not vague because it’s objective. Other reasonable doctors would recognize when a colleague acted outside the scope of a legitimate medical purpose, or outside the usual course of medical practice. But Kavanaugh said that’s precisely why it is vague.

KAVANAUGH: And there could be close calls, right? Close calls as to what the evidence shows objectively was legitimate?

FEIGIN: Yes, Your Honor, but if I may be permitted to—

KAVANAUGH: Okay. And so…if you're on the wrong side of a close call about what you believed, you go to prison for 20 years?

JR: Close calls. Life is full of them—for everyone. Unexpected tragedies can change our circumstances in an instant.

JULIE FORMBY: I know a lot about opioids from my pharmacology classes in vet school.

JR: Julie Formby is a veterinarian employed by the U.S. Army. She also works at a small animal clinic in her hometown of Sumrall, Mississippi. In addition to her medical background, she has personal experience with opioids. On January 15th, 2013, she, her husband, Lourie, and their little girl, Ella, met friends for dinner.

FORMBY: And Ella was 5.

MR: Nobody had any alcohol to drink. After dinner, Julie, Lourie, and Ella got into their 1940 Chevrolet. An antique car. Hard. Steel. No airbags. The front seats didn’t have seatbelts, but Ella was strapped in a booster seat in the back. It was after dark. Full moon. A vehicle approached from behind. That person had been drinking. And driving about 70 miles per hour on a rural two-lane road. The impact flipped the Formbys’ car off the road.

FORMBY: I just flew out of the vehicle about 25 yards and landed in the mud.

JR: Ella had no visible injuries. She was walking and talking and crying for Julie. Julie had a head injury. Eight broken ribs. A broken clavicle. A collapsed lung. And a hemopneumothorax—blood and air in her chest.

The paramedics hadn’t realized Ella’s lungs had gotten smashed in the accident. On the way to the emergency room, she stopped breathing. The paramedics only had an adult intubation tube. They inserted it and sedated her.

FORMBY: One of the physicians came in that had been working on her. And he told us all…“The good news is, tonight, no one’s going to die.”

MR: He was wrong. Later that night, doctors decided to switch Ella to a pediatric-sized tube. But when they did, Ella’s lungs filled with froth. And they couldn’t insert the tube in time.

FORMBY: She suffered oxygen deprivation to her brain. And that was her fatal injury.

MR: Julie and Lourie left the hospital as a family of two instead of three. And then had to learn to live with the pain of having lost a child. Three weeks after the accident, Julie was home, healing physically and emotionally.

FROMBY: Even with the oxycodone and the muscle relaxers…there was no way to get comfortable. And it occurred to me that I needed to stop the oxycodone. I guess I finally became aware enough that I realized that addiction was going to become an issue. It was like the fog cleared and the pain was more intense, the mental pain. I was sitting there thinking to myself, this is why people become addicted to opioids because it feels so much better. Life and the emotions are so much easier to handle when you’re on opioids. Suddenly the weight of what had happened, Ella not being here, not ever coming back on this earth, you know it was a lot heavier. It felt like the opioids were keeping it a little bit lighter. It just came crashing down when they were gone. I had been taking them for three weeks, and I just quit.

JR: After she quit, she took over the counter meds for physical pain. For emotional pain management, her sister-in-law, Anne, walked the difficult road with her, figuratively and literally.

FORMBY: Anne was here. She’s very encouraging about walking. Movement. It speeds up healing. Walking. Talking. Hey, let’s go to this thrift store. Let’s go by Starbucks. Okay. What else have I got to do right now? It was like the worst time in my entire life and at the same time, it was the best time of my entire life. She helped walk me through that and there was a closeness. I felt like I had a friend that was here all the time and helped take care of me, you know, just kind of some things that I would never imagined another person, you know, help get me in and out of the bathtub.

JR: The pastor, Dr. E, agrees. That’s the number one prescribed drug therapy for emotional pain.

EASLEY: Really good friends. Really good friends. That’s the best medicine. You need people that encourage you, people that’ll be with you. They’ll coax you out of it. Those are the people who are better than a pill that will help you through that emotional pain. You know, a lot of people don’t have any friends. But that to me is the number one cure. The people in my life have carried me.

MR: Let’s wrap up. In the end, Justice Breyer wrote the opinion. 9-0 in favor… of the doctors. Law professor Joel Johnson points out that despite all those colorful exchanges about grammar during oral argument—

JOHNSON: With Justice Breyer going so far as to name drop his childhood grammar teacher, and then at one point, the Chief Justice joked that he couldn't remember the name of his grammar teacher, but ultimately, that strict grammatical argument that Justice Breyer seemed to be pushing during oral argument didn't make it into the majority opinion, and I think that was for good reason, and I think it's because the argument doesn't really work.

MR: Well, if grammar wasn’t Breyer’s main argument, what was? The majority pointed to two key reasons why subjective intent applies. That the doctors personally must have the knowledge and intent to write prescriptions outside the usual course of medical practice to be convicted under the Controlled Substances Act. First, the presumption that it does apply. We mentioned before that’s a longstanding principle in criminal law.

JOHNSON: And importantly, it cites a significant case from 2019 Involving a similar issue.

MR: In that case, a law on the books made it a crime for a felon to knowingly possess a firearm. And the court held knowingly applies to both possession of a firearm and felony status.

JOHNSON: A defendant has to know not just that they possess a firearm, but also that they have the status of being a felon. That’s the element that is the key element for the crime. In other words, it’s what distinguishes lawful behavior from unlawful behavior. So gun possession in itself is not unlawful. It’s the felon status that makes it unlawful. Applying that rationale here, it’s the fact that the doctor issued the unauthorized prescription that renders the doctor’s conduct wrongful, not the fact of the prescription itself.

JR: That’s reason one. Reason two for the court’s holding: the vague language in the DEA regulation that doesn’t draw a clear line between legitimate medical prescriptions and illegitimate ones.

JOHNSON: It makes it difficult for physicians to know what exactly is permitted. There’s a gray zone, as Justice Breyer put it, which may ultimately result in over-deterrence. Meaning, some doctors may refrain from writing prescriptions in borderline cases, even when they believe it’s in the best interest of their patients to do so. When the court encounters vague language like this, it often tries to look for ways to interpret it narrowly to ensure that society is given sort of clear and fair notice as to what conduct is in fact criminal.

JR: So the doctors’ convictions for violating the Controlled Substances Act are vacated. Canceled. And the cases are remanded to the lower courts to comply with the Supreme Court’s opinion. Justices Alito, Barrett, and Thomas concurred with the decision, but not with the majority’s reasoning.

JOHNSON: Justice Alito's concurring opinion results in the same outcome, vacating and remanding, but it reads like a dissent, and that is that it vigorously disagrees with the majority's approach. He says the except as authorized clause it allows for affirmative defenses. So, an affirmative defense is something for which the defendant rather than the government bears the burden of proving. It would mean that all the government has to prove beyond a reasonable doubt is that the doctor knowingly wrote the prescription. And then the entire burden of proof would be on the physician to show his innocence.

JR: But that’s not the reasoning that won out.

MR: As the law now stands, you could say doctors have more freedom to prescribe drugs in situations when they sincerely believe doing so is best. That can promote innovation. Trying unconventional uses of medicines to find new treatments. Still, Clarke believes the ruling won’t make that big of a difference. Here’s why:

CLARKE: What it comes down to is what a jury believes. If a physician prescribes opioids for somebody who says, you know, my toenail hurts…and takes cash and insists you fill the prescription at one pharmacy. I think a jury is going to see through that and they’re not going to believe you thought you were acting in an authorized manner.

JR: What about all the doctors who have already been convicted? Johnson didn’t have good news for them.

JOHNSON: It's very unlikely that this decision will be applied retroactively to any final judgments or to any doctors already convicted and not still in the appeals system.

JR: A ruling typically only applies retroactively with a new rule of constitutional law.

JOHNSON: And this decision is just a statutory interpretation decision, right? It merely clarifies the meaning of federal statutory criminal law.

JR: A statutory interpretation decision. Cases that center on interpreting text, that cause us to examine adverbs microscopically? Some may argue they’re not as important as those that center on a new issue of constitutional law. But grammar teacher Melinda Mahand suggests they, in fact, hold great value. Because they serve as a wonderful example that the human language is precise.

MAHAND: Words are precise. And when we use them well, we communicate well. And we can rid conversations of confusion, such as the confusion we’re seeing in this Supreme Court case. We have the incredible and I would say even sacred privilege of using words…Whether that is expressing our laws. Or whether we are using words to give encouragement, to build up, to praise, to edify. We’re really imitating God when we use words rightly.

JR: Legal Docket is produced by the creative team at WORLD Radio. I’m Jenny Rough.

MR: And I’m Mary Reichard.

JR: We’re the hosts each week, and we write the scripts. Our script editors are Nick Eicher and Paul Butler, who’s also our producer. Lillian Hamman gave audio support. Special thanks to Michael Easley (a.k.a. Dr. E), Shaun Clarke, Joel Johnson, Michele Zumwalt, Melinda Mahand, and Julie Formby.

MR: Audio in this episode from Breaking Bad and SupremeCourt.gov. If you like this podcast and find it valuable, please tell a friend. It’s fun to get new people interested in the law! And will you consider leaving a review right now? It helps others find us, and gets the word out about this very special podcast.


WORLD Radio transcripts are created on a rush deadline. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of WORLD Radio programming is the audio record.

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