Petition for Writ of Certiorari — Donovan Dave Dixon, Petitioner v. United States

Supreme Court briefMay 18, 2020

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Text

No.

In the

Supreme Court of the United States

DONOVAN DAVE DIXON,

Petitioner,

v.

UNITED STATES OF AMERICA,

Respondent.

-----------------------------------------ON PETITION FOR WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

------------------------------------------

PETITION FOR WRIT OF CERTIORARI

------------------------------------------

Raymond C. Tarlton

Counsel of Record

209 Fayetteville Street

Suite 105

Raleigh, NC 27601

(919) 948-6464

rtarlton@tarltonpolk.com

Counsel for Petitioner

GibsonMoore Appellate Services, LLC

206 East Cary Street ♦ Richmond, VA 23219

804-249-7770 ♦ www.gibsonmoore.net

i

QUESTION PRESENTED

Because prescribing controlled substances is a

quintessential part of a physician’s professional life,

when those controlled substances have medical uses,

the Controlled Substances Act (“CSA”) empowers

physicians to do so. But that authority has limits.

Specifically, the CSA “bars doctors from using their

prescription-writing powers as a means to engage in

illicit drug dealing and trafficking as conventionally

understood.” Gonzalez v. Oregon, 546 U.S. 243, 270

(2006). A doctor, therefore, is criminally liable for

unlawfully distributing a controlled substance when

acting as “a drug ‘pusher,’” and “not as a physician.”

United States v. Moore, 423 U.S. 122, 126, 143 (1975).

The practice of instructing juries in the Fourth

Circuit, however, strips the CSA, as applied to

physicians, of any meaningful mens rea component

and blurs this clear line between criminal and merely

unprofessional or negligent conduct, and allows

medical practitioners to be convicted of felony drug

trafficking based on malpractice or other disputes

about the standard of care.

The question presented is:

Whether juries must be instructed that the

government must prove that a physician acted with

the mens rea of intent as to issuing a prescription

outside the usual course of professional practice or not

for a legitimate medical purpose and that that action

and intent must mean that a physician has

abandoned medical practice and engaged in “illicit

drug dealing and trafficking as conventionally

understood” in order to prevent a criminal conviction

for malpractice under the CSA?

ii

PARTIES TO THE PROCEEDING

Donovan Dixon, petitioner on review, was the

defendant-appellant below.

The United States of America, respondent on

review, was the appellee below.

iii

RELATED PROCEEDINGS

United States Court of Appeals for the Fourth

Circuit:

United States v. Dixon, No. 18-4936 (4th Cir.

Dec. 20, 2019)

United States District Court for the Eastern

District of North Carolina:

United States v. Dixon, No. 7:16-cr-30-D-1

(E.D.N.C. Aug. 30, 2018).

iv

TABLE OF CONTENTS

Page:

QUESTION PRESENTED .......................................... i

PARTIES TO THE PROCEEDING ........................... ii

RELATED PROCEEDINGS .....................................iii

TABLE OF CONTENTS............................................ iv

TABLE OF AUTHORITIES ..................................... vii

OPINION BELOW ..................................................... 1

JURISDICTION ......................................................... 1

FEDERAL PROVISIONS INVOLVED ...................... 2

STATEMENT OF THE CASE ................................... 2

A. Statutory Background ..................................... 2

B. Procedural History ........................................... 5

1. Dr. Dixon ran a small medical

practice

in

the

rural

and

impoverished area of Robeson

County, North Carolina .............................. 5

2. Consistent with circuit precedent,

the district court failed to give a mens

rea instruction to the jury as to what

the government must prove that a

physician intended when they wrote

prescriptions while allegedly acting

outside the usual course of

professional practice or without a

legitimate medical purpose, or to

otherwise delineate the line between

medical malpractice and criminal

conduct ........................................................ 6

v

3. The Fourth Circuit rejected Dr.

Dixon’s challenge to the jury

instructions ............................................... 10

REASONS FOR GRANTING THE WRIT ............... 11

I. THE

FOURTH

CIRCUIT’S

INSTRUCTIONAL PRACTICE FAILS

TO SET OUT A MENS REA THE

GOVERNMENT MUST PROVE &

LEAVES

JURIES

UNINFORMED

ABOUT THE CLEAR LINE THIS

COURT HAS DRAWN BETWEEN

CIVIL

MALPRACTICE

AND

CRIMINAL LIABILITY RESULTING

FROM

DRUG

DEALING

AS

CONVENTIALLY UNDERSTOOD .............. 11

II. THE FOURTH CIRCUIT’S PRACTICE

DEVOID OF A MENS REA ELEMENT

CRIMINALIZES DISPUTES ABOUT

THE PROPER STANDARD OF CARE ......... 18

III.THE

QUESTION

PRESENTED

ABOUT WHAT THE GOVERNMENT

MUST PROVE TO ESTABLISH A

PRACTITIONER’S

CRIMINAL

LIABILITY

HAS

SIGNIFICANT

CONSEQUENCES FOR MEDICAL

PRACTICE NATIONWIDE ........................... 22

CONCLUSION ......................................................... 26

vi

APPENDIX

Opinion

United States Court of Appeals

For The Fourth Circuit

entered December 20, 2019 ........................... 1a

Judgment

United States Court of Appeals

For The Fourth Circuit

entered December 20, 2019 ........................... 7a

21 CFR 1306.04 ................................................... 8a

21 USCS § 802 ................................................... 10a

21 USCS § 829 ................................................... 43a

21 USCS § 841, Part 1 of 6 ................................ 48a

Excerpts of

Transcript of Trial Proceedings Before

The Honorable James C. Dever, III (Day 4)

on April 16, 2018 .......................................... 67a

vii

TABLE OF AUTHORITIES

Page(s):

Cases:

Arthur Andersen LLP v. United States,

125 S. Ct. 2129 (2005) ......................................... 14

Bond v. United States,

572 U.S. 844 (2014) ............................................. 21

Gonzalez v. Oregon,

546 U.S. 243 (2006) ..................................... passim

Jin Fuey Moy v. United States,

254 U.S. 189 (1920) ............................................. 13

Kelly v. United States,

590 U.S. ___ (2020) .............................................. 20

Linder v. United States,

268 U.S. 5 (1925) ................................................. 13

Maslenjak v. United States,

137 S. Ct. 1918 (2017) ......................................... 20

McDonnell v. United States,

136 S. Ct. 2355 (2016) ......................................... 20

Morissette v. United States,

342 U.S. 246 (1952) ............................................. 14

Rehaif v. United States,

139 S. Ct. 2191, 204 L. Ed. 2d 594 (2019) .......... 14

Staples v. United States,

511 U.S. 60 (1994) ............................................... 14

United States v. Behrman,

258 U.S. 280 (1922) ............................................. 13

United States v. Feingold,

454 F.3d 1001 (9th Cir. 2006) ............................. 15

viii

United States v. Hurwitz,

459 F.3d 463 (4th Cir. 2006) ........................... 4, 17

United States v. Kirk,

584 F.2d 773 (6th Cir. 1978) ............................... 16

United States v. McIver,

470 F.3d 550 (4th Cir. 2006) ............................... 15

United States v. Moore,

423 U.S. 122 (1975) ..................................... passim

United States v. Singh,

54 F.3d 1182 (4th Cir. 1995) ................................. 4

United States v. Smith,

573 F.3d 639 (8th Cir. 2009) ............................... 15

United States v. Tran Trong Cuong,

18 F.3d 1132 (4th Cir. 1994) ............................... 16

United States v. United States Gypsum Co.,

438 U.S. 422 (1978) ............................................. 14

United States v. Volkman,

797 F.3d 377 (6th Cir. 2015) ................................. 4

United States v. X-Citement Video, Inc.

513 U.S. 64 (1994) ............................................... 14

Webb v. United States,

249 U.S. 96 (1919) ............................................... 13

Yates v. United States,

135 S. Ct. 1074 (2015) ......................................... 21

Statutes:

18 U.S.C. § 201(a)(3) ................................................. 21

18 U.S.C. § 229(a)(1) ................................................. 21

18 U.S.C. § 1425(a) ................................................... 20

18 U.S.C. § 1519........................................................ 21

ix

21 U.S.C. § 802............................................................ 2

21 U.S.C. § 802(19) ..................................................... 2

21 U.S.C. § 802(21) ..................................................... 2

21 U.S.C. § 822(b) ....................................................... 2

21 U.S.C. § 829............................................................ 2

21 U.S.C. § 841...................................................... 2, 15

21 U.S.C. § 841(a) ........................................... 3, 12, 15

21 U.S.C. § 841(a)(1) ............................................... 2, 6

21 U.S.C. § 846............................................................ 6

28 U.S.C. § 1254(1) ..................................................... 2

28 U.S.C. § 1291.......................................................... 1

Regulations:

21 C.F.R. § 1306.03 ..................................................... 2

21 C.F.R. § 1306.04 ..................................................... 2

21 C.F.R. § 1306.04(a) ................................................ 3

Other Authorities:

CDC Guideline for Prescribing Opioids for

Chronic Pain – United States, 2016, Morbidity

and Mortality Weekly Report (MMWR),

March 15, 2016 .................................................... 22-23

Centers for Disease Control and Prevention,

et. al., Guideline for Prescribing Opioids for

Chronic Pain, J. Pain & Palliative Care

Pharmacotherapy, 2016, Jun;

Vol. 30(2):138-40 ....................................................... 22

Controlled Substances Act,

H.R. Rep. No. 91-1444 .............................................. 25

x

K. Tate Chambers, A Primer on Investigating

Doctors Who Illegally Prescribe Opioids, 66

U.S. Att’y Bull. (July 2018) ...................................... 24

Kelly K. Dineen & James M. DuBois, Between

A Rock and A Hard Place: Can Physicians

Prescribe Opioids to Treat Pain Adequately

While Avoiding Legal Sanction?, 42 Am. J.L.

& Med. 7, 36 (2016)................................................... 23

Lenny Bernstein, White House opioid

commission calls for wide-ranging changes to

anti-drug policies, Washington Post,

Nov. 1, 2017 .............................................................. 22

Michael Nedelman, Doctors increasingly face

charges for patient overdoses, CNN,

July 31, 2017 ............................................................. 23

U.S. Dep’t of Health and Human Services,

Press Release, HHS Acting Secretary Declares

Public Health Emergency to Address National

Opioid Crisis, Ex. Order 13784

(March 29, 2017) ....................................................... 23

U.S. Dep’t of Justice, Press Release, Attorney

General Sessions Announces Opioid Fraud

and Abuse Detection Unit (Aug. 2, 2017) ................ 24

U.S. Dep’t of Justice, Press Release, Attorney

General Sessions Announces New Prescription

Interdiction and Litigation Task Force

(Feb. 27, 2018)........................................................... 24

1

IN THE

Supreme Court of the United States

_________

No.

_________

DONOVAN DAVE DIXON,

Petitioner,

v.

UNITED STATES OF AMERICA,

Respondent.

_________

On Petition for a Writ of Certiorari to the

United States Court of Appeals

for the Fourth Circuit

_________

PETITION FOR A WRIT OF CERTIORARI

_________

Donovan Dixon respectfully petitions for a writ of

certiorari to review the judgment of the United States

Court of Appeals for the Fourth Circuit.

OPINION BELOW

The Fourth Circuit’s opinion is unpublished but

available at Pet. App. 3a-4a.

JURISDICTION

The District Court entered on the docket the final

judgment on August 30, 2018. The Fourth Circuit had

jurisdiction pursuant to 28 U.S.C. § 1291 and entered

judgment on December 20, 2019. Pet. App. 7a. On

March 19, 2020, this Court extended deadline to file

petitions for a writ of certiorari by 150 days from the

2

date of the lower court judgment due to the ongoing

public health concerns relating to COVID-19. This

Court has jurisdiction under 28 U.S.C. § 1254(1).

FEDERAL PROVISIONS INVOLVED

The relevant statutory provisions are codified at

21 U.S.C. §§ 802, 829, 841, and 21 C.F.R. § 1306.03,

1306.04, and are set forth fully in the Appendix. See

Pet. App. 8a-66a.

STATEMENT OF THE CASE

A. Statutory Background

Because this is a physician-prescribing case, it has

a unique legal posture under federal drug law.

The Controlled Substances Act (CSA) generally

prohibits any person from dispensing or distributing

a controlled substance. See 21 U.S.C. § 841(a)(1). But

many of the controlled substances covered by the Act

have important medical uses, thus the Act exempts

physicians and other medical “practitioners” from this

prohibition and authorizes them to write prescriptions for certain controlled substances “in the course

of professional practice.” 21 U.S.C. §§ 802(21), 829.

For a physician’s controlled substance prescriptions to be lawful, there are two important conditions.

First, the physician must register with the Attorney General. See 21 U.S.C. §§ 802(19), 822(b); 21

C.F.R. § 1306.03. There is no dispute Dr. Dixon was

lawfully registered.

Second, the physician must be acting as a physician, that is, “in the course of professional practice.”

21 U.S.C. § 802(19). Regulations promulgated by the

Attorney General further provide that to be lawful, a

prescription “must be issued for a legitimate medical

3

purpose by an individual practitioner acting in the

usual course of his professional practice.” 21 C.F.R. §

1306.04(a). The regulation does not define the terms

“legitimate medical purpose” or “usual course of professional practice,” nor does it provide any further explanation about the differences between civil and

criminal liability vis a visa a failure to comply with a

particular standard of care. It lacks an articulation of

the mens rea required to convict a physician for prescribing controlled substances, conduct that is at the

very core of a physician’s responsibilities towards caring for their patients.

This Court has consistently drawn the line between civil and criminal liability. That is, the CSA

“bars doctors from using their prescription writing

powers as a means to engage in illicit drug dealing

and trafficking as conventionally understood,” Gonzalez, v. Oregon, 546 U.S. 243, 270 (2006), and that a

doctor, therefore, is criminally liable for unlawfully

distributing a controlled substance when acting as “a

drug pusher,” and “not as a physician.” United States

v. Moore, 423 U.S. 122, 126, 143 (1975).

The Fourth Circuit employs the “legitimate medical purpose” and usual course of professional practice”

language of § 1306.04(a) when instructing juries

about the elements the government must prove to

convict a physician for unlawfully prescribing (that is,

for a violation of the common drug crime of distribution of a controlled substance under 21 U.S.C. §

841(a)).

The Fourth Circuit’s precedents on jury instructions for applying the CSA to physicians do not contain a mens rea element as to the language from §

1306.04(a) and do not inform juries that conduct akin

4

to civil malpractice is insufficient to sustain a conviction and that acting outside the usual course of professional practice or without a legitimate medical purpose is conduct akin to drug dealing conventionally

understood. See, e.g., United States v. Hurwitz, 459

F.3d 463, 475-77, 479 (4th Cir. 2006); United States v.

Singh, 54 F.3d 1182, 1187 (4th Cir. 1995). Furthermore, the panel in the Fourth Circuit below relied on

other circuit decisions, see United States v. Volkman,

797 F.3d 377, 385-86 (6th Cir. 2015), to determine

that this Court’s decision in Gonzalez “imposed no

new requirements [in jury instructions] to establish a

violation of the CSA.” Pet. App. 3a-4a.

Thus, juries in the Fourth Circuit are instructed,

as the jury in Dr. Dixon’s case was, that there are no

specific guidelines but that a physician is criminally

liable for issuing a prescription for a controlled substance if they determine that prescription “was not for

a legitimate medical purpose or was outside the usual

course of professional medical practice.” Pet. App.

81a. Juries are given a non-binding list of factors

tending to show professional regulation violations

that they may take into consideration in making the

determination of whether the physician’s conduct was

outside the usual course of professional practice or

without a legitimate medical purpose. Id. at 82a.

5

B. Procedural History

1. Dr. Dixon ran a small medical practice in

the rural and impoverished area of Robeson County, North Carolina.

In 1998, Dr. Dixon graduated from medical school

and afterwards completed residencies in family medicine and OB/GYN. (JA 850-51).1 In 2005, Dr. Dixon

served as an Army physician and treated very seriously injured service members. (Id.). He was honorably discharged from the Army and received numerous

awards. (Id.).

In 2011, Dr. Dixon opened his own clinic, focusing

on pain management, in Robeson County, North Carolina, an impoverished rural area outside of the Army

base at Fort Bragg. (Id. at 841.). The North Carolina

Medical Board reprimanded Dr. Dixon in 2014 for

failing to comply with professional regulations relating to the dispensing of pain medications, and, after

another complaint of inappropriate prescribing, in

2015, Dr. Dixon executed a consent order with the

North Carolina Medical Board agreeing not to prescribe controlled substances. (Id. at 842). In fact, Dr.

Dixon stopped practicing medicine in the United

States and moved back to Jamaica, where he was

born. (Id. at 793).

However, in 2016, the government obtained an indictment against Dr. Dixon for his prescribing practices between 2012 and 2015, conduct constituting

professional regulation violations addressed by the

North Carolina Medical Board. (Id. at 18-21). He was

1 Citations are to the record on appeal—the joint appendix—in

the Fourth Circuit. The citations are provided for the Court’s

convenience in the event this Court deems it necessary to review

the record to resolve this petition. See Sup. Ct. R. 12.7.

6

arrested while on a visit back to the United States.

(Id. at 850).

In 2017, the government brought additional

charges for the conduct addressed by the North Carolina Medical Board in a superseding indictment,

charging Dr. Dixon with conspiracy to unlawfully dispense and distribute controlled substances in violation of 21 U.S.C. § 846 and also with twenty counts of

unlawfully dispensing and distributing controlled

substances in violation of 21 U.S.C. § 841(a)(1). (Id. at

40-44).

2. Consistent with circuit precedent, the district court failed to give a mens rea instruction to the jury as to what the government must prove that a physician intended when they wrote prescriptions

while allegedly acting outside the usual

course of professional practice or without

a legitimate medical purpose, or to otherwise delineate the line between medical

malpractice and criminal conduct.

There was no dispute at trial that the prescriptions in question were for controlled substances and

had been written by Dr. Dixon, i.e., that he had “distributed” or “dispensed” a controlled substance. The

only issue was the exercise of his professional judgment, and whether the prescriptions were written for

a “legitimate medical purpose” and within his “usual

course of professional practice.”

The district court failed to instruct the jury on the

mens rea the government must prove beyond a reasonable doubt than an accused physician acted with

in connection with these phrases or otherwise clarify

that these phrases create a different and higher

7

standard than the civil standards for medical malpractice.2

Without clarification for the jury, the disposition

of this critical issue turned mostly on the testimony of

the government’s expert, Dr. Greenblatt, a doctor and

medical school professor practicing in a large urban

hospital, when weighed against the testimony of Dr.

Dixon’s former spouse, Dr. Baptiste, a doctor with experience in pain management in impoverished rural

areas.3

Dr. Greenblatt recognized that the North Carolina

Medical Board had not adopted the 2014 national

guidelines for opioid safety promulgated by the Centers for Disease Control (“CDC”) until 2017, well after

the allegations in the case occurred. (Id. at 518-19).

That said, Dr. Greenblatt testified to an unwritten

standard of care that, in his opinion, was in effect

back in 2012 through 2014, focusing on the need to

perform physical examinations and obtaining medical

records for the patient generated by other provides.

(Id.). When asked how a practitioner would know this

standard of care during the relevant time frame, Dr.

Greenblatt testified that most learn it during their

post-medical school residencies. (Id. at 520).

2 The

pertinent instructions ultimately given by the district

court appear below in the Pet. App. 81a to 84a.

3 The Government also relied, in part, on incentivized witnesses,

i.e., testimony from people they had charged in the case for obtaining prescriptions from Dr. Dixon, as well as a former employee of Dr. Dixon’s clinic who had become an informant for the

DEA. (JA 176-196, 247-257, 379-429). No undercover investigative work that could have been audio or video recorded was conducted to corroborate the allegations that these witnesses made

against Dr. Dixon.

8

Furthermore, for example, Dr. Greenblatt himself

did not have the medical records for one of the testifying co-defendants, J.F., who had been a patient of Dr.

Dixon, and so Dr. Greenblatt’s opinions, informed by

that former patient’s testimony, on when the physician-patient relationship had turned illegitimate was

based on the credibility of a person facing criminal

prosecution who was an admitted addict. (Id. at 52932). On cross examination, Dr. Greenblatt admitted

that when patients have limited financial resources,

and they are self-pay without extra funds for radiological studies, etc, it presents a challenge to the physician treating for pain management. (Id. at 543).

While Dr. Dixon’s former attorneys, who were trial

counsel in this case, did not seek to have Dr. Baptiste

formally tendered as an expert, she also testified

about the relevant standards of care as they applied

in the actual communities being served, especially in

impoverished rural areas. (Id. at 603-628). She was a

family medicine physician for the Department of Defense. (Id. at 604). She had previously worked for the

VA in the area where Dr. Dixon practiced, and described that practice in that rural area as very challenging, especially due to the poverty. (Id. at 608-09).

In the area where Dr. Dixon practiced, Dr. Baptiste explained that there is only one hospital in the

Pembroke area. (Id. at 609). As a result, “[t]here is not

a lot of access to physical therapy, x-rays, MRIs, even

pain management clinics.” Id. That affected her medical practice because her patients could not always

travel to Fayetteville to get x-rays which, according to

Dr. Greenblatt, may have been necessary medical information for a doctor to review before prescribing

opiates. Id. Dr. Baptiste testified that when a doctor

9

has no records to refer to, or x-rays to examine, because a patient did not have access to those medical

services, the only thing a doctor can use is his or her

ability to examine the patient, the doctor’s training

and the patient’s history – or what the patient tells

the doctor. (Id. at 610-611).

Dr. Baptiste continued by explaining that sometimes a doctor-patient relationship can be formed

even when the doctor and patient have never met

face-to-face. (Id. at 622). She explained, that “there

are situations * * * that a doctor might prescribe for a

family member [of a patient] because they know that

family member, whether it be a husband or wife,

whatever, and they choose to write a hand-script for

them.” (Id. at 627-628).

Dr. Baptiste testified that it can be very difficult

to differentiate between an addict and a person genuinely in pain. (Id. at 613). She said, “when a patient

comes in complaining of pain, you don’t know if they

have pain * * * you’re just basically going off what

they’re telling you. And if they’re coming to see you

for pain, you’re required to address it.” Id. She explained that people, and addicts in particular, can be

very manipulative. (Id. at 614). “[Y]ou have to balance

your clinical training and your desire to help someone

and relieve their pain with trying to see through the

fog, and see do they really have pain, how are they

walking, what’s going on.” (Id.).

She also testified that, when dealing with patients

complaining of pain, some doctors are more aggressive than others. (Id.). Furthermore, doctors in combat situations are even more aggressive in pain management treatment because when they are taking on

gun fire, they cannot have soldiers “laid up” in pain.

10

(Id. at 614). She said, “[s]o, if someone comes in with

– like I see it in my clinic every day, and we’re not

even a combat zone – but we see people who come

back from combat who have injuries that they couldn’t

have gotten through if they didn’t have that pain relief.” (Id.). Thus, the actual practice of prescribing

pain medication varies based on both the doctor’s experience and the patient’s circumstances. (Id.).

Dr. Baptiste testified that the first time she ever

wrote a prescription for an opiate, it was after she

completed her residency. (Id. at 611). Contrary to

what Dr. Greenblatt testified was the norm, Dr. Baptiste had not learned how to prescribe opiates in medical school or her residency. (Id.). She had to consult

the Physician’s Desk Reference to learn the appropriate dosages to prescribe her patient. (Id.). Dr. Baptiste stated that it has only been in the last few years

that doctors have become more versed in the use of

pain medications, and opiates in particular. (Id. at

612). However, Dr. Baptiste conceded effectively that

Dr. Dixon was at least negligent in some of his prescribing practices by saying she would not have engaged in some of those practices. (Id. at 626).

The jury ultimately convicted Dr. Dixon on all 21

counts in the indictment. (Id. at 759-774). At the end

of the sentencing hearing, the district court sentenced

Dr. Dixon to 240 months imprisonment (20 years). See

Pet. App. 2a.

3. The Fourth Circuit rejected Dr. Dixon’s

challenge to the jury instructions.

On appeal, despite even the government alleging

in the superseding indictment that Dr. Dixon acted

with the mens rea of intending to act outside the usual

course of professional practice and not for a legitimate

11

medical purpose (but, critically, not instructed on by

the district court), the panel in the Fourth Circuit—

in an unpublished decision—rejected Dr. Dixon’s

challenge to the jury instructions, in part citing that

other circuits had determined that this Court’s decision in Gonzalez did not impose any new requirements in the body of law on instructing juries when a

physician is prosecuted under the CSA. See Pet. App.

3a-4a.

REASONS FOR GRANTING THE WRIT

I. THE FOURTH CIRCUIT’S INSTRUCTIONAL

PRACTICE FAILS TO SET OUT A MENS REA

THE GOVERNMENT MUST PROVE &

LEAVES JURIES UNINFORMED ABOUT

THE CLEAR LINE THIS COURT HAS

DRAWN BETWEEN CIVIL MALPRACTICE

AND CRIMINAL LIABILITY RESULTING

FROM DRUG DEALING AS CONVENTIALLY

UNDERSTOOD

By developing the law of jury instructions in unlawful prescribing trials without instructing on a

mens rea that the government must prove that a physician acted with in relation to the key terms “legitimate medical purpose” and “usual course of medical

practice,” and without otherwise instructing about

the line between criminal conduct and bad or merely

disputed medical practice, the Fourth Circuit is failing to enforce an important line that Congress and

this Court have drawn.

Most recently, in discussing the reach of the Controlled Substances Act (“CSA”) in Gonzalez v. Oregon,

this Court emphasized the Act’s narrow scope when it

comes to the practice of medicine. Specifically, the

Court explained the CSA is a statute concerned with

12

combating recreational drug abuse, and not an attempt (or authorization to the federal government) to

regulate medical practice generally. 546 U.S. 243, 272

(2006). This Court explained that the CSA draws a

clear and important line between criminal and noncriminal conduct:

The [CSA] and our case law amply support the

conclusion that Congress regulates medical

practice insofar as it bars doctors from using

their prescription-writing powers as a means to

engage in illicit drug dealing and trafficking as

conventionally understood. Beyond this, however, the statute manifests no intent to regulate the practice of medicine generally.

Id. at 269-70.

This is the same line this Court drew when it upheld the government’s prosecution of a physician under the CSA in United States v. Moore, the only case

where this Court has directly dealt with a physician

being prosecuted under the CSA on the merits. 423

U.S. 122, 143 (1975).

In Moore, this Court held that physicians were not

categorically exempt from criminal prosecution under

the CSA’s unlawful distribution provisions, i.e., 21

U.S.C. § 841(a). And criminal liability existed in

Moore, because the doctor “acted as a large scale

‘pusher’ not as a physician.” Id. This clear line, where

the government must prove that the physician acted

with a mens rea that they were engaged in drug dealing as conventionally understood effectuates what

this Court sought to clarify when deciding Moore,

which involved a doctor “prescribing as much and as

frequently as the patient demanded…not charg[ing]

for medical services rendered, but graduat[ing] his fee

13

according to the number of tablets desired.” Id. at 14243.

This clear line—that the accused physician intended (the mens rea) to act as a drug dealer as conventionally understood—is also embodied in the same

line that this Court drew a century ago in cases interpreting the 1914 Harrison Act (the predecessor to the

CSA), and where this Court affirmed convictions from

prosecutions where the doctor “[i]n reality [ ] became

party to sales of drugs.” Linder v. United States, 268

U.S. 5, 20-22 (1925); see, e.g., Jin Fuey Moy v. United

States, 254 U.S. 189, 194 (1920) (affirming conviction

of doctor who prescribed large quantities of morphine,

where prescriptions were demonstrably just sales to

drug addicts, where doctor, inter alia, charged according to the amount of drugs “prescribed”); Webb v.

United States, 249 U.S. 96, 99 (1919) (affirming conviction where physician and druggist conspired to sell

large quantities of morphine under the guise of issuing prescriptions); United States v. Behrman, 258

U.S. 280, 288-89 (1922) (affirming conviction where

physician “indiscriminate[ly] dol[ed] out narcotics” in

such large quantities to a known addict that the “so

called prescriptions” could only be for drug use or

sale); compare with Linder, 268 U.S. at 17, 22 (reversing conviction of a physician because, unlike in Jin

Fuey Moy, Webb or Behrman, the physician’s distribution of only a small quantity of drugs did not give rise

to such clear inference of unlawful actions and failure

to comply with professional standards, or in other

words a “conscious design to violate the law”).

Against this backdrop, the line that has been

drawn by this Court, and Congress, is when a physician intends (the mens rea) to cease to act as a physician and instead intends to act as a drug dealer that

14

causes a doctor to face federal criminal prosecution

and serve potentially years, or decades, in prison.

This Court in Moore implicitly approved of a mens rea

instruction by acknowledging that subjective good

faith by a physician would be a defense to an accusation that a physician acted outside the usual course of

professional practice. 423 U.S. at 139.

The lack of a mens rea as to the element of prescribing (distributing) controlled substances outside

of the usual course of professional practice or without

a legitimate medical purpose violated two basic principles of our criminal justice system. That lack ignores

the principle that “[t]he existence of a mens rea is the

rule of, rather than the exception to, the principles of

Anglo-American criminal jurisprudence.” United

States v. United States Gypsum Co., 438 U.S. 422, 436

(1978). That rule is “universal and persistent in mature systems of law.” Morissette v. United States, 342

U.S. 246, 250 (1952). Its application is especially critical “where the act underlying the conviction” – here,

a doctor prescribing medicine – “is by itself innocuous.” Arthur Andersen LLP v. United States, 125 S.

Ct. 2129, 2134 (2005). This Court has emphasized this

principle repeatedly. “Morissette, reinforced by Staples [v. United States, 511 U.S. 60 (1994)], instructs

that the presumption in favor of a scienter requirement should apply to each of the statutory elements

that criminalize otherwise innocent conduct.” United

States v. X-Citement Video, Inc. 513 U.S. 64, 72

(1994); see also Rehaif v. United States, 139 S. Ct.

2191, 2200, 204 L. Ed. 2d 594 (2019) (clarifying that

government must prove that in a prosecution for unlawfully possessing a firearm the accused knew they

belonged to the relevant category of persons barred

from possessing a gun).

15

Without this mens rea, which is the current state

of the law in the Fourth Circuit, leaves a realm of conduct up for debate in the jury room that is better

suited to medical malpractice proceedings or state

medical board or licensing actions. Cf. Gonzalez, 546

U.S. at 270-21 (noting traditional reservation to the

states of the regulation of the medical profession).

Some circuits, recognizing the ambiguity in the concepts of usual course of professional practice and legitimate medical purpose, have cautioned district

courts of the perils of lowering the standard for criminal liability. See, e.g., United States v. Smith, 573

F.3d 639, 649 (8th Cir. 2009) (recognizing danger in

confusing mere medical malpractice and 21 U.S.C. §

841 standards); United States v. Feingold, 454 F.3d

1001, 1010 (9th Cir. 2006) (noting this Court’s care in

Moore to emphasize that the defendant had so wantonly ignored basic protocols of medical profession

that he acted as a large-scale pusher and not as a physician); and, the Fourth Circuit has made a similar

warning (but is not required in the instruction practice in the district courts), United States v. McIver,

470 F.3d 550, 558 (4th Cir. 2006) (noting potential for

juries to confuse the civil standard of care applied in

medical malpractice cases).

Only the Ninth Circuit has read into its body of

law for instructions a mens rea requirement as to the

concepts of usual course of professional practice and

legitimate medical purpose, that is “criminal liability

under § 841(a) requires more than proof of a doctor's

intentional failure to adhere to the standard of care."

Feingold, 454 F.3d at 1011. “A practitioner becomes a

criminal not when he is a bad or negligent physician,

but when he ceases to be a physician at all.” Id. Other

16

circuits, recognize the ultimate danger, i.e. convictions for civil malpractice, resulting from a lack of a

clear articulation of the mens rea that must be proven

but fail to make a mens rea requirement a core part

of their body of law on instructions governing the application of the CSA to physician prescribing practices. See United States v. Tran Trong Cuong, 18 F.3d

1132, 1137 (4th Cir. 1994) (noting that a criminal conviction “requires more” than a showing of malpractice); see also United States v. Kirk, 584 F.2d 773, 784

(6th Cir. 1978) (stating that there are no specific

guidelines concerning what is required to support a

conclusion that the accused acted outside the usual

course of professional practice).

Telling juries that a doctor must have acted with

“a legitimate medical purpose” or within “the usual

course of professional practice” to escape criminal liability, gives them a free hand to decide for themselves

what the standard of care is, and then convict on any

deviation from that standard. It is not at all the same

thing as telling them that criminal liability can only

attach when a doctor intentionally abandons his or

her role as a physician to become a drug dealer as conventionally understood. Cf. Gonzalez, 546 U.S. at 258

(“All would agree, we should think, that the statutory

phrase ‘legitimate medical purpose’ is a generality,

susceptible to more precise definition and open to varying constructions, and thus ambiguous in the relevant sense.”).

Moreover, a “good faith” jury instruction, as was

given here is no answer to these concerns. It creates

circular logic, because that instruction simply re-incorporates the very same terms, still without defining

them, thus allowing a conviction for a species of civil

malpractice:

17

[i]f a doctor dispenses a drug in good faith, in

medically treating a patient, then the doctor

has dispensed that drug for a legitimate medical purpose in the usual course of medical practice. That is, he has dispensed the drug lawfully. Good faith in this context means good intentions, and the honest exercise of professional judgment as to the patient’s needs. It

means that the defendant acted in accordance

with what he reasonably believed to be a legitimate medical purpose and… in accordance

with the usual course of generally accepted

medical practice.

See, e.g., Pet. App. 82a. Additionally, the dissent

in Hurwitz pointed out the logical contradiction between the concept of good faith (the intent of the actor) and an objective inquiry (the act in question) and

concluded that good faith should be a subjective

standard. 459 F.3d 463, 483 (4th Cir. 2006) (Widener,

J., dissenting).

The failure to instruct the jury on a mens rea that

the government had to prove, as was actually alleged

in the counts in indictment, erases the line that Congress and this Court have drawn to separate negligence and malpractice from the realm of intent and

conduct that establishes criminality, creating the

very real possibility of conviction on grounds broader

than “drug dealing and trafficking as conventionally

understood.”

18

II. THE FOURTH CIRCUIT’S PRACTICE

DEVOID OF A MENS REA ELEMENT

CRIMINALIZES DISPUTES ABOUT THE

PROPER STANDARD OF CARE

By failing to define what is—and what is not—encompassed by the terms “legitimate medical purpose”

and “usual course of professional practice,” and then

also failing to articulate what mens rea a physician

must have when deviating from those terms in their

prescribing practices in order to be lawfully prosecuted under the CSA, the Fourth Circuit’s practice effectively criminalizes disputes about the proper

standard of care.

Without an instruction on mens rea in this context,

and further clarification on what is and is not the

usual course of professional practice and a legitimate

medical purpose, the gravamen of physician-prescribing cases is almost always going to be the physician’s

exercise of professional judgment.

Not only do juries have a free hand under this legal regime to decide for themselves what the standard

of care is in a given case, and then to convict on a deviation from that standard, this legal regime also empowers the government to mold a standard of care

through the use of their experts in these trials, even

if, as what occurred in the trial below, another doctor

testifies in disagreement with the government’s expert.

This outcome is in tension with the limits on the

federal government’s ability to define standards for

the proper medical care and treatment of patients. As

this Court explained in Gonzalez, the CSA evidences

no Congressional intent to permit the Attorney General to make such a general definition; in fact, to the

19

contrary, it affirmatively “conveys unwillingness to

cede medical judgments to an executive official who

lacks medical expertise.” 546 U.S. at 265-66. Yet the

government’s use of experts to testify in a trial where

the jury is ultimately charged without any meaningful principle for distinguishing between negligence or

malpractice, on the one hand, and conduct that is outside the “usual course of professional practice” and

without “a legitimate medical purpose,” i.e., criminal

behavior, on the other, and then without a mens rea

element as to those concepts, is so problematic because bad and outright wrong medical judgments may

occur within the usual course of a physician’s professional practice.

Here, two doctors with experience in treating

chronic pain testified on what was often different

sides of the line. Also, Dr. Dixon’s interview with the

DEA was played to the jury, where there was an effective admission of negligence on his part. The disagreements by the testifying doctors in this case is unsurprising given how fluid and uncertain the concepts

of usual course of professional practice and legitimate

medical purpose are, and why this Court’s articulation in Moore and Gonzalez of where that line rests

makes a great deal of sense. But the practice in the

Fourth Circuit, and other circuits, in instructing juries on the application of the CSA to a physician’s prescribing practices fails to give effect to where this

Court and Congress has identified where that line

rests. Physicians are critical to the wellbeing of our

society, now more than ever, however, a legal regime

that subjects a physician to great ambiguity on where

the line rests for criminal prosecution and exposure to

what this Court recognized in Moore as “severe criminal penalties” is untenable. 423 U.S. at 135.

20

In contrast, explaining to juries that criminal prosecutions are not evaluating malpractice, and that a

doctor intentionally acts outside of “a legitimate medical purpose” and the “usual course of professional

practice” only when they intentionally become a drug

“pusher” engaging in drug dealing as “conventionally

understood,” provides a clear and meaningful benchmark to evaluate the expert testimony, and allows juries to serve as a check against unchained prosecution. But failing to expressly delineate these critical

boundaries through a mens rea element and the clarification of the narrow application of the CSA to physicians that this Court articulated in Gonzalez, risks

criminalizing the practices of physicians who may be

negligent or exercising poor judgment, even engaging

in professional norm violations, but are not crossing

the line into the behavior of drug dealers conventionally understood.

This Court has repeatedly intervened to rein in the

government’s overly expansive interpretation and application of criminal statutes. See, e.g., Kelly v. United

States, 590 U.S. ___ (2020) (reversing convictions of

local officials for causing crippling and dangerous

traffic jams on the George Washington bridge by holding federal wire fraud statute does not reach all forms

of deception through use of the wires but instead only

those schemes where the object is obtaining money or

property); Maslenjak v. United States, 137 S. Ct. 1918,

1927 (2017) (rejecting government’s broad interpretation of 18 U.S.C. § 1425(a), which would “give prosecutors nearly limitless leverage” because “Congress…did not go so far as the Government claims”);

McDonnell v. United States, 136 S. Ct. 2355, 2367-68

(2016) (rejecting government’s broad interpretation of

21

18 U.S.C. § 201(a)(3), which read statutory term “official act” to “encompass nearly any activity by a public

official,” and instead “adopt a more bounded interpretation of ‘official act’’); Yates v. United States, 135 S.

Ct. 1074, 1081 (2015) (plurality opinion) (rejecting

government’s broad interpretation of 18 U.S.C. §

1519, which read undersized fish as falling within

phrase “any record, document, or tangible object,” because it was an “unrestrained reading’”); Bond v.

United States, 572 U.S. 844, 857-61 (2014) (rejecting

government’s broad interpretation of 18 U.S.C. §

229(a)(1) and statutory implementation of chemical

weapons treaty as including local crime of poisoning

a romantic rival).

This Court should rein in the application of the

CSA to the prescribing practices of physicians

through a mens rea element and clarification on the

concepts of usual course of professional practice and

legitimate medical purpose in order to re-establish

the line that this Court has already drawn. Indeed, it

has been nearly 46 years since this Court last reviewed the federal government’s criminal prosecution

of a physician for unlawfully prescribing controlled

substances in Moore. (Gonzalez, while important to

this question, arose as an action for injunctive relief

by the State of Oregon and others against an interpretive rule issued by the Attorney General indicating

that physicians who assisted the suicide of terminally

ill patients under state law would be violating the

CSA, see 546 U.S. at 248, 254.) There is no substitute

for reaffirming the line between criminal conduct and

negligence or professional malfeasance in an actual

criminal prosecution.

22

III. THE QUESTION PRESENTED ABOUT

WHAT THE GOVERNMENT MUST PROVE

TO

ESTABLISH

A

PRACTITIONER’S

CRIMINAL LIABILITY HAS SIGNIFICANT

CONSEQUENCES

FOR

MEDICAL

PRACTICE NATIONWIDE.

Now, especially in an era that has brought us a

national emergency and global pandemic due to

COVID-19, and rampant debate within the medical

community on the efficacy of potential treatments,

this is an important time for this Court to intervene

and require juries to be instructed more clearly about

when a physician is criminally liable for prescribing a

controlled substance.

Specifically to this case, in the years since the prescriptions in this case were written back in 2012

through 2014, the national attention on the use, and

misuse, of opioids and other prescription drugs has increased drastically. See, e.g., Lenny Bernstein, White

House opioid commission calls for wide-ranging

changes to anti-drug policies, Washington Post, Nov.

1, 2017 (recounting national attention on prescription

drug abuses). In 2016, the Centers for Disease Control

and Prevention published a guideline for prescribing

opioid pain medications in primary care settings. See

Centers for Disease Control and Prevention, et. al.,

Guideline for Prescribing Opioids for Chronic Pain, J.

Pain & Palliative Care Pharmacotherapy, 2016, Jun;

Vol. 30(2):138-40; 4 CDC Guideline for Prescribing

4 Available at, https://www.ncbi.nlm.nih.gov/pubmed/27301691;

https://www.tandfonline.com/doi/full/10.3109/15360288.2016.11

73761.

23

Opioids for Chronic Pain – United States, 2016, Morbidity and Mortality Weekly Report (MMWR), March

15, 2016.5

In 2017, the Acting Secretary of Health and Human Services declared the national opioid abuse epidemic a public health emergency, and the President

established a commission to study the problem and

make recommendations. See, e.g., U.S. Dep’t of Health

and Human Services, Press Release, HHS Acting Secretary Declares Public Health Emergency to Address

National Opioid Crisis, Ex. Order 13784 (March 29,

2017) (establishing Presidential Commission).6

The government has also responded by prosecuting doctors. See, e.g., Michael Nedelman, Doctors increasingly face charges for patient overdoses, CNN,

July 31, 2017 (reporting that “[b]etween 2011 and

2016, the number of doctors punished by the DEA

jumped more than five times”); Kelly K. Dineen &

James M. DuBois, Between A Rock and A Hard Place:

Can Physicians Prescribe Opioids to Treat Pain Adequately While Avoiding Legal Sanction?, 42 Am. J.L.

& Med. 7, 36 (2016) (suggesting that “[t]here are some

indications that law enforcement scrutiny of physicians has grown recently in reaction to the rise in prescription drug abuse”).

The government has identified prosecutions of

physicians under the CSA as a high priority area,

thus there is an expectation that these prosecutions

will be recurring events with a profound impact on the

Available at, https://www.cdc.gov/mmwr/volumes/65/rr/rr

6501e1.htm.

6 Available at, https://www.hhs.gov/about/news/2017/10/26/hhsacting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.

5

24

medical profession. See K. Tate Chambers, A Primer

on Investigating Doctors Who Illegally Prescribe Opioids, 66 U.S. Att’y Bull. (July 2018) at 19-32 (recounting efforts to make the “overprescribing of opioids by

health care professionals a top priority of the Department of Justice,” and providing guidance on such

prosecutions); 7 see also U.S. Dep’t of Justice, Press

Release, Attorney General Sessions Announces Opioid Fraud and Abuse Detection Unit (Aug. 2, 2017);8

U.S. Dep’t of Justice, Press Release, Attorney General

Sessions Announces New Prescription Interdiction

and Litigation Task Force (Feb. 27, 2018).9

Accordingly, the courts are likely to continue to

grapple with many cases involving physicians

charged with unlawfully prescribing controlled substances, and predictably beyond just the opioid crises.

Instructing juries with greater specificity, uniformly

across the country, will ensure that they can adequately distinguish well-meaning but mistaken doctors (and even bad doctors engaged in professional

malfeasance) from drug dealers conventionally understood. Doing so with an emphasis on the mens rea that

the government must prove to convict a physician (or

other qualified practitioner) still protects the government’s important efforts to shut down problematic

“pill mills” and “pain clinics” that are medical practices in name only, or to prosecute doctors “who sold

drugs, not for legitimate purposes, but ‘primarily for

Available

at,

https://www.justice.gov/usao/page/file/

1083791/download.

8 Available at, https://www.justice.gov/opa/pr/attorney-generalsessions-announces-opioid-fraud-and-abuse-detection-unit.

9 Available at, https://www.justice.gov/opa/pr/attorney-generalsessions-announces-new-prescription-interdiction-litigationtask-force.

7

25

the profits to be derived therefrom.’” Moore, 423 U.S.

at 135 (quoting legislative history of the Controlled

Substances Act, H.R. Rep. No. 91-1444 at 10).

Adding this clarity to the legal regime governing

prosecutions of physicians under the CSA, with a

mens rea element and further clarification on the concepts of usual course of professional practice and legitimate medical purpose, will curtail the over- criminalization of disputes about the proper exercise of

medical judgment, holding the line of criminal liability where Congress and this Court have appropriately

set it, at those who “engage in illicit drug dealing and

trafficking as conventionally understood.” Gonzalez,

546 U.S. at 270.

The instructional practice in the Fourth Circuit,

and in other circuits, has obscured this clear line and

risks convictions and imposing serious penalties, including years or decades in prison, for a species of civil

medical malpractice. This Court’s intervention is necessary to reaffirm the line and ensure that juries are

properly instructed.

26

CONCLUSION

The petition for a writ of certiorari should be

granted.

Respectfully submitted,

/S/ RAYMOND C. TARLTON

RAYMOND C. TARLTON

Counsel of Record

209 Fayetteville Street

Suite 105

Raleigh, NC 27601

(919) 948-6464

rtarlton@tarltonpolk.com

Counsel for Petitioner

MAY 18, 2020

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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Petition for Writ of Certiorari — Donovan Dave Dixon, Petitioner v. United States | Frix