Respondents Brief — Xiulu Ruan, Petitioner v. United States

Supreme Court briefJan 19, 2022

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Nos. 20-1410 and 21-5261

In the Supreme Court of the United States

XIULU RUAN, PETITIONER

UNITED STATES OF AMERICA

SHAKEEL KAHN, PETITIONER

UNITED STATES OF AMERICA

ON WRITS OF CERTIORARI

TO THE UNITED STATES COURTS OF APPEALS

FOR THE TENTH AND ELEVENTH CIRCUITS

BRIEF FOR THE UNITED STATES

ELIZABETH B. PRELOGAR

Solicitor General

Counsel of Record

KENNETH A. POLITE, JR.

Assistant Attorney General

ERIC J. FEIGIN

Deputy Solicitor General

NICOLE FRAZER REAVES

Assistant to the Solicitor

General

JOSHUA K. HANDELL

DAVID M. LIEBERMAN

Attorneys

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTION PRESENTED

Whether a physician is entitled to avoid conviction

for unlawful drug distribution under 21 U.S.C. 841(a),

based solely on his unreasonable subjective views about

drug prescription, where he fails to make an objectively

“honest effort,” United States v. Moore, 423 U.S. 122,

142 n.20 (1975) (citation omitted), to conform his conduct to the terms of a federal registration limiting him

to prescriptions “issued for a legitimate medical purpose by an individual practitioner acting in the usual

course of his professional practice,” 21 C.F.R. 1306.04(a).

(I)

TABLE OF CONTENTS

Page

Opinions below .............................................................................. 1

Jurisdiction .................................................................................... 1

Statutory and regulatory provisions involved ........................... 2

Statement ...................................................................................... 2

A. Legal background ..................................................... 3

B. Petitioners’ convictions ............................................. 4

1. Ruan .................................................................... 5

2. Kahn................................................................... 11

Summary of argument ............................................................... 16

Argument..................................................................................... 18

I. Dispensing drugs without any objectively

reasonable effort to actually practice medicine

violates 21 U.S.C. 841(a) ............................................... 19

A. A registration to prescribe drugs under the

CSA is limited to prescriptions for a legitimate

medical purpose in the usual course of a

medical practice ....................................................... 20

B. The wholly subjective views of a physician who

has not reasonably tried to practice medicine

as conventionally understood do not preclude

conviction under Section 841(a) ............................. 24

1. The CSA prohibits a physician from selfdef ining the scope of his medical practice...... 24

2. This Court has recognized that a physician

can violate Section 841(a) when he fails to

make an “honest effort” to rely in “good

faith” on his DEA registration ........................ 26

3. Congress designed the CSA to allow for

the prosecution of doctors who elevate

their own views of acceptable medicine

above the medical community’s....................... 31

C. Petitioners’ arguments for a solely subjective

definition of lawful prescribing practices under

Section 841(a) are unsound .................................... 33

(III)

Table of Contents—Continued:

Page

1. Petitioners’ construction of Section

841(a) is textually foreclosed and

unnecessary ....................................................... 34

2. The terms of the regulatory standard do

not invite self-def inition of medicine .............. 36

3. The regulatory standard does not contain

an independent wholly subjective

component ......................................................... 37

4. The legal standard for physician

prosecutions under Section 841(a)

is not unconstitutionally vague ........................ 39

5. Reference to the usual course of

professional practice respects the

tradition of state medical regulation .............. 40

6. Petitioners’ practical concerns are

unsupported ...................................................... 41

II. Petitioners’ convictions should be affirmed ................ 44

A. The juries in petitioners’ cases were

sufficiently instructed on the requirements

of Section 841(a) ...................................................... 44

B. Any instructional defect was harmless ................. 47

Conclusion ................................................................................... 49

Appendix — Statutory and regulatory provisions ................ 1a

TABLE OF AUTHORITIES

Cases:

Bain v. Colbert Cnty. Nw. Ala. Health Care

Auth., 233 So. 3d 945 (Ala. 2017) ....................................... 41

Bryan v. United States, 524 U.S. 184 (1998) ...................... 25

Carter v. United States, 530 U.S. 255 (2000) ...................... 36

Cheek v. United States, 498 U.S. 192 (1991) ................. 25, 34

Elonis v. United States, 575 U.S. 723 (2015) ...................... 34

Garnett v. Coyle, 33 P.3d 114 (Wyo. 2001) .......................... 42

Cases—Continued:

Page

Global-Tech Appliances, Inc. v. SEB S. A.,

563 U.S. 754 (2011).............................................................. 35

Gonzales v. Oregon, 546 U.S. 243 (2006) .................... passim

Jin Fuey Moy v. United States,

254 U.S. 189 (1920), overruled in part on

other grounds by Funk v. United States,

290 U.S. 371 (1933)........................................................ 31, 32

Linder v. United States, 268 U.S. 5 (1925) ......................... 32

Liparota v. United States, 471 U.S. 419 (1985) .................. 34

Rehaif v. United States, 139 S. Ct. 2191 (2019) .................. 34

Seisinger v. Siebel, 203 P.3d 483 (Ariz. 2009) ..................... 42

United States v. Behrman, 258 U.S. 280 (1922) ................. 32

United States v. Davis, 139 S. Ct. 2319 (2019) ................... 39

United States v. Lane, 474 U.S. 438 (1986) ......................... 47

United States v. Lovern,

590 F.3d 1095 (10th Cir. 2009) ..................................... 23, 39

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

United States v. Nelson,

383 F.3d 1227 (10th Cir. 2004) ........................................... 38

United States v. Williams, 553 U.S. 285 (2008) ................. 39

United States v. Yermian, 468 U.S. 63 (1984) .............. 16, 24

Victor v. Nebraska, 511 U.S. 1 (1994) .................................. 44

Village of Hoffman Estates v. The Flipside, Hoffman

Estates, Inc., 455 U.S. 489 (1982) ................................ 39, 40

Warger v. Shauers, 574 U.S. 40 (2014) ................................ 45

Statutes, regulations, and rule:

Comprehensive Drug Abuse Prevention and Control

Act of 1970, Pub. L. No. 91-513,

Pmbl., 84 Stat. 1236 .................................................. 3, 29, 31

Statutes, regulations, and rule—Continued:

Page

Controlled Substances Act,

Pub. L. No. 91-513, Tit. II, 84 Stat. 1242

(21 U.S.C. 801 et seq.) ........................................................... 3

21 U.S.C. 802(20) (1970) .................................................. 30

21 U.S.C. 802(21) ................................................. 21, 30, 1a

21 U.S.C. 802(56)(C) ........................................................ 21

21 U.S.C. 812(b)(2)(B) ..................................................... 22

21 U.S.C. 812(b)(3)(B) ..................................................... 22

21 U.S.C. 812(b)(4)(B) ..................................................... 22

21 U.S.C. 812(b)(5)(B) ..................................................... 22

21 U.S.C. 821 .............................................................. 20, 1a

21 U.S.C. 822 .............................................................. 20, 1a

21 U.S.C. 822(a)(2)..................................................... 21, 1a

21 U.S.C. 822(b) ............................................... 3, 17, 21, 2a

21 U.S.C. 823(f )................................................ 3, 21, 43, 2a

21 U.S.C. 823(g ) ............................................................... 43

21 U.S.C. 824(a)(4)........................................................... 21

21 U.S.C. 829 .............................................................. 21, 4a

21 U.S.C. 829(e)(2)(A) ......................................... 21, 37, 6a

21 U.S.C. 830(b)(3)(A)(ii) ................................................ 21

21 U.S.C. 841 ....................................... 27, 28, 30, 33, 38, 42

21 U.S.C. 841(a) .................................................passim, 7a

21 U.S.C. 841(a)(1).............................. 2, 3, 7, 12, 15, 18, 7a

21 U.S.C. 841(b)(1)(C) ................................................. 3, 12

21 U.S.C. 841(b)(2) ...................................................... 3, 12

21 U.S.C. 843(b) ............................................................... 12

21 U.S.C. 844(a) ......................................................... 22, 37

21 U.S.C. 846 .................................................................. 2, 7

21 U.S.C. 848(a) ............................................................... 12

21 U.S.C. 848(b) ............................................................... 12

21 U.S.C. 848(c) ............................................................... 12

VII

Statutes, regulations, and rule—Continued:

Page

21 U.S.C. 885(a)(1)......................................... 16, 25, 26, 7a

Harrison Act of 1914, ch. 1, 38 Stat. 785........................ 29, 31

§ 2(a), 38 Stat. 786 ..................................................... 31, 36

18 U.S.C. 371 ............................................................................ 7

18 U.S.C. 924(c)(1) (2012)...................................................... 12

18 U.S.C. 1001 (1982)............................................................. 25

18 U.S.C. 1341 .......................................................................... 7

18 U.S.C. 1343 .......................................................................... 7

18 U.S.C. 1347 .......................................................................... 7

18 U.S.C. 1349 .......................................................................... 7

18 U.S.C. 1956(h) ..................................................................... 7

18 U.S.C. 1957 .................................................................... 7, 13

18 U.S.C. 1962(d) ..................................................................... 7

42 U.S.C. 1320a-7b(b) (2012) .................................................. 7

Ala. Admin. Code r. (Supp. June 30, 2020):

§ 540-x-4-.06 to 540-x-4-.09 ............................................. 23

§ 540-x-4-.09(8) ................................................................. 24

Ariz. Rev. Stat. Ann. (2020):

§ 32-1491 (Supp. 2020) .................................................... 23

§§ 32-3248 et seq. ............................................................. 23

§ 32-3248.02 ...................................................................... 24

Wyo. Stat. Ann. (2021):

§ 33-26-202(b)(xiv) ........................................................... 24

§ 35-7-1030........................................................................ 23

21 C.F.R. 1306.04(a) ................................................passim, 8a

28 C.F.R. 0.100(b) .................................................................. 20

Fed. R. Crim. P. 52(a) ........................................................... 47

VIII

Miscellaneous:

Page

Ala. Bd. of Med. Exam’rs & Med. Licensure

Comm’n, Prescribing Issues (2022),

https://go.usa.gov/xtgWr.................................................... 23

Ariz. Dep’t of Health Servs., 2018 Arizona Opioid

Prescribing Guidelines (updated Dec. 2019),

https://go.usa.gov/xtgWC................................................... 23

Ctrs. for Disease Control & Prevention,

U.S. Dep’t of Health & Human Servs.,

CDC Guideline for Prescribing Opioids for

Chronic Pain, https://go.usa.gov/xtgGC

(last visited Jan. 18, 2022) .................................................... 4

Deborah Dowell et al., CDC Guideline for

Prescribing Opioids for Chronic Pain —

United States, 2016, 65 Morbidity & Mortality

Weekly Report, No. 1 (Mar. 18, 2016),

https://go.usa.gov/xtBTW .................................................. 23

36 Fed. Reg. 7776 (Apr. 24, 1971) ........................................ 21

Nat’l Inst. on Drug Abuse, Nat’l Insts. of Health,

Opioid Overdose Crisis (Mar. 11, 2021),

https://go.usa.gov/xtgGb ...................................................... 4

The American Heritage Dictionary of the

English Language (1969)............................................. 22, 23

Webster’s Third New International Dictionary

of the English Language (1968) .................................. 22, 23

In the Supreme Court of the United States

No. 20-1410

XIULU RUAN, PETITIONER

UNITED STATES OF AMERICA

No. 21-5261

SHAKEEL KAHN, PETITIONER

UNITED STATES OF AMERICA

ON WRITS OF CERTIORARI

TO THE UNITED STATES COURTS OF APPEALS

FOR THE TENTH AND ELEVENTH CIRCUITS

BRIEF FOR THE UNITED STATES

OPINIONS BELOW

The opinion of the court of appeals in Ruan v. United

States, No. 20-1410 (Ruan Pet. App. 1a-128a) is reported at 966 F.3d 1101. The opinion of the court of appeals in Kahn v. United States, No. 21-5261 (Kahn Pet.

App. A1-A40) is reported at 989 F.3d 806.

JURISDICTION

The judgment of the court of appeals in Ruan was

entered on July 10, 2020. A petition for rehearing was

denied on November 4, 2020 (Ruan Pet. App. 129a). The

petition for a writ of certiorari was filed on April 5,

2021 (Monday) and granted on November 5, 2021. The

(1)

judgment of the court of appeals in Kahn was entered

on February 25, 2021. The petition for a writ of certiorari was filed on July 26, 2021 (Monday) and granted on

November 5, 2021. The jurisdiction of this Court rests

on 28 U.S.C. 1254(1).

STATUTORY AND REGULATORY PROVISIONS

INVOLVED

Pertinent statutory and regulatory provisions are

reprinted in an appendix to this brief. App., infra, 1a10a.

STATEMENT

Following a jury trial in the United States District

Court for the Southern District of Alabama, petitioner

Ruan was convicted on three counts of conspiring to unlawfully distribute controlled substances, in violation of

21 U.S.C. 841(a)(1) and 846; five counts of unlawfully

distributing a controlled substance, in violation of 21

U.S.C. 841(a)(1); and additional offenses. Ruan J.A.

248-249. He was sentenced to 252 months of imprisonment, to be followed by four years of supervised release.

Id. at 251-252. The court of appeals vacated one of

Ruan’s two convictions for conspiring to accept kickbacks in relation to a federal healthcare program, affirmed his remaining convictions, and remanded to the

district court for resentencing. Ruan Pet. App. 38a,

128a. While Ruan’s petition for a writ of certiorari was

pending before this Court, the district court entered an

amended judgment, again sentencing Ruan to 252

months of imprisonment, to be followed by four years of

supervised release. Ruan J.A. 262-263.

Following a jury trial in the United States District

Court for the District of Wyoming, petitioner Kahn was

convicted on one count of conspiring to dispense and

distribute controlled substances resulting in death, in

violation of 21 U.S.C. 841(a)(1), (b)(1)(C), and (b)(2);

eight counts of unlawfully dispensing a controlled substance, in violation of 21 U.S.C. 841(a)(1) and (b)(1)(C);

three counts of possessing a controlled substance with

intent to distribute, in violation of 21 U.S.C. 841(a)(1)

and (b)(1)(C); and additional offenses. Kahn Pet. App.

A41-A42. He was sentenced to 300 months of imprisonment, to be followed by five years of supervised release.

Id. at A44-A45. The court of appeals affirmed. Id. at

A1-A40.

A. Legal Background

Congress enacted the Controlled Substances Act

(CSA or Act), Pub. L. No. 91-513, Tit. II, 84 Stat. 1242

(21 U.S.C. 801 et seq.), to strengthen controls over substances that are susceptible to abuse. See Comprehensive Drug Abuse Prevention and Control Act of 1970

(1970 Act), Pub. L. No. 91-513, Pmbl., 84 Stat. 1236. A

central feature of the CSA is 21 U.S.C. 841(a)’s prohibition against the knowing or intentional distribution of

controlled substances “[e]xcept as authorized by” the

Act.

The CSA’s exceptions to the prohibition against drug

distribution include an exception for physicians who are

“registered by” the federal Drug Enforcement Administration (DEA) and who prescribe controlled substances only “to the extent authorized by their registration and in conformity with the other provisions” of the

Act. 21 U.S.C. 822(b); see 21 U.S.C. 823(f ). A federal

regulation limits the scope of the authorization by specifying that a “prescription for a controlled substance

* * * must be issued for a legitimate medical purpose

by an individual practitioner acting in the usual course

of his professional practice.” 21 C.F.R. 1306.04(a). “An

order purporting to be a prescription issued not in the

usual course of professional treatment” is deemed “not

a prescription,” and the “person issuing it[] shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” Ibid.

Shortly after the Act was passed, this Court confirmed in United States v. Moore, 423 U.S. 122 (1975),

“that registered physicians can be prosecuted under § 841 when their activities fall outside the usual

course of professional practice.” Id. at 124. And in

Moore, the Court upheld the conviction of a physician

based on evidence about his deficient prescription

practices—which included cursory or nonexistent physical exams, ignoring test results, inadequate precautions against diversion or misuse of drugs, and profitseeking behavior—where the jury found that the physician had not made an “ ‘honest effort’ to prescribe for

detoxification in compliance with an accepted standard

of medical practice.” Id. at 142-143 & n.20 (citation

omitted).

B. Petitioners’ Convictions

The past two decades have seen a massive nationwide crisis in the abuse of prescription opioids. Deaths

from prescription opioid overdoses average more than

40 per day, with a total of more than 165,000 such deaths

since 1999. Ctrs. for Disease Control & Prevention,

U.S. Dep’t of Health & Human Servs., CDC Guideline

for Prescribing Opioids for Chronic Pain 1. Prescription opioids are abused for non-medical purposes by 4.3

million Americans each month. Ibid. The “total ‘economic burden’ of prescription opioid misuse alone in the

United States is $78.5 billion a year, including the costs

of healthcare, lost productivity, addiction treatment,

and criminal justice involvement.” Nat’l Inst. on Drug

Abuse, Nat’l Insts. of Health, Opioid Overdose Crisis 1

(Mar. 11, 2021). Petitioners Ruan and Kahn not only

contributed to that crisis, but sought to profit from it,

using their medical registrations as a cover for drug

trafficking on a massive scale, abdicating their medical

judgment, and plying desperate drug users with highly

addictive—and potentially lethal—drugs in order to line

their own pockets.

1. Ruan

a. Ruan and his business partner, John Patrick

Couch, were DEA-registered physicians who engaged

in a long-running scheme of issuing prescriptions that

“tracked financial incentives” rather than “patients’

medical needs.” Ruan Pet. App. 9a. They operated

through a jointly owned medical clinic in Mobile, Alabama, and a connected pharmacy whose sole business

was dispensing drugs prescribed at the clinic. Id. at 5a6a. Between January 2011 and May 2015, the clinic issued nearly 300,000 controlled-substance prescriptions,

the majority of which were for drugs on CSA Schedule

II—“the most powerful and dangerous drugs that can

be lawfully prescribed.” Id. at 7a; see Ruan J.A. 153170.

Their prescriptions repeatedly included the extremely dangerous “Holy Trinity” of drugs—opioids,

benzodiazepines (such as Xanax, and Valium), and carisoprodol (a muscle relaxant marketed as Soma)—whose

combination has little medical use but high demand

among drug abusers. Ruan Pet. App. 7a; see id. at

7a-8a, 43a, 127a; see also Ruan J.A. 109-113, 119-120,

133-134. Ruan “often” signed prescriptions without

seeing patients and failed to provide patients with warnings before prescribing dangerous opioids. Ruan Pet.

App. 23a-24a; see Ruan J.A. 184-188, 193-194, 196-198.

Many records at the clinic “contained numerous errors,

including not listing all prescriptions written” and listing “exams and tests” that “did not occur.” Ruan Pet.

App. 24a. Nurse practitioners, who did not have DEA

registrations to prescribe controlled substances, routinely wrote drug prescriptions, filling out prescription

pads that Ruan pre-signed. Ruan J.A. 185-188; see id.

at 197-199; 2/8/17 Ruan Tr. 69; see also Ruan Pet. App.

20a-23a, 30a-31a, 119a-120a (Ruan’s knowledge that

Couch did the same).

Ruan “often prescribed medications based solely on

what was in stock” at the pharmacy. Ruan Pet. App.

17a; see Ruan J.A. 202. He and Couch also focused on

their own financial incentives, rather than patient

needs, in prescribing transmucosal immediate-release

fentanyl (TIRF ) drugs, which are approved by the Federal Drug Administration only for “breakthrough pain

in adult cancer patients who are already receiving and

who are tolerant to around-the-clock opioid therapy.”

Ruan Pet. App. 8a-10a. Ruan and Couch prescribed

more than 475,000 doses of TIRF drugs to over 1000 patients, and over half of the patients receiving the largest

amounts did not have cancer diagnoses. Id. at 9a & n.3.

Ruan and Couch were among the top prescribers of

TIRFs nationwide, “often surpass[ing] the next highest

prescriber by more than double.” Id. at 9a. And they

sought to profit from that status not only through direct

drug sales from their pharmacy, but in other ways as

well.

Between November 2013 and January 2014, Ruan

and Couch purchased more than $1.3 million of stock in

Galena Biopharma, which manufactured the TIRF drug

“Abstral.” Ruan Pet. App. 8a-10a. During that period,

Ruan increased his Abstral prescriptions a hundredfold, from 25,600 micrograms in September 2013 to

more than 2.6 million micrograms in March 2014. Id. at

10a-11a. And the clinic overall “account[ed] for 30% of

the total prescriptions for Abstral” in the United States.

Id. at 12a; see Ruan J.A. 243. Ruan and Couch were

also financially motivated to prescribe the TIRF drug

“Subsys,” manufactured by Insys Therapeutics, which

paid them to participate in a sham “speaker program”

that was designed to “influence how many prescriptions

[they] wr[o]te,” rather than actually reach potential

new prescribers. Ruan Pet. App. 13a. Following their

participation in the program, Ruan and Couch became

top-ten nationwide prescribers of Subsys, which made

them “whales” for Insys. Ibid.; see Ruan J.A. 165-170,

190-191, 242.

b. In 2016, a federal grand jury returned an indictment charging Ruan with three counts of conspiring

to unlawfully distribute controlled substances, in violation of 21 U.S.C. 841(a)(1) and 846; five counts of unlawfully distributing a controlled substance, in violation of

21 U.S.C. 841(a)(1); one count of conspiring to commit

healthcare fraud, in violation of 18 U.S.C. 1347 and

1349; two counts of conspiring to receive kickbacks in

relation to a federal healthcare program, in violation of

18 U.S.C. 371 and 42 U.S.C. 1320a-7b(b) (2012); one

count of conspiring to commit mail and wire fraud, in

violation of 18 U.S.C. 1341, 1343, and 1349; one count of

conspiring to launder the proceeds of illegal activity, in

violation of 18 U.S.C. 1956(h); two counts of laundering

the proceeds of illegal activity, in violation of 18 U.S.C.

1957; and one count of conspiring to commit racketeering, in violation of 18 U.S.C. 1962(d). Ruan J.A. 46-81.

Ruan proceeded to a joint trial with Couch, who had

been charged with similar offenses. Ruan J.A. 46-81.

The government’s trial evidence included testimony

from the clinic’s nurse practitioners and other staff, 15

patients and family members, and three medical experts, as well as documentary evidence including the

clinic’s own records. Ruan Pet. App. 4a-30a. That evidence showed “that Ruan and Couch treated approximately three dozen” patients “outside the usual course

of professional practice or prescribed them medications

for no legitimate medical purpose.” Id. at 24a. It demonstrated that Ruan, in particular, prescribed opioids to

individuals who “display[ed] red flags for diversion and

abuse”; rapidly increased opioid dosages in a manner

unnecessary for pain control; and failed to refer patients for other treatments that would have been more

appropriate. Id. at 25a; see id. at 16a-17a, 22a-25a, 39a40a, 43a-48a; Ruan J.A. 105-142, 146-152, 171-172. And

it established that prescribing a drug for profit, rather

than patient need, is outside the course of professional

practice. 2/15/17 Ruan Tr. 174; see 2/6/17 Ruan Tr. 198.

At the close of trial, Ruan proposed the following

jury instruction:

If a physician dispenses or distributes a Controlled

Substance in good faith while medically treating a

patient, then the physician has dispensed or distributed that Controlled Substance for a legitimate medical purpose and within the usual course of professional practice, and you must return a not guilty verdict for the applicable count. 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 proper medical

practice. If you find that a Defendant acted in good

faith in dispensing or distributing a Controlled

Substance, as charged in the indictment, then you

must return a not guilty verdict.

Ruan J.A. 102.

Ruan also urged the district court to instruct the jury

that “the Government must prove, beyond a reasonable

doubt, that the physician’s decisions to distribute or dispense a Controlled Substance were inconsistent with

any accepted method of treating a pain patient—that

the physician, in fact, operated as a drug pusher.” Ruan

J.A. 103. The court declined to give Ruan’s proposed

instructions, finding his “subjective view of what is the

usual course of professional practice,” as well as his specific “ ‘drug pusher’ ” language, to be improper. Ruan

Pet. App. 104a, 134a.

The district court did, however, instruct the jury on

the issue of good faith. After instructing the jury that,

“[f ]or a controlled substance to be lawfully dispensed by

a prescription,” the physician must have prescribed the

substance “both within the usual course of professional

practice and for a legitimate medical purpose,” the

court provided the following instruction:

A controlled substance is prescribed by a physician

in the usual course of a professional practice and,

therefore, lawfully if the substance is prescribed by

him in good faith as part of his medical treatment of

a patient in accordance with the standard of medical

practice generally recognized and accepted in the

United States. The defendants in this case maintain

at all times they acted in good faith and in accordance

with the standard of medical practice generally recognized and accepted in the United States in treating

patients.

Ruan Pet. App. 139a.

The jury found Ruan guilty on all charged counts.

Ruan J.A. 248-249.

c. The court of appeals largely affirmed, reversing

only Ruan’s conviction on one count of conspiring to receive unlawful kickbacks. Ruan Pet. App. 1a-128a.

The court of appeals rejected the contention that the

district court had abused its discretion in declining to

issue Ruan’s particular proposed “good faith” jury instruction. Ruan Pet. App. 105a-107a. Relying on this

Court’s decision in Moore, the court of appeals agreed

with the district court that the proposed instruction incorrectly stated the law because the question “[w]hether a defendant acts in the usual course of his professional practice must be evaluated based on an objective

standard, not a subjective standard.” Id. at 105a (citation omitted; brackets in original); see id. at 106a. The

court of appeals emphasized that Ruan’s proposed instruction would have allowed a physician to escape conviction “as long as [he] subjectively believes that he is

meeting a patient’s medical needs by prescribing a controlled substance, * * * no matter how far outside the

bounds of professional medical practice his conduct

falls.” Id. at 106a.

The court of appeals also found that the rejection of

Ruan’s preferred instruction did not “seriously impair

[his] ability to present an effective defense” because the

district court provided a good-faith instruction linked to

the “standards of medical practice generally recognized

and accepted in the United States.” Ruan Pet. App.

107a. And the court of appeals reasoned that the proposed “ ‘drug pusher’ ” instruction was “an incorrect

statement of the law” under this Court’s decision in

Moore, which had “described the physician-defendant

in that case as a ‘large-scale [drug] pusher,’ ” but “held

that a physician violates the [CSA] if his conduct ‘falls

outside the usual course of professional practice.’ ” Id.

at 108a (quoting Moore, 423 U.S. at 124, 143) (brackets

altered).

2. Kahn

a. Petitioner Kahn was a DEA-registered physician

with an advertised specialty in pain management who

regularly sold prescriptions for cash, including prescriptions for the potentially toxic “Holy Trinity.” Kahn Pet.

App. A3-A4; see, e.g., Kahn J.A. 327-328, 333, 338-339,

425-427. He routinely performed only a perfunctory examination or no examination before issuing prescriptions

for highly addictive drugs. See, e.g., Kahn J.A. 213, 384392, 409-413; 5/2/19 Kahn Tr. 135-140. He also falsified

notes in medical charts—indicating that he had seen patients in person, completed assessments, made referrals, and collected urine samples—when in reality he

had taken none of those measures. Kahn J.A. 450-475.

Kahn priced his services based on the number of pills

he prescribed—the more pills, the more he charged for

an office visit. Kahn Pet. App. A4; Kahn J.A. 138-139.

His fees “closely tracked the ‘street price’ of the pills,”

which Kahn “often discussed with patients.” Kahn Pet.

App. A4. If a patient could not afford to pay as much as

Kahn requested, Kahn prescribed fewer pills or refused

to write a prescription at all. Ibid. Although Kahn generally operated his practice on a “cash-only” basis, he

occasionally accepted firearms and other personal property as payment. Ibid.

At times, Kahn’s brother, employed as an office

manager, met patients in parking lots to exchange prescriptions written by Kahn for cash. Kahn Pet. App.

A2-A3, A5; see Kahn J.A. 467-468. And after a few

years, Kahn began requiring his patients to sign a “drug

addiction statement” proclaiming that Kahn was not a

“drug dealer,” that the patient was not an “addict[],”

and that the patient would be liable to Kahn for $100,000

in the event that a civil or criminal action was brought

against Kahn related to that patient’s treatment. Kahn

Pet. App. A4-A5.

After the pharmacies near his original Arizona location started refusing to fill prescriptions that Kahn had

signed, he opened a second office in Wyoming. Kahn

Pet. App. A5. Kahn invited some of his Arizona patients

to travel to Wyoming, where they could more easily obtain drugs, and some did so. Ibid.; Kahn J.A. 125-126,

390-397, 413-416. In 2015, Kahn wrote high-dose prescriptions for the “Holy Trinity” of drugs for a young

woman who paid him $1250. Kahn J.A. 326-336, 417428. She filled the prescriptions and died of an oxycodone overdose two days later. Id. at 428.

b. In 2018, a federal grand jury returned an indictment against Kahn and co-conspirators, charging Kahn

with one count of conspiring to unlawfully dispense and

distribute controlled substances resulting in death, in

violation of 21 U.S.C. 841(a)(1), (b)(1)(C), and (b)(2); one

count of possessing a firearm in furtherance of a federal

drug trafficking crime, in violation of 18 U.S.C. 924(c)(1)

(2012); eight counts of unlawfully dispensing a controlled substance, in violation of 21 U.S.C. 841(a)(1) and

(b)(1)(C); three counts of unlawfully possessing a controlled substance with intent to distribute, in violation

of 21 U.S.C. 841(a)(1) and (b)(1)(C); five counts of unlawfully using a communications facility in connection

with a controlled-substance offense, in violation of 21

U.S.C. 843(b); one count of engaging in a continuing

criminal enterprise, in violation of 21 U.S.C. 848(a), (b),

and (c); and two counts of laundering the proceeds of

illegal activity, in violation of 18 U.S.C. 1957. Kahn J.A.

44-64.

Kahn went to trial, where the evidence against him

included his own records, as well as testimony from 22

patients and multiple expert witnesses. See Kahn Pet.

App. A40; Kahn J.A. 212. Medical experts testified that

Kahn acted without a legitimate medical purpose and

outside the course of usual medical practice by, among

other things, excessively prescribing high-dose opioids,

prescribing opioids in dangerous combinations without

properly monitoring or counseling patients, failing to

document legitimate medical reasons for his prescriptions, and prescribing controlled substances without

visits while falsely documenting that visits had, in fact,

occurred. See Kahn J.A. 127-129, 206-211, 217-223, 230232, 236-238, 240-243, 245-246, 263-264, 273-274, 277,

281-282, 286, 297-301, 305-309, 312-316, 323-325, 330331. As one expert put it, Kahn “g[ave] an illusion of

practicing medicine, but it [wa]s just an illusion.” Id. at

341.

At the close of trial, the district court instructed the

jury that in order to return a guilty verdict for unlawfully dispensing a controlled substance, or conspiring to

do so, it was required to find, inter alia, that Kahn

“knowingly or intentionally distributed or dispensed

the controlled substance outside the usual course of professional medical practice or without a legitimate medical purpose.” Kahn J.A. 485; see id. at 482. Kahn asked

the court to instruct the jury that guilt required independent findings as to each of those requirements, but

the court declined to do so. Kahn Pet. App. A62-A63.

Kahn also proposed that the jury be instructed that

“[t]he good faith of a defendant, whether or not objectively reasonable, is a complete defense to the crimes

charged, because good faith on the part of a defendant

is inconsistent with specific intent, which is an essential

part of the charges.” Kahn J.A. 96. The district court

declined to issue that particular instruction, but instructed the jury that

[t]he good faith of * * * Kahn is a complete defense

to the charges in [the conspiracy count and the eight

counts of unlawfully dispensing a controlled substance] because good faith on the part of * * * Kahn

would be inconsistent with knowingly and intentionally distributing and/or dispensing controlled substances outside the usual course of professional practice and without a legitimate medical purpose which

is an essential part of the charges.

Id. at 486. The court further instructed that “[g]ood

faith connotes an attempt to act in accordance with what

a reasonable physician should believe to be proper medical practice.” Ibid. The court explained to the jury that

“[t]he good faith defense requires the jury to determine

whether * * * Kahn acted in an honest effort to prescribe for patients’ medical conditions in accordance

with generally recognized and accepted standards of

practice.” Ibid.

The jury found Kahn guilty on all counts. Kahn Pet.

App. A41-A42.

c. The court of appeals affirmed. Kahn Pet. App.

A1-A40.

The court of appeals found no abuse of discretion in

the district court’s denial of Kahn’s proposed good-faith

instruction. Kahn Pet. App. A30-A34. Relying on circuit precedent and this Court’s decision in Moore, see

ibid., the court of appeals stated that the “relevant inquiry” is “whether a defendant-practitioner objectively

acted within” the scope of his professional practice,

“regardless of whether he believed he was doing so,” id.

at A31. The court rejected Kahn’s contention that such

an inquiry “ ‘negates the mens rea element’ ” for Section

841(a) offenses, stating that “good faith defines the

scope” of the CSA’s prescription exception for registered physicians and the scope of “the lawfulness of the

actus reus.” Id. at A33 (citation omitted).

The court of appeals also rejected Kahn’s related

contention that the jury could have found him guilty for

“mere acts of malpractice or negligence.” Kahn Pet.

App. A33. The court observed that because the jury instructions specified that Kahn “need only ‘attempt’ to

act reasonably, and that such an attempt must be made

in an ‘honest effort[,]’ ” Kahn could not be convicted “for

merely failing to apply the appropriate standard of

care.” Id. at A33-A34 (citations omitted). The court explained that, under the instructions as given, the jury

“could only convict * * * Kahn if it found, beyond a reasonable doubt, that [he] failed to even attempt or make

some honest effort to apply the appropriate standard of

care.” Id. at A34.

The court of appeals also declined Kahn’s request “to

revisit [its] prior holding that a licensed physician may

be convicted under [Section] 841 for either prescribing

‘outside the scope of professional practice’ or ‘for no legitimate medical purpose.’ ” Kahn Pet. App. A25 (citation omitted). Referring back to Section 841(a)(1) and

21 C.F.R. 1306.04(a), the court explained that “a practitioner is authorized to dispense controlled substances”

under federal law “only if he acts with a legitimate medical purpose and in the usual course of professional

practice.” Ibid. (citation omitted). “Conversely,” the

court continued, “a practitioner would be unauthorized

to dispense a controlled substance if he acts without a

legitimate medical purpose or outside the usual course

of professional practice.” Ibid. (citation omitted).

SUMMARY OF ARGUMENT

The Controlled Substances Act does not permit a

physician to simply decide for himself that any manner

or volume of drug distribution is “medicine.” The Act

instead provides for a careful registration scheme under which physicians may dispense drugs in accord with

accepted medical standards. A doctor who makes a mistake in construing or applying those standards is not

criminally liable so long as he has made an objectively

reasonable good-faith effort to learn and comply with

medical norms. A doctor who fails to take even that

modest step, however, has abandoned the medical profession altogether and cannot seek its shelter.

A physician who is federally “authorized” to dispense

drugs is “[e]xcept[ed]” from 21 U.S.C. 841(a)’s general

prohibition against the knowing or intentional distribution of controlled substances. That exception textually

precedes Section 841(a)’s specification of its “knowingly

or intentionally” mens rea, which thus modifies only the

actions (“manufacture,” “distribute,” “dispense,” and

“possess”) that follow those adverbs. Ibid.; see United

States v. Yermian, 468 U.S. 63, 69-70 (1984). And as

Ruan recognizes (Br. 21 n.11), the exception comes into

play only when the defendant claims that his activities

were, in fact, authorized. See 21 U.S.C. 885(a)(1).

The government may rebut such a claim by a DEAregistered physician by proving beyond a reasonable

doubt that he did not even make an objectively reasonable attempt to ascertain and act within the bounds of

professional medicine. A DEA registration authorizes

a doctor to write controlled-substance prescriptions

only “to the extent authorized by [his] registration.”

21 U.S.C. 822(b). And under the terms of the registration, a prescription “must be issued for a legitimate

medical purpose by an individual practitioner acting in

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

1306.04(a). A physician who has failed to make a reasonable effort to familiarize himself with professional

standards, or who has made no effort to adhere to them,

has not relied on that registration.

This Court’s decision in United States v. Moore, 423

U.S. 122 (1975), directly illustrates that a defendant

who has not reasonably tried to conform to medical

norms, but has instead chosen to create his own separate norms, violates Section 841(a). The Court in Moore

affirmed the Section 841(a) conviction of a doctor, notwithstanding his claim that his methadone prescriptions

were a new form of medical treatment, where the jury

was instructed that it could find guilt if the defendant

had not acted in “good faith” with “ ‘an honest effort’ to

* * * compl[y] with an accepted standard of medical

practice.” Id. at 124, 142 n.20. In so doing, the Court

emphasized that the conviction accorded with the history of prosecuting rogue physicians under the CSA’s

statutory predecessor. Id. at 132.

Petitioners’ efforts to disrupt accepted law are unsound. The objective honest-effort standard appropriately distinguishes between innocent and guilty minds

by protecting even a physician’s errors in ascertaining

and acting within the bounds of professional practice—

so long as he undertook the threshold step of reasonably

trying to situate himself within the medical community.

The standard also comports with the language of the

prescription regulation, which mirrors the statutory

text and centers on the “usual course” of medical

practice. 21 C.F.R. 1306.04(a). That “usual course”

benchmark is no more vague here than it was in Moore,

and juries can capably discern its quite generous parameters through documentary and expert evidence.

Because those parameters are State-specific, a Section

841(a) prosecution raises no federalism concerns. Nor

are any significant practical concerns raised by adhering to Moore and its predecessors, which do not criminalize mere negligent malpractice, do not meaningfully

chill experimentation or off-label prescriptions, and do

not penalize honest medical disagreements.

The juries in petitioners’ cases were sufficiently instructed on Section 841(a)’s requirements, and even

if an error occurred, it was harmless. The evidence

overwhelmingly demonstrated that petitioners simply

cloaked themselves in medical garb while acting as drug

dealers, lining their own pockets by dispensing addictive, dangerous, and lethal drugs, aware all the while

that their profit-seeking came at the expense of their

patients’ health.

ARGUMENT

The Controlled Substances Act provides ample room

for genuine medical practice. But it does not go so far

as to treat any individual physician’s subjective view of

“medicine,” untethered from any objectively reasonable

practice, as controlling. The Act allows physicians to

register with the DEA as authorized prescribers of controlled substances, and then “[e]xcept[s]” such “authorized” prescriptions from 21 U.S.C. 841(a)(1)’s general

prohibition against knowingly or intentionally distributing or dispensing a controlled substance. But 21

C.F.R. 1306.04(a) limits the scope of a registration to

prescriptions “issued for a legitimate medical purpose

by an individual practitioner acting in the usual course

of his professional practice.” Accordingly, as this Court

recognized in United States v. Moore, 423 U.S. 122

(1975), a physician who makes no objectively reasonable

“honest effort” to conform to that standard is not relying in “good faith” on the registration. Id. at 139, 142

n.20 (citation omitted). Petitioners’ alternative conception of “good faith”—which would allow any doctor to

substitute his own views in place of recognizable medical practice—has no sound foothold in the Act, its history, this Court’s decisions, or practical considerations.

Petitioners’ convictions should be affirmed.

DISPENSING DRUGS WITHOUT ANY OBJECTIVELY

REASONABLE EFFORT TO ACTUALLY PRACTICE

MEDICINE VIOLATES 21 U.S.C. 841(a)

The Court’s decision in Moore, which has been the

law for nearly the entire half-century that the CSA has

been in force, explicitly “h[e]ld that registered physicians can be prosecuted under § 841 when their activities fall outside the usual course of professional practice.” 423 U.S. at 124. A physician who believes in “good

faith” that his activities fall within that standard lacks

the requisite mens rea for the crime. Id. at 139 (citation

omitted). But a physician cannot have such a “good

faith” belief unless he makes some objectively reasonable “honest effort” to ascertain and adhere to professional medical boundaries. Id. at 142 n.20 (citation omitted). A physician who fails even to take that modest

step has chosen to treat his DEA prescription registration not as a limited authorization to prescribe controlled substances, but instead as a blank check for anything he personally believes, irrespective of whether it

is recognizable medicine. Such a physician has a culpable mens rea and can be convicted of violating Section

841(a).

A. A Registration To Prescribe Drugs Under The CSA Is

Limited To Prescriptions For A Legitimate Medical

Purpose In The Usual Course Of A Medical Practice

The CSA “creates a comprehensive, closed regulatory regime criminalizing the unauthorized manufacture, distribution, dispensing, and possession of substances classified in any of the Act’s five schedules.”

Gonzales v. Oregon, 546 U.S. 243, 250 (2006). The tentpole feature of that regime is Section 841(a), which provides that “[e]xcept as authorized by this subchapter, it

shall be unlawful for any person knowingly or intentionally * * * to manufacture, distribute, or dispense, or

possess with intent to manufacture, distribute, or dispense, a controlled substance.”

The CSA accounts for the bona fide practice of medicine, while still “prevent[ing] diversion of controlled

substances” from medical to nonmedical uses, through

a physician-registration process in which State-licensed

doctors are authorized to write prescriptions in accord

with general state medical practice, thereby exempting

such practice from the compass of Section 841(a). Gonzales, 546 U.S. at 250; see id. at 250-252. The CSA instructs the Attorney General to establish a system that

will register physicians for a period of up to three years,

during which they will be authorized to dispense controlled substances according to the terms of the registration. See 21 U.S.C. 821, 822. The Attorney General

has delegated that authority to the Administrator of the

DEA. See 28 C.F.R. 0.100(b).

In keeping with the CSA’s general “rel[iance] upon a

functioning medical profession regulated under the

States’ police powers,” Gonzales, 546 U.S. at 270, the

Act presumptively requires the DEA to register a physician who is authorized to dispense controlled

substances “under the laws of the State in which he

practices,” 21 U.S.C. 823(f ). The DEA “may,” however,

“deny, suspend, or revoke [a] registration” when such a

registration “would be ‘inconsistent with the public interest,’ ” as informed by certain statutory considerations. Gonzales, 546 U.S. at 251 (quoting 21 U.S.C.

824(a)(4) and citing 21 U.S.C. 822(a)(2)). And the CSA

makes clear that registrants are “authorized to possess,

manufacture, distribute, or dispense [controlled] substances or chemicals (including any such activity in the

conduct of research)” only “to the extent authorized by

their registration and in conformity with the other provisions” of the CSA. 21 U.S.C. 822(b).

Since 1971, the “extent authorized by [a] registration,” 21 U.S.C. 822(b), has been delimited by the language currently in 21 C.F.R. 1306.04(a), which specifies

that a “prescription for a controlled substance to be effective must be issued for a legitimate medical purpose

by an individual practitioner acting in the usual course

of his professional practice.” See Gonzales, 546 U.S. at

250; see also 36 Fed. Reg. 7776, 7799 (Apr. 24, 1971).

The terms of that regulation mirror the CSA itself,

which repeatedly employs exactly those words. See

Moore, 423 U.S. at 137 n.13, 140-142. For example, Section 829 generally defines a “ ‘valid prescription’ ” as “a

prescription that is issued for a legitimate medical purpose in the usual course of professional practice by” a

qualifying practitioner. 21 U.S.C. 829(e)(2)(A); see, e.g.,

21 U.S.C. 830(b)(3)(A)(ii) (similar definition of “valid

prescription” applicable to certain reporting requirements). *

See also 21 U.S.C. 802(21) (defining “ ‘practitioner’ ” to include “a

physician” who is “registered” to “distribute [or] dispense * * * a

controlled substance in the course of professional practice”); 21

Indeed, the CSA only allows such substances to be

prescribed in the first place because they have “a

currently accepted medical use in treatment in the

United States.” 21 U.S.C. 812(b)(2)(B), (3)(B), (4)(B),

and (5)(B). The regulation accordingly makes clear,

through a single unitary standard that comports with

the CSA’s text, that a DEA-registered physician is authorized to prescribe controlled substances only when

he is practicing some recognized form of medicine. Specifically, it permits a doctor to prescribe controlled substances only when he is providing “legitimate medical”

care in the course of a “professional practice.” 21

C.F.R. 1306.04(a). It thereby effectuates Congress’s efforts to “bar[] doctors from using their prescriptionwriting powers as a means to engage in illicit drug dealing and trafficking as conventionally understood.” Gonzales, 546 U.S. at 270. And it allows the States’ medical

communities to provide the substantive benchmark for

that “conventional[] underst[anding]” of the boundary

between actual medicine and drug dealing. Ibid.

The word “usual” in this context plainly refers to the

customary conduct of professional practitioners. See,

e.g., The American Heritage Dictionary of the English

Language 1410 (1969) (American Heritage) (“[s]uch as

is commonly or frequently encountered, experienced,

observed, or used; ordinary; normal”); Webster’s Third

New International Dictionary of the English

U.S.C. 802(56)(C) (defining “ ‘filling new prescriptions for controlled

substances in schedule III, IV, or V ’ ” as including the requirement

that “the practitioner, acting in the usual course of professional

practice, determines there is a legitimate medical purpose for the

issuance of the new prescription”); 21 U.S.C. 844(a) (forbidding possession of controlled substances except “pursuant to a valid prescription or order, from a practitioner, while acting in the course of

his professional practice”).

Language 2524 (1968) (Webster’s) (“such as accords

with usage, custom, or habit”). Likewise, the “use of the

word ‘legitimate’ connotes an objective standard of

‘medicine.’ ” Gonzales, 546 U.S. at 285 (Scalia, J., dissenting); see, e.g., American Heritage 747 (“[i]n compliance with the law,” “[i]n accordance with traditional or

established patterns and standards”); Webster’s 1291

(“conforming to recognized principles or accepted rules

and standards”). And while federal law generally eschews its own substantive definition of that standard,

see Gonzales, 546 U.S. at 269-272, it is readily discernible in the “contemporary norms of the medical profession,” United States v. Lovern, 590 F.3d 1095, 1100

(10th Cir. 2009) (Gorsuch, J.).

The medical profession has well-worn, objective

standards for controlled-substance prescriptions. See

Gonzales, 546 U.S. at 270-271. States and state medical

boards, supplemented by the federal government, frequently provide extensive guidance as to what those

standards are. See, e.g., Ala. Admin. Code r. 540-x-4-.06

to 540-x-4-.09 (Supp. June 30, 2020); Ariz. Rev. Stat.

Ann. § 32-1491 (Supp. 2020); Ariz. Rev. Stat. Ann. §§ 323248 et seq. (2020); Wyo. Stat. Ann. § 35-7-1030 (2021);

see also Ariz. Dep’t of Health Servs., 2018 Arizona Opioid Prescribing Guidelines (updated Dec. 2019); Ala.

Bd. of Med. Exam’rs & Med. Licensure Comm’n, Prescribing Issues (2022); Deborah Dowell et al., CDC

Guideline for Prescribing Opioids for Chronic Pain —

United States, 2016, 65 Morbidity & Mortality Weekly

Report, No. 1 (Mar. 18, 2016). And to ensure that physicians do not run afoul of those standards inadvertently, States and state medical boards routinely mandate that physicians who are authorized to prescribe

controlled substances participate in regular continuing

education on the responsible prescribing of controlled

substances. See, e.g., Ala. Admin. Code r. 540-x-4-.09(8)

(Supp. June 30, 2020); Ariz. Rev. Stat. Ann. § 32-3248.02

(2020); Wyo. Stat. Ann. § 33-26-202(b)(xiv) (2021).

B. The Wholly Subjective Views Of A Physician Who Has

Not Reasonably Tried To Practice Medicine As Conventionally Understood Do Not Preclude Conviction Under

Section 841(a)

A DEA-registered physician is authorized to issue

a controlled-substance prescription, and is thereby

excepted from Section 841(a), only when the prescription is “for a legitimate medical purpose * * * in the

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

1306.04(a). A physician who fails to adhere to that

standard, after failing to make an objectively reasonable effort to ascertain and conform to it, has satisfied

both the actus reus and the mens rea of Section 841(a).

1. The CSA prohibits a physician from self-defining the

scope of his medical practice

The text of the CSA does not treat a physician’s subjective view of medical practice as automatically dispositive of the legality of his dispensation of drugs. Nothing in the statute or the regulations implementing it invites a physician to invent his own definition of usual

medical practice. Instead, a physician can violate Section

841(a) when he makes no objectively reasonable attempt

to conform his conduct to something that his fellow doctors would view as medical care.

The “knowingly or intentionally” mens rea in Section

841(a) comes after the “[e]xcept as authorized by this

subchapter” clause. As this Court’s decision in United

States v. Yermian, 468 U.S. 63 (1984), makes clear, that

mens rea requirement thus applies only to the verbs

that follow it, and not to the exception clause. Yermian

construed a similarly structured statute, which criminalized “in any matter within [federal] jurisdiction[,]

* * * knowingly and willfully . . . mak[ing] any false,

fictitious or fraudulent statements or representations.”

Id. at 68 (quoting 18 U.S.C. 1001 (1982)). This Court

explained that the statute’s structure “unambiguously

dispense[d] with any requirement * * * that those

statements were made with actual knowledge of federal

agency jurisdiction.” Id. at 69-70.

It is likewise unambiguous here that Section 841(a)’s

“knowingly or intentionally” mens rea does not reach

backward to the provision’s prefatory clause. Indeed,

that mens rea does not readily fit the “[e]xcept as authorized by this subchapter” proviso. 21 U.S.C. 841(a);

see Bryan v. United States, 524 U.S. 184, 192 (1998)

(“[T]he knowledge requisite to knowing violation of a

statute is factual knowledge as distinguished from

knowledge of the law.”) (citation omitted). Requiring

proof that a defendant did not know that his conduct

was forbidden by the CSA would run afoul of the “general rule that ignorance of the law or a mistake of law is

no defense to criminal prosecution.” Cheek v. United

States, 498 U.S. 192, 199 (1991). A physician is not entitled to obtain a DEA registration to prescribe drugs

and then remain ignorant that the registration is limited to prescriptions “for a legitimate medical purpose

* * * in the usual course of his professional practice.”

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

Section 841(a)’s prefatory exception clause is also

subject to 21 U.S.C. 885(a)(1), which provides that “[i]t

shall not be necessary for the United States to negative

any exemption or exception set forth in this subchapter

in any complaint, information, indictment, or other

pleading or in any trial, hearing, or other proceeding

under this subchapter.” Instead, “the burden of going

forward with the evidence with respect to any such

exemption or exception shall be upon the person claiming its benefit.” Ibid. As Ruan recognizes, Section

885(a)(1) makes Section 841(a)’s exception clause relevant only when “a defendant presents a claim that he

falls within” it. Br. 21 n.11 (citation omitted). The government, however, can rebut a physician’s claim that he

relied on his DEA registration by proving beyond a reasonable doubt that the physician made no objectively

reasonable attempt to in fact conform his conduct to the

regulation’s terms.

A physician who does not even try to issue his prescriptions “for a legitimate medical purpose * * * in the

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

1306.04(a), has either decided not to educate himself

about current medicine (often in derogation of state requirements, see pp. 23-24, supra), or actually knows

about it yet has decided that his own idiosyncratic view

of “medicine” is all that matters. When his choice to remain ignorant or altogether disregard medical norms

leads him to drug distribution that exceeds those

boundaries, he is not plausibly practicing medicine—or

even looking to do so. He is, instead, a drug dealer,

plain and simple.

2. This Court has recognized that a physician can violate Section 841(a) when he fails to make an “honest

effort” to rely in “good faith” on his DEA registration

This Court effectively endorsed that very standard

in Moore, where the standard was described (as it typically is) in the terminology of a physician’s “ ‘good

faith’ ” and “ ‘honest effort’ to * * * compl[y] with an

accepted standard of medical practice.” 423 U.S. at 124,

142 n.20 (citation omitted). As Ruan acknowledges (Br.

28), in upholding the physician-defendant’s Section

841(a) conviction, Moore “implicitly approved” jury instructions that described the standard that way.

a. The physician in Moore had prescribed large quantities of methadone, an addictive substitute for heroin, to

heroin addicts. 423 U.S. at 125-126. Although methadone has legitimate uses in treating such addicts, this

doctor had dispensed methadone far in excess of what

accepted treatments would require, claiming that “he

had devised a new method of detoxification.” Id. at 126.

The jury instructions in the physician’s prosecution

for violating Section 841(a) required the jury to find, inter alia, that

a physician, who knowingly or intentionally, did dispense or distribute [methadone] by prescription, did

so other than in good faith for detoxification in the

usual course of a professional practice and in accordance with a standard of medical practice generally

recognized and accepted in the United States.

Moore, 423 U.S. at 138-139 (citation omitted; brackets

in original). The instructions also provided that the defendant “could not be convicted if he merely made ‘an

honest effort’ to prescribe * * * in compliance with an

accepted standard of medical practice.” Id. at 142 n.20

(citation omitted).

Under those instructions, a physician who either did

not make an objectively reasonable effort to ascertain

the usual course of medical practice, or did not try to act

consistently with it, would violate Section 841. And the

Court affirmatively relied on the “ ‘honest effort’ ” instruction in concluding that the trial evidence “was sufficient for the jury to find that [the defendant’s] conduct

exceeded the bounds of ‘professional practice.’ ” Moore,

423 U.S. at 142 & n.20 (citation omitted).

The Court observed that the physician in Moore had

issued over 11,000 prescriptions during a six-month period, consisting of “some 800,000 methadone tablets”;

“wrote over 100 prescriptions a day” for 54 days during

that period; “used a ‘sliding-fee scale’ pegged solely to

the quantity prescribed, rather than to the medical services performed”; “g[a]ve[] only the most perfunctory

examination” to patients seeking prescriptions; issued

prescriptions “for the amount requested by the patient”; did not conduct physical examinations at followup appointments; did not keep accurate records or record the quantity prescribed; and did not “supervis[e]”

the drug’s administration. 423 U.S. at 126-127. If that

conduct was sufficient for conviction, notwithstanding

the physician’s claim of an idiosyncratic treatment

method, then conduct ( like petitioners’ own) that likewise demonstrates a failure to make an objectively

“honest effort” to conform to federal registration requirements would be as well.

b. The Court in Moore directly addressed and rejected arguments against applying such an objective

standard. In particular, the Court rejected the defendant’s arguments that registered physicians categorically

cannot be prosecuted under Section 841, see Moore, 423

U.S. at 131; that, “in any event, [the defendant] c[ould]

[not] be prosecuted under § 841 because his conduct was

‘authorized by’ ” the CSA, ibid.; and that he did not engage in criminal conduct because his prescriptions were

issued in furtherance of “experimenting with a new

* * * theory of detoxification,” id. 143; see id. at 126.

Addressing the first argument, the Court observed

that “[i]n enacting the CSA Congress attempted to

devise a more flexible penalty structure than that used

in” the CSA’s statutory predecessor, the Harrison Act

of 1914, ch. 1, 38 Stat. 785. Moore, 423 U.S. at 132. The

Court found it “unlikely that Congress” sought “to

carve out a major new exemption, not found in the Harrison Act, for physicians and other registrants,” particularly given that the CSA “was intended to ‘strengthen,’

rather than to weaken, ‘existing law enforcement authority in the field of drug abuse.’ ” Id. at 132-133 (quoting 1970 Act, Pmbl., 84 Stat. 1236). The Court therefore

“h[e]ld that only the lawful acts of registrants are exempted.” Id. at 131. And in the course of doing so, the

Court observed that the regulatory language that today

is located in 21 C.F.R. 1306.04(a) made “explicit” the

“medical purpose requirement” that was both implicit

and explicit in other relevant provisions of the CSA. Id.

at 137 n.13.

The Court accordingly found no merit to the physician’s second argument, that his prescriptions were “authorized by” the CSA. See Moore, 423 U.S. at 138-143.

The Court explained that “[u]nder the Harrison Act

physicians who departed from the usual course of medical practice were subject to the same penalties as street

pushers with no claim to legitimacy.” Id. at 139. And

the Court found “no indication” in the CSA “that Congress intended to eliminate the existing limitation on

the exemption given to doctors” who prescribed controlled substances. Ibid. The Court emphasized that

the CSA “limit[s] a registered physician’s dispensing

authority to the course of his ‘professional practice,’ ”

noting in particular that the Act’s definition of “ ‘practitioner’ * * * describes the type of registration contemplated by the Act” as “limited to the dispensing and use

of drugs ‘in the course of professional practice or

research.’ ” Id. at 140-141 (quoting 21 U.S.C. 802(20)

(1970), now codified at 21 U.S.C. 802(21)).

The Court then addressed the defendant-physician’s

assertion “at trial that he was experimenting with a new

‘blockade’ theory of detoxification” for drug addicts.

Moore, 423 U.S. at 143. The Court noted that the jury—

which was instructed as described above—“did not believe” that assertion. Ibid. The Court further made

clear that the physician’s conviction under Section 841

was consistent with Congress’s “concern[] that the drug

laws not impede legitimate research and that physicians

be allowed reasonable discretion in treating patients

and testing new theories.” Ibid. The Court determined

that the defendant’s practices were not a “legitimate detoxification program,” went beyond federally “approved

practice,” and “exceeded the bounds of ‘professional

practice.’ ” Id. at 142-144. The Court also observed that

the defendant’s “interpretation of the Act” as permitting such a putatively novel treatment method “would

go far beyond authorizing legitimate research and experimentation by physicians” and “compel exemption

from the provisions of [Section] 841 of all ‘registrants.’ ”

Id. at 143.

That observation, like the rest of Moore’s reasoning

and its result, show that a physician is not empowered

by his DEA registration, or his medical license, simply

to do whatever he might subjectively think best, without

regard to whether other doctors would recognize it as

actual medicine. Instead, the Court’s analysis makes

clear that a physician has the requisite mens rea to violate Section 841(a) when he arrogates to himself the definition of accepted medical practice, failing to make an

objectively honest or good-faith effort to act as a reasonable doctor would.

3. Congress designed the CSA to allow for the prosecution of doctors who elevate their own views of acceptable medicine above the medical community’s

As the Court recognized in Moore, the conviction of

a physician who has not made an honest effort to comply

in good faith with the terms of his DEA registration is

consistent with the history of the CSA. The CSA “was

intended to ‘strengthen’ ” the prohibitions of its predecessor, the Harrison Act. Moore, 423 U.S. at 132 (quoting 1970 Act, Pmbl., 84 Stat. 1236). Enacted in 1914, the

Harrison Act “provide[d] for the registration of * * *

all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away

opium or coca leaves, their salts, derivatives, or preparations.” 38 Stat. 785. Under that Act, the “dispensing

or distribution” of opium or coca “to a patient by a physician * * * registered under th[e] Act” could lawfully

occur “in the course of his professional practice only.” §

2(a), 38 Stat. 786.

In Jin Fuey Moy v. United States, 254 U.S. 189

(1920), overruled in part on other grounds by Funk v.

United States, 290 U.S. 371 (1933), this Court confirmed

that a registered physician who dispensed opium pursuant to a prescription could face criminal liability under

the Harrison Act. The Court found “no necessary repugnance between prescribing and selling” because

“one may take a principal part in a prohibited sale” of a

controlled substance “by unlawfully issuing a prescription to the would-be purchaser.” Id. at 192. The Court

emphasized that the Harrison Act “confine[d] the immunity of a registered physician * * * strictly within

the appropriate bounds of a physician’s professional

practice.” Id. at 194. And the Court upheld the conviction of a physician where the “evidence show[ed] that

defendant” engaged in only “a superficial physical examination” or “none at all” before prescribing morphine; “his prescriptions called for large quantities of

morphine”; and “[h]is charges were not according to the

usual practice of medical men, but according to the

amount of the drug prescribed.” Id. at 192-193.

This Court’s later Harrison Act cases involving

rogue doctors are similar in their application of its criminal provisions. In United States v. Behrman, 258 U.S.

280 (1922), for example, the Court reiterated that

“[f ]ormer decisions of this court have held that the purpose of the exception is to confine the distribution of

these drugs to the regular and lawful course of professional practice.” Id. at 287. And in upholding the sufficiency of the indictment in that case, the Court relied on

“Wood’s United States Dispensatory, a standard work

in general use,” to compare “the ordinary dose[s]” of

controlled substances to those prescribed by the defendant and to find that the defendant prescribed an

“enormous number of doses.” Id. at 288-289. The Court

also emphasized that “[i]f the offense be a statutory one,

and intent or knowledge is not made an element of it,

the indictment need not charge such knowledge or intent.” Id. at 288.

Congress’s incorporation (or strengthening) of the

Harrison Act’s standards for physician prosecutions

when it enacted the CSA, see Moore, 423 U.S. at 132133, demonstrates that physicians may not avoid liability by rejecting or ignoring the norms of the medical

profession. While the Court reversed Harrison Act convictions where, for example, the indictment failed to “allege that [a physician] dispensed the drugs otherwise

than to a patient in the course of his professional practice or for other than medical purposes,” Linder v.

United States, 268 U.S. 5, 17 (1925), it did not do so on

the theory that a physician’s subjective view of medical

practice was alone dispositive of his criminal liability.

And no such standard can be found, or should be grafted

onto, the CSA.

C. Petitioners’ Arguments For A Solely Subjective Definition Of Lawful Prescribing Practices Under Section

841(a) Are Unsound

Petitioners do not dispute that a doctor’s prescription of drugs falls within Section 841’s prefatory clause

only when it is issued for a “legitimate medical purpose

by an individual practitioner acting in the usual course

of his professional practice” under 21 C.F.R. 1306.04(a).

They nevertheless urge a freewheeling subjective approach to the statute, under which even the most aggressive forms of drug dealing imaginable (e.g., writing

opioid prescriptions for anyone and everyone) are excepted from Section 841 liability so long as a doctor has

an idiosyncratic theory that they are in patients’ best

interests (e.g., that opioids are always beneficial)—even

if that theory is wildly out of step with what any other

doctor would consider legitimate medical practice. See,

e.g., Ruan Br. 29 (stating that the jury “must look only

to the physician’s subjective belief—eschewing both

constructive knowledge and reference to general professional norms”). That approach would excuse the conduct of physicians who make no honest effort to conform

to the terms of their DEA registrations, expand the notion of good faith beyond plausible limits, and upset existing legal understandings for no practical reason.

1. Petitioners’ construction of Section 841(a) is textually foreclosed and unnecessary

Petitioners’ principal argument (e.g., Ruan Br. 1725) is that the explicit “knowingly” mens rea in the text

of Section 841(a) modifies not only the verbs that follow

it (“manufacture, distribute, or dispense, or possess

with intent to manufacture, distribute, or dispense, a

controlled substance”), but also the prefatory exception

clause that precedes it (“[e]xcept as authorized by this

subchapter”). As explained above, see pp. 24-25, supra,

however, that antigrammatical argument is directly refuted by Yermian, which found that similarly structured “statutory language was unambiguous” in its exclusively forward-looking application of a textual mens

rea. Liparota v. United States, 471 U.S. 419, 432 (1985).

The mens rea for any preceding requirements was instead determined by other principles, see ibid., with the

jurisdictional nature of the preceding requirement in

Yermian suggesting that no mens rea was necessarily

required, see Rehaif v. United States, 139 S. Ct. 2191,

2196 (2019).

Furthermore, unless petitioners’ proposed standard

would actually amount to strict willfulness—in the

sense of a “voluntary, intentional violation of a known

legal duty,” Cheek, 498 U.S. at 201 (citation omitted)—

it is not clear that it would make a difference in many

(or any) cases. A defendant generally has a culpable

mental state when he “ ‘know[s] the facts that make his

conduct fit the definition of the offense,’ * * * even if

he does not know that those facts give rise to a crime.”

Elonis v. United States, 575 U.S. 723, 735 (2015) (citation omitted). Thus, a physician would have a guilty

mindset so long as he knew that he lacked a “legitimate

medical purpose * * * in the usual course of his

professional practice,” 21 C.F.R. 1306.04(a), in writing

a prescription. A physician who opts to indulge in medical solipsism, rather than respecting the profession,

can be deemed to have such knowledge. See GlobalTech Appliances, Inc. v. SEB S. A., 563 U.S. 754, 766

(2011) (recognizing the “well established” principle under which “defendants cannot escape the reach” of a

“criminal statute[] requir[ing] proof that a defendant

acted knowingly” simply “by deliberately shielding

themselves from clear evidence of critical facts that are

strongly suggested by the circumstances”).

In effect, the objective aspect of the inquiry simply

looks to the broader picture of a physician’s decisions,

including the point (or points) in time at which he came

to the view that he could ignore or disregard the terms

of his DEA registration. It thereby ensures that the

doctor did not actually rely on the registration, which is

limited to the usual course of medical practice, but instead elected to rely on an outsized view of his own ability to define the boundaries of his federally granted authority. So long as the doctor has made an objectively

reasonable honest effort to practice medicine as conventionally understood, a mistake about what constitutes a

“legitimate medical purpose * * * in the usual course of

his professional practice,” 21 C.F.R. 1306.04(a), would

preclude criminal liability. Isolated errors in the course

of an objectively good-faith medical practice are not

criminal. But the terms of the CSA, this Court’s decision in Moore, and the century-long history of prosecuting physician drug dealers illustrates that a doctor cannot claim an innocent mind when he opts to remain ignorant of medical conventions or deems himself above

them.

Contrary to petitioners’ contentions (Ruan Br. 17-23;

Kahn Br. 19-21), that standard comports with the mens

rea presumption applicable to the construction of criminal statutes, which “requires a court to read into a statute only that mens rea which is necessary to separate

wrongful conduct from ‘otherwise innocent conduct.’ ”

Carter v. United States, 530 U.S. 255, 268-269 (2000) (citation omitted). Because the statute does not criminalize mistakes—even unreasonable ones—by a doctor

who objectively tries to rely on his DEA registration, it

does not operate as a trap for the unwary. In contrast,

a doctor who obtains a DEA registration, makes no reasonable effort to respect professional norms, and

thereby elevates his own notions of medical practice to

the point where other doctors would not describe them

as such, does not have an innocent mind. And when he

violates the terms of his registration by prescribing

mass quantities of dangerous opioids to drug addicts, he

is just as blameworthy as—if not more blameworthy

than—a layperson who does the same thing without

hypocritically claiming that he is practicing medicine.

2. The terms of the regulatory standard do not invite

self-definition of medicine

Ruan suggests (Br. 34-35) that the phrase “usual

course of his professional practice,” 21 C.F.R. 1306.04(a)

(emphasis added), allows a physician to set his own limits (if any). But the phrase “his professional practice”

appeared in the governing standard of the Harrison

Act, see § 2(a), 38 Stat. 786, which was interpreted by

this Court to allow for the prosecution of physicians who

acted outside objective medical boundaries, see pp. 3133, supra. Correspondingly, the CSA uses the phrase

interchangeably with language that does not include the

possessive pronoun. Compare, e.g., 21 U.S.C. 844(a) (using “his”), with 21 U.S.C. 829(e)(2)(A) (not using “his”).

Accordingly, in interpreting the CSA, the Court in

Moore employed various objective formulations—“the

usual course of professional practice,” “generally accepted medical practices,” “ ‘a standard of medical practice generally recognized and accepted in the United

States,’ ” “the usual course of medical practice,” “medical practice within accepted limits,” “accepted medical

use,” “approved practice,” and “an accepted standard of

medical practice”—as synonyms for “ ‘his professional

practice.’ ” See 423 U.S. at 124, 126, 139, 142 & n.20, 144

(citations omitted). Use of the pronoun simply accounts

for the reality that physicians with different specialties

have different “course[s]” of “professional practice.”

The “usual” prescribing practice for one specialty (say,

radiology) may differ from what is “usual” for another

(say, cardiology).

3. The regulatory standard does not contain an independent wholly subjective component

Kahn argues (Br. 33-42) that the requirement of a

“legitimate medical purpose by an individual practitioner acting in the usual course of his professional

practice,” 21 C.F.R. 1306.04(a), is divisible into two independent components, with a wholly subjective “legitimate medical purpose” component. But nothing in the

text of the regulation—or the CSA provisions that it

mirrors—allows for an untethered subjective approach

to legitimacy.

The regulatory text sets forth a unitary requirement

that a prescription be issued “for a legitimate medical

purpose by an individual practitioner acting in the

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

1306.04(a) (emphasis added). Even if it were not the

case that “use of the word ‘legitimate’ connotes an objective standard of ‘medicine,’ ” Gonzales, 546 U.S. at

285 (Scalia, J., dissenting), “[i]t is difficult to imagine

* * * circumstances in which a practitioner could have

prescribed controlled substances with a legitimate medical purpose and yet be outside the usual course of medical practice,” United States v. Nelson, 383 F.3d 1227,

1231 (10th Cir. 2004), or at least where the latter would

not serve as compelling evidence of the former.

Presented with identical regulatory language in

Moore, see 423 U.S. at 136 n.12, the Court consistently

referred only to “professional practice” in describing

criminal liability under Section 841, id. at 140-142. And

the Court upheld a conviction where the jury instructions did not require a separate finding that the defendant lacked a “legitimate medical purpose.” See id. at

138-139. “Under [this Court’s] reasoning in Moore,”

therefore, “writing prescriptions that are illegitimate

* * * is certainly not ‘in the [usual] course of professional practice.’ ” Gonzales, 546 U.S. at 285 (Scalia, J.,

dissenting) (second set of brackets in original).

Moreover, even assuming that the regulatory standard were grammatically or substantively divisible, it

still would not authorize petitioners’ physician-defined

subjective approach. At a minimum, the regulatory text

would require a physician to prescribe drugs both with

a “legitimate medical purpose” and “in the usual course

of his professional practice.” 21 C.F.R. 1306.04(a). His

conduct would therefore be unauthorized so long as he

failed to do one or the other.

4. The legal standard for physician prosecutions under

Section 841(a) is not unconstitutionally vague

In service of his argument that the regulatory standard should be dichotomized, Kahn asserts (Br. 42-52)

that an objective “usual course of professional practice”

component is unconstitutionally vague. But a criminallaw standard is not void for vagueness simply because

“[c]lose cases can be imagined,” or because “it will

sometimes be difficult to determine whether the incriminating fact it establishes has been proved.” United

States v. Williams, 553 U.S. 285, 306 (2008). Instead, it

is unconstitutionally vague only if it requires proof of an

“incriminating fact” so “indetermina[te]” as to be incapable of discernment. Ibid.

Here, however, juries are entirely capable of determining the “usual course of professional practice the

old-fashioned way: through witnesses and documentary

proof at trial focused on the contemporary norms of the

medical profession.” Lovern, 590 F.3d at 1100; see, e.g.,

Williams, 553 U.S. at 306-307 (discussing juries’ competence); see also United States v. Davis, 139 S. Ct.

2319, 2327 (2019) (similar). Physicians themselves have

resources for keeping abreast of medical practices—

and often have an affirmative obligation to do so. See

pp. 23-24, supra. A physician who makes an “honest effort” to act within the bounds of legitimate medical

practice is not subject to criminal liability, no matter

how unreasonable his good-faith mistake.

Kahn moreover does not appear to claim that an objective component would be “impermissibly vague in all

of its applications.” Village of Hoffman Estates v. The

Flipside, Hoffman Estates, Inc., 455 U.S. 489, 497

(1982); see, e.g., Br. 51. His vagueness concern is therefore best construed not as a facial claim, but an as-

applied challenge that can succeed only if he demonstrates he did not receive clear warning that his own

conduct was proscribed. See Village of Hoffman Estates, 455 U.S. at 495. But he cannot establish that he

lacked fair notice that his conduct—which closely mirrors the culpable conduct of the physician in Moore, see

p. 28, supra—was prohibited.

5. Reference to the usual course of professional practice

respects the tradition of state medical regulation

Ruan asserts (Br. 38) that rejecting his proposed

mens rea standard would “present serious federalism

concerns” by “vastly expand[ing] federal regulation of

medicine.” As an initial matter, however, the CSA validly bars physicians from writing prescriptions for controlled substances unless they have a federal registration and act within the scope of that registration. See

Gonzales, 546 U.S. at 269-270. The federal government

has a distinct sovereign interest in ensuring that physicians adhere to the limits of their federal registrations.

In any event, as described above, see pp. 23-24, supra, those limits look to state practices for their definition. In the absence of any direct federal regulation,

when practices differ from State to State, the question

of whether a physician acted outside the course of his

professional practice, and therefore outside the scope of

his DEA registration, is determined by reference to the

relevant standards governing the practice of medicine

set by the State and the state medical board. In many

cases (including these) a defendant’s conduct (here,

pursuing profit by signing off on dangerous and excessive opioid prescriptions for unexamined drug addicts)

would unambiguously fail any state standard. But so

long as a registered physician makes an honest effort to

comply with the standards of his State, he does not

violate Section 841(a). An unnaturally heightened mens

rea is thus neither necessary for, nor even germane to,

preserving an “area[] traditionally supervised by the

States’ police power.” Gonzales, 546 U.S. at 274.

6. Petitioners’ practical concerns are unsupported

Petitioners lack any meaningful foundation for their

dire predictions (Ruan Br. 40-45; Kahn Br. 47-52) about

the consequences of reaffirming that conduct like theirs

is drug dealing. Moore has provided the governing law

for nearly half a century, and neither petitioners nor

any of their amici have identified any actual instances in

which physicians have been convicted for true goodfaith conduct.

a. Respondents err in suggesting (e.g., Ruan Br. 3537) that an examination of whether a physician made an

objectively honest effort to conform to recognized medical practice would transform physician malpractice

from a civil violation to a criminal one. See Kahn Pet.

App. A33-A34 (rejecting similar suggestion). Section

841(a)’s honest-effort standard, which is applied

through the reasonable-doubt standard of proof, does

not put physicians at risk of criminal conviction for the

sorts of mistakes that can give rise to civil liability. The

isolated mistakes of a physician who reasonably tries to

learn and comply with prevailing medical norms may

amount to medical malpractice, but they do not violate

Section 841(a).

In Ruan’s home state of Alabama, a claim for medicalmalpractice consists of three elements: “1) the appropriate standard of care, 2) that the defendant healthcare provider breached that standard of care, and 3) a

proximate causal connection between the health-care

provider’s alleged breach and the identified injury.”

Bain v. Colbert Cnty. Nw. Ala. Health Care Auth., 233

So. 3d 945, 953 (Ala. 2017) (per curiam) (citation omitted). Malpractice claims in Wyoming and Arizona,

where Kahn practiced, are evaluated under a substantively similar rubric. See Seisinger v. Siebel, 203 P.3d

483, 492 (Ariz. 2009) (en banc); Garnett v. Coyle, 33 P.3d

114, 121 (Wyo. 2001). That standard would impose civil

liability on a physician who is fully aware and informed

of medical standards, tries to conform with them, but

falls short—e.g., a surgeon who slips up during an operation.

The honest-effort criminal standard, in contrast, is

vastly more accommodating. It allows for criminal conviction only where a doctor’s lack of reasonable steps to

accord with accepted medical practice show that he has

decided no longer to act recognizably as a doctor. Accordingly, in both of petitioners’ cases, defense counsel

were able to make clear to the jury that a defendant who

merely fell short of a standard of care through negligence is not criminally liable under Section 841. See

p. 45, infra (excerpting such arguments from Ruan’s

case); 5/21/2019 Kahn Tr. 111 (defense counsel arguing

to the jury that “[i]t is not enough to prove negligence,

malpractice, carelessness or sloppiness”).

b. To the extent that petitioners assert (Ruan Br. 4045; Kahn Br. 47-52) a chilling effect on medical experimentation or research, the relevant provisions have not

materially changed since Moore, which directly addressed that issue. See 423 U.S. at 143-145. In rejecting the defendant-physician’s claim of experimentation

there, Moore explained that the CSA’s line-drawing already accounts for “concern[] that the drug laws not impede legitimate research and that physicians be allowed

reasonable discretion in treating patients and testing

new theories,” with the defendant’s conduct there

implicating a “particularly clear” example of congressional line-drawing. Id. at 143-144.

The Section 841(a) standard that Moore endorses reflects the balance that Congress struck between that

concern and its “particular[] concern[] with the diversion of drugs from legitimate channels to illegitimate

channels.” 423 U.S. at 135; see 21 U.S.C. 823(f ) and (g)

(specialized provisions addressing physician research

and narcotics treatments). Contrary to Ruan’s suggestion (Br. 40-41), that standard would not unwarrantedly

chill physicians from medically appropriate prescriptions of controlled substances for off-label uses. Offlabel prescriptions, like on-label prescriptions, do not

violate Section 841(a) unless the physician has abandoned a recognizable form of medicine. If the physician

has taken reasonable steps to respect the limits of his

federal registration, an off-label prescription does not

violate Section 841(a).

c. Petitioners’ asserted concern (Ruan Br. 42; Kahn

Br. 47-48) with criminalizing medical practices adopted

by a subgroup of physicians, but not the majority of

them, is unfounded. The practice of medicine, like any

professional practice, is not uniform, and some practitioners do things differently from others. Such goodfaith disagreements are not the subject of criminal liability.

The question is not one of nose-counting, but instead

of whether a defendant’s activities are recognizable

to the state medical community as the activities of a doctor. The facts of these cases, like Moore, involve such

plainly out-of-bounds practices—such as failing to

examine patients, signing blank prescription forms,

prescribing for personal profit, and regularly issuing

dangerous prescriptions to patients who were (or would

thereby become) drug addicts—that they clearly cross

the line.

II. PETITIONERS’ CONVICTIONS SHOULD BE AFFIRMED

The juries in petitioners’ cases rejected their claims

that they were treating patients as doctors and found

that they were simply dealing drugs in the name of medicine. Those verdicts were based on instructions that

sufficiently conveyed the mens rea of petitioners’ Section 841(a) (and related) offenses. And even if the instructions were deficient, the error was harmless. Petitioners’ convictions should be affirmed.

A. The Juries In Petitioners’ Cases Were Sufficiently

Instructed On The Requirements Of Section 841(a)

1. In Ruan’s case, the district court instructed the

jury that, “[f ]or a controlled substance to be lawfully

dispensed,” it must have been prescribed “both within

the usual course of professional practice and for a legitimate medical purpose,” while making clear that a physician who prescribes a substance “in good faith as part

of his medical treatment of a patient in accordance with

the standard of medical practice” satisfies that standard. Ruan Pet. App. 139a. The court further instructed

that “[t]he defendants in this case maintain at all times

they acted in good faith and in accordance” with “generally recognized” standards of medical practice. Ibid.

Those instructions, particularly in light of the arguments made at trial, accord with the correct legal standard. See Victor v. Nebraska, 511 U.S. 1, 5 (1994) (jury

instructions sufficient when “taken as a whole,” they

“correctly conve[y]” the relevant “concept”) (citation

omitted) (brackets in original).

To the extent that the district court’s instructions

might be parsed after the fact in such a way as to allow

for conviction even if Ruan attempted to practice medicine as conventionally defined, that is not the way that

the jury would have understood them. The court twice

mentioned “good faith,” Ruan J.A. 139a, which the jury

would naturally understand as encompassing a sincere

belief at which Ruan had reasonably arrived. The jury

would likewise have naturally understood that a “medical” practice by a “professional” will inherently allow

for considerable individualized physician judgment. A

jury brings its own common experience to bear, see, e.g.,

Warger v. Shauers, 574 U.S. 40, 51 (2014), and conflicting first and second opinions from two doctors is just

such a common experience.

Consistent with that understanding of the jury instructions, counsel for Ruan’s co-defendant was permitted to argue to the jury that the question in the case

was not whether he had “committed malpractice” but

whether he had in fact been “practicing medicine.”

Ruan J.A. 234. As counsel explained, “poor care,” “neglect[ful] care” and “even malpractice” are “within the

usual course of medicine. It’s only when you step outside the practice of medicine or you’re outside the usual

course of professional practice, that’s where the government has to get you.” Ibid. The government did not

object to that line of argument, and it observed on appeal that a “jury that believed defendants committed

only negligent misprescribing and not intentional drug

distribution would have acquitted.” Ruan Gov’t C.A.

Br. 97. The court of appeals agreed. See Ruan Pet.

App. 111a-113a.

Finally, the district court did not abuse its discretion

in declining to provide Ruan’s proposed instructions.

It is unclear how his proposed definition of good faith

as “good intentions,” “honest exercise of professional

judgment as to the patient’s needs,” and “act[ing] in accordance with what [the defendant] reasonably believed

to be proper medical practice,” Ruan J.A. 102, meaningfully differed from the instruction that the district

court provided. To the extent that Ruan’s proposed instruction was more permissive, it was unnecessary or

improper. And Ruan’s proposal to instruct the jury that

his guilt turned on whether he was a “drug pusher,” id.

at 103, was an overreading of Moore. Although the

Court in Moore remarked that, “[i]n practical effect,”

the defendant “acted as a large-scale ‘pusher’—not as a

physician,” 423 U.S. at 143, the jury instructions that

the Court implicitly approved did not frame the requisite finding in those terms. Ruan’s proposed instruction

would have confused the issue by introducing an amorphous colloquialism potentially in tension with the

proper legal standard.

2. The district court in Kahn’s case instructed the

jury, inter alia, that a finding that Kahn acted in “good

faith” would be “a complete defense” to the relevant

charges; that “[g]ood faith connotes an attempt to act in

accordance with what a reasonable physician should believe to be proper medical practice”; and that the “good

faith defense require[d] the jury to determine whether”

Kahn “acted in an honest effort to prescribe for patients’ medical conditions in accordance with generally

recognized and accepted standards of practice.” Kahn

J.A. 486. That instruction both substantively and terminologically tracked the “honest effort” standard that

this Court approved in Moore. See 423 U.S. at 124, 142

n.20 (citation omitted).

And as in Ruan’s case, the district court in Kahn’s

case did not abuse its discretion in declining to adopt defense counsel’s proposed instructions. Kahn’s proposed

instructions would have misstated the requirements of

21 C.F.R. 1306.04(a) by incorrectly requiring the government to prove both that Kahn acted without a legitimate purpose and outside the usual course of professional practice. To the extent that Kahn’s instructions

would have embodied a solely self-defining approach to

the authorized prescription of drugs, they were improper.

B. Any Instructional Defect Was Harmless

At all events, any instructional defect in these cases

was harmless. See Fed. R. Crim. P. 52(a). The evidence

overwhelmingly demonstrated that petitioners acted as

drug dealers disguised as medical professionals, dispensing addictive drugs that endangered their patients

simply to line their own pockets. See, e.g., United

States v. Lane, 474 U.S. 438, 450 (1986) (“In the face of

overwhelming evidence of guilt shown here, we are satisfied that the claimed error was harmless.”). Even if

the district courts had adopted petitioners’ self-defining

approach to the scope of their DEA registrations, their

juries would not have concluded that petitioners’ prescriptions were issued in good faith.

1. Ruan, with his partner Couch, repeatedly prescribed powerful and dangerous drugs in order to profit

from their sale, heedless whether the drugs would harm

or benefit his patients. He routinely overprescribed

controlled substances; issued prescriptions without examining patients; ignored obvious warning signs of

drug abuse; left blank, pre-signed prescriptions at the

office; and had unregistered nurse practitioners themselves determine the amount of drugs to prescribe. Experts provided extensive testimony confirming that his

practices sharply departed from the professional standards of Alabama doctors. See, e.g., 1/24/17 Ruan Tr.

144-150, 203-204; 2/8/17 Ruan Tr. 77-84; 2/10/17 Ruan

Tr. 94-97; 2/15/17 Ruan Tr. 162-168.

Ruan complains (Br. 9 n.3, 50) that the district court

did not permit him to introduce evidence that he may

have treated some patients in good faith. But he has not

presented that evidentiary claim, which the court of appeals considered separately from his jury-instruction

claim, see Ruan Pet. App. 77a-89a, as a separate question for this Court. And the court of appeals did not err

in finding no abuse of discretion in excluding the contested evidence. Even if Ruan acted as a doctor with

respect to some patients, the evidence convincingly

demonstrated that he discarded that role with many of

them. Section 841(a) does not require the government

to prove that all of a physician’s prescriptions fell outside the scope of his DEA registration, and lawful prescribing in one instance does not negate unlawful prescribing in another.

2. Kahn, with the help of co-conspirators, acted exactly the way that a drug dealer would, all the way down

to cash purchases by customers who met his representative in a parking lot. His prices were based on the

street prices of the pills he prescribed, rather than any

medical treatment that he purported to provide. And

he accepted payments only in cash, or in objects like

firearms.

Although Kahn held himself out as a doctor, he prescribed dangerous controlled substances in high doses

with little or no examination of patients; falsified medical records for exams, tests, and referrals that never occurred; and, when pharmacies in Arizona stopped filling

his prescriptions, shifted operations to Wyoming and invited patients to travel long distances to feed their addictive habits. Experts extensively testified that Kahn

defied both general and Wyoming professional norms.

See, e.g., Kahn J.A. 117, 123-128, 158-161, 168-170, 207212. And Kahn’s novel insistence that patients sign a

“drug addiction statement” affirming that he was not a

“drug dealer” and accepting liability in the event Kahn

faced civil or criminal action for his prescribing decisions, Kahn Pet. App. A4, illustrates beyond peradventure that he knew he was a drug dealer.

Like Ruan, he could not plausibly have believed otherwise. His conviction, like Ruan’s, should accordingly

be affirmed.

CONCLUSION

The judgments of the courts of appeals should be affirmed.

Respectfully submitted.

ELIZABETH B. PRELOGAR

Solicitor General

KENNETH A. POLITE, JR.

Assistant Attorney General

ERIC J. FEIGIN

Deputy Solicitor General

NICOLE FRAZER REAVES

Assistant to the Solicitor

General

JOSHUA K. HANDELL

DAVID M. LIEBERMAN

Attorneys

JANUARY 2022

APPENDIX

21 U.S.C. 802(21) provides:

Definitions

As used in this subchapter:

(21) The term “practitioner” means a physician,

dentist, veterinarian, scientific investigator, pharmacy,

hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction

in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or

use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

21 U.S.C. 821 provides:

Rules and regulations

The Attorney General is authorized to promulgate

rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture,

distribution, and dispensing of controlled substances

and to listed chemicals.

21 U.S.C. 822 provides in pertinent part:

Persons required to register

(a)

Period of registration

(2) Every person who dispenses, or who proposes to

dispense, any controlled substance, shall obtain from the

(1a)

Attorney General a registration issued in accordance

with the rules and regulations promulgated by him.

The Attorney General shall, by regulation, determine

the period of such registrations. In no event, however,

shall such registrations be issued for less than one year

nor for more than three years.

(b)

Authorized activities

Persons registered by the Attorney General under

this subchapter to manufacture, distribute, or dispense

controlled substances or list I chemicals are authorized

to possess, manufacture, distribute, or dispense such

substances or chemicals (including any such activity in

the conduct of research) to the extent authorized by

their registration and in conformity with the other provisions of this subchapter.

(f )

Inspection

The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration

in accordance with the rules and regulations promulgated by him.

* * * * *

21 U.S.C. 823(f ) provides:

Registration requirements

(f )

Research by practitioners; pharmacies; research applications; construction of Article 7 of the Convention on Psychotropic Substances

The Attorney General shall register practitioners (including pharmacies, as distinguished from pharmacists)

to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V and shall modify the

registrations of pharmacies so registered to authorize

them to dispense controlled substances by means of the

Internet, if the applicant is authorized to dispense, or

conduct research with respect to, controlled substances

under the laws of the State in which he practices. The

Attorney General may deny an application for such registration or such modification of registration if the Attorney General determines that the issuance of such

registration or modification would be inconsistent with

the public interest. In determining the public interest,

the following factors shall be considered:

(1) The recommendation of the appropriate

State licensing board or professional disciplinary authority.

(2) The applicant’s experience in dispensing, or

conducting research with respect to controlled substances.

(3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

(4) Compliance with applicable State, Federal,

or local laws relating to controlled substances.

(5) Such other conduct which may threaten the

public health and safety.

Separate registration under this part for practitioners

engaging in research with controlled substances in

schedule II, III, IV, or V, who are already registered

under this part in another capacity, shall not be re-

quired. Registration applications by practitioners wishing to conduct research with controlled substances in

schedule I shall be referred to the Secretary, who shall

determine the qualifications and competency of each

practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such

controlled substances from legitimate medical or scientific use. Registration for the purpose of bona fide research with controlled substances in schedule I by a

practitioner deemed qualified by the Secretary may be

denied by the Attorney General only on a ground specified in section 824(a) of this title. Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions

upon, research involving drugs or other substances

scheduled under the convention which is conducted in

conformity with this subsection and other applicable

provisions of this subchapter.

21 U.S.C. 829 provides in pertinent part:

Prescriptions

(a)

Schedule II substances

Except when dispensed directly by a practitioner,

other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription

drug as determined under the Federal Food, Drug, and

Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed

without the written prescription of a practitioner, except

that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act

[21 U.S.C. 353(b)]. Prescriptions shall be retained in

conformity with the requirements of section 827 of this

title. No prescription for a controlled substance in

schedule II may be refilled.

(b)

Schedule III and IV substances

Except when dispensed directly by a practitioner,

other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food,

Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be

dispensed without a written or oral prescription in conformity with section 503(b) of that Act [21 U.S.C.

353(b)]. Such prescriptions may not be filled or refilled

more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.

(e)

Controlled substances dispensed by means of the Internet

(1) No controlled substance that is a prescription

drug as determined under the Federal Food, Drug, and

Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered,

distributed, or dispensed by means of the Internet without a valid prescription.

(2) As used in this subsection:

(A) The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—

(i) a practitioner who has conducted at least 1

in-person medical evaluation of the patient; or

(ii) a covering practitioner.

(B)(i) The term “in-person medical evaluation”

means a medical evaluation that is conducted with the

patient in the physical presence of the practitioner,

without regard to whether portions of the evaluation

are conducted by other health professionals.

(ii) Nothing in clause (i) shall be construed to

imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

with respect to a patient, a practitioner who conducts

a medical evaluation (other than an in-person medical

evaluation) at the request of a practitioner who—

(i) has conducted at least 1 in-person medical

evaluation of the patient or an evaluation of the

patient through the practice of telemedicine,

within the previous 24 months; and

(ii) is temporarily unavailable to conduct the

evaluation of the patient.

(3) Nothing in this subsection shall apply to—

(A) the delivery, distribution, or dispensing of a

controlled substance by a practitioner engaged in the

practice of telemedicine; or

(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.

21 U.S.C. 841(a) provides:

Prohibited acts A

(a)

Unlawful acts

Except as authorized by this subchapter, it shall be

unlawful for any person knowingly or intentionally—

(1) to manufacture, distribute, or dispense, or

possess with intent to manufacture, distribute, or dispense, a controlled substance; or

(2) to create, distribute, or dispense, or possess

with intent to distribute or dispense, a counterfeit

substance.

21 U.S.C. 885 provides in pertinent part:

Burden of proof; liabilities

(a)

Exemptions and exceptions; presumption in simple

possession offenses

(1) It shall not be necessary for the United States to

negative any exemption or exception set forth in this

subchapter in any complaint, information, indictment, or

other pleading or in any trial, hearing, or other proceeding under this subchapter, and the burden of going for-

ward with the evidence with respect to any such exemption or exception shall be upon the person claiming its

benefit.

(b)

Registration and order forms

In the absence of proof that a person is the duly authorized holder of an appropriate registration or order

form issued under this subchapter, he shall be presumed

not to be the holder of such registration or form, and the

burden of going forward with the evidence with respect

to such registration or form shall be upon him.

21 C.F.R. 1306.04 provides:

Purpose of issue of prescription.

(a) A prescription for a controlled substance to be

effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual

course of his professional practice. The responsibility

for the proper prescribing and dispensing of controlled

substances is upon the prescribing practitioner, but a

corresponding responsibility rests with the pharmacist

who fills the prescription. An order purporting to be a

prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as

well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an

individual practitioner to obtain controlled substances

for supplying the individual practitioner for the purpose

of general dispensing to patients.

prescription is for a Schedule III, IV, or V narcotic drug

approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment

and the practitioner is in compliance with requirements

in § 1301.28 of this chapter.

(d) A prescription may be issued by a qualifying

practitioner, as defined in section 303(g)(2)(G)(iii) of the

Act (21 U.S.C. 823(g)(2)(G)(iii), in accordance with

§ 1306.05 for a Schedule III, IV, or V controlled substance for the purpose of maintenance or detoxification

treatment for the purposes of administration in accordance with section 309A of the Act (21 U.S.C. 829a) and

§ 1306.07(f ). Such prescription issued by a qualifying

practitioner shall not be used to supply any practitioner

with a stock of controlled substances for the purpose of

general dispensing to patients.

9. 36 Fed. Reg. 7799 (Apr. 24, 1971) provides in pertinent part:

306.04

Purpose of issue of prescription.

(a) A prescription for a controlled substance to be

effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual

course of his professional practice. The responsibility

10a

for the proper prescribing and dispensing of controlled

substances is upon the prescribing practitioner, but a

corresponding responsibility rests with the pharmacist

who fills the prescription. An order purporting to be a

well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an

individual practitioner to obtain controlled substances

for supplying the individual practitioner for the purpose

of general dispensing to patients.

drug dependent person for the purpose of continuing his

dependence upon such drugs, in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.

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.