Petitioners Brief — Xiulu Ruan, Petitioner v. United States

Supreme Court briefDec 20, 2021

Ask Donna

What actually matters in this document.

Text

No. 20-1410

In the Supreme Court of the United States

DR. XIULU RUAN,

Petitioner,

UNITED STATES OF AMERICA,

Respondent.

On Writ Of Certiorari

To The United States Court Of Appeals

For The Eleventh Circuit

BRIEF FOR THE PETITIONER

LAWRENCE S. ROBBINS

Counsel of Record

WILLIAM J. TRUNK

JEFFREY C. THALHOFER

CAROLYN M. FORSTEIN

LESLIE C. ESBROOK

ROBBINS, RUSSELL, ENGLERT,

ORSECK & UNTEREINER LLP

2000 K Street, NW, 4th Fl.

Washington, DC 20006

(202) 775-4500

lrobbins@robbinsrussell.com

December 20, 2021

Counsel for Petitioner

QUESTION PRESENTED

A physician otherwise authorized to prescribe

controlled substances may be convicted of unlawful

distribution under 21 U.S.C. § 841(a)(1) if his

prescriptions “fall outside the usual course of

professional practice.” United States v. Moore, 423

U.S. 122, 124 (1975). To ensure that physicians are

not convicted for merely negligent conduct, however,

the federal courts generally permit doctors to advance

a “good faith” defense.

The question presented is whether a physician

alleged to have prescribed controlled substances

outside the usual course of professional practice may

be convicted under Section 841(a)(1) without regard to

whether, in good faith, he “reasonably believed” or

“subjectively intended” that his prescriptions fell

within the usual course of professional practice.

(i)

PARTIES TO THE PROCEEDING

Petitioner, defendant-appellant below, is Dr.

Xiulu Ruan.

Respondent is the United States of America,

appellee below.

Under this Court’s Rule 12.6,

Dr. John Patrick Couch, defendant-appellant below,

is also considered a respondent.

RELATED PROCEEDINGS

United States v. John Patrick Couch, No. 1616361, United States Court of Appeals for the

Eleventh Circuit. Judgment entered Aug. 15, 2017.

United States v. Xiulu Ruan, No. 19-11508,

United States Court of Appeals for the Eleventh

Circuit. Judgment entered Jan. 8, 2020.

United States v. Ling Cui, No. 19-12661, United

States Court of Appeals for the Eleventh Circuit.

Judgment entered May 11, 2020.

United States v. Lori L. Carver, No. 17-13402,

United States Court of Appeals for the Eleventh

Circuit. Judgment entered Oct. 17, 2018.

iii

TABLE OF CONTENTS

Page

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

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

RELATED PROCEEDINGS ...................................... ii

TABLE OF AUTHORITIES........................................ v

OPINIONS AND RULINGS BELOW ........................ 1

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

STATUTORY AND REGULATORY

PROVISIONS INVOLVED ......................................... 1

INTRODUCTION ........................................................ 4

STATEMENT .............................................................. 5

SUMMARY OF THE ARGUMENT .......................... 14

ARGUMENT ............................................................. 16

I. PETITIONER’S CSA AND CSADEPENDENT CONVICTIONS

SHOULD BE REVERSED BECAUSE A

PHYSICIAN AUTHORIZED TO

PRESCRIBE CONTROLLED

SUBSTANCES MAY NOT BE

CONVICTED UNLESS SHE ACTS

WITHOUT A GOOD FAITH MEDICAL

PURPOSE. ...................................................... 16

TABLE OF CONTENTS—Continued

Page

A. The CSA’s Text, Structure, And

History Show That Prescribing

Physicians Must Be Permitted To

Assert A Defense Of Good Faith

Medical Purpose. ....................................... 17

B. The “Good Faith Medical Purpose”

Standard Accords With The

“Subjective” Good Faith Standard

Adopted By The First, Seventh, And

Ninth Circuits............................................ 30

C. A Subjective Good Faith Standard Is

Essential To The Practice And

Progress Of Medicine ................................ 40

D. At A Bare Minimum, Any “Objective”

Good Faith Standard Must Afford

Physicians Breathing Room For

Honest Departures From Professional

Norms. ....................................................... 47

II. EVEN UNDER AN “OBJECTIVE”

GOOD FAITH STANDARD—INDEED,

UNDER ANY CIRCUIT’S LAW BUT

THE ELEVENTH’S—PETITIONER’S

CONVICTIONS SHOULD BE

REVERSED. ................................................... 48

CONCLUSION .......................................................... 51

TABLE OF AUTHORITIES

Page(s)

Arthur Andersen LLP v. United States,

544 U.S. 696 (2005) .................................. 33, 37, 38

Barsky v. Board of Regents,

347 U.S. 442 (1954) .............................................. 38

Bond v. United States,

572 U.S. 844 (2014) .......................................... 5, 17

Boyd v. United States,

271 U.S. 104 (1926) .............................................. 27

Buckman Co. v. Plaintiffs’ Legal

Comm.,

531 U.S. 341 (2001) .............................................. 35

Carter v. United States,

530 U.S. 255 (2000) .............................................. 29

Cheek v. United States,

498 U.S. 192 (1991) .............................................. 46

Cleveland v. United States,

531 U.S. 12 (2000) .................................................. 5

Elonis v. United States,

575 U.S. 723 (2015) ............................ 20, 29, 33, 34

Gonzales v. Carhart,

550 U.S. 124 (2007) .............................................. 37

Gonzales v. Oregon,

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

Hawker v. New York,

170 U.S. 189 (1898) .............................................. 38

TABLE OF AUTHORITIES—Continued

Page(s)

Jin Fuey Moy v. United States,

254 U.S. 189 (1920) .............................................. 26

Kelly v. United States,

140 S. Ct. 1565 (2020) ............................................ 5

Linder v. United States,

268 U.S. 5 (1925) ............................................ 27, 45

Liparota v. United States,

471 U.S. 419 (1985) .................................. 19, 21, 46

McDonnell v. United States,

136 S. Ct. 2355 (2016) .......................................... 51

Morissette v. United States,

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

New York Trust Co. v. Eisner,

256 U.S. 345 (1921) .............................................. 42

NFIB v. Sebelius,

567 U.S. 519 (2012) .............................................. 39

Rehaif v. United States,

139 S. Ct. 2191 (2019) .......................................... 17

Smith v. United States,

568 U.S. 106 (2013) .............................................. 22

Staples v. United States,

511 U.S. 600 (1994) ...................................... passim

Torres v. Lynch,

578 U.S. 452 (2016) ........................................ 18, 21

vii

TABLE OF AUTHORITIES—Continued

Page(s)

United States v. Arny,

831 F.3d 725 (6th Cir. 2016) ................................ 50

United States v. Balint,

258 U.S. 250 (1922) .............................................. 27

United States v. Burwell,

690 F.3d 500 (D.C. Cir. 2012)

(en banc) ............................................................... 18

United States v. Chube,

538 F.3d 693 (7th Cir. 2008) ................................ 31

United States v. Doremus,

249 U.S. 86 (1919) ................................................ 26

United States v. Enmon,

686 Fed. Appx. 769 (11th Cir. 2017) ............. 16, 48

United States v. Feingold,

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

United States v. Hooker,

541 F.2d 300 (1st Cir. 1976) ................................ 22

United States v. Hurwitz,

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

United States v. Joseph,

709 F.3d 1082 (11th Cir. 2013) ............................ 13

United States v. Kohli,

847 F.3d 483 (7th Cir. 2017) ................................ 31

United States v. McIver,

470 F.3d 550 (4th Cir. 2006) ................................ 49

viii

TABLE OF AUTHORITIES—Continued

Page(s)

United States v. Moore,

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

United States v. Murray,

618 F.2d 892 (2d Cir. 1980) ................................. 21

United States v. Outler,

659 F.2d 1306 (5th Cir. 1981) ........................ 21, 22

United States v. Rosenberg,

515 F.2d 190 (9th Cir. 1975) .......................... 21, 32

United States v. Sabean,

885 F.3d 27 (1st Cir. 2018) ...................... 31, 32, 49

United States v. Singh,

390 F.3d 168 (2d Cir. 2004) ................................. 32

United States v. Smith,

573 F.3d 639 (8th Cir. 2009) ................................ 49

United States v. Steele,

147 F.3d 1316 (11th Cir. 1998)

(en banc) ............................................................... 22

United States v. Tobin,

676 F.3d 1264 (11th Cir. 2012) ............................ 48

United States v. Tran Trong Cuong,

18 F.3d 1132 (4th Cir. 1994) ................................ 37

United States v. United States

Gypsum Co.,

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

TABLE OF AUTHORITIES—Continued

Page(s)

United States v. Vamos,

797 F.2d 1146 (2d Cir. 1986) ............................... 32

United States v. Varma,

691 F.2d 460 (10th Cir. 1982) .............................. 22

United States v. Volkman,

797 F.3d 377 (6th Cir. 2015) .......................... 32, 36

United States v. Voorhies,

663 F.2d 30 (6th Cir. 1981) .................................. 32

United States v. Wexler,

522 F.3d 194 (2d Cir. 2008) ........................... 32, 36

United States v. Williams,

836 F.3d 1 (D.C. Cir. 2016) .................................. 51

United States v. Wiltberger,

18 U.S. (5 Wheat.) 76 (1820) .......................... 18, 19

United States v. X-Citement Video, Inc.,

513 U.S. 64 (1994) .......................................... 17, 34

United States v. Yermian,

468 U.S. 63 (1984) .......................................... 20, 21

Webb v. United States,

249 U.S. 96 (1919) ................................................ 27

Whalen v. Roe,

429 U.S. 589 (1977) .............................................. 38

Yates v. United States,

574 U.S. 528 (2015) .............................................. 19

TABLE OF AUTHORITIES—Continued

Page(s)

Statutes and Regulation

15 U.S.C. § 1 .............................................................. 18

Controlled Substances Act, 21 U.S.C. § 801 et seq.

21 U.S.C. § 801(1) ................................................ 22

21 U.S.C. § 822(a)(1) .............................................. 4

21 U.S.C. § 822(a)(2) .............................................. 4

21 U.S.C. § 822(b) .......................................... 20, 25

21 U.S.C. § 823(b) ................................................ 24

21 U.S.C. § 823(e) ................................................. 24

21 U.S.C. § 823(g)(2)(H)(i) ................................... 25

21 U.S.C. § 829(a) ................................................ 22

21 U.S.C. § 829(c) ................................................. 22

21 U.S.C. § 829(e)(2)(A) ....................................... 22

21 U.S.C. § 830(b)(3)(A)(ii)................................... 22

21 U.S.C. § 841(a)(1) .................................... passim

21 U.S.C. § 841(b)(1)(C) ....................................... 24

21 U.S.C. § 842(a)(2) ............................................ 23

21 U.S.C. § 842(a)(12)(B) ..................................... 23

21 U.S.C. § 842(c)(1)(A)........................................ 24

21 U.S.C. § 842(c)(2)(A)........................................ 23

21 U.S.C. § 885(a)(1) ............................................ 21

42 U.S.C. § 290bb-2a ................................................. 39

Ala. Code § 6-5-548(b) ............................................... 36

Ala. Code § 6-5-548(c) ................................................ 36

Ala. Code § 6-5-548(d) ............................................... 36

Ala. Code § 6-5-549.1 ................................................. 36

TABLE OF AUTHORITIES—Continued

Page(s)

Harrison Act § 2(a), 38 Stat. 785 .............................. 26

Pub. L. No. 91-513, 84 Stat. 1236 (1970) .................. 28

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

Miscellaneous

Joel Achenbach & Lenny Bernstein, Opioid

crackdown forces pain patients to taper off

drugs they say they need, Wash. Post

(Sept. 10, 2019) .................................................... 44

Agency for Healthcare Research and Quality,

“Off-Label Drugs: What You Need to

Know” (Sept. 2015),

https://perma.cc/6M65-AHXR .............................. 41

Niyaz Ahmed, 23 years of the discovery of

Helicobacter pylori: Is the debate over?,

Annals of Clinical Microbiology and

Antimicrobials, Oct. 31, 2005 .............................. 43

American Cancer Society, “Off-label drug

use” (Mar. 2015), https://perma.cc/HW96RFWR ................................................................... 42

Timothy Bella, A Texas scientist was called

'foolish' for arguing the immune system

could fight cancer. Then he won the Nobel

Prize, Wash. Post (Mar. 25, 2019),

https://perma.cc/LVU5-4JMS .............................. 43

1 J. Bishop, Commentaries on the Criminal

Law § 227 (1st ed. 1856) ...................................... 15

xii

TABLE OF AUTHORITIES—Continued

Page(s)

4 W. Blackstone, Commentaries ............................... 17

Roberto Bolli, William Harvey and the

Discovery of the Circulation of the BloodPart III, 124 Circulation Research 1428

(2019) .................................................................... 43

Ronald W. Chapman II, Defending

Hippocrates: Representing Physicians in

the Wake of the Opioid Epidemic, 43

Champion (Nat’l Ass'n of Crim. Defense

Law.) 40 (2019)..................................................... 42

3 E. Coke, Institutes of the Laws of England

(1809 ed.) .............................................................. 17

Kelly K. Dineen & James M. DuBois,

Between a Rock and a Hard Place: Can

Physicians Prescribe Opioids to Treat

Pain Adequately While Avoiding Legal

Sanction?, 42 Am. J.L. & Med. 7 (2016).............. 45

S.M. Drogovoz et al., Experience and

Prospects for the Use of Off-Label Drugs

in Oncology, 43 Experimental Oncology 1

(2021) .................................................................... 42

Henry M. Hart, Jr., The Aims of the

Criminal Law, 23 Law & Contemp.

Probs. 401 (1958)) ................................................ 19

Joseph Heller, Catch 22 (S&S Classic ed.

1999) (1961) .......................................................... 49

xiii

TABLE OF AUTHORITIES—Continued

Page(s)

Diane E. Hoffmann, Treating Pain v.

Reducing Drug Diversion and Abuse:

Recalibrating the Balance in Our Drug

Control Laws and Policies, 1 St. Louis U.

J. Health L. & Pol’y 231 (2008) ........................... 41

Oregon Health & Science University,

“History, Charles Theodore Dotter,”

https://perma.cc/B955-SAEM .............................. 43

Shannon G. Panther et al., Off-label

Prescribing Trends for ADHD

Medications in Very Young Children,

22 J. Pediatric Pharmacology and

Therapeutics 423 (2017) ...................................... 41

Wesley J. Smith, Pain Doctors Face Greater

Scrutiny Than Death Doctors, National

Review (May 3, 2018),

https://perma.cc/84R5-S5W9 .............................. 44

Randall S. Stafford, Regulating Off-Label

Drug Use-Rethinking the Role of the FDA,

358 New Eng. J. Med. 1427 (2008) ...................... 41

Maia Szalavaitz, The Pain Was Unbearable.

So Why Did Doctors Turn Her Away?,

WIRED (Aug. 11, 2021),

https://perma.cc/J5E4-ZNYG ......................... 44, 45

Theodore H. Tulchinsky & Elena A.

Varavikova, A History of Public Health,

The New Public Health, Oct. 10, 2014 ................ 43

BRIEF FOR THE PETITIONER

OPINIONS AND RULINGS BELOW

The opinion of the court of appeals is reported at

966 F.3d 1101. Pet. App. 1a-128a. The order of the

Eleventh Circuit denying rehearing is unreported. Id.

at 129a.

JURISDICTION

The court of appeals’ judgment was entered on

July 10, 2020. The Eleventh Circuit denied rehearing

on November 4, 2020. Pet. App. 129a. The petition

for a writ of certiorari was filed on April 5, 2021, and

granted by this Court on November 5, 2021. This

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

STATUTORY AND REGULATORY

PROVISIONS INVOLVED

Section 822(b) of the Controlled Substances Act

(CSA), 21 U.S.C. § 822, provides:

(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.

(1)

Section 829 of the CSA, 21 U.S.C. § 829, provides

in relevant part:

(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, may be

dispensed without the written prescription of a

practitioner . . . .

(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, may be

dispensed without a written or oral prescription

....

No controlled substance in schedule V which is a

drug may be distributed or dispensed other than

for a medical purpose.

***

(e) Controlled substances dispensed by means of

the Internet

***

(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.

Section 841(a)(1) of the CSA, 21 U.S.C. § 841

provides:

(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[.]

21 C.F.R. § 1306.04(a) 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

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

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.

INTRODUCTION

The Controlled Substances Act (CSA) makes it

unlawful for “any person knowingly or intentionally

. . . to manufacture, distribute, or dispense” a

controlled substance, “[e]xcept as authorized by this

subchapter.” 21 U.S.C. § 841(a)(1). The subchapter

requires physicians to “obtain annually a registration

issued by the Attorney General in accordance with the

rules and regulations promulgated by him.” Id.

§ 822(a)(1)-(2). One of those rules provides that an

“effective” prescription is one that is “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).

To ensure that licensed medical professionals do

not risk criminal prosecution and felony conviction

based on simple malpractice, nearly all courts,

construing the CSA and the implementing

regulations, require that the government prove that

the physician lacked a good faith basis for her

prescription. See Pet. 4-5, 18-27. But not the

Eleventh Circuit. According to the court of appeals, a

doctor may be convicted under the CSA if her

prescription fell outside of professional norms—

without regard to whether she believed in good faith

that the prescription served a bona fide medical

purpose. That outlier position, if sustained, would

result in the kind of “sweeping expansion of federal

criminal jurisdiction” that this Court has repeatedly

condemned. Kelly v. United States, 140 S. Ct. 1565,

1574 (2020) (quoting Cleveland v. United States, 531

U.S. 12, 24 (2000)); see also Bond v. United States, 572

U.S. 844, 862-865 (2014). It would also chill medical

progress, disrupt the doctor-patient relationship, and

criminalize prescriptions whenever a lay jury is

persuaded that the physician exceeded the “usual”

practice of medicine.

Petitioner’s judgment of conviction should be

reversed.

STATEMENT

1. Petitioner Dr. Xiulu Ruan practiced medicine

as a board-certified interventional pain specialist in

Mobile, Alabama. Together with his partner Dr. John

Patrick Couch, Dr. Ruan owned and operated a pain

clinic (Physicians’ Pain Specialists of Alabama

(PPSA)) and an affiliated pharmacy (C&R Pharmacy).

Pet. App. 5a-6a. As of May 2015, the two physicians

had 57 employees and served more than 8,000

patients. Ibid.

In April 2016, a grand jury indicted Petitioner

and his partner on substantive and conspiracy

charges of unlawful distribution of controlled

substances under 21 U.S.C. § 841(a)(1), racketeering

conspiracy, health care fraud conspiracy, mail and

wire fraud conspiracy, and anti-kickback conspiracy.

Pet. App. 3a-4a. Dr. Ruan (but not Dr. Couch) was

also charged with money laundering and conspiracy

to commit money laundering. Pet. App. 4a. The

indictment included the Section 841(a)(1) violations

as predicate offenses for the majority of these

additional charges. See J.A. 52-54, 63-64, 80-83. The

doctors pleaded not guilty and were tried together.

2. At trial, the government acknowledged “that

there were certainly instances where Dr. Ruan and

Dr. Couch did a really good job for their patients,” and

that, “[b]y and large, their patients were legitimate

patients.” Pet. App. 84a. One government witness

described PPSA as “one of the best, well-rounded pain

centers in this area.” J.A. 174. It was “undisputed”

that PPSA was not a “sham practice”; it accepted only

patients with insurance (and thus accepted those

insurers’ oversight), refused cash payments, and used

a variety of sophisticated “[d]iagnostic tools” to

discover the source of patient pain. Pet. App. 84a-85a.

The government alleged, however, that some of

Dr. Ruan’s prescriptions fell outside a “usual course of

professional practice.” To sustain that allegation, the

government devoted much of the trial to proof that,

taken separately or together, was indistinguishable

from simple negligence.

For example, the government presented medical

experts who testified at length that Petitioner and his

partner had prescribed medication “outside [the]

standard of care.” Tr. 2357:10-11 (Jan. 24, 2017); see

also Tr. 661-1061 (Jan. 12-13, 2017) (Dr. Greenberg);

Tr. 2246-2542 (Jan. 23-24, 2017) (Dr. Vohra); Tr.

4328-4520 (Feb. 6, 2017) (Dr. Aultman). One such

witness opined that the defendants too frequently

“jumped to an opioid medication first” when there are

“a lot of other things that you can do for patients with

chronic pain.” Tr. 4437:4-5, 16-22 (Feb. 6, 2017). The

experts identified patients who, by their lights, should

have been referred to a psychiatrist, a detox facility,

or a physical therapist. See Tr. 731:10-11 (Jan. 12,

2017); Tr. 743:11-14 (Jan. 12, 2017) (detox facility

would have been “ideal”); see also Tr. 730:24-731:2

(Jan. 12, 2017) (physical therapy “would have been

perfect”).

The government’s expert witnesses also chided

Dr. Ruan for not having identified or acted upon “red

flags.” See Tr. 749:16-750:9 (Jan. 12, 2017); Tr.

4407:19-4408:15 (Feb. 6, 2017).

For example,

although the defendants regularly tested patients to

confirm that they had taken their prescriptions (and

not diverted them to the black market), one

government expert, Dr. Greenberg, characterized a

particular test as “inadequate,” criticizing “the

doctor’s [un]willingness to spend the tiny bit more

money” to “protect his patients the best that he can.”

Tr. 923:1-4 (Jan. 13, 2017).1

This platonic notion of the “standard of care”

suffused the entire trial. The government’s medical

experts claimed that Dr. Ruan had mismanaged his

medical practice through recordkeeping failures, e.g.,

Tr. 746:5-6 (Jan. 12, 2017), and excessive reliance on

nurse practitioners and other staff to help provide

care for his large population of patients, e.g., Tr.

681:12 (Jan. 12, 2017). Even for the non-narcotics

charges, the government’s case hinged on whether the

1 Shortly after Dr. Greenberg’s testimony, the government

alerted the district court that Greenberg “thought he had earlyonset dementia and was consulting a neurologist.” Pet. App. 40a.

The government stated that it would investigate to determine

whether a jury instruction was warranted, see Tr. 1068:13-24;

Tr. 1070:16-1071:6 (Jan. 17, 2017), but never presented any

further information to the court, Pet. App. 41a. At closing

arguments, the government admitted that “at times” Dr.

Greenberg was “confused about small matters,” “had some

mistakes and . . . forgot some things.” J.A. 232-233.

physicians reasonably exercised their professional

judgment. See Tr. 6303:15-22 (Feb. 16, 2017) (“the

doctor should have known” not to write fentanyl

prescriptions; “[t]hey are trained to notice that”); Tr.

6152:23-6153:1 (Feb. 16, 2017) (on healthcare fraud,

Dr. Ruan is “billing through C&R Pharmacy drugs

that were being prescribed outside the usual course of

professional practice and that’s being paid by

healthcare providers”).2

3. Dr. Ruan and Dr. Couch sharply disputed the

government’s allegations.

They called medical

experts of their own, who testified that the defendants

complied

with

(indeed,

exceeded)

relevant

professional standards of care. See Tr. 4763-4914

(Feb. 8, 2017) (Dr. Warfield); Tr. 6034-6078 (Feb. 15,

2017) (Dr. Gharibo); Tr. 5205-5341 (Feb. 10, 2017) (Dr.

Gudin). Dr. Gharibo, for instance, reviewed patient

files and “found Dr. Ruan’s treatment in many ways

exemplary.” J.A. 226. He also testified that Dr.

Ruan’s patient care was “multi-modal and multidisciplinary” and “clearly in the higher end of the

standard of care.” J.A. 230. Similarly, Dr. Gudin

testified that for “each and every patient chart” he had

reviewed, Dr. Ruan’s “prescribing seemed appropriate

and certainly within the course of legitimate medical

practice.” J.A. 203-204. Even one of the government’s

witnesses allowed that “doctors can in good faith

2 The government did put on some evidence that may have

transcended simple malpractice, including evidence that

defendants prescribed products of a company in which they held

stock and of another company for which they served as speakers.

Pet. App. 13a; see id. at 10a-11a, 17a. But that evidence was

strongly contested by defendants, see, e.g., Tr. 4878:11-20 (Feb.

8, 2017), 4906:3-9 (Feb. 8, 2017), 5798:13-5799:7 (Feb. 14, 2017),

and it was over-matched by proof of ordinary malpractice.

disagree with each other about the application of

guidelines” and the “appropriate treatment for a

particular patient in a particular situation.” Tr.

4458:2-11 (Feb. 6, 2017) (Dr. Aultman).3

Petitioner himself took the stand to explain how

he at all times believed his prescribing was for a

legitimate medical purpose. He testified that he

always made an “individualized decision” as to

“[w]hat medication to use” and did so “based on the

patient’s best interest,” J.A. 209-210. He further

explained that his treatment decisions were always

motivated by “caring for [his] patients.” J.A. 223; 225

(similar). He would prescribe only for “[p]atient need,

that’s all there is.” J.A. 209; 208 (similar); 211 (“I tried

to use [abuse-deterrent features] whenever my

3 Dr. Ruan also sought to introduce videos showing that he

had declined to prescribe opioids to patients who turned out to

be undercover DEA agents. Dr. Ruan explained to one such

“patient” that “it was not appropriate to prescribe controlled

substances because of better alternatives.” Pet. App. 85a. Dr.

Ruan also sought to call several patients not identified by the

government to confirm that his treatment had been exceptional

and to explain why controlled substances comprise the only

effective treatment for certain chronic forms of pain. See Pet.

App. 80a-89a. This evidence would have gone directly to the

question of whether Dr. Ruan prescribed for a legitimate medical

purpose and whether he “primarily practiced good medicine.”

Status Conf. Tr. 16:13-15 (Jan. 3, 2017). All of this evidence was

excluded as “not relevant,” because it would be “wasted time” to

show the jury “legitimate medical patients” or “legitimate

prescriptions,” despite the fact that the district court recognized

the government was seeking to prove “the criminal nature of the

practice.” Id. at 17:3-13. See Pet. App. 19a-20a, 27a. See also

Pet. App. 84a (in affirming convictions, the court of appeals

stated that this evidence was “not necessary” to “complete the

picture”).

patient get[s a] benefit.”); 216 (“the decision” what to

prescribe “is still based on the need of the patient”).

Dr. Ruan emphasized, for example, that he had

prescribed especially potent fentanyl medications only

for “very severe breakthrough pain,” and that he

would not prescribe it for “regular breakthrough

pain.” J.A. 206-207. He also testified that the

medication was a “lifesaver” for patients who would

otherwise “have to go to [the] ER” during such an

episode. J.A. 207. And, with respect to patients

exhibiting “red flags,” Dr. Ruan testified that he

would “terminate the relationship” once he “decide[d]

[he] can no longer help” the patient. J.A. 217. Dr.

Ruan saw “[e]very patient who comes to the clinic, if

there’s an issue,” and was “involved in every decision

making, medications, [and] procedures.” J.A. 221.

4. At the close of evidence, Dr. Ruan requested

that the district court give the jury a good faith

instruction to explain “the terms ‘usual course of

professional practice’ and ‘legitimate medical

purpose.’” J.A. 102. Dr. Ruan’s proposed instruction

stated:

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.

J.A. 102.

Dr. Ruan also requested an additional instruction

to give context to this good faith definition. He asked

that the district court instruct that “[i]n making a

medical judgment concerning the right treatment for

an individual patient, physicians have wide discretion

to choose among a wide range of options. No single

national standard exists.” Ibid. He also requested that

the district court instruct the jury that “[t]o prove a

violation of the Controlled Substances Act in this case,

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”

J.A. 103 (emphasis added), to underscore the difference

between a charge under the CSA and mere medical

malpractice or negligence.

The district court refused to give any of these

instructions. Agreeing only to “throw[] a bone to your

good faith language,” and emphasizing that this was

“as far as I’m willing to go” Pet. App. 136a, the district

court gave the following jury instruction over Dr.

Ruan’s objection (ibid.; Status Conf. Tr. 42:3-6 (Jan. 3,

2017)):

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.

Thus a medical doctor has violated section 841

when the government has proved beyond a

reasonable doubt that the doctor’s actions were

either not for a legitimate medical purpose or

were outside the usual course of professional

medical practice.

Pet. App. 139a (emphasis added).

In short, although the district court mentioned

“good faith” in passing, it told the jury, in the very

next breath, that, regardless of Dr. Ruan’s good faith,

the jury could convict if it found that he had acted

“outside the usual course of professional medical

practice.”

5. Dr. Ruan was convicted on all but two counts

in the second superseding indictment. Pet. App. 2a3a.4 He was sentenced to 252 months’ imprisonment,

to be followed by four years of supervised release, and

ordered to pay more than $15 million in restitution

and more than $5 million in forfeiture. Ibid. Seven of

the counts on which he was convicted were controlled

substances charges. Save for the two Anti-Kickback

charges,5 every count of conviction either explicitly

4 He was acquitted on one count of unlawful distribution of

controlled substances, Pet. App. 5a; the government dismissed

one count under the Anti-Kickback statute at trial, Tr. 4524:244525:8 (Feb. 6, 2017).

5 Even the Anti-Kickback charges, though, related to the

government’s theory that Dr. Ruan did not prescribe for a

legitimate medical purpose. See, e.g., J.A. 71 (alleging Dr. Ruan

was induced to “prescrib[e] high volumes of Subsys,” and that

“nearly all of [those prescriptions]” were prescribed for off-label

relied on the controlled substances offenses as a

predicate or implicitly relied on the facts underlying

those offenses and the allegation that Dr. Ruan did

not prescribe for legitimate purposes for the theory of

wrongdoing.6 Sentencing for all counts relied on the

controlled substances offenses to calculate the base

level offense range. Couch Sentencing Tr. 37:23-38:4

(May 25, 2017); Pet. App. 32a-34a; PSR ¶ 64.7

6. The court of appeals affirmed on the jury

instruction. Pet. App. 106a-107a. It first rejected Dr.

Ruan’s proposed good faith instruction as “an

incorrect statement of the law.” Pet. App. 105a (citing

United States v. Joseph, 709 F.3d 1082, 1097 (11th

Cir. 2013)). Although the requested instruction

expressly focused on what Dr. Ruan “reasonably

use). Moreover, one of the Anti-Kickback convictions (Count 16)

was reversed on appeal for insufficient evidence, Pet. App. 60a,

and on the other (Count 17), Dr. Ruan has already served his

term of imprisonment.

See Tr. 6330:5-11 (Feb. 17, 2017) (racketeering

conspiracy); Tr. 6344:3-13 (Feb. 17, 2017) & J.A. 63-64 (health

care fraud conspiracy); J.A. 71; Tr. 6163:21-25 (Anti-Kickback

statute); Tr. 6349:19-6351:6 (Feb. 17, 2017) (money laundering

conspiracy and substantive money laundering); J.A. 76-77 (wire

and mail fraud conspiracy based on selecting patient

prescriptions for reasons other than “the needs of the patient”).

7 For these reasons, reversal of the controlled-substances

charges would require vacatur of the sentence on all counts. See

PSR ¶ 64 (grouping all counts as to Ruan under USSG § 3D1.2(d)

as closely related for purposes of sentencing); Dkt. 642, Gov’t

Sentencing Mem. 2 (“The guidelines for these convictions is

driven largely by the drug quantities associated with these

conspiracies.”). For example, the wire and mail fraud conspiracy

count sentence was calculated based on the drug quantities

underlying the CSA counts. See Dkt. 642, Gov’t Sentencing

Mem. 3 & n.1; Ruan Sentencing Tr. 61:3-5 (May 26, 2017).

believed,” the panel held that the instruction would

wrongly permit an acquittal based only on Dr. Ruan’s

“subjective[] belie[f].” Pet. App. 106a.

The panel next held that the district court’s good

faith instruction was correct. In the panel’s view, a

physician may assert good faith only “as long as [his]

conduct also was in accordance with the standards of

medical practice generally recognized and accepted in

the United States.” Pet. App. 107a (emphasis added).

The court did not explain what purpose a good faith

defense serves if it is available only to physicians

whose prescriptions already fall within professional

norms.

On November 4, 2020, the Eleventh Circuit

denied Dr. Ruan’s petition for rehearing without

comment (Pet. App. 129a), and on November 5, 2021,

this Court granted Dr. Ruan’s petition for a writ of

certiorari.8

SUMMARY OF THE ARGUMENT

I.A. The CSA’s text, structure, history, and

implementing regulations all confirm that a physician

otherwise authorized to prescribe controlled

substances may not be convicted under Section

841(a)(1) unless she acts without a good faith medical

purpose. A “medical purpose” standard—which is

substantially identical to the “subjective” good faith

8 The court of appeals also reversed one of the AntiKickback convictions for insufficient evidence. Pet. App. 60a. On

remand from the vacatur of that conviction, the district court resentenced Petitioner to the same term as before. J.A. 259-270.

That judgment was appealed to the court of appeals on July 27,

2021 (11th Cir., Case No. 21-12521), but the appeal has been

stayed pending the disposition of this case. See Order, No. 2112521 (11th Cir. Nov. 19, 2021).

standard embraced by three circuits—means that a

physician who believes in good faith that her

prescription serves a valid medical purpose may not

be convicted simply because her belief proves to be

unpopular. This standard honors the fundamental

premise in our criminal law that “the essence of an

offence is the wrongful intent, without which it cannot

exist.” 1 J. Bishop, Commentaries on the Criminal

Law § 227, at 198-199 (1st ed. 1856).

Any more restrictive good faith standard—

including the so-called “objective” standard applied in

several circuits—inevitably exposes doctors to

draconian prison sentences for conduct better suited

to state administrative sanctions and civil litigation.

Such diluted conceptions of good faith also raise

serious federalism concerns, chill the doctor-patient

relationship, and, more generally, stifle the very

progress of science, whose lifeblood depends on

dissent and outlier opinions. The CSA was never

intended to “impede legitimate research” or curtail

physicians’ “reasonable discretion in treating patients

and testing new theories.” United States v. Moore, 423

U.S. 122, 143 (1975).

B. At the very least, any “objective” good faith

standard must afford some breathing room for error.

Convicting a doctor because a lay jury finds her beliefs

“unreasonable” results in little more than malpractice

actions parading as prosecutions. At a minimum,

therefore, a doctor should be acquitted under Section

841(a)(1) if she honestly sought to comply with a

reasonable professional standard of care.

II. Even if this Court subscribes to the

“objective” good faith standard adopted in some

circuits, it should still vacate all of Petitioner’s

convictions.

The trial court, sustained by the

Eleventh Circuit, instructed Dr. Ruan’s jury that it

could convict him if it found that he had exceeded

professional norms, regardless of his state of mind. In

the Eleventh Circuit, a physician’s “good faith belief

that he dispensed a controlled substance in the usual

course of his professional practice is irrelevant.”

United States v. Enmon, 686 Fed. Appx. 769, 773

(2017) (per curiam) (emphasis added).

The

government itself, though it chose not to confess error

in this case, has sensibly declined to defend that

standard. Because Petitioner may therefore have

been convicted (and, given the nature of the evidence,

likely was convicted) for conduct that was not

unlawful, his convictions should be reversed even

under the (erroneous) “objective” good faith standard.

ARGUMENT

PETITIONER’S CSA AND CSA-DEPENDENT

CONVICTIONS SHOULD BE REVERSED

BECAUSE A PHYSICIAN AUTHORIZED TO

PRESCRIBE CONTROLLED SUBSTANCES

MAY NOT BE CONVICTED UNLESS SHE

ACTS WITHOUT A GOOD FAITH MEDICAL

PURPOSE.

A conviction under the CSA requires that the

defendant act “knowingly or intentionally.” 21 U.S.C.

§ 841(a)(1). The statute’s text, structure, history, and

implementing regulations all confirm that this mens

rea requirement insulates physicians with a good

faith belief that their prescription serves a medical

purpose. Any lower standard—whether “objective”

good faith (an oxymoron, in our view) or the entirely

contentless rule adopted by the Eleventh Circuit—

fails to distinguish ordinary malpractice from federal

criminal conduct. Because Petitioner was convicted

under instructions that deprived him of any good faith

protection, the judgment below should be reversed.

The CSA’s Text, Structure, And History

Show That Prescribing Physicians Must

Be Permitted To Assert A Defense Of

Good Faith Medical Purpose.

1. The CSA’s text

and implementing

regulations are dispositive: a prescription is criminal

only when dispensed without a good faith medical

purpose.

a. “Part of a fair reading of statutory text is

recognizing that Congress legislates against the

backdrop of certain unexpressed presumptions.”

Bond v. United States, 572 U.S. 844, 857 (2014)

(cleaned up). Among the “traditional legal concepts,”

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

422, 437 (1978), against which Congress enacted the

CSA is the well-settled principle that “a ‘vicious will’”

is required “to establish a crime,” Staples v. United

States, 511 U.S. 600, 616-617 (1994) (quoting 4 W.

Blackstone, Commentaries *21). See also 3 E. Coke,

Institutes of the Laws of England 107 (1809 ed.)

(“Actus non facit reum nisi mens sit rea”: The act does

not make one guilty unless the mind is also guilty).

effectuate

this

“firmly

embedded”

requirement, Staples, 511 U.S at 605, this Court

presumes that a statute’s mens rea requirement

(whether it is express or unstated) extends to “each of

the statutory elements that criminalize otherwise

innocent conduct.” Rehaif v. United States, 139 S. Ct.

2191, 2195 (2019). See United States v. X-Citement

Video, Inc., 513 U.S. 64, 70 (1994); Morissette v.

United States, 342 U.S. 246, 248 n.2, 271 (1952). This

mens rea presumption is “a sturdy background

principle against which Congress legislates”—and it

governs “unless Congress has plainly indicated

otherwise.” United States v. Burwell, 690 F.3d 500,

531, 537 (D.C. Cir. 2012) (en banc) (Kavanaugh, J.,

dissenting). See Morissette, 342 U.S. at 254 n.14

(requiring a “clear command” from Congress); Torres

v. Lynch, 578 U.S. 452, 467 (2016) (courts presume

that “the defendant must know each fact making his

conduct illegal” “absent an express indication to the

contrary”).

Honoring this mens rea presumption is all the

more essential when a statute uses imprecise

standards to impose criminal liability on activity that

is often entirely innocuous. The Court addressed such

a statute in Gypsum. The Sherman Act criminalizes

“[e]very contract, combination in the form of trust or

otherwise, or conspiracy, in restraint of trade or

commerce.” 15 U.S.C. § 1. Although the statute does

not expressly impose any mens rea requirement, this

Court held that intent is an element of criminal pricefixing. 438 U.S. at 443-444.

The Court began with the traditional

presumption of mens rea, “reinforced” by

considerations that apply with equal or greater force

in the present case.9 As the Court explained, the

9 The Court grounded the mens rea presumption in a

common law tradition that made intent a “critical factor,” 438

U.S. at 437, and in the rule of lenity—a rule “perhaps not much

less old than construction itself,” United States v. Wiltberger, 18

U.S. (5 Wheat.) 76, 95 (1820) (Marshall, C.J.). See Gypsum, 438

U.S. at 437. The rule of lenity is based on the importance of

Sherman Act “does not, in clear and categorical terms,

precisely identify the conduct which it proscribes.” Id.

at 438. As a practical matter, therefore, “open-ended

and fact-specific standards” end up being “applied [by

juries] to broad classes of conduct.” Ibid. Because “the

behavior proscribed by the Act is often difficult to

distinguish from the gray zone of socially acceptable

and economically justifiable business conduct,”

imposing criminal liability without regard to intent

would improperly threaten a federal conviction for

“even a good-faith error of judgment.” Id. at 440-441.

“[T]he use of criminal sanctions in such circumstances

would be difficult to square with the generally

accepted functions of the criminal law.” Id. at 442

(citing Henry M. Hart, Jr., The Aims of the Criminal

Law, 23 Law & Contemp. Probs. 401, 422-425 (1958)).

Moreover, ignoring a defendant’s intent (and thus

“simply . . . regulat[ing] business practices,” ibid.)

would risk chilling commercial activity with social

utility.

b. Only the strongest textual evidence to the

contrary could overcome the presumption that the

CSA likewise requires proof that the physician

intended to prescribe beyond his “authoriz[ation].”

But far from overcoming that presumption, the text

and structure of the CSA strongly confirm the

conclusion that a physician otherwise authorized to

prescribe controlled substances may not be treated as

“provid[ing] fair warning concerning conduct rendered illegal,”

Yates v. United States, 574 U.S. 528, 548 (2015) (plurality

opinion) (quoting Liparota v. United States, 471 U.S. 419, 427

(1985)), and on “the plain principle that the power of punishment

is vested in the legislative, not in the judicial department.”

Wiltberger, 18 U.S. at 95.

a “drug dealer” unless he lacks a good faith belief in

the medical purpose of the prescription.

Section 841(a)(1) provides that “[e]xcept as

authorized by this subchapter,” it is “unlawful for any

person knowingly or intentionally . . . to manufacture,

distribute, or dispense . . . a controlled substance.” 21

U.S.C. § 841(a)(1). True, Section 841(a)(1)’s mens rea

requirement comes only after the “except as

authorized” clause. But “far more than the simple

omission of the appropriate phrase from the statutory

definition is necessary to justify dispensing with an

intent requirement.” Gypsum, 438 U.S. at 438. After

all, for physicians otherwise authorized to prescribe

controlled substances, “the crucial element separating

legal innocence from wrongful conduct,” Elonis v.

United States, 575 U.S. 723, 737 (2015), is whether

prescribing is “authorized by this subchapter,” 21

U.S.C. § 841(a)(1). It is not improper—much less

“unlawful”—for a physician merely to knowingly or

intentionally “distribute” controlled substances. See

id. § 841(a)(1); id. § 822(b); 21 C.F.R. § 1306.04(a).

Were it otherwise, we would not have pharmacies.

“The mental state requirement must therefore apply”

to the fact that a prescription is not “authorized.”

Elonis, 575 U.S. at 737. Indeed, to apply Section

841(a)(1)’s mens rea requirement only to whether a

physician distributed or dispensed a controlled

substance would protect only those physicians who

prescribe in their sleep.10 Not even the government

makes that argument. See BIO 11.

10 That distinguishes United States v. Yermian, which

addressed the question whether a mens rea requirement applied

to the statutory section’s preceding jurisdictional hook. 468 U.S.

Nor could it. This Court considered a similar

scheme in Liparota v. United States, 471 U.S. 419

(1985). There, a food-stamp fraud statute provided

that “whoever knowingly uses, transfers, acquires,

alters, or possesses coupons or authorization cards in

any manner not authorized by [the statute] or the

regulations” would be subject to fine and

imprisonment. Id. at 420. The government urged

that “knowingly” did not modify the “not authorized”

element; the defendant countered that this

interpretation, “by dispensing with mens rea,

dispenses with the only morally blameworthy element

in the definition of the crime.” Id. at 423. Siding with

the defendant, the Court held that the statute

“requires a showing that the defendant knew his

conduct to be unauthorized by statute or regulations.”

Id. at 425.

So, too, here. As in Liparota, Section 841(a)(1)

requires proof that the defendant-physician knew or

intended that her prescribing was “unauthorized.”11

63, 68-69 (1984). “Jurisdictional language need not contain the

same culpability requirement as other elements of the offense.”

Id. at 68. See Torres, 578 U.S. at 468.

11 This is not affected by 21 U.S.C. § 885(a)(1), which

provides that the government need not “negative any exemption

or exception set forth in this subchapter” and places “the burden

of going forward with the evidence with respect to any such

exemption or exception . . . upon the person claiming its benefit.”

That provision merely assigns a prima facie burden to the

defendant; “[o]nce a defendant presents a claim that he falls

within the exemption, the government must prove beyond a

reasonable doubt that the accused does not fall within it.” United

States v. Rosenberg, 515 F.2d 190, 199 (9th Cir. 1975). See

United States v. Outler, 659 F.2d 1306, 1309-1310 & n.3 (5th Cir.

1981); United States v. Murray, 618 F.2d 892, 901 (2d Cir. 1980);

And under the text of the CSA, only a prescription

lacking a good faith medical purpose is unauthorized.

As the CSA expressly finds, “[m]any of the drugs

included within this subchapter have a useful and

legitimate medical purpose and are necessary to

maintain the health and general welfare of the

American people.” 21 U.S.C. § 801(1) (emphasis

added).

Not surprisingly, therefore, the CSA

repeatedly uses “medical purpose” to separate lawful

from unlawful prescriptions. See, e.g., id. § 829(c)

(requiring a “medical purpose” for dispensing the least

controlled substances, those in Schedule V); id.

§ 830(b)(3)(A)(ii) (CSA’s reporting provision defining a

“valid prescription” as one “issued for a legitimate

medical purpose”); id. § 829(e)(2)(A) (“The term ‘valid

prescription’

means

[for

Internet-prescription

provision] a prescription that is issued for a legitimate

medical purpose in the usual course of professional

practice”); id. § 829(a) (prescription provision that

“ensures patients use controlled substances under the

supervision of a doctor,” and, “[a]s a corollary, . . . bars

United States v. Hooker, 541 F.2d 300, 305 (1st Cir. 1976). See

also, e.g., United States v. Hurwitz, 459 F.3d 463, 475 (4th Cir.

2006) (listing § 1306.04(a)’s “medical purpose” and “usual course”

requirements as elements that the government must prove

under § 841(a)(1)); United States v. Varma, 691 F.2d 460, 462

(10th Cir. 1982) (same). But cf. United States v. Steele, 147 F.3d

1316, 1319-1320 (11th Cir. 1998) (en banc) (holding that “the

course of professional practice” “need not be negated in the

indictment,” but declining to address “who bears the burden of

persuasion”). To hold otherwise would impermissibly shift to

physician-defendants the burden of proof on a defense that

“negate[s] an element of the crime”—mens rea. Smith v. United

States, 568 U.S. 106, 110 (2013). See Outler, 659 F.2d at 1309

(the “lack of a legitimate medical reason” “embodies the

culpability of the offense”).

doctors from peddling to patients who crave the drugs

for those prohibited uses.” Gonzales v. Oregon, 546

U.S. 243, 274 (2006) (emphasis added)).

c. Nearby provisions confirm that Congress

granted physicians robust mens rea protection when

the government prosecutes them as drug dealers. For

example, the relatively modest administrative

penalties in Section 842 lack any mens rea element,

except in narrow enumerated circumstances. See,

e.g., 21 U.S.C. § 842(a)(2) (unlawful for any person

“who is a registrant to distribute or dispense a

controlled substance not authorized by his

registration to another registrant or other authorized

person or to manufacture a controlled substance not

authorized by his registration”). One such exception:

where Section 842 imposes misdemeanor liability, it

requires a “knowing” mens rea. See id. § 842(c)(2)(A)

(violators subject to “imprisonment of not more than

one year or a fine” if “a violation of this section is

prosecuted by an information or indictment which

alleges that the violation was committed knowingly

and the trier of fact specifically finds that the violation

was so committed”). It is unthinkable that Congress

intended no meaningful mens rea protection for

physicians at risk of life in prison under Section 841—

and yet carefully excepted Section 842’s misdemeanor

penalty from the section’s general lack of mens rea

requirements.

Likewise, Section 842(a)(12)(B) forbids regulated

sellers “to knowingly or recklessly sell at retail”

certain substances.

(emphasis added).

When

Congress wanted to impose liability for reckless

distribution, it did so expressly—and it made the

penalties less severe than under Section 841(a)(1).

See 21 U.S.C. § 842(c)(1)(A) (violators “subject to a

civil penalty of not more than $25,000”). The clear

implication: a higher standard of mens rea than

recklessness is necessary to convict doctors as “drug

pushers.”

Indeed, Section 841(a)(1)’s “severe

penalt[ies]” themselves suggest that Congress

intended a robust mens rea requirement. See Staples,

511 U.S. at 618. Compare Gypsum, 438 U.S. at 442

n.18 (penalty of “imprisonment for up to three years”

bolstered presumption of mens rea), with 21 U.S.C.

§ 841(b)(1)(C) (unauthorized distribution of Schedule

II substances punishable by “not more than 20 years”

imprisonment, with life sentence authorized “if death

or serious bodily injury results from the use of such

substance”).

Having expressly lowered the scienter standard

for lower-level drug offenses elsewhere in the CSA,

Congress clearly intended to reserve the harsh

penalties of Section 841(a)(1) for cases in which

physicians “us[e] their prescription-writing powers as

a means to engage in illicit drug dealing and

trafficking as conventionally understood.” Oregon,

546 U.S. at 269-270.

d. The good faith “medical purpose” standard

we are urging the Court to adopt is confirmed by the

plain language of the CSA’s implementing

regulations.

The CSA delegates to the Attorney General the

power to authorize physicians to prescribe controlled

substances unless “inconsistent with the public

interest.” 21 U.S.C. § 823(b), (e). Once authorized,

doctors may “possess, manufacture, distribute, or

dispense such substances or chemicals . . . to the

extent authorized by their registration and in

conformity with the other provisions of this

subchapter.” Id. § 822(b). But the CSA was also clear

that regulations could not give federal officials the

power “to exercise supervision or control over the

practice of medicine or the manner in which medical

services are provided.” Id. § 823(g)(2)(H)(i).

The Attorney General exercised that delegated

authority by promulgating 21 C.F.R. § 1306.04(a).

See Oregon, 546 U.S. at 257 (Section 1306.04(a) “does

little more than restate the terms of the statute

itself.”). Section 1306.04(a) defines a “prescription” as

one “issued for a legitimate medical purpose by an

individual practitioner acting in the usual course of

his professional practice.” (emphasis added).

Section 1306.04(a) strongly supports the “medical

purpose” test in two related ways. First and most

obviously, it expressly defines a “prescription” as one

“issued for a legitimate medical purpose.” Reinforcing

that first pillar is the second: only a prescription

outside the “individual practitioner[’s]” own

practice—“his professional practice,” not the norms of

the profession as a whole—is proscribed. (emphasis

added). These requirements are really just two sides

of the same coin: when a prescribing physician acts

without a good faith medical purpose, he has also

abandoned his individual practice and is no longer

“prescribing” within the meaning of the CSA.12

12 Consolidated case No. 21-5261 presents the question

“Should the ‘usual course of professional practice’ and ‘legitimate

medical purposes’ prongs of C.F.R § 1306.04(a) be read in the

conjunctive or the disjunctive?” Because § 1306.04(a) sets forth

a single standard, these two phrases must be read in the

conjunctive.

2. The CSA’s statutory and legislative history

confirm that prescribing physicians must be

permitted to advance a robust good faith defense

based on the physician’s medical purpose.

a. The CSA’s predecessor statute, the Harrison

Narcotics Act, closely tracked the language that

delineates the scope of a physician’s “authorization”

under the CSA. In particular, it regulated the

distribution of narcotic drugs, excepting “dispensing

or distribution . . . to a patient by a physician . . .

regularly registered under this act in the course of his

professional practice only.” United States v. Doremus,

249 U.S. 86, 91 (1919) (quoting Harrison Act § 2(a), 38

Stat. 785) (emphasis added).

This Court’s precedents construing the Harrison

Act underscore that physicians may not be convicted

as federal felons unless they act without a medical

purpose. Soon after the Harrison Act’s passage in

1914, this Court interpreted Section 2’s general

prohibition to apply to physicians who prescribed

without a medical purpose.

In assessing one

physician’s sufficiency-of-the-evidence challenge, the

Court explained that a physician could be convicted if

he prescribed to addicts “for the mere purpose, as the

jury might find, of enabling such persons to continue

the use of the drug, or to sell it to others.” Jin Fuey

Moy v. United States, 254 U.S. 189, 193 (1920). The

Court also rejected as a “perversion of [the] meaning”

of “a physician’s prescription” (and therefore outside

Section 2(a)’s exemption) a prescription issued not “in

the course of professional treatment in the attempted

cure of the habit, but . . . for the purpose of providing

the user with morphine sufficient to keep him

comfortable by maintaining his customary use.” Webb

v. United States, 249 U.S. 96, 99 (1919).

Five years later, in Linder v. United States, 268

U.S. 5 (1925), the Court reinforced the point.

Although the “[m]ere pretense” of bona fide medical

purpose could not insulate a physician from

prosecution, id. at 18, the Court vacated Dr. Linder’s

conviction because a physician who prescribes “in

good faith” and without a “conscious design to violate

the law” may not be convicted. Id. at 17.

Linder’s holding is especially notable for two

reasons. First, a separate section of the Act—Section

8, covering possession of narcotics—expressly

provided for a good faith defense, whereas Section 2

did not, id. at 14. That distinction did not deter the

Court from applying a robust good faith standard in

Dr. Linder’s favor. Second, the Court had previously

held that Section 2’s general prohibition was a strictliability offense. See United States v. Balint, 258 U.S.

250, 253-254 (1922). That, too, did not dissuade the

Court from setting aside Dr. Linder’s drug trafficking

conviction because he lacked a “conscious design to

violate the law.”13

b. In 1970, Congress enacted the CSA in an

effort to “devise a more flexible penalty structure than

that used” previously, Moore, 423 U.S. at 132, while

also “strengthen[ing] . . . existing law enforcement

13 Linder’s holding was reinforced in Boyd v. United States,

271 U.S. 104 (1926), in which “[t]he disputed question was

whether the defendant issued the prescriptions in good faith.”

Id. at 105. The Court affirmed the convictions because the jury

instructions had appropriately advised the jury to acquit if the

physician had acted “honestly and in good faith” in an “effort to

cure disease.” Id. at 108.

authority in the field of drug abuse,” ibid. (quoting

Pub. L. No. 91-513, 84 Stat. 1236 (1970) (preamble)).

But Congress gave “no indication” that the new

statute brought a “sharp departure,” Moore, 423 U.S.

at 132, from the longstanding good faith defense

endorsed by Linder and its progeny. For one, if

Congress had wanted to eliminate this important

mens rea protection, it would have spoken clearly;14 it

did the opposite, requiring that unauthorized

prescribing be “knowing or intentional,” 21 U.S.C.

§ 841(a)(1). And as this Court explained in Moore, the

CSA also embodies the policy that “physicians be

allowed reasonable discretion in treating patients and

testing new theories.” 423 U.S. at 143. Consistent

with that principle, Dr. Moore’s jury instructions

(implicitly approved by the Court) provided that Dr.

Moore could be convicted only if he acted “other than

in good faith” and did not make at least “‘an honest

effort’ to prescribe . . . in compliance with an accepted

standard of medical practice.” Id. at 139, 142 n.20.

Since Moore, this Court has confirmed that

Section 841(a)(1)’s application to physicians is narrow

and targeted; it is not a tool for regulating medical

practice by punishing doctors who practice bad

medicine in good faith. In assessing the federal

government’s attempt to define the phrase “legitimate

medical purpose,” the Court explained that “[t]he

statute and our case law amply support the conclusion

that Congress regulates medical practice insofar as it

bars doctors from using their prescription-writing

powers as a means to engage in illicit drug dealing and

trafficking as conventionally understood.” Oregon,

See Morissette, 342 U.S. at 254 n.14 (presumption of

mens rea may be overcome by a “clear command” from Congress).

546 U.S. at 269-270. But the CSA “manifests no

intent to regulate the practice of medicine,” id. at 270,

beyond prohibiting doctors from acting “as a drug

‘pusher’ instead of a physician.” Id. at 269 (quoting

Moore, 423 U.S. at 143).

The proper standard, then, is one that separates

physicians operating at the fringes of medical

innovation from those who abandon medicine entirely

to engage in “conventional[ ]” “drug dealing and

trafficking,” Oregon, 546 U.S. at 270. A physician may

not be convicted if she believes in good faith that her

prescription has a legitimate medical purpose. This

good faith defense must look only to the physician’s

subjective belief—eschewing both constructive

knowledge and reference to general professional

norms. No other standard is up to the task of

“separat[ing] wrongful conduct from otherwise

innocent conduct.” Elonis, 575 U.S. at 736 (quoting

Carter v. United States, 530 U.S. 255, 269 (2000)).

Requiring a physician’s good faith belief to be

“reasonable”

imposes

negligence

liability—

criminalizing and federalizing malpractice. See infra

Part I.B. And measuring good faith by reference to

objective standards is both inconsistent with the

statute and regulation and insufficiently protective of

physicians’ “traditional[ ]” and “widely accepted,”

Staples, 511 U.S. at 612, discretion in treating

patients and “testing new theories,” Moore, 423 U.S.

at 143. See infra Part I.B-C.

To be sure, a physician’s claim that he prescribed

with a good faith medical purpose may not be credible.

But that is a question to be resolved by the jury, which

is free “not [to] believe him,” Moore, 423 U.S. at 143.

See Morissette, 342 U.S. at 263 (“The purpose and

obvious effect of doing away with the requirement of

a guilty intent is to ease the prosecution’s path to

conviction, to strip the defendant of such benefit as he

derived at common law from innocence of evil purpose,

and to circumscribe the freedom heretofore allowed

juries.”).

The “Good Faith Medical Purpose”

Standard Accords With The “Subjective”

Good Faith Standard Adopted By The

First, Seventh, And Ninth Circuits.

1. The “medical purpose” test we propose is not

meaningfully different from the so-called “subjective”

good faith standard adopted by the First, Seventh,

and Ninth Circuits.

a. United States v. Feingold is the leading

articulation of the subjective standard. There, the

Ninth Circuit, relying on Moore, held that the

government is required to prove “that the practitioner

intentionally has distributed controlled substances for

no legitimate medical purpose and outside the usual

course of professional practice.” 454 F.3d 1001, 1010

(2006) (emphasis added); id. at 1011 (“standard for

criminal liability under § 841(a) requires more than

proof of a doctor’s intentional failure to adhere to the

standard of care”). This standard asks whether a

doctor’s prescription conforms to what she believes is

a generally accepted standard of medical practice and

is serving what she believes to be a legitimate medical

purpose.

Failure to prove either of those

requirements beyond a reasonable doubt requires

acquittal. Were it otherwise, the Ninth Circuit has

said, juries could convict “solely on a finding that [a

physician] has committed malpractice,” id. at 1010,

rather than convicting only when a physician “ceases

to be a physician at all,” id. at 1011.

The Seventh Circuit takes the same view, holding

that the government must prove a physician

“deliberately made the prescriptions outside the

ordinary scope of professional practice and with no

acceptable medical justification.” United States v.

Kohli, 847 F.3d 483, 490 (2017) (emphasis added); see

id. at 491 (affirming conviction where evidence proved

that physician “intentionally and knowingly

prescribed controlled substances outside the usual

course of professional medical practice and without a

legitimate medical purpose”); United States v. Chube,

538 F.3d 693, 698 (2008) (“[T]he jury must make a

finding of intent not merely with respect to

distribution, but also with respect to the doctor’s

intent to act as a pusher rather than a medical

professional.” (quoting Feingold, 454 F.3d at 1008)).

The First Circuit likewise focuses on the

physician’s subjective intent. See United States v.

Sabean, 885 F.3d 27, 45-46 (2018) (affirming

instruction that government must prove defendant

“was aware to a high probability the prescription was

not given for a legitimate medical purpose in the usual

course of professional practice” because that

“luminously clear language” “elucidated the

distinctions between intentional and negligent

misconduct”).

The “medical purpose” test we propose is not

meaningfully different from the standard adopted in

the First, Seventh, and Ninth Circuits. Each of those

circuits requires the government to prove that the

doctor intended to prescribe without a proper medical

purpose. E.g., Feingold, 454 F.3d at 1008 (“[T]he jury

must look into a practitioner’s mind to determine

whether he prescribed the pills for what he thought

was a medical purpose.”). The only point of departure

is that those circuits also require the prosecutor to

show that the physician intended to exceed

professional norms.15 But the two inquiries are really

just two ways of saying the same thing. See, e.g.,

United States v. Rosenberg, 515 F.2d 190, 197 (9th Cir.

1975) (“The two phrases . . . have essentially the same

meaning.”).

b. By contrast, the Second, Fourth, and Sixth

Circuits have articulated an “objective standard” of

good faith. United States v. Hurwitz, 459 F.3d 463,

475, 477-478 (4th Cir. 2006). Accord United States v.

Wexler, 522 F.3d 194, 206 (2d Cir. 2008); United States

v. Singh, 390 F.3d 168, 186 (2d Cir. 2004); United

States v. Vamos, 797 F.2d 1146, 1152 (2d Cir. 1986);

United States v. Voorhies, 663 F.2d 30, 34 (6th Cir.

1981). In those circuits, it does not suffice that the

physician “acted according to what he believed to be

proper medical practice.” Hurwitz, 459 F.3d at 478.

Instead, because the good faith inquiry “must be an

objective one,” a physician acts in good faith only if he

prescribes “in accordance with what he reasonably

believed to be proper medical practice.” Id. at 478-480

(emphasis added); see Wexler, 522 F.3d at 205-206;

United States v. Volkman, 797 F.3d 377, 387-388 (6th

Cir. 2015).

15 It is not altogether clear whether the First Circuit views

Section 1306.04(a)’s “legitimate medical purpose” and “usual

course of his professional practice” prongs as separate standards.

See Sabean, 885 F.3d at 45.

2. The circuits adopting a subjective standard

have the better of the argument.

a. “Good faith,” by its nature, is a subjective

concept. It asks about the state of the defendant’s

mind, not the objective nature of his conduct. By

contrast, a requirement that the doctor’s good faith be

“reasonable” is, at bottom, a negligence standard—

which is not the level of “culpability . . . we usually

require in order to impose criminal liability.” Arthur

Andersen LLP v. United States, 544 U.S. 696, 706

(2005). The traditional rule is that a defendant must

“know the facts that make his conduct fit the

definition of the offense.” Elonis, 575 U.S. at 735

(emphasis added) (quoting Staples, 511 U.S. at 608

n.3).

By contrast, a “reasonableness” qualifier

converts good faith into constructive knowledge—and

in the process disregards our law’s traditional “belief

in freedom of the human will and a consequent ability

and duty of the normal individual to choose between

good and evil,” Morissette, 342 U.S. at 250. It is also

incompatible with other CSA provisions that impose a

higher standard (recklessness) yet impose far less

drastic penalties. See supra pp. 23-24.

As this Court explained in rejecting a similar

“reasonableness” construction of the federal-threats

statute, a “‘reasonable person’ standard is a familiar

feature of civil liability in tort law, but is inconsistent

with ‘the conventional requirement for criminal

conduct—awareness of some wrongdoing.’” Elonis,

575 U.S. at 737-738 (quoting Staples, 511 U.S., at 606607). “Having liability turn on” whether a physician’s

good faith belief in her medical purpose is

“reasonable”—“regardless of what the [physician]

thinks—reduces culpability on the all-important

element of the crime to negligence.”

(quotation marks omitted).

Id. at 738

Nor is Elonis the only case that rejects a

“reasonable belief” standard. Just such a standard

was implicitly rejected in Staples—a case in which,

unlike here, the statute lacked any express mens rea

requirement. There, the Court held that “to be

criminally liable a defendant must know that his

weapon possessed automatic firing capability so as to

make it a machinegun” (and thus fit the definition of

the offense). X-Citement Video, 513 U.S. at 71

(discussing Staples). It was not enough that an owner

should reasonably have believed that the firearm was

unlawful. See Staples, 511 U.S. at 609-610 (rejecting

argument that guns “should alert their owners to the

probability of regulation”).

An “objective” good faith standard is also difficult

to square with the CSA’s implementing regulation,

which focuses, not on the “usual course of professional

practice,” but instead on the course of the physician’s

own practice. 21 C.F.R. § 1306.04(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.”) (emphasis added). The

AG’s formulation appropriately recognizes that a

physician who sincerely believes that her medical

purpose is legitimate should not be charged as a

federal drug dealer merely because she should have

known that most other doctors would prescribe

differently.

Using felony prosecutions to yoke

physicians to objective professional norms dishonors

physicians’ “traditional[ ]” and “widely accepted,”

Staples, 511 U.S. at 612, discretion in treating

patients and “testing new theories,” Moore, 423 U.S.

at 143. See also Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341, 350, 351 n.5 (2001) (off-label

prescribing “is an accepted and necessary corollary of

the FDA’s mission to regulate in this area without

directly interfering with the practice of medicine”).

b. In the cauldron of actual Section 841(a)(1)

prosecutions, a “reasonable belief” requirement

cannot be distinguished from a civil malpractice

lawsuit.

Whether a physician’s good faith is

“reasonable” is typically determined by calling

competing experts who offer warring opinions on

whether the defendant followed the “usual course of

professional practice.” This case is an object lesson.

Evidence of simple malpractice suffused the

government’s case in chief.

For example, the

government put on medical experts who testified that

Dr. Ruan prescribed “outside [the] standard of

care, . . . outside the usual practice.” Tr. 2357:10-11

(Jan. 24, 2017); see also Tr. 661-1061 (Jan. 12-13,

2017) (Dr. Greenberg); Tr. 2246-2542 (Jan. 23-24,

2017) (Dr. Vohra); Tr. 4328-4520 (Feb. 6, 2017) (Dr.

Aultman). One government expert testified that in

her opinion “[t]he ideal thing for the doctor to have

done would have been to transfer the patient for

detoxification at a licensed detoxification facility,” or

have patients “referred to a psychiatrist” rather than

prescribing opioids as a first step of treatment. Tr.

731:10-11 (Jan. 12, 2017); Tr. 743:11-14 (Jan. 12,

2017).

Another expert opined that Dr. Ruan

excessively relied on nurse practitioners, which, in the

expert’s view, fell outside “the usual practice of

practicing medicine in the state of Arizona.” Tr.

688:17-21 (Jan. 12, 2017) (emphasis added); Tr.

681:12 (Jan. 12, 2017) (“I normally [examine the

patient] by myself.”); Tr. 2375:20-24 (Jan. 24, 2017)

(similar). Yet another hired government expert

testified that certain of Petitioner’s drug-testing

practices were “inadequate” and demonstrated “the

doctor’s [un]willingness to spend the tiny bit more

money and go ahead and protect his patients the best

that he can.” Tr. 923:1-4 (Jan. 13, 2017). Such

testimony would barely be admissible in a civil case

(in Alabama, anyway); it hardly showed that

Petitioner “completely betrayed any semblance of

legitimate medical treatment,” as required for a felony

conviction under Section 841(a)(1). Feingold, 454 F.3d

at 1010.16

But this is what CSA prosecutions invariably

devolve to in “objective good faith” jurisdictions. In

the Volkman prosecution in the Sixth Circuit, the

government’s expert witnesses testified at length to

the appropriate “standard of care,” 797 F.3d at 388390. In the Second Circuit’s Wexler case, government

experts claimed that defendant’s skin excisions were

unreasonable because “people don’t have that much

skin to spare,” 522 F.3d at 198. And in the Hurwitz

prosecution in the Fourth Circuit, the government’s

16 In fact, prosecutors may produce expert witnesses in

criminal CSA trials who would not meet the standards required

for expert witnesses in state malpractice cases. Alabama,

recognizing the difficulty of establishing a standard of care and

the deleterious impact of the “continuing and ever increasing

threat of legal actions for alleged medical injury” on patient care,

requires that expert witnesses in civil cases against physicians

be “similarly situated” to the physician on trial, defined as

someone who is licensed, trained in the same specialty as the

defendant-physician, and who has practiced in the specialty

during the year prior to the alleged breach of the standard of

care. Ala. Code §§ 6-5-548(b)-(d), 6-5-549.1.

lead expert repeatedly contrasted Dr. Hurwitz’s

prescriptions with the typical quantities for high dose

opioid therapy, 459 F.3d at 467-468 (citing Hurwitz

J.A. at 2456). See United States v. Tran Trong Cuong,

18 F.3d 1132, 1135 (4th Cir. 1994) (government expert

testimony that defendant’s prescriptions “were totally

unreasonable and not appropriate care for a family

physician”).

c. A “reasonable belief” requirement is also

unfair and unworkable given the indeterminacy of the

bounds of professional practice. No physician can

predict whether a lay jury will decide, after hearing

competing expert testimony (and there’s always a

competing expert available), that her course of

treatment was “unreasonable.”

By unmooring

Section 841(a)(1) from the doctor’s subjective intent,

CSA prosecutions almost inevitably fail to give “fair

warning . . . of what the law intends to do if a certain

line is passed.” Arthur Andersen, 544 U.S. at 703.

Indeed, given the protean and rapidly changing

landscape of medical science, a robust, subjective good

faith defense is critical lest the CSA become a “trap

for those who act in good faith,” Gonzales v. Carhart,

550 U.S. 124, 149-150 (2007).

It was precisely such concerns that prompted this

Court in Gypsum to adopt a presumption of mens rea.

As in that case, the CSA and its implementing

regulation do not “in clear and categorical terms,

precisely identify the conduct which [they]

proscribe[]”—lawful behavior is often “difficult to

distinguish” from unlawful, and, in practice, “openended and fact-specific standards” end up being

clarified only after they are “applied” by juries “to

broad classes of conduct.” 438 U.S. at 438, 440-441.

This Court’s “traditional[ ] . . . restraint in assessing

the reach of a federal criminal statute” is therefore

especially appropriate—and a subjective good faith

standard mitigates notice concerns and leaves

criminal lawmaking to Congress. Arthur Andersen,

544 U.S. at 703. A legal standard that gives

physicians fair warning has the additional benefit of

avoiding a chilling effect on “salutary . . . conduct

lying close to the borderline of impermissible conduct

[that] might be shunned by [physicians] who chose to

be excessively cautious.” Gypsum, 438 U.S. at 441.

d. Adopting an “objective” good faith standard

would also present serious federalism concerns. “It is

elemental that a state has broad power to establish

and enforce standards of conduct within its borders

relative to the health of everyone there”—indeed, that

is “a vital part of a state’s police power.” Barsky v.

Board of Regents, 347 U.S. 442, 449 (1954). This is

particularly true with respect to physicians, “whose

relations to life and health are of the most intimate

character.” Hawker v. New York, 170 U.S. 189, 194

(1898). It is thus “well settled that the State has broad

police powers in regulating the administration of

drugs by the health professions.” Whalen v. Roe, 429

U.S. 589, 603 n.30 (1977) (collecting cases).

Interpreting the CSA to “regulate[ ] medical

practice beyond prohibiting a doctor from acting as a

drug ‘pusher’ instead of a physician,” Oregon, 546 U.S.

at 269, would vastly expand federal regulation of

medicine. And a regime that imposes criminal

liability based on simple negligence (or, as in the

Eleventh Circuit, what amounts to strict liability)

would do just that. Nothing in the CSA suggests an

intent to replace medical boards and damages awards

with United States Attorneys and prison terms.

Indeed, far from displacing the States’ regulation of

medicine, “[t]he structure and operation of the CSA

presume and rely upon a functioning medical

profession regulated under the States’ police powers.”

Id. at 270. Confirming the point: Congress did

specifically displace State standards in one discrete

area—the treatment of addicts. See id. at 271-272

(discussing 42 U.S.C. § 290bb-2a). When Congress

wants to regulate medical practice, rather than

punish conventional “drug dealing and trafficking,” it

“does so by explicit language in the statute.” Id. at

270, 272.

Beyond seriously altering the relationship

between the States and the federal government,

extending Section 841(a)(1) sanctions to doctors who

act “unreasonably” would threaten a “fundamental[ ]

chang[e]” in “the relation between the citizen and the

Federal Government,” NFIB v. Sebelius, 567 U.S. 519,

555 (2012) (opinion of Roberts, C.J.). Physicians’

autonomy is only one side of the coin. There is also

the freedom of citizens to choose among physicians

and treatment options, subject to local regulation of

medical practice. The in terrorem effect of overzealous

CSA prosecutions has already disrupted this balance,

depriving chronic pain patients of medical choice and

affecting their quality of life.

See Pet. 32-33.

Deference

the

traditional

doctor-patient

relationship is especially important for sufferers of

chronic pain—pain is by nature unusually subjective

and often cannot be assessed using scans or diagnostic

tests.

A Subjective Good Faith Standard Is

Essential To The Practice And Progress

Of Medicine.

1. In

enacting

the

CSA,

“Congress

understandably was concerned that the drug laws not

impede legitimate research and that physicians be

allowed reasonable discretion in treating patients and

testing new theories.” Moore, 423 U.S. at 143. While

seeking to place “some limits on free experimentation

with drugs,” Congress was also mindful not to

constrain “legitimate research and experimentation.”

Ibid.

Limiting criminal liability to circumstances in

which physicians lack a good faith medical purpose

balances the need to deter and punish drug pushing

with the need for innovative medical research and

effective patient care.

In order to preserve

“reasonable discretion” for physicians, Moore, 423

U.S. at 143, doctors must have “latitude” in “trying to

determine the current boundaries of acceptable

medical practice.” Hurwitz, 459 F.3d at 477. A

subjective good faith defense preserves this latitude,

and makes space for both legitimate medical research

and individualized patient care.

Medical practice, after all, is an iterative and

highly individualized process. There are numerous

valid reasons why doctors may take divergent

approaches to treatment of specific patients or in

treatment philosophy more generally, including

prescribing controlled substances for uses not yet

recognized by the FDA (so-called “off-label” use). As

scholars have recognized, there are differences of

opinion “in the medical community over whether

certain patterns of prescribing for pain treatment are

appropriate.” Diane E. Hoffmann, Treating Pain v.

Reducing Drug Diversion and Abuse: Recalibrating

the Balance in Our Drug Control Laws and Policies, 1

St. Louis U. J. Health L. & Pol’y 231, 291 (2008). The

“standard of care in the treatment of non-malignant

chronic pain patients,” for instance, “is an area of

medical practice in which the boundaries and

contours are in flux and one in which the boundaries

may differ significantly from patient to patient.” Ibid.

Giving physicians the freedom to tailor their

treatment, including the “freedom to prescribe drugs

off-label,” therefore “carries important advantages.”

Randall S. Stafford, Regulating Off-Label Drug Use—

Rethinking the Role of the FDA, 358 New Eng. J. Med.

1427, 1427 (2008). Off-label prescribing permits

“innovation in clinical practice, particularly when

approved treatments have failed,” gives patients

“earlier access to potentially valuable medications,”

and allows physicians to respond to “‘orphan’

conditions” that would otherwise lack treatment.

Ibid. Indeed, doctors routinely prescribe controlled

substances for off-label use. See, e.g., Agency for

Healthcare Research and Quality, “Off-Label Drugs:

What You Need to Know” (Sept. 2015),

https://perma.cc/6M65-AHXR

(“one

five

prescriptions written today are for off-label use”).

17 As but a few examples, methylphenidate (i.e., Ritalin), an

approved ADHD medicine for children over age five, is routinely

prescribed off-label for children under five; the anti-anxiety drug

Ativan is often used off-label as an anti-nausea drug during

cancer treatment; and naltrexone, an addiction treatment

medication, is used to treat cancer and autoimmune diseases.

See Shannon G. Panther et al., Off-label Prescribing Trends for

ADHD Medications in Very Young Children, 22 J. Pediatric

Federal drug trafficking cases against doctors

“are the only realm in which juries are tasked with

applying complicated medical concepts to vague

elements in order to determine if a physician should

be convicted and sentenced to decades in prison due to

a medical disagreement.” Ronald W. Chapman II,

Defending Hippocrates: Representing Physicians in

the Wake of the Opioid Epidemic, 43 Champion (Nat’l

Ass’n of Crim. Defense Law.) 40, 41 (2019). And

asking juries to shoulder that task under an

“objective” standard of good faith only compounds the

challenge. Given the differences of opinion even

among medical practitioners and the continually

developing understanding of various drugs and their

uses, a subjective good faith defense provides an

essential buffer for doctors to make reasoned

prescription decisions without fear that a jury may

later regard those decisions to be too unorthodox—

and thus punishable by decades in prison.

Here, as elsewhere, “a page of history is worth a

volume of logic.” New York Trust Co. v. Eisner, 256

U.S. 345, 349 (1921). Dissent has always been

essential to medical progress. As the aphorism goes,

“[a]ll truth passes through three stages. First, it is

ridiculed. Second, it is violently opposed. Third, it is

accepted as being self-evident.” When Dr. William

Harvey discovered that blood circulates continually

throughout the body, disproving the then-prevailing

17th century theory that blood was produced by the

Pharmacology and Therapeutics 423, 426 (2017); American

Cancer Society, “Off-label drug use” (Mar. 2015),

https://perma.cc/HW96-RFWR; S.M. Drogovoz et al., Experience

and Prospects for the Use of Off-Label Drugs in Oncology, 43

Experimental Oncology 1, 4 (2021).

liver and absorbed into the body’s tissue, he “was

attacked viciously” as his findings “set off a storm in

medical and philosophical circles.” Roberto Bolli,

William Harvey and the Discovery of the Circulation

of the Blood—Part III, 124 Circulation Research 1428,

1428 (2019). Louis Pasteur’s 19th century publication

of germ theory was initially “met with ridicule by the

medical establishment.” Theodore H. Tulchinsky &

Elena A. Varavikova, A History of Public Health, The

New Public Health, Oct. 10, 2014, at 19. These days,

germs are regarded with disfavor.

More recently, Dr. Robin Warren and Dr. Barry

Marshall’s discovery that gastric ulcers are caused by

H. pylori bacteria was met with “skepticism and a lot

of criticism” by a medical community that had long

linked ulcers to stress, spicy foods, and other lifestyle

choices. Niyaz Ahmed, 23 years of the discovery of

Helicobacter pylori: Is the debate over?, Annals of

Clinical Microbiology and Antimicrobials, Oct. 31,

2005. Dr. Charles Dotter’s invention of angioplasty,

now used extensively in the treatment of heart

disease, was “[i]nitially met with hostility and

skepticism in the United States.” Oregon Health &

Science University, “History, Charles Theodore

Dotter,” https://perma.cc/B955-SAEM.

And Dr.

James Allison, who pioneered the use of

immunotherapy as a treatment for cancer, contended

with “doubt from his peers” for more than fifteen years

before the FDA approved an immuno-oncology drug in

2011. Timothy Bella, A Texas scientist was called

‘foolish’ for arguing the immune system could fight

cancer. Then he won the Nobel Prize, Wash. Post (Mar.

25, 2019), https://perma.cc/LVU5-4JMS.

Doctors should not have to risk felony liability

whenever they choose unpopular treatments. Such a

construction of the CSA would disserve both the

development of medicine generally, and the individual

needs of patients for whom medical trials or other

novel treatments may present the only possibility of

recovery. Indeed, physicians’ guiding principle—to

“do no harm”—may in some instances require them to

prescribe unorthodox treatment.

It is no exaggeration to say that CSA prosecutions

of physicians have already impaired the treatment of

chronic pain. In response to the opioid crisis, fear of

prosecution has increasingly prompted pain

management doctors to avoid or reduce opioid

prescriptions, even when those decisions leave chronic

pain patients without recourse. See, e.g., Maia

Szalavaitz, The Pain Was Unbearable. So Why Did

Doctors Turn Her Away?, WIRED (Aug. 11, 2021),

https://perma.cc/J5E4-ZNYG (describing how fear of

prosecution can leave “patients who have chronic pain

but do not have addictions . . . cut off from medication

that could help them”); Joel Achenbach & Lenny

Bernstein, Opioid crackdown forces pain patients to

taper off drugs they say they need, Wash. Post (Sept.

10, 2019), https://perma.cc/9S6U-2Q75 (explaining

that some chronic pain patients “have the kind of pain

that’s unbearable,” and “their doctors are terrified”);

Wesley J. Smith, Pain Doctors Face Greater Scrutiny

Than Death Doctors, National Review (May 3, 2018),

https://perma.cc/84R5-S5W9

(“Legitimate

pain

patients are being abandoned to agony that could be

relieved because the responsible are being swept up

with the dysfunctional and criminal.”). Fear of

unwarranted prosecution has also resulted in other

adverse outcomes, as forced tapering “without

providing effective alternative care is associated with

nearly triple the risk of overdose death.” Szalavaitz,

Unbearable, supra p.44. As “fear of false accusation

drives those physician behaviors that do not prioritize

patient well-being,” the good faith defense is an

essential safeguard for both physicians and their

patients. Kelly K. Dineen & James M. DuBois,

Between a Rock and a Hard Place: Can Physicians

Prescribe Opioids to Treat Pain Adequately While

Avoiding Legal Sanction?, 42 Am. J.L. & Med. 7, 39

(2016).

2. Taking good faith seriously will not be a getout-of-jail-free card for physicians who truly act as

drug pushers. While juries may not be best suited to

assess evolving medical standards, they are able to

evaluate subjective intent, and can look to evidence

concerning a physician’s practice in assessing the

veracity of a physician’s claim to have acted in good

faith.

Indeed, juries are routinely asked to evaluate

subjective intent by drawing inferences from objective

facts. In Linder, for instance, the Court explained

that an “enormous quantity of drugs ordered,

considered in connection with the recipient’s

character, without explanation” could indicate

“prohibited sales” and “exclude the idea of bona fide

professional action” under the CSA’s predecessor

statute. 268 U.S. at 22. Likewise, in Liparota, the

Court explained that requiring proof that the

defendant knew his conduct was unauthorized would

“not put an unduly heavy burden on the Government

in prosecuting violators” because, “as in any other

criminal prosecution requiring mens rea, the

Government may prove by reference to facts and

circumstances surrounding the case that petitioner

knew that his conduct was unauthorized or illegal.”

471 U.S. at 433-434. And while a defendant may seek

to avoid criminal tax liability by proving she did not

act “willfully,” “the more unreasonable the asserted

beliefs or misunderstandings are, the more likely the

jury will consider them to be nothing more than

simple disagreement with known legal duties,” rather

than a lack of mens rea. Cheek v. United States, 498

U.S. 192, 203-204 (1991). Factors such as the extent

of deviation from generally accepted medical practice

may appropriately inform the scienter determination

under Section 841(a)(1). See, e.g., Feingold, 454 F.3d

at 1007 (“Knowing how doctors generally ought to act

is essential for a jury to determine whether a

practitioner has acted not as a doctor, or even as a bad

doctor, but as a ‘pusher’ whose conduct is without a

legitimate medical justification.”).

Moreover, the CSA is not the sole bulwark

against physician misconduct. Far from it: numerous

federal and state laws impose criminal and civil

liability for a wide range of improper acts. State level

medical practice statutes allow state medical boards

to regulate and discipline medical providers for

unprofessional conduct, including conduct that

violates medical ethics or exceeds professional norms.

Individuals may bring civil malpractice lawsuits

against doctors for injuries suffered in treatment.

And at the federal level, a network of laws including

the Health Insurance Portability and Accountability

Act and the Anti-Kickback Act preclude doctors from

violating patient confidentiality and engaging in

healthcare fraud. Recognizing subjective good faith as

a defense to CSA liability will not undercut the

regulation of physicians or give doctors a free pass to

engage in unchecked medical experimentation. It

will, however, ensure that States, as the primary

regulators of health professionals and the

administration of drugs, are able to effectively

regulate physician conduct.

D. At A Bare Minimum, Any “Objective”

Good Faith Standard Must Afford

Physicians Breathing Room For Honest

Departures From Professional Norms.

At the close of trial, Petitioner asked the district

court to instruct the jury that it should acquit him if

the government failed to prove that he had “good

intentions” and displayed “the honest exercise of

professional judgment” in conforming to “what he

reasonably believed to be proper medical practice.”

J.A. 102. Although we believe that a purely subjective

good faith standard best accords with the text and

history of the CSA, at the very least a doctor must be

acquitted if he honestly tried to meet reasonable

professional standards. Indeed, the Solicitor General

conceded the point in its brief in opposition. See BIO

11 (“[t]he touchstone for liability under Moore is

whether” “at a minimum, [defendant] ‘made “an

honest effort”’ to act” according to professional norms

(quoting Moore, 423 U.S. at 142 n.20)). Unlike the

purely objective standard embraced by the Second,

Fourth and Sixth Circuits—which requires that the

physician’s intent be “reasonable”—this standard

asks only whether the doctor’s intent is “honest.”

In the present case, of course, Petitioner was

deprived of any good faith standard. For that reason,

as we next explain, Dr. Ruan’s convictions should be

reversed under any plausible formulation of the good

faith defense.

II. EVEN UNDER AN “OBJECTIVE” GOOD

FAITH STANDARD—INDEED, UNDER ANY

CIRCUIT’S LAW BUT THE ELEVENTH’S—

PETITIONER’S CONVICTIONS SHOULD

BE REVERSED.

1. The district court told Petitioner’s jury that

it could convict him under the CSA if it found that he

had exceeded professional norms. Full stop. Although

the court purported to “throw[] [Petitioner] a bone” by

adverting to his good faith defense, in the very next

breath it rendered good faith irrelevant:

Thus a medical doctor has violated section 841

when the government has proved beyond a

reasonable doubt that the doctor’s actions were

either not for a legitimate medical purpose or

were outside the usual course of professional

medical practice.

Pet. App. 139a (emphasis added).

The Eleventh Circuit agreed. In its view, good

faith is a defense only “as long as the appellants’

conduct also was in accordance with the standard of

medical practice generally recognized and accepted in

the United States.” Pet. App. 107a (emphasis added).

That ruling reflected the Eleventh Circuit’s

idiosyncratic notion that a physician’s “good faith

belief that he dispensed a controlled substance in the

usual course of his professional practice is irrelevant.”

United States v. Enmon, 686 Fed. Appx. 769, 773

(2017) (per curiam) (emphasis added); see also United

States v. Tobin, 676 F.3d 1264, 1283 (11th Cir. 2012)

(exclusion of “evidence of good faith” is “consistent

with [this circuit’s] holdings”).

The Eleventh Circuit’s treatment of good faith

saps the defense of any actual content. By reserving

the defense only for physicians whose prescriptions

already fall within professional norms, the Eleventh

Circuit ensures that good faith may be invoked only

by defendants who don’t need it. That is the kind of

defense only Joseph Heller’s Major Major could

appreciate.18

Needless to say, the Eleventh Circuit’s rule is a

complete outlier. Every other circuit to pass on the

question has endorsed some kind of good faith defense

as essential to “explain[] to the jury a critical

difference between” civil and criminal liability.

Sabean, 885 F.3d at 45 (quoting United States v.

Smith, 573 F.3d 639, 650 (8th Cir. 2009) (quoting in

turn United States v. McIver, 470 F.3d 550, 560 (4th

Cir. 2006))).

2. It follows that even if the Court adopts the

“objective” good faith standard embraced by the

18 “What shall I say to the people who do come to see you

while you’re here?

“Tell them I’m in and ask them to wait.”

“Yes, sir. For how long?”

“Until I’ve left.”

“And then what shall I do with them?”

“I don’t care.”

“May I send them in to see you after you’ve left?”

“Yes.”

“But you won’t be here then, will you?”

“No.”

Joseph Heller, Catch 22 100 (S&S Classic ed. 1999) (1961).

Second, Fourth, and Sixth Circuits, it should reverse

Petitioner’s convictions.

By directing the jury to focus only on whether Dr.

Ruan exceeded professional norms, the district court

authorized the jury to disregard the abundant

evidence of Petitioner’s subjective good faith. So

instructed, Dr, Ruan’s jury had no reason to consider

the government’s concession that he “did a really good

job for [his] patients,” and that “[b]y and large, [his]

patients were legitimate patients.” Pet. App. 84a.

Nor did the jury need to assess Dr. Ruan’s testimony

that he always made an “individualized decision” as

to “[w]hat medication to use” “based on the patient’s

best interest.” J.A. 209-210.

Instead, Petitioner’s case devolved into a battle of

experts, much like any run-of-the-mill malpractice

lawsuit. Experts may well differ about best practices,

or even “the usual course of professional practice,”

Moore, 423 U.S. at 124. But a lay jury’s assessment of

the cut of an expert’s jib should not spell the difference

between guilt or innocence. And here, the jury was

especially at a loss because, guided by the Eleventh

Circuit’s idiosyncratic views, the district court

excluded critical evidence that Petitioner refused to

prescribe to undercover DEA agents and evidence that

Petitioner’s treatments were lifesaving for certain

patients. See supra pp. 9-10 & n.3. That evidence

bore directly on Petitioner’s good faith and “would

have rebutted the government’s evidence that

[Petitioner’s] prescriptions lacked a legitimate

medical purpose.” United States v. Arny, 831 F.3d

725, 734, 736 (6th Cir. 2016).

By depriving Petitioner of any substantive good

faith defense—even one as diluted as the “objective”

standard adopted by the Second, Fourth, and Sixth

Circuits—the district court, sustained by the court of

appeals, invited the jury to convict Petitioner based on

a strict liability standard. Nothing in the CSA or its

implementing regulations authorizes that wholesale

disruption of medical practice and scientific

progress.19

CONCLUSION

For the foregoing reasons, this Court should

reverse the judgment of the court of appeals.

19 The error was not harmless. Because “the jury was not

correctly instructed on the meaning of [the good faith defense], it

may have convicted [Petitioner] for conduct that is not unlawful.”

McDonnell v. United States, 136 S. Ct. 2355, 2375 (2016). That

alone precludes any finding that the “errors in the jury

instructions were harmless beyond a reasonable doubt.” Ibid.

(quotation marks omitted). “By concluding that good faith was

not applicable to the § 841 charges,” the district court “effectively

deprived the jury of the opportunity to consider [Petitioner’s]

defense.” Hurwitz, 459 F.3d at 482. “In a criminal appeal where

a mens rea-related jury instruction issue may have made a

difference to the conviction and sentence, it is critically

important to ensure that the jury had a correct understanding of

the relevant law.” United States v. Williams, 836 F.3d 1, 20 (D.C.

Cir. 2016) (Kavanaugh, J., concurring). For its part, the

government has never claimed that Dr. Ruan was not entitled to

a good faith instruction.

Respectfully submitted.

LAWRENCE S. ROBBINS

Counsel of Record

WILLIAM J. TRUNK

JEFFREY C. THALHOFER

CAROLYN M. FORSTEIN

LESLIE C. ESBROOK

ROBBINS, RUSSELL, ENGLERT,

ORSECK & UNTEREINER LLP

2000 K Street, NW, 4th Fl.

Washington, DC 20006

(202) 775-4500

lrobbins@robbinsrussell.com

December 20, 2021

Counsel for Petitioner

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.