Amicus Curiae Brief — Xiulu Ruan, Petitioner v. United States

Supreme Court briefDec 27, 2021

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No. 20-1410

IN THE

Supreme Court of the United States

________________

DR. XIULU RUAN,

UNITED STATES OF AMERICA,

________________________

Petitioner,

Respondent.

On Writ of Certiorari to the United States Court of

Appeals for the Eleventh Circuit

_________________________________________________

BRIEF OF THE CATO INSTITUTE AS

AMICUS CURIAE SUPPORTING PETITIONER

_________________________________________________

December 27, 2021

Clark Neily

Counsel of Record

Trevor Burrus

Gregory Mill

CATO INSTITUTE

1000 Mass. Ave., NW

Washington, DC 20001

(202) 425-7499

cneily@cato.org

QUESTION PRESENTED

Whether physicians 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,

they “reasonably believed” or “subjectively intended”

that their prescriptions fall within that course of

professional practice.

TABLE OF CONTENTS

Page

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

TABLE OF AUTHORITIES .................................... iv

INTEREST OF AMICUS CURIAE .......................... 1

SUMMARY OF ARGUMENT................................... 1

ARGUMENT ............................................................. 3

THE GOOD-FAITH DEFENSE FOR

DOCTORS ACCUSED OF

MISPRESCRIBING CONTROLLED

SUBSTANCES HAS BEEN PART OF

FEDERAL LAW FOR OVER 100 YEARS .. 3

II. THE ELEVENTH CIRCUIT’S

EXPANSIVE INTERPRETATION OF

THE CSA PREVENTS STATES FROM

EXERCISING THEIR SUPERIOR

JUDGMENT OVER REGULATION

WITHIN THEIR BORDERS ....................... 9

A. Section 841(a)(1) Regulates a

Narrow Scope of Conduct ...................... 12

B. Without a Scienter Requirement,

the CSA Effectively Regulates

the Practice of Medicine ........................ 14

C. Patients Benefit from State Control

Over Medical Practices .......................... 16

iii

III. WITHOUT A SUBJECTIVE

GOODFAITH COMPONENT,

PRESCRIBING PHYSICIANS DON’T

KNOW WHEN THEIR CONDUCT IS AT

RISK OF PUNISHMENT UNDER THE

STATUTE................................................... 18

A. There Is No One Discernable

“Usual Course of Their Professional

Practice” to which Practitioners

Can Conform Their Conduct ................. 19

B. An Objective Standard Turns the

Vague Requirements of Section

841(a)(1) into a Strict

Liability Crime for Doctors.................... 23

CONCLUSION ........................................................ 25

TABLE OF AUTHORITIES

Page(s)

Cases

Bond v. United States, 572 U.S. 844 (2014) ............ 14

Conant v. Walters, 309 F.3d 629 (9th Cir. 2002),

cert. denied, 540 U.S. 946 (2003) ........................... 9

Connally v. Gen. Constr. Co., 269 U.S. 385 (1926) . 19

Flores-Figueroa v. United States, 556 U.S. 646

(2009) .................................................................... 24

Gonzales v. Carhart, 550 U.S. 124 (2007) ............... 24

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

Grayned v. City of Rockford, 408 U.S. 104 (1972)... 19

Kolender v. Lawson, 461 U.S. 352 (1983) ................ 19

Linder v. United States. 268 U.S. 5 (1925)............ 7, 8

Liparota v. United States, 471 U.S. 419 (1985) ...... 25

Morissette v. United States, 342 U.S. 246 (1952) .... 25

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

(1978) .................................................................... 25

Pegram v. Herdrich, 530 U.S. 211 (2000)................ 14

Raygor v. Regents of Univ. of Minn., 534 U.S. 533

(2002) .................................................................... 13

Slaughter-House Cases, 83 U.S. 36 (1872) ................ 9

Solid Waste Agency of N. Cook Cty. v. U.S. Army

Corps of Eng’rs, 531 U.S. 159 (2001) ................... 14

Staples v. United States, 511 U.S. 600 (1994) ......... 24

United States v. Behrman, 258 U.S. 280 (1922) ....... 7

United States v. Feingold, 454 F.3d 1001

(9th Cir. 2006)........................................... 12, 15, 22

United States v. Godofsky, 943 F.3d 1011

(6th Cir. 2019)....................................................... 22

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

(4th Cir. 2006)................................................. 16, 22

United States v. Jin Fuey Moy,

241 U.S. 394 (1916) .................................. 3, 4, 5, 10

United States v. Kohli, 847 F.3d 483

(7th Cir. 2017)................................................. 15, 22

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

(1975) ........................................................ 12, 16, 17

United States v. Sabean, 885 F.3d 27

(1st Cir. 2018) ................................................. 15, 22

United States v. Smith, 573 F.3d 639 (8th Cir. 2009)

............................................................................... 15

United States v. Voorhies, 663 F.2d 30

(6th Cir. 1981)....................................................... 16

United States v. Wexler, 522 F.3d 194

(2d Cir. 2008) .................................................. 16, 22

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

513 U.S. 64 (1994) ................................................ 24

Webb v. United States, 249 U.S. 96 (1919) ............ 5, 6

Constitutional Provisions

U.S. Const. amend. X ................................................. 9

Statutes

21 U.S.C. § 822(b)..................................................... 24

21 U.S.C. § 823(g)(2)(H)(i) ....................................... 13

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

21 U.S.C. § 903 ......................................................... 11

21 U.S.C. 13 § 801 et seq ............................................ 9

Harrison Act § 2(a), 38 Stat. 785 ............................... 3

Regulations

21 C.F.R. § 1306.04(a) .............................................. 18

Other Authorities

“Not Allowed to Be Compassionate,”

Human Rights Watch (Dec. 18, 2018).................. 22

38 H.R. Rep. No. 91-1444 (1970) ............................. 13

Christine Vestal, “Rapid Opioid Cutoff is Risky

Too, Feds Warn,” Pew: Stateline, May 15, 2019 .. 17

Cynthia Marietta & Amy L. McGuire, Direct-toConsumer Genetic Testing: Is It the Practice of

Medicine?, 37 J.L. Med. & Ethics 369 (2009) ...... 15

Deborah Dowell et al., Ctrs. for Disease Control &

Prevention, CDC Guideline for Prescribing Opioid

for Chronic Pain-United States, 65 Morbidity &

Mortality Wkly. Rpt., Recommendations &

Rpts. 1 (2016) ........................................................ 20

Deborah Hellman, Prosecuting Doctors for Trusting

Patients, 16 Geo. Mason L. Rev. 701 (2009) ........ 23

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) ............ 12, 13, 20

George Comerci et al., Controlling the Swing of the

Opioid Pendulum, 378 New Eng. J. Med. 691

(2018) .................................................................... 21

vii

James Dahlhamer et al., Prevalence of Chronic Pain

and High Impact Chronic Pain Among Adults, 67

Morbidity & Mortality Wkly. Rpt. 1001 (2018) ... 16

Johann Hari, Chasing the Scream: The First and

Last Days of the War on Drugs (2015) ................... 5

John F. Decker, Addressing Vagueness, Ambiguity,

and Other Uncertainty in American Criminal

Laws, 80 Denv. U. L. Rev. 241 (2002).................. 20

Jury Instructions, United States v. Hurwitz

(E.D. Va. Apr. 17, 2007) (No. 1:03CR467) ........... 23

Kelly K. Dineen & Elizabeth Pendo, Substance Use

Disorder Discrimination and the Cares Act: Using

Disability Law to Inform Part 2 Rulemaking,

52 Ariz. St. L.J. 1143 (2020)................................. 18

Kelly K. Dineen, Definitions Matter: A Taxonomy of

Inappropriate Prescribing to Shape Effective

Opioid Policy and Reduce Patient Harm,

67 U. Kan. L. Rev. 961 (2019) ....................... passim

Laurie L. Levenson, Good Faith Defenses: Reshaping

Strict Liability Crimes, 78 Cornell L. Rev. 401

(1993) .................................................................... 23

Meredith Lawrence, How the CDC Guidelines Killed

My Husband, 8 Narrative Inquiry in Bioethics

219 (2018) ............................................................. 17

Michael C. Barnes et al., Demanding Better: A Case

for Increased Funding and Involvement of State

Medical Boards in Response to America’s Drug

Abuse Crisis, 106 J. Med. Reg. 3 (2020)............... 17

Nadia N. Sawicki, Character, Competence, and the

Principles of Medical Discipline, 13 J. Health

Care L. & Pol’y 285 (2010) ................................... 15

viii

Off. of Diversion Control, Drug Enforcement

Admin., Practitioner’s Manual (2006) ................. 20

Paul J. Larkin, Jr., Strict Liability Offenses,

Incarceration, and the Cruel and Unusual

Punishments Clause, 37 Harv. J.L. & Pub.

Pol’y 1065 (2014)................................................... 24

Press Release, U.S. Food & Drug Admin., Statement

from FDA Commissioner Scott Gottlieb, M.D., on

Agency’s Approval of Dsuvia and the FDA's Future

Consideration of New Opioids (Nov. 2, 2018) ...... 21

Public Health Reports (1896-1970), Vol. 31, No. 19

(May 12, 1916) ........................................................ 4

Ronald W. Chapman II, Defending Hippocrates:

Representing Physicians in the Wake of the

Opioid Epidemic, 43 Champion 40 (2019) ........... 11

Rufus King, The Drug Hang-up: America’s

Fifty-Year Folly (1972) ........................................... 5

Timothy S. Jost et al., Consumers, Complaints, and

Professional Discipline: A Look at Medical

Licensure Boards, 3 Health Matrix 309 (1993) ... 15

William N. Eskridge, Jr. & Philip P. Frickey, QuasiConstitutional Law: Clear Statement Rules as

Constitutional Lawmaking, 45 Vand. L. Rev.

593 (1992) ............................................................. 13

INTEREST OF AMICUS CURIAE 1

The Cato Institute was established in 1977 as a

nonpartisan public policy research foundation

dedicated to advancing the principles of individual

liberty, free markets, and limited government. Cato’s

Robert A. Levy Center for Constitutional Studies was

established in 1989 to promote the principles of

limited constitutional government that are the

foundation of liberty. Toward those ends, Cato has

participated as amicus curiae in numerous cases

before federal courts. Cato also works to defend

individual rights through publications, lectures,

conferences, public appearances, and the annual Cato

Supreme Court Review, and files amicus briefs.

This case interests Cato because the federal

government cannot and should not criminalize good

faith, legitimate medical practice. Misguided

prescription-drug regulation upsets federalism and

denies care to patients in desperate need.

SUMMARY OF ARGUMENT

Dr. Xiulu Ruan is currently facing 21 years in

prison due to the Eleventh Circuit’s unique strict

liability regime for interpreting the Controlled

Substances Act (CSA). After a lengthy jury trial in

which various medical experts disagreed with each

other over proper medical procedures—as doctors

inevitably do—a jury was asked to render a verdict

without consideration as to whether Dr. Ruan

1 Rule 37 statement: All parties were timely notified of and

consented to the filing of this brief. No part of this brief was

authored by any party’s counsel, and no person or entity other

than amicus funded its preparation or submission.

prescribed controlled substances in good faith. This

amounts to, in essence, the federal regulation of the

practice of medicine under a strict liability standard.

If the CSA were really meant to work that way,

Congress would presumably have said so.

But that is not how the CSA is supposed to work,

as over a hundred years of case law tells us. The

CSA—and its predecessor the Harrison Narcotics Act

of 1914—were designed to exist within a framework

that “presum[es] and rel[ies] upon a functioning

medical profession regulating under the States’ police

powers.” Gonzales v. Oregon, 546 U.S. 243, 270 (2006).

Respecting the states’ police powers means not

turning good-faith medical disputes—of the kind that

civil courts and state licensing boards hear every

day—into federal crimes. Federal jurisdiction under

the CSA begins when a doctor has abandoned the

subjective belief of practicing medicine and becomes a

mere drug dealer. Until that occurs, it is a dispute

over the practice of medicine that is properly

adjudicated under state law.

That was understood from the very moment the

federal government got involved in regulating

controlled substances. The cases heard by this Court

between 1916 and 1925—all arising from the

prosecution of doctors—demonstrate that the

practicing-medicine-in-good-faith defense was simply

assumed to be part of the Harrison Act. It was even

assumed to be part of the law by Treasury officials

before this Court ever heard a case arising under the

Act. That assumption came from a due appreciation

of federalism, something that is no less warranted

today.

Finally, both the strict liability standard that the

Eleventh Circuit applied here and the objective

standard requested by the government undermine

federalism and are functionally unworkable in a

constitutionally permissible way. Despite the

contrary assertions of the DEA and the CDC, there is

no definition of “overprescribing” sufficiently coherent

in this context to avoid the specter of unconstitutional

vagueness in the context of criminal prosecutions.

The Court should vacate Dr. Ruan’s conviction and

restore appropriate constitutional limits to the CSA.

ARGUMENT

THE GOOD-FAITH DEFENSE FOR

DOCTORS

ACCUSED

MISPRESCRIBING CONTROLLED SUBSTANCES HAS BEEN PART OF

FEDERAL LAW FOR OVER 100 YEARS

The Harrison Narcotics Act of 1914 was a tax and

registration act that regulated opiates and cocaine.

United States v. Jin Fuey Moy, 241 U.S. 394, 399–401

(1916). The Act created a registration requirement for

those authorized to dispense opiates, and it contained

an explicit exemption for medical practice: “Nothing

contained in this section shall apply . . . to the dispensing or distribution of any of the aforesaid drugs

to a patient by a physician, dentist, or veterinary surgeon registered under this Act in the course of his professional practice only[.]” Harrison Act § 2(a), 38 Stat.

785. It was assumed from the beginning that the Act

included a good-faith defense for doctors accused of

misprescribing opiates.

As a tax law, the Harrison Act was enforced by the

Treasury Department. Initial guidance issued by the

department on May 11, 1915—before this Court

heard any challenge to the Act—assumed a good-faith

defense was inherent in the law:

In cases of treatment of addicts these prescriptions should show the good faith of the physician in the legitimate practice of his profession

by a decreasing dosage or reduction of the quantity prescribed from time to time[.]

Public Health Reports (1896-1970), Vol. 31, No. 19, at

1205 (May 12, 1916). 2 The theme here is a recurring

one: There’s no doubt a good-faith defense exists; the

dispute was whether certain prescribing practices

furnish sufficient circumstantial evidence of “bad

faith.”

When it heard the first challenge to the Act—a

challenge to its constitutionality and scope—this

Court took it as seemingly obvious that the medical

exception included a good-faith defense. As Justice

Holmes wrote for the Court, Dr. Jin Fuey Moy was

accused of writing a “prescription for the morphine

sulphate, and that he did not issue it in good faith,

but knew that the drug was not given for medicinal

purposes[.]” Jin Fuey Moy, 241 U.S. at 399. Later in

the opinion, Justice Holmes again invokes the goodfaith defense in delineating the scope of the Act:

“There is a proviso that the section shall not apply to

any employee of a registered person and certain others, with qualifications, or to the possession of any of

2 Available at https://bit.ly/3J9XTEH.

the drugs which have been prescribed in good faith

by a physician registered under the act.” Id. at 400.

In the aftermath of Dr. Jin Fuey Moy’s case, Treasury Department agents began interpreting the Act as

prohibiting doctors from prescribing opiates to compulsive users for the purpose of “maintaining” their

addiction. Rufus King, The Drug Hang-up: America’s

Fifty-Year Folly 32–50 (1972). A virtual war on opiateprescribing doctors was inaugurated, and eventually

“[s]ome 20,000 doctors were charged with violating

the Harrison Act[.]” Johann Hari, Chasing the

Scream: The First and Last Days of the War on Drugs

38 (2015). During that time many “horrified juries refused to convict, because they could see the doctors

were only treating the sick the best they could.” Id.

Yet in the subsequent cases heard by this Court,

the question whether a good-faith defense was available was never seriously challenged. The question instead was whether prescribing maintenance doses to

compulsive opiate users qualified as a medical purpose “in the course of professional practice” under the

statute. In Webb v. United States, the Court held

maintenance doses did not qualify as a medical purpose. 249 U.S. 96, 99 (1919). Yet the Court was also

explicit in stating that Dr. Webb and his co-defendant

were not issuing prescriptions in good faith: “It was

the intent of Webb and Goldbaum that morphine

should thus be furnished to the habitual users thereof

by Goldbaum and without any physician’s prescription issued in the course of a good faith attempt to cure

the morphine habit.” Id. at 98 (emphasis added). The

Court, in a medically dubious ipse dixit, took it as literally beyond discussion that a maintenance dose prescribed to a compulsive user had no legitimate

medical function and thus the good-faith defense was

unavailable. Id. at 99–100 (“to call such an order for

the use of morphine a physician’s prescription would

be so plain a perversion of meaning that no discussion

of the subject is required”).

Prosecutions of doctors continued. Yet doctors

were never categorically stripped of the good-faith defense but were instead simply precluded from arguing

that providing maintenance doses could be categorized as good faith. In United States v. Behrman, some

members of the Court began dissenting from the idea

that a good-faith defense could not encompass the prescribing of maintenance doses and seemed uneasy

with the idea of the justices second-guessing the professional judgment of medical doctors. And, again, no

justice disagreed that the good-faith defense was

available, but only whether the concept of “good faith”

permitted a court to exclude from that defense entire

categories of conduct as a matter of law. As Justice

Holmes wrote in dissent, joined by Justices McReynolds and Brandeis:

In view of the allegation that I have quoted and

the absence of any charge to the contrary, it

must be assumed that he gave them in the

regular course of his practice and in good faith.

…

It seems to me impossible to construe the

statute as tacitly making such acts, however

foolish, crimes, by saying that what is in form a

prescription and is given honestly in the course

of a doctor’s practice, and therefore, so far as

the words of the statute go, is allowed in terms,

is not within the words, is not a prescription

and is not given in the course of practice, if the

Court deems the doctor’s faith in his patient

manifestly unwarranted. It seems to me wrong

to construe the statute as creating a crime in

this way without a word of warning.

United States v. Behrman, 258 U.S. 280, 290 (1922)

(Holmes, J., dissenting).

Three years later, however, Justice Holmes’s

dissenting opinion in Behrman became the law in

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

the trial court gave jury instructions believed to be in

line with the decision in Behrman. The instructions

allowed for a good-faith defense but did not allow that

defense to be raised if Dr. Linder “knew that this

woman was addicted to the use of narcotics, and if he

dispensed these drugs to her for the purpose of

catering to her appetite or satisfying her cravings for

the drug[.]” Id. at 16. The trial court’s instructions

continued:

If, on the other hand, you believe from the

testimony that the defendant believed in good

faith this woman was suffering from cancer or

ulcer of the stomach, and administered the

drug for the purpose of relieving her pain, or if

you entertain a reasonable doubt upon that

question, you must give the defendant the

benefit of the doubt and find him not guilty.

Id. These jury instructions—which were found

deficient as regards the good-faith defense—were

nevertheless more favorable to the defendant than

those in Dr. Ruan’s trial.

In the Linder decision, the Court eventually

arrived at the standard that should inform this

Court’s opinion in this case as well:

The opinion cannot be accepted as authority for

holding that a physician who acts bona fide and

according to fair medical standards may never

give an addict moderate amounts of drugs for

self-administration in order to relieve

conditions incident to addiction. Enforcement of

the tax demands no such drastic rule, and if the

Act had such scope, it would certainly

encounter grave constitutional difficulties.

…

Federal power is delegated, and its prescribed

limits must not be transcended even though the

end seems desirable. The unfortunate condition

of the recipient certainly created no reasonable

probability that she would sell or otherwise dispose of the few tablets intrusted [sic] to her, and

we cannot say that, by so dispensing them, the

doctor necessarily transcended the limits of

that professional conduct with which Congress

never intended to interfere.

Id. at 22–23 (emphasis added).

The Linder Court’s regard for comity-based constitutional constraints is notable, and every bit as relevant today. Although the scope of congressional

powers has changed drastically since 1925, the states

still regulate their medical practitioners as part of

their police powers and that was fully understood by

the Congresses that passed both the Harrison Act and

the Controlled Substances Act.

II.

THE ELEVENTH CIRCUIT’S EXPANSIVE INTERPRETATION OF THE CSA

PREVENTS STATES FROM EXERCISING THEIR SUPERIOR JUDGMENT

OVER REGULATION WITHIN THEIR

BORDERS

States regulate the practice of medicine under

their general police power to protect the health,

safety, and welfare of state citizens. U.S. Const.

amend. X; Slaughter-House Cases, 83 U.S. 36, 62

(1872) (describing the police power as extending “to

the protection of the lives, limbs, health, comfort, and

quiet of all persons. . . . within the State”); Gibbons v.

Ogden, 22 U.S. 1, 203 (1824) (finding “health laws of

every description” form “a portion of that immense

mass of legislation, not surrendered to the general

government”). “The doctor-patient relationship is an

area that falls squarely within the states’ traditional

police powers [and] the federal government may not

force the states to regulate that relationship to advance federal policy.” Conant v. Walters, 309 F.3d 629,

647 (9th Cir. 2002), cert. denied, 540 U.S. 946 (2003).

Accordingly, when Congress passed the Controlled

Substances Act to regulate certain drugs, it took care

to preserve the historical delegation of power between

the federal government and the states. 21 U.S.C. 13 §

801 et seq; Gonzales, 546 U.S. at 269–70 (finding the

CSA manifests no intent to regulate the practice of

medicine beyond illicit drug dealing and trafficking).

State-level regulation allows for policies tailored

to local conditions and enables experimentation in

response to pain management and addiction. Good

faith, legitimate medical practice may look much

different in West Virginia than it does in Hawaii. As

do lawyers, doctors often disagree in good faith, and

including particularly those who practice in distinct

geographic regions and with often much different

patient demographics. Ensuring appropriate space

for states to define the ambit of “legitimate medical

practice” within which doctors may not be convicted

for good-faith acts under the CSA is critical for

millions of vulnerable patients.

Over 100 years ago, in first interpreting the

Harrison Narcotics Act, this Court was concerned

that Congress might have reached too far—under the

taxing power—to regulate every person who

possessed opioids. In reading the statute as being

limited with respect to doctors and others in the

medical field, the Court took it as obvious that

Congress would not stretch its powers to a possibly

unconstitutional degree without clearly saying so:

Only words from which there is no escape could

warrant the conclusion that Congress meant to

strain its powers almost if not quite to the

breaking point in order to make the probably

very large proportion of citizens who have some

preparation of opium in their possession

criminal[.]

Jin Fuey Moy, 241 U.S. at 402. Moreover, “cautioning

against the conclusion that the CSA effectively

displaces the States’ general regulation of medical

practice is the Act’s pre-emption provision, which

indicates that, absent a positive conflict, none of the

Act’s provisions should be ‘construed as indicating an

intent on the part of the Congress to occupy the field

in which that provision operates . . . to the exclusion

of any State law on the same subject matter which

would otherwise be within the authority of the State.’”

Gonzales, 546 U.S. at 270–71 (citing 21 U.S.C. § 903).

Until recently, federal courts generally agreed

that the government had to prove that the practitioners knowingly or intentionally acted without a legitimate purpose outside the usual course of professional

practice to secure a conviction under the CSA. Ronald

W. Chapman II, Defending Hippocrates: Representing

Physicians in the Wake of the Opioid Epidemic, 43

Champion 40 (2019). 3 But the Eleventh Circuit constructively eliminates “knowingly” or “intentionally”

from the burden of proof, expanding the CSA’s criminal penalty to many more prescribing practices than

the CSA intended.

This upsets the balance of power between states

and the federal government over medical practice. Critically, it also prevents states from exercising

their superior judgment over patient care within their

borders. The DEA lacks the institutional competence

to assess what legitimate medical practice looks like

in fifty diverse states. See generally, Kelly K. Dineen,

Definitions Matter: A Taxonomy of Inappropriate Prescribing to Shape Effective Opioid Policy and Reduce

Patient Harm, 67 U. Kan. L. Rev. 961 (2019) [hereinafter “Dineen, Definitions Matter”]. A heavy-handed,

monolithic approach denies care to patients in need

and prevents doctors from pursuing effective harmreduction.

3 Available at https://bit.ly/32iATCP.

A. Section 841(a)(1) Regulates a Narrow

Scope of Conduct

“The Controlled Substances Act . . . regulates medical practice insofar as it bars doctors from using their

prescription-writing powers as a means to engage in

illicit drug dealing and trafficking as conventionally

understood. Beyond this . . . the statute manifests no

intent to regulate the practice of medicine.” Gonzales,

546 U.S. at 269–70. “Conventionally understood”

drug dealing and trafficking means “[selling] drugs,

‘primarily for the profits to be derived therefrom’ and

. . . acting so far outside the usual course of professional practice that their behavior is akin to that of a

‘large-scale [drug] pusher, not as a physician.’” United

States v. Moore, 423 U.S. 122, 135 (1975) (citations

omitted). Federal courts have consistently held that a

deviation from the standard of care is not sufficient to

meet the mens rea requirement under the Controlled

Substances Act. See, e.g., United States v. Feingold,

454 F.3d 1001, 1007 (9th Cir. 2006). Instead, providers must depart further from being even a “bad doctor” to “a ‘pusher’ whose conduct is without a

legitimate medical justification.” Id. The key question

for whether a physician may be prosecuted under the

CSA, then, is whether she acted as a doctor or intentionally abandoned that role in favor of becoming a

drug trafficker. 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, 235 (2008) [hereinafter “Hoffmann, Treating Pain”]. Thus, physicians

may not be convicted under the CSA simply for prescribing in ways that violate professional standards

or for negligently allowing patients to misuse or divert their medications. Id.

But by effectively denying a good-faith defense under the CSA, the Eleventh Circuit criminalizes prescribing practices far beyond “illicit drug dealing and

trafficking as conventionally understood.” 546 U.S. at

270. This Court has recognized that “obviously, direct

control of medical practice in the States is beyond the

power of the Federal Government.” Linder, 268 U.S.

at 18. The CSA itself provides that “[n]othing in such

regulations or practice guidelines may authorize any

Federal official or employee to exercise supervision or

control over the practice of medicine or the manner in

which medical services are provided.” 21 U.S.C. §

823(g)(2)(H)(i). Further, the House Report accompanying the CSA states that the law “provides for control by the Justice Department of problems related to

drug abuse through registration . . . of [those] in the

legitimate distribution chain, and making transactions outside the legitimate distribution chain illegal.” 38 H.R. Rep. No. 91-1444, pt. 1 at 1, 3 (1970). If

prescribing directly to patients with pain issues is not

in the “legitimate distribution chain,” it is hard to imagine what could be.

This Court relies on the clear-statement canon for

cases involving “congressional regulation of core state

functions” to prevent excessively broad statutory constructions like the Eleventh Circuit’s. William N.

Eskridge, Jr. & Philip P. Frickey, Quasi-Constitutional Law: Clear Statement Rules as Constitutional

Lawmaking, 45 Vand. L. Rev. 593, 623–24 (1992);

Raygor v. Regents of Univ. of Minn., 534 U.S. 533, 543

(2002) (finding that when Congress intends to alter

the usual constitutional balance between the States

and the Federal Government, it must make its intention to do so “unmistakably clear in the language of

the statute.”); Bond v. United States, 572 U.S. 844,

857–60 (2014) (refusing to interpret a statute in a way

that would upset the usual balance of federal and

state powers absent a clear statement from Congress). Thus, any construction of the CSA that would

permit the federal government to intrude on a state’s

right to regulate medical malpractice and deviations

from the standard of care must be grounded in “a clear

indication that Congress intended that result.” Solid

Waste Agency of N. Cook Cty. v. U.S. Army Corps of

Eng’rs, 531 U.S. 159, 172 (2001); Pegram v. Herdrich,

530 U.S. 211, 237 (2000) (“[I]n the field of health care,

a subject of traditional state regulation, there is no . .

. preemption without clear manifestation of congressional purpose.”); Gonzales, 546 U.S. at 272 (“When

Congress wants to regulate medical practice in the

given scheme, it does so by explicit language in the

statute.”). In the absence of any indication in statutory text that the CSA criminalizes practices outside

of “conventionally understood” trafficking and drug

dealing, much less a clear statement to this effect, the

Eleventh Circuit erred in finding that the CSA criminalizes good-faith prescriptions of controlled substances.

B. Without a Scienter Requirement, the CSA

Effectively Regulates the Practice of Medicine

Most state statutes and courts define medical

practice as (1) the diagnosis of disease, condition, or

injury; and (2) prescribing, administering, or providing treatment. Cynthia Marietta & Amy L. McGuire,

Direct-to-Consumer Genetic Testing: Is It the Practice

of Medicine?, 37 J.L. Med. & Ethics 369, 371 (2009). A

state’s regulation of medical practice includes defining the scope of “legitimate medical purpose,” licensing practitioners, and imposing penalties for conduct

such as deviations from the standard of care and aiding in the unauthorized practice of medicine. Timothy

S. Jost et al., Consumers, Complaints, and Professional Discipline: A Look at Medical Licensure

Boards, 3 Health Matrix 309, 326–30 (1993); Nadia

N. Sawicki, Character, Competence, and the Principles of Medical Discipline, 13 J. Health Care L. &

Pol’y 285, 290 (2010).

An effective good-faith defense, alongside consideration of whether a practice falls within a state’s definition of “legitimate medical purpose,” is needed to

preserve the distinction between malpractice and

“conventionally understood” drug dealing and trafficking. Gonzales, 546 U.S. at 270. Identifying the importance of this distinction, most circuits offer some

version of good-faith defense. The First Circuit held

that “a sincere effort to act in accordance with proper

medical practice, even if flawed, could not undergird

a guilty verdict” under the CSA. United States v. Sabean, 885 F.3d 27, 45 (1st Cir. 2018). “Because good

faith is a defense to criminal charges under Section

841(a) but not to civil liability for medical malpractice, ‘inclusion of a good faith instruction is . . . a plainspoken method of explaining to the jury a critical

difference between the two standards.’” Id. (quoting

United States v. Smith, 573 F.3d 639, 650 (8th Cir.

2009); see also United States v. Kohli, 847 F.3d 483,

489 (7th Cir. 2017); Feingold, 454 F.3d at 1006. Likewise, the Second, Fourth, and Sixth Circuits held that

a good-faith defense is “necessary” because, without

it, a physician might be convicted “for a gross mistake

or malpractice,” instead of “as a ‘drug pusher.’” United

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

also United States v. Hurwitz, 459 F.3d 463, 479–82

(4th Cir. 2006); United States v. Voorhies, 663 F.2d 30,

34 (6th Cir. 1981). Though it did not address what instruction the CSA requires, this Court in Moore took

no issue with lower court’s jury instruction to “find

beyond a reasonable doubt that a physician, who

knowingly or intentionally, did dispense or distribute

methadone by prescription, did so other than in good

faith for detoxification. . .” Moore, 423 U.S. at 138. But

the Eleventh Circuit’s holding collapses the meaning

of drug dealing and trafficking into noncompliance

with the standard of care.

C. Patients Benefit from State Control Over

Medical Practices

The CSA was ostensibly enacted to prevent harm

from drug abuse and dependence, but courts can

create a public-health crisis under it when they

criminalize good-faith, legitimate medical practice.

Approximately twenty million people in the United

States live with “high-impact chronic pain” which

impedes “life or work activities on most days or every

day.” James Dahlhamer et al., Prevalence of Chronic

Pain and High Impact Chronic Pain Among Adults,

67 Morbidity & Mortality Wkly. Rpt. 1001, 1002

(2018). Prescription opioids are essential for many of

these patients to function. Id. But “sixty to seventy

percent of all [chronic pain] patients do not receive

adequate pain relief.” Rima J. Oken, Curing

Healthcare Providers’ Failure to Administer Opioids

in the Treatment of Severe Pain, 23 Cardozo L. Rev.

1917, 1917 (2002).

Fear of prosecution is the primary reason

physicians deny patients the treatment they need.

Meredith Lawrence, How the CDC Guidelines Killed

My Husband, 8 Narrative Inquiry in Bioethics 219,

219–21 (2018). When the CDC issued new prescribing

guidelines for opioids in 2016, for example, many

practitioners unwillingly and inappropriately tapered

medications without adequate consideration for the

patient’s well-being, causing so much suffering and

death that the Food and Drug Administration and the

CDC issued warnings. Christine Vestal, “Rapid

Opioid Cutoff is Risky Too, Feds Warn,” Pew:

Stateline, May 15, 2019. This fear “compromise[s]

access to treatment for individuals with legitimate

medical needs . . . [creating] a chilling effect on

prescribers, . . . who are decreasing and altogether

ceasing their prescribing out of fear.” Michael C.

Barnes et al., Demanding Better: A Case for Increased

Funding and Involvement of State Medical Boards in

Response to America’s Drug Abuse Crisis, 106 J. Med.

Reg. 3, 6–21 (2020).

Regulators disproportionately focus on preventing

illegitimate diversion of opioids at the expense of the

human harms associated with insufficient access to

medication. Criminalizing prescribing practice

beyond “conventionally understood” trafficking leads

to widespread mortality, morbidity, and suicidality.

Moore, 423 U.S. at 342; Dineen, Definitions Matter, at

969–75 (describing the serious harms and deaths

from suicide and the shift to illicit drugs after

prescribers abandoned patients, abruptly stopped, or

rapidly tapered patients’ opioids out of fear of legal

scrutiny). When regulators cut the prescription opioid

supply, persons with chronic pain and substance-use

disorders often turn to dangerous illicit drugs like

illicitly manufactured fentanyl, cocaine, and

methamphetamines. Dineen, Definitions Matter, at

969. Many people with substance-use disorder today

lack access to evidence-based care entirely,

precluding effective harm-reduction measures from

taking place. Kelly K. Dineen & Elizabeth Pendo,

Substance Use Disorder Discrimination and the Cares

Act: Using Disability Law to Inform Part 2

Rulemaking, 52 Ariz. St. L.J. 1143, 1148 (2020).

This Court should limit DEA’s enforcement

authority to the narrow conditions specifically

contemplated by the CSA. Strict court review in this

area will ensure that enforcement doesn’t compromise

federalism and that patients face no more obstacles to

receiving the care they need.

III.

WITHOUT A SUBJECTIVE GOODFAITH COMPONENT, PRESCRIBING

PHYSICIANS DON’T KNOW WHEN

THEIR CONDUCT IS AT RISK OF

PUNISHMENT UNDER THE STATUTE

Subjecting medical doctors to the penalties of

Section 841(a)(1) of the Controlled Substances Act

even when they make a good-faith effort to issue

prescriptions only for “legitimate medical purpose . . .

in the usual course of [their] professional practice,” 21

C.F.R. § 1306.04(a), prevents medical doctors from

knowing when their conduct is at risk of punishment

under the statute. Unless the terms of a criminal

statute are “sufficiently explicit to inform those who

are subject to it what conduct on their part will render

them liable to its penalties,” that law violates due

process of law. Connally v. Gen. Constr. Co., 269 U.S.

385, 391 (1926). Medical doctors, like all persons,

must be “free to steer between lawful and unlawful

conduct[.]” Grayned v. City of Rockford, 408 U.S. 104,

108–09 (1972). Trapping “the innocent by not

providing fair warning” is the opposite of due process.

See id.

Moreover, without a reasonably determinate

standard, criminal statutes promote arbitrary and

discriminatory enforcement. Kolender v. Lawson, 461

U.S. 352, 357–58 (1983). Criminal statutes must

“establish minimal guidelines to govern law

enforcement.” Id. They must not create “a

standardless

sweep

that

allows

policemen,

prosecutors, and juries to pursue their personal

predilections." Id. (cleaned up).

Here, the Eleventh Circuit’s interpretation of the

CSA both traps innocent doctors and does not

sufficiently impede arbitrary enforcement. The

correct course of action, then, is to reject and Eleventh

Circuit’s view and apply a good-faith defense under

the CSA for medical practitioners prescribing

controlled substances.

A. There Is No One Discernable “Usual

Course of Their Professional Practice” to

which Practitioners Can Conform Their

Conduct

There is no objective standard for prescribing

opioids. To be sure, the concept of fair notice embodied

in the void for vagueness doctrine does not require

actual notice that a defendant’s actions violate the

law, but rather “that a defendant have constructive

notice that his act is criminal; that is, that the

defendant could have found out whether his conduct

was prohibited by the statute.” John F. Decker,

Addressing Vagueness, Ambiguity, and Other

Uncertainty in American Criminal Laws, 80 Denv. U.

L. Rev. 241, 248 (2002) (emphasis in original).

However, medical views on when to prescribe opioids

vary too much by context, are subject to too much

debate, and federal and state standards are too

ambiguous to permit prescribing doctors to discover

what Section 841(a)(1) of the CSA requires of them.

See Hoffmann, Treating Pain, at 291.

Federal standards for what qualifies as

inappropriate prescribing of opioids are either too

ambiguous to provide clarity for medical practitioners

or are inconsistent. For example, a 2016 CDC

Guideline for prescribing opioids for chronic pain

“does not define inappropriate prescribing at all.”

Dineen, Definitions Matter, at 961–62 (citing Deborah

Dowell et al., Ctrs. for Disease Control & Prevention,

CDC Guideline for Prescribing Opioid for Chronic

Pain-United States, 65 Morbidity & Mortality Wkly.

Rpt., Recommendations & Rpts. 1, 3 (2016)). 4 While

the Drug Enforcement Administration’s Practitioner

Manual lists criteria of what it sees as indicative of

“inappropriate prescribing,” much of the patterns it

lists provide little to no clarity for medical

professionals. Dineen, Definitions Matter, at 986–87.

The first criterion the Manual mentions is whether a

practitioner is prescribing an “inordinately large

quantity of controlled substances[.]” Off. of Diversion

Control, Drug Enforcement Admin., Practitioner’s

Manual 30 (2006). 5 But “‘inordinate’ amounts depend

4 Available at https://bit.ly/3H0tC9t.

5 Available at https://bit.ly/3H4gcJv.

upon context and prescriber specialty.” Dineen,

Definitions Matter, at 987. And while the FDA focuses

on “careless prescribing,” the FDA does not define

that term—a term that itself connotes a negligence

standard that is inappropriate in criminal law. Id. at

987–88 (citing Press Release, U.S. Food & Drug

Admin., Statement from FDA Commissioner Scott

Gottlieb, M.D., on Agency’s Approval of Dsuvia and

the FDA's Future Consideration of New Opioids (Nov.

2, 2018)). 6 Guidelines that medical doctors might

glean from other agencies are often inconsistent or

unhelpful as well. Id. Furthermore, asking doctors to

“glean” standards from outside sources to try to

determine the boundaries of criminal conduct is not

how criminal law should work.

Medical practitioners providing insufficient

prescriptions for patients in pain because of fear of

prosecution is further evidence that a purely objective

standard in this context is unhelpful. See id. at 992–

94. Certainly, there are additional factors at play for

why medical doctors are withholding opioid

prescriptions from patients in need, but there is

growing documentation that “many physicians

believe that the risk of incurring sanctions is too high

for them to continue prescribing opioids.” George

Comerci et al., Controlling the Swing of the Opioid

Pendulum, 378 New Eng. J. Med. 691, 691–93 (2018).

Indeed, there are reports that medical doctors

frequently “avoid opioid analgesics even in cases

when it contradicted their view of what would provide

the best care for their patients[.]” “Not Allowed to Be

Compassionate,” Human Rights Watch, 3–4 (Dec. 18,

6 Available at https://bit.ly/3snXMiT.

2018). 7 All of this suggests that medical practitioners

do not understand how to navigate any supposed

objective standard for treating patients with opioids.

Whereas an objective metric lacks the clarity

necessary to guide the conduct of medical

practitioners, recognizing some form of a good-faith

defense radically minimizes that problem. For

example, under a purely subjective construction of a

good-faith defense—which the First, Seventh, and

Ninth Circuits have all recognized—medical doctors

must only honestly attempt to prescribe controlled

substances in the best interest of their patients to

avoid federal criminal sanction. Sabean, 885 F.3d at

45; Kohli, 847 F.3d at 490–91; Feingold, 454 F.3d at

1008. Obviously, medical practitioners—with decades

of schooling and training as well as strict ethical rules

within the profession—can be expected to do that

much.

Moreover, even under a “reasonable belief”

standard, doctors are given much greater notice of the

requirements of federal law. Several federal circuits

interpret the CSA essentially to require medical

doctors to prescribe controlled substances “in

accordance with what [they] reasonably believe[] to be

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

482 (emphasis added); accord Wexler, 522 F.3d at

205–06; United States v. Godofsky, 943 F.3d 1011,

1022, 1027 (6th Cir. 2019). Under this approach,

prescribing doctors must sincerely attempt “to

conduct [themselves] in accordance with a standard of

medical practice generally recognized and accepted in

7 Available at https://bit.ly/3pgFWME.

the country.” Deborah Hellman, Prosecuting Doctors

for Trusting Patients, 16 Geo. Mason L. Rev. 701, 710

(2009) [hereinafter “Hellman, Prosecuting Doctors”]

(quoting Jury Instructions at 49, United States v.

Hurwitz (E.D. Va. Apr. 17, 2007) (No. 1:03CR467).

This standard is certainly more nebulous than a

purely subjective approach. See id. at 708–11. But at

least medical doctors would only be required by

federal law to attempt to conform to the constantly

evolving and highly contextual standards of medical

practice recognized in the country and not be locked

away for simply prescribing opioids in a situation that

a few fellow practitioners—in other words, expert

witnesses—believe was unwarranted.

B. An Objective Standard Turns the Vague

Requirements of Section 841(a)(1) into a

Strict Liability Crime for Doctors

It is common for doctors who sincerely believe they

are practicing good medicine to disagree with one

another. Sincere belief, however, is not a defense

under Section 841(a)(1) in the Eleventh Circuit,

making it functionally a strict liability crime.

Criminal juries are thus being asked to decide goodfaith medical disputes under vague standards, and

guilty verdicts can mean decades in prison, even for

doctors with the most benign motives.

Strict liability crimes “contradict[] the most basic

principles of modern criminal law.” Laurie L.

Levenson, Good Faith Defenses: Reshaping Strict

Liability Crimes, 78 Cornell L. Rev. 401, 401 (1993).

Thus, insofar as strict liability crimes are permissible,

courts should be reticent to “discover” them,

especially where, as here, there are so many

indications that the Eleventh Circuit is misreading

the CSA.

But even worse than a strict liability crime that

comes from the misreading of a statute is a strict

liability crime based on vague and indeterminable

standards. If strict liability crimes are to exist, the

standards should be clear enough that someone will

know when they have crossed a legal line.

Certainly physicians, like all persons, must

“knowingly or intentionally” distribute a controlled

substance to be convicted under the CSA. 21 U.S.C. §

841(a)(1). Of course, that is itself hardly a meaningful

scienter requirement for medical doctors who are

registered under the Act because they may do what is

generally forbidden “to the extent [that it is]

authorized by their registration.” Id. § 822(b).

But criminal statutes without a scienter

requirement are more likely to be void for vagueness,

because under such statutes defendants are more

likely to be convicted for simple mistakes. Gonzales v.

Carhart, 550 U.S. 124, 149 (2007). Just as with vague

objective standards, “strict liability crimes pose a

considerable risk that the criminal law will be

misused.” Paul J. Larkin, Jr., Strict Liability

Offenses, Incarceration, and the Cruel and Unusual

Punishments Clause, 37 Harv. J.L. & Pub. Pol’y 1065,

1091 (2014). As such, this Court consistently strives

to construe criminal statutes so as not to impose strict

liability. Id. at 1086 (citing Flores-Figueroa v. United

States, 556 U.S. 646, 657 (2009); United States v. XCitement Video, Inc., 513 U.S. 64, 78 (1994); Staples

v. United States, 511 U.S. 600 (1994); Liparota v.

United States, 471 U.S. 419, 433 (1985); United States

v. U.S. Gypsum Co., 438 U.S. 422, 435–36 (1978);

Morissette v. United States, 342 U.S. 246 (1952)). It

should continue that practice here.

CONCLUSION

This Court should reject the Eleventh’s Circuit’s

holding and rationale and affirm that physicians may

not be convicted under Section 841(a)(1) for

prescribing controlled substances outside the usual

course of professional practice when they either

“reasonably believed” or “subjectively intended” that

their prescriptions fall within that course of