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

No. 20-1410

In The

Supreme Court of the United States

____________________

XIULU RUAN,

Petitioner,

v.

UNITED STATES OF AMERICA,

____________________

Respondent.

On Writ of Certiorari

to the United States Court of Appeals

for the Eleventh Circuit

____________________

BRIEF AMICUS CURIAE OF PACIFIC LEGAL

FOUNDATION IN SUPPORT OF PETITIONER

____________________

CALEB KRUCKENBERG

OLIVER J. DUNFORD

Counsel of Record

JOHN F. KERKHOFF

Pacific Legal Foundation

Pacific Legal Foundation

3100 Clarendon Blvd

4440 PGA Blvd., Suite 307

Suite 610

Palm Beach Gardens, FL

Arlington, VA 22201

33410

Telephone: 202.888.6881

Telephone: (916) 503.9060

CKruckenberg@pacificlegal.org ODunford@pacificlegal.org

JKerkhoff@pacificlegal.org

Counsel for Amicus Curiae

Pacific Legal Foundation

i

Table of Contents

TABLE OF AUTHORITIES ...................................... iii

IDENTITY AND INTEREST OF AMICUS

CURIAE ...................................................................... 1

INTRODUCTION AND SUMMARY OF

ARGUMENT ............................................................... 2

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

I. CONGRESS PROHIBITED PRESCRIBING A

CONTROLLED SUBSTANCE ONLY WHEN

DONE WITH KNOWLEDGE THAT THE

PRESCRIPTION WAS ISSUED OUTSIDE

THE COURSE OF PROFESSIONAL

PRACTICE......................................................... 3

II. ALLOWING CONVICTIONS FOR MERE

DEPARTURES FROM PROFESSIONAL

PRACTICE, REGARDLESS OF A

PHYSICIAN’S INTENT, WOULD

JEOPARDIZE CONSTITUTIONAL

PROTECTIONs ................................................. 6

A. The Statute Requires Knowledge of

Wrongdoing .................................................. 6

B. Only Congress May Create a New Criminal

Offense; Allowing DEA To Do So Violates

the Non-Delegation Doctrine ...................... 8

C. Due Process Forbids Criminalizing Good

Faith Efforts To Comply With the CSA .... 13

D. The Rule of Lenity Was Designed To

Prevent These Constitutional Problems ... 16

ii

CONCLUSION.......................................................... 19

iii

Table of Authorities

Page(s)

Cases

A.L.A. Schecter Poultry Corp. v. United

States,

295 U.S. 495 (1935) ........................................... 10

Abramski v. United States,

573 U.S. 169 (2014) ........................................... 19

Bowen v. Georgetown Univ. Hosp.,

488 U.S. 204 (1988) ............................................. 8

Chevron, U.S.A., Inc. v. Nat. Res. Def.

Council, Inc.,

467 U.S. 837 (1984) ............................................. 8

Edward J. DeBartolo Corp. v. Fla. Gulf

Coast Bldg. & Constr. Trades Council,

485 U.S. 568 (1988) ............................................. 9

Elonis v. United States,

575 U.S. 723 (2015) ............................... 14, 15, 16

Guedes v. Bureau of Alcohol, Tobacco,

Firearms & Explosives,

140 S. Ct. 789 (2020) ......................................... 18

Gundy v. United States,

__ U.S. __, 139 S. Ct. 2116 (2019) ..... 9, 10, 12, 13

Lambert v. People of the State of California,

355 U.S. 225 (1957) ........................................... 14

iv

Liparota v. United States,

471 U.S. 419 (1985) ........................... 9, 13, 17, 18

Lucia v. SEC,

138 S. Ct. 2044 (2018) ......................................... 1

McBoyle v. United States,

283 U.S. 25 (1931) ............................................. 17

Mistretta v. United States,

488 U.S. 361 (1989) ............................................. 9

Morissette v. United States,

342 U.S. 246 (1952) ............................... 14, 15, 16

Panama Refining Co. v. Ryan,

293 U.S. 388 (1935) ............................................. 9

Paul v. United States,

__ U.S. __, 140 S. Ct. 342 (2019) ....................... 10

People ex rel. Price v. Sheffield FarmsSlawson-Decker Co., 225 N.Y. 25, 32–33

(1918) ................................................................ 15

Rapanos v. United States,

547 U.S. 715 (2006) ............................................. 1

Sackett v. EPA,

566 U.S. 120 (2012) ............................................. 1

Touby v. United States,

500 U.S. 160 (1991) ........................................... 12

U.S. Army Corps of Eng’rs v. Hawkes Co.,

Inc.,

136 S. Ct. 1807 (2016) ......................................... 1

v

United States v. Apel,

571 U.S. 359 (2014) ........................................... 19

United States v. Bass,

404 U.S. 336 (1971) ........................................... 17

United States v. Eaton,

144 U.S. 677 (1892) ........................................... 11

United States v. Guerrero,

650 F.2d 728 (5th Cir. 1981) ............................... 7

United States v. Hurwitz,

459 F.3d 463 (4th Cir. 2006) ............................... 7

United States v. Joseph,

709 F.3d 1082 (11th Cir. 2013) ........................... 7

United States v. Moore,

423 U.S. 122 (1975) ......................................... 4, 6

United States v. Nasir,

17 F.4th 459 (3d Cir. 2021) ......................... 17, 18

United States v. Phifer,

909 F.3d 372 (11th Cir. 2018) ........................... 18

United States v. Santos,

553 U.S. 507 (2008) ........................................... 17

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

438 U.S. 422 (1978) ..................................... 15, 16

United States v. Wiltberger,

18 U.S. (1 Wheat.) 76 (1820) ............................. 17

vi

Wayman v. Southard,

23 U.S. 1 (1825) ................................................. 11

Statutes

21 U.S.C. § 802(21) ................................................... 4

21 U.S.C. § 822(b) ..................................................... 4

21 U.S.C. § 829(a) ..................................................... 3

21 U.S.C. § 841(a)(1) ................................. 3, 7, 12, 16

21 U.S.C. §§ 842(a), 843(a) ....................................... 4

21 U.S.C. § 871(a), (b) ............................................... 5

Regulations

21 C.F.R. § 1306.04 ................................................... 5

21 C.F.R. § 1306.04(a)........................................... 5, 7

1

IDENTITY AND INTEREST OF

AMICUS CURIAE 1

Founded in 1973, Pacific Legal Foundation is a

nonprofit,

tax-exempt,

California

corporation

established for the purpose of litigating matters

affecting the public interest. PLF provides a voice in

the courts for Americans who believe in limited

constitutional government, private property rights,

and individual freedom.

PLF is the most experienced public-interest

legal organization defending the constitutional

principle of separation of powers in the arena of

administrative law. PLF’s attorneys have participated

as lead counsel in several cases involving the role of

the Judicial Branch as an independent check on the

Executive and Legislative branches under the

Constitution’s Separation of Powers. See U.S. Army

Corps of Eng’rs v. Hawkes Co., Inc., 136 S. Ct. 1807

(2016) (judicial review of agency interpretation of

Clean Water Act); Sackett v. EPA, 566 U.S. 120 (2012)

(same); Rapanos v. United States, 547 U.S. 715 (2006)

(agency regulations defining “waters of the United

States”). It also regularly participates in this Court as

amici. See, e.g., Lucia v. SEC, 138 S. Ct. 2044 (2018)

1 After timely notice was given, counsel for all parties have

consented to the filing of this brief. Pursuant to Rule 37.6,

Amicus Curiae affirms that no counsel for any party authored

this brief in whole or in part, and no counsel or party made a

monetary contribution intended to fund the preparation or

submission of this brief. No person other than Amicus Curiae, its

members, or its counsel made a monetary contribution to its

preparation or submission.

2

(SEC administrative-law judge is “officer of the

United States” under the Appointments Clause).

This case addresses the role that an

administrative agency has in creating a federal

criminal offense. The decision under review allowed a

prosecutorial agency to define a criminal offense, and

even create criminal liability without an element of

the defendant’s knowledge of wrongdoing. PLF,

therefore, writes separately to explain how the result

below threatens the separation of powers and defies

core precepts of due process.

INTRODUCTION AND

SUMMARY OF ARGUMENT

Dr.

Xiulu

Ruan

was

convicted

of

overprescribing controlled substances outside the

usual course of medical practice and was sentenced to

more than 20 years in federal prison. But as the lower

court held, to obtain this extraordinary prison

sentence, the government never had to prove that Dr.

Ruan was aware that he failed to live up to the

prevailing standard of care.

That analysis botches the statutory text (as Dr.

Ruan argues). But it also threatens important

constitutional norms. The question dividing the courts

of appeal centers not on statutory text, but on a

regulation issued by the Drug Enforcement Agency,

an arm of the same Department of Justice prosecuting

Dr. Ruan. Through that regulation, DEA created

criminal liability where there was none before, by

eliminating any requirement that a physician be

aware that his conduct departs from professional

3

practice. Congress cannot (and did not) delegate such

lawmaking authority to an agency, and, even if it

could, due process requires more notice to a criminal

defendant before he can be imprisoned for decades.

That constitutional requirement means that statutory

text permits only one outcome—reading the statute to

prohibit only knowing departures from acceptable

standards of practice. A DEA regulation cannot

supplant statutory text and due process.

ARGUMENT

I.

CONGRESS PROHIBITED PRESCRIBING A

CONTROLLED SUBSTANCE ONLY WHEN

DONE WITH KNOWLEDGE THAT THE

PRESCRIPTION WAS ISSUED OUTSIDE THE

COURSE OF PROFESSIONAL PRACTICE

The Controlled Substances Act makes it

unlawful “except as authorized” by the DEA, to

“knowingly or intentionally” “distribute, or dispense”

“a controlled substance.” 21 U.S.C. § 841(a)(1). To

ensure that this prohibition encompassed the practice

of medicine, Congress also provided that “no

controlled substance . . . may be dispensed without the

written prescription of a practitioner.” 21 U.S.C.

§ 829(a) (Schedule II substances). And stating the

opposite, Congress said that “[p]ersons registered by

the Attorney General” “to distribute, or dispense

controlled substances” “are authorized” to do so, “to

the extent authorized by their registration and in

4

conformity with the other provisions of” the CSA. 21

U.S.C. § 822(b). 2

“Section 822(b) defines the scope of

authorization under the Act in circular terms” though.

Moore, 423 U.S. at 140. But, according to this Court,

“the scheme of the statute, viewed against the

background of the legislative history, reveals an

intent to limit a registered physician’s dispensing

authority to the course of his ‘professional practice.”

Id. Congress defined the term “practitioner,” who is

forbidden to dispense controlled substances without a

prescription under Section 829, to mean “a physician

… permitted, by the United States or the jurisdiction

in which he practices or does research, to distribute,

dispense, conduct research with respect to,

administer, or use in teaching or chemical analysis, a

controlled substance in the course of professional

practice or research.” 21 U.S.C. § 802(21) (emphasis

added).

Congress stopped there, however, and left it up

to the DEA to figure out exactly when, and how,

medical practitioners could dispense controlled

substances “in the course of professional practice.”

Congress provided simply that the “Attorney General

may promulgate and enforce any rules, regulations,

2 Congress also criminalized distribution or dispensing of

controlled substances by a “registrant” when “not authorized by

his registration” or without an appropriate order form. See 21

U.S.C. §§ 842(a), 843(a). These offenses came with lesser

penalties than Section 841, and this Court has held that they do

not displace liability under Section 841 for physicians who

dispense controlled substances. United States v. Moore, 423 U.S.

122, 137 (1975).

5

and procedures which he may deem necessary and

appropriate for the efficient execution of” the CSA,

and the Attorney General was also authorized to

“delegate any of his functions under this subchapter

to any officer or employee of the Department of

Justice.” 21 U.S.C. § 871(a), (b).

The DEA, acting on this delegation provision,

promulgated 21 C.F.R. § 1306.04. That regulation

says that either a “prescribing practitioner” or “the

pharmacist who fills the prescription” “shall be

subject to the penalties provided for violations of the

provisions of law relating to controlled substances”

when the prescription was “issued not in the usual

course of professional treatment or in legitimate and

authorized research” or “issued for a legitimate

medical purpose.” Id. at § 1306.04(a). The regulation

is silent concerning good faith, or any mens rea

concerning the course of professional practice, but

instead attaches liability merely for “knowingly

filling” a prescription issued outside the course of

professional practice. Id.

As Dr. Ruan notes, the interpretation of that

regulation started the Circuits down multiple,

conflicting, and often internally inconsistent paths.

PLF agrees with Dr. Ruan that the Eleventh Circuit’s

strict-liability approach cannot be reconciled with the

regulation. Indeed, Dr. Ruan was convicted based on

an instruction saying that “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.” App. App’x at 139a. This says nothing about

6

the need for Dr. Ruan to knowingly depart from

professional practice, and it did not consider Dr.

Ruan’s subjective good faith. Id. Yet this Court

previously approved an instruction saying that a

defendant “could not be convicted if he merely made

‘an honest effort’ to prescribe ... in compliance with an

accepted standard of medical practice,” so the

Eleventh Circuit’s approach was wrong. See Moore,

423 U.S. at 142 n.20.

II.

ALLOWING CONVICTIONS FOR MERE

DEPARTURES FROM PROFESSIONAL

PRACTICE, REGARDLESS OF A PHYSICIAN’S

INTENT, WOULD JEOPARDIZE

CONSTITUTIONAL PROTECTIONS

Aside from simply misreading the statute, the

Eleventh Circuit’s approach raises more fundamental

problems. The lower court’s holding would allow DEA

to define the bounds of criminal liability in spite of

statutory limits. That holding would have DEA define

a criminal offense in a vacuum, without any

Congressional oversight, and without any respect for

constitutional imperatives of fair notice and the

separation of powers.

A. The Statute Requires Knowledge of

Wrongdoing

The blame for the Eleventh Circuit’s error lies

squarely at the feet of DEA, as its regulation

purporting to define the scope of criminal liability for

physicians is anything but clear. The disagreement

over “good faith” actually appears to reflect a much

more basic question about what role the statutory

7

mens rea requirement serves, as well as what the

agency meant when it said that liability arises for

“knowingly” filling or issuing a prescription issued

outside the course of professional practice. See 21

U.S.C. § 841(a)(1); 21 C.F.R. § 1306.04(a).

Recall that the statute prohibits “knowing or

intentional” conduct. See 21 U.S.C. § 841(a)(1).

Several circuits, including the Eleventh, have noted

that the statute and regulation, therefore, require

proof that a physician knew the prescription was not

issued in the course of professional practice. See, e.g.,

United States v. Joseph, 709 F.3d 1082, 1094 (11th

Cir. 2013) (“To convict a licensed physician under

section 841(a)(1), it is incumbent upon the

government to prove that he dispensed controlled

substances for other than legitimate medical purposes

in the usual course of professional practice, and that

he did so knowingly and intentionally. And to convict

a licensed pharmacist under section 841(a)(1), the

government must prove that the pharmacist filled a

prescription knowing that a physician issued the

prescription without a legitimate medical purpose or

outside the usual course of professional practice.”)

(citations omitted); United States v. Guerrero, 650

F.2d 728, 730 (5th Cir. 1981) (“To convict Dr.

Guerrero, it was incumbent upon the government to

prove that he dispensed controlled substances for

other than legitimate medical purposes in the usual

course of professional practice, and that he did so

knowingly and intentionally.”). The good-faith issue

arguably diverts from this more basic knowledge

requirement. See United States v. Hurwitz, 459 F.3d

463, 475 (4th Cir. 2006) (vacating conviction on other

grounds, and not reaching question of whether good

8

faith instruction improperly “required the jury to

apply the knowledge requirement only to Hurwitz’s

act of writing a prescription, and that the instructions

therefore permitted the jury to convict even if it

concluded that Hurwitz did not know that any given

prescription was not for a legitimate medical purpose

or was beyond the bounds of medical practice”).

The DEA cannot, via regulation, displace the

statute’s mens rea requirement. “It is axiomatic that

an administrative agency’s power to promulgate

legislative regulations is limited to the authority

delegated by Congress.” Bowen v. Georgetown Univ.

Hosp., 488 U.S. 204, 208 (1988). Thus, if “Congress

has directly spoken to the precise question at issue,”

“that is the end of the matter; for the court, as well as

the agency, must give effect to the unambiguously

expressed intent of Congress.” Chevron, U.S.A., Inc. v.

Nat. Res. Def. Council, Inc., 467 U.S. 837, 842–43

(1984). And if the statute requires proof that a

physician knew that he acted outside the scope of

professional practice, then it also requires that he not

act in good faith. After all, if a physician genuinely

believed he acted in the course of professional

practice, even erroneously, it’s hard to see how he

“knew” his conduct was unlawful.

B. Only Congress May Create a New

Criminal Offense; Allowing DEA To Do

So Violates the Non-Delegation

Doctrine

If the statute isn’t clear on this point, though,

then much larger problems arise about DEA’s

authority. The canon of constitutional avoidance

9

instructs that a court must “construe [a] statute to

avoid [serious constitutional] problems unless such

construction is plainly contrary to the intent of

Congress.” Edward J. DeBartolo Corp. v. Fla. Gulf

Coast Bldg. & Constr. Trades Council, 485 U.S. 568,

575 (1988). This rule of construction prevails even

concerning an ambiguous statute or regulation over

which an agency ordinarily would be entitled to

interpretive deference. Id. at 574–75.

Article I of the Constitution provides that “[a]ll

legislative Powers herein granted shall be vested in a

Congress of the United States.” U.S. Const. art. I, § 1.

Moreover, “[t]he definition of the elements of a

criminal offense is entrusted to the legislature,

particularly in the case of federal crimes, which are

solely creatures of statute.” Liparota v. United States,

471 U.S. 419, 424 (1985). Agencies, therefore, may not

exercise Congress’s legislative power to declare “what

circumstances … should be forbidden” by criminal

laws. Panama Refining Co. v. Ryan, 293 U.S. 388,

418–19 (1935).

It’s no secret, however, that this Court has

struggled with defining the limits on the legislature’s

delegation of its authority. Traditionally the Court

has allowed agencies to exercise authority so long as

Congress set out an “intelligible principle to which the

person or body authorized to [exercise the authority]

is directed to conform.” Mistretta v. United States, 488

U.S. 361, 372 (1989). But that test lacks clear

contours. Furthermore, five members of the Court

have recently expressed interest in at least exploring

a reconsideration of that standard. See Gundy v.

United States, __ U.S. __, 139 S. Ct. 2116, 2131–42

10

(2019) (Gorsuch, J., dissenting, joined by Roberts,

C.J., and Thomas, J.); id. at 2130–31 (Alito, J.,

concurring in the judgment); Paul v. United States, __

U.S. __, 140 S. Ct. 342 (2019) (mem.) (Kavanaugh, J.,

statement respecting the denial of certiorari) (stating

that the issues raised in the Gundy dissent “may

warrant further consideration in future cases”).

Of course, even under the “intelligible

principle” standard, this Court has suggested that it

would present “a nondelegation question” if a statute

provides an agency with “unguided” or “unchecked”

authority to define a crime. Gundy, 139 S. Ct. at 2123

(plurality op.). While “administrative” rules

implementing a statute are one thing, rules creating

a new crime are quite another. See id. at 2129.

Moreover, as Justice Gorsuch recently

highlighted in his dissenting opinion in Gundy, a

delegation that “purports to endow the nation’s chief

prosecutor with the power to write his own criminal

code” “scrambles th[e] design” of the Constitution,

which “promises that only the people’s elected

representatives may adopt new federal laws

restricting liberty.” 139 S. Ct. at 2131.

“[W]e know that as long as Congress makes the

policy decisions when regulating private conduct, it

may authorize another branch to fill up the details.”

Id. at 2136. But the opposite is true as well—when

Congress leaves policy decisions up to another branch,

it unlawfully divests itself of power. See A.L.A.

Schecter Poultry Corp. v. United States, 295 U.S. 495,

529 (1935). What constitutes a “policy decision[]” was

illustrated as far back as 1825, when the Court upheld

11

a statute that instructed the federal courts to borrow

state-court procedural rules but allowed them to make

certain “alterations and additions.” Wayman v.

Southard, 23 U.S. 1, 1 (1825). Writing for the Court,

Chief Justice Marshall distinguished between those

“important subjects, which must be entirely regulated

by the legislature itself,” and “those of less interest, in

which a general provision may be made, and power

given to those who are to act ... to fill up the details.”

Id. at 21.

The Court provided a concrete example of this

distinction in United States v. Eaton, 144 U.S. 677

(1892). There, the Court struck down a series of

federal tax regulations that purported to impose

criminal liability even though Congress had not set

out a penalty provision. Id. at 688. As there were “no

common-law offenses against the United States,” it

was up to Congress to provide criminal punishment

for violation of a regulation. Id. at 687. The decision of

whether to punish something as a crime could not be

wholly delegated to an agency, because “[i]t would be

a very dangerous principle” to allow an agency to issue

regulations that, themselves, carried criminal

penalties under the general rubric of being “a needful

regulation” to enforce a statute. Id. at 688. Thus, the

Court held that “[i]t is necessary that a sufficient

statutory authority should exist for declaring any act

or omission a criminal offense,” even if the agency

could otherwise issue regulations that had, “in a

proper sense, the force of law[.]” Id.

In more recent cases this Court has also

questioned whether “something more than an

‘intelligible principle’ is required when Congress

12

authorizes another Branch to promulgate regulations

that contemplate criminal sanctions.” Touby v. United

States, 500 U.S. 160, 165–66 (1991). Indeed, this

Court assumed so where it allowed the Attorney

General to add a substance to a list of prohibited drugs

temporarily if he determined that doing so was

“necessary to avoid an imminent hazard to the public

safety.” Id. at 166 (1991). But, importantly, the Court

blessed the scheme under review in that case because

it delegated a fact-finding role, instead of the policy

question of whether something should be a crime. See

id. As described by Justice Gorsuch, “In approving the

statute, the Court stressed all the[] constraints on the

Attorney General’s discretion and, in doing so, seemed

to indicate that the statute supplied an ‘intelligible

principle’ because it assigned an essentially factfinding responsibility to the executive.” Gundy, 139 S.

Ct. at 2141. This Court must be especially wary,

however, when Congress purports to allow an agency

to exercise criminal policy-making authority. See id.

If there truly is no conflict between Section

841(a)(1) and DEA’s regulations defining what it

means to be “authorized” to prescribe controlled

substances, then Congress has impermissibly allowed

the Executive Branch to write criminal laws. The

delegation is breathtaking—any act of prescribing

controlled substances is a federal crime “except as

authorized” by DEA. 21 U.S.C. § 841(a)(1). The default

is criminality, abated only by the Attorney General’s

good grace—the grace of the prosecutor responsible

for enforcing the statute. The statute doesn’t even

provide limiting principles or guidance on these

questions. Moreover, if, as the court below concluded,

DEA responded to this delegation by criminalizing

13

even unwitting departures from professional

standards, then Congress’s delegation allowed the

prosecution to create a strict liability crime out of

nothing. Surely such “unguided” or “unchecked”

authority to define a crime presents “a nondelegation

question.” See Gundy, 139 S. Ct. at 2123 (plurality

op.). More likely it “scrambles th[e] design” of the

Constitution” See id. at 2131 (Gorsuch, J., dissenting).

Make no mistake—DEA’s creation of a

professional practice offense is an exercise in pure

Congressional policymaking. Defining a criminal

offense, such as how one is guilty of federal drug

offenses, is something that “is entrusted to the

legislature.” See Liparota, 471 U.S. at 424. DEA has

no authority to create a crime, much less exercise the

power to arbitrarily withhold criminal punishment

except where it sees fit.

C. Due Process Forbids Criminalizing

Good Faith Efforts To Comply With

the CSA

Yet another vital constitutional principle

dooms DEA’s attempt to create a crime lacking any

culpable state of mind. Basics of fair notice would

likely prevent Congress from writing a statute

criminalizing good faith mistakes by medical

professionals. DEA certainly cannot escape that same

limit.

“The contention that an injury can amount to a

crime only when inflicted by intention is no provincial

or transient notion. It is as universal and persistent

in mature systems of law as belief in freedom of the

14

human will and a consequent ability and duty of the

normal individual to choose between good and evil.”

Morissette v. United States, 342 U.S. 246, 250 (1952).

Thus, “mere omission from [a statute] of any mention

of intent will not be construed as eliminating that

element from the crimes denounced.” Id. at 263. “This

rule of construction reflects the basic principle that

wrongdoing must be conscious to be criminal.” Elonis

v. United States, 575 U.S. 723, 734 (2015) (citation

omitted).

Thus, strict liability here might violate due

process. “Engrained in our concept of due process is

the requirement of notice. Notice is sometimes

essential so that the citizen has the chance to defend

charges.” Lambert v. People of the State of California,

355 U.S. 225, 228 (1957). If a person is not aware that

his conduct is forbidden, and has no ability to learn so,

due process bars “the imposition of heavy criminal

penalties.” Id. at 230 “Were it otherwise, the evil

would be as great as it is when the law is written in

print too fine to read or in a language foreign to the

community.” Id.

The need for a presumption of mens rea also

maintains the separation of powers, which are critical

to ensuring liberty. “The spirit of the doctrine which

denies to the federal judiciary power to create crimes

forthrightly admonishes that we should not enlarge

the reach of enacted crimes by constituting them from

anything less than the incriminating components

contemplated by the words used in the statute.”

Morissette, 342 U.S. at 263.

15

To be sure, this Court has noted that a “limited

class” of strict liability “offenses against [] statutory

regulations” might comport with constitutional limits.

Id. at 258. But it has also stressed that this exception

applies only when such offenses “were punishable only

by fine moderate in amount,” and “in sustaining the

power so to fine unintended violations we are not to be

understood as sustaining to a like length the power to

imprison.” Id. at 257–58 (quoting People ex rel. Price

v. Sheffield Farms-Slawson-Decker Co., 225 N.Y. 25,

32–33 (1918)). Thus, in a case where a regulatory

offense also came with the possibility of a penalty of

up to three years’ imprisonment, this Court refused to

expose “a good-faith error of judgment” to criminal

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

U.S. 422, 442 (1978). Otherwise, the “criminal

sanctions would be used, not to punish conscious and

calculated wrongdoing at odds with statutory

proscriptions, but instead simply to regulate business

practices regardless of the intent with which they

were undertaken.” Id. (emphasis in original).

The lower court’s interpretation of the statute

threatens these constitutional protections. Dr. Ruan

faced prosecution regardless of his subjective good

faith, based only on an objective standard of whether

he departed, even unwittingly, from professional

practice. Such an objective standard is “inconsistent

with the conventional requirement for criminal

conduct—awareness of some wrongdoing.” See Elonis,

575 U.S. at 738 (citation omitted). Liability based on

an abstract notion of the correct standard of care—

“regardless of what the defendant thinks—reduces

culpability on the all-important element of the crime

to negligence, and we have long been reluctant to infer

16

that a negligence standard was intended in criminal

statutes.” Id. (citations omitted). How could Dr. Ruan

have fair notice of his offense if he lacked any

opportunity to “choose between good and evil?” See

Morissette, 342 U.S. at 250. Moreover, allowing DEA

to “enlarge the reach of [the] enacted crimes” in

Section 841(a)(1) in such a way, doubly frustrates the

guarantees protected by the separation of powers. See

id. at 263.

It is also no excuse for DEA to claim that this is

a “regulatory” offense. Dr. Ruan was sentenced to

more than 20 years in federal prison for violating

Section 841(a)(1), which is the main authority for all

types of drug federal prosecutions. Dr. Ruan clearly

did not suffer a “fine moderate in amount,” for his

offense. See id. at 257–58. Nor was he prosecuted

under a limited regulatory regime. See id. If the

regulation omits a knowledge requirement, then the

harsh punishments set out by the CSA would simply

regulate the medical profession through the threat of

arbitrary punishment. See U.S. Gypsum Co., 438 U.S.

at 442.

D. The Rule of Lenity Was Designed To

Prevent These Constitutional

Problems

This Court has long used a tool of statutory

construction to avoid the precise constitutional

problems discussed above—the rule of lenity. It

should use that rule again now and reject DEA’s effort

to create a new strict liability offense in the absence of

Congressional direction.

17

“[R]equiring mens rea is in keeping with our

longstanding recognition of the principle that

ambiguity concerning the ambit of criminal statutes

should be resolved in favor of lenity.” Liparota, 471

U.S. at 427 (citation omitted). The rule of lenity is a

tool of construction “perhaps not much less old than

construction itself.” United States v. Wiltberger, 18

U.S. (1 Wheat.) 76, 95 (1820). In simple terms, “lenity

requires ambiguous criminal laws to be interpreted in

favor of the defendants subjected to them.” United

States v. Santos, 553 U.S. 507, 514 (2008). Three “core

values of the Republic” underlie the rule of lenity: (1)

due process; (2) the separation of governmental

powers; and (3) “our nation’s strong preference for

liberty.” United States v. Nasir, 17 F.4th 459, 473 (3d

Cir. 2021) (en banc) (Bibas, J., concurring).

Due process requires that “a fair warning

should be given to the world in language that the

common world will understand, of what the law

intends to do if a certain line is passed. To make the

warning fair, so far as possible the line should be

clear.” McBoyle v. United States, 283 U.S. 25, 27

(1931). By construing ambiguities in the defendant’s

favor, lenity prohibits criminal consequences when

Congress did not provide a fair warning through clear

statutory language. Id.

Lenity also protects the freedoms protected by

the separation of powers: the legislature criminalizes

conduct and sets statutory penalties, the executive

prosecutes crimes, and the judiciary interprets the

law’s reach. United States v. Bass, 404 U.S. 336, 348

(1971). Lenity “strikes the appropriate balance

between the legislature, the prosecutor, and the court

18

in defining criminal liability.” Liparota, 471 U.S. at

427.

Finally, and “perhaps most importantly,” lenity

“embodies ‘the instinctive distaste against men

languishing in prison unless the lawmaker has clearly

said they should.’” Nasir, 17 F.4th at 472 (Bibas, J.,

concurring) (quoting Bass, 404 U.S. at 347). By

promoting liberty, lenity “fits with one of the core

purposes of our Constitution, to ‘secure the Blessings

of Liberty’ for all[.]” Id. (quoting U.S. Const. pmbl.).

The rule of lenity is simply the mechanism this

Court must employ to avoid the constitutional errors

intrinsic to the Eleventh Circuit’s decision. Congress

did not criminalize accidental departures from the

standards of professional practice by prescribing

physicians. It did not intend for doctors to languish in

federal prison for decades based on good faith

mistakes. But if there was some question about

Congressional choice, then this Court must come

down on the only side that respects due process and

the separate roles that it, Congress, and the

prosecution play. This Court should therefore require

proof of a physician’s knowledge that he has departed

from professional practice, knowledge that can be

negated by his subjective good faith efforts to comply

with prevailing standards. 3

3 The Eleventh Circuit did not address the possibility that the

government’s reading of the relevant regulation warranted

interpretive deference. But that was because interpretive

“deference does not apply in criminal cases,” because it is

“defeat[ed]” by the “rule of lenity.” United States v. Phifer, 909

F.3d 372, 384–85 (11th Cir. 2018); see also Guedes v. Bureau of

Alcohol, Tobacco, Firearms & Explosives, 140 S. Ct. 789, 790

19

CONCLUSION

Dr. Ruan’s prosecution irrespective of his

subjective good faith efforts to comply with the law is

constitutionally untenable. Congress did not impose

criminal liability in such instances. But a regulatory

agency, particularly a prosecutorial one, cannot

decide, on its own, that such conduct should be

unlawful. Fair notice, the separation of powers, and

our constitution’s essential desire to maximize liberty

must not be so casually cast aside.

DATED: December 2021.

Respectfully submitted,

CALEB KRUCKENBERG

OLIVER J. DUNFORD

Counsel of Record

JOHN F. KERKHOFF

Pacific Legal Foundation

Pacific Legal Foundation

3100 Clarendon Blvd

4440 PGA Blvd., Suite 307

Suite 610

Palm Beach Gardens, FL

Arlington, VA 22201

33410

Telephone: 202.888.6881

Telephone: (916) 503.9060

CKruckenberg@pacificlegal.org ODunford@pacificlegal.org

JKerkhoff@pacificlegal.org

Counsel for Amicus Curiae

Pacific Legal Foundation

(2020) (Gorsuch, J., statement regarding denial of certiorari)

(“[W]hen liberty is at stake,” deference “has no role to play.”);

Abramski v. United States, 573 U.S. 169, 191 (2014) (“The critical

point is that criminal laws are for courts, not for the Government,

to construe.”); United States v. Apel, 571 U.S. 359, 369 (2014)

(“[W]e have never held that the Government’s reading of a

criminal statute is entitled to any deference.”).