Amicus Curiae Brief — Xiulu Ruan and John Patrick Couch, Petitioners v. United States

Supreme Court briefJul 3, 2023

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No. 22-1175

IN THE

Supreme Court of the United States

DR. XIULU RUAN AND DR. JOHN PATRICK COUCH,

Petitioners,

UNITED STATES OF AMERICA,

Respondent.

On Petition for a Writ of Certiorari to the United

States Court of Appeals for the Eleventh Circuit

BRIEF OF AMICI CURIAE ASSOCIATION OF

AMERICAN PHYSICIANS AND SURGEONS

AND JEFFREY A. SINGER, M.D., IN SUPPORT

OF PETITIONERS

ANDREW L. SCHLAFLY

939 OLD CHESTER ROAD

FAR HILLS, NJ 07931

(908) 719-8608

aschlafly@aol.com

Counsel for Amici Curiae

QUESTION PRESENTED

In Ruan v. United States, 142 S. Ct. 2370 (2022),

this Court held that a physician may be convicted

under 21 U.S.C. § 841(a)(1) of the Controlled

Substances Act (“CSA”) only if the government

proves that the defendant “knew or intended that

his or her conduct was unauthorized.” Id. at 2382

(emphasis added). The Court remanded

Petitioners’ case to the Eleventh Circuit, and Dr.

Shakeel Kahn’s companion case to the Tenth

Circuit, so that those courts could consider

whether the jury instructions comported with the

“except as authorized” requirement of the statute.

The question presented, on which the circuits

are divided, is whether, in a CSA jury instruction,

21 C.F.R. § 1306.04(a) may replace the statute’s

“except as authorized” requirement, thereby

permitting the jury to convict a physician simply

because she knew that her prescription would fall

outside the “usual” course of medical practice or

would be regarded as “illegitimate” by most other

doctors, and thus empowering a federal agency to

create a felony offense that Congress itself did not

enact.

TABLE OF CONTENTS

Pages

Question Presented................................................. i

Table of Contents ................................................... ii

Table of Authorities .............................................. iii

Interests of Amici Curiae ...................................... 1

Summary of Argument .......................................... 2

Argument ............................................................... 4

I. The Petition Should Be Granted to Attain

Consistent Fidelity by the Lower Courts to the

Mens Rea Test Articulated by this Court. ............ 4

II. The Substitute Regulatory Wording Is

Improper, Defective, and Inadequate as

Jury Instructions for Multiple Reasons ................ 6

A. It Is Improper to Use Regulatory

Wording as the Definition of a Felony

Punishable by Decades in Prison ................... 7

B. The Regulatory Wording Used Below

Contravenes Ruan and Morissette by

Obscuring the Requisite Mens Rea. ............... 9

C. The Regulatory Jargon Extends

Beyond What Can Be Reasonably

Expected of a Jury to Understand ................ 11

D. The Regulatory Wording Makes Nearly

Every Physician a Felon, Contrary to what

Congress Enacted .......................................... 13

Conclusion ............................................................ 14

iii

TABLE OF AUTHORITIES

Pages

Cases

Am. Iron & Steel Inst. v. EPA,

115 F.3d 979 (D.C. Cir. 1997) ....................... 12

Am. Trucking Ass’ns v. Smith,

496 U.S. 167 (1990) ......................................... 5

Ass’n of Am. Physicians & Surgs. v. Clinton,

997 F.2d 898 (D.C. Cir. 1993) ......................... 2

Ass’n of Am. Physicians & Surgs. v.

Mathews, 423 U.S. 975 (1975)......................... 1

Ass’n of Am. Physicians & Surgs. v. Tex. Med.

Bd., 627 F.3d 547 (5th Cir. 2010) ................... 1

Francis v. Franklin, 471 U.S. 307 (1985)........... 12

Morissette v. United States,

342 U.S. 246 (1952) ............................... ii, 9, 10

Rehaif v. United States,

139 S. Ct. 2191 (2019) ................................... 10

Rodriguez de Quijas v. Shearson/American

Express, Inc., 490 U.S. 477 (1989) .............. 4, 5

Ruan v. United States,

142 S. Ct. 2370

(2022) ...... i, ii, 2, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14

State Oil Co. v. Khan, 522 U.S. 3 (1997) .............. 5

Trudell Med. Int'l v. D R Burton Healthcare

LLC, No. 4:18-CV-00009-BO, 2023 U.S.

Dist. LEXIS 34195

(E.D.N.C. Mar. 1, 2023) ................................. 11

United States v. Jett,

908 F.3d 252 (7th Cir. 2018) ......................... 12

United States v. Lanier, 520 U.S. 259 (1997) .... 12

United States v. Wiltberger,

18 U.S. (5 Wheat.) 76 (1820) ........................... 7

United States v. X-Citement Video, Inc., 513

U.S. 64 (1994) ................................................ 10

Whitman v. Am. Trucking Ass’ns,

531 U.S. 457 (2001) ......................................... 8

Wooden v. United States,

142 S. Ct. 1063 (2022) ................................... 10

Statute and Regulation

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

21 C.F.R. § 1306.04(a) ................................... i, 3, 7

Other Authorities

Oath of Hippocrates ............................................ 13

Mary L. Davenport, M.D., et al., “Right of

Conscience for Health-Care Providers,” 79

Linacre Q. 169 (2012)

https://www.ncbi.nlm.nih.gov/pmc/articles/

PMC6026968/ ................................................ 13

Instisar A. Rabb, “The Appellate Rule of Lenity,”

131 Harv. L. Rev. F. 179 (June 2018).

https://harvardlawreview.org/forum/vol131/the-appellate-rule-of-lenity/ ..................... 6

No. 22-1175

IN THE

Supreme Court of the United States

DR. XIULU RUAN AND DR. JOHN PATRICK COUCH,

Petitioners,

UNITED STATES OF AMERICA,

Respondent.

On Petition for a Writ of Certiorari to the United

States Court of Appeals for the Eleventh Circuit

INTERESTS OF AMICI CURIAE1

Amicus Association of American Physicians and

Surgeons (“AAPS”) is a national association of

physicians, founded in 1943. AAPS is dedicated to

protecting the patient-physician relationship, and has

been a litigant in this Court and in other appellate

courts. See, e.g., Ass’n of Am. Physicians & Surgs. v.

Mathews, 423 U.S. 975 (1975); Ass’n of Am. Physicians

& Surgs. v. Tex. Med. Bd., 627 F.3d 547 (5th Cir. 2010);

1 Amici AAPS, et al., provided the requisite ten days’ prior written

notice to all the parties. Pursuant to Rule 37.6, counsel for amici

curiae authored this brief in whole, no counsel for a party

authored this brief in whole or in part, and no such counsel or a

party made a monetary contribution intended to fund the

preparation or submission of this brief. No person or entity –

other than amici, AAPS’s members, and its counsel – contributed

monetarily to the preparation or submission of this brief.

Ass’n of Am. Physicians & Surgs. v. Clinton, 997 F.2d

898 (D.C. Cir. 1993).

Amicus Jeffrey A. Singer, MD, FACS, is a general

surgeon who has been in private practice for 40 years

as a specialist in general surgery in the state of

Arizona. He is a Fellow of the American College of

Surgeons who received his medical degree from New

York Medical College and completed his general

surgery postgraduate training at Maricopa County

General Hospital in Phoenix. As a surgeon, he often

needs to prescribe medication, including opioids, to

treat both acute and chronic pain resulting from acute

and chronic surgical conditions.

Reflecting the interests by these Amici in this

landmark case, they previously filed an amicus brief

on the merits decided in Ruan v. United States, 142 S.

Ct. 2370 (2022). Subsequently the insistence by

multiple circuits to continue using a vague, difficultto-understand regulatory definition of criminal intent

rather than the one prescribed by this Court, on the

fundamental issue of pain relief, is a matter in which

Amici have continuing strong interests.

SUMMARY OF ARGUMENT

The governing test articulated by this Court is

straightforward for jurors to understand: in order to

convict, a prosecutor must prove that a prescriber of

pain medication “was acting in an unauthorized

manner, or intended to do so.” Ruan, 142 S. Ct. at

2375. The term “unauthorized” is a familiar concept

encountered nearly every day in a variety of contexts,

ranging from parking a car to taking a transfer of

funds. The issue is not whether there is a consensus of

support for the activity, but whether it is within or

outside the parameters of what is authorized. Only if

someone knew or intended to do something

unauthorized does he then have the mens rea essential

for a criminal conviction.

This clear, recent standard established by this

Court should not be replaced, diluted, and confused by

very different, convoluted language coming from an

administrative agency. The alternative regulatory

wording is that a prescription “must be issued for a

legitimate medical purpose by an individual

practitioner acting in the usual course of his

professional practice.” 21 C.F.R. § 1306.04(a). That is

not what this Court held, and thus is not how juries

should be instructed. This regulatory jargon should

not substitute for the simpler standard using ordinary

terminology as recently required by this Court.

There are multiple defects in the regulatory

wording as a jury instruction. First, it is vague and

thus impermissibly unfair to a defendant. Second, it

requires a jury to make a determination about what a

legitimate medical purpose is, for which jurors are illequipped to decide. Third, nearly every physician

inevitably acts outside his usual course of professional

practice in order to properly treat an unusual patient

who has a rare or difficult medical problem. Yet the

regulatory wording would render every physician a

criminal when he tries to address a severe pain issue,

and Congress has surely not criminalized every

medical practice with the 20-year prison sentence

imposed below.

ARGUMENT

The Eleventh Circuit and other lower courts have

split with the Tenth Circuit after the remand from

Ruan, thereby necessitating clarification here that,

indeed, this Court’s standard of proving mens rea

concerning an unauthorized manner of prescribing

must be proven in order to obtain a conviction of

physician carrying a 20-year prison sentence.

I. The Petition Should Be Granted to Attain

Consistent Fidelity by the Lower Courts to

the Mens Rea Test Articulated by this Court.

This Court was clear in holding that the burden of

proof for prosecutors is to demonstrate that the

defendant physician “was acting in an unauthorized

manner, or intended to do so.” Ruan, 142 S. Ct. at

2375. Simple, direct, and clear. The majority decision

left no doubt that this is the standard that must be

applied. Indeed, this Court used “unauthorized” six

times in its relatively short 6-3 majority opinion.

As this

quoted:

Court has repeatedly held and is often

If a precedent of this Court has direct application

in a case, yet appears to rest on reasons rejected in

some other line of decisions, the Court of Appeals

should follow the case which directly controls,

leaving to this Court the prerogative of overruling

its own decisions.

Rodriguez de Quijas v. Shearson/American Express,

Inc., 490 U.S. 477, 484 (1989). “[T]here remains the

question whether [a precedent] deserves continuing

respect under the doctrine of stare decisis. The Court

of Appeals was correct in applying that principle

despite disagreement with [the precedent], for it is this

Court’s prerogative alone to overrule one of its

precedents.” State Oil Co. v. Khan, 522 U.S. 3, 20

(1997); see also Am. Trucking Ass’ns v. Smith, 496 U.S.

167, 180 (1990) (quoting same).

Here, there is not even any other line of decisions

on which lower courts rely in contravening the

precedent of this Court. Instead, the lower courts are

depending entirely on a mere regulation by a federal

agency. On that insufficient basis the lower courts are

imprisoning good physicians for decades. This plainly

contravenes the teaching of this Court in Ruan, and

the imperative of this Court in Rodriguez for lower

courts not to overrule Supreme Court holdings.

The concurrence by this Court in Ruan was not

based primarily on opposition to this requirement of

proving a criminal intent to do something

unauthorized. Rather, the concurrence felt this issue

should not have been reached in that case, yet it was

fully decided by the Court majority. Ruan, 142 S. Ct.

at 2383-84 (Alito, J., concurring, joined in this part by

Thomas, J.). The concurrence disagreed with the

majority as to who should bear the burden of proving

a lack of authorization, but did not dispute the

appropriateness of the “unauthorized” standard of

intent itself.

The failure of the Eleventh Circuit to abide by this

Court’s ruling and thereby reverse the convictions of

Petitioners is particularly striking in light of the rule

of lenity in criminal prosecutions. Dr. Ruan remains

in prison on a 20-year sentence, which is incredibly

harsh for professional conduct not entailing criminal

mens rea. The rule of lenity militates against this

result that the Eleventh Circuit insists upon. As

explained by a remarkable study of this important

check against prosecutorial abuse:

Upon examination of these criminal law statutory

interpretation cases, the Supreme Court’s

approach to lenity stands in relief from the practice

of appellate courts. For its part, in those cases [of

the Roberts Court], the Supreme Court almost

always considers the lenity framework. Moreover,

the Supreme Court applies the rule of lenity in

about one-third of those cases ….

Instisar A. Rabb, “The Appellate Rule of Lenity,” 131

Harv. L. Rev. F. 179 (June 2018).2

Yet appellate courts generally ignore this

important protection against wrongful conviction. “By

contrast, it turns out that appellate courts considered

in this data set … hardly ever invoked the [rule of

lenity] framework or applied the rule.” Id. The rule of

lenity reinforces the need to grant the Petition here.

II. The Substitute Regulatory Wording Is

Improper, Defective, and Inadequate as Jury

Instructions for Multiple Reasons.

Improperly relying on wording by a regulatory

agency, the Eleventh Circuit affirmed much of the

conviction of Dr. Ruan without any proof that he

intended to do anything unauthorized. The Eleventh

Circuit continues to rely on a regulatory definition of

the crime, rather than the elements as established by

Congress and interpreted by this Court in Ruan.

The regulatory wording is as follows:

A prescription for a controlled substance to be

2 https://harvardlawreview.org/forum/vol-131/the-appellate-rule-

of-lenity/ (viewed June 11, 2023).

effective must be issued for a legitimate medical

purpose by an individual practitioner acting in the

usual course of his professional practice.

21 C.F.R. § 1306.04(a).

This regulatory wording is defective and

inadequate as jury instructions for multiple reasons in

addition to not complying with this Court’s ruling.

A. It Is Improper to Use Regulatory Wording

as the Definition of a Felony Punishable by

Decades in Prison.

As Chief Justice John Marshall wrote for a

unanimous Court in overturning a conviction:

The rule that penal laws are to be construed

strictly, is perhaps not much less old than

construction itself. It is founded on the tenderness

of the law for the rights of individuals; and on the

plain principle that the power of punishment is

vested in the legislative, not in the judicial

department.

United States v. Wiltberger, 18 U.S. (5 Wheat.) 76, 95

(1820) (emphasis added). Regulatory agencies are not

properly vested with the power to define the elements

of a federal felony, as the Eleventh Circuit and other

courts continue to do after Ruan.

The substitute regulatory wording used by the

Eleventh Circuit and several circuits other than the

Tenth Circuit is significantly different from the

“unauthorized” standard held by this Court in Ruan to

be the proper one. By declining to require proof that a

prescription was unauthorized, and instead allowing

convictions of prescriptions that are merely unusual,

nearly any good physician could be wrongly convicted.

Incorporating the regulation, the Eleventh Circuit

below embraced this wording:

prescribing a controlled substance is illegal unless

there’s two things that happen: It’s prescribed in

the usual course of professional practice and it’s

prescribed for a legitimate medical purpose.

Petition at 6 (quoting Tr. 28:6-9). Both parts of the

regulatory standard must be satisfied for a defendantphysician to be acquitted under the incorrect view of

the Eleventh Circuit.

The first part – “usual course of professional

practice” – renders criminal every authorized

prescription that is unusual or outside of what

physicians typically do. Under this regulatory view,

every innocent outlier becomes a felony punished by 20

years in prison. Statistically, there are always outliers,

as there should be; there is always a top prescriber in

a state, and always some prescriptions written by

physicians that are different from what he usually

writes. Unusual medical problems require unusual or

more aggressive medical treatments. Congress did not

criminalize any of this, and nothing can be inferred in

the statute to allow such a vast criminalization of the

practice of medicine. Whitman v. Am. Trucking Ass’ns,

531 U.S. 457, 468 (2001) (“Congress … does not, one

might say, hide elephants in mouseholes” for

regulatory power).

The second part of the regulation-based wording

above is also significantly different from the proper

test of “unauthorized”. Juries are not equipped to

determine whether a prescription is “for a legitimate

medical purpose.” It is a phrasing that carries a

prejudicial negative connotation to it, in contrast with

asking whether a prescription was “unauthorized”.

Jurors understand the distinction between what is

authorized and unauthorized, while they are unlikely

to grasp any abstract line-drawing concerning what is

“a legitimate medical purpose.”

B. The Regulatory Wording Used Below

Further Contravenes Ruan and Morissette

by Obscuring the Requisite Mens Rea.

The regulatory wording is impermissibly vague and

thus improper on this additional, independent basis.

Taken literally, the regulatory wording is at odds with

the physician’s professional duty to care in his finest

way possible for the individual needs of each patient.

It criminalizes any variation by a physician from his

usual course of practice, even when in the best interest

of the patient.

The seminal decision of this Court in Morissette v.

United States requires proof of actual criminal intent,

to which the Eleventh Circuit below has declined to

adhere. 342 U.S. 246 (1952). This Court held in

Morissette:

Crime, as a compound concept, generally

constituted only from concurrence of an evilmeaning mind with an evil-doing hand, was

congenial to an intense individualism and took

deep and early root in American soil.

Morissette, 342 U.S. at 251-52. This oft-cited decision

also held that:

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 human will and a consequent ability

and duty of the normal individual to choose

between good and evil.

Id. at 250-51.

There is “the longstanding legal principle that an

act is not culpable unless the mind is guilty.” Wooden

v. United States, 142 S. Ct. 1063, 1076 (2022)

(Kavanaugh, J., concurring) (citing Morissette, 342

U.S. 246, 250-252 (1952)). “[W]e start from a

longstanding presumption, traceable to the common

law, that Congress intends to require a defendant to

possess a culpable mental state regarding ‘each of the

statutory elements that criminalize otherwise

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

2191, 2195 (2019) (quoting United States v. XCitement Video, Inc., 513 U. S. 64, 72 (1994)). The

“otherwise innocent conduct” here is the practice of

medicine to relieve suffering in patients, and this

quintessentially innocent conduct is not criminal.

The substitute regulatory phrasing of the burden of

proof obscures rather than clarifies the mens rea

requirement as this Court’s holding in Ruan did. The

phrasing insisted upon by the Eleventh Circuit is an

incorrect objective standard that marginalizes the

need to prove mens rea, despite how the essential

element of criminal intent was central to this Court’s

articulation in Ruan: “the Government must prove

beyond a reasonable doubt that the defendant knew

that he or she was acting in an unauthorized manner,

or intended to do so.” Ruan, 142 S. Ct. at 2375.

C. The Regulatory Jargon Is Beyond What

Can Be Reasonably Expected of a Jury to

Understand.

Jurors readily understand the concept of

“unauthorized”, as everyone confronts that concept

frequently in routine activities. But the same is not

true about what is meant by “legitimate medical

practice” or what constitutes “the usual course of his

professional practice.” This technical regulatory

jargon may be understood on K Street in D.C., where

lobbyists thrive, but it is predictably incomprehensible

to a typical juror. See, e.g., Trudell Med. Int'l v. D R

Burton Healthcare LLC, No. 4:18-CV-00009-BO, 2023

U.S. Dist. LEXIS 34195, at *10 (E.D.N.C. Mar. 1, 2023)

(denying a motion for a new trial in part because “it is

reasonable to infer the jury found this presentation

incomprehensible” and thus did not have to give it

significant evidentiary weight).

Administrative agencies produce regulations

loaded with jargon perhaps understandable by an

attorney, but such jargon is not a proper substitute for

the clear layman’s standard articulated by this Court

in Ruan. As explained by an exasperated D.C. Circuit

that hears far more cases concerning regulations than

any other appellate court:

We assume the author of these sentences

understands them. Perhaps so do those thoroughly

versed in the intricacies of the Clean Water Act, in

its regulatory jargon, in mathematics, in

toxicology, in biology, oncology and so on. Too bad

AISI did not take the trouble to educate the court.

The first rule of advocacy is to make your argument

understandable.

Am. Iron & Steel Inst. v. EPA, 115 F.3d 979, 990 (D.C.

Cir. 1997).

Unclear jury instructions cause unjust jury

verdicts, in deprivation of due process. This Court has

held that:

Because a reasonable juror could have understood

the challenged portions of the jury instruction in

this case as creating a mandatory presumption that

shifted to the defendant the burden of persuasion

on the crucial element of intent, and because the

charge read as a whole does not explain or cure the

error, we hold that the jury charge does not

comport with the requirements of the Due

Process Clause.

Francis v. Franklin, 471 U.S. 307, 325 (1985)

(emphasis added).

When jurors strain to understand the meaning of

jury instructions, then injustice is likely to result.

While it may appear to a lower court that the

regulatory language is similar to the wording

prescribed by the Ruan decision, a jury could be easily

confused by the jury instructions being substituted

below. That results in a denial of due process to the

defendant, and a denial of access by patients to the

medical care they need to alleviate their suffering. See,

e.g., United States v. Jett, 908 F.3d 252, 268 (7th Cir.

2018) (reversing a conviction for attempted bank

robbery and ordering an acquittal on that charge, after

observing that “[t]he jury instructions provided

no clarity either”). See also United States v. Lanier,

520 U.S. 259, 266 (1997) (“due process bars courts from

applying a novel construction of a criminal statute to

conduct that neither the statute nor any prior judicial

decision has fairly disclosed to be within its scope”).

D. The Regulatory Wording Makes Nearly

Every Physician a Felon, Contrary to what

Congress Enacted.

Finally, nearly every physician sometimes acts

outside his usual course of professional practice in

order to treat an unusual patient who has a rare or

difficult medical problem. Under the non-Ruan jury

instruction being used below, and affirmed by the

Eleventh Circuit after remand by this Court, nearly

every physician could be convicted and imprisoned for

20 years for writing an unusual prescription for an

unusually suffering patient, because that would be

outside his usual course of professional practice.

Regulators typically do not practice medicine and,

even if a few do, they are unlikely to attempt to treat

any irregular and highly unusual cases that arise in

many medical offices nationwide. Practicing

physicians, particularly in rural areas, do not have the

luxury of denying care in a difficult case and referring

it elsewhere. When a patient is in extreme and

unusual pain, most physicians feel a professional

obligation to treat that pain even though it is outside

the scope of his usual professional practice. Indeed, the

Oath of Hippocrates requires such treatment. See

Oath of Hippocrates (c. 400 B.C.), quoted in Mary L.

Davenport, M.D., et al., “Right of Conscience for

Health-Care Providers,” 79 Linacre Q. 169 (2012)

(vowing to “benefit my patients according to my

greatest ability and judgment”).3

Yet under regulatory wording used by the Eleventh

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6026968/

(viewed June 28, 2023).

Circuit and other courts below, all that a prosecutor

need do in his summation to the jury is to explain that

the physician departed from his ordinary

prescriptions, for a patient about whom the

prosecution was based. Many innocent physicians

could be convicted by prosecutorial whim if this jury

instruction were allowed to continue to be used.

The Ruan decision properly shut that down. Yet the

Eleventh Circuit and a few other circuits persist in

allowing this incorrect test of criminality for

physicians as they treat patients in pain. The Petition

should be granted to rein in the departure by some

circuits with what this Court expressly held in Ruan.

CONCLUSION

This Court should grant the Petition for the

reasons stated within it, and for those explained

above.

Respectfully submitted,