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

Supreme Court briefSep 29, 2023

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No. 22-1175

In the Supreme Court of the United States

XIULU RUAN AND JOHN PATRICK COUCH, PETITIONERS

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

ELIZABETH B. PRELOGAR

Solicitor General

Counsel of Record

NICOLE M. ARGENTIERI

Acting Assistant Attorney

General

KEVIN J. BARBER

Attorney

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTION PRESENTED

Whether the court of appeals, which vacated petitioners’ convictions for unlawful drug distribution under 21 U.S.C. 841(a) following a remand from this

Court, was required to vacate more of petitioners’

convictions based on a theory—never raised by petitioners and not reflected in their own proposed jury

instructions—that jury instructions relating to their

“authoriz[ation]” to distribute drugs, ibid., erroneously

incorporated the language in 21 C.F.R. 1306.04(a) that

defines the scope of that authorization.

(I)

TABLE OF CONTENTS

Page

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

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

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

Argument..................................................................................... 11

Conclusion ................................................................................... 23

TABLE OF AUTHORITIES

Cases:

Cutter v. Wilkinson, 544 U.S. 709 (2005) ............................ 14

Gonzales v. Oregon, 546 U.S. 243 (2006) ................. 16, 17, 19

Jin Fuey Moy v. United States,

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

other grounds by Funk v. United States,

290 U.S. 371 (1933).............................................................. 17

Ocasio v. United States, 578 U.S. 282 (2016) ...................... 12

United States v. Bailey, 444 U.S. 394 (1980) ...................... 12

United States v. Henson,

No. 19-3062, 2023 WL 2319289

(10th Cir. Mar. 2, 2023) ...................................................... 22

United States v. Kahn,

58 F.4th 1308 (10th Cir. 2023) ...................................... 20-22

United States v. Moore,

423 U.S. 122 (1975).........................................3, 14, 16, 17, 19

United States v. Williams, 504 U.S. 36 (1992) ................... 14

Webb v. United States, 249 U.S. 96 (1919) .......................... 17

Statutes and regulation:

Controlled Substances Act, 21 U.S. 801 et seq. .................... 3

21 U.S.C. 802(21) ............................................................. 16

21 U.S.C. 802(56)(C) ........................................................ 16

21 U.S.C. 812(b) ............................................................... 16

(III)

Statutes and regulation—Continued:

Page

21 U.S.C. 821 .................................................................... 15

21 U.S.C. 822(b) ..................................................... 3, 15, 16

21 U.S.C. 823(f ) ................................................................. 3

21 U.S.C. 829 .................................................................... 16

21 U.S.C. 829(a) ..................................................... 3, 15, 16

21 U.S.C. 829(e)(2)(A) ..................................................... 16

21 U.S.C. 830(b)(3)(A)(ii) ................................................ 16

21 U.S.C. 841(a) .............................. 3, 5, 8, 9, 11-17, 20, 22

21 U.S.C. 841(a)(1)............................................................. 2

21 U.S.C. 844(a) ............................................................... 16

21 U.S.C. 846 ...................................................................... 2

21 U.S.C. 871(b) ............................................................... 15

18 U.S.C. 371 ............................................................................ 2

18 U.S.C. 1347 .......................................................................... 2

18 U.S.C. 1349 .......................................................................... 2

18 U.S.C. 1956(h) ..................................................................... 2

18 U.S.C. 1957 .......................................................................... 2

18 U.S.C. 1962(d) ..................................................................... 2

42 U.S.C. 1320a-7b(b) .............................................................. 2

21 C.F.R. 1306.04(a) ....................................... 3, 5, 8, 11, 13-20

Miscellaneous:

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

(21 C.F.R. 306.04 (1971)) .................................................... 16

In the Supreme Court of the United States

No. 22-1175

XIULU RUAN AND JOHN PATRICK COUCH, PETITIONERS

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-18a)

is reported at 56 F.4th 1291. A previous decision of this

Court (Pet. App. 19a-54a) is reported at 142 S. Ct. 2370,

and a previous order of this Court is reported at 142

S. Ct. 2895. A previous opinion of the court of appeals

is reported at 966 F.3d 1101.

JURISDICTION

The judgment of the court of appeals was entered on

January 5, 2023. Petitions for rehearing were denied on

March 2, 2023 (Pet. App. 55a-58a). The petition for a

writ of certiorari was filed on May 31, 2023. The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1).

(1)

STATEMENT

Following a jury trial in the United States District

Court for the Southern District of Alabama, petitioners

Xiulu Ruan and John Patrick Couch were convicted

of racketeering conspiracy, in violation of 18 U.S.C.

1962(d); three counts of conspiring to unlawfully distribute controlled substances, in violation of 21 U.S.C.

841(a)(1) and 846; conspiring to commit healthcare

fraud and mail and wire fraud, in violation of 18 U.S.C.

1347 and 1349; and two counts of conspiring to receive

kickbacks in relation to a federal healthcare program,

in violation of 18 U.S.C. 371 and 42 U.S.C. 1320a-7b(b).

Ruan Judgment 1; Couch Judgment 1. Petitioners were

also each individually convicted on multiple counts of

unlawfully distributing a controlled substance, in violation of 21 U.S.C. 841(a)(1). Ruan Judgment 1; Couch

Judgment 1. Ruan was further convicted of conspiring

to launder the proceeds of illegal activity, in violation of

18 U.S.C. 1956(h), and two counts of laundering the proceeds of illegal activity, in violation of 18 U.S.C. 1957.

Ruan Judgment 1. Ruan was sentenced to 252 months

of imprisonment, to be followed by four years of supervised release. Id. at 2-3. Couch was sentenced to 240

months of imprisonment, to be followed by four years of

supervised release. Couch Judgment 2-3.

The court of appeals vacated one of petitioners’

kickback-conspiracy convictions, affirmed their remaining convictions, and remanded for resentencing. 966

F.3d 1101. While petitioners’ petitions for writs of certiorari were pending with this Court, the district court

again sentenced petitioners to the same terms of imprisonment. Ruan Am. Judgment 2-3; Couch Am. Judgment 2-3. This Court granted writs of certiorari, vacated, and remanded. 142 S. Ct. 2895; 142 S. Ct. 2370.

On remand, the court of appeals vacated petitioners’

convictions for unlawfully distributing a controlled substance, affirmed their remaining convictions, and remanded for resentencing. Pet. App. 1a-18a.

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

(CSA or Act), 21 U.S.C. 801 et seq., prohibits the knowing or intentional distribution of controlled substances

“[e]xcept as authorized by” the Act. 21 U.S.C. 841(a).

The CSA’s exceptions to the prohibition against drug

distribution include an exception for physicians who are

“registered by” the Drug Enforcement Administration

(DEA) and who prescribe controlled substances—but

the exception applies only “to the extent authorized

by their registration and in conformity with the other

provisions” of the Act. 21 U.S.C. 822(b); see 21 U.S.C.

823(f ). And controlled substances generally may be dispensed only pursuant to a “written prescription of a

practitioner.” 21 U.S.C. 829(a).

A federal regulation, 21 C.F.R. 1306.04(a), limits the

scope of the authorization by specifying that a “prescription for a controlled substance to be effective must

be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Section 1306.04(a) specifies that

“[a]n order purporting to be a prescription issued not in

the usual course of professional treatment” is deemed

“not a prescription,” and the “person issuing it[] shall

be subject to the penalties provided for violations of the

provisions of law relating to controlled substances.”

Ibid. And in United States v. Moore, 423 U.S. 122

(1975), this Court “h[e]ld that registered physicians can

be prosecuted under § 841 when their activities fall outside the usual course of professional practice.” Id. at

124.

2. Petitioners were business partners and DEAregistered physicians who engaged in a long-running

scheme of issuing prescriptions that “tracked financial

incentives rather than their patients’ medical needs.”

966 F.3d at 1123. They operated through a jointly owned

medical clinic in Mobile, Alabama, and a connected pharmacy whose sole business was dispensing drugs prescribed at the clinic. Id. at 1121. Between January 2011

and May 2015, the clinic issued nearly 300,000 controlledsubstance prescriptions, the majority of which were for

Schedule II drugs—“the most powerful and dangerous

drugs that can be lawfully prescribed.” Id. at 1122.

Petitioners frequently signed prescriptions without

seeing patients and failed to provide patients with warnings before prescribing dangerous opioids. 966 F.3d at

1126-1130. Many records at the clinic “contained numerous errors, including not listing all prescriptions

written” and listing “exams and tests” that “did not

occur.” Id. at 1129-1130. Patients whose drug-test results were inconsistent with the drugs they were being

prescribed—“indicating potential diversion or abuse of

drugs”—were seldom “fired” because that would mean

that petitioners “would lose * * * revenue.” Id. at 1126.

In contrast, petitioners would “fire patients whose insurance would no longer pay for their” prescriptions.

Ibid.

Petitioners also prescribed massive quantities of

transmucosal immediate-release fentanyl (TIRF) drugs,

which are approved by the Food and Drug Administration only to treat breakthrough pain in certain adult

cancer patients. 966 F.3d at 1122-1123. Petitioners “often surpassed the next highest prescriber” of TIRFs

“by more than double”—even though “no more than

15% of [their] patients had cancer.” Id. at 1123.

Petitioners “lied to insurers, telling them that some patients had cancer so that insurers would pay for their

TIRF prescriptions.” Id. at 1131. And over the course

of a few months, petitioners purchased more than $1.3

million in the stock of a manufacturer of TIRFs—

increasing their prescriptions of that manufacturer’s

drugs during and after the stock purchases. Id. at 11231124. Petitioners dispensed so many of those drugs that

when their clinic was shut down in 2015, the manufacturer’s nationwide sales dropped “significantly.” Id. at

1124.

Petitioners were also paid by another TIRF manufacturer to host weekly programs promoting a TIRF

drug marketed as “Subsys,” even though no new prospective prescribers attended those programs. 966

F.3d at 1122, 1124-1125. According to the drug representative who arranged the speaking engagements for

petitioners, the purpose was not to educate other doctors, but instead to influence petitioners to continue

prescribing Subsys. Id. at 1124-1125. The strategy

worked: petitioners’ clinic ranked among the top ten

prescribers of Subsys, and the manufacturer considered petitioners to be “ ‘whales’ ”—i.e., “the top prescribing doctors” for the drug. Id. at 1125.

3. a. In 2016, a federal grand jury in the Southern

District of Alabama returned an indictment charging

petitioners with 22 counts of conspiracy, unlawfully distributing controlled substances, fraud, illegal kickbacks, and money laundering. 966 F.3d at 1120.

At the close of trial, petitioners proposed jury instructions that incorporated the regulatory language in

Section 1306.04(a) as the touchstone for Section 841(a)

liability, as well as liability for other violations based on

violations of the CSA. See D. Ct. Doc. 462 (Feb. 6, 2017).

Petitioners represented to the district court that “Section 841(a)(1) makes it a crime for any physician to

knowingly or intentionally distribute or dispense a Controlled Substance, unless it was done within the usual

course of professional practice and for a legitimate medical purpose.” Id. at 19; see id. at 19-20, 22-24. And they

asked to instruct the jury that “[i]f a physician dispenses or distributes a Controlled Substance in good

faith while medically treating a patient, then the physician has dispensed or distributed that Controlled Substance for a legitimate medical purpose and within the

usual course of professional practice,” while guilt required proof beyond a reasonable doubt “that the decision to dispense or distribute a Controlled Substance

fell below a standard of medical practice generally recognized and accepted in the United States” and “that

the physician’s decisions to distribute or dispense a

Controlled Substance were inconsistent with any accepted method of treating a pain patient.” 966 F.3d at

1165-1166.

The district court rejected petitioners’ proposed instructions as too “subjective,” Pet. App. 72a-73a, but incorporated the regulatory standard, instructing the

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

dispensed by a prescription, the prescription must have

been issued by a practitioner both within the usual

course of professional practice and for a legitimate medical purpose,” id. at 61a. The court further explained

that

[a] controlled substance is prescribed by a physician

in the usual course of professional practice and,

therefore, lawfully if the substance is prescribed by

him in good faith as part of his medical treatment of

a patient in accordance with the standard of medical

practice generally recognized and accepted in the

United States. [Petitioners] maintain at all times

they acted in good faith and in accordance with [the]

standard of medical practice generally recognized

and accepted in the United States in treating patients.

Id. at 61a-62a.

At the close of its case, the government dismissed

one count that charged both petitioners with conspiring

to receive kickbacks in relation to a federal healthcare

program. 966 F.3d at 1120-1121. The jury convicted

Couch on all remaining counts and convicted Ruan on

all remaining counts except one count of unlawfully distributing a controlled substance. Ibid.; see p. 2, supra.

The district court sentenced Ruan to 252 months of imprisonment and Couch to 240 months of imprisonment,

to be followed by four years of supervised release for

each petitioner. Ruan Judgment 2-3; Couch Judgment

2-3.

b. The court of appeals vacated one of petitioners’

kickback-conspiracy convictions and affirmed their

other convictions. 966 F.3d 1101. Relying on circuit

precedent for the view that “whether a defendant acts

in the usual course of his professional practice must be

evaluated based on an objective standard, not a subjective standard,” the court concluded that the district

court had correctly instructed the jury on the CSA

charges. Id. at 1166 (brackets and citation omitted).

While petitioners’ petitions for writs of certiorari

were pending in this Court, the district court resentenced petitioners, imposing the same terms of imprisonment that it had previously imposed. Ruan Am.

Judgment 2-3; Couch Am. Judgment 2-3.

4. This Court granted Ruan’s petition for a writ of

certiorari, consolidated his case with the case of Shakeel

Kahn—another doctor who had been convicted of violating Section 841(a) and other statutes in the Tenth

Circuit—and vacated and remanded. Pet. App. 19a-54a.

The Court held that the “ ‘knowingly or intentionally’

mens rea” in Section 841(a) “applies to the [statute’s]

‘except as authorized’ clause,” such that, “once a defendant meets the burden of producing evidence that

his or her conduct was ‘authorized,’ the Government

must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized

manner.” 142 S. Ct. at 2376. The Court reasoned, inter

alia, that “a lack of authorization is often what separates wrongfulness from innocence.” Id. at 2377. “In

addition,” the Court noted, Section 1306.04(a)’s “regulatory language defining an authorized prescription is

* * * ‘ambiguous,’ written in ‘generalities, susceptible

to more precise definition and open to varying constructions,’ ” and a “strong scienter requirement helps to diminish the risk of ‘overdeterrence’ ” of medical practitioners. Id. at 2377-2378 (brackets and citations omitted).

The Court remanded Ruan’s case to the Eleventh

Circuit and Kahn’s case to the Tenth Circuit for consideration of whether the jury instructions at their trials

complied with its interpretation of Section 841(a) and

whether any errors were harmless. 142 S. Ct. at 2382.

The Court also granted Couch’s pending petition for a

writ of certiorari, vacated, and remanded his case to the

Eleventh Circuit. 142 S. Ct. 2895.

5. On remand, the court of appeals vacated petitioners’ Section 841(a) convictions, affirmed their remaining

convictions, and remanded for a new trial on the Section

841(a) convictions and for resentencing. Pet. App. 1a18a.

The court of appeals concluded that the jury instructions for the unlawful-distribution counts had “inadequately conveyed” the mens rea required by this Court

because the instructions did not adequately explain that

petitioners must have known or intended that their conduct was unauthorized under the CSA. Pet. App. 7a; see

id. at 5a-7a. The court of appeals rejected the government’s harmless-error argument as to the Section

841(a) counts and accordingly vacated petitioners’ convictions on those counts. Id. at 8a-9a.

The court of appeals found, however, that the instructional error did not require it to invalidate petitioners’ remaining convictions. Pet. App. 10a-17a. The

court explained that petitioners’ convictions for conspiring to unlawfully distribute controlled substances remained valid because the instructions for those counts

had required the jury to find that petitioners “agreed to

try and accomplish a shared unlawful plan” to distribute

drugs and “knew the unlawful purpose of the plan and

willfully joined it.” Id. at 11a. The court observed that

“[h]ad the jury in this case concluded that [petitioners]

believed their actions to be for a legitimate medical purpose they could not have found [that petitioners] made

an ‘unlawful plan’ and ‘knew’ its ‘unlawful purpose,’ nor

could they have concluded they ‘willfully’ joined that

plan.” Ibid.

The court of appeals similarly found that the instructional error did not affect petitioners’ convictions for

conspiring to commit healthcare fraud. Pet. App. 12a13a. The court explained that a “health care fraud conspiracy is fundamentally about the submission of false

medical claims to health care benefit programs” and

observed that “whether or not [petitioners] had subjective knowledge that their prescriptions were outside the

‘usual course’ is irrelevant to whether or not” petitioners submitted false medical claims. Ibid. The court

found the instructional error “equally irrelevant to” petitioners’ kickback-conspiracy convictions, explaining

that, as to those counts, the jury necessarily determined

that petitioners “willfully received compensation from

[a] pharmaceutical company * * * in exchange for increased prescriptions of fentanyl.” Id. at 14a. Finally,

the court found that “[t]he mens rea instructions for the

§ 841 conviction[s] have nothing to do with the[] theories” underlying petitioners’ convictions for conspiring

to commit mail and wire fraud, which were based on allegations that “overlapped” with the ones underlying

the healthcare-fraud conspiracy, as well as allegations

that petitioners made stocking and prescribing decisions “based on the profit generated by the higher reimbursement for” particular “drugs rather than medical need.” Id. at 14a-15a.

The court of appeals also upheld petitioners’ convictions for racketeering conspiracy. Pet. App. 15a-16a.

The court noted that it had already found that two of the

three possible predicate offenses for those convictions—

conspiring to unlawfully distribute controlled substances

and mail fraud—remained valid. Id. at 15a. And as to

the remaining possible predicate offense—unlawful

distribution—the court found that the racketeeringconspiracy instruction correctly articulated the applicable mens rea because the jury was required to “find[]

that [petitioners] intended to violate § 841, which means

that [petitioners] would have to have known their acts

were unauthorized.” Id. at 16a (emphasis omitted). Finally, the court upheld Ruan’s convictions for money

laundering and conspiring to commit money laundering

because convictions that “were unaffected by the inadequate instruction for the substantive drug charges”

qualified as the required “specified unlawful activity”

under the money-laundering statute. Id. at 17a.

ARGUMENT

Petitioners contend (Pet. 13-38) that this Court’s decision in Ruan v. United States, 142 S. Ct. 2370 (2022),

requires most of their convictions to be set aside. The

court of appeals correctly rejected that argument on remand and determined that the instructional error identified by this Court required vacatur only of petitioners’

convictions for unlawfully distributing controlled substances, in violation of 21 U.S.C. 841(a). The petition for

a writ of certiorari, however, presents a new argument

that petitioners have never raised before—namely, that

the jury instructions at their trial erroneously used language from Section 1306.04(a) as the measure of whether

their drug-prescribing practices were “authorized” under the CSA. Ibid. That claim was neither pressed nor

passed upon below, is foreclosed by precedent, rests on

a fundamental misunderstanding of the CSA and this

Court’s decision in Ruan, and implicates no conflict

among the courts of appeals. The petition for a writ of

certiorari should be denied.

1. On remand from this Court, the court of appeals

applied Ruan and vacated petitioners’ convictions for

unlawful distribution under Section 841(a) because the

jury instructions for those counts did not apply the statute’s “knowingly or intentionally” mens rea to its “except as authorized” clause. Pet. App. 7a. The court correctly recognized, however, that the error did not affect

petitioners’ other convictions. Id. at 10a-17a.

The court of appeals correctly upheld petitioners’

convictions for conspiring to distribute controlled substances because the relevant instructions required the

jury to find that petitioners “agreed to try and accomplish a shared unlawful plan” to distribute drugs and

“knew the unlawful purpose of the plan and willfully

joined it.” Pet. App. 11a. That accorded with basic principles of conspiracy law, which require proof that a defendant “reach[ed] an agreement with the specific intent that the underlying crime be committed.” Ocasio

v. United States, 578 U.S. 282, 288 (2016) (citation, emphasis, and internal quotation marks omitted); see United

States v. Bailey, 444 U.S. 394, 405 (1980) (explaining

that the “heightened mental state” needed for inchoate

offenses like conspiracy serves to “separate[] criminality itself from otherwise innocuous behavior”). By requiring that petitioners knew that their plans would violate Section 841(a)—that is, that they had knowledge

that controlled substances would be dispensed without

“authoriz[ation],” 21 U.S.C. 841(a)—the conspiracy instructions avoided the mens rea problem that this Court

identified in Ruan.

For the same reason, the court of appeals correctly

upheld petitioners’ convictions for racketeering conspiracy. See Pet. App. 15a-16a. And the court correctly

observed that petitioners’ remaining convictions were

all premised on conduct separate from the conduct underlying petitioners’ unlawful-distribution convictions—

and therefore in no way turned on “whether or not [petitioners] had subjective knowledge.” Id. at 13a; see id.

at 12a-17a.

2. Petitioners do not dispute any aspects of the

court of appeals’ reasoning. Nor do they claim that the

actual analysis in the decision below implicates any

disagreement among the courts of appeals. Petitioners

instead contend (Pet. 31) that the district court’s jury

instructions improperly “substituted the language of 21

C.F.R. § 1306.04(a) for the text of the CSA,” and assert

(Pet. 34-37) that the court of appeals was required to

vacate all convictions whose instructions incorporated

that regulatory language. But petitioners did not raise

that argument in the court of appeals, and that court

never considered it. It is therefore not properly preserved for this Court’s review.

As discussed above, see pp. 5-6, supra, at trial petitioners requested jury instructions that incorporated

the language of Section 1306.04(a) to describe the jury’s

inquiry into whether petitioners’ drug-dispensing practices were “authorized” within the meaning of the CSA’s

core criminal provision, 21 U.S.C. 841(a). The district

court similarly incorporated the regulatory standard

into its instructions. See pp. 6-7, supra. And petitioners admit that, when this case previously came to this

Court, “the parties * * * all agreed that some version

of 21 C.F.R. § 1306.04(a) should be the basis for a CSA

instruction.” Pet. 15 (emphasis omitted).

This Court accepted that consensus in Ruan, “assum[ing] * * * that a prescription is ‘authorized’ and

therefore lawful if it satisfies [the Section 1306.04(a)]

standard.” 142 S. Ct. at 2375. And on remand, petitioners continued to equate “authorization” with acting

within “ ‘the usual course of professional practice’ ” and

with a “ ‘legitimate medical purpose.’ ” Ruan C.A. Supp.

Br. 13-14 (citation omitted); see id. at 9 (stating that one

of the “crucial * * * element[s]” was “whether Dr.

Ruan issued an unauthorized prescription (because

it lacked a legitimate medical purpose and fell outside professional norms)”); Couch C.A. Supp. Br. 1

(“adopt[ing]” Ruan’s arguments “in full” and stating that

“a physician otherwise authorized to prescribe controlled substances may be convicted of unlawful distribution under 21 U.S.C. § 841(a)(1) only if his or her prescriptions ‘fall outside the usual course of professional

practice’ ”) (citation omitted). Even in seeking rehearing en banc in the court of appeals, petitioners did not

try to draw a distinction between a physician’s “authoriz[ation],” 21 U.S.C. 841(a), and the regulatory language that defines that authorization, as they now do in

seeking further review in this Court. See Ruan C.A.

Reh’g Pet. 4-15; Couch C.A. Reh’g Pet. 3-5. The court

of appeals therefore had no occasion to address such a

claim.

This Court is “a court of review, not of first view,”

Cutter v. Wilkinson, 544 U.S. 709, 718 n.7 (2005), and it

traditionally does not grant a writ of certiorari “when

‘the question presented was not pressed or passed upon

below,’ ” United States v. Williams, 504 U.S. 36, 41

(1992) (citation omitted). That principle should preclude a writ of certiorari here. At most, petitioners’

claim would be reviewable for plain error—a demanding

standard that they do not discuss and could not satisfy

for the reasons set forth below.

3. Even if petitioners had preserved their new claim,

it would not warrant this Court’s review. The regulation at issue provides that a prescription for controlled

substances is valid, and accordingly “authorized” for

purposes of 21 U.S.C. 841(a), only if “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,” as

defined in 21 C.F.R. 1306.04(a). And this Court “h[e]ld”

in United States v. Moore, 423 U.S. 122 (1975), “that

registered physicians can be prosecuted under § 841

when their activities fall outside the usual course of professional practice.” Id. at 124. That regulatory standard does not, as petitioners suggest (Pet. 3), “create a

criminal offense,” but instead has defined practitioners’

authority to prescribe controlled substances since the

CSA’s inception, is a valid limit on that authority, and

was not called into question by this Court’s decision in

Ruan.

a. As described above, see p. 3, supra, Section 841(a)

of the CSA prohibits the knowing or intentional distribution of controlled substances “[e]xcept as authorized

by” the Act. 21 U.S.C. 841(a). The CSA’s exceptions to

the drug-distribution prohibition include an exception

for DEA-registered physicians who issue written prescriptions for controlled substances—but only “to the

extent authorized by their registration and in conformity with the other provisions” of the Act. 21 U.S.C.

822(b); see 21 U.S.C. 829(a).

The CSA accordingly authorizes the Attorney General “to promulgate rules and regulations * * * relating

to the registration and control of the manufacture, distribution, and dispensing of controlled substances.” 21

U.S.C. 821; see 21 U.S.C. 871(b). “Persons registered

by the Attorney General * * * to * * * dispense controlled substances * * * are authorized to * * * dispense such substances * * * to the extent authorized

by their registration and in conformity with the other

provisions of this subchapter.” 21 U.S.C. 822(b). The

regulation at issue, 21 C.F.R. 1306.04(a), defines the

scope of the authorization for purposes of physicians

who write prescriptions for controlled substances.

It has done so throughout the five-decade history

of the CSA. The Attorney General promulgated the

current text of Section 1306.04(a) less than a year after

the CSA was enacted. 36 Fed. Reg. 7776, 7799 (Apr.

24, 1971) (21 C.F.R. 306.04 (1971)); see Gonzales v. Oregon, 546 U.S. 243, 250 (2006). Since that time, “[a]n

order purporting to be a prescription issued not in the

usual course of professional treatment” has been

deemed “not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829).” 21 C.F.R.

1306.04(a). As a result, dispensing a covered controlled

substance pursuant to such an order is unauthorized.

See 21 U.S.C. 822(b), 829(a). And it violates Section

841(a) if done knowingly or intentionally. See 21 U.S.C.

841(a).

Section 1306.04(a)’s terms mirror the CSA itself,

which employs the same terminology in multiple different provisions. See Gonzales, 546 U.S. at 257; Moore,

423 U.S. at 137 n.13, 140-142. For example, Section 829

generally defines a “ ‘valid prescription’ ” as “a prescription that is issued for a legitimate medical purpose in

the usual course of professional practice by” a qualifying practitioner. 21 U.S.C. 829(e)(2)(A); see, e.g., 21

U.S.C. 830(b)(3)(A)(ii) (similar definition of “valid prescription” applicable to certain reporting requirements).

Similarly, the CSA defines “ ‘practitioner’ ” to include a

physician who is “registered” to “distribute [or] dispense * * * a controlled substance in the course of professional practice,” 21 U.S.C. 802(21), and allows doctors to prescribe only drugs that have “currently accepted medical use[s],” 21 U.S.C. 812(b).1

See 21 U.S.C. 802(56)(C) (defining “ ‘filling new prescriptions for

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

requirement that “the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose

for the issuance of the new prescription”); 21 U.S.C. 844(a)

The Court thus correctly “h[e]ld” in Moore “that registered physicians can be prosecuted under § 841 when

their activities fall outside the usual course of professional practice.” 423 U.S. at 124; see id. at 135 (observing that Section 841 applies to those who “s[ell] drugs,

not for legitimate purposes, but ‘primarily for the profits to be derived therefrom’ ”) (citation omitted). “Under [the Court’s] reasoning in Moore, writing prescriptions that are illegitimate under § 829 is certainly not

‘in the usual course of professional practice’ under

§ 802(21) and thus not ‘authorized by this subchapter’

under § 841(a).” Gonzales, 546 U.S. at 285 (Scalia, J.,

dissenting) (brackets and citation omitted). And petitioners’ current claims cannot be squared with the reasoning and holding of Moore.

Petitioners’ assertion (Pet. 32) of a nondelegation

problem with the regulation is particularly misplaced.

As this Court observed in Gonzales v. Oregon, Section

1306.04(a) “does little more than restate the terms of

the statute itself ”; the relevant language “comes from

Congress, not the Attorney General.” 546 U.S. at 257.

It was therefore validly incorporated into the jury instructions as defining the scope of petitioners’ limited

“authoriz[ation]” to distribute controlled substances.

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

(forbidding possession of controlled substances except “pursuant to

a valid prescription or order, from a practitioner, while acting in the

course of his professional practice”); see also Webb v. United States,

249 U.S. 96, 99-100 (1919) (finding, under the CSA’s statutory predecessor, that it would be a “plain * * * perversion of meaning” to

call an order for morphine, issued to an addict outside “the course

of professional treatment,” a “prescription” at all); accord Jin Fuey

Moy v. United States, 254 U.S. 189, 194 (1920), overruled in part on

other grounds by Funk v. United States, 290 U.S. 371 (1933).

b. The Court’s decision in Ruan did nothing to upset

the long-held understanding that Section 1306.04(a) defines the scope of practitioners’ prescribing authority.

Instead, the Court “assume[d], as did the courts below

and the parties here, that a prescription is ‘authorized’

and therefore lawful if it satisfies th[e] standard” in Section 1306.04(a). Pet. App. 21a.

Petitioners nevertheless read Ruan as holding that

practitioners may not be convicted even if “they knew

that their prescriptions were objectively outside the

usual course of professional practice or not for a legitimate medical purpose” but they “themselves believed

the prescriptions were appropriate.” Pet. 35. That

reading is unsound. Ruan did not make every registered prescriber of controlled substances a law unto

himself. Instead, the Court’s conclusion that the government must “prov[e] that a defendant knew or intended that his or her conduct was unauthorized” was

informed by an understanding that “the regulation defining the scope of a doctor’s prescribing authority does

so by reference to objective criteria such as ‘legitimate

medical purpose’ and ‘usual course’ of ‘professional

practice’ ”—and that a defendant’s subjective mindset

would be “measured against objective criteria.” 142

S. Ct. at 2382 (citation omitted). The Court’s discussion

of the objective criteria would have been unnecessary if,

as petitioners contend (see Pet. 3, 7, 35), a defendant’s

personal beliefs could always override them, granting

him carte blanche to knowingly violate them.

Petitioners highlight (Pet. 2, 9, 16-17, 34) the Court’s

statement in Ruan that “the regulatory language defining an authorized prescription is, we have said, ‘ambiguous,’ written in ‘generalities, susceptible to more precise definition and open to varying constructions.’ ” 142

S. Ct. at 2377 (quoting Gonzales, 546 U.S. at 258)

(brackets omitted). But that was simply a reference to

a portion of the Court’s opinion in Gonzales—which, as

discussed above, found that Section 1306.04(a) mirrors

the CSA’s statutory requirements—that was itself describing the original “statutory phrase ‘legitimate medical purpose’ ” that the regulation incorporates. 546

U.S. at 258. Furthermore, the fundamental point in

Ruan was that a potential to misinterpret the regulation’s objective criteria supported a more stringent

mens rea, see 142 S. Ct. at 2377—a point that would

make no sense if the Court in fact viewed the regulatory

criteria as irrelevant.

The Court has thus already addressed petitioners’

concerns (Pet. 3; see Pet. 3-4, 22-25) about “chill[ing]”

practitioners from providing “outlying” forms of medical treatment. Although petitioners ask the Court to go

further and leave the distribution of dangerous controlled substances entirely up to individual practitioners’ subjective judgment, the Court has recognized and

respected the balance struck by the CSA and Section

1306.04(a) between concerns about “the diversion of

drugs * * * to illegitimate channels” and practitioners’

need for “reasonable discretion in treating patients and

testing new theories.” Moore, 423 U.S. at 135, 143. And

petitioners err in suggesting (Pet. 14) that Ruan

“smuggles a quasi-negligence standard through the

back door.” To the contrary, Ruan makes clear that a

practitioner who knew or intended that he was acting

without a legitimate medical purpose and outside the

usual course of professional practice can be convicted.

4. Petitioners assert (Pet. 15-22, 25-31) that the decision below, and decisions of other courts of appeals

that continue to approve CSA jury instructions based

on Section 1306.04(a), conflict with the Tenth Circuit’s

remand decision in Kahn’s case, United States v. Kahn,

58 F.4th 1308 (2023). As a threshold matter, as already

discussed the decision below did not address the arguments that petitioners now make in their petition, and

therefore cannot be viewed as part of any circuit conflict

on the question presented.

In any event, the Tenth Circuit’s decision in Kahn

does not provide a sound basis for concluding that it has

foreclosed conviction for violating Section 841(a) based

on an instruction that defines “authoriz[ation],” 21

U.S.C. 841(a), by incorporating Section 1306.04(a) and

requires the jury to find that the defendant knowingly

or intentionally acted outside its scope. In Kahn, the

court found fault with jury instructions that “treated

the inquiry under the first ‘prong’ [of the regulation] as

wholly subjective, considering ‘why a defendant-practitioner subjectively issued that prescription, regardless

of whether other practitioners would have done the

same’ ” and “treated the inquiry under the second prong

as wholly objective, considering ‘whether a defendantpractitioner objectively acted within that scope, regardless of whether he believed he was doing so.’ ” 58 F.4th

at 1316 (citation omitted). The Tenth Circuit concluded

that the instructions were flawed for “two reasons,”

ibid., neither of which clearly adopts the approach that

petitioners now urge.

First, the Tenth Circuit recognized that “Ruan expressly disallows conviction under § 841(a)(1) for behavior that is only objectively unauthorized,” and instead

requires proof that the “defendant ‘knowingly or intentionally acted in an unauthorized manner.’ ” Kahn, 58

F.4th at 1316 (quoting Ruan, 142 S. Ct. at 2376). Second, it viewed Ruan as “treat[ing] the two criteria in

§ 1306.04(a) not as distinct bases to support a conviction, but as ‘reference to objective criteria’ that may

serve as circumstantial evidence of a defendant’s subjective intent to act in an unauthorized manner.” Ibid.

(quoting Ruan, 142 S. Ct. at 2382). And it deemed

Kahn’s jury instructions “erroneous because they allowed the jury to convict Dr. Kahn after concluding either that Dr. Kahn subjectively knew a prescription was

issued not for a legitimate medical purpose, or that he

issued a prescription that was objectively not in the

usual course of professional practice.” Ibid.

Although petitioners read that passage as adopting an

approach under which a defendant may lack knowledge

or intent to act in an unauthorized manner even if he

knows or intends to prescribe drugs not for a medical

purpose and outside the usual course of professional

practice, that reading is questionable. Instead, the

Tenth Circuit’s ultimate conclusion seems to have been

that whereas Ruan requires knowledge or intent to violate objective criteria, neither of the “prong[s]” in

Kahn’s jury instructions included both the objective and

subjective components. Kahn, 58 F.4th at 1316. Instead, the first was “wholly subjective” and the second

“wholly objective.” Ibid.; see id. at 1319 (“[T]he government is correct that the Supreme Court has acknowledged that ‘the scope of a doctor’s prescribing authority’ remains tethered ‘to objective criteria such as legitimate medical purpose and usual course of professional

practice.’ ”) (quoting Ruan, 142 S. Ct. at 2382) (some internal quotation marks omitted). And, consistent with

this Court’s decision in Ruan—and the legal regime

itself—the Tenth Circuit may have been using the regulatory language and the term “authorization” interchangeably.

Accordingly, petitioners have not demonstrated a

circuit conflict.2 Petitioners insist (Pet. 21) that a division must exist because the Eleventh Circuit upheld

most of their convictions after Ruan, whereas the Tenth

Circuit vacated all of Kahn’s convictions, Kahn, 58 F.4th

at 1321-1322. On remand in Kahn, however, the government did not defend the convictions on the merits,

instead staking the continued viability of all of Kahn’s

convictions on harmless error. See Gov’t C.A. Supp. Br.

at 4-20, Kahn, supra (No. 19-8054). And the government focused on Kahn’s Section 841(a) convictions—

and did not make separate harmless-error arguments in

support of Kahn’s other convictions, such as for conspiring to unlawfully distribute controlled substances. See

ibid. The Tenth Circuit was never prompted to consider

whether, as the Eleventh Circuit determined here (Pet.

App. 10a-17a), the instructions for that conspiracy count

or other counts avoided the mens rea error found in

Ruan. The Tenth Circuit therefore engaged in little

analysis and vacated all of Kahn’s convictions because

“the instructions pertaining to [his] charges [were]

predicated, at least in part, on one or more of the erroneous § 841(a)(1) instructions.” Kahn, 58 F.4th at 1322.

The Tenth Circuit’s unpublished order in United States v. Henson, No. 19-3062, 2023 WL 2319289 (Mar. 2, 2023), see Pet. 13, 21,

accepted without analysis the “parties[’] agree[ment] that the appropriate course of action for us is to order the vacatur of all of Dr.

Henson’s counts of conviction, except for” two counts. 2023 WL

2319289, at *1. Henson therefore does nothing to establish a circuit

conflict.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.