Opposition Brief — John Patrick Couch, Petitioner v. United States

Nos. 20-1410 and 20-7934

In the Supreme Court of the United States

XIULU RUAN, PETITIONER

v.

UNITED STATES OF AMERICA

JOHN PATRICK COUCH, PETITIONER

v.

UNITED STATES OF AMERICA

ON PETITIONS FOR WRITS OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

ELIZABETH B. PRELOGAR

Acting Solicitor General

Counsel of Record

NICHOLAS L. MCQUAID

Acting Assistant Attorney

General

JOSHUA K. HANDELL

Attorney

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTION PRESENTED

Whether the district court abused its discretion in

declining a requested jury instruction on the ground

that it would have required acquittal on charges of the

unauthorized distribution of controlled substances, in

violation of 21 U.S.C. 841, based on petitioners’ own

“subjective view” of the “usual course of medical practice.”

(I)

ADDITIONAL RELATED PROCEEDINGS

United States District Court (S.D. Ala.):

United States v. Couch et al., No. 15-cr-88 (May 26,

2017)

United States Court of Appeals (11th Cir.):

United States v. Ruan et al., No. 17-12653 (July 10,

2020)

(II)

TABLE OF CONTENTS

Page

Opinion below ................................................................................ 1

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

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

Argument....................................................................................... 9

Conclusion ................................................................................... 25

TABLE OF AUTHORITIES

Cases:

Armstrong v. United States, 558 U.S. 829 (2009) ................ 9

Brotherhood of Locomotive Firemen & Enginemen

v. Bangor & Aroostook R.R., 389 U.S. 327 (1967) ........... 24

Hamilton-Brown Shoe Co. v. Wolf Bros. & Co.,

240 U.S. 251 (1916).............................................................. 24

Major League Baseball Players Ass’n v. Garvey,

532 U.S. 504 (2001).............................................................. 25

Sun v. United States, 138 S. Ct. 156 (2017) .......................... 9

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

(11th Cir.), cert. denied, 138 S. Ct. 254 (2017) ................. 15

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

(9th Cir.), cert. denied, 549 U.S. 1067 (2006) ............. 21, 24

United States v. Hooshmand, 931 F.2d 725

(11th Cir. 1991) .................................................................... 14

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

(4th Cir. 2006).................................................... 16, 17, 18, 22

United States v. Joseph, 709 F.3d 1082

(11th Cir. 2013), cert. denied, 571 U.S. 1204

(2014) ...................................................................... 7, 8, 15, 22

United States v. Kohli, 847 F.3d 483 (7th Cir.),

cert. denied, 138 S. Ct. 204 (2017) ............................... 20, 21

United States v. Ludwikowski, 944 F.3d 123

(3d Cir. 2019), cert. denied, 141 S. Ct. 872 (2020) ............ 16

(III)

IV

Cases—Continued:

Page

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

(1975) ...............................................................8, 10, 11, 22, 24

United States v. Norris, 780 F.2d 1207 (5th Cir. 1986) ..... 16

United States v. Sabean, 885 F.3d 27 (1st Cir. 2018) ......... 19

United States v. Smith, 573 F.3d 639 (8th Cir. 2009) ........ 16

United States v. Tobin, 676 F.3d 1264

(11th Cir.), cert. denied, 568 U.S. 1026 (2012),

and 568 U.S. 1105 (2013) .................................................... 15

United States v. Vamos, 797 F.2d 1146

(2d Cir. 1986), cert. denied, 479 U.S. 1036 (1987) ............ 16

United States v. Volkman, 797 F.3d 377 (6th Cir.),

cert. denied, 577 U.S. 934 (2015) ....................................... 18

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

(2d Cir. 2008) ....................................................................... 18

Statutes and rule:

Controlled Substances Act, 21 U.S.C. 801 et seq. ............... 10

21 U.S.C. 822(b) ............................................................... 10

21 U.S.C. 823(f )................................................................ 10

21 U.S.C. 841 ........................................................... passim

21 U.S.C. 841(a) ............................................................... 10

21 U.S.C. 841(a)(1)......................................................... 2, 7

21 U.S.C. 846 .................................................................. 2, 7

18 U.S.C. 371 ........................................................................ 2, 7

18 U.S.C. 1347 ...................................................................... 2, 7

18 U.S.C. 1349 ...................................................................... 2, 7

18 U.S.C. 1956(h) ................................................................. 2, 7

18 U.S.C. 1957 ...................................................................... 2, 7

18 U.S.C. 1962(d) ................................................................. 2, 7

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

Fed. R. Crim. P. 52(a) ........................................................... 23

In the Supreme Court of the United States

No. 20-1410

XIULU RUAN, PETITIONER

v.

UNITED STATES OF AMERICA

No. 20-7934

JOHN PATRICK COUCH, PETITIONER

v.

UNITED STATES OF AMERICA

ON PETITIONS FOR WRITS OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

OPINION BELOW

The opinion of the court of appeals (Pet. App. 1a128a) * is reported at 966 F.3d 1101.

JURISDICTION

The judgment of the court of appeals was entered on

July 10, 2020. A petition for rehearing en banc was de-

In this brief, citations to the petition appendix are to the petition

appendix in No. 20-1410.

*

(1)

2

nied on November 4, 2020 (Pet. App. 129a). The petitions for writs of certiorari were filed on April 5, 2021

(Monday). The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1).

STATEMENT

Following a jury trial in the Southern District of

Alabama, petitioners were convicted of racketeering

conspiracy, in violation of 18 U.S.C. 1962(d); drugdistribution conspiracies for Schedule II drugs, Schedule III drugs, and fentanyl, 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. In addition, petitioners were individually convicted on multiple counts

of drug distribution, in violation of 21 U.S.C. 841(a)(1).

Ruan Judgment 1; Couch Judgment 1. Petitioner 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.

Petitioner Ruan was sentenced to 252 months of imprisonment, to be followed by four years of supervised release. Id. at 2-3. Petitioner 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 to the district court for resentencing. Pet.

App. 128a.

3

1. Petitioners were licensed physicians, ostensibly

specializing in pain management, who enriched themselves through a long-running scheme of unlawfully issuing prescriptions for addictive and potent controlled

substances, in response to their own financial incentives

rather than the legitimate medical needs of their patients. See Pet. App. 5a-30a. They jointly owned and

operated a medical clinic and a connected pharmacy in

Mobile, Alabama. Id. at 5a-6a. The pharmacy’s sole

business was dispensing drugs prescribed at petitioners’ clinic. Id. at 6a. Between January 2011 and May

2015, each petitioner made more than $3.7 million from

the clinic and more than $550,000 in prescription service

fees from the pharmacy. Id. at 6a.

Over that same four-year period, petitioners wrote

nearly 300,000 prescriptions for controlled substances,

the majority of which were Schedule II drugs—“the

most powerful and dangerous drugs that can be lawfully

prescribed.” Pet. App. 7a; see Ruan Presentence Investigation Report (PSR) ¶ 25 (noting that petitioner Ruan,

through the clinic’s pharmacy, was the top purchaser in

the State of Alabama of oxycodone from 2011-2015; of

morphine from 2011-2015; and of fentanyl from 20122014). In particular, petitioners were among the top

prescribers nationwide of a potent and expensive version of fentanyl called transmucosal immediate-release

fentanyl (TIRF), which the Food and Drug Administration (FDA) had approved in 2011 to treat “breakthrough

pain in adult cancer patients who are already receiving

and who are tolerant to around-the-clock opioid therapy.” Pet. App. 8a; see id. at 8a-9a. Although no more

than 15% of their clinic’s patients had been diagnosed

with cancer, petitioners prescribed more than 475,000

4

doses of TIRF drugs to over 1000 patients, “often surpass[ing] the next highest prescriber [in the nation] by

more than double.” Id. at 9a.

Petitioners’ outlier prescription practices “tracked

financial incentives rather than their patients’ medical

needs.” Pet. App. 9a. For example, between November

2013 and January 2014, petitioners purchased more

than $1.3 million of stock in Galena Biopharma, the

owner and manufacturer of a TIRF drug marketed as

“Abstral.” Id. at 10a; see id. at 8a. Around the same

time, petitioners massively increased their prescriptions of Abstral, with petitioner Ruan reaching a peak

of more than 2.6 million micrograms per month in

March 2014. Id. at 11a. Petitioners became so important to Galena’s bottom line that the company fired

its CEO at their request, and the new CEO made a trip

to Mobile to meet with petitioners in person. Ibid. And

“national Abstral sales dropped significantly” when

petitioners’ clinic was shuttered in May 2015. Id. at 12a

(internal quotation marks omitted).

Petitioners’ prescription practices also put them in

position to collect substantial speaking fees from Insys,

the manufacturer of a different TIRF drug marketed as

“Subsys.” Pet. App. 8a, 13a. Petitioners were paid to

host weekly programs promoting Subsys, even though

no new prospective prescribers attended those programs. Id. at 13a. According to the Insys 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. Ibid. The strategy worked: Petitioners’ clinic ranked among the top ten prescribers of

Subsys, and Insys considered petitioners to be “whales”

—i.e., “the top prescribing doctors” for the drug. Ibid.

5

Suspecting that petitioners were operating a “pill

mill,” the Drug Enforcement Administration (DEA)

launched an investigation in 2014. Pet. App. 18a. As

part of that investigation, an undercover DEA agent

acted as a patient seeking controlled substances from

petitioners’ clinic. Ibid. Clinic staff did not ask the undercover agent about his pain levels, and the agent told

clinic employees that he had previously been selfmedicating with oxycodone that he had purchased on

the street. Id. at 18a-19a. Nevertheless, petitioner

Couch signed a 90-pill prescription for Roxicodone, a

Schedule II controlled substance, after appearing for

less than one minute of the agent’s initial office visit. Id.

at 19a. On several subsequent occasions, the undercover agent obtained additional prescriptions for oxycodone, sometimes with an increased number of pills,

without seeing either petitioner. Ibid. Those prescriptions appeared to have been pre-dated and signed by

petitioner Couch. Ruan PSR ¶¶ 49-51. Although the

undercover agent was seen by other medical practitioners at the clinic during those visits, none of those practitioners was authorized to prescribe Schedule II controlled substances like oxycodone. See ibid.

2. In 2016, a federal grand jury returned an indictment charging petitioners with 22 counts of conspiracy,

drug distribution, fraud, illegal kickbacks, and money

laundering. See Second Superseding Indictment 13-41.

Both petitioners proceeded to trial, which lasted seven

weeks. Gov’t C.A. Br. 32.

At the close of trial, petitioners proposed that the

jury be instructed as follows:

If a physician dispenses or distributes a Controlled

Substance in good faith while medically treating a

6

patient, then the physician has dispensed or distributed that Controlled Substance for a legitimate medical purpose and within the usual course of professional practice, and you must return a not guilty verdict for the applicable count. Good faith in this context means good intentions and the honest exercise

of professional judgment as to the patient’s needs. It

means that the Defendant acted in accordance with

what he reasonably believed to be proper medical

practice. If you find that a Defendant acted in good

faith in dispensing or distributing a Controlled Substance, as charged in the indictment, then you must

return a not guilty verdict.

Pet. App. 102a-103a. Petitioners also urged the district

court to instruct the jury that “the Government must

prove, beyond a reasonable doubt, that the physician’s

decisions to distribute or dispense a Controlled Substance were inconsistent with any accepted method of

treating a pain patient—that the physician, in fact, operated as a drug pusher.” Id. at 103a.

While the district court offered to give a different instruction including “good faith language,” Pet. App.

136a, it declined to give petitioners’ particular proposed

instruction, id. at 135a. As most relevant here, it determined that the instruction embodied “a subjective view

of what is the usual course of professional practice,”

when “the standard should be an objective one.” Id. at

134a. The court also concluded that the proposed language requiring proof that a physician operated as a

“drug pusher” was legally incorrect. Id. at 104a.

The district court subsequently instructed the jury

that, “[f]or a controlled substance to be lawfully dispensed by a prescription,” the physician must have prescribed the substance “both within the usual course of

7

professional practice and for a legitimate medical purpose.” Pet. App. 104a. The court also offered a goodfaith instruction drawn from circuit case law:

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. The defendants in this case maintain

at all times they acted in good faith and in accordance

with the standard of medical practice generally recognized and accepted in the United States in treating

patients.

Id. at 139a; accord United States v. Joseph, 709 F.3d

1082, 1092 (11th Cir. 2013), cert. denied, 571 U.S. 1204

(2014).

The jury found both petitioners guilty of racketeering conspiracy, in violation of 18 U.S.C. 1962(d); three

counts of conspiring to distribute Schedule II drugs,

Schedule III drugs, and fentanyl, in violation of 21

U.S.C. 841(a)(1) and 846; two counts of conspiring to

commit healthcare fraud and mail and wire fraud, in violation of 18 U.S.C. 1347 and 1349; 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); and five counts of drug distribution,

in violation of 21 U.S.C. 841(a)(1). Ruan Judgment 1;

Couch Judgment 1. The jury also found petitioner Ruan

guilty of conspiring to launder the proceeds of illegal

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

U.S.C. 1957. Ruan Judgment 1. The district court sentenced petitioner Ruan to 252 months of imprisonment,

8

to be followed by four years of supervised release, and

petitioner Couch to 240 months of imprisonment, to be

followed by four years of supervised release. Ruan

Judgment 2-3; Couch Judgment 2-3.

3. The court of appeals largely affirmed petitioners’

convictions, reversing only their convictions on one

count of conspiring to violate the anti-kickback statute.

Pet. App. 1a-128a. The court remanded the cases for

resentencing. Id. at 128a.

As relevant here, the court of appeals rejected petitioners’ arguments that the district court had abused its

discretion in declining to issue their proposed “good

faith” jury instruction. Pet. App. 102a-113a. The court

of appeals agreed with the district court that the proposed instruction had incorrectly stated the law because

the question “[w]hether a defendant acts in the usual

course of his professional practice must be evaluated

based on an objective standard, not a subjective standard.” Id. at 105a (quoting Joseph, 709 F.3d at 1097).

The court of appeals explained that the objective

standard best reflected this Court’s decision in United

States v. Moore, 423 U.S. 122 (1975), which had established that “physicians can be prosecuted for violating

the Controlled Substances Act ‘when their activities fall

outside the usual course of professional practice.’ ” Pet.

App. 106a (quoting Moore, 423 U.S. at 124). The court

observed that petitioners’ proposed instruction would

instead have allowed a physician to escape conviction

“as long as a physician subjectively believes that he is

meeting a patient’s medical needs by prescribing a controlled substance, * * * no matter how far outside the

bounds of professional medical practice his conduct

falls.” Ibid. And the court emphasized that a jury in-

9

struction endorsing “a complete defense” based on subjective “good faith” impermissibly omits “the objective

standard by which to judge the physician’s conduct.”

Ibid. The court also noted that the rejection of petitioners’ preferred instruction did not “seriously impair [petitioners’] ability to present an effective defense” because the district court had provided a good-faith instruction linked to the “standards of medical practice

generally recognized and accepted in the United

States.” Id. at 107a.

The court of appeals likewise affirmed the district

court’s refusal to issue the proposed “drug pusher” instruction, Pet. App. 108a-111a, and its general “instruction at the end of trial defining the criminal standard”

applicable to petitioners’ conduct, id. at 112a; see id. at

111a-113a.

ARGUMENT

Petitioners renew their contention (Ruan Pet. 14-36;

Couch Pet. 5-11) that the district court abused its discretion in declining to deliver their proposed good-faith

instruction to the jury. The court of appeals correctly

rejected that contention, and its decision neither contravenes any precedent of this Court nor meaningfully

conflicts with any decision of another court of appeals.

Even if the district court’s instruction could have been

worded more precisely, the instruction that petitioners

had proposed was inaccurate. This Court has denied review in other cases presenting similar issues. See, e.g.,

Sun v. United States, 138 S. Ct. 156 (2017) (No. 169560); Armstrong v. United States, 558 U.S. 829 (2009)

(No. 08-9339). It should follow the same course here.

In addition, even if the question presented otherwise

10

warranted this Court’s review, this case presents an unsuitable vehicle in which to resolve it. The petitions for

writs of certiorari should be denied.

1. a. Federal law prohibits the distribution of controlled substances “[e]xcept as authorized by” the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq.

21 U.S.C. 841(a). The CSA authorizes physicians who

register with the DEA to dispense controlled substances, but only “to the extent authorized by their registration and in conformity with [the CSA].” 21 U.S.C.

822(b); see 21 U.S.C. 823(f).

In United States v. Moore, 423 U.S. 122 (1975), this

Court held that physicians registered under the CSA

may be subject to criminal liability under Section 841

“when their activities fall outside the usual course of

professional practice.” Id. at 124. The Court reasoned

that, under the Act’s statutory predecessor, physicians

“who departed from the usual course of medical practice” had been subject to the same penalties as “street

pushers,” and “the scheme of the [CSA] * * * reveals

an intent to limit a registered physician’s dispensing authority to the course of his ‘professional practice.’ ” Id.

at 139-140.

Applying that standard, the Court in Moore upheld

the prescribing physician’s conviction because “[t]he evidence presented at trial” in that case “was sufficient for

the jury to find that [his] conduct exceeded the bounds

of ‘professional practice.’ ” 423 U.S. at 142. Although

the Court did not specifically decide what jury instructions were required, it implicitly deemed sufficient the

jury instructions given. Those instructions stated that

the physician could be found guilty of violating Section

841 if he dispensed controlled substances “other than in

good faith * * * in the usual course of a professional

11

practice and in accordance with a standard of medical

practice generally recognized and accepted in the

United States.” Id. at 139 (citation omitted). They also

stated that the defendant could not be found guilty if he

“made ‘an honest effort’ to prescribe * * * in compliance with an accepted standard of medical practice.” Id.

at 142 n.20 (citation omitted).

As the court of appeals in this case correctly recognized, this Court’s decision in Moore contemplates that

a defendant physician’s conduct “must be evaluated

based on an objective standard, not a subjective standard.” Pet. App. 105a (citation omitted). The touchstone

for liability under Moore is whether a defendant acted

—or, at a minimum, “made ‘an honest effort’ ” to act—

consistently with an objectively “accepted standard of

medical practice.” 423 U.S. at 142 n.20 (citation omitted). Framed in terms of “good faith,” the jury instructions implicitly approved in Moore allowed the defendant to argue that he should not be subject to criminal

liability if he had made a good-faith attempt to comply

with generally accepted medical practice. But Moore

did not endorse a freewheeling subjective approach, under which the defendant could argue that he had acted

in good faith by prescribing controlled substances in

any manner that he subjectively viewed as acceptable

medical practice.

Petitioners nonetheless asked the district court in

this case 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,” and the jury

“must return a not guilty verdict for the applicable

12

count.” Pet. App. 130a-131a. Petitioners’ proposed instruction then supplied two definitions of “good faith”:

first, that “[g]ood faith in this context means good intentions and the honest exercise of professional judgment as to the patient’s needs”; and second, that “[i]t

means that the Defendant acted in accordance with

what he reasonably believed to be proper medical practice.” Id. at 131a. The government objected to that instruction on the ground (inter alia) that it “would invite

confusion.” Id. at 133a. And the district court agreed

that the instruction was improper, finding that petitioners were “proposing * * * a subjective view of what is

the usual course of professional practice,” when “the

standard should be an objective one, not a subjective

one.” Id. at 134a.

The court of appeals correctly determined that the

district court acted within its discretion in rejecting

petitioners’ proposed jury instruction. Like the district

court, the court of appeals read petitioners’ proposed

instruction to articulate a wholly subjective standard,

requiring the jury to acquit if it found that petitioners

had acted in accordance with either their “professional

judgment as to the patient’s needs” or their subjective

“belie[f]” as to “proper medical practice,” Pet. App.

103a—regardless of whether petitioners had in fact attempted to comply with generally accepted medical

practice. See id. at 106a. As the court explained, “under [petitioners’] proposed instruction, as long as a physician subjectively believes that he is meeting a patient’s medical needs by prescribing a controlled substance, then he cannot be convicted of violating the Act

no matter how far outside the bounds of professional

medical practice his conduct falls.” Ibid. Because such

a formulation “fail[s] to include the objective standard

13

by which to judge the physician’s conduct,” ibid., it is

inconsistent with this Court’s decision in Moore. The

court of appeals thus correctly affirmed the district

court’s rejection of petitioners’ proposed instruction.

Petitioner Ruan asserts that “[t]he Solicitor General

* * * call[ed]” an instruction like the instruction proposed here “a ‘model of clarity and comprehensiveness.’ ” Ruan Pet. 20 (quoting Br. in Opp. at 12,

Volkman v. United States, 574 U.S. 955 (2014) (No. 138827)). But the quoted language, which was itself a quotation from a specific court of appeals opinion, was addressed to the combination of various “aspects of the instructions” that had been “tailored to the facts of th[at]

case,” not all of which appeared in petitioners’ proposal

here. Br. in Opp. at 6, Volkman, supra (No. 13-8827);

see, e.g., id. at 7 (noting that the jury in that case was

instructed, inter alia, that a “physician’s own individual

treatment methods do not, by themselves, establish

what constitutes a ‘usual course of professional practice’ ”) (citation omitted). And when the government

later directly addressed the question, the government

made clear that Section 841 incorporates an objective

rather than a subjective standard for assessing a defendant’s compliance with the accepted course of professional practice. See Br. in Opp. at 13, Sun, supra

(No. 16-9560).

b. In his petition for a writ of certiorari, petitioner

Ruan principally focuses not on the rejection of his proposed instruction, but instead on the instruction given

by the district court. He asserts (Pet. 2-3, 15-16, 25-26)

that the jury instructions did not permit any good-faith

defense by a physician who reasonably believes that he

is complying with professional norms, or subjectively

intends to do so.

14

To the extent that the district court’s instruction

might be parsed in such a way as to exclude any goodfaith defense, a reasonable jury would not have understood the given instructions to exclude a good-faith defense altogether. See United States v. Hooshmand, 931

F.2d 725, 731 (11th Cir. 1991) (noting that, “[w]hen reviewing jury instructions,” the court of appeals “determines whether the charges as a whole sufficiently instructed the jury so that it understood the issues involved”). The district court twice mentioned “good

faith,” including that 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.” Pet. App. 104a-105a.

And the jury would naturally understand “professional”

“medical” practice as including some reasonable degree

of individualized physician judgment as to how such

practice would translate into individualized treatment

of specific patients. Defense counsel argued to the

jury—without objection from the government—that the

question in the case was not whether petitioners had

“committed malpractice” but whether they had in fact

been “practicing medicine.” D. Ct. Doc. 722-27, at 102

(Dec. 20, 2017). On appeal, the government thus contended that “[a] jury that believed defendants committed only negligent misprescribing and not intentional

drug distribution would have acquitted.” Gov’t C.A. Br.

97. And the court of appeals construed the jury instructions that way, concluding that “the district court instructed the jury that if the [petitioners] acted in good

faith, they acted lawfully.” Pet. App. 112a.

In all events, any impression in the jury instruction

given by the district court would not cast doubt on the

court of appeals’ rejection of petitioners’ argument that

15

“the district court erred in refusing to give their proposed jury instruction,” Pet. App. 102a (emphasis

added). Petitioner Ruan contends that the Eleventh

Circuit has elsewhere determined that “[t]here is no

room for good faith mistakes, reasonable or otherwise.”

Pet. 16; see Pet. 16-17, 23-26. But the decisions on

which he relies do not clearly establish such a rule. In

both United States v. Tobin, 676 F.3d 1264 (11th Cir.),

cert. denied, 568 U.S. 1026 (2012), and 568 U.S. 1105

(2013), and United States v. Joseph, 709 F.3d 1082 (11th

Cir.), cert. denied, 571 U.S. 1204 (2014), the court of appeals rejected challenges to excluded evidence or jury

instructions like the one given here, on the ground that

the usual course of professional practice must be evaluated based on an objective rather than a subjective

standard. See Joseph, 709 F.3d at 1097; Tobin, 676 F.3d

at 1279, 1281, 1283. And in the unpublished decision in

United States v. Enmon, 686 Fed. Appx. 769 (11th Cir.),

cert. denied, 138 S. Ct. 254 (2017), the court concluded

that, even if it had “never (unequivocally) held that good

faith is irrelevant to the objective standard required for

the ‘usual course of his professional practice’ analysis,”

a jury instruction to that effect did not amount to plain

error. Id. at 773; see Joseph, 709 F.3d at 1097 (“The law

of this Circuit is not even clear that [the defendant] was

entitled to a ‘good faith’ jury instruction at all.”). The

Eleventh Circuit thus has not directly considered a proposed jury instruction that—in contrast with the instruction petitioners proposed here—links good faith to

a defendant’s attempt to comply with the objectively accepted professional practice.

2. The court of appeals’ rejection of petitioners’ proposed jury instruction here is consistent with the uni-

16

form view of other courts of appeals, which have recognized that “allowing criminal liability to turn on whether

the defendant-doctor complied with his own idiosyncratic view of proper medical practices is inconsistent

with [this] Court’s decision in Moore.” United States v.

Hurwitz, 459 F.3d 463, 478 (4th Cir. 2006). Every court

of appeals to consider the question has concluded that

Moore calls for “an objective standard” rather than a

subjective one, and that an instruction focused on what

the doctor “ ‘believed to be proper medical practice’ ” is

“not an accurate statement of the law.” Ibid. (citation

and emphasis omitted); see, e.g., United States v. Smith,

573 F.3d 639, 648 (8th Cir. 2009) (explaining that liability turns on an objective standard measured by “generally recognized and accepted medical practices” rather

than “a doctor’s self-defined particular practice”);

United States v. Vamos, 797 F.2d 1146, 1153 (2d Cir.

1986) (“To permit a practitioner to substitute his or her

views of what is good medical practice for standards

generally recognized and accepted in the United States

would be to weaken the enforcement of our drug laws in

a critical area.”), cert. denied, 479 U.S. 1036 (1987);

United States v. Norris, 780 F.2d 1207, 1209 (5th Cir.

1986) (“[T]he district court carefully modelled its

charge after the Moore charge and properly directed

the jury to consider * * * from an objective standpoint

whether the drugs were dispensed in the usual course

of a professional practice.”); cf. United States v. Ludwikowski, 944 F.3d 123, 137 (3d Cir. 2019) (observing

that “if we were to explicitly rule upon the nature of the

‘usual course of professional practice’ standard, we

would likely agree with our sister Circuits that the plain

language of the standard shows it to be an objective

one”), cert. denied, 141 S. Ct. 872 (2020).

17

Nevertheless, petitioners contend (Ruan Pet. 17-27;

Couch Pet. 10-11) that the decision below conflicts with

decisions of other courts of appeals—and, in petitioner

Ruan’s view, with two separate alignments of circuits,

neither of which purportedly adopts the same approach

to Section 841 prosecutions as the Eleventh Circuit.

While some variation exists in the case-specific jury instructions that courts of appeals have upheld over the

years, no court of appeals has reversed a conviction on

the theory that a defendant physician is entitled to a

jury instruction like the one that petitioners proposed

here. Indeed, most of the decisions on which petitioners

rely affirmed convictions of physicians under the

CSA—a result in accord with the result here.

a. Petitioner Ruan first contends (Ruan Pet. 18)

that, “[i]n the Fourth, Second, and Sixth Circuits, physicians are entitled to acquittal if they ‘reasonably believe’ that their conduct complied with professional

norms.” His leading authority for that proposition is

the Fourth Circuit’s decision in United States v. Hurwitz, supra. See Ruan Pet. 18-19; see also Couch Pet.

10 (arguing that “other circuits recognize [that] there

are inherently subjective and objective components in

the liability of physicians under the Controlled Substances Act,” and citing only Hurwitz). In that case,

however, the Fourth Circuit concluded that the district

court had “erred by affirmatively informing the jury

that good faith was relevant only to the fraud charges”

against the defendant and thus was not relevant in any

respect to the Section 841 charges against him. Hurwitz, 459 F.3d at 480. This case does not involve any

analogous set of instructions. And the Fourth Circuit

indicated that a proper good-faith instruction “must reflect an objective rather than subjective standard for

18

measuring [the doctor’s] good faith.” Id. at 482; see Pet.

App. 106a.

The remaining decisions on which petitioner Ruan

relies (Ruan Pet. 19-21) are also consistent with the

court of appeals’ decision in this case. In United States

v. Wexler, 522 F.3d 194 (2008), the Second Circuit rejected a defendant’s challenge to a jury instruction that

“lacked a ‘good intentions’ component,” stating that, instead, “a jury must be informed that the drug has been

legally dispensed if the physician had a good faith belief,

based on a standard of objective reasonableness, that

his prescription ‘was for a legitimate medical purpose

and in accord with the usual course of generally accepted medical practice,’ ” id. at 205 (citation omitted).

That determination is consistent with the court of appeals’ rejection of petitioners’ proposed definition of

“good faith” to “mean[] good intentions.” Pet. App.

131a.

Likewise, in United States v. Volkman, 797 F.3d 377,

cert. denied, 577 U.S. 934 (2015), the Sixth Circuit affirmed a district court’s rejection of a proposed instruction stating that, “in order to find the defendant guilty,

[the jury] must find that he used his prescriptionwriting power as a means to engage in the illicit drugdealing and trafficking as conventionally understood,”

id. at 385. Similarly here, the court of appeals affirmed

the district court’s rejection of petitioners’ proposed instruction that “the Government must prove * * * that

the physician, in fact, operated as a drug pusher,” observing that “the term ‘drug pusher’ connotes imagery

of back-alley illicit drug deals” that need not be part of

a CSA violation. Pet. App. 103a, 108a. Although the

Volkman court also upheld the lengthier good-faith instruction delivered by the district court in that case, it

19

did not hold that any particular good-faith formulation

was a required component of jury instructions on a Section 841 charge.

b. Petitioner Ruan next contends (Pet. 21) that

“[t]he Ninth, First, and Seventh Circuits * * * require

the government to prove that a physician intentionally

exceeded the bounds of professional practice.” But

again, the decisions on which he relies do not meaningfully differ from the court of appeals’ decision here to

reject petitioners’ proposed jury instruction.

The First Circuit’s decision in United States v. Sabean, 885 F.3d 27 (2018), concerned the distinction between criminal liability under Section 841 and civil liability for medical malpractice. In that case, the district

court had instructed jurors that they “may consider

* * * evidence regarding ethical standards and the

standard of care,” but “caution[ed] [them] that this is

not a civil case involving medical negligence for which a

person may recover monetary damages.” Id. at 48-49.

On appeal, the First Circuit confirmed that “medical

negligence alone was insufficient to ground a conviction” for unlawful drug distribution, rejecting the defendant’s assertion that his “proposed alternative language * * * would have better illustrated the distinction between criminal distribution of drugs and medical

malpractice.” Id. at 45.

At trial in this case, petitioners were permitted to argue at length that simple negligence—and even malpractice sufficient for civil liability—did not satisfy the

standard for criminal liability under the CSA. Petitioner Couch’s counsel explained that distinction to the

jury:

There’s poor care. Okay. There’s neglect care, even.

And then there’s even malpractice. * * * All of that

20

is within the usual course of medicine. It’s only when

you step outside the practice of medicine or you’re

outside the usual course of professional practice,

that’s where the government has to get you. Was Dr.

Couch no longer practicing medicine? Had he shed

his white coat and decided to become a drug pusher,

a drug dealer? That’s the question in this case, not

whether he committed malpractice, not whether he

was negligent, not whether his records were perfect.

Was he practicing medicine?

D. Ct. Doc. 722-27, at 101-102.

The government did not object to that line of argument in the district court, and it observed on appeal that

a “jury that believed defendants committed only negligent misprescribing and not intentional drug distribution would have acquitted.” Gov’t C.A. Br. 97. The

court of appeals agreed. See Pet. App. 111a-113a. Accordingly, no party to this case and neither of the courts

below disputes the First Circuit’s holding in Sabean—

that a defendant’s having fallen short of the civil “standard of care” imposed on physicians is not sufficient to

convict for intentional drug distribution.

Petitioner Ruan’s reliance (Pet. 22-23) on United

States v. Kohli, 847 F.3d 483 (7th Cir.), cert. denied, 138

S. Ct. 204 (2017), is similarly misplaced. In that case—

which concerned a defendant’s challenge to the sufficiency of the evidence against him rather than any instructional dispute—the Seventh Circuit stated that

“the critical inquiry is whether the relevant prescriptions were made for a valid medical purpose and within

the usual course of professional practice.” Id. at 491.

Because the defendant’s prescriptions were issued neither for a valid medical purpose nor in the usual course

21

of professional practice, the court of appeals determined that the government had carried its evidentiary

burden. See id. at 490 (“[T]he government presented

ample evidence establishing that Dr. Kohli intentionally

abandoned his role as a medical professional and unlawfully dispensed controlled substances with no legitimate

medical purpose.”). The Seventh Circuit’s decision does

not indicate that it would have reversed petitioners’

convictions here.

Finally, petitioner Ruan’s invocation (Pet. 21) of

United States v. Feingold, 454 F.3d 1001 (9th Cir.), cert.

denied, 549 U.S. 1067 (2006), does not provide support

for petitioners’ proposed instruction. In that case, the

Ninth Circuit upheld a jury instruction stating that, inter alia, a “practitioner may not be convicted of unlawful distribution of controlled substances when he distributes controlled substances in good faith to patients

in the regular course of professional practice.” Id. at

1006. That description of the good-faith defense is substantively identical to the good-faith instruction that the

district court delivered in this case. See Pet. App. 104a

(explaining that a physician lawfully prescribes a controlled substance “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”). And although the Feingold opinion additionally noted that the defendant’s “state of mind” is an important consideration in the prosecution of a Section 841

offense, and commended the district court for “compell[ing] the jury to consider whether Dr. Feingold intended to distribute the controlled substances for a legitimate medical purpose and whether he intended to

act within the usual course of professional practice,” 454

22

F.3d at 1008-1009, the Ninth Circuit did not hold that a

district court would abuse its discretion by declining to

give an instruction like the one proffered by petitioners

in this case, see Pet. App. 103a.

c. Any minor variation that has developed in the decisions applying Moore does not warrant this Court’s

review. Nor is any such division implicated here: Petitioners have failed to demonstrate that any court of appeals would have found that the district court abused its

discretion in declining to give the “good intentions” jury

instruction that petitioners proposed. Pet. App. 103a.

Whatever weight might be given to the Eleventh Circuit’s statement, in decisions other than this one, that a

defendant’s entitlement to a good-faith instruction is

“not * * * clear,” Joseph, 709 F.3d at 1097, the lower

courts in this case, like all of the courts of appeals, recognized that a defendant’s good faith can be relevant to

the Section 841 analysis. See Pet. App. 107a, 136a; see

also, e.g., Hurwitz, 459 F.3d at 477. Like all courts of

appeals, however, the lower courts here recognized that

“the usual course of professional practice” articulated

in Moore, 423 U.S. at 124, must be assessed objectively.

See, e.g., Hurwitz, 459 F.3d at 478. And, like all courts

of appeals, the lower courts here recognized that the

standard for criminal liability under Section 841 is

higher than the standard for civil liability on a medicalnegligence or medical-malpractice claim. See, e.g., id.

at 478-479.

3. Even if petitioners’ challenge to the jury instructions otherwise warranted this Court’s review, this case

would be a poor vehicle in which to consider the question presented.

a. First, any error in the instructions was harmless

beyond a reasonable doubt in light of the overwhelming

23

evidence that petitioners dispensed dangerous and addictive drugs to serve their own financial interests rather than to further any legitimate medical purpose or

adhere to any arguable, reasonable, or subjectively perceived professional standard. See Fed. R. Crim. P.

52(a); see generally Pet. App. 5a-30a. As the government detailed before the court of appeals, petitioners

routinely signed prescriptions without seeing patients

and left blank, pre-signed prescriptions at the office, despite being informed that such a practice was illegal.

Gov’t C.A. Br. 50. That approach allowed petitioners’

clinic to process “upwards of . . . 150 to 200” patients

each day, with patients sometimes quadruple-booked

for the same appointment slots. Id. at 18 (citation omitted). And as exemplified by the experience of an undercover DEA agent, petitioners prescribed drugs based

on minimal, unverified complaints of pain. See Pet.

App. 18a-19a.

Moreover, petitioners’ prescribing habits clearly

tracked their financial incentives, including their substantial investments in and payments received from the

pharmaceutical companies that manufactured and sold

the drugs they were prescribing. Gov’t C.A. Br. 50. Petitioners and their staff pressured patients to fill prescriptions at the clinic’s in-house pharmacy and prescribed medication based on what the pharmacy had in

stock. Id. at 15. They also routinely prescribed potent

and expensive TIRF drugs, which are approved for

opioid-tolerant cancer patients, to patients who did not

have cancer and did not need or want the medication.

Id. at 51. And they ignored evidence of diversion and

abuse, see id. at 24-25, by, for example, continuing to

prescribe opioids for patients who had repeatedly failed

24

drug tests, id. at 17, and disregarding the outright admission of an undercover DEA agent that he had been

obtaining oxycodone on the street before seeking a prescription from their clinic, Ruan PSR ¶ 48. See Gov’t

C.A. Br. 25 (noting that “so many [clinic]-prescribed

opioids ended up on the streets of Mobile that the week

after [petitioners’ clinic] was raided, the street price for

those drugs ‘almost doubled’ ”) (citation omitted).

The trial evidence thus overwhelmingly demonstrated that each petitioner, like the doctor in Moore, “[i]n

practical effect * * * acted as a large-scale ‘pusher’—

not as a physician.” 423 U.S. at 143. Accordingly, petitioners would not have benefitted even from their proposed instruction directing the jury to acquit solely

upon a finding that petitioners believed that their prescribing practices were “proper.” Pet. App. 103a; see,

e.g., Feingold, 454 F.3d at 1012 (determining that any

instructional error in a Section 841 case was harmless

because the evidence was “overwhelming” and included

proof that the defendant physician prescribed drugs “to

undercover law enforcement officials who did little

more than tell him they wanted narcotics”).

b. Second, the interlocutory posture of this case

“alone furnishe[s] sufficient ground for the denial” of

the petition for a writ of certiorari. Hamilton-Brown

Shoe Co. v. Wolf Bros. & Co., 240 U.S. 251, 258 (1916);

see Brotherhood of Locomotive Firemen & Enginemen

v. Bangor & Aroostook R.R., 389 U.S. 327, 328 (1967)

(per curiam) (explaining that a case remanded to district court “is not yet ripe for review by this Court”).

“[E]xcept in extraordinary cases, [a] writ [of certiorari]

is not issued until final decree.” Hamilton-Brown Shoe

Co., 240 U.S. at 258. That approach promotes judicial

efficiency because the issues raised in a petition may be

25

rendered moot by further proceedings on remand, and

because challenges to a criminal defendant’s conviction

and sentence may be consolidated into a single petition

for a writ of certiorari.

Here, the court of appeals vacated one count of conviction as to both petitioners and remanded to the district court for resentencing. Pet. App. 128a. Resentencing has not yet taken place. Following the district

court’s disposition of the case on remand (and any new

appeal taken from the amended judgment), petitioners

will be able to reassert the current claim raised in their

petitions—together with any other claims that may

arise at sentencing—in new petitions for writs of certiorari seeking review of the final judgment against them.

See Major League Baseball Players Ass’n v. Garvey,

532 U.S. 504, 508 n.1 (2001) (per curiam) (noting that the

Court “ha[s] authority to consider questions determined in earlier stages of the litigation where certiorari

is sought from” the most recent judgment). Petitioners

provide no sound reason to depart in this case from the

Court’s usual practice of awaiting final judgment.

CONCLUSION

The petitions for writs of certiorari should be denied.

Respectfully submitted.

ELIZABETH B. PRELOGAR

Acting Solicitor General

NICHOLAS L. MCQUAID

Acting Assistant Attorney

General

JOSHUA K. HANDELL

Attorney

JULY 2021