Opposition Brief — George P. Naum, III, Petitioner v. United States

No. 20-1480

In the Supreme Court of the United States

GEORGE P. NAUM, III, PETITIONER

v.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

ELIZABETH B. PRELOGAR

Acting Solicitor General

Counsel of Record

KENNETH A. POLITE, JR.

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 to admit evidence or to instruct the jury in furtherance of petitioner’s theory that his bad-faith prescription of opioids outside the course of professional

practice is insulated from charges of the unauthorized

distribution of controlled substances, in violation of 21

U.S.C. 841, so long as he could assign a general “legitimate medical purpose” to his activities.

(I)

TABLE OF CONTENTS

Page

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

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

Statement ...................................................................................... 1

Argument....................................................................................... 6

Conclusion ................................................................................... 17

TABLE OF AUTHORITIES

Cases:

Armstrong v. United States, 558 U.S. 829 (2009) .......... 7, 10

Sun v. United States, 138 S. Ct. 156 (2017) .......................... 7

United States v. Alerre, 430 F.3d 681

(4th Cir. 2005), cert. denied, 547 U.S. 1113 (2006)........... 13

United States v. Armstrong, 550 F.3d 382

(5th Cir. 2008), cert. denied, 558 U.S. 829

(2009) ........................................................................ 10, 13, 16

United States v. Bek, 493 F.3d 790 (7th Cir.),

cert. denied, 522 U.S. 1010 (2007) ..................................... 11

United States v. Chube II, 538 F.3d 693

(7th Cir. 2008)...................................................................... 15

United States v. Daniel, 3 F.3d 775

(4th Cir. 1993), cert. denied, 510 U.S. 1130 (1994)........... 11

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

(9th Cir.), cert. denied, 549 U.S. 1067 (2006) ................... 14

United States v. Guillermo Balleza, 613 F.3d 432

(5th Cir.), cert. denied, 562 U.S. 1076 (2010) ................... 10

United States v. Khan, 989 F.3d 806

(10th Cir. 2021) .................................................................... 13

United States v. Kirk, 584 F.2d 773 (6th Cir.),

cert. denied, 439 U.S. 1048 (1978) ..................................... 11

United States v. Limberopoulos, 26 F.3d 245

(1st Cir. 1994) ...................................................................... 13

(III)

IV

Cases—Continued:

Page

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

(1975) ...............................................................5, 6, 7, 8, 11, 12

United States v. Nelson, 383 F.3d 1227

(10th Cir. 2004) .................................................................... 10

United States v. Plesons, 560 F.2d 890 (8th Cir.),

cert. denied, 434 U.S. 966 (1977) ....................................... 11

United States v. Rosenberg, 515 F.2d 190

(9th Cir.), cert. denied, 423 U.S. 1031 (1975) ................... 10

United States v. Rottschaefer, 178 Fed. Appx. 145

(3d Cir.), cert. denied, 549 U.S. 887 (2006) ....................... 11

United States v. Ruan, 966 F.3d 1101

(11th Cir. 2020), petitions for cert. pending,

Nos. 20-1410 and 20-7934 (filed Apr. 5, 2020) .................. 16

United States v. Smith, 573 F.3d 639

(8th Cir. 2009)................................................................ 14, 15

United States v. Tran Trong Cuong, 18 F.3d 1132

(4th Cir. 1994)...................................................................... 13

United States v. Volkman, 736 F.3d 1013

(6th Cir. 2013), cert. granted, judgment vacated,

574 U.S. 95 (2014), op. resubmitted in relevant part,

797 F.3d 377 (6th Cir. 2015) ............................................... 15

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

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

United States v. Williams, 445 F.3d 1302

(11th Cir. 2006), abrogated on other grounds by

United States v. Lewis, 492 F.3d 1219

(11th Cir. 2007) .................................................................... 11

V

Statutes:

Page

Controlled Substances Act, 21 U.S.C. 801 et seq. ................. 7

21 U.S.C. 822(b) ................................................................. 7

21 U.S.C. 823(f ).................................................................. 7

21 U.S.C. 829 .................................................................... 12

21 U.S.C. 841 ...............................................2, 5, 7, 8, 13, 14

21 U.S.C. 841(a) ................................................................. 7

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

21 U.S.C. 846 .................................................................. 2, 5

18 U.S.C. 2 ............................................................................ 2, 5

In the Supreme Court of the United States

No. 20-1480

GEORGE P. NAUM, III, PETITIONER

v.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

OPINION BELOW

The opinion of the court of appeals (Pet. App. A1A18) is not published in the Federal Reporter but is reprinted at 832 Fed. Appx. 137.

JURISDICTION

The judgment of the court of appeals was entered on

October 13, 2020. A petition for rehearing en banc was

denied on November 24, 2020 (Pet. App. A28). The petition for a writ of certiorari was filed on April 20, 2021.

The jurisdiction of this Court is invoked under 28 U.S.C.

1254(1).

STATEMENT

Following a jury trial in the United States District

Court for the Northern District of West Virginia, petitioner was convicted on one count of conspiring to distribute controlled substances, in violation of 21 U.S.C.

(1)

2

841(a)(1) and 846, and four counts of aiding and abetting

the unlawful distribution of controlled substances, in violation of 18 U.S.C. 2 and 21 U.S.C. 841. Judgment 1-2.

He was sentenced to six months in prison, to be followed

by two years of supervised release. Judgment 3-4. The

court of appeals affirmed. Pet. App. A1-A18.

1. Petitioner was one of two licensed physicians employed by Advance Healthcare, a West Virginia clinic

purportedly engaged in the treatment of drug addiction. Pet. App. A2. Petitioner and the clinic’s other doctor, Felix Brizuela, were authorized by the federal Drug

Enforcement Administration (DEA) to prescribe suboxone, a Schedule III controlled substance. Ibid. No

other clinic employee had such prescribing privileges.

Id. at A2-A3.

Petitioner and Brizuela were scheduled to work at

the clinic just one evening per week, and they frequently missed all or part of those scheduled shifts.

Pet. App. A2-A3. Indeed, camera footage from outside

the clinic revealed that, over a two-month period in

2016, petitioner was present at Advance Healthcare

only 13.9% of the time that it was open to patients and

issuing prescriptions and missed half of the shifts at

which he was scheduled to be present. Id. at A3; see

Gov’t C.A. Br. 4. At all other times, Sharon Jackson, a

nurse who did not have DEA prescribing privileges,

handled patient prescriptions. Pet. App. A2-A3.

To keep the operation running in their absence, petitioner and Brizuela “allowed Jackson nearly unfettered use of their DEA numbers” and “delegated most

of the patient care to Jackson.” Pet. App. A3. For example, the doctors generally saw patients only for their

initial visit or for one other visit early in their treatment, while Jackson conducted all follow-up visits. Ibid.

3

And if neither doctor was present for a new patient’s

initial visit, petitioner and Brizuela permitted Jackson

to diagnose the patient with an opioid-use disorder, decide on a daily dose of suboxone, and call in the prescription using one of the doctors’ DEA numbers. Ibid.

As part of an investigation into Advance Healthcare,

an undercover law enforcement officer posed as a patient at the clinic. Pet. App. A5. On his initial visit to

Advance Healthcare, the undercover officer saw petitioner for just over three minutes. Gov’t C.A. Br. 9.

When the officer returned for a follow-up visit the next

week, he met with Jackson for five minutes before receiving a suboxone prescription. Ibid. Four of petitioner’s other patients likewise testified that their examinations, if performed at all, had been equally perfunctory, and that Jackson—rather than either petitioner or Brizuela—had managed their medication regimen thereafter. Ibid.; see Pet. App. A5. Notwithstanding petitioner’s sporadic attendance, the clinic paid petitioner over $300,000 over several years. Gov’t C.A.

Br. 3.

2. In 2018, a federal grand jury returned an indictment charging petitioner, Brizuela, and others with 50

counts of conspiracy, drug distribution, illegal kickbacks, and health-care fraud. Indictment 1-27. Petitioner proceeded to trial, which lasted six days. Gov’t

C.A. Br. 3.

Before trial, the government filed a motion in limine

requesting that the district court prohibit petitioner

from arguing or presenting evidence at trial that the

government must satisfy “a dual standard, that is, that

the government must prove both that the distributions

charged in the indictment were without a legitimate

medical purpose and beyond the bounds of professional

4

medical practice.” D. Ct. Doc. 273, at 1 (Apr. 15, 2019)

(emphasis omitted). The court granted the motion.

D. Ct. Doc. 299, at 1 (Apr. 23, 2019).

At the close of trial, the district court instructed the

jury that, to obtain a conviction under 21 U.S.C. 841, the

government must prove beyond a reasonable doubt that

petitioner “caused the distribution of suboxone as alleged in the Indictment,” that he “did so knowingly or

intentionally,” and that “[h]is actions were outside the

bounds of professional medical practice.” D. Ct. Doc.

319, at 28-29 (Apr. 29, 2019). The court elaborated that,

with respect to the last element, “physicians have discretion to choose among a wide range of options.” Id. at

31. It therefore cautioned that, to determine whether

petitioner had “caused the distribution of suboxone

‘outside the bounds of professional medical practice’ in

this case,” the jury “should examine all of his actions

and the facts and circumstances in the case.” Ibid. (emphasis omitted). In addition, the court noted that petitioner had “assert[ed] that he treated his patients in

‘good faith’ ” and instructed:

A physician cannot be convicted of conspiring to unlawfully distribute suboxone or aiding and abetting

the unlawful distribution of suboxone if he acted in

good faith in issuing the prescription. Good faith in

this context is not merely a physician’s sincere intention towards the patients who come to see him. Rather, it involves his sincerity in attempting to conduct himself in accordance with a standard of professional medical practice generally recognized and accepted in the country. Thus, it indicates an observance of conduct in accordance with what the physician reasonably believed to be proper medical practice.

5

The defendant does not have to prove that he acted

in good faith. The burden of proof remains on the

Government at all times to prove to you beyond a

reasonable doubt that the defendant conspired to

distribute suboxone outside the bounds of professional medical practice, * * * and aided and abetted

the distribution of suboxone outside the bounds of

professional medical practice. * * *

In considering whether the defendant acted in good

faith, you should consider the defendant’s actions

and all the facts and circumstances in the case. If

you find that the defendant acted in good faith, then

you must find him not guilty.

Id. at 34-35.

The jury found petitioner guilty of one count of conspiring to distribute controlled substances, in violation

of 21 U.S.C. 841 and 846, and four counts of aiding and

abetting the distribution of controlled substances, in violation of 18 U.S.C. 2 and 21 U.S.C. 841. Judgment 1-2.

The district court sentenced petitioner to six months of

imprisonment, to be followed by two years of supervised

release. Judgment 3-4.

3. The court of appeals affirmed in an unpublished

per curiam opinion. Pet. App. A1-A18.

As relevant here, the court of appeals rejected petitioner’s contention that the district court had abused its

discretion by declining to allow evidence or argument

“that his treatment of patients” was for a medical purpose and “not for some other purpose, such as drug diversion.” Pet. App. A9; see id. at A9-A10. The court of

appeals observed that this Court’s decision in United

States v. Moore, 423 U.S. 122 (1975), had held that “registered physicians can be prosecuted under § 841 when

6

their activities fall outside the usual course of professional practice.” Pet. App. A9 (quoting Moore, 423 U.S.

at 124). And the court explained that, under circuit

precedent applying Moore, “[t]he Government may

meet its burden by establishing that the physician’s actions were not for legitimate medical purposes in the

usual course of professional medical practice or were

beyond the bounds of professional medical practice.”

Ibid. The court further explained that, because “[t]he

Government is not required to prove both prongs (i.e.

no legitimate purpose and beyond professional bounds),”

the district court did not abuse its discretion “in permitting the Government to proceed only on the theory that

[petitioner]’s actions were beyond the bounds of professional medical practice.” Ibid.

The court of appeals also rejected petitioner’s argument that the jury instructions and admitted evidence

had “permitted [him] to be found guilty upon only a

showing of malpractice.” Pet. App. A12; see id. at A12A13. The court reviewed that argument for plain error

and concluded that, taken as a whole, the instructions

did not equate guilt with malpractice but rather appropriately informed the jury that it “must consider the totality of the circumstances in making its determination

that [petitioner] acted outside the scope of professional

medical practice.” Id. at A13.

ARGUMENT

Petitioner renews his contention (Pet. 11-35) that his

convictions required proof not only that he acted outside the usual course of medical practice, but also that

he lacked a general “legitimate medical purpose.” The

court of appeals correctly rejected that contention, and

its unpublished opinion neither contravenes any precedent of this Court nor meaningfully conflicts with any

7

decision of another court of appeals. This Court has denied review in other cases presenting similar issues.

See, e.g., Sun v. United States, 138 S. Ct. 156 (2017) (No.

16-9560); Armstrong v. United States, 558 U.S. 829

(2009) (No. 08-9339). * It should follow the same course

here.

1. 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 pending petitions for writs of certiorari in Ruan v. United

States, No. 20-1410 (filed Apr. 5, 2021), and Couch v. United States,

No. 20-7934 (filed Apr. 5, 2021), present similar questions about the

appropriate formulation of the mens rea requirement for prescribing physicians charged under Section 841.

*

8

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

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 correctly recognized, under

Moore, a physician who acts for what he believes to be

a medical purpose may still be liable under Section 841

if he ventures “beyond the bounds of medical practice”

in bad faith. Pet. App. A9. 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). As the

court of appeals observed, a defendant like petitioner is

not immune from a drug prosecution simply because he

participates in distributing drugs to people who “suffer[] from addiction and require[] treatment.” Pet. App.

A10. The court thus correctly determined that the district court did not abuse its discretion in preventing petitioner from presenting a theory under which he might

assign a general “legitimate medical purpose” to activi-

9

ties outside the scope of reasonable professional boundaries that no authority had given him permission to perform. Id. at A9.

The district court, in turn, correctly required the

jury to find that petitioner knowingly or intentionally

facilitated the distribution of controlled substances outside the usual course of professional practice. The court

instructed the jury that it was required to find that petitioner “caused the distribution of suboxone as alleged

in the Indictment,” that he “did so knowingly or intentionally,” and that “[h]is actions were outside the

bounds of professional medical practice.” D. Ct. Doc.

319, at 28-29. It also explained that a physician “cannot

be convicted of conspiring to unlawfully distribute suboxone or aiding and abetting the unlawful distribution

of suboxone if he acted in good faith in issuing the prescription.” Id. at 34. And the court elaborated on the

concept of good faith, defining it as a physician’s “sincerity in attempting to conduct himself in accordance

with a standard of professional medical practice generally recognized and accepted in the country” and “an observance of conduct in accordance with what the physician reasonably believed to be proper medical practice.”

Ibid. Those instructions, which repeatedly referred to

petitioner’s state of mind, made clear that the jury could

not find petitioner guilty if he lacked criminal intent or

if he made a good-faith attempt to comply with the usual

course of professional medical practice.

Petitioner nonetheless contends (Pet. 23-31) that requiring the jury to find that he acted “outside the

bounds of professional medical practice,” without a further explicit instruction also to find that he prescribed

medication “without a legitimate medical purpose,” au-

10

thorized the jury to impose criminal liability for “professional disagreements,” Pet. 20, 23 (emphasis omitted), or otherwise diluted the standard of proof. That

contention is incorrect. Courts have repeatedly recognized that no meaningful distinction exists between a

finding that a physician acted “without a legitimate

medical purpose” and a finding that he or she acted

“outside the usual course of his or her professional practice.” See United States v. Armstrong, 550 F.3d 382,

397-398 (5th Cir. 2008) (explaining that “knowingly distributing prescriptions outside the course of professional practice is a sufficient condition to convict a defendant” and that the phrases “outside the scope of professional practice” and “without a legitimate medical

purpose” may be “considered interchangeable”), cert.

denied 558 U.S. 829 (2009), overruled on other grounds

by United States v. Guillermo Balleza, 613 F.3d 432

(5th Cir.) (per curiam), cert. denied 562 U.S. 1076

(2010); United States v. Nelson, 383 F.3d 1227, 1231

(10th Cir. 2004) (noting that “[i]t is difficult to imagine

circumstances in which a practitioner could have prescribed controlled substances within the usual course of

medical practice but without a legitimate medical purpose” and “[s]imilarly, it is difficult to imagine circumstances in which a practitioner could have prescribed

controlled substances with a legitimate medical purpose

and yet be outside the usual course of medical practice”); United States v. Rosenberg, 515 F.2d 190, 197

(9th Cir.) (finding “it difficult to understand how [a physician] can argue that he was not acting for legitimate

medical reasons yet was acting in the course of his professional practice” and explaining that a determination

that a physician acted outside “the course of professional practice” means that he took “action that he d[id]

11

not in good faith believe [was] for legitimate medical

purposes”), cert. denied, 423 U.S. 1031 (1975); see also

United States v. Rottschaefer, 178 Fed. Appx. 145, 147148 (3d Cir.) (noting that several courts have held that

“there is no difference in the meanings” of the two

phrases) (citation omitted), cert. denied, 549 U.S. 887

(2006); United States v. Daniel, 3 F.3d 775, 778 (4th Cir.

1993) (equating the two phrases), cert. denied, 510 U.S.

1130 (1994); United States v. Kirk, 584 F.2d 773, 784

(6th Cir.) (same), cert. denied, 439 U.S. 1048 (1978);

United States v. Plesons, 560 F.2d 890, 897 n.6 (8th Cir.)

(same), cert. denied, 434 U.S. 966 (1977).

Courts of appeals have also rejected defendants’

claims that they were convicted under a civil-malpractice

standard when the jury instructions were worded in the

disjunctive or did not require any specific finding of lack

of a “legitimate medical purpose.” See United States v.

Bek, 493 F.3d 790, 798-799 (7th Cir.) (rejecting the defendant’s assertion that the government had “proved

malpractice, not criminal conduct” and stating that a

disjunctive instruction was “proper”), cert. denied, 552

U.S. 1010 (2007); United States v. Williams, 445 F.3d

1302, 1307-1309 (11th Cir. 2006) (upholding conviction

where the instruction used only the “usual course of

professional practice” standard), abrogated on other

grounds by United States v. Lewis, 492 F.3d 1219 (11th

Cir. 2007); see also Pet. App. A12 (concluding that the

jury instructions, construed “ ‘in light of the whole record’ ” did not permit petitioner “to be found guilty upon

only a showing of malpractice”). Indeed, in Moore itself, the jury instructions, as described by the Court,

did not require a finding that the defendant lacked a “legitimate medical purpose,” see 423 U.S. at 138-139, and

12

the Court used only the “professional practice” standard in describing when physicians who dispense controlled substances are criminally liable under Section

841, id. at 124, 140, 142. The phrase “legitimate medical

purpose” appears only in a quotation, in a footnote, of a

regulation enacted pursuant to 21 U.S.C. 829, which itself ties the concepts together by restricting an “effective” controlled-substance prescription to one “issued

for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional

practice.” Moore, 423 U.S. at 136 n.12.

Petitioner further contends (Pet. 20) that the district

court erroneously prevented him from “introducing evidence that patients were seeking treatment for legitimate purposes,” namely, “treatment for their addiction.” But as the court of appeals recognized (Pet. App.

A9), the mere fact that a patient may have a legitimate

medical need for some type of treatment does not give

a health-care professional free rein to “act[] as a drug

‘pusher,’ ” in a manner that he knows is not in accord

with the generally recognized standard of medical practice. Moore, 423 U.S. at 139. The relevant question is

whether the treatment that petitioner offered was legitimate—i.e., at a minimum, an “honest effort” to act

within the bounds of professional medical practice. Id.

at 142 n.20. The parties accordingly did not dispute that

the patients needed actual treatment; they disputed

only whether that is in fact what petitioner was providing. See Gov’t C.A. Br. 34-35. Additional evidence on

the patients’ actual medical needs was unnecessary, and

would have served only to confuse the jury on the critical issue of whether petitioner was engaged in goodfaith medical practice.

13

2. Petitioner contends (Pet. 25-28) that the decision

below conflicts with decisions of other courts of appeals.

Even if that were correct, the court of appeals’ unpublished decision could not create a circuit conflict

warranting this Court’s review because it does not establish binding precedent. That is particularly relevant

here because petitioner takes the view that the unpublished decision departs from earlier, precedential

decisions in the same circuit that did correctly state the

law. See Pet. 25 (asserting that the decision below deviated from “the Fourth Circuit’s prior interpretation of

the phrase ‘beyond the bounds of medical practice,’ ”

which had “included an analysis of the medical purpose

of the drug”) (citing United States v. Alerre, 430 F.3d

681 (4th Cir. 2005), cert. denied, 547 U.S. 1113 (2006),

and United States v. Tran Trong Cuong, 18 F.3d 1132,

1133 (4th Cir. 1994)); see also Pet. 18 (asserting that

“the Fourth Circuit, for the first time and in an unpublished opinion,” allowed “the Government to proceed only on the theory that [petitioner’s] actions were

beyond the bounds of professional medical practice”).

In any event, the decision below does not in fact conflict with the decisions on which petitioner relies. Every

published decision to have expressly addressed the issue has determined that a Section 841 offense can be

described disjunctively—i.e., as involving the dispensing of a controlled substance either “outside the usual

course of medical practice” or “without a legitimate

medical purpose.” See, e.g., United States v. Khan, 989

F.3d 806, 822 (10th Cir. 2021) (“[A] licensed physician

may be convicted under 21 U.S.C. § 841 for either prescribing ‘outside the scope of professional practice’ or

‘for no legitimate medical purpose.’ ”); Armstrong, 550

14

F.3d at 399-400 (cataloguing appellate decisions upholding disjunctive jury instructions); United States v. Limberopoulos, 26 F.3d 245, 249-250 (1st Cir. 1994) (“[W]ellestablished case law mak[es] clear that [Section 841] applies to a pharmacist’s (or physician’s) drug-dispensing

activities so long as they fall outside the usual course of

professional practice.”).

In contrast, none of the decisions on which petitioner

relies (Pet. 27-28) for his claim of a conflict held that

such a disjunctive instruction is erroneous. In United

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

549 U.S. 1067 (2006), the court of appeals correctly

found that the jury instructions, which included the “legitimate medical purpose” and “course of professional

practice” standards in the conjunctive, as well as a

good-faith instruction similar to the one given below,

correctly “require[d] the jury to find that [the defendant] intentionally acted outside the usual course of professional practice.” Id. at 1008. The court emphasized

the need to distinguish a conviction under Section 841

from “a finding that [a physician] has committed malpractice.” Id. at 1010. And the court found that the instructions given had sufficiently done so, in part because of their good-faith component. See id. at 1012.

The affirmance of the conviction in that case, in which

the court did not directly consider a disjunctive instruction, would not dictate reversal in the circumstances

here.

Likewise, in United States v. Smith, 573 F.3d 639

(8th Cir. 2009), the court of appeals rejected the defendant’s claim that “the definition of ‘usual course of professional practice’ in [the jury instructions] improperly

conflated the standard for criminal liability with the

15

standard for medical malpractice.” Id. at 649. Reviewing the particular instructions delivered in that case,

the court noted that “the jury was unable to convict

Smith unless it found a failure to adhere to prevailing

medical standards and a lack of legitimate medical purpose.” Ibid. But “[t]his dual showing * * * exceed[ing]

that required to establish medical malpractice” was just

one of several aspects of the instructions that assured

the reviewing court that “the jury instructions, taken as

a whole, precluded a conviction based on the civil standard of liability.” Id. at 649-650; see id. at 649 (“Additional indicators that the instructions did not conflate

civil and criminal standards include the fact that the

court explicitly instructed that the standard of proof applicable in this case was ‘beyond a reasonable doubt.’ ”);

id. at 649-650 (“The court also allowed Smith the possibility of a good-faith defense, which is unavailable in

malpractice cases.”). The court never held that a disjunctive instruction would have been categorically erroneous, or a conjunctive instruction categorically necessary, to appropriately define the Section 841 offense.

Finally, petitioner cites (Pet. 27) United States v.

Volkman, 736 F.3d 1013 (6th Cir. 2013), cert. granted,

judgment vacated, 574 U.S. 95 (2014), op. resubmitted

in relevant part, 797 F.3d 377 (6th Cir. 2015), and

United States v. Chube II, 538 F.3d 693 (7th Cir. 2008).

In both cases, the court of appeals acknowledged a distinction between the negligent conduct sufficient for

civil malpractice and the intentional or knowing violation required for a criminal conviction, see Volkman,

736 F.3d at 1022; Chube II, 538 F.3d at 697-699, but did

not prescribe any particular formulation of the government’s burden.

16

Nor, contrary to petitioner’s contention (Pet. 25-26),

has any court of appeals diverged in the opposite direction and imposed criminal liability based on nothing

more than “a simple departure from the standard of

care.” Rather, each of the circuits that petitioner identifies (Pet. 25-27) as having adopted that position—the

Second, Fifth, and Eleventh—has expressly disapproved such an approach in a published decision. See

United States v. Wexler, 522 F.3d 194, 204 (2d Cir. 2008)

(“[A] violation of the standard of care alone is insufficient to support the criminal conviction of a licensed

practitioner under § 841(a).”); Armstrong, 550 F.3d at

401 (5th Cir.) (“[T]he jury ha[s] to make a finding with

respect to [the defendant’s] state of mind,” which “distinguish[es] a § 841 prosecution from a mere civil malpractice suit where a plaintiff may prevail regardless of

a defendant doctor’s good faith intent to act within the

scope of medical practice.”); United States v. Ruan, 966

F.3d 1101, 1169 (11th Cir. 2020) (acknowledging that a

proposed instruction that “ ‘a Defendant’s negligence,

failure to meet a standard of care, or medical malpractice, on its own is not enough to convict him,’ is an accurate statement of the law,” though concluding that the

district court did not abuse its discretion in declining to

give such an instruction in the context of that case), petitions for cert. pending, Nos. 20-1410 and 20-7934 (filed

Apr. 5, 2020). Petitioner has thus failed to establish any

meaningful conflict among the courts of appeals that

would warrant this Court’s review.

17

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

ELIZABETH B. PRELOGAR

Acting Solicitor General

KENNETH A. POLITE, JR.

Assistant Attorney General

JOSHUA K. HANDELL

Attorney

JULY 2021