Opposition Brief — Saad Sakkal, Petitioner v. United States

No. 23-130

In the Supreme Court of the United States

SAAD SAKKAL, PETITIONER

v.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

ELIZABETH B. PRELOGAR

Solicitor General

Counsel of Record

NICOLE M. ARGENTIERI

Acting Assistant Attorney

General

ANN O’CONNELL ADAMS

Attorney

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTION PRESENTED

Whether the court of appeals was required to vacate

petitioner’s convictions for unlawful drug distribution

under 21 U.S.C. 841(a) following a remand from this

Court based on a theory—never raised by petitioner and

not reflected in his own proposed jury instructions—that

jury instructions relating to his “authoriz[ation]” to distribute drugs, ibid., erred by incorporating 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 ...................................................................................... 1

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

Conclusion ................................................................................... 10

TABLE OF AUTHORITIES

Cases:

Ruan v. United States:

597 U.S. 450 (2022) ............................................................ 7

cert. denied, No. 22-1175 (2023) ....................................... 9

United States v. Anderson, 67 F.4th 755

(6th Cir. 2023), petition for cert. pending,

No. 23-238 (filed Sept. 5, 2023) ............................................ 8

United States v. Moore, 423 U.S. 122 (1975) ........................ 9

Statutes and regulation:

Controlled Substances Act, 21 U.S.C. 801 et seq. ................. 2

21 U.S.C. 822(b) ................................................................. 2

21 U.S.C. 823(b) ................................................................. 2

21 U.S.C. 823(f ).................................................................. 2

21 U.S.C. 829(a) ................................................................. 2

21 U.S.C. 841 ...................................................................... 5

21 U.S.C. 841(a) ......................................................... 5, 7, 9

21 U.S.C. 841(a)(1)......................................................... 2, 4

21 U.S.C. 841(b)(1)(C) ................................................... 2, 4

21 U.S.C. 843(a)(2)......................................................... 2, 4

21 U.S.C. 843(d)(1) ........................................................ 2, 4

21 C.F.R. 1306.04(a) .................................................... 2, 3, 7, 9

(III)

In the Supreme Court of the United States

No. 23-130

SAAD SAKKAL, PETITIONER

v.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-19a)

is unreported but is available at 2023 WL 3736778. A

previous order of this Court (Pet. App. 20a) is reported

at 143 S. Ct. 298. A previous opinion of the court of appeals (Pet. App. 21a-33a) is unreported but is available

at 2022 WL 557520.

JURISDICTION

The judgment of the court of appeals was entered on

May 31, 2023. The petition for a writ of certiorari was

filed on August 7, 2023. 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 Southern District of Ohio, petitioner was

convicted on 30 counts of unlawfully distributing a

(1)

2

controlled substance, in violation of 21 U.S.C. 841(a)(1);

one count of distributing a controlled substance resulting in death, in violation of 21 U.S.C. 841(a)(1) and

(b)(1)(C); and six counts of using the registration number of another person to dispense a controlled substance, in violation of 21 U.S.C. 843(a)(2) and (d)(1).

Judgment 1-2. The district court sentenced petitioner

to 240 months of imprisonment, to be followed by three

years of supervised release. Judgment 3-4. The court

of appeals affirmed. Pet. App. 21a-33a. This Court

granted a petition for a writ of certiorari, vacated, and

remanded. Id. at 20a. On remand, the court of appeals

affirmed. Id. at 1a-19a.

1. Section 841(a) of Title 21, which is part 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. 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(b) and (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

3

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. Petitioner was a DEA-registered physician who

practiced medicine at Lindenwald Medical Association.

Pet. App. 3a. The DEA began to investigate petitioner

after a referral from the Ohio Medical Board, which had

received several complaints from pharmacists about petitioner’s issuance of problematic prescriptions. Ibid.

Petitioner prescribed high amounts of controlled substances; dangerous combinations of controlled substances; and multiple substances that served the same

purpose as one another (known as “therapeutic duplication”), which risked “respiratory sedation and death.”

Ibid. Petitioner also ignored warning signs about the

dangers of his prescribing practices, such as drug

screens showing that his patients were taking unprescribed controlled substances or not taking their prescriptions. Id. at 4a. And he failed to use the Ohio Automated Rx Reporting System to monitor whether his

patients were receiving controlled substances prescriptions from other doctors. Ibid.

Petitioner prescribed one of his patients, Ashley Adkins, 17 medications after seeing her for the first time

and “conduct[ing] an examination in ‘medical student

type fashion.’ ” Pet. App. 24a. A month later, Lindenwald received an anonymous call reporting “that Adkins

was abusing her medications and looking to sell or trade

them.” Id. at 25a. That same day, petitioner saw Adkins

4

again; her medical record noted that “[s]he appears to

be under the influence of either drugs or alcohol” and

that “[h]er speech is very slurred, her balance is off.”

Ibid. Despite those signs, petitioner prescribed Adkins

benzodiazepine and oxycodone—a dangerous combination of drugs. Ibid.; see id. at 3a. Adkins immediately

filled the prescriptions; she died the next day as a result

of “benzodiazepine and oxycodone toxicity.” Id. at 25a.

At one point, several pharmacies called Lindenwald

to discuss their concerns about petitioner’s prescribing

practices. Pet. App. 4a. Petitioner met with at least

three pharmacies to discuss their concerns, but he did

not change his practices. Id. at 4a-5a. Some pharmacies

stopped filling petitioner’s controlled substances prescriptions. Id. at 5a.

3. In 2018, a federal grand jury returned an indictment charging petitioner with 30 counts of unlawfully

distributing a controlled substance, in violation of 21

U.S.C. 841(a)(1); two counts of distributing a controlled

substance resulting in death, in violation of 21 U.S.C.

841(a)(1) and (b)(1)(C); and seven counts of using the

registration number of another person to dispense a

controlled substance, in violation of 21 U.S.C. 843(a)(2)

and (d)(1). Indictment 10-14; see Judgment 1-2.

At the close of trial, petitioner proposed jury instructions that incorporated the regulatory language in Section 1306.04(a) as the touchstone for Section 841(a) liability. See D. Ct. Doc. 42 (Mar. 29, 2019). Petitioner

represented to the district court that, “[t]o convict a

practitioner under [Section] 841(a), the government

must prove * * * [t]hat the distribution of th[e] controlled substances was outside the usual course of professional practice and without a legitimate medical purpose.” Id. at 5; see id. at 1, 3, 6, 11. Petitioner also

5

asked to instruct the jury that Section 841(a) requires

the government to prove that a physician “acted with

intent to distribute the drugs and with intent to distribute them outside the course of professional practice”

and that a physician does not violate Section 841 if he

prescribed the substances in “good faith”—that is, “in

accordance with what the physician should reasonably

believe to be a proper medical practice.” Id. at 5-6. Petitioner additionally requested a deliberate indifference

instruction. Id. at 10-11.

The district court rejected petitioner’s proposed

subjective-intent instruction but did issue an instruction incorporating the regulatory standard. See Pet.

App. 5a-7a. The court instructed the jury that:

In order to find the defendant guilty of a violation of

21 U.S.C. 841(a)(1), the government must prove beyond a reasonable doubt each of the following elements:

(1) The defendant distributed or dispensed a controlled substance as alleged in these counts of

the Indictment;

(2) The defendant acted knowingly and intentionally in distributing that controlled substance;

and

(3) The defendant’s act was not for a legitimate

medical purpose in the usual course of his professional practice.

Id. at 6a (brackets omitted). The court also instructed

the jury using petitioner’s good-faith and deliberateindifference instructions. See id. at 5a-7a. As to deliberate indifference, the court told the jury that:

6

[t]he term “knowingly” means that the act was done

voluntarily and intentionally and not because of a

mistake or accident. Although knowledge of the defendant cannot be established merely by demonstrating that he was careless, knowledge may be inferred if the defendant deliberately blinded himself

to the existence of a fact.

No one can avoid responsibility for a crime by deliberately ignoring the obvious. If you are convinced

that the defendant deliberately ignored a high probability that the controlled substances alleged in

these counts were distributed or dispensed outside

the course of professional practice and not for a legitimate medical purpose, then you may find that the

defendant knew this was the case.

But you must be convinced beyond a reasonable

doubt that the defendant was aware of a high probability that the controlled substances were distributed

or dispensed outside the course of professional practice and not for a legitimate medical purpose, and

that the defendant deliberately closed his eyes to

what was obvious.

Carelessness or negligence or foolishness on his part

are not the same as knowledge and are not enough to

find him guilty on any of these counts.

Id. at 7a. Petitioner raised a single objection to the relevant instructions—and the court credited that objection and accordingly modified its instructions before

giving them—but otherwise did not object to the court’s

mens rea instructions. Id. at 6a.

The jury found petitioner guilty of all 30 counts of

unlawfully distributing a controlled substance; one

count of distributing a controlled substance resulting in

7

death; and six counts of using another person’s registration number to dispense a controlled substance.

Judgment 1-2. The district court sentenced petitioner

to 240 months of imprisonment, to be followed by three

years of supervised release. Judgment 3-4.

4. The court of appeals affirmed. Pet. App. 21a-33a.

In doing so, the court declined to consider a claim that

petitioner’s counsel had provided ineffective assistance

by failing to object to the jury instructions on mens rea,

explaining that the “court generally does not entertain

ineffective-assistance-of-counsel claims on direct appeal because there has not been an opportunity to develop an adequate record to evaluate the merits of the

allegations.” Id. at 30a; see id. at 30a n.2.

Before petitioner’s time to file a petition for a writ of

certiorari expired, this Court decided Ruan v. United

States, 597 U.S. 450 (2022). In Ruan, this 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.” Id. at 457

(citation omitted). The Court reasoned, inter alia, that

“a lack of authorization is often what separates wrongfulness from innocence.” Id. at 458. “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

459 (brackets and citations omitted).

8

This Court granted petitioner’s petition for a writ of

certiorari, vacated, and remanded for further consideration in light of Ruan. Pet. App. 20a.

5. On remand, the court of appeals affirmed. Pet.

App. 1a-19a. Applying plain error review, see id. at 10a11a, the court rejected petitioner’s claim that “the district court’s scienter instruction [did not] compl[y] with

the holding of Ruan,” id. at 10a; see id. at 14a-19a.

Petitioner argued that the district court’s jury instructions were erroneous because they specifically tied

the “knowingly or intentionally” mens rea to the act of

dispensing, but not to the requirement that a prescription be “not for a legitimate medical purpose in the

usual course of his professional practice.” Pet. App. 7a;

see id. at 14a-15a. The court of appeals found that its

recent decision in United States v. Anderson, 67 F.4th

755 (6th Cir. 2023), petition for cert. pending, No. 23238 (filed Sept. 5, 2023), “forecloses this negative implication argument” because, as in Anderson, the district

court had further elaborated on the mens rea requirement through a deliberate ignorance instruction. Pet.

App. 15a.

As in Anderson, the court of appeals here observed

that the “ ‘more detailed instructions’ ” provided to the

jury went “beyond an objective view of the ‘usual course

of professional practice’ and instead directed the jury’s

attention to [petitioner’s] subjective mindset in issuing

the prescriptions.” Pet. App. 17a, 19a (citation omitted).

The court therefore found that the instruction for deliberate ignorance that petitioner received “ensured that

the instructions comported with Ruan’s holding.” Id. at

19a (citing Anderson, 67 F.4th at 766). And it accordingly saw no basis for plain-error relief. Ibid.

9

ARGUMENT

Relying on the most recent petition for a writ of certiorari in Ruan v. United States, cert. denied, No. 221175 (2023), petitioner now contends (Pet. 12-13) that

the jury instructions at his trial erred by using language

from Section 1306.04(a) as the measure of whether his

drug-prescribing practices were “authorized” under the

CSA. 21 U.S.C. 841(a). That is a new argument that

petitioner never raised before. See Pet. C.A. Supp. Br.

15-20; Pet. C.A. Supp. Reply Br. 6-11. Indeed, in the

court of appeals petitioner asserted the opposite of what

he now argues in this Court. See Pet. C.A. Supp. Reply

Br. 6 n.3 (“Whether or not a physician is ‘authorized’ to

prescribe controlled substances under Section 841(a) is

governed by 21 C.F.R. § 1306.04(a), which defines an

‘authorized’ prescription as one that is ‘issued for a legitimate medical purpose by an individual practitioner

acting in the usual course of his professional practice.’ ”); see also Pet. C.A. Supp. Br. 2-3.

This Court recently denied the second petition for a

writ of certiorari in Ruan, see Ruan, supra (No. 221175), on which the petition here relies for the substance of its argument. For the reasons explained in the

government’s brief in opposition to the petition in

Ruan, a copy of which is being served on petitioner, petitioner’s new, cross-referenced claim lacks merit and

does not warrant further review. See Br. in Opp. at 1222, Ruan, supra (No. 22-1175). As with the same claim

in Ruan, petitioner’s new argument was never passed

upon below. See id. at 12-14. Petitioner’s claim is also

foreclosed by precedent and rests on a misapprehension

of the CSA and this Court’s decision in Ruan. See id.

at 14-19. And petitioner has not identified any circuit

10

conflict that would warrant review by this Court. See

id. at 19-22.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

ELIZABETH B. PRELOGAR

Solicitor General

NICOLE M. ARGENTIERI

Acting Assistant Attorney

General

ANN O’CONNELL ADAMS

Attorney

DECEMBER 2023