Petition for Writ of Certiorari — Xiulu Ruan and John Patrick Couch, Petitioners v. United States
Supreme Court briefMay 31, 2023
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No. _________
In the Supreme Court of the United States
DR. XIULU RUAN AND DR. JOHN PATRICK COUCH,
Petitioners,
v.
UNITED STATES OF AMERICA,
Respondent.
On Petition For A Writ Of Certiorari
To The United States Court Of Appeals
For The Eleventh Circuit
PETITION FOR A WRIT OF CERTIORARI
LAWRENCE S. ROBBINS
Counsel of Record
DAVID J. RANZENHOFER
FRIEDMAN KAPLAN SEILER
ADELMAN & ROBBINS LLP
7 Times Square
New York, NY 10036-6516
(212) 833-1100
lrobbins@fklaw.com
May 31, 2023
Counsel for Petitioners
QUESTION PRESENTED
In Ruan v. United States, 142 S. Ct. 2370 (2022)
(App., infra, 19a-54a), this Court held that a physician
may be convicted under 21 U.S.C. § 841(a)(1) of the
Controlled Substances Act (“CSA”) only if the
government proves that the defendant “knew or
intended that his or her conduct was unauthorized.”
Id. at 2382 (App., infra, 37a) (emphasis added). The
Court remanded Petitioners’ case to the Eleventh
Circuit, and Dr. Shakeel Kahn’s companion case to the
Tenth Circuit, so that those courts could consider
whether the jury instructions comported with the
“except as authorized” requirement of the statute.
The question presented, on which the circuits are
divided, is whether, in a CSA jury instruction, 21
C.F.R. § 1306.04(a) may replace the statute’s “except
as authorized” requirement, thereby permitting the
jury to convict a physician simply because she knew
that her prescription would fall outside the “usual”
course of medical practice or would be regarded as
“illegitimate” by most other doctors, and thus
empowering a federal agency to create a felony offense
that Congress itself did not enact.
(i)
ii
PARTIES TO THE PROCEEDING
Petitioners, defendants-appellants below, are Dr.
Xiulu Ruan and Dr. John Patrick Couch.
Respondent, appellee below, is the United States
of America.
RELATED PROCEEDINGS
Xiulu Ruan v. United States, No. 20-1410, The
Supreme Court of the United States. Judgment
entered July 29, 2022.
John Patrick Couch v. United States, No. 20-7934,
The Supreme Court of the United States. Judgment
entered August 1, 2022.
United States v. Xiulu Ruan & John Patrick
Couch, Nos. 17-12653, 17-12654, United States Court
of Appeals for the Eleventh Circuit. Judgments
entered July 10, 2020 and January 5, 2023.
United States v. John Patrick Couch, No. 1616361, United States Court of Appeals for the
Eleventh Circuit. Judgment entered August 15, 2017.
United States v. Xiulu Ruan, No. 19-11508,
United States Court of Appeals for the Eleventh
Circuit. Judgment entered January 8, 2020.
United States v. Ling Cui, No. 19-12661, United
States Court of Appeals for the Eleventh Circuit.
Judgment entered May 11, 2020.
United States v. Lori L. Carver, No. 17-13402,
United States Court of Appeals for the Eleventh
Circuit. Judgment entered October 17, 2018.
iii
United States v. John Patrick Couch, No. 1:15-cr00088, United States District Court for the Southern
District of Alabama. Judgments entered on May 31,
2017 and July 14, 2021.
iv
TABLE OF CONTENTS
Page
QUESTION PRESENTED........................................... i
PARTIES TO THE PROCEEDING ............................ii
RELATED PROCEEDINGS .......................................ii
TABLE OF AUTHORITIES....................................... vi
OPINIONS AND RULINGS BELOW ........................ 1
JURISDICTION .......................................................... 1
STATUTORY AND REGULATORY
PROVISIONS INVOLVED ......................................... 1
STATEMENT .............................................................. 2
A.
Statutory and Regulatory
Framework ................................................... 4
B.
Factual Background ..................................... 5
C.
Appellate Proceedings .................................. 8
REASONS FOR GRANTING THE
PETITION ................................................................. 13
A.
The Circuits Are Divided on
the Question Presented .............................. 15
B.
The Question Presented Is
Important and Recurring ........................... 22
C.
The Eleventh Circuit’s Decision
Below Is Wrong .......................................... 31
D.
This Case Presents an
Ideal Vehicle to Resolve the
Question Presented .................................... 37
v
TABLE OF CONTENTS—Continued
Page
CONCLUSION .......................................................... 39
APPENDIX A: Opinion of the United States
Court of Appeals for the Eleventh Circuit,
Filed January 5, 2023 ............................................... 1a
APPENDIX B: Opinion and Concurring in
Judgment of the Supreme Court of the
United States, Dated June 27, 2022 ....................... 19a
APPENDIX C: Order Denying Rehearing in
the United States Court of Appeals for the
Eleventh Circuit, Filed March 2, 2023 ................... 55a
APPENDIX D: Order Denying Rehearing in
the United States Court of Appeals for the
Eleventh Circuit, Filed November 4, 2020 ............. 57a
APPENDIX E: Transcript Excerpts from
the United States District Court for the
Southern District of Alabama,
Dated February 17, 2017 ........................................ 59a
APPENDIX F: Transcript Excerpts from
the United States District Court for the
Southern District of Alabama,
Dated February 16, 2017 ........................................ 70a
vi
TABLE OF AUTHORITIES
Page(s)
Cases
Abramski v. United States,
573 U.S. 169 (2014) .............................................. 33
Becerra v. Empire Health Found.,
for Valley Hosp. Med. Ctr.,
142 S. Ct. 2354 (2022) .......................................... 33
Brizuela v. United States,
2022 WL 4369977
(N.D.W. Va. Sept. 21, 2022) ................................. 28
Buffington v. McDonough,
143 S. Ct. 14 (2022) .............................................. 33
Gundy v. United States,
139 S. Ct. 2116 (2019) .......................................... 32
Loving v. United States,
517 U.S. 748 (1996) .............................................. 32
Michigan v. EPA,
576 U.S. 743 (2015) .............................................. 33
Ruan v. United States,
142 S. Ct. 2370
(2022) ............ 1-3, 8-10, 13, 16-17, 20-21, 23-24, 34
United States v. Adelglass,
2022 WL 6763791
(S.D.N.Y. Oct. 11, 2022) ....................................... 28
vii
TABLE OF AUTHORITIES—Continued
Page(s)
United States v. Ajayi,
64 F.4th 243 (5th Cir. 2023) ..................... 14, 18-19
United States v. Alvear,
2023 WL 3061551
(D. Nev. Apr. 24, 2023) ........................................ 27
United States v. Anderson,
2023 WL 2966356
(6th Cir. Apr. 17, 2023) ............................. 14, 18-20
United States v. Apel,
571 U.S. 359 (2014) ......................................... 33-34
United States v. Blume,
2022 WL 3701449
(S.D.W. Va. Aug. 26, 2022) .................................. 29
United States v. Ferrell,
2022 WL 17404891
(E.D. Tex. Dec. 2, 2022) ....................................... 28
United States v. Ferris,
52 F.4th 235 (5th Cir. 2022) ................................ 27
United States v. Germeil,
2023 WL 1991723
(11th Cir. Feb. 14, 2023) ................................ 14, 18
United States v. Heaton,
59 F.4th 1226
(11th Cir. 2023) ........................................ 14, 17, 25
viii
TABLE OF AUTHORITIES—Continued
Page(s)
United States v. Henson,
2023 WL 2319289
(10th Cir. Mar. 2, 2023) ................................. 13, 21
United States v. Kahn,
58 F.4th 1308
(10th Cir. 2023) .......................... 3, 10-11, 13, 20-21
United States v. Kamra,
2022 WL 4998978
(3d Cir. Oct. 4, 2022) ............................................ 26
United States v. Kistler,
2023 WL 1099726
(S.D. Ohio Jan. 30, 2023) ..................................... 27
United States v. Kraynak,
2022 WL 3161907
(M.D. Pa. Aug. 8, 2022) ........................................ 30
United States v. La,
2023 WL 2731036
(M.D. Tenn. Mar. 30, 2023) ................................. 26
United States v. Lamartiniere,
2023 WL 2424585
(M.D. La. Mar. 9, 2023)........................................ 26
United States v. Lamartiniere,
2023 WL 2645343
(M.D. La. Mar. 27, 2023).......................... 14, 22, 38
ix
TABLE OF AUTHORITIES—Continued
Page(s)
United States v. Maltbia,
2023 WL 1838783
(11th Cir. Feb. 9, 2023) .................................. 14, 18
United States v. Mencia,
2022 WL 17336503
(11th Cir. Nov. 30, 2022)................................ 14, 26
United States v. Murphy,
2023 WL 2090279
(N.D. Ala. Feb. 17, 2023) ..................................... 26
United States v. Naylor,
2022 WL 4371489
(E.D. Tenn. Sept. 21, 2022) .................................. 28
United States v. Oppong,
2022 WL 1055915
(6th Cir. Apr. 8, 2022) .......................................... 25
United States v. Parasmo,
2023 WL 1109649
(E.D.N.Y. Jan. 30, 2023) ...................................... 26
United States v. Parker,
2022 WL 5213206
(W.D. Ark. Oct. 5, 2022) ....................................... 28
United States v. Pham,
No. 8:19-cr-00010-JLS
(C.D. Cal. Apr. 7, 2023) ........................................ 27
x
TABLE OF AUTHORITIES—Continued
Page(s)
United States v. Ranochak,
2022 WL 4298568
(N.D. Ind. Sept. 19, 2022) .................................... 29
United States v. Ruan,
966 F.3d 1101 (11th Cir. 2020) .......................... 5, 8
United States v. Sachy,
2022 U.S. Dist. LEXIS 148403
(M.D. Ga. Aug. 18, 2022) ..................................... 30
United States v. Spayd,
2022 WL 4220192
(D. Alaska Sept. 13, 2022) ................................... 29
United States v. Spayd,
2022 WL 4367621
(D. Alaska Sept. 20, 2022) ................................... 29
United States v. Taylor,
2022 WL 4227510
(E.D. Ky. Sept. 13, 2022) ..................................... 29
United States v. Taylor,
2022 WL 17582270
(E.D. Ky. Dec. 12, 2022) ....................................... 27
United States v. Wells,
2023 WL 3341673
(D. Nev. May 10, 2023) ........................................ 27
Whitman v. United States,
135 S. Ct. 352 (2014) ............................................ 32
xi
TABLE OF AUTHORITIES—Continued
Page(s)
Woo Wai v. United States,
223 F. 412 (9th Cir. 1915) .................................... 35
Statutes and Regulation
21 U.S.C. § 821 .......................................................... 32
21 U.S.C. § 822(b) .................................................. 4, 31
21 U.S.C. § 823(g)(1).................................................... 4
21 U.S.C. § 841(a)(1) ................................ 1, 4, 9, 31-32
21 U.S.C. § 846 ........................................................ 2, 4
21 U.S.C. § 871(b) ...................................................... 32
21 C.F.R. § 1306.04(a) ............................................. 2, 4
Other Authorities
Ninth Circuit Jury Instructions Committee, Manual
of Model Criminal Jury Instructions for the
District Courts of the Ninth Circuit (Mar. 2023),
available at https://www.ce9.uscourts.gov/juryinstructions/model-criminal ................................ 30
xii
TABLE OF AUTHORITIES—Continued
Page(s)
Judicial Committee on Model Jury Instructions for
the Eighth Circuit, Manual of Model Criminal
Jury Instructions for the District Courts of the
Eighth Circuit (2022), available at
https://juryinstructions.ca8.uscourts.gov/
instructions/criminal/Criminal-JuryInstructions.pdf. ................................................... 30
Sixth Circuit Committee on Pattern Criminal Jury
Instructions, Pattern Criminal Jury Instructions
(Mar. 1, 2023), available at
https://www.ca6.uscourts.gov/pattern-juryinstructions .......................................................... 30
PETITION FOR A WRIT OF CERTIORARI
OPINIONS AND RULINGS BELOW
The opinion of the United States Court of Appeals
for the Eleventh Circuit on remand is reported at 56
F.4th 1291. See Petitioners’ Appendix (“App.”), infra,
1a-18a. This Court’s opinion is reported at 142 S. Ct.
2370. See App., infra, 19a-54a. The order of the
Eleventh Circuit denying rehearing on remand is not
reported. See App., infra, 55a-56a. The order of the
Eleventh Circuit denying rehearing of its prior
opinion in this case is not reported. See App., infra,
57a-58a.
JURISDICTION
The Eleventh Circuit’s judgment was entered on
January 5, 2023. App., infra, 1a. The court denied
rehearing on March 2, 2023. App., infra, 55a-56a. This
Court’s jurisdiction is invoked under 28 U.S.C.
§ 1254(1).
STATUTORY AND REGULATORY
PROVISIONS INVOLVED
Section 841(a)(1) of the CSA,
§ 841(a)(1), provides, in pertinent part:
21
U.S.C.
(a) Unlawful acts
Except as authorized by this subchapter, it shall
be unlawful for any person knowingly or
intentionally—
(1)
to manufacture, distribute, or dispense, or
possess with intent to manufacture,
(1)
2
distribute, or
substance[.]
dispense,
a
controlled
Section 846 of the CSA, 21 U.S.C. § 846, provides:
Any person who attempts or conspires to commit
any offense defined in this subchapter shall be
subject to the same penalties as those prescribed
for the offense, the commission of which was the
object of the attempt or conspiracy.
21 C.F.R. § 1306.04(a) provides, in pertinent part:
Purpose of issue of prescription.
(a)
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.
STATEMENT
Following this Court’s decision in Ruan v.
United States, 142 S. Ct. 2370 (2022) (App., infra, 19a54a), the Eleventh Circuit vacated Petitioners’ Section
841(a)(1) convictions but sustained the remaining
ones, nearly all of which were other CSA charges or
rested on CSA predicates. See App., infra, 5a-18a. It
did so, despite the fact that the instructions on which
the remaining CSA convictions were based replaced
the CSA’s “without authorization” requirement with
the “ambiguous” language of 21 C.F.R. § 1306.04(a),
see 142 S. Ct. at 2377 (App., infra, 26a), and the
convictions with CSA predicates relied on instructions
for those predicates that contained the same error. By
contrast, the Tenth Circuit, on remand from the very
3
same decision, held that all of Dr. Shakeel Kahn’s
convictions must be vacated, precisely because the
instructions, like those in Petitioners’ case, replaced
the statutory requirement (“except as authorized”)
with the language from the regulation. United States
v. Kahn, 58 F.4th 1308, 1316-17, 1321-22 (10th Cir.
2023).
Since then, the circuit conflict has widened, and
the confusion in the lower federal courts has
deepened. Indeed, although nearly a year has passed
since Ruan was decided, the lower federal courts
continue to sustain instructions that substitute the
language of 21 C.F.R. § 1306.04(a) for the “except as
authorized” language required by this Court’s
decision, see 142 S. Ct. at 2376 (App., infra, 24a),
thereby allowing an agency regulation to create a
criminal offense that Congress itself did not enact.
Whether that substitution is permissible is an
issue of surpassing importance to physicians and
other health care professionals. If a doctor faces
criminal prosecution simply because she knows that
her conduct differs from what other physicians
“usually” do, or what other physicians might regard as
“illegitimate,” she will be chilled from offering
patients novel but promising treatment. That is
precisely what prompted this Court in Ruan to hold
that “it is the fact that the doctor issued an
unauthorized prescription that renders his or her
conduct wrongful.“ Id. at 2377 (App., infra, 26a).
Giving doctors a wide enough berth to provide
outlying treatment is reason enough—if more reason
4
were needed—to stick to the text that Congress
enacted, and which this Court embraced in Ruan.
Now is the right time for this Court to
intervene. The lower courts confront CSA cases
against practitioners on nearly a daily basis, and are
in an acknowledged disagreement about whether this
Court meant what it said in Ruan. In just a year since
Ruan was decided, numerous courts have sustained
convictions based on a knowing violation of a
regulation, rather than the actual CSA text; a far
smaller number of courts have adhered to this Court’s
mandate in Ruan.
The petition for a writ of certiorari should be
granted.
A. Statutory and Regulatory Framework
The CSA makes it unlawful for “any person
knowingly or intentionally . . . to manufacture,
distribute, or dispense” a controlled substance,”
“[e]xcept as authorized by this subchapter.” 21 U.S.C.
§ 841(a)(1). “[T]his subchapter” authorizes persons
who have registered with the Attorney General to
dispense controlled substances “to the extent
authorized by their registration.” Id. § 822(b). The
CSA also directs the Attorney General to accept the
registration of a medical doctor or other practitioner if
he is “authorized to dispense . . . controlled substances
under the laws of the State in which he practices.” Id.
§ 823(g)(1). The CSA’s conspiracy statute makes it
unlawful for any person to conspire to commit any
offense under the CSA. Id. § 846.
21 C.F.R. § 1306.04(a) provides, in pertinent part:
5
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.
B. Factual Background
1. Petitioners Dr. Xiulu Ruan and Dr. John
Patrick Couch “were board-certified doctors
specializing in pain management” in Mobile,
Alabama. United States v. Ruan, 966 F.3d 1101, 1121
(11th Cir. 2020), vacated and remanded, 142 S. Ct.
2370 (2022) and 142 S. Ct. 2895 (2022). They owned a
pain clinic (Physicians Pain Specialists of Alabama)
and an affiliated pharmacy (C&R Pharmacy). Id.
A grand jury indicted Petitioners for unlawful
distribution of controlled substances under Section
841(a)(1) and conspiracy to violate the CSA by
unlawfully distributing controlled substances under
Sections 841(a)(1) and 846, as well as racketeering
conspiracy, health care fraud conspiracy, wire and
mail fraud conspiracy, and conspiracy to violate the
anti-kickback statute. Id. at 1120. Dr. Ruan (but not
Dr. Couch) was charged with money laundering and
conspiracy to commit money laundering. Id.
2. The government’s entire case was based on the
CSA charges—the non-CSA charges relied either on
the CSA charges as predicates or on the facts
underlying them. See Doc. 269 ¶¶ 55, 57-58, 74(a)
(racketeering conspiracy), ¶ 114 (health care fraud
conspiracy), ¶¶ 135, 137, 139, 141 (anti-kickback
conspiracy), ¶¶ 170, 174 (wire and mail fraud
conspiracy), ¶ 181 (money laundering conspiracy),
6
¶ 184 (money laundering); see also Doc. 269 ¶¶ 1-52,
53, 77, 80, 84, 87, 91, 95, 99, 103, 107, 111, 116, 133,
152, 168, 180, 183 (incorporation into each count of
fifty-two paragraphs of allegations largely concerning
controlled substances). The government insisted that
“prescribing a controlled substance is illegal unless
there’s two things that happen: It’s prescribed in the
usual course of professional practice and it’s
prescribed for a legitimate medical purpose.” Tr. 28:69.
Although the government acknowledged that
“there were certainly instances where Dr. Ruan and
Dr. Couch did a really good job for their patients,” Tr.
47:2-4, it urged the jury to convict them on all counts
if it found that they acted outside “the usual course of
professional practice” and without a “legitimate
medical purpose.” See, e.g., Tr. 6121:4-6, 6276:5-6,
6276:9-10, 6276:12-13, 6276:20-21, 6277:10-11,
6278:3-4, 6278:13-14, 6279:14-15, 6279:24-25, 6281:24, 6281:7-9, 6283:21-22, 6289:9-10, 6289:11-12,
6289:22-23, 6291:6-7, 6291:13-14, 6291:19-21, 6292:67, 6299:14, 6303:4-5, 6304:12-13, 6307:17-18.
Consistent with the government’s theory, the
district court instructed the jury based on 21 C.F.R.
§ 1306.04(a), telling the jury, with respect to both
Section 841(a)(1) and Section 846, that it was
unlawful to prescribe “outside the usual course of
professional medical practice” or without a “legitimate
medical purpose.” App., infra, 59a-68a.
To guard against the prospect that they might be
convicted on what amounted to a simple negligence
standard, Petitioners submitted a proposed
7
instruction on good faith, which emphasized their
subjective beliefs that their prescriptions were
medically appropriate. Doc. 462 at 23 (Defendants’
Requested Instruction Number 18). Rejecting that
request, the district court instead told the jury that:
A controlled substance is prescribed by a
physician in the usual course of a 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.
Thus a medical doctor has violated section 841
when the government has proved beyond a
reasonable doubt that the doctor’s actions were
either not for a legitimate medical purpose or
were outside the usual course of professional
medical practice.
App., infra, 61a-62a; see also App., infra, 68a, 71a-75a.
This “good faith” instruction was given with respect to
both the substantive and conspiracy CSA counts.
App., infra, 61a-62a, 68a.
3. Dr. Ruan was convicted on all but two counts
against him, and Dr. Couch was convicted on all but
one count against him; Dr. Ruan was acquitted on one
CSA count, and the government dismissed one anti-
8
kickback conspiracy count against both Petitioners.
966 F.3d at 1121. Dr. Ruan was sentenced to 21 years
of imprisonment, and Dr. Couch was sentenced to 20
years. Id.
Of the twenty convictions, twelve were CSA
charges, id. at 1120-21, nine of which were vacated on
remand, App., infra, 17a-18a. One anti-kickback
conspiracy count was reversed on appeal for
insufficient evidence. 966 F.3d at 1144-46. Four of the
remaining seven convictions (racketeering conspiracy
and, as to Dr. Ruan, money laundering conspiracy and
money laundering) relied on the CSA charges as
predicate offenses, and all seven relied on the factual
theory that Petitioners prescribed improperly. See
supra at 5-6.
C. Appellate Proceedings
1. Petitioners appealed, raising, among other
issues, the district court’s treatment of their proposed
good faith instruction. 966 F.3d at 1165-67.
The Eleventh Circuit found the requested
instruction to be “an incorrect statement of the law,”
because, in its view, “[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 1166. The court of appeals
thereafter denied rehearing. App., infra, 57a-58a.
2. This Court granted certiorari in Petitioners’
case and a consolidated petition from the Tenth
Circuit filed by Dr. Kahn. On June 27, 2022, the Court
vacated the judgments below and remanded both
cases. 142 S. Ct. at 2382 (App., infra, 38a).
9
The plain text of Section 841(a)(1), the Court
noted, “makes it a federal crime, ‘[e]xcept as
authorized[,] … for any person knowingly or
intentionally … to manufacture, distribute, or
dispense … a controlled substance,’ such as opioids.”
Id. at 2374-75 (App., infra, 20a) (quoting 21 U.S.C.
§ 841(a)). The Court held that Section 841(a)(1)’s
“‘knowingly or intentionally’ mens rea applies to” the
“except as authorized” requirement. Id. at 2375 (App.,
infra, 20a). As the Court explained, “[a]fter a
defendant produces evidence that he or she was
authorized to dispense controlled substances, the
Government must prove beyond a reasonable doubt
that the defendant knew that he or she was acting in
an unauthorized manner, or intended to do so.” Id.
(emphasis added); see also id. at 2376, 2382 (App.,
infra, 24a, 38a). After all, the Court observed, “it is the
fact that the doctor issued an unauthorized
prescription that renders his or her conduct wrongful,
not the fact of the dispensation itself. In other words,
authorization plays a ‘crucial’ role in separating
innocent conduct—and, in the case of doctors, socially
beneficial conduct—from wrongful conduct.” Id. at
2377 (App., infra, 26a).
In holding that “except as authorized” is “crucial”
to convicting a physician of drug dealing, the Court
recognized that the language of 21 C.F.R. § 1306.04(a)
(“legitimate medical purpose”; “usual course of his
professional practice”) was “ambiguous.” Id. That
regulatory language, the Court noted, is “written in
‘generalit[ies], susceptible to more precise definition
and open to varying constructions.’” Id. And so, the
10
Court explained, although the Government “can prove
knowledge of a lack of authorization through
circumstantial evidence,” including “by reference to
objective criteria such as ‘legitimate medical purpose’
and ‘usual course’ of ‘professional practice,’” in the end
the government must prove “that a defendant knew or
intended that his or her conduct was unauthorized.”
Id. at 2382 (App., infra, 37a).
The Court remanded both Petitioners’ case and
Dr. Kahn’s case so that the respective courts of
appeals could determine, among other things,
whether the instructions as a whole sufficiently
required that the physicians knowingly or
intentionally acted without authorization. Id. (App.,
infra, 37a-38a).
3. And that’s when the circuit conflict began. On
remand in Kahn, the Tenth Circuit took this Court at
its word. The court of appeals “conclude[d] that the
jury instructions issued in Dr. Kahn’s case are
inconsistent with the mens rea standard articulated
in Ruan, as they do not require the government to
prove beyond a reasonable doubt that Dr. Kahn
knowingly or intentionally acted in an unauthorized
manner.” 58 F.4th at 1315 (emphasis added). The
court noted that the jury “was repeatedly instructed”
that it could convict if Dr. Kahn “acted outside the
usual course of professional medical practice or
without a legitimate medical purpose.” Id. Those
instructions were erroneous, said the Tenth Circuit,
because they allowed the jury to convict simply
because Dr. Kahn “subjectively knew a prescription
was issued not for a legitimate medical purpose” or
11
“issued a prescription that was objectively not in the
usual course of professional practice,” both of which
“run counter to Ruan.” Id. at 1316. The court held that
that instructional error was not harmless. See id. at
1317-21.
The Tenth Circuit then considered Dr. Kahn’s
other convictions, and “determine[d] that each of Dr.
Kahn’s convictions was impacted by erroneous
instructions in a way that prejudiced him.” Id. at
1321. The court said that the Section 846 charges
“also include the good faith exception,” which was
“erroneous and did not result in harmless error.” Id.
The remaining convictions (aiding and abetting the
co-defendant’s Section 841(a)(1) violations, use of a
communication facility in furtherance of certain CSA
charges, possession of a firearm in furtherance of a
federal drug trafficking crime, continuing criminal
enterprise, and money laundering) were erroneous
because “the instructions predicate[d] conviction on
the jury’s finding of guilt in the erroneouslyinstructed” counts. Id. at 1321-22. Because the
instructions pertaining to all charges were
“predicated, at least in part, on one or more of the
erroneous § 841(a)(1) instructions,” the error “infected
the instructions given on all counts.” Id. at 1322. The
court thus concluded that all convictions must be
vacated. Id.
Put another way: In the Tenth Circuit, the failure
to instruct the jury on the “except as authorized”
requirement undermined both the CSA counts and
the remaining counts that relied on the CSA counts as
predicates.
12
4. The Eleventh Circuit took a very different path.
App., infra, 1a-18a. Recognizing that under Ruan “it
is the defendant’s subjective intent that matters,” the
Eleventh Circuit held that “the district court’s
instruction for the substantive drug charges
inadequately conveyed the required mens rea to
authorize conviction under § 841(a).” App., infra, 6a7a. The court further concluded that, with respect to
the Section 841(a)(1) charges, the erroneous
instruction was not harmless and vacated those
convictions. App., infra, 8a-9a.
With respect to the conspiracy counts under
Section 846, however, the court of appeals held that
the instructions were correct. App., infra, 10a-12a. In
the court’s view, “[b]ecause a conviction under § 846
requires the jury to find that the defendants knew of
the illegal nature of the scheme and agreed to
participate in it, the erroneous jury instruction for the
substantive charges has a limited impact here.” App.,
infra, 10a. Although the instructions made no
mention of the “except as authorized” requirement,
App., infra, 59a-65a, the court found it sufficient that
Petitioners knew or intended that their prescriptions
were not within the “usual course” of practice or
lacked a “legitimate medical purpose.” App., infra,
10a-12a; see also App., infra, 59a-65a. On much the
same basis, the Eleventh Circuit sustained the
balance of Petitioners’ convictions. App., infra, 12a17a.
The court of appeals thereafter denied rehearing.
App., infra, 55a-56a.
13
REASONS FOR GRANTING THE PETITION
In Ruan, this Court held that a physician may not
be convicted of controlled substances violations unless
the government proves that she knew or intended that
“her conduct was unauthorized.” 142 S. Ct. at 2382
(App., infra, 37a). The Court vacated both Petitioners’
and Dr. Kahn’s convictions and remanded so that the
Eleventh and Tenth Circuits could determine, among
other things, whether the instructions, taken as a
whole, required the jury to find this “crucial” statutory
mandate. Id. at 2377, 2382 (App., infra, 26a, 37a-38a).
Once on remand, the Eleventh and Tenth
Circuits, like the two Model-T Fords at (what was
then) the only intersection in Kansas, collided. The
Tenth Circuit, faithfully applying this Court’s
directive, vacated all of Dr. Kahn’s convictions,
including convictions under Section 846, because
“each of Dr. Kahn’s convictions was impacted by
erroneous instructions in a way that prejudiced him.”
Kahn, 58 F.4th at 1321. Without an instruction
requiring a finding of “except as authorized,” the jury
instructions, on both the CSA counts and the counts
charging CSA predicates, could not stand. The Tenth
Circuit applied the same principles in vacating a
second doctor’s Section 841(a)(1) and 846 convictions
in United States v. Henson, 2023 WL 2319289, at *1-2
(10th Cir. Mar. 2, 2023).
Petitioners were not as lucky. Although
Petitioners’ CSA jury instructions, like Dr. Kahn’s,
replaced the “authorization” requirement with
language from 21 C.F.R. § 1306.04(a), the Eleventh
Circuit vacated only Petitioners’ Section 841(a)(1)
14
convictions, and sustained both the Section 846
instructions and the instructions on the compound
charges. App., infra, 5a-18a. The Eleventh Circuit
took the same view in other post-Ruan cases,
confirming that, in its judgment, the regulatory
language may substitute for the statutory text. United
States v. Germeil, 2023 WL 1991723, at *8-10 (11th
Cir. Feb. 14, 2023); United States v. Heaton, 59 F.4th
1226, 1241 (11th Cir. 2023); United States v. Maltbia,
2023 WL 1838783, at *5 (11th Cir. Feb. 9, 2023), cert.
petition filed, No. 22-7531 (U.S. May 11, 2023); United
States v. Mencia, 2022 WL 17336503, at *14 (11th Cir.
Nov. 30, 2022). The Fifth and Sixth Circuits have now
followed suit. United States v. Ajayi, 64 F.4th 243,
247-48 (5th Cir. 2023); United States v. Anderson,
2023 WL 2966356, at *7-8 (6th Cir. Apr. 17, 2023).
The circuit conflict has not gone unnoticed. As one
district court recently declared (with a soupcon of
exasperation), “[i]t is far above this Court’s pay grade
to resolve a Circuit split—if, indeed, there is one.”
United States v. Lamartiniere, 2023 WL 2645343, at
*2 (M.D. La. Mar. 27, 2023). And indeed there is one.
That division gets deeper by the day, as more and
more courts affirm the use of 21 C.F.R. § 1306.04(a) as
a substitute for “authorization” in the text of the CSA.
The implications for physicians and other health
care professionals are dismaying. If physicians may be
convicted merely because they knew they were acting
outside the “usual” course of medical practice, or in
ways that other doctors might find “illegitimate,” it
effectively smuggles a quasi-negligence standard
through the back door. A doctor who knowingly
15
deviates from mainstream treatment practices, even
if grounded in subjectively well-considered (and
effective) medical practice, would become a criminal.
Such a standard is inconsistent with the text of the
CSA and with this Court’s decision in Ruan. It also
effectively permits a federal agency to create a
criminal offense that Congress itself did not enact.
This Court should grant the petition and reiterate
that the text of the CSA means what it says: Doctors
may not be treated as drug dealers unless they
knowingly
or
intentionally
act
“without
authorization.”
A. The Circuits Are Divided on the Question
Presented
Did this Court mean what it said in Ruan? One
certainly would have thought so. After all, every party
to that case urged the Court to adopt an instruction
based on some incarnation of the “usual course of his
professional practice” and/or “legitimate medical
purpose” language. See Brief for the Petitioner at 4-5,
10-12, 14-16, Ruan v. United States, No. 20-1410 (Dec.
20, 2021); Brief of Petitioner at 3, 12-13, Kahn v.
United States, No. 21-5261 (Dec. 20, 2021); Brief for
the United States at 16-19, Ruan v. United States and
Kahn v. United States, Nos. 20-1410, 21-5261 (Jan. 19,
2022). While the parties vigorously disagreed about
what kind of mens rea should attach to those
regulatory elements, they all agreed that some version
of 21 C.F.R. § 1306.04(a) should be the basis for a CSA
instruction.
16
But this Court had none of it. Instead, relying on
the plain language of the statute itself, the Court held
that a jury must be instructed that it may convict a
physician only if she knowingly or intentionally acted
without “authorization.” Ruan, 142 S. Ct. at 2375
(App., infra, 20a). The terms of 21 C.F.R. § 1306.04(a)
are simply too “ambiguous” to substitute for the text.
Id. at 2377 (App., infra, 26a). While a knowing breach
of the regulation may be probative of “unauthorized”
conduct, it is not a substitute for the language that
Congress actually enacted. Id. at 2382 (App., infra,
37a).
The Eleventh, Fifth, and Sixth Circuits did not get
the memo. By contrast, the Tenth Circuit did.
1. Although the Eleventh Circuit correctly
reversed Petitioners’ Section 841(a)(1) instructions, it
held that the Section 846 instructions were correct,
App., infra, 10a-12a, as were all the compound
offenses that rested on a CSA predicate (whether
Section 841(a)(1), Section 846, or both), App., infra,
12a-13a, 15a-17a. The Section 846 instructions told
the jury that:
Each defendant can be found guilty of the
conspiracy alleged in one or more of [the drug
conspiracy] counts . . . only if . . . One, two or more
people in some way agreed to try and accomplish
a shared and unlawful plan to distribute or
dispense outside the usual course of professional
practice and not for a legitimate medical purpose
the alleged controlled substance or substances;
and, two, the defendant knew the unlawful
purpose of the plan and willfully joined in it.
17
App., infra, 63a. In the Eleventh Circuit’s view,
because that instruction required the jury to find that
Petitioners “knew” that they were acting “outside the
usual course of professional practice” and without “a
legitimate medical purpose,” the jury necessarily
concluded that Petitioners knew they were
prescribing in an “unauthorized” manner. App., infra,
10a-12a.
The Eleventh Circuit reached this conclusion even
though (1) the Section 846 instructions (and indeed,
the instructions as a whole) made no mention of the
“without authorization” element, App., infra, 59a-65a;
see also Tr. 6321:25-6360:5; (2) this Court
characterized the language of 21 C.F.R. § 1306.04(a)
as “ambiguous,” Ruan, 142 S. Ct. at 2377 (App., infra,
26a); and (3) the Section 846 instructions included an
erroneous “good faith” instruction that referenced
“[t]he standard of medical practice generally
recognized and accepted in the United States,” App.,
infra, 61a-62a. Having sustained the Section 846
instructions, the Eleventh Circuit had no trouble
sustaining as correct the instructions on all other
offenses that rested on CSA charges as predicates.
App., infra, 12a-13a, 15a-17a.
The Eleventh Circuit’s most recent cases confirm
that, in that court’s view, the regulatory language
may be substituted for the CSA text. See Heaton, 59
F.4th at 1238, 1241-42 (instructions that described
“unauthorized” element as dispensing “outside the
usual course of professional practice or for no
legitimate medical purpose” were erroneous because
they “allowed the jury to convict Heaton without
18
considering whether he knowingly or intentionally
issued prescriptions outside the usual course of
professional practice,” but finding error harmless due
to “overwhelming evidence that Heaton subjectively
knew his conduct fell outside the usual course of his
professional practice” (italics added)); see also
Germeil, 2023 WL 1991723, at *8-10 (approving
instructions that the defendant was “charged with
knowingly and intentionally prescribing controlled
substances to her patients outside the usual course of
professional medical practice”); Maltbia, 2023 WL
1838783, at *5 (equating “authorization” with
regulatory criteria).
2. The Fifth and Sixth Circuits have now joined
the Eleventh Circuit in sustaining CSA instructions
that substitute 21 C.F.R. § 1306.04(a) for the
statutory “authorization” requirement. See Ajayi, 64
F.4th at 247-48; Anderson, 2023 WL 2966356, at *7-8.
In Ajayi, a case against a pharmacist, the jury was
instructed that an element of Section 846 charges is
that “two or more persons . . . reached an agreement
to dispense and distribute and possess with intent to
dispense and distribute a controlled substance outside
the scope of professional practice and not for a
legitimate medical purpose.” Jury Charge at 12,
United States v. Ajayi, No. 4:20-cr-00290-O (N.D. Tex.
Mar. 2, 2021) (Doc. 1208). The Section 841(a)(1)
instructions similarly charged that it is a crime to
distribute controlled substances “outside the scope of
professional practice or not for a legitimate medical
purpose.” Id. at 13-14. The court further instructed
that the jury:
19
[M]ust decide whether the controlled substances
were (1) prescribed for what the defendant
subjectively considered to be a legitimate medical
purpose; and (2) from an objective standpoint,
were dispensed in the usual course of professional
practice.
The phrase “usual course of professional practice”
means acting in accordance with a standard of
medical practice generally recognized and
accepted in the United States. This is an objective
standard that considers what is generally
recognized in the medical profession, not what an
individual practitioner subjectively believes the
standard should be.
Id. at 18-19 (emphasis added). The Fifth Circuit
upheld those instructions. 64 F.4th at 247-48.
In Anderson, the Sixth Circuit considered Section
841(a)(1) instructions. The district court had
instructed that the elements were: “First, the
defendant knowingly or intentionally dispensed or
distributed a Schedule II controlled substance . . . ;
and, Second, that the defendant, Dr. Anderson,
prescribed the drug without a legitimate medical
purpose and outside the course of professional
practice.” 2023 WL 2966356, at *7. The court further
told the jury that it could convict if the defendant
“deliberately ignored a high probability that the
controlled substance was distributed or dispensed
without a legitimate medical purpose in the usual
course of professional practice” or “was aware of a
high probability that the controlled substances were
distributed or dispensed other than for a legitimate
20
medical purpose while acting in the usual course of
professional practice.” Id. Despite the fact that these
instructions replaced the “authorization” requirement
with the language of 21 C.F.R. § 1306.04(a), the Sixth
Circuit held that they “appear to comport with Ruan,”
id. at *8, although one member of the panel dissented
in part because “the second element’s instruction
identified no mens rea requirement,” which did not
“comport with Ruan,” id. at *12-13 (White, J.
concurring in part and dissenting in part).
In short, the Fifth and Sixth Circuits, like the
Eleventh Circuit, permit the government to substitute
the dictates of 21 C.F.R. § 1306.04(a) for the statutory
language that this Court held to be “crucial,” 142 S.
Ct. at 2377 (App., infra, 26a).
3. The Tenth Circuit, by contrast, has applied the
text of the CSA and this Court’s Ruan decision
faithfully. Noting that this Court “ruled that, to
establish mens rea, it is insufficient for the
government to prove that a defendant acted without
‘a legitimate medical purpose’ or outside the ‘usual
course’ of generally recognized ‘professional practice,’”
the court rejected Section 841(a)(1) jury instructions
because they “repeatedly” told the jury “that it could
convict Dr. Kahn if it concluded that he acted outside
the usual course of professional medical practice or
without a legitimate medical purpose.” Kahn, 58 F.4th
at 1314-15. The court noted that “Ruan treats the two
criteria in § 1306.04(a) not as distinct bases to support
a conviction, but as ‘reference to objective criteria’ that
may serve as circumstantial evidence of a defendant’s
subjective intent to act in an unauthorized manner.”
21
Id. at 1316 (quoting Ruan, 142 S. Ct. at 2377, 2382).
The regulatory language cannot substitute for the
text: “Under § 841(a)(1),” the Tenth Circuit held, “the
government always has the burden of ‘proving that a
defendant knew or intended that his or her conduct
was unauthorized.’” Id. (quoting Ruan, 142 S. Ct. at
2382).
The Tenth Circuit therefore reversed all of Dr.
Kahn’s convictions, including under Sections 841(a)(1)
and 846, because they were “impacted by erroneous
instructions in a way that prejudiced him.” 58 F.4th
at 1321. The court reasoned that “[f]or each § 841(a)(1)
charge on which Dr. Kahn was convicted, the
instructions erroneously articulated the mens rea
requirement in light of Ruan. As regards the
remaining charges, the instructions pertaining to
those charges are likewise predicated, at least in part,
on one or more of the erroneous § 841(a)(1)
instructions.” Id. at 1322.
The Tenth Circuit has since applied the identical
principle in vacating another physician’s Section
841(a)(1) and 846 convictions and most other
convictions. See Henson, 2023 WL 2319289, at *1. The
jury instructions for Sections 841 and 846 again relied
on 21 C.F.R. § 1306.04(a). Jury Instructions at 21-22,
29-30, 32, 34, United States v. Henson, No. 6:16-cr10018-JWB (D. Kan. Oct. 23, 2018) (Doc. 368).
The circuit conflict has not gone unnoticed. As one
district court has observed, “the Eleventh Circuit [in
Mencia] affirmed that ‘authorization’ is still measured
by reference to” 21 C.F.R. § 1306.04(a), whereas in
Kahn “the Tenth Circuit seems to question this
22
interpretation
(without
mentioning
Mencia).”
Lamartiniere, 2023 WL 2645343, at *1. The court then
said “[i]t is far above this Court’s pay grade to resolve
a Circuit split—if, indeed, there is one.” Id. at *2. The
court resolved to “stay in its lane—determining the
facts—leaving the law for appeal,” id., suggesting,
correctly, that it is this Court’s province to address the
problem.
The conflict is as unjustified as it is palpable.
Petitioners will sit in jail for two decades (and Ajayi
for over a decade and Anderson for eight years) on the
basis of instructions that warranted a new trial for Dr.
Kahn in the Tenth Circuit. That conflict—and
injustice—alone justify a grant of certiorari.
B. The Question Presented Is Important and
Recurring
1. Jury instructions that replace the statutory “as
authorized” language with the regulatory language—
“usual” course of professional practice and
“legitimate” medical purpose—effectively lower the
standard for criminal conviction, and threaten to chill
novel but promising medical approaches to patient
care.
The key regulatory words—“usual” and
“legitimate”—beg the question: in whose eyes? Those
terms focus, most naturally, on what most doctors
deem “usual” and “legitimate.” That may not
constitute a pure negligence standard, since the doctor
must still “know” or “intend” to depart from what most
physicians would do. But it comes pretty close to
simple negligence, and the chilling effect is just about
23
the same. A physician who proposes a novel treatment
regime likely “knows” that he is acting differently
from the “usual” medical practitioner, and perhaps in
ways that the “usual” practitioner would regard as
“illegitimate.” So simply adding “knowingly or
intentionally” to the language of 21 C.F.R.
§ 1306.04(a) is cold comfort to a doctor whose
approach to medical practice differs from the
mainstream. That is precisely what this Court sought
to forestall in Ruan. See Ruan, 142 S. Ct. at 2381
(App., infra, 34a-35a) (rejecting the government’s
proposed standard that “would turn a defendant’s
criminal liability on the mental state of a hypothetical
‘reasonable’ doctor, not on the mental state of the
defendant himself or herself”). The regulatory factors
may be probative of criminal conduct, but they do not
define it. See id. at 2382 (App., infra, 37a).
A criminal standard based on 21 C.F.R.
§ 1306.04(a), rather than the actual text of the CSA,
sends physicians back to Square 1. A doctor who, for
example, knowingly adheres to older prescribing
trends, rather than the most current prescribing
trends, would be a criminal, even if she believed that
the earlier treatment methods were more effective. A
doctor who evaluated the pros and cons of different
courses of treatment (e.g., the tradeoff between
efficacy and side effects) and follows her reasoned
conclusion that she knows falls outside the
mainstream would be a criminal. Or a doctor who
developed an innovative but off-label use of a
controlled substance to treat an illness in a new way
would be a criminal. By replacing the plain language
24
of the CSA with words plucked from an agency
regulation, jury instructions stifle innovation and
creativity. And simply requiring that the doctor must
“know” that she is prescribing “unusually” or even
“illegitimately” (in the eyes of mainstream physicians)
provides little to no protection for an innovative
practitioner (or any practitioner who thinks
differently from other doctors).
That is why this Court emphasized in Ruan that
deliberately acting without authorization is of utmost
importance: “In § 841 prosecutions, then, it is the fact
that the doctor issued an unauthorized prescription
that renders his or her conduct wrongful, not the fact
of the dispensation itself. In other words,
authorization plays a ‘crucial’ role in separating
innocent conduct—and, in the case of doctors, socially
beneficial conduct—from wrongful conduct.” Id. at
2377 (App., infra, 26a). In holding that a “strong
scienter requirement” applies, the Court noted that
Ҥ 841 imposes severe penalties upon those who
violate it, including life imprisonment and fines up to
$1 million.” Id. (App., infra, 27a). By imposing such
severe penalties on doctors simply because they knew
they were departing from the mainstream threatens
to turn dissenters into criminals, to the obvious
detriment of therapeutic practice and medical
progress.
Substituting 21 C.F.R. § 1306.04(a) for the
statutory text is especially chilling in those circuits
(including the Eleventh) that permit CSA convictions
for physicians who either knew they were acting
outside the “usual” norms or knew they lacked a
25
“legitimate” medical purpose. See Heaton, 59 F.4th at
1239-40 (Eleventh Circuit case rejecting challenge to
disjunctive instruction); United States v. Oppong,
2022 WL 1055915, at *4-5 (6th Cir. Apr. 8, 2022)
(approving disjunctive instruction under plain error
standard and discussing use of disjunctive standard
in the Fifth, Tenth, and Eleventh Circuits and
conjunctive standard in Eighth and Ninth Circuits).
In those circuits, doctors face felony prosecution
simply because they knew they were acting outside
professional norms. Perhaps the doctor was trying a
method of last resort for a patient for whom the
“usual” techniques had failed. Or maybe the physician
applied experimental treatments for a patient intent
on exhausting every possible medical approach. Must
such physicians look over their shoulders for Inspector
Javert seeking mandatory minimum jail sentences for
knowing departures from the “usual” medical
practices?
To be sure, the further a physician departs from
what she knows to be “usual” and “legitimate,” the
likelier it is that she will also know she is acting
without authorization. So a deliberate violation of 21
C.F.R. § 1306.04(a) is, as we noted, probative of the
“except as authorized” inquiry. But it cannot be a
substitute for that inquiry, and courts should not
continue to invite juries to convict on that basis.
2. Nevertheless, in just a year since this Court’s
June 27, 2022 decision, dozens of courts have
substituted, and continue to substitute, the regulatory
language for the CSA text, in plain defiance of the
statute and this Court’s Ruan decision. See supra 16-
26
20 (discussing Ruan, Heaton, Germeil, Maltbia, Ajayi,
and Anderson); Mencia, 2022 WL 17336503, at *14
(instructions using language of 21 C.F.R. § 1306.04
were “not plain error” under Ruan because they
“communicated” that the government must prove
“that the prescriptions he had written were
unauthorized or, in other words, that they were
outside the scope of professional practice and not for a
legitimate medical purpose” (emphasis added));
United States v. Kamra, 2022 WL 4998978, at *1-3 (3d
Cir. Oct. 4, 2022) (in a case against pharmacy
marketing executive, approving instruction that
purpose of conspiracy was to distribute “outside the
usual course of professional practice and for no
legitimate medical purpose”); United States v. La,
2023 WL 2731036, at *10-11 (M.D. Tenn. Mar. 30,
2023) (approving instruction that “[t]he defendant
knowingly or intentionally distributed the substance
without a legitimate medical purpose outside the
usual course of professional practice”); United States
v. Lamartiniere, 2023 WL 2424585, at *3 (M.D. La.
Mar. 9, 2023) (instruction equating “authorization”
with “issued for a legitimate medical purpose and
within the usual course of a practitioner’s professional
practice” was “complete and correct” under Ruan
because “21 C.F.R. § 1306.04 remains the touchstone
for
defining
‘authorization’
under
§ 841”),
reconsideration denied, 2023 WL 2645343 (M.D. La.
Mar. 27, 2023); United States v. Murphy, 2023 WL
2090279, at *3 (N.D. Ala. Feb. 17, 2023) (vacating
Section 841(a)(1) conviction but sustaining Section
846 convictions, where instructions for both sections
used regulatory language); United States v. Parasmo,
27
2023 WL 1109649, at *16-21 (E.D.N.Y. Jan. 30, 2023)
(instruction that “the defendant knowingly and
intentionally prescribed the controlled substances
outside the bounds of professional medical practice
and not for a legitimate medical purpose” “is precisely
what Ruan commands”); see also United States v.
Ferris, 52 F.4th 235, 241 (5th Cir. 2022) (sentencing
challenge by non-provider; “21 U.S.C. § 841(a) permits
registered doctors to prescribe controlled substances
to their patients if the prescriptions are for a
legitimate medical purpose in the usual course of
professional practice” (cleaned up)), cert. denied, 143
S. Ct. 846 (2023); United States v. Wells, 2023 WL
3341673, at *3-4 (D. Nev. May 10, 2023) (dismissing
indictment because mens rea applied “to the act of
distribution but not to the language defining without
authorization,” which was from 21 C.F.R.
§ 1306.04(a)); United States v. Alvear, 2023 WL
3061551, at *4 (D. Nev. Apr. 24, 2023) (motions in
limine; citing 21 C.F.R. § 1306.04(a) for definition of
“authorized”); Order (1) Denying Defendant’s Motion
to Withdraw Plea and (2) Denying Government Ex
Parte Application for Judicial Finding of Breach of
Plea Agreement at 3, United States v. Pham, No. 8:19cr-00010-JLS (C.D. Cal. Apr. 7, 2023) (motion to
withdraw plea; stating that Ruan “equates ‘lack of
authorization’ with conduct ‘outside of the ordinary
course of professional practice and not for a legitimate
medical purpose’”); United States v. Kistler, 2023 WL
1099726, at *1 (S.D. Ohio Jan. 30, 2023) (motions in
limine; defendant charged with prescribing “outside of
the usual course of professional practice and not for
legitimate medical purposes”); United States v.
28
Taylor, 2022 WL 17582270, at *8 (E.D. Ky. Dec. 12,
2022) (motion to suppress; citing 21 C.F.R.
§ 1306.04(a) for definition of “authorized”); United
States v. Ferrell, 2022 WL 17404891, at *2 (E.D. Tex.
Dec. 2, 2022) (motion to withdraw plea; “Ferrell thus
admitted that he ‘knowingly and intentionally’
possessed with the intent to distribute controlled
substances ‘outside the normal course of practice and
without legitimate medical purpose’”); United States
v. Adelglass, 2022 WL 6763791, at *3 (S.D.N.Y. Oct.
11, 2022) (motion to dismiss indictment; equating
“authorization” with regulatory criteria); United
States v. Parker, 2022 WL 5213206, at *3 (W.D. Ark.
Oct. 5, 2022) (motion for admittance of deposition
testimony; “the government must establish . . . that
Defendant: was acting outside the bounds of
professional medical practice, as his authority to
prescribe controlled substances was being used not for
treatment of a patient, but for the purpose of assisting
another in the maintenance of a drug habit or of
dispensing controlled substances for other than a
legitimate medical purpose”); United States v. Naylor,
2022 WL 4371489, at *1 (E.D. Tenn. Sept. 21, 2022)
(motion to exclude; charges for distributing and
conspiring to distribute outside the usual course of
professional practice and without a legitimate medical
purpose); Brizuela v. United States, 2022 WL
4369977, at *6 (N.D.W. Va. Sept. 21, 2022) (motion to
vacate, set aside, or correct sentence; “the Court twice
informed Brizuela that, should he decide to go to trial,
the Government would be required to prove beyond a
reasonable doubt that he knowingly distributed
controlled substances outside the bounds of
29
professional medical practice, or in other words that
he knew the distribution was not authorized”); United
States v. Spayd, 2022 WL 4367621, at *7 (D. Alaska
Sept. 20, 2022) (motions in limine in case against
nurse practitioner; “pursuant to Ruan, a medical
professional will only be held liable under § 841 if the
Government proves beyond a reasonable doubt that
they
knowingly
or
intentionally
prescribed
medications without a legitimate medical purpose and
while acting outside the usual course of professional
practice”); United States v. Ranochak, 2022 WL
4298568, at *11, *15 (N.D. Ind. Sept. 19, 2022)
(motions in limine in case against pharmacist;
prescription “‘authorized’ when a licensed practitioner
issues it ‘for a legitimate medical purpose … acting in
the usual course of his professional practice’”); United
States v. Spayd, 2022 WL 4220192, at *4 (D. Alaska
Sept. 13, 2022) (motion to dismiss indictment by nurse
practitioner; rejecting argument that “the definition of
authorization was broader than 21 C.F.R.
§ 1306.04(a)” because “the Ruan Court specifically
recognized that 21 C.F.R. § 1306.04(a) determined the
bounds of a prescriber’s authorization”); United States
v. Taylor, 2022 WL 4227510, at *1-4 (E.D. Ky. Sept.
13, 2022) (motion to dismiss indictment; equating
“authorization” with regulatory criteria); United
States v. Blume, 2022 WL 3701449, at *2 (S.D.W. Va.
Aug. 26, 2022) (motion for production of grand jury
materials; “Defendants point out that the Fourth
Superseding Indictment fails to reference 21 C.F.R.
§ 1306.04, which is the subjective standard aligned
with the scienter requirement set forth in Ruan”), set
aside, 2022 WL 4076065 (S.D.W. Va. Sept. 3, 2022);
30
United States v. Sachy, 2022 U.S. Dist. LEXIS
148403, at *2 (M.D. Ga. Aug. 18, 2022) (motion to
withdraw plea; citing 21 C.F.R. § 1306.04(a) for
definition of “authorized”); United States v. Kraynak,
2022 WL 3161907 (M.D. Pa. Aug. 8, 2022) (motion to
withdraw plea; “the only dispute as to Kraynak’s guilt
is whether he knowingly or intentionally issued the
controlled substances outside the usual course of
professional practice and not for a legitimate medical
purpose”).
There is every reason to think that the problem
will persist. None of the circuits has yet to issue a
pattern instruction properly implementing Ruan. In
fact, the Sixth Circuit pattern instructions expressly
equate the “without authorization” requirement with
the regulatory language. See Sixth Circuit Committee
on Pattern Criminal Jury Instructions, Pattern
Criminal Jury Instructions, Instruction 14.02C (Mar.
1,
2023),
available
at
https://www.ca6.uscourts.gov/pattern-juryinstructions. Although the Eighth and Ninth Circuit
pattern instructions reference Ruan in comments,
they do not contain model instructions for
practitioners. See Judicial Committee on Model Jury
Instructions for the Eighth Circuit, Manual of Model
Criminal Jury Instructions for the District Courts of
the Eighth Circuit, 610-614, 626, 639-640 (2022),
available
at
https://juryinstructions.ca8.uscourts.gov/instructions/
criminal/Criminal-Jury-Instructions.pdf.;
Ninth
Circuit Jury Instructions Committee, Manual of
Model Criminal Jury Instructions for the District
31
Courts of the Ninth Circuit, Instructions 12.4 & 12.5
(Mar.
2023),
available
at
https://www.ce9.uscourts.gov/juryinstructions/model-criminal. The remaining circuits
either do not publish pattern instructions or do not
include in their pattern instructions specific
instructions for CSA charges against practitioners.
C. The Eleventh Circuit’s Decision Below Is
Wrong
1. The Eleventh Circuit was wrong to vacate only
Petitioners’ Section 841(a)(1) convictions and not the
closely related Section 846 charges. That decision
departs from the statutory text and this Court’s Ruan
decision and dilutes the mens rea requirement.
The CSA makes it unlawful to distribute or
dispense controlled substances “[e]xcept as authorized
by this subchapter,” 21 U.S.C. § 841(a)(1), and “this
subchapter” authorizes persons registered by the
Attorney General, like physicians, to distribute or
dispense controlled substances “to the extent
authorized by their registration,” 21 U.S.C. § 822(b).
The statute does not say that it is unlawful to
prescribe “outside the course of professional practice”
or not for a “legitimate medical purpose.” 21 U.S.C.
§ 841(a)(1).
Nonetheless, for both the substantive and
conspiracy CSA charges in this case, the jury
instructions substituted the language of 21 C.F.R.
§ 1306.04(a) for the text of the CSA. App., infra, 59a68a. That substitution is reason enough to reject the
Eleventh Circuit’s decision—the Attorney General’s
32
rulemaking authority under the CSA, see 21 U.S.C.
§§ 821, 871(b), does not give him the power rewrite
criminal laws enacted by Congress (and, if the
Attorney General had such authority, it would be an
impermissible delegation of Congress’ lawmaking
power). See Gundy v. United States, 139 S. Ct. 2116,
2144-45 (2019) (Gorsuch, J., dissenting, joined by
Roberts, C.J., and Thomas, J.) (“To allow the nation’s
chief law enforcement officer to write the criminal
laws he is charged with enforcing—to unit[e] the
legislative and executive powers ... in the same
person—would be to mark the end of any meaningful
enforcement of our separation of powers and invite the
tyranny of the majority that follows when lawmaking
and law enforcement responsibilities are united in the
same hands.”); Whitman v. United States, 135 S. Ct.
352, 354 (2014) (Scalia, J., respecting denial of
certiorari) (“[T]he rule of lenity . . . vindicates the
principle that only the legislature may define crimes
and fix punishments. Congress cannot, through
ambiguity, effectively leave that function to the
courts—much
less
to
the
administrative
bureaucracy.”). Nor does Section 841(a)(1) make
violating a regulation promulgated by the Attorney
General unlawful. See 21 U.S.C. § 841(a)(1); Loving v.
United States, 517 U.S. 748, 768 (1996) (“We have
upheld delegations whereby the Executive or an
independent agency defines by regulation what
conduct will be criminal, so long as Congress makes
violation of regulations a criminal offense . . . .
(emphasis added)).
33
Likewise, courts should not unduly defer, if at all,
to agencies’ interpretations of what statutes mean and
instead should stick to the text of the statutes. See,
e.g., Buffington v. McDonough, 143 S. Ct. 14, 22 (2022)
(Gorsuch, J., dissenting) (“We should acknowledge
forthrightly that Chevron did not undo, and could not
have undone, the judicial duty to provide an
independent judgment of the law’s meaning in the
cases that come before the Nation’s courts. Someday
soon I hope we might.”); Becerra v. Empire Health
Found., for Valley Hosp. Med. Ctr., 142 S. Ct. 2354,
2368-69 (2022) (Kavanaugh, J., dissenting) (“[T]his
case is resolved by the most fundamental principle of
statutory interpretation: Read the statute.”);
Michigan v. EPA, 576 U.S. 743, 761 (2015) (Thomas,
J., concurring) (“Chevron deference precludes judges
from exercising [their independent] judgment, forcing
them to abandon what they believe is the best reading
of an ambiguous statute in favor of an agency’s
construction. It thus wrests from Courts the ultimate
interpretative authority to say what the law is and
hands it over to the Executive.”). Indeed, it may well
be that the government’s interpretations of criminal
statutes are entitled to no deference by courts. See
United States v. Apel, 571 U.S. 359, 369 (2014)
(addressing United States Attorneys’ Manual and
opinions of the Air Force Judge Advocate General, and
stating, “we have never held that the Government’s
reading of a criminal statute is entitled to any
deference”); see also Abramski v. United States, 573
U.S. 169, 191 (2014) (addressing ATF circular and
prior version of ATF form, and stating, “[t]he critical
point is that criminal laws are for courts, not the
34
Government, to construe” (citing Apel, 571 U.S. at
369)).
The widespread substitution of 21 C.F.R.
§ 1306.04(a) for the actual text of the statute also
defies this Court’s decision in Ruan and the principles
that animated it. As the Court noted, the regulatory
language is “ambiguous” and “open to varying
constructions.” 142 S. Ct. at 2377 (App., infra, 26a).
What does “usual” mean”? What does “legitimate”
mean? In whose eyes must those terms be defined? If,
as the terms suggest, it suffices to convict a doctor as
a drug dealer because she knows that most other
doctors disagree, 21 C.F.R. § 1306.04(a) would just reestablish the very problem this Court sought in Ruan
to resolve. That is why the Ruan Court concluded
that, while the government may rely on
“circumstantial evidence . . . by reference to objective
criteria such as ‘legitimate medical purpose’ and
‘usual course’ of ‘professional practice,’” the ultimate
question—the one the jury must be asked to decide—
is whether “a defendant knew or intended that his or
her conduct was unauthorized.” Id. at 2382 (App.,
infra, 37a).
The Eleventh Circuit disregarded these
principles. In its view, Petitioners’ jury was perfectly
entitled to convict them of conspiracy if Petitioners
“agreed to try and accomplish a shared and unlawful
plan to distribute or dispense outside the usual course
of professional practice and not for a legitimate
medical purpose the alleged controlled substance or
substances; and, two, [they] knew the unlawful
purpose of the plan and willfully joined in it.” App.,
35
infra, 63a (emphasis added); see also App., infra, 10a12a. The instructions defined the “unlawful plan” of
the conspiracy as “distribut[ing] or dispens[ing]
outside the usual course of professional practice and
not for a legitimate medical purpose”—not
distributing without authorization. App., infra, 63a.
The jury could therefore convict Petitioners if it found
that they knew that their prescriptions were
objectively outside the usual course of professional
practice or not for a legitimate medical purpose, i.e., if
other physicians would disagree with their medical
determinations but Petitioners themselves believed
the prescriptions were appropriate. But, under Ruan,
that is wrong—a jury may convict only when the
physician has subjective knowledge that prescriptions
are unauthorized. The Eleventh Circuit departed from
the statutory text and Ruan by substituting the
language of the regulation.
Put another way, the Eleventh Circuit has
created a back door to convict a physician under
Section 846 for conspiracy to do something that is not
itself unlawful under Section 841(a)(1). That is wrong.
See Woo Wai v. United States, 223 F. 412, 415 (9th Cir.
1915) (“If no violation of the law was to be
accomplished by the act of the defendants, it follows
that they could not be held for conspiracy to do that
act.”).
2. The same basic error infects the court of
appeals’ treatment of most of Petitioners’ remaining
convictions. With respect to racketeering conspiracy,
the Eleventh Circuit said that, even if the jury relied
on the Section 841(a)(1) convictions as predicates, the
36
instructional error made no difference because the
jury “would still have made a finding that the
defendants intended to violate § 841, which means
that the defendants would have to have known their
acts were unauthorized.” App., infra, 15a-16a. But
that conclusion founders on the same error the court
of appeals made with respect to the CSA instruction—
the jury could convict Petitioners if it found that they
knew that their prescriptions were objectively outside
the usual course of professional practice or not for a
legitimate medical purpose. The racketeering
instructions themselves contained no instruction
about lack of authorization. Tr. 6328:9-6331:4.
So, too, for the health care fraud conspiracy
charges. The district court told the jury that it could
convict if it found that “a defendant conspired to
commit healthcare fraud by one or more of the[] four
means [listed in the indictment].” App., infra, 68a69a. Two of the four means were taken straight from
21 C.F.R. § 1306.04(a): (1) “[b]illing patients’
insurance providers for Controlled Substances that
were not prescribed for a legitimate medical purpose
or were prescribed outside the usual course of
professional practice,” and (2) “[r]unning and then
billing patients’ insurance providers for various lab
tests, including urine drug screens, for no legitimate
medical purpose and outside the usual course of
professional practice.” Doc. 269 ¶ 114.
As for Dr. Ruan’s money laundering and money
laundering conspiracy convictions, those were
compound offenses predicated, in pertinent part, on
CSA conspiracy and health care fraud conspiracy.
37
App., infra, 16a-17a. Because those predicates relied
on the impermissible language of 21 C.F.R.
§ 1306.04(a), the compound offenses cannot stand.
D. This Case Presents an Ideal Vehicle to
Resolve the Question Presented
Petitioners’ case was very close on the merits. As
the court of appeals recognized in rejecting the
government’s harmless error argument with respect
to the Section 841(a)(1) convictions:
The jury could have weighed all of this evidence
and concluded that Dr. Ruan and Dr. Couch
subjectively believed their conduct was in accord
with the appropriate standard of care. But under
the erroneous instruction that was given, the jury
could convict the defendants if they found that a
reasonable doctor would not have believed the
conduct was in accord with the appropriate
standard. In other words, a properly instructed
jury may not have convicted the defendants had it
known that Dr. Ruan’s and Dr. Couch’s subjective
beliefs that they were acting properly was a
defense to these charges. Similar to McDonnell,
under the erroneous instruction in this case the
jury was authorized to convict the defendants for
conduct that was lawful.
App., infra, 9a. It follows that the erroneous jury
instructions on the compound offenses were almost
surely outcome-determinative.
Moreover, the circuit conflict could scarcely be
starker. Petitioners’ case in the Eleventh Circuit and
Dr. Kahn’s case in the Tenth arise from the same
38
decision of this Court. They involve jury instructions
exhibiting the same problem—the language of 21
C.F.R. § 1306.04(a) erroneously substitutes for the
language of the CSA. Each of the physicians
challenged the instructions for much the same
reasons. The only difference is that the Tenth Circuit
faithfully applied this Court’s Ruan decision and the
Eleventh Circuit didn’t.
Finally, Petitioners’ case returns to this Court at
the right time. As we noted above, supra at 25-30, as
each day goes by, another district court instructs a
jury that a knowing violation of 21 C.F.R. § 1306.04(a)
constitutes a violation of the CSA. Undoing that
spiraling error is doubtless “far above th[e] [lower
federal] [c]ourt[s’] pay grade.” Lamartiniere, 2023 WL
2645343, at *1. That leaves only this Court to set
matters right.
39
CONCLUSION
The petition for a writ of certiorari should be
granted.
Respectfully submitted.
LAWRENCE S. ROBBINS
Counsel of Record
DAVID J. RANZENHOFER
FRIEDMAN KAPLAN SEILER
ADELMAN & ROBBINS LLP
7 Times Square
New York, NY 10036-6516
(212) 833-1100
lrobbins@fklaw.com
May 31, 2023
Counsel for Petitioners
APPENDIX
i
TABLE OF APPENDICES
Page
A P P E N DI X A — O P I N IO N O F T H E
UNITED STATES COURT OF APPEALS
F O R T H E E L E V E N T H C I R C U I T,
FILED JANUARY 5, 2023 . . . . . . . . . . . . . . . . . . . . 1a
A PPEN DI X B — OPINION A N D
CONCURRING IN JUDGMENT OF THE
SUPREME COURT OF THE UNITED
STATES, DATED JUNE 27, 2022 . . . . . . . . . . . . . 19a
A P P E N DI X C — O R D E R D E N Y I N G
REHEA RING IN THE U NITED
STAT ES COU RT OF A PPEA LS FOR
T H E ELE V EN T H CIRCU I T, FI LED
MARCH 2, 2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55a
A P P E N DI X D — O R D E R D E N Y I N G
REHEA RING IN THE U NITED
STAT ES COU RT OF A PPEA LS FOR
T H E ELE V EN T H CIRCU I T, FI LED
NOVEMBER 4, 2020 . . . . . . . . . . . . . . . . . . . . . . . . .57a
A PPENDI X E — TR A NSCRIP T
E XCER P T S F ROM T H E U N I T ED
STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF ALABAMA,
DATED FEBRUARY 17, 2017 . . . . . . . . . . . . . . . . 59a
ii
Table of Appendices
Page
A PPENDI X F — TR A NSCRIP T
E XCER P T S F ROM T H E U N I T ED
STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF ALABAMA,
DATED FEBRUARY 16, 2017 . . . . . . . . . . . . . . . . . 70a
1a
APPENDIX A — Appendix
OPINIONAOF THE UNITED
STATES COURT OF APPEALS FOR THE
ELEVENTH CIRCUIT, FILED JANUARY 5, 2023
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
No. 17-12653
UNITED STATES OF AMERICA,
Plaintiff-Appellee,
versus
XIULU RUAN, JOHN PATRICK COUCH,
Defendants-Appellants.
Appeal from the United States District Court
for the Southern District of Alabama
D.C. Docket No. 1:15-cr-00088-CG-B-2
January 5, 2023, Filed
Opinion of the Court
ON REMAND FROM THE SUPREME COURT OF
THE UNITED STATES
Before Wilson, Newsom, Circuit Judges, and Coogler,*
Chief District Judge.
* Honorable L. Scott Coogler, United States Chief District
Judge for the Northern District of Alabama, sitting by designation.
2a
Appendix A
PER CURIAM:
This case returns to our court on remand from the
Supreme Court. Ruan v. United States, 142 S. Ct. 2370, 213
L. Ed. 2d 706 (2022) (Ruan II). We ordered supplemental
briefing to address whether the mens rea jury instruction
used in this case was error and whether any such error
was harmless. After careful consideration, we conclude
that the jury instruction used in this case is inconsistent
with the Supreme Court’s guidance and did not convey an
adequate mens rea to the jury for the substantive drug
convictions under 21 U.S.C. § 841. We further find that
this error was not harmless beyond a reasonable doubt
for Dr. Xiulu Ruan’s and Dr. John Couch’s (collectively,
the defendants) substantive drug charges. However,
we conclude that the instructional error was harmless
as to the other convictions in this case. Accordingly, we
VACATE in part and AFFIRM in part the defendants’
convictions.1
I.
The factual and procedural history at trial were
thoroughly recounted in our prior panel opinion, United
1. In the defendants’ original appeal, they raised a number of
other challenges, including sufficiency of the evidence, evidentiary,
and sentencing challenges. On remand these issues were not rebriefed, and nothing in the Supreme Court’s decision alters our
consideration of those issues. Accordingly, we adopt the reasoning
of the previous panel opinion, but not the discussion relating to the
good-faith instruction in Part C.1. See United States v. Ruan, 966
F.3d 1101 (11th Cir. 2020).
3a
Appendix A
States v. Ruan, 966 F.3d 1101, 1119-36 (11th Cir. 2020)
(Ruan I). Among other things, the defendants challenged
the jury instructions used for their substantive drug
convictions under 21 U.S.C. § 841(a), which prohibits the
“knowing[] or intentional[]” dispensing of controlled
substances “[e]xcept as authorized.” The relevant drugs in
this case are only “authorized” to be dispensed pursuant
to a prescription, and an effective prescription must be
made for a “legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice.” 21 C.F.R. § 1306.04(a). The defendants
requested that the jury be instructed that their good faith
be a defense to an allegation that they acted outside the
“usual course of professional practice.”
In Ruan I, we affirmed on all but Count 162 and held
that we were bound by prior Eleventh Circuit precedent to
reject the defendants’ request for a good-faith instruction.
See, e.g., United States v. Joseph, 709 F.3d 1082 (11th Cir.
2013); United States v. Tobin, 676 F.3d 1264 (11th Cir.
2012); United States v. Merrill, 513 F.3d 1293 (11th Cir.
2008); United States v. Williams, 445 F.3d 1302 (11th Cir.
2006). We reaffirmed that the “usual course of professional
practice” prong was evaluated using an objective standard,
not a subjective one. Ruan I, 966 F.3d at 1167. Accordingly,
good faith was irrelevant to the question of whether a
doctor acted in the usual course of professional practice;
though it was relevant to whether the doctor prescribed a
2. We remanded the remaining counts for resentencing and
after the district court resentenced the defendants they appealed
again. Those appeals are currently pending and stayed awaiting
resolution of this case.
4a
Appendix A
controlled substance for a “legitimate medical purpose.”
See id. The defendants then petitioned for, and the
Supreme Court granted, certiorari to consider whether
good faith is a defense on the usual course of professional
practice prong. See Ruan v. United States, 142 S. Ct. 457,
211 L. Ed. 2d 278 (2021).
The Supreme Court reversed. It reasoned that
§ 841(a)’s scienter provision (requiring the defendant to
act “knowingly or intentionally”) applied not only to the
statute’s actus reus—here dispensing—but also to the
“except as authorized” exception. Ruan II, 142 S. Ct. at
2378. Thus, to obtain a conviction under this section, the
government must prove beyond a reasonable doubt that
a defendant (1) knowingly or intentionally dispensed a
controlled substance; and (2) knowingly or intentionally
did so in an unauthorized manner. Id. at 2382. The Court
held that an objective standard would inappropriately
import a civil negligence standard into a criminal
prosecution. See id. at 2381. Instead, what matters is the
defendant’s subjective mens rea. Id. at 2382.
The Supreme Court expressly declined to apply its
new standard to the facts in this case and remanded to
this court to consider the issue in the first instance. Id.
II.
We review de novo whether a challenged jury
instruction “misstated the law or misled the jury to the
prejudice of the objecting party.” United States v. Cochran,
683 F.3d 1314, 1319 (11th Cir. 2012). Jury instructions
5a
Appendix A
need not be perfect, and we review the instructions in
light of the “entire charge” and do not isolate individual
statements in order to contrive error. Id.
Where the error is the omission of an element of the
crime we will reverse unless it can be shown the error
was harmless beyond a reasonable doubt. Neder v. United
States, 527 U.S. 1, 15-16, 119 S. Ct. 1827, 144 L. Ed. 2d
35 (1999).
III.
The district court in this case followed then-binding
Eleventh Circuit precedent and denied the defendants’
request for a good-faith instruction reflecting their
subjective intent. Instead, the district court gave an
alternative instruction on good faith:
A controlled substance is prescribed by a
physician in the usual course of a 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 government argues in its supplemental briefing
that this instruction, read together with the whole
charge, adequately instructed the jury that it had to find
the defendants acted with knowledge or intent in order
to convict them under § 841(a). We disagree for three
reasons.
6a
Appendix A
First, the passing reference to “good faith” excerpted
above is inadequate. The Supreme Court recognized
that § 841 “uses the familiar mens rea words ‘knowingly
or intentionally.’ It nowhere uses words such as ‘good
faith’ . . . .” Ruan II, 142 S. Ct. at 2381. The Supreme
Court then explicitly rejected the government’s proffered
compromise instruction that objective good faith or “honest
effort” should govern the usual course of professional
practice prong. Id. Instead, it is the defendant’s subjective
intent that matters. The government argues that our cases
have conceptually linked “good faith” and “knowledge”
in the past, and that this instruction gave the “functional
equivalent of a knowledge instruction.” But, at best, even
if the concepts are linked, good faith is an imprecise proxy
for knowledge.
Without further qualification, the phrase “good faith”
encompasses both subjective and objective good faith. In
the context of § 841 though, as the Supreme Court has
explicitly held, only the subjective version is appropriate.
The instruction given by the district court did not contain
any qualification to make this clear to the jury. And, of
course, the instruction did not contain this qualification.
The district court’s instruction is substantially identical
to one this court first approved in Williams. See 445
F.3d at 1309. Over the next fifteen years we reaffirmed
this language repeatedly because it comported with our
understanding that the “usual course of his professional
practice must be evaluated based on an objective
standard.” See, e.g., Joseph, 709 F.3d at 1097. At the same
time, we consistently rejected attempts by defendants to
change this language and introduce other formulations
7a
Appendix A
that had a subjective character. Id.; Tobin, 676 F.3d at
1283; Merrill, 513 F.3d at 1306. Based on all of this, we
conclude this phrase on its own inadequately conveyed
the required mens rea.
Second, even viewing this phrase in the context of
the “entire charge,” the remaining jury instructions did
not help convey that a subjective analysis was required
for the “except as authorized” exception. The district
court enumerated the elements of a § 841(a) charge: (1)
the defendant dispensed the controlled substance; (2) “the
[d]efendant did so knowingly and intentionally;” and (3)
the defendant did not have authorization. Grammatically,
the “did so” phrase links the mens rea element to the
preceding element describing the actus reus of dispensing
the controlled substance, but not to the “except as
authorized” exception.
Third and finally, the summary of the charge also did
not help to convey the required mens rea. The district
court essentially repeated the language from 21 C.F.R.
§ 1306.04(a) without linking it to any requirement that the
jury find a lack of good faith or scienter for this exception.
Therefore, we conclude that the district court’s
instruction for the substantive drug charges inadequately
conveyed the required mens rea to authorize conviction
under § 841(a).
8a
Appendix A
IV.
We turn now to whether the error in the jury
instructions was harmless beyond a reasonable doubt.
Neder, 527 U.S. at 15-16. The Supreme Court has held that
while the omission of an element from the jury instruction
is unconstitutional, “most constitutional errors can be
harmless.” Id. at 8 (quoting Arizona v. Fulminante, 499
U.S. 279, 306, 111 S. Ct. 1246, 113 L. Ed. 2d 302 (1991)).
In McDonnell v. United States, the Supreme Court
held that the erroneous omission of limiting language for
the definition of “official act” under the federal bribery
statute was not harmless. 579 U.S. 550, 577-80, 136 S.
Ct. 2355, 195 L. Ed. 2d 639 (2016). In that case, extensive
evidence was presented both of acts that arguably fell
within the overinclusive instruction, and of acts that
would still qualify as “official acts” had the proper limiting
instruction been given. Id. at 577. Under this circumstance,
the Supreme Court held that the jury may have convicted
the defendant “for conduct that [was] not unlawful,” and
therefore the error was not harmless beyond a reasonable
doubt. Id. at 579-80.
Here, the district court did not adequately instruct
the jury that the defendants must have “knowingly or
intentionally” prescribed outside the usual course of their
professional practices. At a minimum, as discussed above,
without the limiting qualification that only subjective good
faith was sufficient for conviction, the jury was authorized
to convict under the sort of objective good faith or honest
effort standard rejected by the Supreme Court.
9a
Appendix A
For Dr. Ruan, both sides presented expert evidence
about the appropriate standard of care. In his defense,
Dr. Ruan introduced witnesses who testified to his
practices and procedures at the clinic to guard against
abuse. He also testified in his own defense about how he
always centered the patient’s medical needs. Dr. Couch
also introduced both expert witnesses who testified to
the standard of care and lay witnesses who testified to
his activities at the clinic. Like Dr. Ruan, Dr. Couch
testified that he believed his actions to be in accord with
the applicable standard of care.
The jury could have weighed all of this evidence
and concluded that Dr. Ruan and Dr. Couch subjectively
believed their conduct was in accord with the appropriate
standard of care. But under the erroneous instruction
that was given, the jury could convict the defendants
if they found that a reasonable doctor would not have
believed the conduct was in accord with the appropriate
standard. In other words, a properly instructed jury may
not have convicted the defendants had it known that Dr.
Ruan’s and Dr. Couch’s subjective beliefs that they were
acting properly was a defense to these charges. Similar
to McDonnell, under the erroneous instruction in this
case the jury was authorized to convict the defendants
for conduct that was lawful. Thus, we cannot conclude
that these errors were harmless. We therefore vacate the
defendants’ substantive drug convictions under § 841(a).
10a
Appendix A
V.
Given that we have found error in the district court’s
instructions for the § 841(a) charges, all that remains is
to decide which, if any, of the other charges must also be
vacated.
1.
We begin with the conspiracy to violate the Controlled
Substances Act charges, violations of 21 U.S.C. § 846. To
violate § 846 the government must prove: “(1) there was an
agreement between two or more people to commit a crime
(in this case, unlawfully dispensing controlled substances
in violation of § 841(a)(1)); (2) the defendant knew about
the agreement; and (3) the defendant voluntarily joined
the agreement.” United States v. Azmat, 805 F.3d 1018,
1035 (11th Cir. 2015).
Because a conviction under § 846 requires the jury
to find that the defendants knew of the illegal nature of
the scheme and agreed to participate in it, the erroneous
jury instruction for the substantive charges has a limited
impact here. Consider what a jury who voted to convict
under § 846 would have to find. The jury would need to
find that the defendant knew the illegal object of the
conspiracy. For a defendant to know that the aim of their
agreement was illegal in this context means that they
would need to know both that (1) they were dispensing
a controlled substance and (2) that they were doing so in
an unauthorized manner. If the jury concluded that the
defendant did not know either of these things, then they
11a
Appendix A
could not conclude the defendant knew the illegal object
of the conspiracy and could not vote to convict.
In this circumstance, the inadequate substantive jury
instruction would have no effect on the jury’s analysis for
the conspiracy counts. The jury did not need an additional
instruction clarifying between subjective and objective
good faith for the “except as authorized” exception,
because the conspiracy instructions already required
them to find that the defendant acted with subjective
knowledge.
Here, the jury instructions for the drug conspiracy
charges tracked our precedent and conveyed the adequate
mens rea. The jurors in this case were instructed to
convict only if they found “two or more people in some
way agreed to try and accomplish a shared unlawful
plan to distribute or dispense . . . the alleged controlled
substance or substances.” Further, they were instructed
to convict only if they found that the defendants “knew
the unlawful purpose of the plan and willfully joined
it.” The instructions told the jury that a person acts
with willfulness only when they act “voluntarily and
purposefully . . . to do something the law forbids.” Had
the jury in this case concluded that Dr. Ruan or Dr.
Couch believed their actions to be for a legitimate medical
purpose they could not have found the defendants made
an “unlawful plan” and “knew” its “unlawful purpose,”
nor could they have concluded they “willfully” joined that
plan. The jury was properly instructed on these counts,
and considering all the evidence, voted to convict. So the
instructions for the drug conspiracy charges were not
12a
Appendix A
erroneous, and any error in the substantive drug charges
was harmless to these convictions.
2.
Next, the inadequate instruction does not affect the
defendants’ convictions for conspiracy to commit health
care fraud in violation of 18 U.S.C. §§1347 and 1349. A
health care fraud conspiracy is fundamentally about the
submission of false medical claims to health care benefit
programs. United States v. Gonzalez, 834 F.3d 1206, 1214
(11th Cir. 2016). Here, the government proceeded on four
distinct factual theories, that the defendants conspired to:
(1) falsely certify that some patients had cancer when they
did not; (2) bill office visits with nurse practitioners as if
Dr. Couch conducted them; (3) bill insurers for medically
unnecessary drug tests; and (4) bill insurers for office
visits that prescribed medically unnecessary drugs. See
Ruan I, 966 F.3d at 1142-44 (summarizing charges and
evaluating sufficiency of the evidence).
None of these theories is affected by the inadequate
jury instruction for the substantive drug charges. The
jury was properly instructed by the district court for the
health care fraud conspiracy charges, and the defendants
do not challenge the jury instructions for these charges.
They argue nonetheless that United States v. Ignasiak,
667 F.3d 1217 (11th Cir. 2012), requires us to consider
the substantive drug charges and the fraud counts
“together” because in that case we stated such charges
may be “inextricably intertwined.” Id. at 1235. But the
defendants overstate Ignasiak. In that case we considered
13a
Appendix A
the sufficiency of the evidence for substantive drug
convictions under § 841 and convictions for health care
fraud under 18 U.S.C. § 1347. Id. at 1219. The government’s
theory of the case for the drug charges turned on whether
the prescriptions were legitimate, and submitting the
illegitimate prescriptions was the fraud perpetrated on
the health care benefit programs. Id. at 1227. Thus, in the
context of a sufficiency of the evidence challenge, both
sets of charges rose and fell together. Had the defendant
in that case shown the evidence was insufficient for the
jury to find the prescriptions were illegitimate, then both
the substantive drug charges and the fraud counts would
fall. This is all Ignasiak was saying; it was not announcing
any broader principle about how the two types of charges
relate to one another.
Here, whether or not the defendants had subjective
knowledge that their prescriptions were outside the “usual
course” is irrelevant to whether or not the defendants also
(1) falsely certified that patients had cancer; (2) falsely
billed for office visits when the doctor was not present;
(3) falsely billed insurers for unnecessary medical tests;
or (4) falsely billed insurers for office visits to prescribe
unnecessary drugs. Thus, the inadequate jury instruction
was harmless as to the health care fraud conspiracy
convictions.
3.
Nor are the defendants’ convictions under Count 17
for conspiring to violate the Anti-Kickback Statute, 18
U.S.C. § 371 and 42 U.S.C. § 1320a-7b, affected by the
14a
Appendix A
inadequate instruction. The defendants were convicted of
willfully receiving compensation from the pharmaceutical
company InSys in exchange for increased prescriptions
of InSys branded fentanyl. By doing so the jury found
that the defendants willfully received compensation
from the pharmaceutical company InSys in exchange for
increased prescriptions of fentanyl. Like the health care
fraud charges, the jury was properly instructed on this
count. For the reasons previously stated for the health
care fraud conspiracy charges, the inadequate instruction
is equally irrelevant to the defendants’ conviction under
the Anti-Kickback Statute.
4.
The defendants were convicted of two counts of
conspiracy to commit mail or wire fraud, in violation
of 18 U.S.C. §§ 1341, 1343, and 1349. Three different
theories were used to convict the defendants, none of
which is affected by the inadequate instruction. Two
theories overlapped with the health care fraud conspiracy
charges: (1) falsely billing insurers for visits with a nurse
practitioner at the higher rate for a visit with a doctor;
and (2) falsely certifying that patients had cancer to
justify prescribing expensive drugs. These theories are
unaffected by the jury instructions for the same reasons
stated previously. Unique to this count, the government’s
third theory alleged that the defendants selected more
expensive drugs to stock in their workers’ compensation
dispensary and made decisions about which drug to
prescribe based on the profit generated by the higher
reimbursement for these drugs rather than medical need.
15a
Appendix A
Again, the jury was properly instructed on this count.
The mens rea instructions for the § 841 conviction have
nothing to do with these theories.
5.
The defendants were charged with one count of
conspiring to violate the Racketeer Inf luenced and
Corrupt Organizations Act (RICO). 18 U.S.C. § 1962(d).
RICO requires the government to prove a “pattern
of racketeering activity” which generally means the
commission of two or more predicate offenses. 18 U.S.C.
§ 1962(a); id. § 1961(1), (5). In this case, the government
identified 21 U.S.C. § 841 (substantive drug charges);
21 U.S.C. § 846 (conspiracy drug charges); 18 U.S.C.
§ 1341 (mail fraud); and 18 U.S.C. § 1343 (wire fraud) as
the predicate offenses. To prove a RICO conspiracy, the
government need only prove that the defendants agreed
to participate in the enterprise and that there was an
agreement to preform the predicate offenses. United
States v. Pepe, 747 F.2d 632, 660 n.44 (11th Cir. 1984).
There is no requirement that the predicate offenses even
occur, just that the defendants agreed to commit them.
As an initial matter, we have already held that the
inadequate instruction for the substantive drug charges
did not affect the defendants’ convictions for conspiracy to
violate the Controlled Substances Act and conspiracy to
commit mail or wire fraud. To the extent the jury relied
on these charges, the inadequate instruction was harmless
to the RICO conspiracy conviction. But even had the jury
been relying entirely on the substantive drug charges as
16a
Appendix A
the predicates for the RICO conspiracy, the inadequate
instruction is still harmless. Similar to the § 846 charges,
in order to convict the defendants for RICO conspiracy,
the jury was instructed it had to find “the Defendant[s]
had the specific intent either to personally participate in
committing . . . or else to participate in the enterprise’s
affairs, knowing that other members of the conspiracy
would commit” the predicate offenses. Thus, if the jury
relied entirely on the § 841 charges, they would still have
made a finding that the defendants intended to violate
§ 841, which means that the defendants would have to
have known their acts were unauthorized. For these
reasons we hold the inadequate jury instruction for the
substantive drug charges was harmless to the RICO
conspiracy conviction.
6.
Finally, turning to Dr. Ruan’s money laundering
convictions, these were also unaffected by the inadequate
instruction. He was convicted of two counts of substantive
money laundering offenses in violation of 18 U.S.C.
§ 1957(a) and one count of conspiracy to commit money
laundering in violation of 18 U.S.C. § 1956(h).
Subst a ntive money launder i ng under § 19 57
criminalizes the know ing execution of “monetary
transaction[s]” over $10,000 that use money “derived from
specified unlawful activity.” 18 U.S.C. § 1957(a). Here, the
government alleged that the health care conspiracies (18
U.S.C. § 1347); the Anti-Kickback Statute conspiracies
(18 U.S.C. § 371; 42 U.S.C. § 1320a-7b); and the drug
17a
Appendix A
conspiracies (21 U.S.C. § 846) were the specified unlawful
activity. As we have previously said, these convictions
were unaffected by the inadequate instruction for the
substantive drug charges. Therefore, the inadequate
instruction was harmless to the substantive money
laundering convictions under § 1957(a).
Conspiracy to commit money laundering criminalizes
those who conspire to violate either of the two money
laundering sections, 18 U.S.C. §§ 1956 and 1957. Because
we hold that the instruction was harmless to the substantive
money laundering convictions it cannot possibly affect the
money laundering conspiracy conviction.
VI.
For the reasons stated above we VACATE in part
and AFFIRM in part the defendants’ convictions. We
VACATE both of the defendants’ sentences on all counts
consistent with our ordinary practice in multi-indictment
cases. See United States v. Fowler, 749 F.3d 1010, 101718 (11th Cir. 2014) (collecting cases and noting “we have
always . . . presumed that sentences on each count of a
multi-count indictment are part of a package”). We remand
to the district court for further proceedings consistent
with the following instructions:
(1) We VACATE Dr. Ruan’s convictions under
21 U.S.C. § 841 in Counts 8, 9, 11, and 12. We
REMAND for new trial.
18a
Appendix A
(2) We VACATE Dr. Couch’s convictions under 21
U.S.C. § 841 in Counts 5, 6, 7, 13, and 14. We
REMAND for new trial.
(3) We AFFIRM the defendants’ convictions on all
remaining counts.
(4) We VACATE the defendants’ sentence for all
counts and REMAND for resentencing on the
surviving counts.
19a
AppendixAND
B
APPENDIX B — OPINION
CONCURRING
IN JUDGMENT OF THE SUPREME COURT OF
THE UNITED STATES, DATED JUNE 27, 2022
SUPREME COURT OF THE UNITED STATES
Nos. 20-1410 and 21-5261
20-1410
XIULU RUAN,
Petitioner,
v.
UNITED STATES.
ON WRIT OF CERTIORARI TO THE UNITED
STATES COURT OF APPEALS FOR THE
ELEVENTH CIRCUIT
21-5261
SHAKEEL KAHN,
Petitioner,
v.
UNITED STATES.
ON WRIT OF CERTIORARI TO THE UNITED
STATES COURT OF APPEALS FOR THE
TENTH CIRCUIT
[June 27, 2022]
20a
Appendix B
Justice Breyer delivered the opinion of the Court.
A provision of the Controlled Substances Act,
codified at 21 U. S. C. §841, makes it a federal crime,
“[e]xcept as authorized[,] . . . for any person knowingly
or intentionally . . . to manufacture, distribute, or
dispense . . . a controlled substance,” such as opioids. 84
Stat. 1260, 21 U. S. C. §841(a) (emphasis added). Registered
doctors may prescribe these substances to their patients.
But, as provided by regulation, a prescription is only
authorized when a doctor issues it “for a legitimate medical
purpose . . . acting in the usual course of his professional
practice.” 21 CFR §1306.04(a) (2021).
In each of these two consolidated cases, a doctor was
convicted under §841 for dispensing controlled substances
not “as authorized.” The question before us concerns the
state of mind that the Government must prove to convict
these doctors of violating the statute. We hold that the
statute’s “knowingly or intentionally” mens rea applies to
authorization. After a defendant produces evidence that he
or she was authorized to dispense controlled substances,
the Government must prove beyond a reasonable doubt
that the defendant knew that he or she was acting in an
unauthorized manner, or intended to do so.
I
The question we face concerns §841’s exception from
the general prohibition on dispensing controlled substances
contained in the phrase “[e]xcept as authorized.” In
particular, the question concerns the defendant’s state
21a
Appendix B
of mind. To prove that a doctor’s dispensation of drugs
via prescription falls within the statute’s prohibition and
outside the authorization exception, is it sufficient for the
Government to prove that a prescription was in fact not
authorized, or must the Government prove that the doctor
knew or intended that the prescription was unauthorized?
Petitioners Xiulu Ruan and Shakeel Kahn are both
doctors who actively practiced medicine. They both
possessed licenses permitting them to prescribe controlled
substances. The Government separately charged them
with unlawfully dispensing and distributing drugs in
violation of §841. Each proceeded to a jury trial, and each
was convicted of the charges.
At their separate trials, Ruan and Kahn argued
that their dispensation of drugs was lawful because the
drugs were dispensed pursuant to valid prescriptions. As
noted above, a regulation provides that, “to be effective,”
a prescription “must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual
course of his professional practice.” 21 CFR §1306.04(a).
We assume, as did the courts below and the parties here,
that a prescription is “authorized” and therefore lawful
if it satisfies this standard. At Ruan’s and Kahn’s trials,
the Government argued that the doctors’ prescriptions
failed to comply with this standard. The doctors argued
that their prescriptions did comply, and that, even if not,
the doctors did not knowingly deviate or intentionally
deviate from the standard.
Ruan, for example, asked for a jury instruction that
would have required the Government to prove that he
22a
Appendix B
subjectively knew that his prescriptions fell outside the
scope of his prescribing authority. The District Court,
however, rejected this request. The court instead set forth
a more objective standard, instructing the jury that a
doctor acts lawfully when he prescribes “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.” App. to Pet. for Cert.
in No. 20-410, p. 139a. The court further instructed
the jury that a doctor violates §841 when “the doctor’s
actions were either not for a legitimate medical purpose
or were outside the usual course of professional medical
practice.” Ibid. The jury convicted Ruan, and the trial
court sentenced him to over 20 years in prison and ordered
him to pay millions of dollars in restitution and forfeiture.
The Eleventh Circuit affirmed Ruan’s convictions.
See 966 F. 3d 1101, 1120, 1166-1167 (2020). The appeals
court held that a doctor’s “subjectiv[e] belie[f] that he
is meeting a patient’s medical needs by prescribing a
controlled substance” is not a “complete defense” to a
§841 prosecution. Id., at 1167. Rather, the court said,
“‘[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
1166 (quoting United States v. Joseph, 709 F. 3d 1082,
1097 (CA11 2013); emphasis added; alteration in original).
Kahn’s trial contained similar disagreements over
the proper mens rea instructions. Ultimately, the District
Court instructed the jury that it should not convict if it
found that Kahn acted in “good faith,” defined as “an
23a
Appendix B
attempt to act in accordance with what a reasonable
physician should believe to be proper medical practice.”
App. 486. The court added that to find “good faith,” the
jury must conclude that Kahn “acted in an honest effort
to prescribe for patients’ medical conditions in accordance
with generally recognized and accepted standards of
practice.” Ibid. The court also told the jury that “good
faith” was a “complete defense” because it “would be
inconsistent with knowingly and intentionally distributing
and/or dispensing controlled substances outside the usual
course of professional practice and without a legitimate
medical purpose.” Ibid. The jury convicted Kahn of the
§841 charges, and he was sentenced to 25 years in prison.
The Tenth Circuit affirmed Kahn’s convictions.
See 989 F. 3d 806, 812, 824-826 (2021). In doing so, the
court held that to convict under §841, the Government
must prove that a doctor “either: (1) subjectively knew
a prescription was issued not for a legitimate medical
purpose; or (2) issued a prescription that was objectively
not in the usual course of professional practice.” Id., at 825.
Both Ruan and Kahn filed petitions for certiorari.
We granted the petitions and consolidated the cases to
consider what mens rea applies to §841’s authorization
exception.
II
A s we h ave s a id , §8 41 m a ke s it u n l aw f u l ,
“[e]xcept as authorized[,] . . . for any person knowingly
or intentionally . . . to manufacture, distribute, or
24a
Appendix B
dispense . . . a controlled substance.” We now hold that
§841’s “knowingly or intentionally” mens rea applies to
the “except as authorized” clause. This means 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. Our conclusion rests upon several considerations.
A
First, as a general matter, our criminal law seeks to
punish the “‘vicious will.’” Morissette v. United States,
342 U. S. 246, 251, 72 S. Ct. 240, 96 L. Ed. 288 (1952); see
also id., at 250, n. 4, 72 S. Ct. 240, 96 L. Ed. 288 (quoting
F. Sayre, Cases on Criminal Law, p. xxxvi (R. Pound
ed. 1927)). With few exceptions, “‘wrongdoing must be
conscious to be criminal.’” Elonis v. United States, 575
U. S. 723, 734, 135 S. Ct. 2001, 192 L. Ed. 2d 1 (2015)
(quoting Morissette, 342 U. S., at 252, 72 S. Ct. 240, 96
L. Ed. 288). Indeed, we have said that consciousness of
wrongdoing is a principle “as universal and persistent in
mature systems of [criminal] law as belief in freedom of
the human will and a consequent ability and duty of the
normal individual to choose between good and evil.” Id.,
at 250, 72 S. Ct. 240, 96 L. Ed. 288.
Consequently, when we interpret criminal statutes,
we normally “start from a longstanding presumption,
traceable to the common law, that Congress intends to
require a defendant to possess a culpable mental state.”
Rehaif v. United States, 588 U. S.
,
, 139 S. Ct.
25a
Appendix B
2191, 2195, 204 L. Ed. 2d 594 (2019). We have referred
to this culpable mental state as “scienter,” which means
the degree of knowledge necessary to make a person
criminally responsible for his or her acts. See ibid.; Black’s
Law Dictionary 1613 (11th ed. 2019); Morissette, 342 U.
S., at 250-252, 72 S. Ct. 240, 96 L. Ed. 288.
Applying the presumption of scienter, we have read
into criminal statutes that are “silent on the required
mental state”—meaning statutes that contain no mens rea
provision whatsoever—“‘that mens rea which is necessary
to separate wrongful conduct from “otherwise innocent
conduct.”’” Elonis, 575 U. S., at 736, 135 S. Ct. 2001, 192
L. Ed. 2d 1 (quoting Carter v. United States, 530 U. S. 255,
269, 120 S. Ct. 2159, 147 L. Ed. 2d 203 (2000); emphasis
added). Unsurprisingly, given the meaning of scienter, the
mens rea we have read into such statutes is often that of
knowledge or intent. See, e.g., Staples v. United States, 511
U. S. 600, 619, 114 S. Ct. 1793, 128 L. Ed. 2d 608 (1994);
United States v. United States Gypsum Co., 438 U. S. 422,
444-446, 98 S. Ct. 2864, 57 L. Ed. 2d 854 (1978).
And when a statute is not silent as to mens rea but
instead “includes a general scienter provision,” “the
presumption applies with equal or greater force” to the
scope of that provision. Rehaif, 588 U. S., at
, 139 S.
Ct. 2191, 2195, 204 L. Ed. 2d 594 (emphasis added). We
have accordingly held that a word such as “knowingly”
modifies not only the words directly following it, but also
those other statutory terms that “separate wrongful from
innocent acts.” Id., at
, 139 S. Ct. 2191, 2197, 204 L.
Ed. 2d 594; see, e.g., ibid.; United States v. X-Citement
26a
Appendix B
Video, Inc., 513 U. S. 64, 72, 115 S. Ct. 464, 130 L. Ed. 2d
372 (1994); Liparota v. United States, 471 U. S. 419, 426,
105 S. Ct. 2084, 85 L. Ed. 2d 434 (1985).
Section 841 contains a general scienter provision—
“knowingly or intentionally.” And in §841 prosecutions, a
lack of authorization is often what separates wrongfulness
from innocence. Defendants who produce evidence that
they are “authorized” to dispense controlled substances
are often doctors dispensing drugs via prescription. We
normally would not view such dispensations as inherently
illegitimate; we expect, and indeed usually want, doctors
to prescribe the medications that their patients need. In
§841 prosecutions, then, it is the fact that the doctor issued
an unauthorized prescription that renders his or her
conduct wrongful, not the fact of the dispensation itself.
In other words, authorization plays a “crucial” role in
separating innocent conduct—and, in the case of doctors,
socially beneficial conduct—from wrongful conduct.
X-Citement Video, 513 U. S., at 73, 115 S. Ct. 464, 130 L.
Ed. 2d 372. Applying §841’s “knowingly or intentionally”
mens rea to the authorization clause thus “helps advance
the purpose of scienter, for it helps to separate wrongful
from innocent acts.” Rehaif, 588 U. S., at
, 139 S. Ct.
2191, 2197, 204 L. Ed. 2d 594; see also X-Citement Video,
513 U. S., at 72-73, 115 S. Ct. 464, 130 L. Ed. 2d 372.
In addition, the regulatory language defining an
authorized prescription is, we have said, “ambiguous,”
written in “generalit[ies], susceptible to more precise
definition and open to varying constructions.” Gonzales
v. Oregon, 546 U. S. 243, 258, 126 S. Ct. 904, 163 L. Ed.
27a
Appendix B
2d 748 (2006); see id., at 257, 126 S. Ct. 904, 163 L. Ed.
2d 748 (regulation “gives little or no instruction on”
major questions); see also 21 CFR §1306.04(a) (regulation
defining “effective” prescription as one “issued for a
legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice”).
The conduct prohibited by such language (issuing invalid
prescriptions) is thus “often difficult to distinguish
from the gray zone of socially acceptable . . . conduct”
(issuing valid prescriptions). United States Gypsum,
438 U. S., at 441, 98 S. Ct. 2864, 57 L. Ed. 2d 854. A
strong scienter requirement helps to diminish the risk of
“overdeterrence,” i.e., punishing acceptable and beneficial
conduct that lies close to, but on the permissible side of,
the criminal line. Ibid.
The statutory provisions at issue here are also not the
kind that we have held fall outside the scope of ordinary
scienter requirements. Section 841 does not define a
regulatory or public welfare offense that carries only
minor penalties. Cf. Rehaif, 588 U. S., at
, 139 S. Ct.
2191, 2197, 204 L. Ed. 2d 594 (slip op., at 6); Staples, 511
U. S., at 606, 114 S. Ct. 1793, 128 L. Ed. 2d 608. Rather,
§841 imposes severe penalties upon those who violate it,
including life imprisonment and fines up to $1 million. See
§841(b)(1)(C); see generally §841(b). Such severe penalties
counsel in favor of a strong scienter requirement. See
Staples, 511 U. S., at 618-619, 114 S. Ct. 1793, 128 L. Ed.
2d 608 (noting that “a severe penalty is a further factor
tending to suggest that . . . the usual presumption that
a defendant must know the facts that make his conduct
illegal should apply”); United States Gypsum, 438 U. S.,
at 442, n. 18, 98 S. Ct. 2864, 57 L. Ed. 2d 854.
28a
Appendix B
Nor is the “except as authorized” clause a jurisdictional
provision, to which the presumption of scienter would not
apply. Cf. Rehaif, 588 U. S., at
, 139 S. Ct. 2191, 2197,
204 L. Ed. 2d 594 (slip op., at 4); United States v. Yermian,
468 U. S. 63, 68-69, 104 S. Ct. 2936, 82 L. Ed. 2d 53
(1984). To the contrary, and as we have explained, a lack
of authorization is often the critical thing distinguishing
wrongful from proper conduct.
B
Analogous precedent reinforces our conclusion. In
Liparota, we interpreted a statute penalizing anyone
who “‘knowingly uses [food stamps] in any manner not
authorized by’” statute. 471 U. S., at 420, 105 S. Ct. 2084,
85 L. Ed. 2d 434. We held that “knowingly” modified both
the “use” of food stamps element and the element that
the use be “not authorized.” Id., at 423, 433, 105 S. Ct.
2084, 85 L. Ed. 2d 434. We applied “knowingly” to the
authorization language even though Congress had not
“explicitly and unambiguously” indicated that it should so
apply. Id., at 426, 105 S. Ct. 2084, 85 L. Ed. 2d 434. But
if knowingly did not modify the fact of nonauthorization,
we explained, the statute “would . . . criminalize a broad
range of apparently innocent conduct.” Ibid.
Similarly, in X-Citement Video, we interpreted a
statute penalizing anyone who “‘knowingly transports’”
or “‘knowingly receives’” videos “‘involv[ing] the use of
a minor engaging in sexually explicit conduct.’” 513 U.
S., at 68, 115 S. Ct. 464, 130 L. Ed. 2d 372. We held that
“knowingly” applied not only to the element of transporting
29a
Appendix B
or receiving videos but also to the elemental fact that the
videos involve “the use of a minor.” Id., at 66, 115 S. Ct.
464, 130 L. Ed. 2d 372. We recognized that this was not
“the most grammatical reading of the statute.” Id., at 70,
115 S. Ct. 464, 130 L. Ed. 2d 372. But, we explained, “the
age of the performers is the crucial element separating
legal innocence from wrongful conduct,” for possessing
sexually explicit videos involving nonminors is protected
First Amendment activity. Id., at 72-73, 115 S. Ct. 464,
130 L. Ed. 2d 372.
Finally, in Rehaif, we interpreted a statutory scheme
in which one statutory subsection provided penalties for
anyone who “knowingly violates” a separate subsection.
588 U. S., at
, 139 S. Ct. 2191, 2195-2196, 204 L.
Ed. 2d 594. This latter subsection made it “unlawful” for
people with certain statuses (i.e., being a felon or being in
the country unlawfully) to possess a gun. Ibid. We held
that the first subsection’s “knowingly” language applied
to the status element in the second subsection. Id., at
,
139 S. Ct. 2191, 204 L. Ed. 2d 594 (slip op., at 5). To convict
under the statute, then, the Government had to prove
that a defendant knew he had one of the listed statuses.
Ibid. “Without knowledge of that status,” we reasoned,
“the defendant may well lack the intent needed to make
his behavior wrongful,” because “[a]ssuming compliance
with ordinary licensing requirements, the possession of a
gun can be entirely innocent.” Id., at
, 139 S. Ct. 2191,
2197, 204 L. Ed. 2d 594.
Like the statutes at issue in these cases, the statute
here contains a scienter provision. Section 841 states:
30a
Appendix B
“Except as authorized by this subchapter, it shall be
unlawful for any person knowingly or intentionally . . .
to manufacture, distribute, or dispense . . . a controlled
substance.” (Emphasis added.) Like those three cases, the
question here concerns the mental state that applies to a
statutory clause (“[e]xcept as authorized”) that does not
immediately follow the scienter provision. Like the three
cases, the statutory clause in question plays a critical
role in separating a defendant’s wrongful from innocent
conduct. And, like the Court in those cases, we conclude
that the statute’s mens rea applies to that critical clause.
III
We are not convinced by the Government’s arguments
to the contrary. First, the Government correctly points
out, and the concurrence emphasizes, that the statutory
language at issue in the cases we have just described set
forth elements of the offense. Here, the Government and
the concurrence say, the “except as authorized” clause
does not set forth an element. See, e.g., post, at 4-7 (A lito,
J., concurring in judgment).
The Government and the concurrence point to two
ways in which the “except as authorized” clause is unlike
an element, both of which rely on a different provision
of the Controlled Substances Act—§885. Section 885
says that the Government need not “negative”—i.e.,
refute—“any exemption or exception . . . in any complaint,
information, indictment, or other pleading.” This means
that, in a prosecution under the Controlled Substances Act,
the Government need not refer to a lack of authorization
31a
Appendix B
(or any other exemption or exception) in the criminal
indictment. Cf. United States v. Resendiz-Ponce, 549 U. S.
102, 108, 127 S. Ct. 782, 166 L. Ed. 2d 591 (2007) (criminal
indictment must set forth all elements of the charged
crime). Section 885 also says that the Government need not
“negative any exemption or exception . . . in any trial,” and
that “the burden of going forward with the evidence with
respect to any such exemption or exception shall be upon
the person claiming its benefit,” not upon the prosecution.
Cf. Patterson v. New York, 432 U. S. 197, 210, 97 S. Ct.
2319, 53 L. Ed. 2d 281 (1977) (Government bears burden
of proving all elements of charged offense).
But even assuming that lack of authorization is unlike
an element for the two purposes that §885 sets forth, those
two purposes have little or nothing to do with scienter
requirements. The first has to do with the indictment. It
simply says that the Government need not set forth in an
indictment a lack of authorization, or otherwise allege that
a defendant does not fall within the many exceptions and
exemptions that the Controlled Substances Act contains.
The Act excepts, for example, licensed professionals
such as dentists, veterinarians, scientific investigators,
and pharmacists from the prohibition on dispensing
controlled substances. See 21 U. S. C. §802(21). The Act
also excepts employees of drug manufacturers, common
carriers, and people with sick family members or pets
from the prohibition on possessing controlled substances.
See §§802(27), 822(c). Section 885 merely absolves the
Government of having to allege, in an indictment, the
inapplicability of every statutory exception in each
Controlled Substances Act prosecution.
32a
Appendix B
Section 885’s second purpose refers only to “the
burden of going forward with the evidence,” i.e., the
burden of production. See Black’s Law Dictionary, at
244. It says nothing regarding the distinct issue of the
burden of persuasion—i.e., the burden of proving a
lack of authorization. Cf. Director, Office of Workers’
Compensation Programs v. Greenwich Collieries, 512 U.
S. 267, 274, 114 S. Ct. 2251, 129 L. Ed. 2d 221 (1994) (“our
opinions consistently distinguis[h] between burden of
proof, which we defined as burden of persuasion, and . . .
the burden of production or the burden of going forward
with the evidence”); see also Schaffer v. Weast, 546 U. S.
49, 56, 126 S. Ct. 528, 163 L. Ed. 2d 387 (2005). Section
885 can thus be understood as providing a presumptive
device, akin to others we have recognized in the criminal
context, which “merely shift[s] the burden of production
to the defendant, following the satisfaction of which the
ultimate burden of persuasion returns to the prosecution.”
County Court of Ulster Cty. v. Allen, 442 U. S. 140, 157-158,
n. 16, 99 S. Ct. 2213, 60 L. Ed. 2d 777 (1979); see Parker v.
Matthews, 567 U. S. 37, 42, n. 1, 132 S. Ct. 2148, 183 L. Ed.
2d 32 (2012) (per curiam). Contrary to the concurrence’s
assertion, see post, at 9-11, the differences between these
two burdens and the use of procedural mechanisms to
shift one burden but not the other are well established.
See, e.g., 29 Am. Jur. 2d Evidence §207, p. 246 (2019) (“due
process does not prohibit the use of a . . . procedural
device that shifts to a defendant the burden of producing
some evidence contesting a fact that may otherwise be
inferred, provided the prosecution retains the ultimate
burden of proof”); 1 W. LaFave, Substantive Criminal Law
§1.8(a), p. 102 (3d ed. 2018) (similar). In a §841 prosecution,
33a
Appendix B
then, once the defendant satisfies the initial burden of
production by producing evidence of authorization, the
burden of proving a lack of authorization shifts back to
the Government. And, as with §885’s indictment-related
purpose, §885’s burden-related purpose simply relieves
the Government from having to disprove, at the outset
of every Controlled Substances Act prosecution, every
exception in the statutory scheme.
Section 885 thus does not provide a basis for inferring
that Congress intended to do away with, or weaken,
ordinary and longstanding scienter requirements. At the
same time, the language of §841 (which explicitly includes
a “knowingly or intentionally” provision); the crucial role
authorization (or lack thereof ) plays in distinguishing
morally blameworthy conduct from socially necessary
conduct; the serious nature of the crime and its penalties;
and the vague, highly general language of the regulation
defining the bounds of prescribing authority all support
applying normal scienter principles to the “except as
authorized” clause. That statutory requirement, while
differing from an element in some respects, is sufficiently
like an element in respect to the matter at issue here as
to warrant similar legal treatment.
And the Government does not deny that, once
a defendant claims that he or she falls within the
authorization exception and the burden shifts back to
the Government, the Government must prove a lack of
authorization by satisfying the ordinary criminal law
burden of proof—beyond a reasonable doubt. See Brief
for United States 26; Tr. of Oral Arg. 50-51; see also id.,
34a
Appendix B
at 62-65. But see post, at 10-11 (concurrence suggesting,
contrary to the position advanced by all parties to these
cases, that the Government need only prove lack of
authorization by a preponderance of the evidence). Once
the defendant meets his or her burden of production, then,
the Government must prove lack of authorization beyond
a reasonable doubt.
Resisting the “knowingly or intentionally” standard,
the Government instead offers a substitute mens rea
standard. The Government says that rather than simply
apply the statute’s “knowingly or intentionally” language
to the authorization clause, we should read the statute as
implicitly containing an “objectively reasonable good-faith
effort” or “objective honest-effort standard.” Brief for
United States 16-17; cf. post, at 13 (concurrence arguing
that doctors can defend against a §841 prosecution by
proving that they have “act[ed] in subjective good faith
in prescribing drugs”). That is to say, once a defendant
meets his or her burden of production, the Government
can convict “by proving beyond a reasonable doubt
that [the defendant] did not even make an objectively
reasonable attempt to ascertain and act within the bounds
of professional medicine.” Brief for United States 16.
We are not convinced. For one thing, §841, like many
criminal statutes, uses the familiar mens rea words
“knowingly or intentionally.” It nowhere uses words such
as “good faith,” “objectively,” “reasonable,” or “honest
effort.”
For another, the Government’s standard would turn
a defendant’s criminal liability on the mental state of
35a
Appendix B
a hypothetical “reasonable” doctor, not on the mental
state of the defendant himself or herself. Cf. id., at 24
(Government arguing that “a physician can violate Section
841(a) when he makes no objectively reasonable attempt to
conform his conduct to something that his fellow doctors
would view as medical care” (emphasis added)).
We have rejected analogous suggestions in other
criminal contexts. In Elonis, for example, we considered
the mental state applicable to a statute that criminalized
threatening communications but contained no explicit
mens rea requirement. 575 U. S., at 732, 135 S. Ct.
2001, 192 L. Ed. 2d 1. The Government argued that the
statute required proof that a reasonable person would
find the communications threatening. Id., at 738-739,
135 S. Ct. 2001, 192 L. Ed. 2d 1. But, we said, “[h]aving
liability turn on whether a ‘reasonable person’ regards
the communication as a threat—regardless of what
the defendant thinks—reduces culpability on the allimportant element of the crime to negligence.” Id., at 738,
135 S. Ct. 2001, 192 L. Ed. 2d 1 (some internal quotation
marks omitted). “[A]nd,” we emphasized, “we ‘have long
been reluctant to infer that a negligence standard was
intended in criminal statutes.’” Ibid. (quoting Rogers v.
United States, 422 U. S. 35, 47, 95 S. Ct. 2091, 45 L. Ed. 2d
1 (1975) (Marshall, J., concurring)). We believe the same
of the Government’s proposed standard here.
The Government asserts that we held to the contrary,
and “effectively endorsed” its honest-effort standard, in
United States v. Moore, 423 U. S. 122, 96 S. Ct. 335, 46
L. Ed. 2d 333 (1975). Brief for United States 26. But the
36a
Appendix B
question in Moore was whether doctors could ever be held
criminally liable under §841. 423 U. S., at 124, 96 S. Ct.
335, 46 L. Ed. 2d 333. Moore did not directly address the
issue before us here regarding the mens rea required to
convict under the statute.
Further, the Government, citing Yermian, notes
that the authorization clause precedes the words
“knowingly or intentionally.” And, the Government
argues, grammatically speaking, that fact prevents the
latter mens rea provision from modifying the former
clause. See Brief for United States 24-25. But Yermian
based its holding on the fact that the clause preceding
the mens rea provision set forth a jurisdictional criteria,
which is typically not subject to a scienter requirement.
468 U. S., at 68-69, 104 S. Ct. 2936, 82 L. Ed. 2d 53; see
also Rehaif, 588 U. S., at
, 139 S. Ct. 2191, 204 L. Ed.
2d 594 (slip op., at 4). Yermian did not base its holding on
the grammatical positioning of the statutory language.
Finally, the Government argues that requiring it to
prove that a doctor knowingly or intentionally acted not as
authorized will allow bad-apple doctors to escape liability
by claiming idiosyncratic views about their prescribing
authority. See, e.g., Brief for United States 33. This kind of
argument, however, can be made in many cases imposing
scienter requirements, and we have often rejected it on
bases similar to those we have set forth in Part II of this
opinion. See, e.g., Rehaif, 588 U. S., at
, 139 S. Ct. 2191,
204 L. Ed. 2d 594 (slip op., at 8); Liparota, 471 U. S., at
433-434, 105 S. Ct. 2084, 85 L. Ed. 2d 434.
37a
Appendix B
We do the same here. The Government, of course,
can prove knowledge of a lack of authorization through
circumstantial evidence. See ibid. And the regulation
defining the scope of a doctor’s prescribing authority does
so by reference to objective criteria such as “legitimate
medical purpose” and “usual course” of “professional
practice.” 21 CFR §1306.04(a); see Gonzales, 546 U.
S., at 285, 126 S. Ct. 904, 163 L. Ed. 2d 748 (Scalia, J.,
dissenting) (“The use of the word ‘legitimate’ connotes
an objective standard of ‘medicine’”); Moore, 423 U. S.,
at 141-142, 96 S. Ct. 335, 46 L. Ed. 2d 333 (describing
Congress’ intent “to confine authorized medical practice
within accepted limits” (emphasis added)). As we have said
before, “the more unreasonable” a defendant’s “asserted
beliefs or misunderstandings are,” especially as measured
against objective criteria, “the more likely the jury . . .
will find that the Government has carried its burden of
proving knowledge.” Cheek v. United States, 498 U. S.
192, 203-204, 111 S. Ct. 604, 112 L. Ed. 2d 617 (1991). But
the Government must still carry this burden. And for
purposes of a criminal conviction under §841, this requires
proving that a defendant knew or intended that his or her
conduct was unauthorized.
IV
The Government argues that we should affirm Ruan’s
and Kahn’s convictions because the jury instructions at
their trials conveyed the requisite mens rea. Alternatively,
the Government argues that any instructional error was
harmless. But the Court of Appeals in both cases evaluated
the jury instructions under an incorrect understanding
38a
Appendix B
of §841’s scienter requirements. We decline to decide in
the first instance whether the instructions complied with
the standard we have set forth today. Cf. Rehaif, 588 U.
S., at
, 139 S. Ct. 2191, 204 L. Ed. 2d 594 (slip op., at
11). We leave that and any harmlessness questions for the
courts to address on remand.
***
We conclude that §841’s “knowingly or intentionally”
mens rea applies to the “except as authorized” clause.
This means that in a §841 prosecution in which a
defendant meets his burden of production under §885,
the Government must prove beyond a reasonable doubt
that the defendant knowingly or intentionally acted in an
unauthorized manner. We vacate the judgments of the
Courts of Appeals below and remand the cases for further
proceedings consistent with this opinion.
It is so ordered.
39a
Appendix B
Justice A lito, with whom Justice Thomas joins, and
with whom Justice Barrett joins as to Parts I-A, I-B,
and II, concurring in the judgment.
In criminal law, the distinction between the elements
of an offense and an affirmative defense is well-known and
important. In these cases, however, the Court recognizes
a new hybrid that has some characteristics of an element
and some characteristics of an affirmative defense. The
consequences of this innovation are hard to foresee, but
the result may well be confusion and disruption. That risk
is entirely unnecessary.
We granted certiorari in these cases to decide whether
a physician may be convicted of dispensing or distributing
drugs by prescription under a provision of the Controlled
Substances Act of 1970 (CSA), 21 U. S. C. §841(a), if he
or she believed in good faith that the prescription was
within the course of professional practice. In my view,
there is a straightforward answer to this question. The
CSA contains an exception for prescriptions issued in
the course of professional practice, and this exception is
a carry-over from the CSA’s predecessor, the Harrison
Narcotics Act of 1914, 38 Stat. 785. In interpreting the
Harrison Act, this Court held that a registered physician
acts “in the course of his professional practice” when the
physician writes prescriptions “in good faith.” Linder v.
United States, 268 U. S. 5, 17-18, 45 S. Ct. 446, 69 L. Ed.
819 (1925). I would hold that this rule applies under the
CSA and would therefore vacate the judgments below and
remand for further proceedings.
40a
Appendix B
The Court declines to adopt this approach and instead
takes a radical new course. It holds that the mental state
expressed by the terms “knowingly or intentionally” in
§841(a) applies to the provision’s “[e]xcept as authorized”
proviso. It bases this conclusion not on anything in the
language of the CSA, but instead on the “presumption,
traceable to the common law, that Congress intends to
require a defendant to possess a culpable mental state.”
Rehaif v. United States, 588 U. S.
,
, 139 S. Ct.
2191, 2195, 204 L. Ed. 2d 594 (2019) (slip op., at 3).
The Court’s analysis rests on an obvious conceptual
mistake. A culpable mental state — or, to use the
traditional Latin term, “mens rea”—is the mental state
an accused must have in relation to the elements of an
offense. But the authorizations in the CSA that excuse
acts that are otherwise unlawful under §841(a) are not
elements of the offenses created by that provision. They
are affirmative defenses. The presumption that elements
must be accompanied by a culpable mental state—which I
will call “the mens rea canon”—provides no guidance on
what a defendant must prove to establish an affirmative
defense. And for that reason, that canon does not help to
decide whether there is a good-faith defense in §841(a)
prosecutions of physicians.
The Court does not claim that the “[e]xcept as
authorized” proviso actually constitutes an element of
dispensing or distributing a controlled substance. But it
concludes, based on a vague four-part test, that the proviso
is “sufficiently like an element in respect to the matter
at issue here as to warrant similar treatment.” Ante, at
41a
Appendix B
12. How many other affirmative defenses might warrant
similar treatment, the Court does not say. It leaves
prosecutors, defense attorneys, and the lower courts in
the dark. I cannot accept this cavalier treatment of an
important question.
Nor can I accept the Court’s conclusion that once
a defendant produces 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.” Ante, at 5.
We did not grant certiorari on the question of the burden of
proof applicable to authorizations to dispense or distribute
controlled substances. No party has briefed this issue, and
its resolution is not essential to our decision in these cases.
In keeping with our normal practice, I would not address
this question. But because the Court volunteers its own
answer, I will offer one as well. As I see it, the text of the
CSA does not show that Congress intended to deviate
from the common-law rule that the burden of proving
“affirmative defenses—indeed, ‘all . . . circumstances
of justification, excuse or alleviation’—rest[s] on the
defendant.” Patterson v. New York, 432 U. S. 197, 202, 97 S.
Ct. 2319, 53 L. Ed. 2d 281 (1977) (quoting 4 W. Blackstone
Commentaries *201). And absolutely nothing in the text
of the statute indicates that Congress intended to impose
a burden on the Government to disprove all assertions of
authorization beyond a reasonable doubt.
42a
Appendix B
I
A
As relevant here, §841(a)(1) provides that “except as
authorized by this subchapter, it shall be unlawful for any
per-son knowingly or intentionally . . . to manufacture,
distribute, or dispense, or possess w ith intent to
manufacture, distribute, or dispense, . . . a controlled
substance.” According to the Court’s reasoning, the terms
“knowingly or intentionally” in §841(a)(1) apply to the
“except as authorized” proviso at the beginning of the
provision. But it is hard to see how this could be true.
As a matter of elementary syntax, the adverbs
“knowingly” and “intentionally” are most naturally
understood to modify the verbs that follow, i .e.,
“manufacture,” “distribute,” etc., and not the introductory
phrase “except as authorized.” That phrase, in turn,
clearly modifies the term “unlawful.”
The Court does not suggest otherwise. It does not
claim that “knowingly or “intentionally” modifies the
introductory proviso in a grammatical sense. (If it did,
the introductory phrase would clearly be an element,
and for reasons that I will explain, infra, at 5-6, 21 U. S.
C. §885 unmistakably rules that out.) Instead, the Court
pointedly uses different terminology. It repeatedly says
that the phrase “knowingly or intentionally” “applies” to
the introductory phrase, ante, at 2, 4, 6, 9, 15 (emphasis
added). And it reaches this conclusion based on grounds
that have nothing to do with grammar or syntax.
43a
Appendix B
Specifically, the Court relies on a substantive canon
of interpretation—the mens rea canon. Under this canon,
the Court interprets criminal statutes to require a mens
rea for each element of an offense “even where ‘the most
grammatical reading of the statute’ does not support”
that interpretation. Rehaif, 588 U. S., at
, 139 S. Ct.
2191, 2197, 204 L. Ed. 2d 594 (quoting United States v.
X-Citement Video, Inc., 513 U. S. 64, 70, 115 S. Ct. 464, 130
L. Ed. 2d 372 (1994)).* But until today, this canon has been
applied only to elements, and the “except as authorized”
introductory phrase in §841(a)(1) is plainly not an element.
* Why we have held that the mens rea canon allows courts
to ignore obvious textual evidence of congressional intent is not
obvious. In our constitutional system, it is Congress that has the
power to define the elements of criminal offenses, not the federal
courts. Liparota v. United States, 471 U. S. 419, 424, 105 S. Ct. 2084,
85 L. Ed. 2d 434 (1985); see also United States v. Davis, 588 U. S.
,
, 139 S. Ct. 2319, 2325, 204 L. Ed. 2d 757 (2019) (“Only the
people’s elected representatives in the legislature are authorized
to ‘make an act a crime’” (quoting United States v. Hudson, 11 U.S.
32, 7 Cranch 32, 34, 3 L. Ed. 259 (1812))). The mens rea canon is
legitimate when it is used to determine what elements Congress
intended to include in the definition of an offense. See, e.g., Staples
v. United States, 511 U. S. 600, 605, 114 S. Ct. 1793, 128 L. Ed. 2d
608 (1994) (explaining that the canon is founded on an inference
of congressional intent). But applying that canon to override the
intentions of Congress would be inconsistent with the Constitution’s
separation of powers. Federal courts have no constitutional authority
to re-write the statutes Congress has passed based on judicial
views about what constitutes “sound” or “just” criminal law. Cf.
X-Citement Video, 513 U. S., at 80-82, 115 S. Ct. 464, 130 L. Ed. 2d
372 (Scalia, J., dissenting) (criticizing our mens rea canon precedents
for “convert[ing a] rule of interpretation into a rule of law” binding
on Congress).
44a
Appendix B
“The definition of the elements of a criminal offense
is entrusted to the legislature, particularly in the case
of federal crimes, which are solely creatures of statute.”
Liparota v. United States, 471 U. S. 419, 424, 105 S. Ct.
2084, 85 L. Ed. 2d 434 (1985). See also Dixon v. United
States, 548 U. S. 1, 7, 126 S. Ct. 2437, 165 L. Ed. 2d 299
(2006). But authorization to dispense or distribute a
controlled substance lacks the most basic features of an
element of an offense. For one thing, it is black-letter
law that an indictment must allege “the elements of the
offense charged.” Hamling v. United States, 418 U. S. 87,
117, 94 S. Ct. 2887, 41 L. Ed. 2d 590 (1974). So if lack of
authorization were an element, it would be necessary to
allege that in every §841(a)(1) indictment. But §885 says
that it is not “necessary for the United States to negative
any exemption or exception set forth in [the relevant
subchapter] in any . . . indictment.” Beyond that, the
prosecution bears the burden of producing evidence with
respect to every element of a crime. Patterson, 432 U.
S., at 215, 97 S. Ct. 2319, 53 L. Ed. 2d 281. But §885(a)(1)
also provides that “the burden of going forward with the
evidence with respect to any such exemption or exception
shall be upon the person claiming its benefit.” It could
hardly be more obvious that Congress did not cast the
“except as authorized” introductory proviso as an element
of distributing or dispensing a controlled substance.
Instead, that proviso clearly creates an affirmative
defense—that is, a “justification or excuse which is a
bar to the imposition of criminal liability” on conduct
that satisfies the elements of an offense. 1 W. LaFave,
Substantive Criminal Law §1.8(c) (3d ed. 2018). Section
45a
Appendix B
841(a)(1) has two main parts: a principal clause generally
prohibiting “knowingly or intentionally” doing certain
things with respect to controlled substances (i.e.,
manufacturing them, distributing them, etc.), and a
proviso indicating that these acts are unlawful “except
as authorized” by other statutory provisions. As we have
long held, the default rule for interpreting provisions with
this structure is that “‘an exception made by a proviso or
other distinct clause’” designates an affirmative defense
that the Government has no duty to “‘negative.’” Dixon,
548 U. S., at 13, 126 S. Ct. 2437, 165 L. Ed. 2d 299 (quoting
McKelvey v. United States, 260 U. S. 353, 357, 43 S. Ct. 132,
67 L. Ed. 301 (1922)); see also United States v. Dickson,
40 U.S. 141, 15 Pet. 141, 165, 10 L. Ed. 689 (1841) (calling
this “the general rule of law which has always prevailed”).
When this rule applies, it is “‘incumbent on one who relies
on such an exception to set it up and establish it.’” Dixon,
548 U. S., at 13, 126 S. Ct. 2437, 165 L. Ed. 2d 299 (quoting
McKelvey, 260 U. S., at 357, 43 S. Ct. 132, 67 L. Ed. 301).
The CSA explicitly incorporates this default rule. As
noted, §885(a)(1) provides that the prosecution need not
“negative any exemption or exception set forth in this
subchapter in any complaint, information, indictment,
or other pleading or in any trial, hearing, or other
proceeding.” (Emphasis added.) Short of using the words
“affirmative defense,” there is no clearer way of indicating
that authorization constitutes an affirmative defense.
On the most natural reading, then, §841(a)(1) creates
an offense that has as its elements (1) knowingly or
intentionally (2) distributing or dispensing (3) a controlled
46a
Appendix B
substance. The “[e]xcept as authorized” proviso recognizes
an affirmative defense that excuses or justifies conduct
that otherwise would fall within §841(a)(1)’s general
prohibition. The mens rea canon does not speak to the
constituents of that defense.
B
While the Court does not claim that the “[e]xcept as
authorized” proviso is an element of a §841(a)(1) offense,
the Court argues that the proviso is “sufficiently like an
element in respect to the matter at issue here” for the
mens rea canon to apply, ante, at 12. The Court provides
four reasons for this conclusion: “[T]he language of §841
(which explicitly includes a ‘knowingly or intentionally’
provision); the crucial role authorization (or lack thereof)
plays in distinguishing morally blameworthy conduct
from socially necessary conduct; the serious nature
of the crime and its penalties; and the vague, highly
general language of the regulation defining the bounds
of prescribing authority.” Ibid. Not one of these reasons
withstands scrutiny.
“[T]he language of §841.” The Court notes that this
provision expressly sets out a mens rea that applies to the
elements of the offense, ante, at 13, but the vast majority
of criminal statutes share this characteristic. Therefore,
this feature does not set §841 apart.
“[T]he crucial role authorization (or lack thereof)
plays in distinguishing morally blameworthy conduct
from socially necessary conduct.” The Court claims that
47a
Appendix B
authorization separates out morally blameworthy innocent
conduct; but something very similar may be said about
most, if not all, affirmative defenses. Take the commonlaw defense of duress. Duress “excuse[s] criminal conduct
where the actor was under an unlawful threat of imminent
death or serious bodily injury” and the “threat caused the
actor to engage in conduct violating the literal terms of
the criminal law.” United States v. Bailey, 444 U. S. 394,
409, 100 S. Ct. 624, 62 L. Ed. 2d 575 (1980). But a person
who acts under duress is not “morally blameworthy”—
that is part of what it means to say that duress excuses
otherwise-criminal conduct. Similarly, individuals who kill
or wound another person in self-defense to prevent their
own death or serious injury are not considered morally
blameworthy. No one supposes that these defenses are
hybrids, or that the mens rea canon is a guide to their
content.
It is unclear why the Court thinks that §841(a)’s
affirmative defense is different. There are hints in the
Court’s opinion that it has crafted a special rule for
doctors—for example, the Court describes their conduct in
writing prescriptions as not just “innocent,” but “socially
beneficial” and “socially necessary.” Ante, at 6, 12. But
§841(a) is not a doctor-specific provision. Section 841(a)’s
proviso presumably applies in the same way for all §841(a)
defendants—whether they are drug dealers accused of
selling heroin or are physicians charged with abusing
their authority to prescribe painkillers.
“[T]he serious nature of the crime and its penalties.”
The Court also suggests that authorization is “like an
48a
Appendix B
element” because dispensing or distributing a controlled
substance is a felony that carries a substantial sentence.
But would all felonies qualify? If not, where would the
Court draw the line? The Court provides no answers.
“[T]he vague, highly general language of the
regulation defining prescribing authority.” As the Court
explains, the regulation defining the authority of physicians
to prescribe controlled substances allows them to issue
a prescription “for a legitimate medical purpose . . . in
the usual course of . . . professional practice.” 21 CFR
§1306.04(a) (2021). But §841(a) applies to many other types
of violations and many other categories of defendants. Is
the proviso a hybrid element/defense only for doctors?
Would its status change if the regulation were reframed
in more specific terms? How can the status of a phrase in
a statute depend upon an implementing regulation? The
Court provides no answer to these or any other questions
naturally raised by its ipse dixit that the exception in
§841(a) is “sufficiently like” an element to require that it
be treated as such in some respects but not others.
C
The Court also errs in holding that, if a §841(a)(1)
defendant “meets the burden of producing evidence that
his or her conduct was ‘authorized,’” the Government
has the burden to “prove beyond a reasonable doubt
that the defendant knowingly or intentionally acted
in an unauthorized manner,” ante, at 5. As noted, the
common-law rule was that the defendant had the burden
of production and persuasion on any affirmative defense.
49a
Appendix B
And the Court has held that when Congress does not
address the burden of proof in the text of a statute, “we
presume that Congress intended to preserve the commonlaw rule.” Smith v. United States, 568 U. S. 106, 112, 133
S. Ct. 714, 184 L. Ed. 2d 570 (2013); see also Dixon, 548
U. S., at 13-14, 126 S. Ct. 2437, 165 L. Ed. 2d 299.
The Court identifies one and only one reason for
deviating from this background rule—the fact that §885(a)(1)
states that “the burden of going forward with the evidence
with respect to any . . . exemption or exception shall
be upon the person claiming its benefit.” Because this
provision does not say expressly that a defendant also has
the burden of persuasion, the Court infers that Congress
meant to allocate that burden to the prosecution. That
inference is unwarranted. Section 885(a)(1) explicitly
relieves the Government of the burden of “negativ[ing]”
exceptions “in any trial.” And it is hard to see how the
Government does not have the burden to “negative”
exceptions if it must affirmatively disprove a prima facie
case of authorization any time a defendant satisfies the
initial burden of production.
But even if one credits the majority’s assumption
that the CSA partly deviates from the common-law rule
by shifting the burden of persuasion to the Government,
the majority’s further holding that the Government must
carry that burden with proof “beyond a reasonable doubt”
comes out of thin air. The usual rule is that affirmative
defenses must be proved “by a preponderance of the
evidence.” Id., at 17, 126 S. Ct. 2437, 165 L. Ed. 2d 299. But
the majority does not identify a single word in §§841(a)(1),
50a
Appendix B
885(a)(1), or any other provision of the CSA that even
suggests that the statute imposes a burden of disproving
authorization defenses beyond a reasonable doubt.
The only thing that could conceivably justify reading
a reasonable-doubt requirement into a statute that says
nothing on the subject is the principle that an ambiguous
statute must be interpreted, when possible, to avoid
unconstitutionality. See A. Scalia & B. Garner, Reading
Law: The Interpretation of Legal Texts 247-251 (2012). But
the Court does not claim that it would be unconstitutional
for Congress to require the Government to prove lack of
authorization by only a preponderance of the evidence.
Indeed, the Court does not even claim that it would be
unconstitutional to shift the burden of persuasion to the
defendant. Nor could it. Our precedents establish that
governments are “foreclosed from shifting the burden
of proof to the defendant only ‘when an affirmative
defense . . . negate[s] an element of the crime.’” Smith,
568 U. S., at 110, 133 S. Ct. 714, 184 L. Ed. 2d 570 (quoting
Martin v. Ohio, 480 U. S. 228, 237, 107 S. Ct. 1098, 94 L.
Ed. 2d 267 (1987) (Powell, J., dissenting)). And we have
held that when an affirmative defense instead justifies or
“‘excuse[s] conduct that would otherwise be punishable,’”
the “Government has no constitutional duty to overcome
the defense beyond a reasonable doubt.” 568 U. S., at 110,
133 S. Ct. 714, 184 L. Ed. 2d 570 (quoting Dixon, 548 U.
S., at 6, 126 S. Ct. 2437, 165 L. Ed. 2d 299).
The author ization defense made available to
prescribing physicians by the CSA plainly does not
negate any of the defining elements of dispensing or
51a
Appendix B
distributing a controlled substance in violation of §841(a)(1).
As a result, the Court has no basis for reading a
requirement to disprove authorization into the CSA.
And at a minimum, even if the Government must bear
the ultimate burden of persuasion once the burden of
production is satisfied, the CSA should be read to preserve
a traditional preponderance-of-the-evidence standard for
authorization defenses.
II
My analysis thus far establishes that authorization is
an affirmative defense to liability under §841(a)(1), and the
constituents of that defense cannot be identified through
brute-force application of a canon designed to identify the
elements of an offense. In my view, the contours of that
defense can be elucidated only by examining the text,
structure, and history of the provisions of the CSA that
define it. I turn to that task now.
The authorization relied on by the petitioners in
these cases permits physicians registered with the
federal Drug Enforcement Administration to prescribe
controlled substances to patients by prescription. §§822(b),
823(f), 829(a). As we have previously interpreted it,
this authorization does not allow physicians to dispense
controlled substances by prescription for any reason
they choose; instead, the authorization “is limited to the
dispensing and use of drugs ‘in the course of professional
practice or research.’” United States v. Moore, 423 U. S.
122, 141, 96 S. Ct. 335, 46 L. Ed. 2d 333 (1975) (quoting
§802(20) (1970 ed.)).
52a
Appendix B
The notion of action taken “in the course of professional
practice” is not defined in the CSA, but our precedents
hold that when Congress employs a term of art “obviously
transplanted from another legal source,” it “brings the old
soil with it.” George v. McDonough, 596 U. S.
,
,
2022 U.S. LEXIS 2944 at *11 (2022) (quoting Taggart v.
Lorenzen, 587 U. S.
,
, 139 S. Ct. 1795, 1801, 204
L. Ed. 2d 129 (2019); internal quotation marks omitted).
And the notion that a prescription is authorized if it is
issued in the course of professional practice is directly
traceable to the Harrison Act, which prohibited “any
person” from distributing or dispensing coca leaves or
opium “except in pursuance of a written order” issued by
a practitioner “in the course of his professional practice
only.” §2, 38 Stat. 786. Arguably, the phrase “in the course
of . . . professional practice” could have been read to refer
only to conduct that conforms to the standards of medical
practice as a purely objective matter. But our Harrison
Act precedents interpreted that phrase to refer to “bona
fide medical practice,” which meant that any prescription
issued “in good faith” qualified as an authorized act of
dispensing one of the drugs proscribed by the statute.
Linder, 268 U. S., at 17-18, 45 S. Ct. 446, 69 L. Ed. 819;
see also Boyd v. United States, 271 U. S. 104, 107, 46 S.
Ct. 442, 70 L. Ed. 857 (1926); Webb v. United States, 249
U. S. 96, 99, 39 S. Ct. 217, 63 L. Ed. 497, 17 Ohio L. Rep.
88 (1919).
Nothing in the CSA suggests that Congress intended
to depart from the preexisting understanding of action “in
the course of professional practice.” We have previously
held that the CSA incorporates settled understandings of
53a
Appendix B
“the exemption given to doctors” to dispense controlled
substances “‘in the course of . . . professional practice’”
under the Harrison Act. Moore, 423 U. S., at 139-140, 96
S. Ct. 335, 46 L. Ed. 2d 333 (quoting 38 Stat. 786). And
the language of the CSA supports the same conclusions
that we previously reached about the Harrison Act. As
our CSA precedents have explained, to act “in the course
of professional practice” is to engage in the practice of
medicine—or, as we have put it, to “act ‘as a physician.’”
Moore, 423 U. S., at 141, 96 S. Ct. 335, 46 L. Ed. 2d 333. For
a practitioner to “practice medicine,” he or she must act
for a medical purpose—which means aiming to prevent,
cure, or alleviate the symptoms of a disease or injury—and
must believe that the treatment is a medically legitimate
means of treating the relevant disease or injury.
But acting “as a physician” does not invariably mean
acting as a good physician, as an objective understanding
of the “in the course of professional practice” standard
would suggest. A doctor who makes negligent or even
reckless mistakes in prescribing drugs is still “acting as
a doctor”—he or she is simply acting as a bad doctor. The
same cannot be said, however, when a doctor knowingly or
purposefully issues a prescription to facilitate “addiction
and recreational abuse,” Gonzales v. Oregon, 546 U. S. 243,
274, 126 S. Ct. 904, 163 L. Ed. 2d 748 (2006). Objectives of
that kind are alien to medical practice, and a doctor who
prescribes drugs for those purposes is not “acting as a
physician” in any meaningful sense.
I would thus hold that a doctor who acts in subjective
good faith in prescribing drugs is entitled to invoke
54a
Appendix B
the CSA’s authorization defense. Under the correct
understanding of that defense, a doctor acts “in the
course of professional practice” in issuing a prescription
under the CSA if—but only if—he or she believes in good
faith that the prescription is a valid means of pursuing
a medical purpose. A doctor who knows that he or she
is acting for a purpose foreign to medicine—such as
facilitating addiction or recreational drug abuse—is
not protected by the CSA’s authorization to distribute
controlled substances by prescription. Such doctors may
be convicted of unlawfully distributing or dispensing a
controlled substance under §841(a)(1).
Based on this holding, I would vacate the judgments of
the Courts of Appeals below. And like the Court, I would
leave it to those courts to determine on remand whether
the instructions provided in petitioners’ respective trials
adequately described the good-faith defense and whether
any errors in the instructions were harmless.
55a
Appendix
C
APPENDIX C — ORDER
DENYING
REHEARING
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT,
FILED MARCH 2, 2023
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
No. 17-12653-DD
UNITED STATES OF AMERICA,
Plaintiff-Appellee,
versus
XIULU RUAN, JOHN PATRICK COUCH,
Defendants-Appellants.
Appeal from the United States District Court
for the Southern District of Alabama
ON PETITION(S) FOR REHEARING AND
PETITION(S) FOR REHEARING EN BANC
BEFORE: WILSON, NEWSOM, Circuit Judges, and
COOGLER,* Chief District Judge.
* Honorable L. Scott Coogler, United States Chief District
Judge for the Northern District of Alabama, sitting by designation.
56a
Appendix C
PER CURIAM:
The Petitions for Rehearing En Banc are DENIED,
no judge in regular active service on the Court having
requested that the Court be polled on rehearing en banc.
(FRAP 35) The Petitions for Panel Rehearing are also
denied. (FRAP 40)
57a
Appendix
D
APPENDIX D — ORDER
DENYING
REHEARING
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT,
FILED NOVEMBER 4, 2020
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
No. 17-12653-DD
UNITED STATES OF AMERICA,
Plaintiff-Appellee,
v.
XIULU RUAN, JOHN PATRICK COUCH,
Defendants-Appellants.
Appeal from the United States District Court
for the Southern District of Alabama
ON PETITION(S) FOR REHEARING
AND PETITION(S) FOR REHEARING EN BANC
Before WILSON and NEWSOM, Circuit Judges, and
COOGLER,* District Judge.
* Honorable L. Scott Coogler, United States District Judge for
the Northern District of Alabama, sitting by designation.
58a
Appendix D
PER CURIAM:
The Petitions for Rehearing En Banc are DENIED,
no judge in regular active service on the Court having
requested that the Court be polled on rehearing en banc.
(FRAP 35) The Petitions for Panel Rehearing are also
denied. (FRAP 40)
59a
Appendix E EXCERPTS FROM
APPENDIX E — TRANSCRIPT
THE UNITED STATES DISTRICT COURT FOR
THE SOUTHERN DISTRICT OF ALABAMA,
DATED FEBRUARY 17, 2017
[6314]
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF ALABAMA
CASE NO. CR15-00088
COURTROOM 2B
MOBILE, ALABAMA
FRIDAY, FEBRUARY 17, 2017
UNITED STATES OF AMERICA
v.
JOHN PATRICK COUCH, M.D.,
and XIULU RUAN, M.D.,
Defendants.
DAY 28 OF TRIAL BEFORE THE HONORABLE
CALLIE V. S. GRANADE, UNITED STATES
DISTRICT JUDGE, AND JURY
***
[6331:5] Counts two, three, and four of the indictment
each allege that the defendants conspired with each other
and with others to violate the Controlled Substances Act,
Title 21, United States Code, Section 846.
60a
Appendix E
That statute makes it a separate federal crime or
offense for anyone to conspire or agree with someone else
to do something which, if actually carried out, would be a
violation of section 841(a)(1). That section makes it a crime
for anyone to knowingly or intentionally distribute or
dispense a controlled substance, unless it was prescribed
by a practitioner within the usual course of professional
practice and for a legitimate medical purpose.
Specifically, count two of the indictment charges
that beginning during or at least in 2011 and continuing
through May 20, 2015, Defendants Couch and Ruan
conspired to knowingly and unlawfully distribute and
dispense, possess with intent to distribute and dispense,
and cause to be distributed and dispensed schedule II
controlled substances, including oxycodone, oxymorphone,
hydromorphone, and morphine, by means of prescriptions
and other methods outside the usual course of professional
medical practice and not for a legitimate medical [6332]
purpose, in violation of Title 21, United States Code,
Section 841(a)(1).
Count three charges that beginning during and
at least in 2011 and continuing through May 20, 2015,
Defendants Couch and Ruan conspired to knowingly and
unlawfully distribute and dispense, possess with intent
to distribute and dispense, and cause to be distributed
and dispensed more than 40 grams of the schedule II
controlled substance fentanyl outside the usual course
of professional medical practice and not for a legitimate
medical purpose, in violation of Title 21, United States
Code, Section 841(a)(1).
61a
Appendix E
Count four charges that beginning during or at least
in 2011 and continuing through May 20, 2015, Defendants
Couch and Ruan conspired to knowingly and unlawfully
distribute and dispense, possess with intent to distribute
and dispense, and cause to be distributed and dispensed
schedule III controlled substances, including hydrocodone,
by means of prescriptions and other methods outside the
usual course of professional medical practice and not for a
legitimate medical purpose, in violation of Title 21, United
States Code, Section 841(a)(1).
Title 21, United States Code, Section 841(a)(1) makes
it a crime for a physician to knowingly or intentionally
distribute or dispense a controlled substance unless it
was done within the usual course of professional practice
and for a legitimate medical purpose. Dispense can mean
to prescribe a [6333] controlled substance. Distribute can
mean to deliver other than by dispensing a controlled
substance.
For a controlled substance to be lawfully dispensed by
a prescription, the prescription must have been issued by
a practitioner both within the usual course of professional
practice and for a legitimate medical purpose. If the
prescription was issued either, one, not for a legitimate
medical purpose or, two, outside the usual course of
professional practice, then the prescription was not
lawfully issued.
A controlled substance is prescribed by a physician in
the usual course of a professional practice and, therefore,
lawfully if the substance is prescribed by him in good faith
62a
Appendix E
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 standard of medical practice generally
recognized and accepted in the United States in treating
patients.
Thus a medical doctor has violated section 841 when
the government has proved beyond a reasonable doubt
that the doctor’s actions were either not for a legitimate
medical purpose or were outside the usual course of
professional medical practice.
[6334] A conspiracy is an agreement by two or more
persons to commit an unlawful act. In other words, it is a
kind of partnership for criminal purposes. Every member
of the conspiracy becomes the agent or partner of every
other member.
The government does not have to prove that all the
people named in the conspiracy counts were members
of the plan or that those who were members made any
kind of formal agreement. The heart of a conspiracy is
the making of the unlawful plan itself, so the government
do
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