Petition for Writ of Certiorari — Dzung Ahn Pham, Petitioner v. United States
Supreme Court briefFeb 3, 2025
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No. ___________
IN THE SUPREME COURT OF THE UNITED STATES
________________________
DZUNG AHN PHAM,
Petitioner,
V.
UNITED STATES OF AMERICA,
Respondent.
________________________
On Petition for Writ of Certiorari to the United
States Court of Appeals for the Ninth Circuit
________________________
PETITION FOR WRIT OF CERTIORARI
________________________
Beau B. Brindley
COUNSEL OF RECORD
For Petitioner Dzung Ahn Pham
Law Offices of Beau B. Brindley
53 W Jackson Blvd. Ste 1410
Chicago IL 60604
(312)765-8878
bbbrindley@gmail.com
QUESTIONS PRESENTED
I.
Is authorization under the Controlled Substances Act defined in terms of
the regulatory definition of an effective prescription or by the plain meaning
of the statutory text?
II.
Does the mens rea required under 21 U.S.C. § 841(a) and this Court’s
opinion in Ruan attach to the fact of non-authorization or to the regulatory
standard for an effective prescription contained in 21 C.F.R. § 1306.04?
LIST OF PARTIES TO THE PROCEEDINGS
Petitioner, defendant-appellant below, Dzung Ahn Pham.
Respondent is the United States of America, appellee below.
RELATED PROCEEDINGS
Ninth Circuit Court of Appeals:
United States v. Pham, 120 F.4th 1368 (9th Cir. 2024).
Entered November 5, 2024.
United States District Court for the Central District of California:
United States v. Pham, No 8:19-cr-00010-JLS-1.
Judgement and conviction entered June 12, 2023.
2
TABLE OF CONTENTS
Question Presented........................................................................................................ 2
Parties to the Proceedings ............................................................................................. 2
Related Proceedings....................................................................................................... 2
Table of Contents ........................................................................................................... 3
Table of Authorities ....................................................................................................... 4
Opinions and Rulings Below ......................................................................................... 6
Jurisdiction .................................................................................................................... 6
Statement ....................................................................................................................... 6
Factual Background ...................................................................................................... 8
Reasons for Granting Review ...................................................................................... 12
Conclusion .................................................................................................................... 33
INDEX TO APPENDICES
APPENDIX A – Court of Appeals Opinion Affirming Judgment ..............................A1
APPENDIX B - District Court Judgment Order ......................................................A12
APPENDIX C - District Court Order Denying Plea Withdrawal ...........................A17
TABLE OF AUTHORITIES
3
Cases
Allison Engine Co. v. U.S. ex rel. Sanders, 553 U.S. 662 (2008) ................................ 22
Barnhart v. Sigmon Coal Co., 534 U.S. 438 (2002) .................................................... 22
Bond v. United States, 572 U.S. 844 (2014) ................................................................ 24
Fischer v. United States, 603 U.S. 480 (2024) ............................................................ 24
Gonzales v. Oregon, 546 U.S. 243 (2006) .............................................................. 23, 25
Grayned v. City of Rockford, 408 U.S. 104 (1972) ...................................................... 26
Hill v. Colorado, 530 U.S. 703 (2000) ......................................................................... 26
Hoffman Estates v. Flipside, Hoffman Estates, 455 U.S. 489 (1982) ......................... 26
Kolender v. Lawson, 461 U.S. 352 (1983) ................................................................... 27
Liparota v. United States, 471 U.S. 419 (1985) .................................................... 14, 18
United States v. Bek, 493 F.3d 790 (7th Cir. 2007) .................................................... 12
United States v. Cristobal, No. 23-6107, 2024 WL 1506750 (2d Cir. Apr. 8, 2024) .. 14
United States v. Davis, 588 U.S. 445 (2019) ......................................................... 24, 27
United States v. Feingold, 454 F.3d 1101 (9th Cir. 2006) .......................................... 12
United States v. Hudson, 7 Cranch 32, 3 L.Ed. 259 (1812) ........................................ 18
United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) ............................................. 13
United States v. Jones, 825 F. App'x 335 (6th Cir. 2020); .......................................... 13
United States v. Kahn, 17-cr-00029-ABJ, U.S. Dist. Wyoming (2017) ...................... 16
United States v. Kahn, 989 F.3d 806 (10th Cir. 2021) ............................................... 12
United States v. Kohli, 847 F.3d 483 (7th Cir. 2017) ................................................. 12
United States v. Li, 819 F. App'x 111 (3d Cir. 2020) .................................................. 13
4
United States v. Lubetsky, No. 23-10142, 2024 WL 577543 (11th Cir. Feb. 13, 2024)
................................................................................................................................... 13
United States v. Merrill, 513 F.3d 1293 (11th Cir. 2008) ........................................... 12
United States v. Moore, 423 U.S. 122 (1975) .................................................. 18, 20, 23
United States v. Nelson, 383 F.3d 1227 (10th Cir. 2004) ........................................... 12
United States v. Nichols, 784 F.3d 666 (10th Cir. 2015) ............................................ 27
United States v. Norris, 780 F.2d 1206 (5th Cir. 1986) .............................................. 12
United States v. Pham, 120 F.4th 1368 (9th Cir. 2024) ............................................. 17
United States v. Ruan, 966 F.3d 1101 (11th Cir. 2020) ............................................. 12
United States v. Sabean, 885 F.3d 27 (1st Cir. 2018) ................................................. 13
United States v. Smith, 573 F.3d 639 (8th Cir. 2009) .......................................... 12, 13
United States v. Titus, 78 F.4th 595 (3d Cir. 2023) .................................................... 12
United States v. Tobin, 676 F.3d 1264 (11th Cir. 2012) ............................................. 12
United States v. Vamos, 797 F.2d 1146 (2d Cir. 1986) ............................................... 12
United States v. Wexler, 522 F.3d 194 (2d Cir. 2008) ................................................. 13
W. Virginia v. Env't Prot. Agency, 597 U.S. 697 (2022) ............................................. 24
Whitman v. United States, 574 U.S. 1003 (2014) ....................................................... 27
Statutes
21 U.S.C. § 802 ............................................................................................................. 20
21 U.S.C. § 822 ............................................................................................................. 19
21 U.S.C. § 841(a) ........................................................................................................ 19
21 U.S.C.S. § 829 ......................................................................................................... 20
5
Regulations
21 CFR §1306.04 .......................................................................................................... 11
OPINIONS AND RULINGS BELOW
United States v. Pham, 120 F.4th 1368 (9th Cir. 2024)
JURISDICTION
This is a federal criminal case involving an appeal from a final judgment
entered in the Central District of California. The Ninth Circuit of Appeals entered
judgement on November 5, 2024. This Court's jurisdiction is invoked under 28
U.S.C. § 1254(1).
STATEMENT
This case involves an attempt to withdraw a guilty plea based on this Court’s
holding in Ruan v. United States, 597 U.S. 450 (2022). In Ruan, this Court held that
21 U.S.C. § 841’s “‘knowingly or intentionally’ mens rea applies to authorization.”
Ruan v. United States, 597 U.S. 450, 454 (2022). “[F]or purposes of a criminal
6
conviction under § 841, this requires proving that a defendant knew or intended that
his or her conduct was unauthorized.” Id. at 467.
Petitioner was indicted on one count of conspiring to violate the controlled
substances act, under 21 U.S.C. § 846, as well as twenty counts alleging substantive
violations of 21 U.S.C. § 841. Each count stemmed from allegations that Petitioner, a
licensed medical professional registered with the DEA at all times pertinent to the
indictment, issued prescriptions for no legitimate medical purpose and outside the
usual course of professional practice.
Petitioner pleaded guilty to the conspiracy count several months after Ruan
was decided. Petitioner’s counsel at the time, however, did not advise him that, under
Ruan, the government would be required to prove that he knew or intended that his
conduct was unauthorized. Instead, he was told that a medical practitioner’s guilt
under §841 was governed by the standard defining an effective prescription contained
in 21 C.F.R. § 1306.04. Prior to sentencing, Petitioner sought to withdraw his guilty
plea, claiming that it was involuntary because he was not adequately informed of the
nature of the charges to which he pled guilty. The district court denied Petitioner’s
request to withdraw his guilty plea, and the Ninth Circuit affirmed the district court’s
denial.
Since this Court’s decision in Ruan, a circuit split has developed as to the
correct mens rea under § 841. The Tenth Circuit, on remand from one of the
companion cases in Ruan, construed the Ruan opinion as requiring the government
to prove a defendant’s subjective knowledge or intent as it pertains to the fact of non-
7
authorization. Other circuits have continued to rely on the regulatory language to
define authorization and the statute’s mens rea. Even among these circuits, however,
there remain substantial variations in how they apply the statute. This Court’s
review is necessary to resolve the split.
FACTUAL BACKGROUND
Petitioner Dzung Ahn Pham was charged with twenty substantive counts of
distributing specific prescriptions outside the usual course of professional practice
and without a legitimate medical purpose and one count of conspiring to issue
prescriptions outside the usual course of professional practice and without a
legitimate medical purpose. R.43 1-21.
At all times relevant to the indictment, Petitioner was a physician authorized
to practice medicine in the state of California and maintained an active DEA
registration. On October 7, 2022, Petitioner entered a plea of guilty to Count 1 of the
First Superseding Indictment.
R.91.
Petitioner’s plea agreement described the
nature of the offense as follows:
Defendant understands that for defendant to be guilty of the crime
charged in count one, that is, conspiracy to distribute controlled
substances, in violation of Title 21, United States Code, Section 846, the
following must be true: (1) beginning on a date unknown and continuing
to on or about December 17, 2018, there was an agreement between two
or more persons to distribute controlled substances, including
oxycodone, hydrocodone, and amphetamine salts, in violation of Title 21,
United States Code, Sections 841(a)(1), (b)(1)(C); (2) the distribution of
the controlled substances were outside the usual course of professional
practice and without a legitimate medical purpose; and (3) defendant
joined in the agreement knowing of its purpose and intending to help
accomplish that purpose. Defendant admits that defendant is, in fact,
8
guilty of this offense as described in count one of the first superseding
indictment.
R.78 at 3. The elements read at the Rule 11 Plea colloquy mirrored those contained
in the plea agreement. The Factual Basis of the plea agreement contained the
following facts
Defendant admits that defendant is, in fact, guilty of the offense to
which defendant is agreeing to plead guilty. Defendant and the USAO
agree to the statement of facts provided below and agree that this
statement of facts is sufficient to support a plea of guilty to the charge
described in this agreement and to establish the Sentencing Guidelines
factors set forth in paragraph 12 below but is not meant to be a complete
recitation of all facts relevant to the underlying criminal conduct or all
facts known to either party that relate to that conduct. Defendant
DZUNG AHN PHAM, a physician licensed to practice medicine in the
State of California, operated a medical office in Irvine, California. Codefendant Jennifer NGUYEN, a pharmacist licensed to practice in the
State of California, operated Bristol Pharmacy in Irvine, California.
Beginning on a date unknown, and continuing to at least on or about
December 17, 2018, in Orange County, within the Central District of
California, and elsewhere, Defendant and co-defendant NGUYEN
conspired with each other to knowingly and intentionally distribute
Schedule II narcotic drug controlled substances, including oxycodone,
hydrocodone, and amphetamine salts, while acting and intending to act
outside the usual course of professional practice and without a
legitimate medical purpose. Defendant issued prescriptions for
oxycodone, hydrocodone, amphetamine salts, and other controlled
substances in exchange for cash and insurance payments, knowing that
the prescriptions were issued outside the usual course of professional
medical practice and without a legitimate medical purpose. As
defendant knew many pharmacies would not fill his prescriptions, he
would direct his patients to codefendant NGUYEN and Bristol
Pharmacy to fill the prescriptions.
On or about November 6, 2017, November 20, 2017, November 29, 2017,
and December 4, 2017, defendant wrote prescriptions to S.C., a patient
defendant knew was an addict, for 240, 84, 180, and 200 pills of 30mg
oxycodone, respectively. On or about August 4, 2018, and August 27,
2018, defendant wrote prescriptions in the name of R.C. for 30 and 45
9
pills of 30mg oxycodone, respectively, even though R.C., the spouse of
S.C., was never a patient of defendant, never saw defendant for any
medical appointment, and was not aware that defendant was issuing
the prescription in her name for S.C.
As part of the conspiracy, defendant wrote prescriptions for Schedule II
narcotic drug controlled substances to the following individuals outside
the usual course of professional medical practice and without a
legitimate medical purpose: B.T.; S.S.; A.B.; S.F.; J.B.; E.G.; S.C.; R.C.;
A.K.; E.S.; C.C.; D.B.; R.V.; S.H.; D.P.; D.C.; J.D.; and G.P.
Between January 1, 2013 and December 17, 2018, defendant wrote
prescriptions for a total of approximately 53,693 pills of oxycodone,
approximately 68,795 pills of hydrocodone, and approximately 29,286
pills of amphetamine salts. The prescriptions were filled using the
patient names B.T.; S.S.; A.B.; S.F.; J.B.; E.G.; S.C.; R.C.; A.K.; E.S.;
C.C.; D.B.; R.V.; S.H.; D.P.; D.C.; J.D.; and G.P. In issuing these
prescriptions, defendant acted with intent to distribute the drugs and
with intent to distribute them outside the course of professional practice
and without a legitimate medical purpose.
As a licensed physician, defendant abused his position of trust in a
manner that significantly facilitated the commission of the conspiracy
charged in count one of the first superseding indictment.
Id. at 5-8. During the Rule 11 plea colloquy, the factual basis was read aloud to
Petitioner, and he agreed to it. TR.24-27. The district court accepted Petitioners
guilty plea.
Between the entry of the guilty plea and sentencing, Petitioner learned that
this Court’s opinion in Ruan applied to 21 U.S.C. § 841’s “except as authorized”
clause, and that, under Ruan, the government is required to prove that Petitioner
knew or intended that his conduct was unauthorized to sustain a conviction under
§ 841. While the charge that Petitioner plead guilty to alleged a conspiracy under §
846, the underlying offense was a violation of § 841, and thus implicated Ruan.
10
Prior to entering his guilty plea, however, Petitioner had not been advised that
the government would have to prove his knowledge or intent as it related to the fact
of authorization if he proceeded to trial. Instead, he was simply advised that the
government would have to prove that he knowingly or intentionally distributed
controlled substances other than for a medical purpose and not in the usual course of
professional practice.
After learning of the Ruan holding, Petitioner moved to withdraw his guilty
plea, arguing that it was involuntary because he did not adequately understand the
nature of the offense in light of the Ruan opinion and that the factual basis did not
establish the mens rea required under Ruan. R.123. The district court denied the
motion, as well as a motion to reconsider, holding that applying the statute’s mens
rea to the regulatory criteria in CFR § 1306.04 is sufficient to satisfy Ruan. R.145 at
4. Petitioner was sentenced to 151 months in of custody, and appealed.
Appellate Proceedings
On appeal, Petitioner argued that, under Ruan, it is insufficient for the
government to prove that a defendant knowingly or intentionally acted in a manner
that was objectively unauthorized, even if one knows the facts that could render a
prescription unauthorized. App.R.9.1 at 26. Rather, the government must prove
knowledge or intent as it relates to the fact of non-authorization. Id. at 14-15.
Petitioner asserted that the definition of authorization must be a matter of statutory
construction, rather than simply deferring to the regulatory language. Id. at 24. And
11
because the plea agreement, Rule 11 colloquy, and prior counsel failed to adequately
inform Petitioner of the elements of the offense, his plea was invalid. Id. at 26-32.
The appellate court disagreed. It held that Ruan “recognized that while § 841
itself does not in so many words define what prescriptions are ‘authorized,’ the
applicable regulation does.” Pham, 120 F.4th at 1371. The appellate court found
that “[i]n both the plea agreement and the colloquy, Pham admitted to knowingly
and intentionally committing acts that were not authorized by the CSA,” because
knowledge of the regulatory standards is sufficient under Ruan.
Id. at 1373.
According to the Ninth Circuit, Ruan does not require the government to prove
knowledge or intent as it relates to the fact of non-authorization. Id. at 1372. It
thus affirmed the district court. Id. at 1373.
REASONS FOR GRANTING REVIEW
I.
THE CIRCUITS
PRESENTED.
ARE
DIVIDED
ON
THE
QUESTION
The regulation relied upon in the court below, 21 CFR §1306.04, states that
in order for “[a] prescription for a controlled substance to be effective [it] must be
issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.” Prior to Ruan, the Circuits held that any
prescription that is not “effective” as defined by CFR § 1306.04 is not “authorized”
12
under § 841. The elements were, therefore, dependent upon the circuit’s
interpretation of the meaning of the language of the CFR.
Prior to Ruan, most of the circuits interpreted “medical purpose” and “usual
course of professional practice” to provide two different theories of guilt that could
be proven in the disjunctive. Under the circuits’ interpretation of the CFR, “medical
purpose” is a subjective question regarding whether the doctor intended the
prescription to alleviate what she believed to be a bona fide medical condition. By
contrast “usual course of professional practice” turns on a doctor’s compliance with
“medical norms” or “the standards of medical practice generally recognized
throughout the United States.” United States v. Vamos, 797 F.2d 1146, 1153 (2d Cir.
1986); United States v. Hurwitz, 459 F.3d 463, 480 (4th Cir. 2006); United States v.
Norris, 780 F.2d 1206, at 1209 (5th Cir. 1986); United States v. Smith, 573 F.3d 639,
647-48 (8th Cir. 2009); United States v. Bek, 493 F.3d 790, 798 (7th Cir. 2007);
United States v. Feingold, 454 F.3d 1101, 1011 n.3 (9th Cir. 2006); United States v.
Nelson, 383 F.3d 1227, 1233 (10th Cir. 2004); United States v. Merrill, 513 F.3d
1293, 1306 (11th Cir. 2008).
Prior to Ruan, a circuit split had developed as to the mens rea the
government must establish when it seeks to convict a defendant under the theory
that the charged prescriptions were issued outside the “usual course of professional
practice.” While all circuits agreed that “medical purpose” was a subjective
question, some circuits held that “usual course of professional practice” was an
entirely objective one. United States v. Tobin, 676 F.3d 1264 (11th Cir. 2012);
13
United States v. Kahn, 989 F.3d 806, 825 (10th Cir. 2021); United States v. Ruan,
966 F.3d 1101 (11th Cir. 2020). Others held that the government is required to
prove that the defendant knew that the charged prescription was outside the “usual
course of professional practice”. United States v. Kohli, 847 F.3d 483, 490 (7th Cir.
2017); United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006). Still others
imposed something close to a negligence standard. United States v. Sabean, 885
F.3d 27, 45 (1st Cir. 2018); United States v. Wexler, 522 F.3d 194, 206 (2d Cir. 2008);
United States v. Li, 819 F. App'x 111, 118 (3d Cir. 2020) (unpublished); United
States v. Hurwitz, 459 F.3d 463, 478, 480 (4th Cir. 2006); United States v. Jones,
825 F. App'x 335, 339 (6th Cir. 2020); United States v. Kohli, 847 F.3d 483, 490 (7th
Cir. 2017); United States v. Smith, 573 F.3d 639, 649–50 n.4 (8th Cir. 2009).
Each circuit based its ruling on a parsing of the language of CFR § 1306.04,
without reference to the plain meaning or intent of the drafters of the CSA.
In the opinion below, the Ninth Circuit held that Ruan did nothing more than
apply § 841’s mens rea to the regulatory standard articulated in § 1306.04.
The Fifth, Sixth Seventh, Ninth, and Eleventh Circuits agree. In those
circuits, CFR §1306.04 continues to define the elements of the offense. United States
v. Lamartiniere, 100 F.4th 625, 638 (5th Cir. 2024). (“As to the third element, we
acknowledged that it was ‘not expressly required by the text of § 841, but relevant
regulations [21 C.F.R. § 1306.04(a)] provide’…”); Anderson, 67 F.4th at 764; Heaton,
59 F.4th at 1240 (“As the government points out, the plain language of 21 C.F.R. §
1306.04(a) demonstrates that the jury instruction here correctly used “or” in
14
defining the elements of a § 841(a) offense.” … Thus, both requirements must be
satisfied to make a prescription authorized.”); United States v. Lubetsky, No. 2310142, 2024 WL 577543, at 1 (11th Cir. Feb. 13, 2024) (unpublished) (“Because the
government did not prove a lack of legitimate medical purpose, the argument goes,
the government did not prove the prescriptions were unauthorized. …[defendants]
first argument is squarely foreclosed by circuit precedent.”) (unpublished); see also,
United States v. Cristobal, No. 23-6107, 2024 WL 1506750, at 4 (2d Cir. Apr. 8,
2024) (upholding jury instructions that rest on the language of CFR § 1304.06
requiring that the defendant “act[] in accordance with a standard of medical
practice generally recognized and accepted in the State of New York.”); United
States v. Titus, 78 F.4th 595, 598–99 (3d Cir. 2023) (“Here, the instructions required
the jury to find that Titus had knowingly or intentionally distributed controlled
substances outside “the usual course of professional practice and not for a
legitimate medical purpose.”).
The Tenth Circuit’s interpretation of the scope and breadth of Ruan is vastly
different. The Tenth Circuit interpreted Ruan as imposing something close to
specific intent. In the Tenth Circuit, the government is required to prove “that
petitioner knew that his conduct was unauthorized or illegal.” Kahn II, 58 F.4th at
1315 (quoting Liparota, 471 U.S. at 434); id. at 1317 (jury instructions did not
require the government to prove that “[the defendant] intended to act without
authorization”). In the Tenth Circuit, “it [is not] enough that the jury accepted that
[the defendant] subjectively knew a prescription was issued not for a legitimate
15
medical purpose, and/or issued a prescription that was objectively not in the usual
course of professional practice. Both approaches run counter to Ruan.” Id. at 1320.
Following Ruan, in the Tenth Circuit the language of CFR §1306.04 does not serve
“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.” Kahn II, 58 F.4th at 1316 (quoting Ruan, 597 U.S. at 455).
In the Tenth Circuit, a defendant stepping outside of the bounds of medical practice
is a data point a jury may consider when deciding whether she knew a given
prescription to be outside of her authorization under the CSA. By contrast, under
the instructions approved of by the Fifth, Sixth, Seventh, and Eleventh circuits,
stepping outside of the “usual course of professional practice” as defined by medical
“norms” or “generally accepted standards of practice” or the “standard of care” is,
itself, the crime. Lamartiniere, 100 F.4th at 638; Anderson, 67 F.4th at 764; Heaton,
59 F.4th at 1240.
This is not a minor or technical disagreement. The Tenth Circuit denounced
as insufficient to capture the mens rea required by Ruan an elements instruction
that is materially indistinguishable from that which the Ninth Circuit upheld in the
instant case. On remand from Kahn II, the district court issued a jury instruction
defining authorization that is materially aligned with the interpretation Petitioner
argued below. 1 That instruction defined an “authorized” prescription as one issued
1 The instruction issued in defendant Kahn’s retrial following remand from the
Tenth Circuit stated in part:
16
with the aim to “prevent, cure, or alleviate the symptoms of a disease or injury.”
United States v. Kahn, 17-cr-00029-ABJ, U.S. Dist. Wyoming, Dkt. No. 1301, pp. 25
(2017). A prescription is not authorized, by contrast “when it is issued for a purpose
foreign to medicine, such as facilitating addiction, recreational abuse, or unlawful
distribution.” Id. The instruction went on to state that:
“A registered practitioner only violates 21 U.S.C. § 841(a)(1) if he
or she knowingly or intentionally issues an unauthorized prescription
and, at the time, knew the prescription was unauthorized or intended
it to be unauthorized.”
“To be authorized under the law, a controlled substances
prescription must be issued by an individual practitioner acting in the
course of professional practice. For purposes of a registered practitioner,
to act in the course of professional practice means to practice medicine.
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. Conversely, a prescription is not authorized when it is issued for
a purpose foreign to medicine, such as facilitating addiction,
recreational abuse, or unlawful distribution.
However, issuing an unauthorized prescription (that is, a
prescription not issued for a medical purpose while acting in the course
of professional practice) is not, by itself, a crime. A registered
practitioner only violates 21 U.S.C. § 841(a)(1) if he or she knowingly or
intentionally issues an unauthorized prescription and, at the time,
knew the prescription was unauthorized or intended it to be
unauthorized.”
United States v. Kahn, 17-cr-00029-ABJ, U.S. Dist. Crt. Wyoming, Dkt. No. 1301,
pp. 25-26 (2017).
17
Id. (emphasis in original). These instructions are consistent with Petitioner’s
proposed interpretation below. See R. 23 at 3-7.
Defendants in the Tenth Circuit are tried based on a radically different mens
rea (and as argued below radically different actus reus) than are defendants in the
Fifth, Sixth, Seventh, Ninth and Eleventh Circuits. Both sides of the circuit split
rest their positions on this Court’s language in Ruan. Someone is wrong.
It is difficult to see how this circuit split can resolve itself in the absence of
review from this Court. The government will not be able to appeal from acquittals
in the Tenth Circuit cases where instructions require the government to prove
specific intent. Circuits that attach the knowledge element to the two theories of
guilt under CFR §1306.04 do so in reliance on this Court’s assumption that the
scope of authorization under §841 is defined by 21 C.F.R. § 1306.04(a). See, e.g.,
Pham, 120 F.4th at 1371; Hofschulz, 105 F.4th at 929, Lamartiniere, 100 F.4th at
641; Heaton, 59 F.4th at 1240.
II.
THE NINTH CIRCUIT’S OPINION BELOW IS WRONG.
a. The Opinion Below is Based on a Fundamental Misreading of
Ruan.
The Ninth Circuit’s opinion was based on the premise that this Court, in Ruan,
“recognized that while § 841 itself does not in so many words define what
18
prescriptions are ‘authorized,’ [21 C.F.R. § 1306.04] does.” United States v. Pham, 120
F.4th 1368, 1371 (9th Cir. 2024). That understanding is incorrect both in regard to
what this Court decided in Ruan and in regard to the meaning of the regulation.
Whether the regulation does or does not define authorization was not at issue in
Ruan. Because the cases below did not challenge the regulation, the Court assumed
its applicability:
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 C.F.R. § 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.
Ruan, 597 U.S. at 455 (emphasis added). While the Court assumed the applicability
of the regulation, it continuously spoke in terms of “statutory provisions,” id. at 459,
and “the mental state that applies to a statutory clause (‘[e]xcept as authorized’) . . .
.” Id. at 461 (emphasis added). The repeated reference to the text of the statute itself
is consistent with the Court’s long-held understanding that “[t]he 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 (1985) (citing United States v. Hudson, 7 Cranch 32, 3 L.Ed. 259
(1812)).
19
Presumably, if the Court intended to depart from that paradigm of criminal
statutory construction and instead rely on the regulation to define the mens rea
required by the statutory provisions rather than the text of the statute itself, it would
have said so clearly. Indeed, the petitioner in Kahn invited the Court to adopt a
standard similar to that established in a prior Ninth Circuit case. If the Court had
accepted the invitation, it simply could have resolved the circuit split in favor of the
Ninth Circuit’s interpretation. But it did not. It took what Justice Alito’s concurrence
described as “a radical new course” and held “that the mental state expressed by the
terms ‘knowingly or intentionally’ in § 841(a) applies to the provision's ‘[e]xcept as
authorized’ proviso.” Ruan, 597 U.S. at 469 (Alito, J., concurring). Had Ruan adopted
the standard in the Ninth Circuit, there would be nothing radical or new about its
holding.
Critically, the Ninth Circuit ignored Ruan’s strong reliance on Liparota, which
interpreted a similarly worded statute to require knowledge of the fact of nonauthorization.
b. Using the Regulatory Language to Define § 841’s Mens Rea is
Inconsistent with the Text, Structure, and History of the CSA.
The Ninth Circuit’s application of § 841’s mens rea to the regulatory language
defining an effective prescription cannot be squared with the text, structure, and
history of the Controlled Substances Act. Section 841 states: “Except as authorized
by this subchapter, it shall be unlawful for any person knowingly or intentionally . .
20
. to distribute[] or dispense . . . a controlled substance . . . .” 21 U.S.C. § 841(a). Section
822(b) outlines the scope of a registrant’s authorization under the CSA:
Persons registered by the Attorney General under this subchapter to
manufacture, distribute, or dispense controlled substances or list I
chemicals are authorized to possess, manufacture, distribute, or
dispense such substances or chemicals (including any such activity in
the conduct of research) to the extent authorized by their registration
and in conformity with the other provisions of this subchapter.
21 U.S.C. § 822(b). Though this definition of authority may seem somewhat “circular,”
an examination of the text and structure of the CSA and the regulatory regime for
registration elucidates the authority conferred by registration.
Section 802(21) defines the term “practitioner” for purposes of the CSA and the
type of registration contemplated by the Act. United States v. Moore, 423 U.S. 122,
141 (1975). That provision provides:
“The term ‘practitioner’ means a physician . . . licensed, registered, or
otherwise permitted, by the United States or the jurisdiction in which
he practices . . . to distribute[ or] dispense . . . a controlled substance in
the course of professional practice or research.”
21
21 U.S.C. § 802(21). Thus, the text of the statute contemplates that the authorization
conferred by registration extends to acts taken in the course of professional practice.
Moore, 423 U.S. at 141.
The regulatory requirement that a prescription may only be written in the
usual course of professional practice is narrower than the scope of authority provided
for in the text of the CSA. Not only is the regulatory language narrower in scope than
the statute, but it is also significantly less clear than the statutory language. The
language, “usual course of professional practice” carries the implication that one can
act within the course of professional practice while simultaneously acting outside the
scope of their authority under the CSA. While it is clear that one who acts “for a
purpose foreign to medicine—such as facilitating addiction or recreational drug
abuse”—has not acted in the course of professional practice, Ruan, 142 S. Ct. at 2389
(Alito, J., concurring), neither courts nor the government have been unable to provide
clear guidance as to what distinguishes the usual course of professional practice from
the practice generally. How unusual must one’s practice be to cross the line into
criminal conduct? The regulation provides no answers.
Similarly, the text of the CSA only requires that there be a medical purpose for
the distribution or dispensation of a controlled substance. 21 U.S.C.S. § 829(c) (“No
controlled substance in schedule V which is a drug may be distributed or dispensed
other than for a medical purpose.”); cf. Moore, 423 U.S. at 137 n.13 (“The medical
purpose requirement explicit in subsection (c) could be implicit in subsections (a) and
(b).”). The regulation’s requirement that there be a legitimate medical purpose is, once
22
again, inconsistent with the text of the CSA itself. One need not strain to see the
inconsistency. Certain schedule V controlled substances are prescription drugs. 2
Hence, one could satisfy the demands of the statute by issuing a prescription for a
medical purpose. The regulation, however, imposes an undefined legitimacy
requirement, and it again injects ambiguity into the scope of a registrant-physician’s
prescribing authority.
Moreover, the most logical reading of the statute does not lead to the conclusion
that § 829’s use of the term “medical purpose” was intended to limit the scope of a
practitioner’s authority. Moore, 423 U.S. at 138 (“On its face s 829 addresses only the
form that a prescription must take. . . . [Section] 829 by its terms does not limit the
authority of a practitioner.”). But the regulatory language has led to significant
variation regarding whether there are two distinct means to secure a conviction
under § 841.
Further textual evidence makes clear, however, that the authorization
contemplated by §§ 841 and 822(b) does not contemplate regulatory restrictions on
the scope of a practitioner’s authority. Of particular note, both provisions refer back
to the statute itself, rather than indicating that authorization requires compliance
with the Attorney General’s regulations. Section 822 contains other provisions that
explicitly require one to act “in accordance with the rules and regulations
2 There is no indication in the text of the CSA that there is a higher standard
required for issuing a prescription for prescription drugs listed in schedules II-IV.
Moreover, the text of CFR § 1306.04 does not limit the regulations application to
prescriptions issued for controlled substances in any particular schedule.
23
promulgated by [the Attorney General].” § 822(a)(1), (a)(2). The inclusion of the
requirement to act in accordance with the rules and regulations in subsection (a)(1)
and (a)(2), combined with the absence of similar language in subsection (b) suggests
that Congress did not intend for a practitioner’s authorization to be dependent on
compliance with implementing regulations. See Allison Engine Co. v. U.S. ex rel.
Sanders, 553 U.S. 662, 671 (2008). “[W]hen Congress includes particular language in
one section of a statute but omits it in another section of the same Act, it is generally
presumed that Congress acts intentionally and purposely in the disparate inclusion
or exclusion.” Id. (quoting Barnhart v. Sigmon Coal Co., 534 U.S. 438, 452 (2002))
(alteration in original).
A similar rationale applies with respect to § 823(d), which expressly limits the
authority of registrant manufacturers and dispensers of schedule I and II controlled
substances and, in conjunction with § 826, permits the Attorney General to impose
limitations on such registrants’ authority. 21 U.S.C. §§ 823(d), 826. No similar
restriction is imposed on registrant practitioners, and there is no authorization for
the Attorney General to impose limitations on such registrants.
The historical context in which the CSA was passed provides further support
for the contention that the Attorney General does not have the authority to restrict
the prescribing authority of a registrant doctor beyond the restrictions imposed by
the CSA itself. In drafting the CSA, Congress sought to correct the fact that, under
the Harrison Act and its implementing regulations, “the appropriate method of the
practice of medicine” was effectively determined “through criminal prosecution of
24
physicians whose methods of prescribing narcotic drugs have not conformed to the
opinions of Federal prosecutors of what constitutes appropriate methods of
professional practice.” H.R. Rep. No. 91-1444, p. 15. Vague regulations permitted
prosecutors and narcotics authorities to target physicians who treated narcotics
addicts, leading many in the medical profession to fear accepting such persons as
patients would create an undue risk of prosecution:
The practicing physician has thus been confused as to when he may
prescribe narcotic drugs for an addict. Out of a fear of prosecution many
physicians refuse to use narcotics in the treatment of addicts except
occasionally in a withdrawal regimen lasting no longer than a few
weeks. In most instances they shun addicts as patients.
Id. (quoting Report of the President's Advisory Commission on Narcotic and Drug
Abuse, 57 (1963) (“Prettyman Report”).
Congress’s solution was to enact a provision “require[ing] the Secretary of
Health, Education, and Welfare, after consultation with the Attorney General and
national addict treatment organizations, to ‘determine the appropriate methods of
professional practice in the medical treatment of . . . narcotic addiction . . . .’” Moore,
423 U.S. at 144 (quoting Pub.L. 91-513, Title I, § 4, Oct. 27, 1970, 84 Stat. 1241
(current version at 42 U.S.C. § 290bb-2a)). That was the only area “in which Congress
set general, uniform standards of medical practice.” Gonzales v. Oregon, 546 U.S. 243,
271 (2006). The scope of a registrant’s prescribing powers is, at bottom, a medical
25
decision. The fact that Congress deliberately vested authority over medical standards
in the Secretary rather than the Attorney General indicates the CSA does not
empower the Attorney General to define the scope of a physician’s prescribing powers.
By relying on the regulatory language, the Ninth Circuit adopted an interpretation
“which is inconsistent with ‘the context from which the statute arose.’” Fischer v.
United States, 603 U.S. 480, 498 (2024) (quoting Bond v. United States, 572 U.S. 844,
860 (2014)). The Court should take this opportunity to correct the error.
c. Deferring to the Regulation to Define Authorization for §
841’s Criminal Prohibitions is Inconsistent with the
Constitutional Separation of Powers.
“Only the people's elected representatives in the legislature are authorized to
‘make an act a crime.’” United States v. Davis, 588 U.S. 445, 451 (2019) (quoting
United States v. Hudson, 7 Cranch 32, 34 (1812)). Despite this axiomatic command of
the constitutional separation of powers, prosecutions of medical professionals under
§ 841 have turned not on the meaning of the statutory text, enacted through the
process of bicameralism and presentment. Instead, each case hinges on the case-bycase interpretation of vague regulatory language enacted by unelected bureaucrats.
Unsurprisingly, this has led to variation in the application of the criminal law across
jurisdictions, variation which has withstood this Court’s opinion in Ruan.
Courts have assumed that the issuance of § 1306.04 was within the Attorney
General’s statutory under the CSA. But such assumptions are inconsistent with the
major questions doctrine. That doctrine stands for the proposition that “in certain
extraordinary cases, both separation of powers principles and a practical
26
understanding of legislative intent make [courts] reluctant to read into ambiguous
statutory text the delegation claimed to be lurking there.” W. Virginia v. Env't Prot.
Agency, 597 U.S. 697, 723 (2022). In such cases, “something more than a merely
plausible textual basis for the agency action is necessary. The agency instead must
point to ‘clear congressional authorization’ for the power it claims.” Id. (quoting Util.
Air Regulatory Grp. v. EPA, 573 U.S. 302, 324 (2014)).
Authority over the regulation of medicine, as previously discussed, was an
issue of major political and economic significance, and there is no textual basis
sufficient to support a construction under which the Attorney General has the
authority to define a registered practitioner’s prescribing authority. To the contrary,
“[t]he structure of the CSA, then, conveys unwillingness to cede medical judgments
to an executive official who lacks medical expertise.” Gonzales v. Oregon, 546 U.S.
243, 266 (2006). Moreover, the “regulation of health and safety is primarily, and
historically, a matter of local concern,” id. at 271 (quotation marks omitted), and
nothing in the statute shows a congressional intention to upset that balance. To the
contrary, “[t]he statute and [this Court’s] case law amply support the conclusion
that Congress regulates medical practice insofar as it bars doctors from using their
prescription-writing powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood.” Id. at 269-270. “Beyond this, however, the
statute manifests no intent to regulate the practice of medicine generally.” Id. at
270.
27
Regulation 1306.04, however, is inconsistent with this principal. The
regulation makes the implicit judgment that some medical purposes are legitimate
while others are not. So too does it imply that one’s professional practice can become
so unusual that, while they have not yet abandoned the practice of medicine, they
entered the realm of drug trafficking. These unexplained assumptions are
ungrounded in the text of the statute and inconsistent with Congress’s delegation of
decisions that require medical judgment to the Secretary.
Moreover, the requirement that a prescription be issued for a “legitimate
medical purpose in the usual course of professional practice” is impermissibly vague
as it provides no meaningful guidance to those enforcing the CSA. “It is a basic
principle of due process that an enactment is void for vagueness if its prohibitions
are not clearly defined.” Grayned v. City of Rockford, 408 U.S. 104, 108 (1972).
A statute can be impermissibly vague for either of two independent
reasons. First, if it fails to provide people of ordinary intelligence a
reasonable opportunity to understand what conduct it prohibits. Second,
if it authorizes or even encourages arbitrary and discriminatory
enforcement.
Hill v. Colorado, 530 U.S. 703, 732 (2000). While requiring knowledge of a lack of
authorization lessens the concerns that one may be punished without adequate
notice of the offense, see Hoffman Estates v. Flipside, Hoffman Estates, 455 U.S.
489, 499 (1982) (noting that “the scienter requirement may mitigate a law's
28
vagueness, especially with respect to the adequacy of notice to the complainant that
his conduct is proscribed” (emphasis added)), a scienter requirement does not
alleviate all vagueness concerns:
Although the doctrine focuses both on actual notice to citizens and
arbitrary enforcement, [the Supreme Court has] recognized . . . that the
more important aspect of the vagueness doctrine “is not actual notice,
but the other principal element of the doctrine -- the requirement that a
legislature establish minimal guidelines to govern law enforcement.”
Kolender v. Lawson, 461 U.S. 352, 357-58 (1983) (quoting Smith v. Goguen, 415 U.S.
566, 574 (1974)).
The second element of the vagueness doctrine is rooted in the understanding
that “[v]ague laws . . . undermine the Constitution’s separation of powers and the
democratic self-governance it aims to protect.” United States v. Davis, 588 U.S. at
451. “Vague statutes threaten to hand responsibility for defining crimes to
relatively unaccountable police, prosecutors, and judges, eroding the people’s ability
to oversee the creation of the laws they are expected to abide.” Id. The language of
the 21 CFR § 1306.04 is entirely deficient in this respect.
This is not the typical vagueness circumstance, where the statute itself
leaves gaps that are ripe for abuse. Here, it is a regulatory interpretation that
injects vagueness into a statute in a manner that invites arbitrary enforcement.
And the vague regulation has been issued under the claimed authority of the very
29
actor charged with enforcing the law. “If the separation of powers means anything,
it must mean that the prosecutor isn't allowed to define the crimes he gets to
enforce.” United States v. Nichols, 784 F.3d 666, 668 (10th Cir. 2015) (Gorsuch, J.,
dissenting from the denial of rehearing en banc); cf. “Deferring to the prosecuting
branch's expansive views of these statutes would turn their normal construction
upside-down, replacing the doctrine of lenity with a doctrine of severity.” Whitman
v. United States, 574 U.S. 1003 (2014) (Scalia, J., statement respecting the denial of
certiorari) (quotation marks, brackets, and ellipsis omitted)). Such an interpretation
is not compatible with the separation of powers, and has led to precisely the perils
Congress sought to correct in drafting the CSA.
And, while Petitioner contends that the ordinary tools of statutory
construction demonstrate the erroneousness of the Ninth Circuit and other Courts’
reliance on the regulations, should the Court find the statue ambiguous, it should
apply the rule of lenity.
III.
THE ISSUE PRESENTED IS OF VAST IMPORTANCE TO THE
MEDICAL COMMUNITY AND IS RECURANT.
The CSA was not intended to interfere with the legitimate practice of medicine.
However, this is precisely what has occurred due to the lack of clear standards
delineating when a prescriber can issue prescriptions for controlled substances and
aggressive prosecution of prescribers. Rather than fulfilling the purpose of the CSA,
the DEA and United States Attorney’s Office have acted as a de facto national medical
board, curtailing practices it disagrees with through criminal prosecutions of
30
prescribing physicians. Congress witnessed a similar situation under the Harrison
Act, and it sought to prevent its recurrence in drafting the CSA. However, reliance
on the vague regulatory language has allowed and encouraged exactly that which
Congress sought to cure.
One area that has been disproportionately impacted is the field of pain
management. According to a 2019 report released by Health and Human Services, 3
“[r]egulatory oversight has also led to fears of prescribing among clinicians, with some
refusing to prescribe opioids even to established patients who report relief and
demonstrate improved function on a stable opioid regimen.” HHS report at 12. Fears
of arbitrary enforcement have had a negative effect on proper prescribing:
“Clinicians who treat acute and chronic pain, particularly with opioids,
may experience stigma from colleagues and society in general that — in
addition to fear of scrutiny from state medical boards and the DEA —
may also dissuade them from using opioids appropriately.”
Id. at 57. Intervention from this Court is needed to clarify the standards applicable
to medical professionals under the CSA. This case provides an opportunity to clarify
the standards for the medical community so it can minimize the patient harms that
3 U.S. Department of Health and Human Services (2019, May) (“HHS Report”).
Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps,
Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health
and Human Services website: https://www.hhs.gov/sites/default/files/pmtf-finalreport-2019-05-23.pdf.
31
have resulted from the enduring uncertainty regarding the standards governing the
CSA.
IV.
THIS CASE PRESENTS AN IDEAL VEHICLE TO RESOLVE THE
QUESTION PRESENTED.
This case has unique benefits compared to other cases that have sought review
of the question presented. The issue in this case is narrow: what is the correct mens
rea under § 841 and Ruan. Unlike other cases that have petitioned this Court for
certiorari, this case has not been to trial. Thus, there will be no argument or
discussion of what the evidence did or did not establish after a trial. The consideration
and argument can therefore be focused solely on the legal issues involving the
construction of § 841’s mens rea after Ruan, without any fact arguments creeping in.
This case is solely one of statutory construction, and it offers a prime opportunity to
address this recurring issue without the baggage of a jury verdict.
Moreover, because the opinion below was decided on narrow grounds, this case
can be resolved without consideration of ancillary legal issues. For instance, the
opinion below made no finding regarding whether Petitioner would have presented a
fair and just reason for withdrawal if, indeed, his interpretation of the CSA and Ruan
is correct. Thus, should the Court agree with Petitioner’s construction of the statute,
it would be entirely proper for the Court to remand the case to the Ninth Circuit to
consider the issue in the first instance. Should the Court disagree with Petitioner’s
32
construction of the statute, the Court will have the opportunity to clarify which—if
any—of the various constructions circulating the federal courts is correct. Similarly,
the opinion below did not rest on any distinction between § 846 and § 841, so any
issues related thereto could be left to the appellate court to decide in the first instance.
Simply put, this case is the cleanest opportunity to consider the important and
recurring issue of § 841’s mens rea. The cases before have all had various
complications that are absent from the present case. And the Court is not likely to
see a case as narrowly focused on the pertinent issue as is presented here. This
Court’s opinion in Moore was misinterpreted by federal courts across the nation for
nearly half of a century. The present case offers the opportunity to ensure that Ruan
does not suffer the same fate.
CONCLUSION
For the foregoing reasons, Petitioner respectfully prays that this Honorable
Court will grant his Petition for Certiorari.
Respectfully Submitted,
Dzung Ahn Pham
February 3, 2025
By: /s/ Beau B Brindley
Beau B. Brindley
COUNSEL OF RECORD
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For Petitioner Dzung Ahn Pham
Law Offices of Beau B. Brindley
53 W Jackson Blvd. Ste 1410
Chicago IL 60604
(312)765-8878
bbbrindley@gmail.com
34
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.