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No. 10357580
United States Court of Appeals for the Ninth Circuit
United States v. Enriquez
No. 10357580 · Decided March 18, 2025
No. 10357580·Ninth Circuit · 2025·
FlawFinder last updated this page Apr. 2, 2026
Case Details
Court
United States Court of Appeals for the Ninth Circuit
Decided
March 18, 2025
Citation
No. 10357580
Disposition
See opinion text.
Full Opinion
FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
UNITED STATES OF AMERICA, No. 23-4424
D.C. No.
Plaintiff - Appellee,
2:18-cr-00375-
AB-7
v.
JUAN CARLOS ENRIQUEZ,
OPINION
Defendant - Appellant.
Appeal from the United States District Court
for the Central District of California
André Birotte Jr., District Judge, Presiding
Argued and Submitted February 19, 2025
El Centro, California
Filed March 18, 2025
Before: Richard C. Tallman and John B. Owens, Circuit
Judges, and Ruth Bermudez Montenegro, District Judge. *
Opinion by Judge Tallman
*
The Honorable Ruth Bermudez Montenegro, United States District
Judge for the Southern District of California, sitting by designation.
2 USA V. ENRIQUEZ
SUMMARY **
Criminal Law
The panel affirmed the district court’s denial of Juan
Carlos Enriquez’s motion to dismiss an indictment charging
him with conspiracy to receive healthcare kickbacks in
violation of 18 U.S.C. § 371 and receiving prohibited
payments in violation of the Anti-Kickback Statute (AKS).
Enriquez—a pharmacy technician employed by his
alleged co-conspirator, Irina Sadovsky—was involved in a
scheme to refer Medicare and Medi-Cal beneficiaries to
Sadovsky’s pharmacies in return for a kickback.
Enriquez moved to dismiss the indictment for failure to
state an offense or, alternatively, for lack of specificity,
because the charging document had not negatived the safe
harbor for a bona fide employment relationship set forth in
42 U.S.C. § 1320a-7b(b)(3)(B). That safe harbor provides
an affirmative defense that the AKS does not apply to
conduct the statute otherwise prohibits if the kickbacks were
payments from an employer to a bona fide employee for
employment-related items or services.
Enriquez’s arguments relied on expanding in two ways
the reach of Ruan v. United States, 597 U.S. 450 (2022),
which held that Controlled Substances Act (CSA) Section
841’s exception for authorized prescriptions must be proven
beyond a reasonable doubt. First, he argued that the
statutory interpretive principles from Ruan should be applied
**
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
USA V. ENRIQUEZ 3
outside the CSA to the AKS. Second, he argued that the
AKS bona fide employment safe harbor should be treated as
a “quasi-element” not only for burden of proof and scienter
purposes, as Ruan held for the CSA’s authorization
exception, but also for purposes of pleading.
The panel declined to extend Ruan to (a) the AKS and
(b) pleading requirements. Because Ruan provides no
reason to stray from the bedrock principle that indictments
need not allege affirmative defenses, the panel affirmed the
district court’s denial of Enriquez’s motion to dismiss for
failure to state an offense.
As to the indictment’s specificity, Enriquez argued that
he was not put on notice as to why the AKS safe harbor did
not protect him. The panel affirmed the denial of the motion
to dismiss on this ground because all elements of the
conspiracy crime were pled in adequate detail.
COUNSEL
Ethan A. Sachs (argued), Attorney, Appellate Section,
Criminal Division; Alexis D. Gregorian and Siobhan M.
Namazi, Trial Attorneys; Jeremy R. Sanders, Assistant Chief
& Appellate Counsel; Criminal Division, Fraud Section;
Steven S. Michaels, Trial Attorney; Lisa H. Miller, Deputy
Assistant Attorney General; Nicole M. Argentieri, Principal
Deputy Assistant Attorney General; E. Martin Estrada,
United States Attorney; United States Department of Justice,
Office of the United States Attorney, Washington, D.C.;
David R. Friedman, Assistant United States Attorney,
United States Department of Justice, Office of the United
States Attorney, Los Angeles, California; for Plaintiff-
Appellee.
4 USA V. ENRIQUEZ
David A. Schlesinger (argued), Jacobs & Schlesinger LLP,
San Diego, California, for Defendant-Appellant.
OPINION
TALLMAN, Circuit Judge:
Appellant Juan Carlos Enriquez was a pharmacy
technician employed by his alleged co-conspirator, Irina
Sadovsky. Enriquez was involved in a scheme to refer
Medicare and Medi-Cal beneficiaries to Sadovsky’s
pharmacies in return for a kickback. The government
charged Enriquez by indictment with conspiracy to receive
healthcare kickbacks in violation of 18 U.S.C. § 371 and
receiving prohibited payments in violation of the Anti-
Kickback Statute (“AKS”).
Enriquez moved to dismiss the indictment for lack of
specificity and failure to state an offense because the
charging document had not negatived the statutory safe
harbor for a bona fide employment relationship. 42 U.S.C.
§ 1320a-7b(b)(3)(B). That safe harbor provides an
affirmative defense that the AKS does not apply to conduct
the statute otherwise prohibits if the kickbacks were
payments from an employer to a bona fide employee for
employment-related items or services. Id.
The district court denied Enriquez’s motion. Enriquez
pleaded guilty but reserved the right to appeal the denial of
his pretrial motion to dismiss. Following the entry of
Enriquez’s conditional plea, the district court sentenced him
to one day of imprisonment followed by two years of
USA V. ENRIQUEZ 5
supervised release and ordered him to pay $121,115 in
restitution.
On appeal, Enriquez contends the district court erred in
denying his motion to dismiss the indictment because it
failed to state an offense or, alternatively, was insufficiently
specific. Both arguments rely on expanding the reach of
Ruan v. United States, 597 U.S. 450 (2022), which held that
Controlled Substances Act (“CSA”) Section 841’s exception
for authorized prescriptions must be proven beyond a
reasonable doubt. Enriquez argues that under Ruan’s logic,
any “facially applicable” exception must be treated as a
“quasi-element” and alleged in the indictment. More
specifically, he argues that because his indictment alleged an
employee-employer relationship, the government was
required to plead facts alleging why the AKS bona fide
employment relationship safe harbor did not apply. Because
his indictment failed to allege the safe harbor’s
inapplicability, Enriquez argues, the indictment failed to
state an offense and the district court therefore erred by
denying his motion to dismiss the indictment. We disagree
that Ruan supports Enriquez’s position, and we affirm the
denial of his motion to dismiss.
I
The district court had jurisdiction under 18 U.S.C.
§ 3231. We have jurisdiction under 28 U.S.C. § 1291.
II
When, as here, a defendant has challenged an indictment
before trial, we review the challenge de novo. United States
v. Qazi, 975 F.3d 989, 992 (9th Cir. 2020). In so doing, we
assume that an indictment’s allegations are true and then
assess whether the charged conduct satisfies all elements of
6 USA V. ENRIQUEZ
the criminal offense without considering extrinsic evidence
beyond the charging document’s “four corners.” United
States v. Kelly, 874 F.3d 1037, 1047 (9th Cir. 2017). A count
that does not set forth all elements fails to state an offense—
a fatal flaw requiring dismissal. United States v. Du Bo, 186
F.3d 1177, 1179 (9th Cir. 1999).
III
Enriquez asks us to view the AKS safe harbor as a
“quasi-element” akin to Section 841’s authorization
exception—the provision considered in Ruan. Section 841
is a provision of the CSA that makes it a crime for any person
to knowingly or intentionally manufacture, distribute, or
dispense a controlled substance, “[e]xcept as authorized[.]”
21 U.S.C. § 841(a). The “except as authorized” clause
spares from liability doctors who may lawfully prescribe a
controlled substance “for a legitimate medical purpose . . . in
the usual course of [their] professional practice.” 21 C.F.R.
§ 1306.04(a) (2020). The issue before the Supreme Court
involved what state of mind the government must prove to
convict doctors of dispensing controlled substances outside
their therapeutic authorization—not for a legitimate
purpose—in violation of Section 841. Ruan, 597 U.S. at
454.
The Court held that Section 841’s “knowingly or
intentionally” mens rea applies to the authorization
exception. Id. “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.” Id. The Court reasoned that
because the “except as authorized” clause distinguished
legal from illegal dispensing, it “is sufficiently like an
USA V. ENRIQUEZ 7
element in respect to [scienter] as to warrant similar legal
treatment[]” despite “differing from an element in some
respects.” Id. at 464. In addressing the concurrence’s point
that the authorization exception is unlike an element, the
majority emphasized its holding was limited to scienter,
which “has little or nothing to do” with the indictment or
burden shifting responsibilities set forth in Section 885. Id.
at 462–64. Section 885 expressly states that the government
need not “negative” any exception in an indictment or other
pleading, and at trial, the burden of production lies not with
the government but with the party claiming the exception.
21 U.S.C. § 885.
Enriquez asks this Court to extend Ruan’s reasoning in
two ways. First, Enriquez argues that the statutory
interpretive principles from Ruan should be applied outside
the CSA to the AKS. Second, Enriquez argues that the AKS
bona fide employment safe harbor should be treated as a
“quasi-element” not only for burden of proof and scienter
purposes, as Ruan held for the CSA’s authorization
exception, but also for purposes of pleading. Neither
argument is convincing.
A
First, the CSA and AKS have substantial differences that
counsel against extending Ruan’s logic to the AKS. While
each statute contains a specific intent requirement, their
placement differs in significant ways. Section 841 of the
CSA includes its authorization exception, mens rea clause,
and prohibited acts in a single provision. 1 In contrast, the
1
The provision states: “Except as authorized . . ., it shall be unlawful for
any person knowingly or intentionally . . . to manufacture, distribute, or
dispense, or possess with intent to [do the same], a controlled substance.”
21 U.S.C. § 841(a)(1).
8 USA V. ENRIQUEZ
AKS’ numerous exceptions (i.e., safe harbors) are each
contained in their own separate provision (§§ 1320a-
7b(b)(3)(A)–(L)). Congress chose to include each AKS safe
harbor in a subsection full of statutory exceptions distinct
from the prohibited conduct specified in Sections 1320a-
7b(b)(1) and (b)(2). That choice is consequential because it
puts the AKS within the “settled rule” that statutory
exceptions are treated as affirmative defenses when they are
contained in “a proviso or other distinct clause, whether in
the same section or elsewhere[.]” McKelvey v. United
States, 260 U.S. 353, 357 (1922); see also United States v.
Freter, 31 F.3d 783, 787–88 (9th Cir. 1994) (even though
contained in the same sentence as an element, an exception
for “federally permitted” release of a hazardous substance is
an affirmative defense because it is a distinct clause).
In light of the structural differences between the two
statutes, courts treat the CSA exceptions differently than the
AKS safe harbors. Even before Ruan, we treated the CSA’s
authorization exception as a statutory element the
government must prove beyond a reasonable doubt. See
United States v. Feingold, 454 F.3d 1001, 1006, 1012 (9th
Cir. 2006); United States v. King, 587 F.2d 956, 965–66 (9th
Cir. 1978) (“lack of authorization is an element of” Section
841); United States v. Kim, 298 F.3d 746, 750 (9th Cir. 2002)
(confirming that King requires the government to plead
“except as authorized” as an element in a Section 841
indictment).
In contrast, courts have repeatedly concluded that the
AKS’s bona fide employment relationship safe harbor is an
affirmative defense. In an unpublished opinion, we affirmed
a district court holding that the safe harbor is an affirmative
defense, explaining that “[a] contrary holding would lead to
absurd indictments requiring the government to plead the
USA V. ENRIQUEZ 9
negative of every enumerated safe harbor[.]” United States
v. Ekwebelem, 669 F. App’x 868, 686 (9th Cir. 2016). Other
circuits have reached the same conclusion 2 or indicated
agreement with it. 3 District courts to consider the issue are
also in alignment that the AKS safe harbors are affirmative
defenses. 4
B
Second, Enriquez’s argument requires extending Ruan’s
holding—limited to scienter and burden of proof purposes—
to the government’s pleading obligations. But we read
Ruan’s holding more narrowly than Enriquez suggests.
Ruan does not treat Section 841’s authorization exception
“like an element” for every purpose. In contrast, the majority
describes how treating the authorization exception as an
element for purposes of scienter and burden of proof at trial
does not necessarily warrant the same treatment for other
2
United States v. Vernon, 723 F.3d 1234, 1271 (11th Cir. 2013); United
States v. Turner, 561 F. App’x 312, 319–320 (5th Cir. 2014) (“The safe
harbor provision is an affirmative defense which the defendant must
prove . . . .”); United States v. Norton, 17 F. App’x 98, 102 (4th Cir.
2001) (per curiam).
3
United States v. George, 900 F.3d 405, 413 (7th Cir. 2018) (“Once the
government establishes the elements of a violation of the [AKS], the
burden shifts to a defendant to demonstrate . . . that her conduct fell
within the safe harbor provision of the statute.”); see also United States
v. Yielding, 657 F.3d 688, 700 (8th Cir. 2011) (noting that the parties did
not dispute that the bona fide employment relationship safe harbor
provision creates an affirmative defense).
4
E.g., U.S. ex rel. Bartlett v. Ashcroft, 39 F. Supp. 3d 656, 676 (W.D.
Pa. 2014) (AKS’s “safe harbors are affirmative defenses, and the
defendant carries the burden of proof at trial”); United States v. George,
171 F. Supp. 3d 810, 818 (N.D. Ill. 2016) (government “need not prove,
as an element of its case, that defendant’s conduct does not fit within a
safe harbor” of the AKS).
10 USA V. ENRIQUEZ
purposes, including those related to indictments. See Ruan,
597 U.S. at 462–63 (stating that indictments and burdens of
production “have little or nothing to do with scienter
requirements”). Rather, per another CSA provision, Section
885, the government need not negative “any exemption or
exception . . . in any complaint, information, indictment, or
other pleading.” Id. at 462 (quoting 21 U.S.C. § 885). Thus,
Section 885 “relieves the Government from having to
disprove, at the outset of every Controlled Substances Act
prosecution, every exception in the statutory scheme.” Id. at
464. 5
Enriquez points to two district court cases to support his
reading of Ruan. A District of Nevada court dismissed a
Section 841 indictment for failure to state an offense
because, even though it pleaded that the defendant’s conduct
was unauthorized, it failed to plead the “Ruan-added mens
rea, which is an element in the Ninth Circuit.” United States
v. Wells, 672 F. Supp. 3d 1066, 1071 (D. Nev. 2023). In
5
Enriquez argues that Ruan did not require negative pleading of the
authorization exception because Section 885 explicitly states it is not
required. Absent a provision like Section 885, Enriquez argues, the
government must plead around the AKS’s list of safe harbors. But the
absence of a section analogous to Section 885 leads more logically to the
opposite conclusion: that Congress intentionally omitted it because the
AKS’s construction obviates the need for one. Unlike the CSA, the
AKS’s safe harbors are contained in subsequent sections. Under well-
established law, those are treated as affirmative defenses. As such, there
would have been no reason for Congress to explicitly state that the
government need not negative safe harbors in an AKS indictment.
That’s not to say that Section 885 is merely statutory surplus. Rather,
because Section 841’s authorization exemption is included in the same
provision as the prohibited conduct, Congress saw it necessary to
explicitly clarify that the government need not treat the authorization
exception as an element it must plead in the indictment.
USA V. ENRIQUEZ 11
other words, “Ruan’s holding requires that indictments of
medical practitioners under § 841 allege that a medical
practitioner ‘knowingly and intentionally’ acted without
authorization.” Id. at 1070. A District of Alaska decision
similarly found that “lack of authorization, even if it is
something of a ‘quasi-element,’” must be pled in the
indictment. United States v. Spayd, 627 F. Supp. 3d 1058,
1062–63 (D. Alaska 2022). 6, 7
But neither Wells nor Spayd advances Enriquez’s
argument. Spayd misinterprets Ruan by extending its
“quasi-element” treatment to pleading when the Supreme
Court’s rationale for treating the authorization exception
“like an element” was limited to burden of proof and scienter
purposes. Ruan, 597 U.S. at 462–63. Wells, meanwhile,
found that Section 841’s authorization exception must be
pled in the indictment not because of Ruan but because Ninth
Circuit precedent has required as much since 1978. See
King, 587 F.2d at 965–66; Kim, 298 F.3d at 750. Because
the authorization exception was already considered an
element in the Ninth Circuit, Ruan merely extended Section
841’s “knowingly and intentionally” mens rea to the
6
In so finding, the court acknowledged that “although it is clear that
Ruan altered what the Government must prove under § 841, it is not clear
whether Ruan changed what the Government must plead” because Ruan
did not squarely hold that Section 841’s authorization exception is an
element of the offense. Spayd, 627 F. Supp. 3d at 1062. The court
further explained that, despite the uncertainty coming out of Ruan and
“[d]espite the language of § 885,” the government must plead the
authorization exception to avoid the “risk that an indictment may
describe conduct that is wholly on the permissible side of the criminal
line.” Id. at 1063.
7
At least one district court outside this circuit has similarly concluded.
See United States v. Henson, 2024 U.S. Dist. LEXIS 3549, at *5–12 (D.
Kan. Jan. 5, 2024).
12 USA V. ENRIQUEZ
pleading requirement. Wells, 672 F. Supp. 3d at 1071. In
contrast, as discussed supra, the Ninth Circuit has never
treated the AKS safe harbors as elements. Thus, even if
Ruan (and not just Ninth Circuit precedent) required the
government to allege Section 841’s authorization exception
in an indictment, the same does not follow for the AKS’ safe
harbors, which no court has ever deemed to be an element or
a “quasi-element” of the statute.
Furthermore, Spayd and Wells represent the minority
view. Most courts to consider the issue have found that
while Ruan requires the government to carry the burden
regarding authorization, it does not require the government
to negative the authorization exception in the indictment.
See, e.g., United States v. Fletcher, No. 21-cr-63, 2023 WL
4097026, at *4 (E.D. Ky. June 20, 2023) (rejecting
defendant’s motion to dismiss an indictment charging
Section 841 because Ruan requires the government to prove
a lack of authorization at trial, not in an indictment); United
States v. Goodman, No. 22-cr-435, 2023 WL 5672834, at *3
(E.D. Pa. Sept. 1, 2023) (rejecting defendants’ motion to
dismiss and explaining that “Ruan de[alt] with the
Government’s burden . . . under § 841 at trial” and “did not
alter any pleading standards”); United States v. Och, No. 21-
cr-40026, Docket No. 53, Electronic Order (D. Mass. Jan.
31, 2023) (“Ruan did not modify the pleading standards for
indictments under the Controlled Substances Act.”).
We decline to extend Ruan to (a) the AKS and
(b) pleading requirements. Because Ruan provides no
reason to stray from the bedrock principle that indictments
need not allege affirmative defenses, McKelvey, 260 U.S. at
357, we affirm the denial of Enriquez’s motion to dismiss
for failure to state an offense.
USA V. ENRIQUEZ 13
IV
The indictment provided fair notice to Enriquez to
comport with due process of law and to permit him to
prepare his defense. An indictment must satisfy certain
minimal standards of specificity to avoid being dismissed
under Rule 12(b)(3)(B)(iii). See United States v. Cecil, 608
F.2d 1294, 1296 (9th Cir. 1979) (per curiam). Even if an
indictment has pled each of an offense’s essential elements,
it still lacks requisite specificity if it “fails to allege sufficient
facts to facilitate the proper preparation of a defense and to
ensure that the defendant[] [is] prosecuted on facts presented
to the Grand Jury.” Id. at 1297 (finding insufficient an
indictment that merely tracked statutory language, named
states in which the conspiracy occurred, and named some co-
conspirators because it “clearly lacked a statement of the
facts and circumstances that would inform the accused of the
specific offenses with which they were charged”).
Enriquez argues that contrary to Cecil’s principles, he
was not put on notice as to why the AKS safe harbor did not
protect him. This argument is unconvincing. “The test for
sufficiency of the indictment is not whether it could have
been framed in a more satisfactory manner, but whether it
conforms to minimal constitutional standards.” United
States v. Awad, 551 F.3d 930, 935 (9th Cir. 2009) (quoting
United States v. Hinton, 222 F.3d 664, 672 (9th Cir. 2000)
(internal quotation marks omitted)). In a conspiracy
indictment under Section 371, an indictment satisfies its
constitutional requirements if it alleges (1) the agreement,
(2) the unlawful object towards which the agreement is
directed, and (3) an overt act in furtherance of the
conspiracy. United States v. Giese, 597 F.2d 1170, 1177 (9th
Cir. 1979) (citation omitted).
14 USA V. ENRIQUEZ
Here, the indictment alleged all three elements:
(1) Paragraph 56 specifies that Enriquez and co-conspirators
“knowingly combined, conspired, and agreed to” pay and
receive kickbacks in violation of the AKS; (2) Paragraphs 53
to 55 describe the role each conspirator played while
Paragraph 57 describes how the object of the conspiracy—
receiving illicit kickbacks for financial gain—was carried
out; and (3) Paragraph 58 lists an overt act—Enriquez
received a kickback check in exchange for referring
beneficiaries’ prescriptions to the pharmacy that employed
him.
Because all elements of the conspiracy crime were pled
in adequate detail, we affirm the district court’s denial of
Enriquez’s motion to dismiss the indictment for insufficient
specificity under Rule 12(b)(3)(B)(iii). See Awad, 551 F.3d
at 935 (“An indictment is sufficient if it contains ‘the
elements of the charged crime in adequate detail to inform
the defendant of the charge and to enable him to plead double
jeopardy.’” (citation omitted)).
***
We find no reason to stretch Ruan beyond its logical
limits. Because the government is not required to plead
affirmative defenses in an indictment, and it pleaded all
elements of the conspiracy offense in detail, count nine of
the indictment was sufficient. Accordingly, the district court
properly denied Enriquez’s motion to dismiss for failure to
state an offense and lack of specificity.
AFFIRMED.
Plain English Summary
FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT UNITED STATES OF AMERICA, No.
Key Points
01FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT UNITED STATES OF AMERICA, No.
02Owens, Circuit Judges, and Ruth Bermudez Montenegro, District Judge.
03* Opinion by Judge Tallman * The Honorable Ruth Bermudez Montenegro, United States District Judge for the Southern District of California, sitting by designation.
04ENRIQUEZ SUMMARY ** Criminal Law The panel affirmed the district court’s denial of Juan Carlos Enriquez’s motion to dismiss an indictment charging him with conspiracy to receive healthcare kickbacks in violation of 18 U.S.C.
Frequently Asked Questions
FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT UNITED STATES OF AMERICA, No.
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This case was decided on March 18, 2025.
Use the citation No. 10357580 and verify it against the official reporter before filing.