United States v. Steven Chun
CourtCourt of Appeals for the Eleventh Circuit
Date FiledAugust 18, 2026
Docket22-14192
StatusPublished
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Full Opinion
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FOR PUBLICATION
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 22-14192
____________________
UNITED STATES OF AMERICA,
Plaintiff-Appellee,
versus
STEVEN CHUN,
DANIEL TONDRE,
Defendants-Appellants.
____________________
Appeal from the United States District Court
for the Middle District of Florida
D.C. Docket No. 8:20-cr-00120-WFJ-JSS-1
____________________
Before NEWSOM, BRASHER, and TJOFLAT, Circuit Judges.
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2 Opinion of the Court 22-14192
TJOFLAT, Circuit Judge:
BACKGROUND
In United States v. Simon, 12 F.4th 1 (1st Cir. 2021), the First
Circuit affirmed the convictions of the founder and four executives
of Insys Therapeutics, Inc. (“Insys”), 1 under the Racketeer Influ-
enced and Corrupt Organizations Act (“RICO”), 18 U.S.C.
§ 1962(d), 2 for conspiring to bribe physicians to prescribe Subsys, a
fentanyl-laced spray medication administered beneath the tongue.
Insys developed, and the U.S. Food and Drug Administration
(“FDA”) approved, Subsys in early 2012 for use in the treatment of
breakthrough cancer pain. 3 The “icing on the cake” of the bribery
scheme was the “speaker program,” id. at 17, in which Insys paid
selected physicians—in particular those specializing in pain medi-
cine and prescribing Subsys off-label—hefty honoraria to speak at
dinner meetings Insys’ representatives hosted. The purpose of
1 Insys was a publicly held pharmaceutical firm. Simon, 12 F.4th at 15.
2 The defendants were also found guilty of mail fraud and wire fraud, which
constituted the predicate acts underlying the RICO offense. Four of the de-
fendants were found guilty of honest services mail and wire fraud. Those acts
also constituted predicate acts.
3 The term ‘‘breakthrough cancer pain’’ is a term of art: it refers to brief spikes
in pain (typically lasting less than one hour) in patients with cancer who are
already dealing with constant and relatively steady pain. All other uses of Sub-
sys were deemed ‘‘off-label.’’ Simon, 12 F.4th at 15.
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22-14192 Opinion of the Court 3
these speaker programs was ostensibly to introduce Subsys to phy-
sicians in the community, but their true purpose was to put cash in
the hands of the prescribing physicians.
Michael Babich, Insys’ President and Chief Executive Of-
ficer, and Alec Burlakoff, Insys’ Vice President of Sales, pleaded
guilty to the RICO conspiracy 4 and testified as prosecution wit-
nesses at the trial. Burlakoff referred to the speakers, including Dr.
Steven Chun, an appellant here, as “whales”:
physicians who “had agreed in a very clear and con-
cise manner that they were up for the deal, which
meant that they would be compensated based on the
number of prescriptions of Subsys they wrote. A cor-
ollary to that deal was that “the more they wrote and
the more they increased the dose, the more they’d get
paid to speak.” At Burlakoff’s urging, regional sales
managers were to have a “candid conversation” with
each potential whale and make clear that if the physi-
cian was going to receive payments from Insys, he
was “going to write a significant amount of Subsys
prescriptions to new patients as well as increase the
doses of current patients.” Burlakoff told sales man-
agers to view speakers as their “business partners.”
4 Burlakoff pleaded guilty to the RICO conspiracy. On January 23, 2020, the
District Court sentenced him to 26 months in prison and a three years of su-
pervised release. USA v. Babich et al., 1:16-cr-10343, ECF No. 1313 (D. Mass.
Jan. 10, 2019).
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Id. at 18 (alterations adopted). As for the speaker program, Burla-
koff had this to say:
[T]he speaking events themselves had little to no at-
tendance. Often, only the speaker, a friend or family
member, and the sales representative were on hand.
Even when more people were in attendance, the
speaker programs were mostly “social outings” or
“just a reason to gather people and have dinner and
pay [the doctor].” Although sales representatives
were required to submit sign-in forms and attendee
evaluation forms to a third-party compliance firm (Sci
Medica), they frequently submitted inaccurate docu-
mentation, including sign-in sheets with names and
signatures of people who were not present, to give
the speaking programs an aura of legitimacy.
Id. at 19. The dinners were obvious shams. They were created to
hide the fact that the honoraria Insys paid the speakers violated the
“Anti-Kickback Statute,” 42 U.S.C. § 1320a-7b(b), which prohibits
the payment or receipt of kickbacks in connection with a federal
healthcare program, such as Medicare.
The jury returned verdicts against the founder of Insys and
four of its executives on May 2, 2019. USA v. Babich et al., 1:16-cr-
10343, ECF No. 841 (D. Mass. Jan. 10, 2019). This brings us to the
case at hand.
* * *
On March 12, 2020, a Middle District of Florida grand jury
returned an indictment against Steven Chun and Daniel Tondre.
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22-14192 Opinion of the Court 5
The grand jury superseded the indictment on February 5, 2022—
34 months later. The superseded version charged the defendants
with committing 16 separate offenses, all based on the bribery
scheme involved in Simon.
Count One alleged that, from August 2012 through July
2015, six individuals conspired in violation of 18 U.S.C. § 371 to vi-
olate the Anti-Kickback Statute by soliciting or receiving bribes for
prescribing Subsys. Those six individuals were (1) Chun, a physi-
cian specializing in pain medicine and an enrolled Medicare pro-
vider; (2) Tondre, a sales representative and trainer for Insys whose
sales territory included Chun and his medical practice; (3) Babich,
Insys’ President and Chief Executive Officer; (4) Burlakoff, Insys’
Vice President of Sales; (5) Liz Gurrieri, an Insys technician; and
(6) Pharmacist 1, who filled Chun’s prescriptions.
Counts Two through Six alleged that, between May 4 and
June 22, 2015, Tondre violated the Anti-Kickback Statute by paying
Chun a bribe for prescribing Subsys. Counts Seven through Eleven
alleged that Chun violated the Anti-Kickback Statute by accepting
payments for writing Subsys prescriptions. Counts Twelve
through Sixteen alleged that Chun on two occasions and Tondre
on five committed identification fraud—using without authority
the identification of another—between April 4 and June 16, 2015,
in violation of 18 U.S.C. § 1028(a)(7).
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6 Opinion of the Court 22-14192
Chun and Tondre entered pleas of not guilty to both indict-
ments and stood trial before a jury on May 9, 2022. 5 The Govern-
ment rested its case on May 19, and Chun did likewise. Tondre
chose to testify at trial. At the close of the evidence, the defendants
moved the District Court for judgment of acquittal. 6 The Court de-
nied their motions. The jury found Chun guilty on Counts One and
Seven through Eleven and Tondre guilty on Counts One through
Six, Twelve, and Sixteen. Following the District Court’s imposition
of their sentences,7 Chun and Tondre appealed their convictions
and sentences.
Both Chun and Tondre challenge the District Court’s denial
of the motions for judgment of acquittal. We discuss the Court’s
ruling in Part I. In Part II, we consider the District Court’s handling
of two notes the jury submitted to the Court during deliberations.
5 On the eve of trial, the District Court, on the Government’s motion, dis-
missed Counts Thirteen though Fifteen pending against Chun and Tondre.
6 See Fed. R. Crim. P. 29(a). On May 23, the Court granted Chun’s motion as
to Counts Twelve and Sixteen.
7 After denying Chun’s Rule 29(c) and Rule 53 alternative motions for judg-
ment as a matter of law and for a new trial, the District Court sentenced Chun
on December 5, 2022, to concurrent prison terms of 42 months on the six
counts of conviction and a three-year term of supervised release. On Decem-
ber 15, 2022, the District Court sentenced Tondre to concurrent prison terms
of 48 months on the eight counts of conviction and a three-year term of super-
vised release.
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22-14192 Opinion of the Court 7
Part III addresses an issue involving Chun’s sentence. Part IV con-
cludes, finding no basis for disturbing the District Court’s judg-
ments, and therefore affirms.
I. MOTIONS FOR JUDGMENT OF ACQUITTAL
We must preface the Part I discussion with an explanation
of how the Government chose to try this case. It treated the trial as
an extension of the trial in Simon except that the Simon defendants
would not be standing in the dock, and the trial would be held in
Tampa, Florida, not in Boston, Massachusetts. But the Govern-
ment’s star witnesses, Babich and Burlakoff, would be the same.
They had been charged as RICO conspirators in Simon and having
pleaded guilty, testified at the trial of their co-conspirators. And
they had been charged as Count One conspirators here, although
not indicted, and, as in Simon, testified at the trial of two of their
co-conspirators, repeating much of what they testified to in Simon.
And the time frames of the Simon conspiracy and the Count One
conspiracy are the same, August 2012 through July 2015.
So, although the jury would not know about Simon, it would
learn that Babich and Burlakoff had pleaded guilty to criminal con-
duct that occurred while they were at Insys, a conspiracy involving
themselves and four Insys executives—John Kapoor, Joe Rowan,
Sunrise Lee, and Mike Curry—that occurred during the time frame
of the conspiracy alleged in Count One. The jury would also learn
of the price they paid for their criminal conduct. Babich testified
that he made $60 million exercising Insys stock options. Burlakoff
had this to say: “It was all taken. . . . I owe 59 million in restitution.”
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8 Opinion of the Court 22-14192
Asked if it was “joint and several with anyone else, he said, “[with]
Mike Babich and John Kapoor.”
* * *
We now discuss whether the court erred in denying Chun
and Tondre’s motion for judgments of acquittal. The questions this
part poses are whether the evidence was sufficient to convict
Chun8 on Count One and on Counts Seven through Eleven. We
answer those questions by reviewing the evidence de novo count
by count, considering it in the light most favorable to the Govern-
ment and drawing all reasonable inferences and credibility choices
in favor of the jury’s verdicts. United States v. Trujillo, 146 F.3d 838,
845 (11th Cir. 1998). Evidence is sufficient to sustain a conviction if
any rational trier of fact could have found the essential elements of
the crime beyond a reasonable doubt. United States v. Starr, 159
F.4th 901, 910 (11th Cir. 2025) (citing Cavazos v. Smith, 565 U.S. 1,
7, 132 S. Ct. 2, 6 (2011)). The guilty verdict need not be inevitable
based on the evidence presented at trial; it need only be reasonable.
United States v. Browne, 505 F.3d 1229, 1253 (11th Cir. 2007). We
begin our review with the Count One conspiracy.
8 Tondre makes largely the same insufficiency argument as Chun, so we refer
to them collectively as “Chun” in sections A and B—unless otherwise stated.
Tondre makes a separate safe harbor provision argument, which we address
individually in section C.
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A. Conspiracy Count
We begin with the first count, that Chun conspired to vio-
late the Anti-Kickback Statute. The elements of conspiracy are
“(1) an agreement among two or more persons to achieve an un-
lawful objective; (2) knowing and voluntary participation in the
agreement; and (3) an overt act by a conspirator in furtherance of
the agreement.” United States v. Hasson, 333 F.3d 1264, 1270 (11th
Cir. 2003). An agreement is rarely, if ever, established by direct ev-
idence. Rather it is usually shown by circumstantial evidence.
United States v. Pulido, 133 F.4th 1256, 1276–77 (11th Cir. 2025).
What the Government must prove is “the existence of an agreement
to achieve an unlawful objective and the defendant’s knowing par-
ticipation in that agreement.” United States v. Chandler, 388 F.3d
796, 806 (11th Cir. 2004).
As discussed, Count One alleged that, from August 2012
through July 2015, Chun was a member of a conspiracy consisting
of himself, Insys, Babich, Burlakoff, Tondre, Gurrieri, and Pharma-
cist 1. The conspirators’ objective was to violate the Anti-Kickback
Statute by paying physicians to prescribe Subsys. The first question
we must ask is whether the evidence presented at trial established
an agreement to violate the Anti-Kickback Statute. If so, we must
then ask whether the evidence showed that Chun was a party to
the agreement at some point in time and that one of the parties to
the agreement committed an overt act in furtherance of the agree-
ment’s objective. To answer the first question, we go back in time,
to Insys’ organization and the development of the scheme where
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10 Opinion of the Court 22-14192
Insys paid physicians to prescribe Subsys to their patients. Babich
and Burlakoff take us there.
Babich came on the scene before Subsys became a reality.
Insys was a privately held corporation. John Kapoor founded it in
2004. He hired Babich, a banker, in 2009. At the time, Insys’ scien-
tists were in the process of developing drugs and putting them
through clinical trials in anticipation of FDA’s eventual approval of
the drugs for distribution. The clinical trial of Subsys concluded in
2011, and, in January 2012, the FDA approved Subsys as a treat-
ment for “breakthrough cancer pain”— “the spikes of pain that pa-
tients experience when they have cancer.” With Subsys’ approval
in hand, Kapoor appointed Babich as the company’s Chief Execu-
tive Officer.
At this point, Insys’ executives “were getting ready to launch
Subsys itself, meaning sell[ing] it across the United States.” And Ba-
bich was “prepar[ing] the company for [an] initial public offering,”
going to New York, and trying to raise money, with the hope that
Insys would “be on one of the stock exchanges.”
The Subsys marketing program in the first six months of
2012 was not successful. As Babich expressed it, “we were not
bringing in as much revenue of the drug as possible that we
thought we could, patients were starting on too low of doses and
dropping off, and we had many sales reps who weren’t getting . . .
more than one script per month.” To generate more prescriptions,
they launched a speaker program in mid-2012 as a pilot project. By
the fall of 2012, the project was well underway nationwide. The
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22-14192 Opinion of the Court 11
program focused on the high prescribing doctors. Insys’ “greatest
chance at success” was getting the top doctors to use its product
because they were already prescribing large volumes of other rapid
onset fentanyl prescriptions.
Babich opined that the speaker program was a “legitimate
marketing strategy.” He explained:
As a legitimate marketing strategy it’s commonplace
for companies to have a physician educate other phy-
sicians in their area about their experiences with the
product itself. Usually you might have seen them
when you go to dinner sometimes, there will be a pri-
vate dining room and people in suits or nice dresses
having dinner, and if it looks like a doctor or someone
speaking, that’s usually a speaker program. So by de-
sign that’s the way that they’re supposed to go.
Some of Insys’ sales representatives and physicians did the
speaker programs “very well.” But some didn’t. They put on what
Babich would call “illegal sales programs,” where the physicians in-
vited to the speaker dinners didn’t even show up. The Insys sales
representative “may have signed forged sign-in sheets or done an-
ything to make it look . . . to the corporate office that the program
was done correctly in order to get the payment to the physician.”
Babich admitted the speaker programs were illegal because “we
traded cash for prescriptions.”
Burlakoff joined Insys in June 2012. He came from an Insys
competitor, Cephalon, where he had been in charge of speaker de-
velopment in his role as Market Development Manager. He knew
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12 Opinion of the Court 22-14192
Tondre, a Cephalon sales representative, and Chun, a pain medi-
cine specialist.
In June 2012, Insys did not have a speaker program. Soon
after arriving at Insys, Burlakoff met Chun and learned that he had
been trained as a speaker. Sometime later, in the summer of 2012,
he went to dinner with Chun; Aqsa Nawaz, Chun’s girlfriend; and
Tracy Kane, an Insys sales representative. They “talked about sev-
eral things to try to break the ice, but ultimately the conversation
revolved around [Burlakoff’s] desire to utilize [Chun] as a speaker
in exchange for his business.” In Burlakoff’s words, “I needed him
to write Subsys and a lot of it.”
I said, listen, this is my position as Vice President of
Sales, I have bosses to answer to, I do have a large
budget, at least in respect -- in perspective to other
pharmaceutical companies, I had 100,000, I let him
know I had 100,000, I planned on using every
Penni [sic] of it so long as he was prescribing Subsys
in return.
Chun “verbally agreed” with Burlakoff’s plan.
Insys had a form speaker agreement drafted by legal counsel.
On July 17, 2012, Chun became the first physician to sign the agree-
ment. Babich signed for Insys. The agreement provided that the
payment to the physician as speaker would be consistent with the
fair market value of the services provided by the speaker and not
based on the volume or value of any business the speaker gener-
ated for Insys. As Burlakoff put it, the notion that the physician
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22-14192 Opinion of the Court 13
would not be paid on the basis of the volume or value of any busi-
ness he generated was “false.” It was “just fluff language that no
one at the company reads, nor do any of the physicians read.” “If
we didn’t have a 2-to-1 return on investment, that speaker no
longer spoke.” Exhibit B to the agreement provided for a $2,400
honorarium for each program Chun conducted and $1,200 for any
additional programs conducted the same day.
Once the speaker program was fully underway, Insys’ Direc-
tor of Sales targeted physicians he referred to as “high decile cus-
tomers.” As Burlakoff explained, “the doctors [we]re decile based
on . . . the number of prescriptions, net revenue and gross revenue
they produce[d] for the rapid onset opioid market, so that would
include us and all competitors, and then separately just Subsys.”
Chun was a high decile customer. Insys’ Director of Sales Opera-
tions “analyzed him as someone that was just an extremely high
prescriber of the rapid onset opioid market.” Insys rated him as “a
10 for the rapid onset opioid market and an 8 or 9 for Subsys.” Bur-
lakoff received an email from Babich stating: “Chun is the Six Mil-
lion Man. A rep could theoretically make 600,000 a year just off
him.”
Burlakoff referred to doctors who would prescribe Subsys in
return for speaker events as: “Game changers, President’s Club
makers, a rep’s dream, you know, golden goose, I mean, but more
often than not we used the term whales.” President’s Club makers,
Burlakoff said, “meant that that physician, if he does what he says
he’s going to do and prescribes Subsys in exchange for the speaker
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14 Opinion of the Court 22-14192
programs we give him, he’s going to send the representative to
President’s Club, which is the highest reward a representative can
be given in the industry.”
Burlakoff left Insys in the summer of 2015. Chun served as
an Insys speaker from July 2012, when he signed the speaker agree-
ment, until Burlakoff departed. Tondre, who made the arrange-
ments for the majority of Chun’s speaker programs, testified that
he set up 100 programs. By the time the Insys speaker program had
run its course in 2015, Chun had received honoraria totaling
$278,900.
Michael Frey—a former family medicine physician who, in
2018, pleaded guilty twice to conspiracy to violate the Anti-Kick-
back Statute, and, cooperating with the Government, 9 testified
against colleagues in similar cases—was well acquainted with
Chun. Frey attended a three-day “speaker training” session with
Chun and over 50 other physicians in Boca Raton, Florida, on No-
vember 14–16, 2014. He testified that during the session, he, Chun,
Dr. De la Garza, and another physician were sitting at a table talk-
ing about the speaker fees they were receiving, and that “Dr. Chun
. . . bragged that he was the highest paid speaker in the country for
his prescription writing.”
The Government’s proof that the Count One conspiracy ex-
isted as alleged was overwhelming. The jury found, and we affirm,
9 United States v. Michael Frey, M.D., No. 2: 18-cr-71-FLM-99CM, 2018 WL
2835942 (M.D. Fla. May 18, 2018).
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22-14192 Opinion of the Court 15
that Chun conspired with four of his co-conspirators—Insys, Ba-
bich, Burlakoff and Tondre—to violate the Anti-Kickback Statute.
B. Substantive Counts
We now move to Counts Two though Eleven, alleging the
Anti-Kickback Statute crimes Chun, Tondre, and their Count One
co-conspirators agreed to commit. The Anti-Kickback Statute
states:
Whoever knowingly and willfully solicits or receives
any remuneration (including any kickback, bribe, or
rebate) directly or indirectly, overtly or covertly, in
cash or in kind--
(A) in return for referring an individual to a
person for the furnishing or arranging for the
furnishing of any item or service for which
payment may be made in whole or in part un-
der a Federal health care program, or
(B) in return for purchasing, leasing, ordering,
or arranging for or recommending purchasing,
leasing, or ordering any good, facility, service,
or item for which payment may be made in
whole or in part under a Federal health care
program,
shall be guilty of a felony and upon conviction
thereof, shall be fined not more than $100,000 or im-
prisoned for not more than 10 years, or both.
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42 U.S.C. § 1320a-7b(b)(1) (emphasis added). 10
Chun is alleged to have committed the offenses described in
Counts Seven through Eleven in 2015. 11 On May 4, 5, 11, 12 and
June 22, respectively, he allegedly received kickbacks in the form
of speaker honoraria for programs that took place in restaurants in
Florida: in Sarasota on April 14 and 28, May 4 and 9, and June 16,
and in Naples twice on May 8. The honoraria totaled $16,700.
Chun presents two arguments in challenging these five
counts. One is that the Government failed to tether the Insys
speaker program scheme to the Anti-Kickback Statute federal
healthcare requirement. The other is that the Government failed
to prove that, in accepting the speaker fees, he acted with the spe-
cific intent to disobey the law. We consider these arguments in
turn.
1. Federal Healthcare Requirement
The Anti-Kickback Statute prohibits a practitioner from
“knowingly” accepting remuneration in exchange for “any item or
service for which payment may be made in whole or in part under
a Federal health care program.” 42 U.S.C. § 1320a-7b(b)(1). We
have not addressed in a published opinion what the Government
10 The Government charged Tondre under Section 1320a-7b(b)(1)’s counter-
part, 42 U.S.C. § 1320a-7b(b)(2), which makes “knowingly and willfully of-
fer[ing] or pay[ing] any remuneration” a felony as well.
11 The offenses Tondre committed as alleged in Counts Two through Six oc-
curred in 2015 on the same dates. On those dates, he paid Chun kickbacks in
the amounts indicated in the text.
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must show to establish this element. But the Fifth Circuit addressed
it in United States v. Shah, 95 F.4th 328 (5th Cir. 2024). There, the
Court held that the Government need only show that the defend-
ant “knowingly agreed to accept remuneration for referring pa-
tients that could be federally insured.” Id. at 352.
We choose to adopt the Fifth Circuit’s reading for two rea-
sons. First, the statute requires only that the “payment may be
made . . . under a Federal health care program.” 42 U.S.C. § 1320a-
7b(b)(1) (emphasis added). The word “may” suggests that the de-
fendant is liable if there is a possibility that payment could come
from a federal health care program. This makes sense given the na-
ture of most medical practices, where Medicare constitutes a por-
tion, but not the entirety, of the patients’ insurance coverage. Sec-
ond, this reading is in line with the plain reading of 42 U.S.C.
§ 1320a-7b(h) (“[A] person need not have actual knowledge of this
section or specific intent to commit a violation of this section.”).
Here, the Government introduced evidence that Chun had
participated in the Medicare program, and, therefore, that he had
Medicare patients. Based on this, a jury had sufficient evidence to
find that Chun knowingly agreed to accept remuneration for refer-
ring patients who could be federally insured.
2. Specific Intent
Willful conduct under the Anti-Kickback Statute requires
that the act be “committed voluntarily and purposely, with the spe-
cific intent to do something the law forbids.” United States v. Nerey,
877 F.3d 956, 969 (11th Cir. 2017) (quoting United States v. Vernon,
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18 Opinion of the Court 22-14192
723 F.3d 1234, 1256 (11th Cir. 2013)). 12 Chun points to several
pieces of evidence as proof that he lacked the specific intent to vio-
late the law. First, he states that he was not aware ahead of time
who or how many people would be attending the events. Second,
he had no role in forging or submitting the forged sign-in sheets.
Finally, Chun argues that from the circumstantial evidence in the
record, the jury could not have found that he served as a speaker
for Insys in exchange for writing Subsys prescriptions.
While these points could have been persuasive at trial, the
jury ultimately chose not to accept them. The evidence that Chun
had the specific intent to do something the law forbids was over-
whelming. He knew the speaker programs were shams, and he
nevertheless collected payment for them. For example, several at-
tendees testified that Chun’s programs lacked any educational
component, were poorly attended, or were attended by inappro-
priate people—such as family members. The jury also heard testi-
mony that Tondre asked Chun who he wanted to invite to his
speaker programs. The Government introduced evidence that dur-
ing the time these sham events were occurring, Chun began pre-
scribing more and more Subsys—proof that the speaker programs
existed to induce him to prescribe more.
12 Chun also argues that the jury’s conviction for illegal renumerations re-
quired an impermissible stacking of inferences. The stacking-of-inference ar-
gument is a ubiquitous argument, made in countless criminal, and civil, cases.
It is frivolous. So, we do not address it.
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22-14192 Opinion of the Court 19
As for the sign-in sheets, the Government introduced evi-
dence that they contained forged signatures for each of the speaker
events described in Counts Two through Eleven. Additionally, sev-
eral attendees appeared on multiple sign-in sheets. And Chun’s
nurse practitioner testified that her signature had been forged on
multiple sign-in sheets and, in one instance, had been misspelled in
the same way Chun frequently misspelled it. Not only does this
contradict Chun’s argument that he had no role in forging the sign-
in sheets, but it is also circumstantial evidence that he was aware
of the illegitimate purpose of the speaker programs.
Chun seems to have missed the essence of what made his
conduct illegal. His crime was not forging the signatures of physi-
cians and others who did not attend his programs. His crime was
being paid to prescribe—for which the Government provided am-
ple evidence. In sum, the jury had sufficient evidence to support its
verdicts. 13
13 Tondre alludes to an insufficiency of the evidence argument for the substan-
tive counts in the “Summary of the Argument” section of his initial brief. He
argues that he did not pay Chun for the events nor did he cause Chun’s pay to
be increased in any material way. Like with Chun, there was overwhelming
evidence for the jury to find that Tondre acted with specific intent to do some-
thing the law forbids. In addition to introducing evidence that Tondre forged
the sign-in sheets, which he concedes, the Government also introduced evi-
dence that Tondre was aware that the speaker programs were poorly at-
tended, had inappropriate attendees, and lacked a proper educational compo-
nent. A reasonable jury could easily find that Tondre knew the true purpose
of the speaker programs was not to educate local physicians about Subsys, but
rather to transfer cash from Insys to Chun in exchange for prescribing Subsys.
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20 Opinion of the Court 22-14192
C. Safe-Harbor Provision
Finally, we address Tondre’s remaining challenge to the Dis-
trict Court’s denial of his motion for judgment of acquittal. Tondre
argues that there was insufficient evidence introduced at trial for
the jury to convict him of participating in a conspiracy to violate
the Anti-Kickback Statute. Specifically, he argues the Anti-Kickback
Statute contains a safe-harbor provision for employees, and, as an
employee of Insys, he is shielded from prosecution. Tondre did not
raise this issue below. However, he asserts that since the safe har-
bor provision is not an affirmative defense, but rather a broad ex-
clusion of who the Anti-Kickback Statute applies to, his failure to
raise the issue at the District Court does not constitute a waiver.
The safe harbor provision of the Anti-Kickback Statute pro-
vides that “Paragraphs (1) and (2) shall not apply to . . . any amount
paid by an employer to an employee (who has a bona fide employ-
ment relationship with such employer) for employment in the pro-
vision of covered items or services.” 42 U.S.C. § 1320a-7b(3)(B).
We have previously held that the safe harbor provision con-
tained in 42 U.S.C. § 1320a-7b(3)(B) is an affirmative defense. See
Vernon, 723 F.3d at 1271. Affirmative defenses, if not raised at trial,
are waived. See United States v. Najjar, 283 F.3d 1306, 1308 (11th Cir.
2002). Because Tondre failed to raise this affirmative defense at
trial, it is waived and we do not consider it further.
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22-14192 Opinion of the Court 21
II. JURY QUESTIONS
Chun14 argues that, by answering two questions posed by
the jury, the District Court invaded the province of the jury.
“A trial judge has some obligation to make reasonable ef-
forts to answer a question from the jury.” United States v. Rodriguez,
765 F.2d 1546, 1553 (11th Cir. 1985). The district court has consid-
erable discretion when responding to jury questions, but it does not
have the discretion to “misstate the law or confuse the jury.” United
States v. Lopez, 590 F.3d 1238, 1247–48 (11th Cir. 2009). Challenged
supplemental jury instructions are reviewed in light of the entire
jury charge to determine whether the jury was misled. Id. at 1248.
District courts should “answer within the specific limits of the ques-
tion presented and resolve the jury’s difficulties with concrete ac-
curacy.” United States v. Joyner, 882 F.3d 1369, 1375 (11th Cir. 2018)
(internal quotation marks omitted).
“We review a district court’s response to a jury question for
an abuse of discretion.” Lopez, 590 F.3d at 1247. When applying an
abuse of discretion standard,