United States Court of Appeals
`For the First Circuit
`
`
`
`No. 19-1621
`
`
`
`
`
`UNITED STATES,
`Appellee,
`v.
`CHRISTOPHER CLOUGH,
`Defendant, Appellant.
`
`APPEAL FROM THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW HAMPSHIRE
`
`[Hon. Joseph Laplante, U.S. District Judge]
`
`
`Before
`
`Howard, Chief Judge,
`Lynch, and Thompson, Circuit Judges.
`
`
`William E. Christie, Shaheen & Gordon, PA, for appellant.
`
`Scott W. Murray, United States Attorney, with whom Seth R.
`
`Aframe, Assistant United States Attorney was on brief, for
`appellee.
`
`
`
`
`
`October 23, 2020
`
`
`
`
`
`
`
`
`For the First Circuit
`
`
`
`No. 19-1621
`
`
`
`
`
`UNITED STATES,
`Appellee,
`v.
`CHRISTOPHER CLOUGH,
`Defendant, Appellant.
`
`APPEAL FROM THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW HAMPSHIRE
`
`[Hon. Joseph Laplante, U.S. District Judge]
`
`
`Before
`
`Howard, Chief Judge,
`Lynch, and Thompson, Circuit Judges.
`
`
`William E. Christie, Shaheen & Gordon, PA, for appellant.
`
`Scott W. Murray, United States Attorney, with whom Seth R.
`
`Aframe, Assistant United States Attorney was on brief, for
`appellee.
`
`
`
`
`
`October 23, 2020
`
`
`
`
`
`
`
`
`
`THOMPSON, Circuit Judge. In a pattern of drug company
`kickback schemes repeating through criminal prosecutions across
`the United States, a jury convicted Christopher Clough of violating
`federal laws by conspiring to receive, and of actually receiving,
`kickbacks from the pharmaceutical company Insys in exchange for
`prescribing its synthetic opioid Subsys.1 Clough was one of the
`country's top-five prescribers of Subsys, and some of his patients
`suffered the unfortunate consequences of that ranking, including
`opioid addiction. Insys repaid Clough's prescribing diligence by
`giving him a place in the company's speaker program -- a perk that
`paid him nearly $50,000, often to "educate" non-existent audiences
`about the miracles of Subsys. On appeal Clough claims the
`government introduced insufficient evidence to support his
`convictions and that the government had the burden to prove that
`his conduct fell outside of the Anti-Kickback Statute's personal
`services safe harbor provision. And compounding this error, says
`Clough, was the district court's failure to instruct the jury about
`that same safe harbor provision. Finding no merit in Clough's
`arguments, we affirm.
`
`
`1 Subsys is a transmucosal immediate release fentanyl
`("TIRF") drug that is delivered into the body by means of a spray
`under the tongue and that the FDA approved for terminal cancer
`patients who experience extreme "breakthrough pain" and who are
`otherwise already on round-the-clock opioids. The major risks
`associated with TIRF drugs include respiratory depression (slowed
`breathing), sedation, and addiction.
`
`- 2 -
`
`
`
`BACKGROUND
`Because Clough challenges the sufficiency of the
`
`
`evidence, "we will recite the facts in the light most compatible
`with the jury's verdict." United States v. Serunjogi, 767 F.3d
`132, 135 (1st Cir. 2014) (citing United States v. Polanco, 634
`F.3d 39, 40 (1st Cir. 2011)). We summarize the facts to begin,
`adding more later as needed for our legal discussions.
`Speaker for Hire
`
`
`With disappointing profits following Subsys's initial
`release, Insys crafted a sham speaker program. This is how it
`worked. Company executives undertook to supercharge prescriptions
`of the expensive drug by finding "just one good doc[tor]" or
`physician assistant2 in areas across the country willing to push
`its pharmaceutical without constraint. The scheme was simple; the
`more prescriptions that medical providers wrote for higher doses
`(which brought in sinful profits to Insys), the more meetings got
`scheduled in which Insys would pay providers like Clough to tout
`the phenomenal benefits of Subsys to other medical prescribers.3
`
`
`2 For simplicity, we will collectively refer to doctors,
`nurse practitioners, physician assistants, and other medical
`providers as "medical providers" throughout the opinion.
` Indeed, Insys deployed this scheme across the nation. See
`Stacey A. Tovino, Fraud, Abuse, and Opioids, 67 U. Kan. L. Rev.
`901, 909-914 (June 2019) (describing multiple convictions for
`violations of Anti-Kickback Statute of medical providers who
`participated in Insys's speaker program across the nation); see
`also United States v. Ruan, 966 F.3d 1101, 1146 (11th Cir. 2020)
`
` 3
`
`- 3 -
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`
`
`All too often though, nobody showed up for these presentations.
`Yet, Insys still paid the speakers, thus "hook[ing]" them in the
`same way that Subsys threatened to hook patients. Clough concedes
`that the Insys speaker program was an illegal scheme designed to
`incentivize physicians and providers to prescribe Subsys. He just
`contends he kept free from the taint.
`
`
`Natalie Levine,4 an Insys pharmaceutical representative
`who sold Subsys and who "pled guilty to a conspiracy with
`prescribers to [organize] sham speaker programs" with "kickbacks"
`for those prescribers, barely broke a sweat looping Clough, a
`licensed physician assistant, into the scheme. When the two met,
`Clough worked at PainCare, a pain management clinic located in
`Somersworth, New Hampshire.5 As it happened, in the summer of
`
`
`(affirming guilty verdict for two doctors who conspired to violate
`the Anti-Kickback Statute because defendants agreed to "sham"
`speaker program with Insys); United States v. Schlifstein, No. 18-
`CR-217 (KMW), 2020 WL 2539123, at *1 (S.D.N.Y. May 19, 2020)
`(describing "sham" Insys speaker programs for doctors who pled
`guilty to violating Anti-Kickback Statute, which "operated as
`follows: Insys paid kickbacks to the defendants in the form of
`speaker fees for sham Speaker Programs, and, in exchange, the
`defendants prescribed Subsys to their patients"); United States v.
`Freedman, No. 18-CR-217 (KMW), 2019 WL 3296967, at *1 (S.D.N.Y.
`July 23, 2019) (same).
` Following the events described, Natalie Levine married
`Insys President and CEO Michael Babich. Throughout his briefing,
`Clough refers to Levine using her married name, Natalie Babich.
`However, to steer clear of any possible confusion, we will refer
`to her by her maiden name.
` In New Hampshire, a physician assistant can prescribe
`medication under the supervision of a practicing physician.
`
` 4
`
` 5
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`- 4 -
`
`
`
`2013, Clough inherited from a departing physician a patient who
`needed a refill of his prescription for Subsys. Because Clough
`had never prescribed the drug, PainCare invited Levine to attend
`Clough's first appointment with the patient to teach Clough how to
`navigate the complicated process of prescribing Subsys6 and of
`getting a specialty pharmacy to fill and dispense it. Moments
`after Clough approved and completed the Subsys refill (and while
`the patient was still in the room), Levine asked Clough if he would
`like to participate in the Insys paid speaker program. Clough
`jumped at the opportunity, but, as he explained, he wanted "doctor
`money."
`Becoming an Insys Proselytizer to No One in Particular
`
`
`Despite Clough's eagerness, Insys required medical
`providers to hand out multiple doses to multiple patients before
`approving the provider as a speaker. So, Clough went at it.
`Clough had already written a second prescription on the very same
`
`
`However, the supervising physician is not required to approve each
`prescription that the physician assistant writes, even for
`controlled substances such as fentanyl.
` Prescribing Subsys was an onerous task. First, as a schedule
`II-controlled substance, medical providers needed to work through
`a specialty pharmacy to deliver Subsys to patients. Second,
`insurance companies did not want to cover Subsys due to its high
`cost and because medical providers could alternatively prescribe
`much cheaper generic TIRF drugs. To overcome that boundary, Insys
`representatives helped medical providers and their staffs obtain
`a "prior authorization" from the insurance company by convincing
`the companies that the patient needed Subsys instead of other,
`cheaper drugs.
`
` 6
`
`- 5 -
`
`
`
`day, June 27, 2013, that he first voiced interest in becoming an
`Insys speaker. Once Levine informed him of Insys's prescription
`requirement, Clough accelerated his pace, writing thirty-two
`prescriptions in July, almost all for doses higher than the
`recommended starting amount.
`Clough's whole-hearted embrace of Subsys did not escape
`Insys's notice. During a phone call in early August with Alec
`Burlakoff, Insys's Vice President of Sales, Burlakoff claimed he
`"could literally feel" Clough's enthusiasm about prescribing
`Subsys "coming through the phone;" this, even though Clough had
`almost certainly not had any follow-up visits with patients to
`whom he had prescribed the drug only a few weeks prior. Weeks
`into doling out Subsys, Clough had yet to lead any speaker
`programs. So Burlakoff stepped in and ordered Insys to provide
`Clough with substantial speaker opportunities. Those executing
`Burlakoff's demand, including Levine's boss, Jeffrey Pearlman,
`testified that the directive from the higher ups indicated clearly
`that "Clough was on board with the speaker programs and [with]
`Insys's way of using him" to drum up prescriptions. Indeed, it
`was Insys's strategy to "throw[] it in [the providers'] face[s]"
`that they would get "X [speaker] programs for X dollars" in
`speaker's fees.
`
`
`On August 16, 2013, Clough signed the standard "Speaker
`Agreement" provided by Insys to its participating medical
`
`- 6 -
`
`
`
`providers. That agreement contains an express clause disclaiming
`any whiff of a notion that Insys would induce Clough to write more
`prescriptions in exchange for providing him with more speaker
`opportunities at $1,000 a pop.7 Yet Insys sales representatives,
`including Levine, testified to a separate unwritten but clearly
`understood side deal -- "kind of just like a little contract, but
`not an actual piece of paper contract" -- by which Insys paid
`medical providers speakers' fees in exchange for prescriptions.
`The number of prescriptions was the "only factor" in how Insys
`allocated those events, and Levine stated that Clough knew as much.
`Once Clough put his signature on the Speaker Agreement, he upped
`his prescription ante, meting out Subsys to an increasing number
`of patients in increasing dosages, sometimes without ever
`informing his patients of the prescription or the substantial risks
`associated with the drug, let alone telling them about his
`financial interest in the success of Subsys.8
`
`
`7 According to the agreement, Clough's compensation for
`participating in the speaker's program "will not be based upon the
`volume or value of any business generated between speaker and INSYS
`with respect to INSYS products."
` The parties stipulated that the federal government, through
`Medicare, paid about $2.1 million for a portion of the Subsys
`prescriptions that Clough wrote.
`
`
` 8
`
`- 7 -
`
`
`
`Speaking to No One in Particular
`Between September 2013 and October 2014, Clough
`
`
`participated in approximately one Insys speaker program per week,
`earning himself about $49,303 in fees.9 If the event turned out
`to be a no-show, Clough's contract with Insys formally mandated
`that the program be cancelled resulting in no payment to the
`speaker. Informally though, Insys executives preferred for the
`events, all of which got booked in high-end restaurants, not to be
`cancelled so as to keep prescribers hooked on the money. For a
`majority of the dinners for which Insys paid Clough, Levine gave
`Clough notice in advance that no other providers had RSVP'd to
`attend. But none of the dinners were kiboshed. Instead, Clough
`provided Levine with the names of other medical providers, mostly
`his colleagues, and then forged their signatures on a sign-in
`sheet, which concealed the illegitimacy of the sham speaking
`engagement, and which gave cover to Insys to pay Clough without
`appearing to violate the Anti-Kickback Statute. Multiple medical
`providers with whom Clough had worked, including his ex-wife with
`whom he was going through a divorce at that time, testified that
`
`
`9 This does not include the value of the many dinners at
`fancy restaurants for which Insys paid.
`
`- 8 -
`
`
`
`they never attended events for which their names appeared on
`Clough's sign-in sheets.
`Trial with an Audience of 12
`Following an investigation into this scheme, Clough was
`charged with one count of conspiracy to accept kickbacks for
`prescribing drugs paid for by a federal health care program in
`violation of 18 U.S.C. § 371 and seven counts of accepting such
`kickbacks in violation of the Anti-Kickback Statute, 42 U.S.C.
`§ 1320a-7b(b). During the six-day trial that ensued, Clough
`properly moved for judgment of acquittal pursuant to Federal Rule
`of Criminal Procedure 29, arguing "that there's not enough
`[evidence] to proceed to the jury." The court reserved judgment
`allowing the case to go to a New Hampshire jury which found Clough
`guilty of all charges. Thereafter, the district court denied
`Clough's Rule 29 motion and imposed sentence.10 And here we are.
`DISCUSSION
`Before us Clough advances arguments which boil down to
`
`
`two overarching claims of error: (1) the government did not
`present sufficient evidence to prove that he participated in a
`conspiracy to receive kickbacks, or to prove that he accepted those
`kickbacks in exchange for prescribing Subsys; and (2) the district
`
`
`10 The district court sentenced Clough to forty-eight months
`imprisonment, followed by two years of supervised release, and
`ordered Clough to pay $700,000 in restitution for a serious crime
`akin to "drug trafficking."
`
`- 9 -
`
`
`
`court committed plain error by not (sua sponte) instructing the
`jury about a safe harbor provision within the Anti-Kickback
`Statute. Neither argument convinces.
`1. Sufficiency of the Evidence
`Defendants who challenge the sufficiency of the evidence
`
`
`journey a road well-traveled. Because Clough moved for a judgment
`of acquittal at trial asserting the same arguments below as here,
`he, as lawyers say, preserved the argument for appeal, and we
`accordingly review his appeal as if we were the first court to
`examine the question (i.e. de novo). See United States v. Acevedo-
`Hernández, 898 F.3d 150, 161 (1st Cir. 2018). To answer Clough's
`sufficiency challenge, we look at the evidence in the light most
`favorable to the verdict. See id. From there, we determine
`whether any reasonable jury, using common sense inferences based
`on their life experiences and knowledge, "could find all the
`elements of the crime proven beyond a reasonable doubt." Id.; see
`United States v. Iwuala, 789 F.3d 1, 11 (1st Cir. 2015) (reviewing
`conviction for health care fraud). We will not "weigh the evidence
`or make credibility judgments; these tasks are solely within the
`jury's province." Serunjogi, 767 F.3d at 139 (quoting United
`States v. Hernández, 218 F.3d 58, 64 (1st Cir. 2000)).
`Importantly, both direct and circumstantial evidence, whether
`alone or in concert, can sustain a conviction. See Hernández, 218
`
`- 10 -
`
`
`
`F.3d at 64 (1st Cir. 2000) (quoting United States v. Ortiz, 966
`F.2d 707, 711 (1st Cir. 1992)).
`
`This standard applies both to Clough's challenge to the
`conspiracy conviction and to the conviction of violating the Anti-
`Kickback Statute. We tackle each in turn.
`A. Agreeing to Violate the Agreement (Conspiracy)
`To prove that Clough conspired "to defraud the United
`
`
`States, or any agency thereof," under 18 U.S.C. § 371, the
`prosecution must demonstrate beyond a reasonable doubt
`that: (1) there was an agreement to commit an unlawful act --
`here violating the Anti-Kickback Statute -- between the defendant
`and at least one other party; (2) the defendant participated
`knowingly and voluntarily in the conspiracy with the intent to
`violate the Anti-Kickback Statute; and (3) the defendant or
`another conspirator committed an overt act in furtherance of the
`conspiracy to violate the Anti-Kickback Statute.11 See Acevedo-
`
`
`11 The third element -- an overt act -- is not in dispute
`because Clough wisely does not contend that he or a coconspirator
`never acted overtly in furtherance of the conspiracy. See United
`States v. Acevedo-Hernández, 898 F.3d 150, 161 (1st Cir. 2018).
`Such an argument would fall flat on its face considering that
`Clough participated in the speaker program, prescribed Subsys, and
`even fraudulently claimed that prescribers had attended his talks.
`Although 18 U.S.C. § 371 by its language requires an overt act to
`prove a conspiracy, see 18 U.S.C. § 371 ("[i]f two or more persons
`conspire either to commit any offense against the United States,
`or to defraud the United States, or any agency thereof in any
`manner or for any purpose, and one or more of such persons do any
`act to effect the object of the conspiracy.") (emphasis added),
`not every conspiracy statute in the United States Code mandates
`
`- 11 -
`
`
`
`Hernández, 898 F.3d at 161; United States v. Nowlin, 640 F. App'x
`337, 343 (5th Cir. 2016) (reviewing sufficiency challenge of
`conviction for conspiracy to violate Anti-Kickback Statute
`pursuant to 18 U.S.C. § 371). To succeed, the government therefore
`needed to prove that Clough conspired with Insys to receive illegal
`remuneration (the kickback payments through the speaker's program)
`as an inducement and in exchange for his prescribing Subsys to his
`patients in violation of the Anti-Kickback Statute.12 See United
`States v. Gorski, 880 F.3d 27, 31-32 (1st Cir. 2018) (government
`must not only prove defendant intended to agree, but that defendant
`
`
`that the government prove this third element, see, e.g., 18 U.S.C.
`§ 1349 (criminalizing "[a]ny person who attempts or conspires to
`commit any offense under this chapter"); 21 U.S.C. § 846 (no overt
`act requirement for conspiracy to possess drugs with the intent to
`distribute pursuant to 21 U.S.C. § 841(a)(1)).
`
`12 The full text of the Anti-Kickback Statute, 42 U.S.C.
`§ 1320(a)-7b(b), reads:
`(b) Illegal remunerations
`(1) 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 under 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 imprisoned for
`not more than 10 years, or both.
`
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`- 12 -
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`
`
`willfully entered agreement with intent to violate underlying
`statute).
`In general, the government may prove "a conspiracy . . .
`
`
`based on a tacit agreement shown from a[] . . . working
`relationship." United States v. Willson, 708 F.3d 47, 54 (1st
`Cir. 2013) (quoting United States v. Patrick, 248 F.3d 11, 20 (1st
`Cir. 2001)); see also United States v. Ríos-Ortiz, 708 F.3d 310,
`315-16 (1st Cir. 2013) ("A conspiratorial agreement . . . 'need
`not be express so long as its existence can plausibly be inferred
`from the defendants' words and actions . . . .'") (quoting United
`States v. Famania–Roche, 537 F.3d 71, 78 (1st Cir. 2008)).
`Further, as with any conviction, the government can prove that a
`defendant agreed to conspire based on circumstantial evidence.
`See United States v. McDonough, 727 F.3d 143, 156 (1st Cir. 2013)
`(quoting United States v. Rivera Calderón, 578 F.3d 78, 88 (1st
`Cir. 2009)). Moreover, in a case such as this, because a written
`contract disavowing kickbacks does not necessarily defeat the
`government's case, we must examine whether a rational jury, based
`on all evidence presented, could find that Clough had otherwise
`entered into a conspiracy with Insys to defraud the government
`notwithstanding his signature on the Speaker Agreement containing
`the disclaimer. See United States v. Tull-Abreu, 921 F.3d 294,
`305 (1st Cir. 2019) (holding that no direct testimony needed from
`
`- 13 -
`
`
`
`coconspirators to prove agreement to conspire to commit health
`care fraud).
`Clough struggles to speak over the volume of the
`government's case by arguing that the prosecution could not prove
`either of the first two elements of conspiracy: (1) the existence
`of an agreement; and (2) his knowing and voluntary participation
`with the intent to violate the Anti-Kickback Statute. Clough tries
`to shield himself by pointing to the formal Speaker Agreement and
`its explicit terms prohibiting Insys from tying speaker fees to
`Clough's prescribing habits.13 Because of those terms, Clough
`assiduously insists that he could not have willfully entered into
`a conspiracy with the intent to violate the Anti-Kickback Statute
`because he understood his relationship with Insys to be exactly as
`
`
`13 In this line of argument, Clough also maintains that
`because the government's case was based on circumstantial evidence
`(which it was), the government had the burden of proving that
`participation in the paid speaker program was an "obviously illegal
`activity" and that Clough was "ready to assist" in a criminal
`enterprise. That argument ends before Clough's presentation
`begins. That quoted standard is relevant to a charge of aiding
`and abetting, not conspiracy. See, e.g., United States v. Pérez-
`Meléndez, 599 F.3d 31, 42 (1st Cir. 2010) (holding that in
`circumstantial evidence cases, aiding and abetting liability
`requires proof "(1) that the vessel was engaged in obviously
`illegal activity and (2) that each defendant was ready to assist
`in the criminal enterprise") (quoting United States v. Guerrero,
`114 F.3d, 332, 342 (1st Cir. 1997)). The government did not charge
`Clough with aiding and abetting a conspiracy. See 18 U.S.C. § 2
`(general aiding and abetting statute). At trial, the government
`had no burden to address whether Clough participated in an
`"obviously illegal activity" or that he was ready to assist in a
`criminal enterprise.
`
`
`- 14 -
`
`
`
`the document describes, legal in every respect. Even if he had a
`"casual" understanding that Insys intended the speaker program to
`incent him to write prescriptions, Clough argues that the
`government provided insufficient direct evidence that he agreed to
`such a scheme. Dripping with incredulity, the government's brief
`hammers the wealth of circumstantial evidence that works against
`Clough's sophistry. So we turn to the evidence examined by the
`jury regarding Clough's conspiratorial decision-making, keeping in
`mind Clough's sufficiency challenge.
`On the first day Clough prescribed Subsys, he informed
`Levine that he wanted to join the speaker program, so long as he
`was paid "doctor money." When Levine soon thereafter told Clough
`that he could not participate without prescribing Subsys to
`multiple patients in multiple doses, Clough stepped up his
`prescription-writing prowess. In a matter of weeks, he had gone
`from having just learned about Subsys, and having only rarely
`prescribed other fast-acting fentanyl drugs in his career, to
`writing up copious Subsys scripts. He also expressed his palpable-
`through-the-phone excitement about the drug to Insys executive
`Burlakoff in early August, likely before he had done any patient
`follow-up. By the time Clough signed the Speaker Agreement on
`August 16, 2013, he had prescribed Subsys around fifty times to
`his patients. A reasonable juror could infer that Clough's
`enthusiasm and prescribing practices came not from an infatuation
`
`- 15 -
`
`
`
`with the drug's efficacy as Clough argues, but from his knowledge
`that Insys would pay him through speaking events if he were to
`maintain or to accelerate his eye-popping Subsys prescribing pace.
`See, e.g., Iwuala, 789 F.3d at 11 (jury could find agreement to
`conspire to commit health care fraud from circumstantial
`evidence).
`Also, Clough's avarice, in the eyes of the jury, could
`well have demonstrated that he entered into a tacit agreement with
`Insys that went beyond the words of the Speaker Agreement. Levine
`testified that she and Clough had a "mutual understanding that if
`[he] write[s more] prescriptions [for Subsys], [he]'ll get more
`speaker programs." She described the understanding as more or
`less an oral agreement. At a dinner with Clough, Levine's boss
`made it clear that he "just need[ed] a few more patients and I can
`get you [(Clough)] a few more programs." Clough, according to
`Levine, responded in a way to make it clear that "he was fine with
`it; he was fine writing the drug." Clough's Insys business
`partners, as brought out during trial, certainly believed that
`they had a tacit agreement with Clough, and it was rational for a
`jury to find that Clough comprehended the true nature of his
`relationship to Insys. See Willson, 708 F.3d at 54; see also,
`Serunjogi, 767 F.3d at 139 (credibility determinations are for the
`trier of fact).
`
`- 16 -
`
`
`
`Further, Levine and Clough had a close working
`relationship; they spent many nights having dinner, either alone
`or with a group of Levine's friends, when no one would show up for
`Clough's nearly weekly speaking engagements (for which he still
`received pay despite doing no work other than prescribing Subsys).
`Levine also often travelled to Clough's office to help with the
`mountainous paperwork required to prescribe controlled substances
`like Subsys.14 Because of this regular business contact, a rational
`jury could find that Clough understood and tacitly agreed to
`Levine's "casually" conveyed message that Insys would pay Clough
`kickbacks through its speaker program so long as he prescribed
`Subsys in satisfactory quantities and doses (Insys would earn even
`more money when Clough prescribed higher doses). The jury had
`sufficient evidence, viewed in the light most favorable to the
`verdict, to conclude that the written speaker agreement was nothing
`but a smokescreen to hide Clough's conspiratorial conduct. See
`Willson, 708 F.3d at 54; Serunjogi, 767 F.3d at 139; United States
`v. Pfizer, 188 F. Supp. 3d 122, 134 (D. Mass. 2016) ("Formal
`
`
`14 Clough even had Levine complete certain applications to
`insurance companies that had denied coverage for Subsys to
`patients. The applications are supposed to be tailored to the
`individual patient, with the medical provider providing
`individualized reasons that they believe the previously denied
`medication was medically necessary for the patient. Rather than
`drafting those individualized applications himself, Clough
`provided a standard form to Levine to complete. The completed
`forms described a common collection of symptoms, often word for
`word, no matter what the patient actually suffered.
`
`- 17 -
`
`
`
`policies, of course, are only as good as their implementation; the
`very nature of a sham is that it pretends to be compliant when it
`is not.").
`
`
`Turning to Clough's contention that the government
`provided insufficient evidence for a rational jury to find that he
`knowingly and voluntarily participated in the conspiracy with the
`intent to violate the Anti-Kickback Statute, we first sketch out
`the government's legal burden before applying law to facts. To
`prove Clough's intent, the government had to show that the
`defendant agreed to engage in the forbidden conduct, see United
`States v. Feola, 420 U.S. 671, 687 (1975), which here involved
`"knowingly and willfully" receiving illegal kickbacks in exchange
`for doling out prescriptions, see 42 U.S.C. § 1320a-7b(b)(2)(A).
`Without direct evidence, the government could prove "[a]
`defendant's knowing and [willful] participation" through
`"'inferences from acts committed by the defendant that furthered
`the conspiracy's purposes.'" Acevedo-Hernández, 898 F.3d at 162
`(quoting United States v. Castro-Davis, 612 F.3d 53, 60 (1st Cir.
`2010)). The already-described circumstantial evidence that Clough
`and Insys had an agreement to conspire also provides ample examples
`that Clough did so willingly and with the intent to violate the
`Anti-Kickback Statute so we need not repeat it here.15 But there
`
`
`15 A defendant need not have the intent to violate the Anti-
`Kickback Statute for a jury to convict the defendant of violating
`
`- 18 -
`
`
`
`is plenty more, some of which we highlight to explain why Clough's
`appeal cannot succeed.
`For one, Clough lied to an FBI investigator in 2016 about
`his interactions with Insys and about his prescribing habits for
`Subsys. When asked about Levine, Clough pretended not to be able
`to remember her name, despite their multiple business and social
`interactions -- he even took her to a World Series game at Fenway
`Park. Clough also falsely told the FBI investigator that he
`started most patients at the minimum dosage of Subsys (100
`micrograms) and that he never prescribed more than 400 or 500
`micrograms.16 The jury heard statistical evidence that put the
`truth to the lie. Another FBI investigator analyzed Clough's
`prescribing habits; he only prescribed 100 micrograms of Subsys
`once through his first 100 prescriptions, and he often prescribed
`the maximum of 1600 micrograms. The jury could have believed that
`Clough's memory failed him regarding Levine's name and his
`prescribing habits due to his rough emotional state at the time of
`
`
`the statute. It is enough that he knowingly and voluntarily
`accepts kickbacks. See 42 U.S.C. § 1320a-7b(b).
`
`16 The jury also heard evidence from which they could have
`inferred that Clough lied about why he stopped prescribing Subsys
`to his patients in 2014 when an insurance company investigated
`whether Clough's prescriptions, for which they paid, were
`legitimate. Clough claimed that he slowly stopped prescribing the
`medicine in early 2014 because he believed that its efficacy was
`diminishing, yet he continued to be a paid Insys speaker and to
`prescribe the drug through August 2014.
`
`- 19 -
`
`
`
`the interview, as he so testified. Or the jury could have inferred
`that Clough had fibbed to the FBI because he knew that his
`arrangement with Insys was conspiratorial and illegal. See United
`States v. Davis, 909 F.3d 9, 19 (1st Cir. 2019) ("It is a well-
`settled principle that false exculpatory statements are evidence
`-- often strong evidence -- of guilt.") (internal citation and
`quotation marks omitted).
`As for other evidence submitted to prove that Clough
`knowingly and willingly participated in the kickback scheme,
`recall this. Levine "let [Clough] know" that Insys was "so happy
`that you've been writing a lot of their drug, so in return, we're
`going to give you some more speaker programs," and "I just need a
`few more patients and I can get you a few more programs." Remember
`too, the multiple no-show events wherein Levine testified that
`Clough forged the signatures of his co-workers to ensure Insys
`would pay him for speaker programs. The jury has the right to
`credit Levine's testimony which shows Clough was aware that the
`conspiracy involved kickbacks in exchange for prescriptions. See
`Serunjogi, 767 F.3d at 140.
`
`
`The manner in which Clough treated his patients is
`additional evidence that he knowingly and voluntarily joined the
`conspiracy with the intent to violate the Anti-Kickback Statute.
`For several of them, Subsys endangered their health (if not their
`lives). Clough gave opioid-dependent patients high dosages of
`
`- 20 -
`
`
`
`this highly-addictive fentanyl drug, even when patients had no
`problems with their existing medicine regimen or when patients
`requested that Clough not change their existing prescriptions to
`include Subsys because they, in fact, worried about opioid
`addiction. Clough was apparently "fairly insistent" about his
`patients taking the drug, even going so far as to send Subsys
`prescriptions to two patients who did not know that he had
`prescribed it for them until it was delivered to their front doors.
`And he refused to change the Subsys prescription for patients who
`complained that the drug made them fall asleep at work or in
`public, telling one patient to stop "being a baby." Patients made
`Clough aware of other health problems resulting from their use of
`Subsys, but he did not lower their dosage or stop prescribing.
`Few, if any, of those patients had terminal cancer, which is the
`type of patient for whom Insys purportedly developed Subsys. Nor
`did Clough tell his patients about the drug's substantial risks.
`Continuing the abhorrent pattern, Clough withheld from them that
`he was a paid Insys speaker, which ethical rules required him to
`do so that his patients could decide whether Clough prescribed
`them medicine for their benefit or for his own. Finally, a clear
`pattern emerged showing a direct correlation between Clough
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