United States v. Clough, 978 F.3d 810

Background

Christopher Clough, a physician assistant and one of the nation's top Subsys prescribers, participated in Insys’s paid "speaker" program and received about $49,303 in speaker fees.
Insys operated sham speaker events (often no shows); Insys sales reps gave speakers fees tied informally to prescribing volume despite a written Speaker Agreement disclaiming such ties.
Clough increased Subsys prescriptions and doses after joining the program, sometimes without patient notice or medical justification; co-workers’ names were forged on sign‑in sheets for no‑show events.
Federal prosecutors charged Clough with conspiracy to receive kickbacks (18 U.S.C. § 371) and multiple substantive violations of the Anti‑Kickback Statute (42 U.S.C. § 1320a‑7b(b)); a jury convicted him on all counts.
On appeal Clough argued (1) insufficient evidence for both the conspiracy and substantive AKS convictions and (2) the district court erred by failing to instruct the jury about the AKS personal‑services safe harbor.
The First Circuit affirmed: it found ample circumstantial evidence of a tacit pay‑for‑prescriptions agreement and held any safe‑harbor theory was either forfeited or, in any event, rebutted by the evidence.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Sufficiency of evidence for conspiracy to receive kickbacks	Circumstantial proof (oral "mutual understanding," prescribing spike, payments, forged sign‑in sheets, lies to FBI) shows tacit agreement and intent	Written Speaker Agreement disavowed pay‑for‑prescriptions; Clough thought program lawful and lacked criminal intent	Jury rationally inferred agreement and willful participation; conspiracy conviction affirmed
Sufficiency of evidence for substantive Anti‑Kickback violation	Payments were remuneration tied to volume/value of Subsys prescriptions and thus outside the safe harbor; evidence supports knowing receipt	Speaker Agreement brought payments within the safe harbor; government failed to disprove safe‑harbor protection	Evidence sufficed to show payments were determined by prescription volume; substantive convictions affirmed
Burden regarding safe harbor (who must disprove it)	Government met any burden to show payments fell outside the safe harbor	Clough contends government had to prove he was outside safe harbor because of the written agreement	Court noted unsettled circuit law on burden but held that even assuming govt had the burden, the record rebutted safe‑harbor protection
Omission of safe‑harbor jury instruction	No instruction required because defendant did not request or rely on safe‑harbor theory at trial	Failure to sua sponte instruct on safe harbor deprived jury of necessary legal framework	Claim waived for failure to request; alternatively no plain error because Clough did not request or rely on that instruction

Key Cases Cited

United States v. Serunjogi, 767 F.3d 132 (1st Cir. 2014) (sufficiency review views evidence in light most favorable to verdict)
United States v. Acevedo‑Hernández, 898 F.3d 150 (1st Cir. 2018) (de novo review where sufficiency challenge preserved)
United States v. Iwuala, 789 F.3d 1 (1st Cir. 2015) (separate analyses for conspiracy and substantive offense)
United States v. Vega, 813 F.3d 386 (1st Cir. 2016) (discusses Anti‑Kickback Statute personal‑services safe harbor)
Guilfoile v. Shields, 913 F.3d 178 (1st Cir. 2019) (Anti‑Kickback Statute criminalizes kickbacks for prescribing)
United States v. Willson, 708 F.3d 47 (1st Cir. 2013) (tacit agreement can be inferred from working relationship)
Feola v. United States, 420 U.S. 671 (1975) (conspiracy requires intent to agree to commit the underlying offense)
United States v. Davis, 909 F.3d 9 (1st Cir. 2019) (false exculpatory statements are strong evidence of guilt)