United States v. Simon

12 F.4th 1
CourtCourt of Appeals for the First Circuit
DecidedAugust 25, 2021
Docket20-1368P
StatusPublished
Cited by28 cases

This text of 12 F.4th 1 (United States v. Simon) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Simon, 12 F.4th 1 (1st Cir. 2021).

Opinion

United States Court of Appeals For the First Circuit

Nos. 20-1368 20-1412 UNITED STATES OF AMERICA,

Appellee/Cross-Appellant,

v.

RICHARD M. SIMON,

Defendant, Appellant/Cross-Appellee.

Nos. 20-1369 20-1411 UNITED STATES OF AMERICA,

SUNRISE LEE,

Nos. 20-1370 20-1413 UNITED STATES OF AMERICA,

JOSEPH A. ROWAN,

Defendant, Appellant/Cross-Appellee. Nos. 20-1382 20-1409

UNITED STATES OF AMERICA,

JOHN KAPOOR,

Nos. 20-1410 20-1457

MICHAEL J. GURRY,

APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Allison D. Burroughs, U.S. District Judge]

Before

Howard, Chief Judge, Selya, Circuit Judge, and Gelpí,* District Judge.

William W. Fick, with whom Daniel N. Marx and Fick & Marx LLP were on brief, for defendant Simon. Peter Charles Horstmann for defendant Lee.

* Of the District of Puerto Rico, sitting by designation. Michael Kendall, with whom Karen Eisenstadt, Alexandra I. Gliga, and White & Case LLP were on brief, for defendant Rowan. Martin G. Weinberg and Kosta S. Stojilkovic, with whom Martin G. Weinberg Law, P.C., Beth A. Wilkinson, Chanakya A. Sethi, and Wilkinson Walsh LLP were on brief, for defendant Kapoor. Megan A. Siddall, with whom Tracy A. Miner and Miner Orkand Siddall LLP were on brief, for defendant Gurry. David M. Lieberman, Attorney, Appellate Section, United States Department of Justice, with whom Nicholas L. McQuaid, Acting Assistant Attorneys General, Criminal Division, Robert A. Zink, Acting Deputy Assistant Attorney General, Nathaniel R. Mendell, Acting United States Attorney, Donald C. Lockhart, Appellate Chief, and Mark T. Quinlivan, Fred Wyshak, K. Nathaniel Yeager, and David G. Lazarus, Assistant United States Attorneys, were on brief, for the United States.

August 25, 2021 SELYA, Circuit Judge. A noted British ethologist once

observed that "[t]he total amount of suffering per year in the

natural world is beyond all decent contemplation." Richard

Dawkins, River Out of Eden 131-32 (Basic Books 1995). Some of

this suffering is unavoidable, but some is caused by those who

callously place profits over principle. The facts of this mammoth

case, as supportably found by the jury, tell a chilling tale of

suffering that did not need to happen. It involves a group of

pharmaceutical executives who chose to shunt medical necessity to

one side and shamelessly proceeded to exploit the sickest and most

vulnerable among us — all in an effort to fatten the bottom line

and pad their own pockets.

The tale told by this case chronicles the pernicious

practices employed by a publicly held pharmaceutical firm, Insys

Therapeutics, Inc. (Insys), with respect to the marketing and sale

of Subsys, a fentanyl-laced medication approved by the United

States Food and Drug Administration (FDA) for use in the treatment

of breakthrough cancer pain. When the government got wind of these

practices, it launched an investigation. That investigation

produced evidence that led a federal grand jury to indict seven of

the company's top executives on charges brought under the Racketeer

Influenced and Corrupt Organizations Act (RICO), 18 U.S.C

§ 1962(d). Two of the executives eventually entered into plea

agreements, but the rest stood their ground. Following a fifty-

- 4 - one-day trial, the jury convicted the five remaining defendants as

charged (with an exception described below), and the district court

(again with an exception described below) declined to set aside

the jury verdicts. The court then sentenced the defendants to

prison terms of varying lengths, ordered defendant-specific

restitution, and directed the forfeiture of certain assets.

On appeal, the defendants — ably represented — raise a

gallimaufry of claims. The government cross-appeals, assigning

error to the district court's refusal to embrace the whole of the

jury verdicts and to its computation of the forfeiture amounts.

After careful consideration of an amplitudinous record, we uphold

the jury verdicts in full, affirm the defendants' sentences (which

are unchallenged), vacate the restitution and forfeiture orders,

and remand for further proceedings consistent with this opinion.

I

We begin with a snapshot of the relevant facts drawn

from the evidence adduced at trial. We then briefly rehearse the

travel of the case.

A

Insys is a pharmaceutical firm founded by one of the

defendants, Dr. John Kapoor. Under the Insys umbrella, Kapoor

sought to develop sublingual spray drug-delivery formulations.

The firm explored various options, but soon concentrated on

- 5 - developing a sublingual fentanyl spray. This product came to be

called "Subsys."

In early 2012, the FDA approved Subsys for the treatment

of patients suffering from "breakthrough cancer pain." 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 Subsys were deemed "off-label."

When Subsys went on the market, its FDA-approved label

declared that "[t]he initial dose of Subsys to treat episodes of

breakthrough cancer pain is always 100 micrograms." Moreover, the

label warned that "Subsys contains fentanyl," which is a "Schedule

II controlled substance with an abuse liability similar to other

opioid analgesics." Relatedly, the label carried a limitation on

who could prescribe the drug: due to "the risk for misuse, abuse,

addiction and overdose," Subsys could be prescribed "only through

a restricted program . . . called 'Risk Evaluation and Mitigation

Strategy'" (REMS). This program formed part of the FDA's

Transmucosal Immediate Release Fentanyl REMS Access Program, which

required patients, prescribers, and pharmacists to sign a form

stating that they understood the risks presented by the prescribed

drug.

Subsys made its debut in the marketplace in March of

2012 (shortly after FDA approval was secured). At that point in

- 6 - time, Kapoor was serving as Insys's executive chairman, Michael

Babich was serving as its chief executive officer, Shawn Simon was

serving as its vice president of sales, and Matthew Napoletano was

serving as its vice president of marketing.

Around the time of the Subsys launch, Insys assembled a

marketing team. It proceeded to provide its sales force with

access to data that ranked physicians "based on their history of

prescribing within the opiate market, in particular, the fentanyl

market." The ranking system assigned a number between 1 and 10 to

each doctor — the higher the number the greater the volume of

prescriptions written. Salespeople were instructed to target

doctors ranked 5 or above and to give their "highest attention" to

those assigned a 10. They were also told to employ a "switch

strategy" aimed at persuading prescribers whose patients already

had been determined to need a similar fentanyl product to jettison

the similar product in favor of Subsys. Although the only approved

use for Subsys was for treatment of breakthrough cancer pain, most

of the prescribers listed in the database were pain-management

specialists, not oncologists.

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Bluebook (online)
12 F.4th 1, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-simon-ca1-2021.