Melvin Gross v. Biogen Inc.

CourtCourt of Chancery of Delaware
DecidedApril 14, 2021
DocketC.A. No. 2020-0096-PAF
StatusPublished

This text of Melvin Gross v. Biogen Inc. (Melvin Gross v. Biogen Inc.) is published on Counsel Stack Legal Research, covering Court of Chancery of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Melvin Gross v. Biogen Inc., (Del. Ct. App. 2021).

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

) MELVIN GROSS, ) ) Plaintiff, ) ) v. ) C.A. No. 2020-0096-PAF ) BIOGEN INC., ) a Delaware corporation, ) ) Defendant. ) )

MEMORANDUM OPINION

Date Submitted: January 11, 2021 Date Decided: April 14, 2021

Kurt M. Heyman, Gillian L. Andrews, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, Delaware; Gustavo F. Bruckner, Daryoush Behbood, POMERANTZ LLP, New York, New York; Attorneys for Plaintiff Melvin Gross.

Kevin G. Abrams, J. Peter Shindel, Jr., Eliezer Y. Feinstein, ABRAMS & BAYLISS LLP, Wilmington, Delaware; Attorneys for Defendant Biogen Inc.

FIORAVANTI, Vice Chancellor I. INTRODUCTION

Plaintiff Melvin Gross seeks an order to compel inspection of books and

records of Biogen Inc. (“Biogen” or the “Company”) pursuant to Section 220 of the

Delaware General Corporation Law (“DGCL”). Plaintiff aims to investigate, among

other things, potential corporate wrongdoing and mismanagement arising from a

federal investigation and a former employee’s allegations in a wrongful termination

suit. In this post-trial Memorandum Opinion, I conclude that Plaintiff is entitled to

inspect some, but not all, of the categories of books and records sought in his demand

for inspection.

II. FACTUAL BACKGROUND

The following facts were either stipulated or proven at trial by a

preponderance of the evidence.

A. The Company

Biogen is a Delaware corporation with its headquarters in Cambridge,

Massachusetts.1 Biogen is a global pharmaceutical company that develops drug

therapies to treat neurological and neurodegenerative diseases.2 Among the

1 Pre-Trial Stipulation and Order (“PTO”) ¶ 1. 2 Id. ¶ 2. 2 Company’s drug therapies are Tysabri and Zinbryta, both of which are used to treat

multiple sclerosis (MS). 3

Biogen operates in a heavily regulated industry, and its governance documents

recognize that risk oversight is paramount. Under Biogen’s Governance Principles,

its board of directors (the “Board”) is responsible for, among other things,

“[r]eviewing, approving and monitoring . . . material government and other

investigations” and “[e]nsuring processes are in place for maintaining . . .

compliance with law . . . .” 4 The Board has a standing Audit Committee, which

oversees the Company’s compliance program with a focus on “[f]inancial,

accounting, disclosure, corporate compliance, distributors, insurance, capital, credit,

anti-bribery and anti-corruption matters and other risks reviewed in its oversight of

the internal audit and corporate compliance functions.” 5 The Board also oversees

Biogen’s compliance program, which is led by a Corporate Compliance Committee

of senior officers.6 The compliance program enumerates policies and practices that

“prohibit illegal remuneration in violation of federal and state anti-kickback statutes”

and that provide for “appropriate . . . making of grants and charitable contributions

so that such funds are not conditioned, express or implied, on any agreement to

3 JX 16; Pl.’s Pre-Trial Br. 8. 4 JX 24 at 1. 5 JX 42 at 41. 6 JX 58 at 9. 3 prescribe, purchase, recommend, influence or provide favorable formulary status for

any Biogen product.”7

Biogen acknowledges that sales of its products “depend, to a significant

extent, on the availability of and extent of adequate coverage, pricing and

reimbursement from government health administration authorities, private health

insurers and other organizations.” 8 For this reason, Biogen’s sales partly rely on

certain charities that provide financial assistance to Medicare patients. These

charities “operate[] funds that receive payments from pharmaceutical manufacturers

and others, and that then use those payments, less administrative fees that [the

charity] charges, to cover the drug co-pay obligations of patients, including

Medicare patients.”9 Those practices, however, are subject to state and federal laws

pertaining to health care fraud and abuse. Among those laws is the federal Anti-

Kickback Statute, which generally prohibits a prescription drug manufacturer from

directly or indirectly receiving or paying any remuneration to generate business,

including the purchase or prescription of a particular drug. 10 A violation of the Anti-

7 JX 57 at 2. 8 JX 13 at 49. 9 JX 22 at Recital B. 10 42 U.S.C. § 1320a-7b(b)(2) (“Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—(A) to refer 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 4 Kickback Statute constitutes a fraudulent claim for purposes of the federal False

Claims Act. 11

B. Biogen Is Subpoenaed in Federal and State Investigations

On April 21, 2016, Biogen disclosed that it had received subpoenas from state

and federal authorities that were investigating Biogen’s “sales and promotional

practices.”12 In the same disclosure, Biogen revealed that it had also received a

document subpoena on March 4, 2016 as part of a federal investigation (the

“Investigation”) into Biogen’s “relationship with non-profit organizations that

provide assistance to patients taking drugs sold by Biogen.” 13 Biogen’s disclosure

did not identify which agencies had issued the subpoenas. On May 27, 2016,

Bloomberg reported that Biogen was among three pharmaceutical companies that

had recently disclosed having received federal subpoenas for documents concerning

their relationships with charities that help patients to afford their products.14 The

(B) to purchase, lease, order, or arrange for or recommend 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.”). 11 Id. § 1320a-7b(g) (“[A] claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of subchapter III of chapter 37 of title 31 [the False Claims Act].”). 12 JX 2 at 31. 13 Id. 14 See JX 23 (citing Ben Elgin & Robert Langreth, Gilead Subpoenaed as Feds Probe Drugmaker-Charity Connections, Bloomberg (May 27, 2016, 5:00 AM EDT), 5 article reported that the other two companies—Gilead Sciences, Inc. (“Gilead”) and

Jazz Pharmaceuticals plc (“Jazz”)—disclosed that their subpoenas were issued by

the United States Attorney’s Office for the District of Massachusetts, which operates

a health-care fraud unit.15

Following its initial disclosure about the subpoenas in 2016, Biogen regularly

reported in filings with the U.S. Securities and Exchange Commission (the “SEC”)

that it had received those subpoenas.16 In its Form 10-Q for the second quarter of

2020, Biogen disclosed:

We have learned that state and U.S. governmental authorities are investigating our sales and promotional practices and have received related subpoenas. We are cooperating with the investigation.

We have received subpoenas and other requests from the U.S.

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