Hartman v. Gilead Sciences Inc

CourtCourt of Appeals for the Ninth Circuit
DecidedAugust 11, 2008
Docket06-16185
StatusPublished

This text of Hartman v. Gilead Sciences Inc (Hartman v. Gilead Sciences Inc) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hartman v. Gilead Sciences Inc, (9th Cir. 2008).

Opinion

FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

In re: GILEAD SCIENCES SECURITIES  LITIGATION.

RICK HARTMAN, on behalf of himself and all others similarly situated; TRENT ST. CLARE; TERRY No. 06-16185 JOHNSON, Plaintiffs-Appellants,  D.C. No. CV-03-04999-MJJ v. OPINION GILEAD SCIENCES, INC.; JOHN C. MARTIN; JOHN F. MILLIGAN; MARK L. PERRY; NORBERT W. BISCHOFBERGER; ANTHONY CARRACIOLO; JOHN EICHLER, Defendants-Appellees.  Appeal from the United States District Court for the Northern District of California Martin J. Jenkins, District Judge, Presiding

Argued and Submitted December 6, 2007—San Francisco, California

Filed August 11, 2008

Before: Alex Kozinski, Chief Judge, Michael Daly Hawkins, and Robert E. Cowen,* Circuit Judges.

*The Honorable Robert E. Cowen, Senior United States Circuit Judge for the Third Circuit, sitting by designation.

10319 10320 IN RE GILEAD SCIENCES SECURITIES LITIGATION Opinion by Judge Hawkins 10322 IN RE GILEAD SCIENCES SECURITIES LITIGATION

COUNSEL

Susan K. Alexander (briefed and argued), Lerach, Coughlin, Stoia, Geller, Rudman & Robbins LLP, San Francisco, Cali- fornia, for the plaintiffs-appellants.

John C. Dwyer (briefed and argued), Grant Fondo and Jeffrey M. Kaban (appeared only), Cooley, Godward, Kronish, LLP, Palo Alto, California, for the defendants-appellees.

OPINION

HAWKINS, Circuit Judge:

A group of individual investors brought this securities fraud action on behalf of themselves and a proposed class compris- ing all individuals (collectively, the “Investors”) who pur- chased Gilead Sciences, Inc.’s (“Gilead”) publicly traded securities between July 14, 2003, and October 28, 2003 IN RE GILEAD SCIENCES SECURITIES LITIGATION 10323 (“class period”). They allege that Gilead misled the investing public by representing that demand for its most popular prod- uct was strong without disclosing that unlawful marketing was the cause of that strength.

The district court dismissed under Rule 12(b)(6) of Civil Procedure, holding that the Investors failed to sufficiently allege loss causation. We have jurisdiction under 28 U.S.C. § 1291, and we reverse.

FACTS AND PROCEDURAL HISTORY

I. The Complaint’s Allegations

The Investors’ Fourth Amended Complaint (“complaint”) alleges violations of sections 10(b) and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. §§ 78j(b), 78t(a), and SEC Rule 10b-5, 17 C.F.R. § 240.10b-5. The complaint names as defendants Gilead and some of its top officers (“Officers”).

Taking its allegations as true, the complaint tells the fol- lowing story about Gilead and its marketing practices.1

Gilead is a biopharmaceutical company that specializes in developing and marketing treatments for life-threatening dis- eases. One of the company’s commercial products is Viread, an antiretroviral agent used in combination with other drugs to treat HIV.

Gilead’s fortunes, as reflected in its stock price, depended heavily on Viread’s commercial success. Sales of Viread amounted to about 65% of Gilead’s total revenues at all rele- 1 We recount only those facts necessary for understanding the loss cau- sation issue. The complaint, which spans over seventy pages, offers much greater detail. Because we disagree with the district court on the issue, we frequently quote the complaint to demonstrate that the Investors did in fact explicate the causal logic underlying their theory. 10324 IN RE GILEAD SCIENCES SECURITIES LITIGATION vant times of this action. “Wall Street analysts looked to sales of Viread, Gilead’s most important and most promoted drug, to gauge whether the Company’s business was on track and growing. If Gilead failed to publicly report healthy, growing Viread sales, its stock price would be greatly diminished.”

Although Gilead had a clear incentive to aggressively pro- mote Viread, it was required to comply with federal law, including the Food and Drug Administration’s (“FDA”) mar- keting regulations. Generally, those regulations prohibit the marketing of drugs for non-FDA-approved uses, commonly referred to as “off-label” uses. “For example, it would be con- sidered off-label for a company to market a FDA-approved HIV/AIDS drug as also being effective for fighting Hepatitis B infection . . . if such use of the drug had not been reviewed and approved by the FDA and included in the” drug’s FDA- approved package labeling. While physicians are free to pre- scribe drugs for off-label uses,2 they rely on the FDA- approved prescribing information to determine which drugs can be used safely and effectively by patients with specific health problems. The FDA approved Viread for use in approximately 40% of the available HIV patient pool. Repeat- edly violating the FDA’s off-label marketing regulations in an effort to have Viread prescribed to some of the remaining 60% of available HIV patients, Gilead and its officers:

implemented a scheme to promote and market Viread with off-label, false, and misleading state- ments in violation of the Federal Food, Drug, and Cosmetic Act. In order to gain market share, artifi- cially increase perceived demand, and increase sales, Gilead officers, executives, and clinical personnel, 2 See 21 U.S.C. § 396; Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350-51 & n.5 (2001) (explaining that “the FDA is charged with the difficult task of regulating the marketing and distribution of medical devices without intruding upon decisions statutorily committed to the dis- cretion of health care professionals”). IN RE GILEAD SCIENCES SECURITIES LITIGATION 10325 with the express knowledge and approval of the [Officers], routinely and consistently provided Gile- ad’s sales and marketing team with off-label infor- mation and encouraged, expected, and directed them to use it to sell Viread . . . .

Gilead’s management began preparing Gilead’s sales staff for off-label marketing as early as September 2001, one month before Viread received FDA approval. Management continued to encourage off-label marketing throughout 2002 and the first half of 2003.

These training efforts produced their intended effect. According to two confidential witnesses who served as Gilead salespeople,3 Viread “off-label marketing took three forms: (1) marketing to HIV patients co-infected with Hepatitis B; (2) marketing Viread as a first-line or initial therapy for HIV infection; and (3) marketing against Viread’s safety profile.” Ultimately, 75% to 95% of Viread sales resulted from off- label marketing efforts.

The company and its Officers emphasized to the public that they carefully complied with federal and state regulations, when in fact they knew that they were acting unlawfully by aggressively marketing Viread for off-label uses.

The first sign of trouble came on March 14, 2002, when the FDA sent an “Untitled Letter” to Gilead that accused the com- pany of understating the risks of Viread—a form of improper off-label marketing. The letter ordered Gilead to “immedi- ately cease” this practice.

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