55 petition for rehearing en banc and for panel rehearing 09/02

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No. 06-16185 UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT In re: GILEAD SCIENCES SECURITIES LITIGATION TRENT ST. CLARE and TERRY JOHNSON, On behalf of themselves and all others similarly situated, Plaintiffs-Appellants, V. GILEAD SCIENCES, INC.; JOHN C. MARTIN; JOHN F. MILLIGAN; MARK L. PERRY; NORBERT W. BISCHOFBERGER; ANTHONY CARRACIOLO; and WILLIAM LEE, Defendants-Appellees. On Appeal from the United States District Court for the Northern District of California at San Francisco No. CV-03-04999-MJJ Honorable Judge Jenkins, Presiding PETITION FOR REHEARING EN BANC AND FOR PANEL REHEARING STEPHEN C. NEAL JOHN C. DWYER GRANT P. FoNDo LORI R.E. PLOEGER COOLEY GODWARD KRONISH LLP Five Palo Alto Square 3000 El Camino Real Palo Alto, CA 94306-2155 (650) 843-5000 (telephone) (650) 857-0663 (facsimile) CARTER G. PHILLIPS SIDLEY AUSTIN LLP 1501 K Street, N.W. Washington, D.C. 20005 (202) 736-8000 ( telephone) (202) 736-8711 ( facsimile) Attornevs for Defendants-Appellees

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Page 1: 55 Petition for Rehearing En Banc and for Panel Rehearing 09/02

No. 06-16185

UNITED STATES COURT OF APPEALSFOR THE NINTH CIRCUIT

In re: GILEAD SCIENCES SECURITIES LITIGATION

TRENT ST. CLARE and TERRY JOHNSON,On behalf of themselves and all others similarly situated,

Plaintiffs-Appellants,

V.

GILEAD SCIENCES, INC.; JOHN C. MARTIN; JOHN F. MILLIGAN;

MARK L. PERRY; NORBERT W. BISCHOFBERGER; ANTHONYCARRACIOLO; and WILLIAM LEE,

Defendants-Appellees.

On Appeal from the United States District Court

for the Northern District of California at San Francisco

No. CV-03-04999-MJJ Honorable Judge Jenkins, Presiding

PETITION FOR REHEARING EN BANCAND FOR PANEL REHEARING

STEPHEN C. NEAL

JOHN C. DWYER

GRANT P. FoNDoLORI R.E. PLOEGER

COOLEY GODWARD KRONISH LLP

Five Palo Alto Square3000 El Camino RealPalo Alto, CA 94306-2155(650) 843-5000 (telephone)(650) 857-0663 (facsimile)

CARTER G. PHILLIPS

SIDLEY AUSTIN LLP

1501 K Street, N.W.Washington, D.C. 20005(202) 736-8000 (telephone)(202) 736-8711 ( facsimile)

Attornevs for Defendants-Appellees

Page 2: 55 Petition for Rehearing En Banc and for Panel Rehearing 09/02

CORPORATE DISCLOSURE STATENIENT

Gilead Sciences, Inc. has no parent corporation, and no publicly held

company owns I0% or more of its stock.

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TABLE OF CONTENTS

PAGE

1. INTRODUCTION AND STATEMENT OF COUNSEL ....................... 1

II. PETITION FOR REHEARING EN BANC ............................................ 6

A. En Banc Review Is Warranted to Resolve a Conflict

Between the Panel Decision and Corinthian ................................. 6

1. The Facts of This Case and Corinthian AreIndistinguishable in All Material Respects ......................... 7

2. The Panel Decision and Corinthian Apply DifferingLoss Causation Standards ................................................. 1 1

3. The Panel Decision and Corinthian Take Conflicting

Positions on What Constitutes an Unwarranted

Inference ............................................................................ 14

B. En Banc Review Is Warranted to Resolve Questions ofExceptional Importance ............................................................... 18

III. PETITION FOR PANEL REHEARING .............................................. 21

IV. CONCLUSION ...................................................................................... 21

-1-

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TABLE OF AUTHORITIES

PAGE(S)

CASES

Bell Atl. Corp. v. Twombly,127 S. Ct. 1955 (2007) ....................................................................18, 19, 20

Dura Pharms., Inc. v. Broudo,544 U.S. 336 (2005) ...................................................................... 1, 4, 12, 18

In re Daou Sys., Inc.,411 F.3d 1006 (9th Cir. 2005) ...................... ................................. 4, 11, 12....

In re Gilead Sciences Sec. Litig.,No. 06-16185, 2008 WL 3271039 (9th Cir. Aug. 11, 2008) ........ .......passim

In re Silicon Graphics Inc. Sec. Litig.,

183 F.3d 970 (9th Cir. 1999) ......................................................... ..............18

In re Syntex Corp. Sec. Litig.,

95 F.3d 922 (9th Cir. 1996) ........................................................... ..............14

Metzler Investment GMBH v. Corinthian Colleges, Inc.,534 F.3d 1068 (9th Cir. 2008), amended and superseded byNo. 06-55826, 2008 WL 3905427 (9th Cir. Aug. 26, 2008) ........ .......passim

Tellabs, Inc. v. Makor Issues & Rights, Ltd.,127 S. Ct. 2499 (2007) ............................. ..................................... 18..............

RULES

Fed. R. App. P. 35(a)(1)-(2) ............................................................... ............ 1, 6

Fed. R. App. P. 40(a)(2) ...................................................... ............... 1, 21..........

Fed. R. Civ. P. 8(a) ............................................................................. ......5, 6, 19

Fed. R. Civ. P. 9(b) ............................................................................. 5, 6, 19, 20

Fed. R. Civ. P. 12(b)(6) ...................................................................... .............. 20

OTHER AUTHORITIES

Cornerstone Research, Securities Class Action Case Filings,2007: A Year in Review (2008) ...................................................................19

H.R. Conf. Rep. No. 105-803 (1998) ............................................................... 18

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I. INTRODUCTION AND STATEMENT OF COUNSEL

Defendants-Appellees Gilead Sciences, Inc. ("Gilead") et al. seek

rehearing en banc of the panel decision in In re Gilead Sciences Securities

Litigation, No. 06-16185, 2008 WL 3271039 (9th Cir. Aug. 11, 2008)

(Kozinski, C.J., Hawkins, Cowen, JJ.) ("panel decision"), in which the panel

reversed the district court's ruling that the Fourth Amended Complaint

("Complaint") had failed adequately to plead loss causation consistent with

Dura Pharmaceuticals, Inc. v. Broudo, 544 U.S. 336 (2005). Rehearing en

banc is warranted to maintain uniformity of decisions in this Circuit and to

address issues of exceptional importance. Fed. R. App. P. 35(a)(l)-(2). Panel

rehearing also is appropriate to address points of law misapprehended or

overlooked by the panel. Fed. R. App. P. 40(a)(2).

The panel decision presents an irreconcilable conflict with the decision

issued less than three weeks earlier by a different panel in Metzler Investment

GMBH v. Corinthian Colleges, Inc., 534 F.3d 1068 (9th Cir. 2008) (Goodwin,

B. Fletcher , Smith , JJ.), amended and superseded by No. 06-55826 , 2008 WL

3905427 (9th Cir. Aug. 26, 2008). In Corinthian, also a securities case, the

panel affirmed the district court's dismissal, on loss causation grounds, of a

complaint alleging facts materially indistinguishable from those in this case.

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The Corinthian and Gilead panels applied different legal standards and

engaged in fundamentally different analytical approaches to reviewing loss

causation allegations. Unless the Gilead decision is reviewed en bane, both

litigants and lower courts will be subject to conflicting standards.

The loss causation allegations in the two cases are remarkably similar.

As here, plaintiffs in Corinthian alleged that a large portion of the company's

success was driven by revenues made possible by underlying fraudulent

practices unrelated to the sale of any securities. In Corinthian, plaintiffs

alleged that defendants had engaged in fraudulent activities to procure federal

funding for its colleges. In Gilead, plaintiffs alleged that defendants had

engaged in widespread off-label marketing of its HIV drug Viread.

In both cases, the announcement of disappointing financial results was

preceded by an earlier third-party disclosure that arguably touched upon the

alleged improper activities . In Corinthian , an article in the Financial Times

disclosed an investigation into federal educational funding practices at one of

Corinthian's campuses. Corinthian's stock price briefly dipped 10 percent

after that disclosure. In Gilead, the Food and Drug Administration ("FDA")

disclosed that it had issued a warning letter to Gilead regarding two instances

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of improper off-label marketing. Gilead's stock price rose slightly after that

disclosure.

In both cases, the companies later announced financial results that failed

to meet analyst expectations. In Corinthian, the company's financial results

were announced a little over a month after the initial disclosure; in Gilead, the

initial disclosure and announcement of financial results were three months

apart. In neither case did the company's announcement link the disappointing

financial results to the allegedly improper practices; in each case, the

announcement attributed the disappointing news to other factors. In both

cases, the company's stock price dropped following the financial-results

announcement, though in neither case was there any indication that the market

attributed the poor financial results to the companies' allegedly improper

practices.

In both cases, plaintiffs argued that they had adequately alleged loss

causation because, according to plaintiffs, the market understood as a result of

the disclosures that the company's financial success was dependent on the

improper practice and this success was now at risk.

Despite these incredibly similar facts, the Gilead and Corinthian panels

reached diametrically opposite results. In Corinthian, the panel affirmed

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dismissal of the complaint, holding that plaintiffs did not adequately plead loss

causation. Interpreting Dura and this Court's decision in In re Daou Systems,

Inc., 411 F.3d 1006 (9th Cir. 2005), the panel held that "the complaint must

allege that the practices that the plaintiff contends are fraudulent were revealed

to the market and caused the resulting losses." Corinthian, 2008 WL 3905427,

at *10. The panel found plaintiffs' argument that the "market understood [the

two disclosures] as a revelation of Corinthian's systematic manipulation of

student enrollment" to be an unwarranted inference, not a fact that had to be

accepted as true. Id. at * 11. Further, the panel concluded that "a far more

plausible reason for the resulting drop in Corinthian's stock price [was that] the

company failed to hit prior earnings estimates ." Id. The Corinthian panel

based its decision not only on the complaint but also on facts judicially noticed

by the district court.

The Gilead panel reached the opposite conclusion and reversed the

judgment of dismissal. The panel criticized the district court for expressing

incredulity regarding plaintiffs' loss causation allegations, holding that "so

long as the plaintiff alleges facts to support a [loss causation] theory that is not

facially implausible, the court's skepticism is best reserved for later stages of

the proceedings when the plaintiff' s case can be rejected on evidentiary

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grounds." Id. at 10335-36. The Gilead panel did not cite or discuss any of the

facts of which the district court took judicial notice.

The irreconcilable results in Gilead and Corinthian' are directly

attributable to the application of differing legal standards regarding pleading

loss causation that will confound the parties and district courts in the Ninth

Circuit unless reconciled by en banc review.

Additionally, rehearing en banc is warranted because this case presents

important issues concerning courts' gatekeeping function in the numerous

securities actions filed in this Circuit. The district courts need clear guidance

on the standards for evaluating loss causation allegations so they can

effectively implement the important goal of weeding out groundless suits

before they reach discovery and become unduly costly. The panel decision

undermines that goal. This problem is compounded by the panel's failure to

apply Federal Rule of Civil Procedure 9(b)'s pleading standard. The panel

stated that it need not decide whether the more stringent Rule 9(b) particularity

standard or the more lenient Rule 8(a) notice standard applies because the

Complaint's loss causation allegations satisfy both standards. But it is apparent

The plaintiffs-appellants in Corinthian requested and received an extension toSeptember 8, 2008 to file a petition for rehearing. Corinthian, No. 06-55826,Docket No. 43 (9th Cir. Aug. 5, 2008).

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that the panel analyzed the allegations solely under Rule 8(a). The Court is

obliged to evaluate whether the allegations meet the more stringent Rule 9(b)

standard, and the Complaint here would not survive such scrutiny.

For the same reasons that rehearing en banc is warranted, panel

rehearing is also warranted.

II. PETITION FOR REHEARING EN BANC

The Court may grant en banc review to secure or maintain uniformity

of the court's decisions" or to resolve "a question of exceptional importance."

Fed. R. App. P. 35(a)(1)-(2). En banc review is warranted here on both

grounds.

A. En Banc Review Is Warranted to Resolve a Conflict Between

the Panel Decision and Corinthian.

The panel decision directly conflicts with Corinthian, resulting in an

irreconcilable split in this Circuit's authority. The two decisions, handed down

less than three weeks apart, come to opposite conclusions on facts that are

indistinguishable in all material respects. The two panels applied different loss

causation standards and fundamentally different analytical frameworks in

reviewing the respective complaints. En banc review should be granted to

resolve the conflict and to maintain uniformity within this Circuit.

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1. The Facts of This Case and Corinthian AreIndistinguishable in All Material Respects.

In Corinthian, plaintiffs alleged that defendants were engaged in

systemic fraud in which they manipulated student enrollment figures to gain

federal funds. 2008 WL 3905427, at *2. Plaintiffs alleged that 50 to 60

percent of the people whom the company represented to the government to be

qualified students were, in fact, not qualified for federal funding. Id.

The Corinthian plaintiffs pointed to two disclosures that, when read in

tandem, purportedly revealed Corinthian's fraudulent practices to the market.

Id. at *6. First, a June 2004 Financial Times article reported on a Department

of Education ("DOE") investigation at one of Corinthian's campuses and stated

that school officials had helped students manipulate financial aid documents in

order to maximize federal payments . Id. As a result of the investigation, one

campus lost the privilege of receiving up-front federal funding and instead was

required to seek reimbursement of expenditures. Id. at *4. Following

publication of the article, Corinthian's stock dipped by 10 percent, but quickly

rebounded. Id. at *6.

Second, a company press release, issued approximately one month after

the Financial Tines article, disclosed reduced earnings and earnings

projections but stated that "student population growth was up nearly 50%

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overall and same-school population increased 15°o ...." Id. at * 11. The press

release also revealed that Corinthian had met with the California Attorney

General regarding an investigation into its admission practices. Id. at *6. The

company attributed the reduced earnings to several factors, including "higher

than anticipated attrition ." Id. at *7. Following the announcement,

Corinthian's stock price fell by 45 percent. Id.

Plaintiffs alleged that the cumulative effect of the two disclosures was to

"peel back the curtain and reveal Corinthian's `impaired and falsely presented

financial condition,' leading to the considerable stock drop that caused

Plaintiffs' claimed damage." Id. at *7. Plaintiffs argued that the statement that

there was "higher than anticipated attrition" was a "euphemism for an

admission" that Corinthian had fraudulently enrolled students. Id. at * 11.

In Gilead, plaintiffs ' loss causation theory follows a remarkably similar

pattern. Plaintiffs allege that Gilead engaged in pervasive "off-label"

marketing of Viread that produced approximately 75 to 95 percent of all Viread

sales. (ER 33-34, 55 ¶¶ 7-9, 87.) FDA regulations prohibit marketing drugs

for non-FDA-approved uses, commonly referred to as "off-label" uses. (ER 44

¶ 50.)

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The Gilead plaintiffs point to two disclosures that, when read in tandem,

purportedly revealed Gilead's fraudulent practices to the market. First, on July

29, 2003, the FDA issued a Warning Letter, made public on August 7, 2003,

asserting that Gilead sales representatives engaged in improper off-label

marketing on two separate occasions at conferences . Gilead, slip op. at 10327-

28, 10338. In plaintiffs' own words, the FDA letter referred to a couple of

stale transgressions" with "little implication for ongoing sales," and the

market did not understand the scope of the off-label marketing. (ER 82-83 ¶^(

191-195.) Following the disclosure, Gilead's stock price increased. Gilead,

slip op. at 10327-28.

Second, Gilead's October 28, 2003 press release, published nearly three

months after the FDA letter was disclosed, stated that, as anticipated, Gilead's

third-quarter Viread revenues had declined, but that "important demand

indicators, such as new and total prescriptions" for the drug had increased.

(ER 86-87 ¶ 205; SER 192.) The company attributed the reduced Viread

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revenues to the reduction in inventory levels by its wholesalers., On October

29th, the day following the announcement, Gilead's stock price fell 12.5

percent, but recovered nearly half that loss within one day and recovered fully

within a month. (ER 36 ¶ 16; SER 202-03.)

Nevertheless, plaintiffs alleged that the off-label marketing scheme,

revealed on August 7th, caused the stock drop on October 29th. (ER 86-88 9

203-208.) Plaintiffs claimed that Gilead's alleged off-label marketing activities

had artificially inflated demand for Viread, accounting for 75 to 95 percent of

all Viread sales (ER 33-34, 55 9 7-9, 87); drug wholesalers , anticipating a

price increase in June 2003, increased their Viread inventories, an action that

would not have happened but for the artificially inflated demand created by

off-label marketing (ER 79, 80 ¶ 181); following public disclosure of the FDA

letter in August 2003, doctors became "less eager to prescribe it to their

2 Though doctors' prescriptions create demand for Viread (ER 32, 34, 79 ¶¶ 5,9, 178), Gilead earns revenues by selling Viread to pharmaceuticalwholesalers, who supply the drug to pharmacies, which fill the prescriptions.(ER 76 9 166-68.) Wholesalers profit by stockpiling large quantities of a drugbefore an expected manufacturer price increase and later selling the drug at thehigher price. (ER 76 ¶ 168.) In July 2003, Gilead had announced that itssecond-quarter revenues had increased substantially, in part due to this sort ofincrease in wholesaler purchases. (ER 78, 80 ¶¶ 174, 183.) Gilead alsoannounced that it anticipated third-quarter revenues would be at or belowsecond-quarter revenues as wholesalers drew down their Viread inventories.(SER 179-180.)

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patients" (ER 85 ¶ 200); competitors used the letter to persuade physicians to

prescribe their products rather than Viread (id.); the result was decreasing

demand for Viread (ER 85, 86 ¶T 201-204); and the market and the public

understood all this when the company disclosed its third-quarter earnings (ER

87-88 208). Plaintiffs sought to establish loss causation on the assertion that

the "October 28, 2003 press release tacitly admitted that demand for Viread

was not as strong as investors were previously led to believe." (Id.)

Despite virtually identical fact patterns, Corinthian and the panel

decision reached irreconcilably different conclusions regarding whether loss

causation had been adequately pled.

2. The Panel Decision and Corinthian Apply Differing Loss

Causation Standards.

Corinthian held that to plead loss causation adequately, "the complaint

must allege that the practices that the plaintiff contends are fraudulent were

revealed to the market and caused the resulting losses." 2008 WL 3905427, at

*10. The panel cited favorably this Court' s earlier decision in In re Daou

Systems, 411 F.3d 1006 (9th Cir. 2005), which held that plaintiffs adequately

pled loss causation "because their complaint alleged that the market learned of

and reacted to [the] fraud, as opposed to merely reacting to reports of the

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defendant ' s poor financial health generally ." Corinthian, 2008 WL 3905427,

at *10.

The Corinthian panel affirmed dismissal of the complaint, reasoning that

neither the Financial Times article nor the August 2nd press release

"disclosed-or even suggested-to the market that Corinthian was

manipulating student enrollment figures company-wide in order to procure

excess federal funding, which is the fraudulent activity that [plaintiffs]

contend[] forced down the stock that caused its losses." Id. The press release

failed to demonstrate "that the market became aware of, and the resulting stock

drop resulted from, widespread enrollment fraud," despite the reference to the

California Attorney General's investigation. Id. at * 1 1. The court rejected

plaintiffs' argument that the "higher than anticipated attrition" statement in the

press release was a "euphemism for an admission" that Corinthian had

improperly enrolled students. The panel wrote:

[N]either Daou nor Dura require an admission or

finding of fraud before loss causation can be properly

pled. But that does not allow a plaintiff to plead loss

causation through "euphemism" and thereby avoid

alleging the necessary connection between

defendant's fraud and the actual loss. So long as

there is a drop in a stock's price, a plaintiff will

always be able to contend that the market,'understood" a defendant's statement precipitating a

loss as a coded message revealing the fraud. Enabling

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a plaintiff to proceed on such a theory wouldeffectively resurrect what Dura discredited-that losscausation is established through an allegation that astock was purchased at an inflated price.

Id.

In contrast, the Gilead decision does not require that the market become

aware of the alleged fraud. The Complaint contains no allegations that the

market became aware of the alleged widespread off-label marketing scheme.

Neither the FDA letter nor the October 28th press release can reasonably be

read to reveal such a scheme. As the panel noted, the FDA letter "discussed

only two instances of off-label marketing" and "did not contain enough

information to significantly undermine" Gilead's previous statements. Gilead,

slip op. at 10338. The press release revealed that Gilead's third-quarter

revenues had declined due to larger-than-anticipated wholesaler inventory

draw-down, but that prescriptions (demand) had continued to rise. The press

release did not mention off-label marketing, the FDA letter, decreasing

prescriptions, or any alleged wrongdoing at Gilead.

Plaintiffs alleged that the "press release tacitly admitted that demand for

Viread was not as strong as investors were previously led to believe." (ER 87-

88 ¶ 208 (emphasis added).) Corinthian rejected just such a theory, stating that

pleading loss causation through "euphemism" is not permitted . Yet in Gilead,

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in direct conflict with Corinthian, the panel held that the Complaint adequately

pled loss causation, and reversed the judgment of dismissal.

3. The Panel Decision and Corinthian Take ConflictingPositions on What Constitutes an Unwarranted

Inference.

The Corinthian panel explained that plaintiffs' allegation that the market

"understood the June 24 and August 2 disclosures as a revelation of

Corinthian's systematic manipulation of student enrollment is not a `fact,"' but

rather, an inference that plaintiffs believe is warranted by the facts. 2008 WL

3905427, at *11. Following Circuit precedent, the Corinthian panel analyzed

whether that inference was "warranted." Id. (citing In re Syntex Corp. Sec.

Litig., 95 F.3d 922, 926 (9th Cir. 1996)).

By contrast, the panel decision here failed to evaluate critically the

inferences plaintiffs urged. While acknowledging that a court need not make

unreasonable or unwarranted inferences, the panel stated: "But so long as the

plaintiff alleges facts to support a theory that is not facially implausible, the

court's skepticism is best reserved for later stages of the proceedings when the

plaintiffs case can be rejected on evidentiary grounds." Gilead, slip op. at

10336.

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The two panels also took different approaches to considering materials

subject to judicial notice in evaluating whether certain inferences were

reasonable. The Corinthian panel expressly based its factual summary on the

allegations in the complaint, matters incorporated therein, and matters

judicially noticed by the district court. 2008 WL 3905427, at *1 n. l . The

Gilead panel did not cite or discuss any of the facts that the district court had

judicially noticed. As a result, the panel ignored several facts that contradict

the central premise of the Complaint's loss causation theory, namely that

demand for Viread had been inflated due to improper activities and that

demand decreased following disclosure of the FDA letter:

• On July 31, 2003, before the FDA letter was disclosed, the

company announced expected total 2003 Viread revenues of $550

to $600 million. (SER 180.) In January 2004, the company

reported that it had met those projections. (SER 219.)

• In the October 28, 2003 press release , the Company announced

that "important demand indicators, such as new and total

prescriptions" had increased during the third quarter. (SER 192.)

• The October 2003 analyst reports cited by plaintiffs reported a

third-quarter Viread prescription increase of 14 to 17 percent. (ER

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87 4_^ 206, 207; ER 1 16; SER 213.) The same reports stated that

Gilead continued to increase its market share during that period,

and that the "[f]undamentals of the business remain as strong as

ever, with Viread scrips continuing to exhibit strong growth."

(SER 208.)

• Fourth-quarter 2003 revenue for Viread exceeded S175 million,

reflecting a 52 percent increase over third-quarter sales. (See SER

192-93, 219.)

The panels' differing approaches directly resulted in conflicting

outcomes. In Corinthian, plaintiffs asked the court to infer that the market

became aware of widespread enrollment fraud and that the decline in revenue

resulted from the DOE investigation. Rejecting this inference, the Corinthian

panel noted that "the August 2 announcement simultaneously reported that

student population growth was up nearly 50% overall and same-school

population increased 15% . . . ." 2008 WL 3905427, at *11. Moreover, "the

August 2 announcement contained a far more plausible reason for the resulting

drop in Corinthian's stock price-the company failed to hit prior earnings

estimates." Id. Thus, the court held that it was "unwarranted to infer that the

reference to `attrition' was understood by the market to mean that Corinthian

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had revealed widespread misrepresentation of student enrollment to

fraudulently procure excess federal funding." Id.

In Gilead, plaintiffs asked the panel to infer that, following the October

2003 press release, the market somehow realized that Viread's remarkable

success was due almost solely to an illegal marketing scheme; the market

understood that, as a result of this scheme, demand for Viread had been

artificially inflated; and the temporary stock drop the following day was

causally linked to this scheme.

Had the Gilead panel applied the analytical approach used by the

Corinthian panel, these inferences certainly would have been rejected. There

is no factual support for the notion that the market linked the stock drop to

concerns about the company's marketing practices or the FDA letter. Further,

the inference urged by plaintiffs that prescriptions (demand) for Viread fell

during the third quarter in response to the FDA letter-the lynchpin of their

loss causation theory-is contradicted by the very documents on which they

rely and by judicially noticed facts. Moreover, as in Corinthian, there is a

much more plausible explanation for why Gilead's stock price fell on October

29th-it reported less revenue due to larger than anticipated inventory draw-

down.

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This Court should grant en bane review to resolve the direct and

irreconcilable conflict between the panel decision and Corinthian.

B. En Bane Review Is Warranted to Resolve Questions ofExceptional Importance.

The potentially abusive and costly nature of shareholder litigation has

long been identified as an issue of exceptional importance. The Private

Securities Litigation Reform Act of 1995 and the Securities Litigation Uniform

Standards Act of 1998 were enacted to ensure uniform standards that would

protect the interests of shareholders and employees by preventing the filing of

frivolous securities class action lawsuits. H.R. Conf. Rep. No. 105-803 (1998);

In re Silicon Graphics Inc. Sec. Litig., 183 F.3d 970, 973 (9th Cir. 1999). The

failure to require uniform and meaningful pleading standards for loss causation

"would permit a plaintiff `with a largely groundless claim to simply take up the

time of a number of other people, with the right to do so representing an in

terrorem increment of the settlement value, rather than a reasonably founded

hope that the [discovery] process will reveal relevant evidence."' Dura, 544

U.S. at 347-48 ( citation omitted); see also Bell All. Corp. v. Twombly, 127 S.

Ct. 1955, 1966-67 (2007); Tellabs, Inc. v. Makor Issues & Rights, Ltd., 127 S.

Ct. 2499, 2504 (2007) ("Private securities fraud actions, however, if not

adequately contained, can be employed abusively to impose substantial costs

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on companies and individuals whose conduct conforms to the law.-). The

importance of providing uniform and consistent guidance in this Circuit is

especially compelling given that on average more securities class actions are

brought here than in any other circuit. See Cornerstone Research, Securities

Class Action Case Filings, 2007: A Year in Review 18 (2008 ). The panel's

reluctance to evaluate loss causation meaningfully at the motion to dismiss

stage stands in stark contrast to Corinthian and undermines the goal of weeding

out groundless suits before costly discovery ensues.

Compounding this problem was the panel's failure to apply the more

stringent pleading standard in Federal Rule of Civil Procedure 9(b), instead

applying Rule 8(a)'s more lenient standard. The panel stated that it need not

decide which standard applies to pleading loss causation because the

Complaint satisfied both standards. Gilead, slip op. at 10334. In reversing

dismissal of the Complaint, the panel was obliged to show how the allegations

meet the more stringent Rule 9(b) particularity standard as well as the more

lenient Rule 8(a) notice standard. Although the panel referred to Rule 9(b), it

is apparent that, in actuality, the panel analyzed the Complaint only under the

Rule 8 ( a) standard , as articulated by the Supreme Court in Twombly. See

Gilead, slip op. at 10335-37. According to the panel, "[s]o long as the

19

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complaint alleges facts that, if taken as true, plausibly establish loss causation,

a Rule 12(b)(6) dismissal is inappropriate." Gilead, slip. op. at 10336. Indeed,

the panel cites Twombly four times in its analysis.

The panel's failure to apply Rule 9(b) is of great consequence because

the loss causation allegations would not survive such scrutiny. The Complaint

fails to cite to any public statement , analyst report, or other document

suggesting that anyone linked Gilead's third-quarter results (and the

subsequent stock drop) to the FDA letter or off-label marketing concerns.

Though plaintiffs allege that physicians stopped prescribing Viread after the

FDA letter became public , they fail to identify a single such doctor, as a

confidential witness or otherwise. Though they allege that competitors were

able to compete more effectively after the letter, they fail to identify a single

such competitor. Though they allege that there was a "marked drop" in

prescriptions, they fail to identify a single patient who stopped using the drug.

Though they allege that wholesalers observed the drop in sales and drew down

their inventories as a result , they fail to identify any such wholesaler or any

document suggesting this was the case. The Complaint simply fails to allege

its attenuated loss causation theory with the particularity that Rule 9(b)

requires.

20

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For these reasons, rehearing en banc should be granted. The Court

should take this opportunity to address these important issues concerning loss-

causation pleading and to clarify the nature and scope of the courts'

gatekeeping function, so that courts will take a consistent approach in the many

securities actions filed in this Circuit.

III. PETITION FOR PANEL REHEARING

For of the same reasons set forth above in support of rehearing en banc,

panel rehearing also is warranted under Rule 40(a)(2).

IV. CONCLUSION

For the foregoing reasons, Gilead respectfully petitions for rehearing en

banc and for panel rehearing.

Dated : September 2, 2008 COOLEY GODWARD KRONISH LLP

tephen C. Neal

Attornevs for Defendants-Appellees

21

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CERTIFICATION OF COMPLIANCE PURSUANT TOCIRCUIT RULES 35-4 AND 40-1

I certify that pursuant to Circuit Rules 35-4 and 40-1, the attached

petition for rehearing en banc and for panel rehearing is proportionately

spaced, has a typeface of 14 points or more, and contains 4,195 words.

Dated : September 2, 2008 COOLEY GODWARD KRONISH LLP

rant P. Fondo

Attornevs for Defendants-Appellees

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FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

In re: GILEAD SCIENCES SECURITIES

LITIGATION.

RICK HARTMAN , on behalf ofhimself and all others similarlysituated; TRENT ST. CLARE; TERRY

JOHNSON,

Plaintiffs-Appellants

V.

GILEAD SCIENCES, INC.; JOHN C.

MARTIN; JOHN F. MILLIGAN; MARK

L. PERRY; NORBERT W.

BISCHOFBERGER; ANTHONY

CARRACIOLO; JOHN EICHLER,

Defendants-Appellees.

No. 06-16185

D.C. No.CV-03-04999-MJJ

OPINION

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

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10320 IN RE GILEAD SCIENCES SECURITIES LITIGATION

Opinion by Judge Hawkins

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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 JeffreyM. 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 fraudaction on behalf of themselves and a proposed class compris-ing all individuals (collectively, the "Investors") who pur-chased Gilead Sciences, Inc.'s ("Gilead") publicly tradedsecurities between July 14, 2003, and October 28, 2003

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IN RE GILEAD SCIENCES SECURITIES LITIGATION 10323

("class period"). They allege that Gilead misled the investingpublic by representing that demand for its most popular prod-uct was strong without disclosing that unlawful marketingwas the cause of that strength.

The district court dismissed under Rule 12(b)(6) of CivilProcedure, holding that the Investors failed to sufficientlyallege loss causation. We have jurisdiction under 28 U.S.C.

1291, and we reverse.

FACTS AND PROCEDURAL HISTORY

1. The Complaint's Allegations

The Investors' Fourth Amended Complaint ("complaint")alleges violations of sections 10(b) and 20(a) of the SecuritiesExchange Act of 1934, 15 U.S.C. §S 78j(b), 78t(a), and SECRule IOb-5, 17 C.F.R. § 240.10b-5. The complaint names asdefendants 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.'

Gilead is a biopharmaceutical company that specializes indeveloping 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, dependedheavily on Viread's conunercial success. Sales of Vireadamounted to about 65% of Gilead's total revenues at all rele-

'We recount only those facts necessary for understanding the loss cau-

sation issue. The complaint, which spans over seventy pages, offers much

on the issue, weGreater detail. Because we disagree with the district court

frequently quote the complaint to demonstrate that the Investors did in fact

explicate the causal logic underlying their theory.

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10324 IN RE GILEAD SCIENCES SECURITIES LITIGATION

vant times of this action. "Wall Street analysts looked to salesof Viread, Gilead's most important and most promoted drug,to gauge whether the Company's business was on track andgrowing. If Gilead failed to publicly report healthy, growingViread 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 themarketing of drugs for non-FDA-approved uses, commonlyreferred to as "off-label" uses. "For example, it would be con-sidered off-label for a company to market a FDA-approvedHIV/AIDS drug as also being effective for fighting HepatitisB infection ... if such use of the drug had not been reviewedand 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,' they rely on the FDA-approved prescribing information to determine which drugscan be used safely and effectively by patients with specifichealth problems. The FDA approved Viread for use inapproximately 40% of the available HIV patient pool. Repeat-edly violating the FDA's off-label marketing regulations in aneffort to have Viread prescribed to some of the remaining60% of available HIV patients, Gilead and its officers:

implemented a scheme to promote and marketViread with off-label, false, and misleading state-ments in violation of the Federal Food, Drug, andCosmetic Act. In order to gain market share, artifi-cially increase perceived demand, and increase sales,Gilead officers, executives, and clinical personnel,

2See 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").

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I\ RzE GILE AD SCIENCES SELL RI T IE: Li-. Iu.^ Io\ 10 32^,

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 thetasto use it to sell Viread ... .

Gilead's management began preparing Gilead's sales stafffor off-label marketing as early as September 2001, onemonth before Viread received FDA approval. Managementcontinued to encourage off-label marketing throughout 2002and the first half of 2003.

These training efforts produced their intended effect.According to two confidential witnesses who served as Gileadsalespeople,' 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 HIVinfection; 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 improperoff-label marketing. The letter ordered Gilead to "itntnedi-ately cease" this practice. On March 21, 2002, per the FDA'srequest, Gilead sent a reply that acknowledged receipt of theFDA's letter and agreed to immediately stop off-label market-

3One of the confidential witnesses served as "a member of Gilead's

Field Marketing Advisory Committee, a select committee of Gilead sales

and marketing staff that periodically met to discuss theories and strategies

for marketing and selling Viread."

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10326 IN RE GILEAD SCIENCES SECURITIES LITIGATION

ing. This was not done. In fact, Gilead's off-label marketingincreased, either at the Officers' direction or with their knowl-edge and tacit encouragement.

By June 2003, Gilead's off-label marketing put it in theposition to raise Viread's price. Consistent with standardindustry practice, Gilead informed national drug wholesalersof this plan in advance of the price increase. The wholesalers(there are the three major ones that purchase approximatelyninety percent of drug manufacturers' drugs) typically stock-pile drugs in advance of price increases so that they can resellat a higher price to retailers after the increase takes effect.

Because Gilead had "illegally inflated sales and artificiallyinflated demand for Viread, the major drug wholesalers stock-piled mass quantities of Viread in advance of the June 2003price increase. This wholesaler stockpiling would not haveoccurred but for the off-label marketing and the resulting cre-ation of an artificially increased demand for Viread." Thestockpiling furthered Gilead's fraudulent scheme by confirm-ing "the impression that Viread was in high demand and thatGilead's financial and operational results were strong."

On July 14, 2003, Gilead issued a press release announcingthat it anticipated its second quarter financial results wouldexceed analysts' expectations, and explaining that the compa-ny's success "was driven primarily by strong sales growth ofViread .... Increasing Viread sales reflect broader prescrib-ing patterns in all commercial markets, as well as increases inU.S. wholesaler inventory levels in the second quarter inanticipation of a Viread price increase."

These statements were materially false and misleadingbecause Gilead and its Officers' "marketing and promotionalactivities for Viread were not in compliance with FDAapproved guidelines, violated federal laws, and created seri-ous public health and safety implications for Viread users."Gilead's promotional scheme was designed to, and did, create

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I^ :,E GILEAD SCEyCes SECSRITIEs LITIG.ATIOy 1032-

the impression that demand for Viread was strong. This cam-paign was misleading, however, because it was unlawful off-label marketing that was driving prescription volume4 -andGilead had already been ordered to cease such marketing.

While securities analysts, for the most part, reacted favor-ably to the July 14. 2003, press release, Gilead and its Offi-cers felt the need to respond to some analysts' concern thatsecond quarter revenues were primarily attributable to thewholesaler stockpiling, and not a result of strong demand. Onthe same day that the press release was issued, a Gileadspokeswoman, acting with the knowledge and approval ofGilead and its officers, told Bloomberg News that "[t]he mainreason for the jump in Viread sales is an increase in prescrip-tions, not inventory stocking." This statement was misleading.It created the impression that demand for Viread was strong,which it was, but for reasons that were not well-understood bythe public. Omitting the role of off-label marketing in a pressrelease highlighting the drug's success made a true statement(that demand was strong) also a misleading one.

Gilead's financial news had a marked effect on its stockprice. On July 14, the price of Gilead shares closed at $67.25,up $7.97 from the previous day's closing price of $59.28 pershare. This 13.4% increase represented a near-record high.

Some two weeks later, the FDA issued a July 29 WarningLetters that chastised Gilead for statements made by one of its

4The Investors concluded that between $86.7 million and $109.82 mil-

lion of Viread's S 115.6 million in domestic sales during the second quarter

of 2003 could be attributed to off-label marketing.

5The Complaint explains:

According to the FDA's website and the FDA's Regulatory Pro-

cedures Manual, warning letters such as this are written commu-

nications from the [FDA] to a company notifying the company

that the [FDA] considers one or more promotional pieces or prac-

tices to be illegal.... A warning letter is much more serious than

an untitled letter.

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10-1128 I' RE GILEAD SCIENCES SECURITIES LITIGATION'

sales representatives at the 15th National HIV/AIDS UpdateConference in March and April of 2003. The letter stated thatthe employee "made oral statements that minimized the riskinformation and broadened the indication for Viread." Itreminded Gilead of the Untitled Letter, expressed the "signifi-cant public health and safety concerns raised by these repeti-tive promotional activities," and ordered Gilead to makecorrective disclosure. Gilead made such disclosure to the con-ference attendees on November 7, 2003.

On August 7. 3003, the FDA made public its Warning Let-ter. Gilead's shareholders and the investing public did not findit very significant, though, because they failed to appreciatethe extent of Gilead's off-label marketing, and thus could notforesee the letter's impact on Viread's sales.

The public's underestimation of Viread's troubles wasreflected in Gilead's share price. Notwithstanding the publicrevelation of the letter, shares closed at higher prices thanthey opened on both August 7 and August 8. Indeed, by theend of August, the stock was trading a few dollars higher thanit had been at the beginning of the month, without havingexperienced any significant fluctuations.

Yet. "[u]nbeknownst to investors, the disclosure of theFDA Warning Letter had a detrimental effect on Viread sales.Physicians, now alerted to Gilead's illegal marketing effortsand to the safety problems with Viread, were less eager toprescribe it to their patients." Competitors invoked the letterin efforts to persuade physicians to switch from Viread totheir products. In the remaining weeks of August, there wasa "marked drop in prescriptions and sales" of Viread.Although the Investors lack precise sales figures, a MorganStanley analyst report shows that Viread prescriptions experi-

enced a "sharp drop" in August 2003, followed by "flattenedgrowth" for the remainder of the third quarter. The prescrip-tions would have suffered further decline were it not for cer-

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l\ RE GILEAD SCIENCES SECURITIES LITIGATION 10329

taro side-effects that made it dangerous for some patients todiscontinue using the drug.

The wholesalers observed the initial drop in sales and pre-scriptions of Viread, and the ensuing slow growth. BecauseViread was underperfonning relative to the expectations gen-erated by the second quarter reports, the wholesalers drewdown much more of their excess inventory than they had orig-inally planned, letting supply of Viread drop to the lowestlevel in four quarters, and well below the industry average forother drugs.

Although wholesalers recognized Viread's struggles, thepublic continued to misunderstand the significance of theWarning Letter. Gilead did nothing to correct that misunder-standing. In its Form 10-Q reporting on the 2003 second quar-

ter, issued on August 14, Gilead persisted in emphasizing theincreased volume of Viread's second quarter sales without

discussing the role of off-label marketing. Although the Form

10-Q did briefly address the Warning Letter, it failed to reveal

the activities that gave rise to that letter, or the impact the let-ter would have on sales of Viread.

The Officers exploited the public's ignorance. In the days

between the receipt and public disclosure of the Warning Let-

ter, two of the Officers each sold over $3 million worth of

stock. On August 7, the day the FDA disclosed the letter, Gil-

ead's Senior Vice President/Chief Financial Officer sold

nearly 5700,000 worth of shares. Throughout August, while

the market misapprehended Gilead's impending troubles, the

Officers continued to sell off substantial numbers of shares.

This activity was "unusual and suspicious" because this was

the first month in which all of the Officers sold stock. More

to the point, this was proof that the Officers acted with knowl-

edge or with deliberate recklessness when they issued materi-

ally false and misleading documents and statements that were

disseminated to the investing public.

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10 i 11 0 1\ RE GILEaD SCIENCES SECLRITIEs LITIGATIOA

Not until October 28, 2003, did the public finally realizethe impact of the off-label marketing and the Warning Letter.After the markets closed that day, Gilead issued a press

release detailing third quarter financial results. The public

learned that Viread sales fell significantly below expectations

because there had been substantially more overstocking bywholesalers than previously reported. Accordingly, third quar-

ter prescriptions were filled by wholesalers' existing inven-

tory, and wholesalers did not reorder Viread at a

commensurate level. Market analysts attributed the disap-

pointing sales to "lower end-user demand." That lower end-

user demand, as noted, was a direct result of the Warning Let-

ter, which had exposed Gilead's unlawful off-label marketing

efforts to physicians.

The market was "stunned" by the third quarter results.Share prices closed at $59.46 on October 28, before the pressrelease was circulated. It may be the case that the market hadalready begun to slowly incorporate the information regardingViread's off-label marketing into the share price. But thethird-quarter earnings release made the effect of that informa-tion inescapably clear. The day after the press release wasissued, trading volume of Gilead shares was up 1,400% fromits average daily level. The day opened with Gilead's priceper share at $50.69, and closed with a price of $52 per share,a 12% decrease from the previous day's closing price.

Summing it all up,

At all relevant times, the material misrepresenta-tions . . . directly or proximately caused or were asubstantial contributing cause of the damages sus-tained by [the Investors]. . . . [Gilead and the Offi-cers] made or caused to be made a series ofmaterially false or misleading statements about Gile-ad's sales, business, product marketing and promo-tion, prospects, operations and financial results.These material misstatements had the cause and

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IN RE GILEAD SCIENCES SECURITIES LITIGATION 10331

effect of creating in the market an unrealisticallypositive assessment of Gilead . . . thus causing theCompany's publicly traded securities to be overval-ued and artificially inflated at all relevant times.

11. The District Court's Decision

The district court dismissed the complaint with prejudice.

Based on the Investors' allegations and judicially-noticed

documents that had been referenced in the complaint, thecourt concluded that the Investors had failed to adequatelyplead loss causation as that requirement was articulated inDura Pharmaceuticals, Inc. v. Broudo, 544 U.S. 336 (2005).

Specifically, the district court found the complaint failed to

connect the following chain of events . . . : 1) that[Gilead's and the Officers'] alleged failure to dis-close the off-label marketing scheme caused a mate-rial increase in sales; 2) that practitioners materiallydecreased their demand for Viread due to the publi-cation of the FDA Warning Letter; and most impor-tantly, 3) that the alleged decrease in sales due to theFDA letter proximately caused Gilead's stock todecrease three months later[.]

The district court rested its decision exclusively on losscausation, and did not consider whether the Investors suffi-ciently alleged falsity or scienter.

DISCUSSION

1. Standards of Review

"We review de novo the district court's dismissal of a com-plaint for failure to state a claim under Federal Rule of CivilProcedure l2(b)(6). On review. we accept the plaintiffs' alle-gations as true and construe them in the light most favorable

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10332 IN Re GILEAD SCIENCES SECURITIES LITIGA T ION'

to plaintiffs." Gompper v. VJSX Inc., 298 F.3d 893, 895 (9thCir. 2002) (citation omitted). "The court need not, however,accept as true allegations that contradict matters properly sub-ject to judicial notice or by exhibit. Nor is the court requiredto accept as true allegations that are merely conclusory,unwarranted deductions of fact, or unreasonable inferences."Spreti+'ell v. Golden State Warriors, 266 F.3d 979, 988 (9thCir. 2001) (citation omitted), amended on other grounds, 275F.3d 1187 (9th Cir. 2001). The complaint is properly dis-missed if it fails to "plead `enough facts to state a claim torelief that is plausible on its face.' " I,Veber v. Dep 't of Veter-ans Affairs, 521 F.3d 1061, 1065 (9th Cir. 2008) (quoting BellAll. Corp. iv. Twombly, 127 S. Ct. 1955, 1974 (2007)).

II. Applicable law

(1) Section 10(b) of the Securities Exchange Act of 1934makes it unlawful "[t]o use or employ, in connection with thepurchase or sale of any security . . . any manipulative ordeceptive device or contrivance in contravention of such rulesand regulations as the Commission may prescribe." 15 U.S.C.§ 78j(b). Pursuant to this section, the Securities and ExchangeCommission promulgated Rule lOb-5, which makes it unlaw-ful:

(a) To employ any device, scheme, or artifice todefraud,

(b) To make any untrue statement of a material factor to omit to state a material fact necessary in orderto make the statements made, in the light of the cir-cumstances under which they were made, not mis-leading, or

(c) To engage in any act, practice, or course of busi-ness which operates or would operate as a fraud ordeceit upon any person. in connection with the pur-chase or sale of any security.

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1V RE GILEAD SCIENCES SECURITIES LITIGATION 10,33

17 C.F.R. § 240.IOb-5.

121 We have identified five basic elements of a Rule lOb-5claim: "(1) a material misrepresentation or omission of fact,(2) scienter, (3) a connection with the purchase or sale of asecurity, (4) transaction and loss causation, and (5) economicloss." In re Daou Svs., Inc., 411 F.3d 1006, 1014 (9th Cir.2005) (citing Dina Pharms., 544 U.S. at 341-42).

Because the district court addressed only loss causationunder Rule lOb-5, we will limit our consideration to thatissue, "following the general rule [that] a federal appellatecourt does not consider an issue not passed upon below." Mi1-ler vv. Thane Int'l, Inc., 519 F.3d 879, 892 (9th Cir. 2008)(alteration in original; internal quotation marks omitted). Aplaintiff bears the burden of proving that a defendant'salleged unlawful act "caused the loss for which the plaintiffseeks to recover damages." 15 U.S.C. § 78u-4(b)(4). To estab-lish loss causation, "the plaintiff must demonstrate a causalconnection between the deceptive acts that form the basis forthe claim of securities fraud and the injury suffered by theplaintiff." Daou, 411 F.3d at 1025. The misrepresentationneed not be the sole reason for the decline in value of thesecurities, but it must be a " `substantial cause.' " Id. (quotingRobbins v. Koger Props., Inc., 116 F.3d 1441, 1447 n.5 (11thCir. 1997)).

Rule 9(b) of Civil Procedure provides: "In alleging frauda party must state with particularity the circumstances

constituting fraud ...." Gilead and the Officers contend thatthe Investors' loss causation arguments should be subject tothis heightened pleading requirement, although they recognizethat the Supreme Court has not decided the issue. See DuraPharrns.. 544 U.S. at 346. The Investors argue that Rule8(a)(2)'s "short and plain statement" requirement should con-trol loss causation pleading.

We need not resolve this issue today. Rule 9(b) imposes theheightened requirement so that the fraud-action defendant

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10-1-14 N RE GILEAD SCIENCES SECURITIES LITIGATION

"can prepare an adequate answer from the allegations." Odornv. Wicrosoft Corp., 486 F.3d 541, 553 (9th Cir. 2007) (inter-nal quotation marks omitted). As we explain below, the Inves-tors' complaint offers "sufficient detail to give defendantsample notice of [their] loss causation theory, and to give ussome assurance that the theory has a basis in fact." Berson v.Applied Signal Tech., Inc., 527 F.3d 982, 989-90 (9th Cir.2008). Therefore, under either Rule 8 or Rule 9, the Investorshave sufficiently pleaded loss causation.

111. The Sufficiency of the Complaint

The district court identified Din-a Pharmaceuticals as theauthority that doomed the Investors' complaint. Dura featuredplaintiffs who alleged that they "paid artificially inflatedprices" for Dura's securities and "suffered damages thereby."Dura. 544 U.S. at 339-40 (alterations, emphasis, and quota-tion marks omitted). The court below had held that loss causa-tion was established merely by demonstrating that shareprices on the date of purchase were inflated. Broudo v. DuraPharins., Inc., 339 F.3d 933, 938 (9th Cir. 2003).

(3] The Supreme Court reversed, and held that an inflatedpurchase price alone is not enough to establish loss causation.Dur-a, 544 U.S. at 342. More is required of plaintiffs-particular allegations as to "what the relevant economic lossmight be," and "what the causal connection might be"between the fraud alleged and the economic losses actuallysuffered. Id. at 347.

141 The complaint in this case is meaningfully different

from that in Dura Phar-nmaceuticals. The Investors here iden-tify a specific economic loss: the drop in value on October 29,

2003, that followed the October 28 press release. They also

allege that this loss was caused by Gilead's misrepresenta-

tions. They provide abundant details of Gilead's off-label

marketing, and they assert that this led to higher demand for

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IN RE GILEAD SCIENCES SECERITIES LITIGATION 10335

Viread, which in turn inflated Gilead's stock price.' As sum-marized in the complaint's introduction,

[T]he market was not told that off-label marketingwas the cornerstone of demand. This mistakenimpression of demand led to, among other things,wholesaler overstocking in reaction to an anticipatedprice increase. When the truth about [Gilead's andthe Officers'] off-label marketing was disclosed,however, [they] could no longer maintain the salesgrowth levels that investors had come to expect, andGilead's stock price dropped accordingly.

Assuming, then, that the Investors' theory is sound and thatthey can prove all that they allege. the district court erred byholding that Dura Pharmaceuticals compelled dismissal ofthis action.

The dismissal order below, though, suggests that the districtcourt was unwilling to make these assumptions. The districtcourt found that the complaint contained "too many logicaland factual gaps."

151 Based on our own review, we find the complaint suffi-

ciently alleges a causal relationship between (1) the increase

in sales resulting from the off-label marketing, (2) the Warn-

ing Letter's effect on Viread orders, and (3) the Warning Let-

ter's effect on Gilead's stock price.

Perhaps what truly motivated the dismissal was the districtcourt's incredulity. The court expressly identified two allega-tions it was unwilling to accept. First, it could not make "theunreasonable inference that a public revelation on August 8

'The complaint includes one concrete example of how Gilead's stock

price was directly inflated by Viread's sales performance: the 13.4% rise

in share value triggered by Gilead's positive statements about demand for

Viread on July 14, 2003, the first day of the class period.

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10336 1\ RE GILEAD SCIENCES SECURITIES LITIGATION

caused a price drop three months later on October 28." OrderGranting Defs.' Mot. to Dismiss at 11. Second, with respectto the Warning Letter's impact on Viread sales, the courtfound "a slowing increase in demand, alone, too speculativeto adequately demonstrate loss causation." Id. at 12 n.10.

[6] As an initial matter, we note that a district court rulingon a motion to dismiss is not sitting as a trier of fact. It is truethat the court need not accept as true conclusory allegations,nor make unwarranted deductions or unreasonable inferences.Spreivell, 266 F.3d at 988. But so long as the plaintiff allegesfacts to support a theory that is not facially implausible, thecourt's skepticism is best reserved for later stages of the pro-ceedings when the plaintiff's case can be rejected on evidenti-ary grounds. "[A] well-pleaded complaint may proceed evenif it strikes a savvy judge that actual proof of those facts isimprobable, and that a recovery is very remote and unlikely."Bell Atl. Corp. v. Twombly, 127 S. Ct. 1955, 1965 (2007)(internal quotation marks omitted).

[7] There is no exception to this rule for the element of loss

causation. The Third Circuit has stated that "loss causation

becomes most critical at the proof stage," and has cited schol-

arly authority stating that it is normally inappropriate to rule

on loss causation at the pleading stage. McCabe v. Er-n7st &

Young, LLP, 494 F.3d 418. 427 n.4 (3rd Cir. 2007) (internal

quotation marks omitted). Similarly, the Second Circuit has

held that loss causation "is a matter of proof at trial and not

to be decided on a Rule 12(b)(6) motion to dismiss." Emer-

gent Capital Inv. Vgmt., LLC. V. Stonepath Group, Inc.. 343

F.3d 189, 197 (2d Cir. 2003). But see Lentell v. Vlerrill Liynnch

& Co., 396 F.3d 161, 172-77 (2d Cir. 2005) (failure to plead

any facts supporting loss causation warranted 12(b)(6) dis-

missal of complaint).

[8] We agree. So long as the complaint alleges facts that,if taken as true, plausibly establish loss causation, a Rule12(b)(6) dismissal is inappropriate. This is not "a probability

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IN RE GILEAD SCIENCES SECURITIES LITIGAI ION 10337

requirement ... it simply calls for enough fact to raise a rea-sonable expectation that discovery will reveal evidence of'loss causation. Bell At!.. 127 S. Ct. at 1965.

The district court's concern about the elapse of timebetween the public issuance of the Warning Letter and thedrop in price recalls our holding in No. 84 Employer-TeamsterJoint Council Pension Trust Fund v. America West HoldingCorp., 320 F.3d 920 (9th Cir. 2003) (internal quotation marksomitted). There, a Rule IOb-5 defendant argued that itsalleged misrepresentations were per se immaterial because theinjurious drop in stock price took place more than one and ahalf months after the market learned the truth about the mis-representations. Id. at 934. We rejected "a bright-line rulerequiring an immediate market reaction" because "[t]he mar-ket is subject to distortions that prevent the ideal of a free andopen public market from occurring." Id. (internal quotationmarks omitted). Instead, we held that courts must engage ina "fact-specific inquiry." Id. (internal quotation marks omit-ted).

191 We believe that America West's discussion of material-ity applies with equal force to the loss causation requirement.A limited temporal gap between the time a misrepresentationis publicly revealed and the subsequent decline in stock valuedoes not render a plaintiff's theory of loss causation per seimplausible.

1101 Our review of the Investors' complaint convinces usthat the October drop in stock price was plausibly caused bythe Warning Letter. Importantly, the drop occurred immnedi-ately after Gilead disclosed less-than-expected revenuesresulting from the reduction in wholesalers' Viread invento-ries, which analysts ascribed to lower end-user demand. Thatlower end-user demand, in turn, is expressly alleged to havebeen caused by the Warning Letter. In this light, the marketdid react immediately to the corrective disclosure-the Octo-ber 28 press release. The Warning Letter, which discussed

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10338 IN RL GILE:\D SIIENCES SECURITIES LITIGATION

only two instances of off-label marketing, would not neces-sarily trigger a market reaction because it did not containenough information to significantly undermine Gilead's July2003 pronouncements concerning demand for Viread. It is notunreasonable that physicians-the targets of the off-labelmarketing-would respond to the Warning Letter while thepublic failed to appreciate its significance.

[Ill The district court also erroneously concluded that aslowing increase in demand is too speculative to establish losscausation. Had the Investors alleged that the Warning Lettereliminated all sales resulting from off-label marketing, itwould be very unlikely that demand would continue toincrease, since the complaint asserts that 75% to 95% of saleswere caused by off-label marketing. But they do not allegethat, and we see no reason why the court cannot proceed tothe evidentiary stages to determine the extent of the WarningLetter's impact on the growth of demand for Viread.

[12] The complaint specifically alleges that physicianswere less eager to prescribe Viread, and competitors used theWarning Letter to lure Viread customers to other drugs. Thisis "enough fact to raise a reasonable expectation that discov-ery will reveal evidence"-or the lack thereof-of the Warn-ing Letter's effect on demand. Bell 4tl., 127 S. Ct. at 1965.

CONCLUSION

For the foregoing reasons, the district court improperlygranted Gilead's and the Officers' Rule 12(b)(6) motion. TheInvestors have sufficiently alleged loss causation and eco-nomic loss. We leave it to the district court to determinewhether they have sufficiently alleged the other elements oftheir claims.

REVERSED and REMANDED.

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CERTIFICATE OF SERVICE

I certify that on September 2, 2008, a copy of the foregoing PETITION

FOR REHEARING EN BANC AND FOR PANEL REHEARING was

served by First Class Mail on the following:

Jack G. Fruchter Marc M. UmedaAbraham, Fruchter & Twersky Robbins Umeda & Fink, LLP

One Penn Plaza, Suite 2805 610 West Ash Street, Suite 1800New York, NY 10119 San Diego, CA 92101

212/279-5050 619/525-3990212/279-3655 (Fax) 619/525-3991 (Fax)

Robert S. Green Laurence D. King

Green Welling LLP Linda M. Fong595 Market Street, Suite 2750 Kaplan, Fox & Kilsheimer LLPSan Francisco, CA 94105 350 Sansome Street, Suite 400

415/477-6700 San Francisco, CA 94104415/477-6710 (Fax) 415/772-4700

415/772-4707(Fax)Lori S. Brody James M. Orman

Kaplan, Fox & Kilsheimer LLP Law Offices of James M. Orman

1801 Century Park East, Suite 1460 1845 Walnut Street, 14th Floor

Los Angeles, CA 90067 Philadelphia, PA 19103310/439-6006 215/523-7800310/439-6004 (Fax) 215/523-9290 (Fax)

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New York, NY 10119 New York, NY 10017212/594-5300 212/907-0878212/868-1229(Fax) 212/818-0477 (Fax)

Page 48: 55 Petition for Rehearing En Banc and for Panel Rehearing 09/02

Juan Carlos Sanchez Robert A. JigarjianClass Action Clearinghouse Jigarjian Law OfficeStanford Digital Law Project - Securities 128 Tunstead Avenue

559 Abbott Way San Anselmo, CA 94960Stanford, CA 94305 415/341-6660

650/725-0479Sanford Svetcov David J. George

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415/288-4545 561/750-3000415/288-4534 (Fax) 561/750-3364(Fax)

Douglas C. McDermott Samuel Rudman

McDermott Newman PLLC Coughlin Stoia Geller Rudman &1001 Fourth Avenue Robbins LLP

Suite 3200 58 South Service Road

Seattle, WA 98154 Suite 200206/749-9296 Melville, NY 11747206/749-9467 (Fax) 631/367-7100

631/367-1173 (Fax)Michael M. GoldbergGlancy & Binkow LLP1801 Avenue of the Stars, Suite 311Los Angeles, CA 90067

310/201-9150310/201-9160 (Fax)

Page 49: 55 Petition for Rehearing En Banc and for Panel Rehearing 09/02

I further certify under Federal Rule of Appellate Procedure 25(B)(ii) that

an original and fifty copies of the foregoing PETITION FOR REHEARING

EN BANC AND FOR PANEL REHEARING were dispatched on

September 2, 2008, for delivery by Courier Service to the Clerk for the United

States Court of Appeals for the Ninth Circuit to the following address:

Mollie C. Dwyer

Clerk of the Court

United States Court of Appeals for the Ninth Circuit95 Seventh StreetSan Francisco, CA 94103-1526

Dated: September 2, 2008

/IS/Jocelyn McIntosh