2008 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

9-9-2008

In Re: Merck & Co

Precedential or Non-Precedential: Precedential

Docket No. 07-2431

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PRECEDENTIAL

UNITED STATES COURT OF APPEALS 

FOR THE THIRD CIRCUIT

 

Nos. 07-2431, 07-2432

 

IN RE: MERCK & CO., INC. SECURITIES,

DERIVATIVE & “ERISA” LITIGATION

(MDL No. 1658)

CONSOLIDATED SECURITIES LITIGATION

Richard Reynolds, Steven LeVan, Jerome Haber and

The Public Employees’ Retirement System of Mississippi,

the Court-Appointed Lead Plaintiffs and Plaintiffs Union

Asset Management Holding AG, Loren Arnoff,

Robert Edwin Burns, Jan Charles Finance S.A.,

Martin Mason, Frank H. Saccone, Charlotte Savarese,

Joe Savarese, Joseph Goldman, Sherrie B. Knuth,

Joseph S. Fisher, M.D., Naomi Raphael,

 Rhoda Kanter, Park East, Inc. and Marc Nathanson, on behalf

 of themselves and the proposed class of purchasers of Merck

 securities during the period between

May 21, 1999 and October 29, 2004,

 Appellants

 

On Appeal from the United States District Court

for the District of New Jersey

(D.C. Nos. 05-cv-01151, 05-cv-02367)

District Judge: Honorable Stanley R. Chesler

 

Argued June 24, 2008

Before: SLOVITER, BARRY, and, ROTH Circuit Judges
2

(Filed September 9, 2008)

______

John P. Coffey (Argued)

Bernstein, Litowitz, Berger & Grossman

New York, NY 10019-0000

Bruce D. Bernstein

New York, NY 10022-0000

Paul B. Brickfield

Brickfield & Donahue

River Edge, NJ 07661-0000

David A.P. Brower

Brower Piven

New York, NY 10022-0000

James E. Cecchi

Lindsey H. Taylor

Carella, Byrne, Bain, Gilfillan, Cecchi,

 Stewart & Olstein

Roseland, NJ 07068-0000

Mark Levine

Stull, Stull & Brody

New York, NY 10017-0000

Michael Miarmi

New York, NY 10119-0165

Lee A. Weiss

New York, NY 10022-0000

Richard H. Weiss

New York, NY 10119-0165

Robert T. Haefele

Motley Rice

Mount Pleasant, SC 29465-0000
3

Attorneys for Appellants

Robert H. Baron

Evan R. Chesler (Argued)

Cravath, Swaine & Moore

New York, NY 10019-0000

Roberta Koss

William R. Stein

Hughes, Hubbard & Reed

Washington, DC 20006-0000

William H. Gussman

Martin L. Perschetz

Sung-Hee Suh

Schulte, Roth & Zabel

New York, NY 10022-0000

Lawrence M. Rolnick

Sheila A. Sadighi

Lowenstein Sandler

Roseland, NJ 07068-0000

Attorneys for Appellees

_____

OPINION OF THE COURT

 

SLOVITER, Circuit Judge.

Appellants, purchasers of Merck & Co., Inc. stock, filed the

first of several class action securities fraud complaints on

November 6, 2003, alleging that the company and certain of its

officers and directors (collectively, “Merck”) misrepresented the

safety profile and commercial viability of Vioxx, a pain reliever

that was withdrawn from the market in September 2004 due to

safety concerns. The District Court granted Merck’s motion to

dismiss the complaint under Rule 12(b)(6) of the Federal Rules of

Civil Procedure, holding that Appellants were put on inquiry notice
 The District Court took judicial notice of the various 1

public documents submitted to it in connection with the motion to

dismiss. Appellants do not challenge this decision on appeal and

we see no reason to disturb it. “The inquiry notice analysis is an

objective one. Whether appellants read the [documents] or were

aware of them is immaterial. They serve only to indicate what was

in the public realm at the time, not whether the contents of those

[documents] were in fact true.” Benak ex rel. Alliance Premier

Growth Fund v. Alliance Capital Mgmt., L.P., 435 F.3d 396, 401

n.15 (3d Cir. 2006).

4

of the alleged fraud more than two years before they filed suit, and

thus their claims were barred by the statute of limitations.

Appellants argue that the District Court erred in finding as a matter

of law that there was sufficient public information prior to

November 6, 2001 to trigger Appellants’ duty to investigate the

alleged fraud. Because the District Court dismissed on the basis of

the complaint, we must accept its allegations as true.1

I.

Factual Background

In May 1999, the Food and Drug Administration (“FDA”)

approved Vioxx, a new drug introduced by the pharmaceutical

company Merck. Vioxx is the brand name of rofecoxib, a

nonsteroidal anti-inflammatory drug (“NSAID”) used in the

treatment of arthritis and other acute pain. Most NSAIDs, such as

aspirin, ibuprofen, and naproxen, function by inhibiting two

enzymes: cyclooxygenase-1 (“COX-1”), which is associated with

the maintenance of gastrointestinal (“GI”) mucus and platelet

aggregation, and cyclooxygenase-2 (“COX-2”), which is associated

with the response to pain and inflammation. The inhibition of

COX-1 leads to harmful GI side effects. Because Vioxx was

designed to suppress COX-2 without affecting COX-1, Merck

marketed Vioxx as possessing the beneficial effects of traditional

NSAIDs but without the harmful GI side effects associated with

those drugs. The market viewed Vioxx as a potential “blockbuster”

drug for the company, App. at 469, and as its “savior,” App. at 494.
 The sources upon which Appellants rely in making these 2

allegations were first made public in November 2004,

approximately a year after Appellants filed their initial complaint.

See Anna Wilde Mathews & Barbara Martinez, Warning Signs:

E-Mails Suggest Merck Knew Vioxx’s Dangers at Early Stage,

Wall St. J., Nov. 1, 2004, at A1; 60 Minutes (CBS television

broadcast Nov. 14, 2004) (transcript available on LexisNexis).

See ALEVE FAQs, http://www.aleve.com/faqs.html#g21 3

(last visited July 25, 2008); Roche Pharmaceuticals in the U.S., Our

Products, Naprosyn, http://www.rocheusa.com/products/naprosyn/

(last visited July 25, 2008).

5

Merck repeatedly touted the safety profile, sales, and commercial

prospects of the drug in press releases, public statements, and

Securities and Exchange Commission (“SEC”) filings throughout

the class period.

A. Pre-FDA Approval and the VIGOR Study (1996 -

March 2000)

Prior to the FDA’s approval of Vioxx, officials at Merck

were concerned that Vioxx could cause harmful cardiovascular

(“CV”) events, such as heart attacks. Internal emails from 1996

and 1997 demonstrate that Merck employees were aware that there

was “a substantial chance” and a “possibility” of CV events that

could “kill [the] drug.” App. at 496. In 1998, an unpublished

internal Merck clinical trial entitled Study 090 revealed that Vioxx

caused a greater incidence of CV events than a placebo or a

different arthritis drug.2

In January 1999, Merck commenced the VIOXX

Gastrointestinal Outcomes Research (“VIGOR”) study, which

compared Vioxx to naproxen, the active ingredient in brand-name

pain relievers such as Aleve and Naprosyn. Although the study 3

showed that Vioxx had a GI safety profile superior to that of

naproxen, it also showed that Vioxx users had a higher incidence

of CV events than naproxen users. In a March 9, 2000 email,

defendant Edward Scolnick, the President of Merck Research

Laboratories, acknowledged the existence of CV events,
6

commenting, “it is a shame but it is a low incidence and it is

mechanism based as we worried it was.” App. at 512.

Merck did not attempt to conceal the results of the VIGOR

study. It made them public in a press release on March 27, 2000,

that emphasized Vioxx’s superior GI safety profile but also noted

the incidence of CV events. Merck stated:

[S]ignificantly fewer thromboembolic events were observed

in patients taking naproxen in this GI outcomes study,

which is consistent with naproxen’s ability to block platelet

aggregation. This effect on these events had not been

observed previously in any clinical studies for naproxen.

Vioxx, like all COX-2 selective medicines, does not block

platelet aggregation and therefore would not be expected to

have similar effects.

App. at 765. The press release also stated that “[a]n extensive

review of safety data from all other completed and ongoing clinical

trials, as well as the post-marketing experience with Vioxx, showed

no indication of a difference in the incidence of thromboembolic

events between Vioxx, placebo and comparator NSAIDs.” App. at

766.

The VIGOR study results were widely reported in the press,

medical journals, and securities analyst reports. Market analysts

and members of the press immediately understood that CV events

could be a side effect of Vioxx. Nonetheless, many observers also

took notice of Merck’s hypothesis that naproxen lowered CV

events (the “naproxen hypothesis”). The naproxen hypothesis

attributed the results of the VIGOR study to the beneficial effects

of naproxen’s blocking of platelet aggregation rather than to the

harmful effects of Vioxx in causing thromboembolic events. The

issue whether naproxen lowered the heart attack risk or Vioxx

caused it was thus presented. While many analysts noted that the

naproxen hypothesis was unproven, some also concluded that it

was the most likely explanation for the increased CV events

observed in the VIGOR study.

One representative article distributed by Reuters on April
7

27, 2000, quoted a Merck spokesman who acknowledged the

“statistically significant” finding that patients of Vioxx had a

higher rate of CV events, but suggested that this might be

explained by a beneficial effect of naproxen. App. at 2287. In that

same article, however, a spokesperson for the manufacturer of

Naprosyn explained that the company had no knowledge that

naproxen prevented heart attacks or strokes; similarly, an analyst

for ABN Amro suggested that he was skeptical of Merck’s

explanation.

B. FDA AAC Hearing (February 8, 2001)

On February 8, 2001, the FDA’s Arthritis Advisory

Committee (“AAC”) held a public hearing to consider Merck’s

request to include the positive GI results from the VIGOR study in

its Vioxx labeling. Six days before that hearing, J.P. Morgan

issued a research report summing up the state of knowledge about

Vioxx after the VIGOR study. The report stated that the basic idea

behind the naproxen hypothesis was “poorly proven,” and that

there was “no way to retrospectively slice the data to prove the

NSAID benefit vs. Vioxx risk argument,” although one existing

theory “might support a ‘Vioxx risk’ hypothesis.” App. at 2547.

J.P. Morgan warned, “[t]his is the type of clinical ‘signal’ that was

ignored, and later haunted the FDA in recent drug recalls like

Warner Lambert’s Rezulin and Glaxo’s Lotronex.” App. at 2547.

During the AAC hearing, defendant Alise Reicin, Executive

Director of Clinical Research at Merck Research Laboratories,

explained to the panel, “when you review the results of VIGOR in

isolation you don’t know whether the imbalance of cardiovascular

events was caused by a decrease in events on a platelet-inhibiting

NSAID, naproxen, or an increase in events on a COX-2 selective

inhibitor,” i.e., Vioxx. App. at 995. She then suggested that

naproxen was likely responsible for the difference in CV events

observed in users of the two drugs. At the public portion of the

hearing, the panel subsequently discussed whether to call for the

inclusion of a warning in the Vioxx labeling stating that it was

“uncertain” whether the CV events noticed in VIGOR were “due

to beneficial cardioprotective effects of naproxen or prothrombotic

effects of [Vioxx], and leave it at that, that basically we don’t know
8

the reason.” App. at 1143.

Nonetheless, some press accounts reported that certain AAC

panel members asserted that “[d]ifferences in cardiac risk between

Vioxx and naproxen appeared to result from a beneficial effect of

naproxen, not a danger from Vioxx,” App. at 2311, and that there

was “some reassurance that what we see, in effect, is a protective

effect of naproxen,” App. at 2306. In subsequent coverage, many

securities analysts reported that the hearing had benefited Merck

and they continued to project substantial future revenues for Vioxx.

However, at least one investment firm issued a report stating, “our

skepticism relating to naproxen having a cardioprotective effect is

reinforced” by the AAC hearing. App. at 2703.

C. First Vioxx Product Liability Lawsuit (May 2001)

In May 2001, a product liability lawsuit was filed jointly

against Merck and the makers of Celebrex, a rival COX-2 selective

inhibitor. The complaint alleged that the pharmaceutical

companies “have consistently marketed Vioxx and Celebrex as

highly effective pain relief drugs for patients suffering from

osteoarthritis,” despite the fact that “Merck’s own research”

demonstrated that “users of Vioxx were four times as likely to

suffer heart attacks as compared to other less expensive

medications, or combinations thereof.” App. at 1748. The

plaintiffs sought “emergency notice to class members and revised

patient warnings, in the form of additional medical labeling which

is presently being considered by the FDA . . . .” App. at 1748.

D. JAMA Article (August 22, 2001)

On August 22, 2001, the Journal of the American Medical

Association (“JAMA”) reported the results of a study of Vioxx and

Celebrex clinical trials. The JAMA article asserted that available

data raised a “cautionary flag” about the risk of CV events

associated with COX-2 inhibitors. App. at 748. It also stated that

“[c]urrent data would suggest that use of selective COX-2

inhibitors might lead to increased cardiovascular events.” App. at

752. The day before that article was published, Bloomberg News

reported the statement of a Merck scientist that “[w]e already have
9

additional data beyond what they cite, and the findings are very,

very reassuring. VIOXX does not result in any increase in

cardiovascular events compared to placebo.” App. at 539. The

JAMA article garnered extensive coverage. Some securities

analysts responding to the article on the date of its publication

referred to the basic content of the article as “not new news,” App.

at 2749, and noted that the FDA “debated many of the same issues

in February of this year,” at the AAC panel hearing. App. at 2751.

The day after the JAMA article’s publication, Merck issued

a press release stating that it “stands behind the overall and

cardiovascular safety profile . . . of VIOXX.” App. at 540. Merck

also sent “‘Dear Doctor’ letters to physicians throughout the

country disparaging the article as ‘not based on any new clinical

study’ and assuring the physicians that Merck ‘stands behind the

overall and cardiovascular safety profile’ of VIOXX.’” App. at

540.

E. FDA Warning Letter (September 21, 2001)

On September 21, 2001, the FDA posted on its website a

warning letter that its Division of Drug Marketing, Advertising,

and Communications (“DDMAC”) had sent to Merck four days

earlier regarding its marketing and promotion of Vioxx. In the

letter, the DDMAC stated that Merck’s “promotional activities and

materials” for the marketing of Vioxx were “false, lacking in fair

balance, or otherwise misleading in violation of the Federal Food,

Drug, and Cosmetic Act (the Act) and applicable regulations.”

App. at 713. The letter explained:

You have engaged in a promotional campaign for Vioxx

that minimizes the potentially serious cardiovascular

findings that were observed in the [VIGOR] study, and thus,

misrepresents the safety profile for Vioxx. Specifically,

your promotional campaign discounts the fact that in the

VIGOR study, patients on Vioxx were observed to have a

four to five fold increase in myocardial infarctions (MIs)

compared to patients on the comparator non-steroidal antiinflammatory drug (NSAID), Naprosyn (naproxen).
 A few representative examples follow: Reuters -- “U.S. 4

regulators have charged . . . Merck . . . with misleading doctors

about its blockbuster painkiller Vioxx with promotions that

downplayed a possible risk of heart attacks.” App. at 2353.

Associated Press -- “Merck has argued that [the VIGOR study

results make] Vioxx falsely look[] risky because naproxen thins the

blood . . . and thus protect[s] against heart attacks. . . . ‘In fact, the

situation is not at all clear,’ [according to] the FDA . . . .” App. at

2360. USA Today -- “Merck’s marketing efforts, aimed mainly at

doctors, have minimized Vioxx’s known and potential

cardiovascular risks, the FDA wrote in an eight-page ‘warning

letter’ . . . . So far this year, the FDA has sent drug companies

fewer than a dozen warning letters, which the agency reserves for

activities that raise significant public health concerns.” App. at

2355. Wall Street Journal -- “Federal regulators warned Merck &

Co. for improper marketing of its blockbuster arthritis drug Vioxx,

saying the company had misrepresented the drug’s safety profile

and minimized its potential risks. . . . While the FDA sends out

dozens of routine citations annually, it issues only a handful of

10

Although the exact reason for the increased rate of MIs

observed in the Vioxx treatment group is unknown, your

promotional campaign selectively presents the following

hypothetical explanation for the observed increase in MIs.

You assert that Vioxx does not increase the risk of MIs and

that the VIGOR finding is consistent with naproxen’s ability

to block platelet aggregation like aspirin. That is a possible

explanation, but you fail to disclose that your explanation is

hypothetical, has not been demonstrated by substantial

evidence, and that there is another reasonable explanation,

that Vioxx may have pro-thrombotic properties.

App. at 713. The letter also directed Merck to issue “Dear

Healthcare provider” letters “to correct false or misleading

impressions and information.” App. at 719.

The FDA warning letter received widespread coverage by

the media and securities analysts. Although many media reports

focused on the mere fact of the warning letter, securities analysts 4
these more-serious warning letters each year.” App. at 2361.

 For example, a report issued by Lehman Brothers stated: 5

“We do not believe this letter will be predictive of the FDA’s

actions on the pending Vioxx label change. . . . Warning letters of

this nature are certainly not unusual and in fact almost a staple of

the pharmaceutical industry today. . . . As pointed out in the FDA

warning letter, DDMAC does not dispute Merck’s claims.” App.

at 2765-66.

 One report issued by Merrill Lynch stated: “The FDA 6

issued a warning letter to Merck . . . [and] is looking for Merck to

cease all violative promotional activities . . . . We do not see how

this issue can be helpful to Merck in promoting Vioxx.” App. at

2752.

 A Dain Rauscher report focused on Vioxx’s position in the 7

actual marketplace, i.e., the doctor’s office: “We believe th[e FDA

warning letter] is unlikely to significantly alter physicians’

prescribing practices [because it] is likely that these issues are

already common knowledge in the medical community . . . .” App.

at 2762. Meanwhile, a CIBC World Markets report considered

how the warning letter might impact Merck’s stock price: “The

FDA warning letter as well as a recent JAMA article raising

concerns of cardiovascular risk will continue to pressure the stock,

now trading close to its 52-week low.” App. at 2755.

11

tended to emphasize the impact the warning letter would likely

have on the prospective Vioxx labeling changes (which were not

forthcoming until April 2002), Merck’s ongoing promotional 5

efforts, and Merck’s position in the market. A report issued by 6 7

UBS Warburg explained, “[t]he FDA pointed out that there is no

definitive study proving or disproving either conclusion [regarding

the higher incidence of CV events associated with Vioxx in the

VIGOR study]. . . . The FDA’s position appears similar to our own,

which is that the data available to date are simply not definitive.”

App. at 2768. Nonetheless, securities analysts were of one voice

in their projections for Merck and Vioxx; analysts from CIBC

World Markets, Credit Suisse First Boston (“CSFB”), Dain

Rauscher, Lehman Brothers, UBS Warburg, SG Cowen, and
12

Morgan Stanley all maintained their ratings for Merck stock at

“buy” or “hold” and/or continued to project increased future

revenues for Vioxx.

In the five days between September 20, 2001 and September

25, 2001, Merck’s stock price declined by $4.16, or 6.6%, closing

at $59.11 on September 25. Reuters reported this drop on

September 25, explaining that “[s]hares of Merck & Co. fell . . .

after U.S. regulators accused the firm of making unsubstantiated

claims about its hot-selling arthritis drug Vioxx and downplaying

a possible risk of heart attack from taking the medicine.” App. at

2357. By October 1, 2001, however, Merck’s stock price had

rebounded to $64.66, $1.39 higher than its closing price before the

warning letter was made public just over a week earlier.

F. Additional Vioxx Lawsuits (September 27, 2001)

A consumer fraud lawsuit was filed against Merck on behalf

of Vioxx users on September 27, 2001. A second product liability

lawsuit and a personal injury lawsuit followed shortly thereafter.

In articulating their allegations of fraud and misrepresentations by

Merck to consumers and Vioxx users, the consumer fraud and

product liability suits relied in large part on the JAMA article, the

FDA warning letter, and various media reports concerning Vioxx.

G. New York Times Article (October 9, 2001)

On October 9, 2001, the New York Times published an

article about COX-2 inhibitors entitled “The Doctor’s World; For

Pain Reliever, Questions of Risk Remain Unresolved.” App. at

653. The article reported on “troubling questions about whether

Vioxx may have an unexpected side effect -- a very slight increase

in the risk of heart attack.” App. at 653. However, the article

explained that “[t]he risk is hypothesized, not proved,” and that

“leading arthritis specialists . . . say that they are not concerned and

that they prescribe the drugs for patients who may have heart

disease.” App. at 653. The article noted that “[a]t issue is the

subtle question of what counts as evidence,” App. at 653,

explaining that the risk that COX-2 inhibitors cause blood-clotting

was originally posed as a theory a few years earlier by a scientist
13

from the University of Pennsylvania.

The article addressed defendant Scolnick’s statements at

length. According to the article, Scolnick said that Merck

“look[ed] specifically for excess heart attacks and strokes in” the

VIGOR study and found a higher incidence in the patients taking

Vioxx. App. at 654. “‘There are two possible interpretations,’ Dr.

Scolnick said. ‘Naproxen lowers the heart attack rate, or Vioxx

raises it.’” App. at 654. The article went on, “while [Merck]

announced the heart attack findings to doctors and the public, it

looked back at its data from studies using different drugs or dummy

pills in comparison to Vioxx. It found no evidence that Vioxx

increased the risk of heart attacks, Dr. Scolnick said.” App. at 654.

“He said that the company decided that ‘the likeliest interpretation

of the data is that naproxen lowered . . . the thrombotic event rate’

. . . . He added that without the theoretical question raised by [the

University of Pennsylvania scientist], ‘no one would have a

question remaining in their mind that their [sic] might be an

additional interpretation.’” App. at 654. The article reported

Scolnick as conceding that “none of the findings to date are enough

to prove that the issue is fully resolved. That lack of proof is why

the F.D.A. demanded that Merck explain both sides of the

hypothesis, telling doctors and patients that it is not known whether

naproxen protects against heart attacks or Vioxx makes them more

likely.” App. at 654.

There was no significant movement in Merck’s stock price

following the publication of the New York Times article.

H. Vioxx’s Labeling Modified to Include CV Risks

(April 2002)

Merck was not required to include the risk of CV events in

its labeling until April 2002. The labeling ultimately incorporating

that information explained the VIGOR study results and stated,

“the risk of developing a serious cardiovascular thrombotic event

was significantly higher in patients treated with VIOXX . . . as

compared to patients treated with naproxen . . . . The significance

of the cardiovascular findings . . . is unknown.” App. at 553. This

language was incorporated into the “precautions” section of the
14

Vioxx labeling, rather than the “warnings” section. In a conference

call discussing the labeling changes, a Merck spokesperson

reiterated the company’s “belief that the effect seen in VIGOR

were [sic] the results of the anti-platelet effect of naproxen. . . . So,

I think that’s a position Merck has always had and now its [sic]

quite clearly laid out in the labeling.” App. at 559.

I. Falling Vioxx Sales and the Harvard Study (October

2003)

On October 22, 2003, Reuters published an article entitled

“Merck to Cut 4,400 Jobs, posts Flat Earnings,” in which it

reported that Merck was “hurt by falling sales of arthritis medicine

VIOXX and a paucity of profitable new drugs. . . . The arthritis

drug is suffering from clinical trial data suggesting it might slightly

raise the risk of heart attacks . . . .” App. at 570. That day,

Merck’s stock price dropped from $48.91 to $45.72, down 6.5%.

On October 30, 2003, the Wall Street Journal published an

article entitled “VIOXX Study Sees Heart-Attack Risk,” which

addressed a recent study by the Harvard-affiliated Brigham and

Women’s Hospital in Boston that found an increased risk of heart

attack in patients taking Vioxx compared with patients taking

Celebrex and placebo (the “Harvard study”). App. at 571.

According to the article, “[i]n the first 30 days, the researchers

found, VIOXX was linked to a 39% increased heart-attack risk

compared with Celebrex. Between 30 and 90 days, that increased

relative risk was 37%.” App. at 571. A researcher stated that this

was “the best study to date” and that it “greatly substantiates our

concerns about the cardiac side effects” of Vioxx. App. at 571.

Merck’s stock price dropped below the S&P 500 Index

during this time, and did not rise above that index during the

remainder of the class period.

J. Merck Withdraws Vioxx From the Market

(September 2004)

On September 30, 2004, Merck announced that it was

withdrawing Vioxx from the market based on a new study showing
15

an “increased risk of confirmed cardiovascular events beginning

after 18 months of continuous therapy.” App. at 584. Merck’s

stock price dropped more than $12 per share that day, to close at

$33.00, down 27% from the previous day’s close. Securities

analysts expressed their surprise at the suddenness of Merck’s

action.

On November 1, 2004, the Wall Street Journal reported,

“internal Merck e-mails and marketing materials as well as

interviews with outside scientists show that the company fought

forcefully for years to keep safety concerns from destroying the

drug’s commercial prospects.” App. at 589. Merck’s stock price

dropped another 9.7% based on this news. The news, which was

first published nearly a year after Appellants filed their complaint,

prompted one securities analyst to remark, “new information

indicates to us that the situation might not be as innocent as we

thought. . . . We recommend that investors sell Merck shares.”

App. at 594.

II.

Procedural History

The first class action securities complaint initiating this

lawsuit was filed on November 6, 2003, just weeks after the media

reported the results of the Harvard study and declining Vioxx sales.

After numerous nationwide class actions were consolidated,

Appellants filed a fourth amended consolidated class action

complaint. The complaint alleged that “Defendants’ statements

and omissions during the Class Period materially misrepresented

the safety and commercial viability of VIOXX,” App. at 489, in

violation of sections 11, 12(a)(2), and 15 of the Securities Act of

1933, sections 10(b), 20(a), and 20A of the Securities Exchange

Act of 1934, and Rule 10b-5 promulgated thereunder.

Merck moved to dismiss Appellants’ claims on the grounds

that they were time-barred and that Appellants had failed to state

a claim. The District Court granted that motion on the basis that

the claims were time-barred. In re Merck & Co., Inc. Sec.,

Derivative & “ERISA” Litig., 483 F. Supp. 2d 407, 425 (D.N.J.
 The District Court did not address Merck’s argument that 8

the allegations contained in the fourth amended consolidated class

action complaint failed to satisfy the heightened standards of the

Private Securities Litigation Reform Act of 1995 for pleading

scienter, and we do not express any opinion on this issue.

16

2007). Appellants timely filed a notice of appeal. 8

III.

Jurisdiction and Standard of Review

The District Court had jurisdiction over this action pursuant

to section 22 of the Securities Act, 15 U.S.C. § 77v; section 27 of

the Securities Exchange Act, 15 U.S.C. § 78aa; and 28 U.S.C. §

1331. We have jurisdiction pursuant to 28 U.S.C. § 1291. We

exercise plenary review over the District Court’s dismissal of

Appellants’ claims for failure to comply with the statute of

limitations. DeBenedictis v. Merrill Lynch & Co., Inc., 492 F.3d

209, 215 (3d Cir. 2007). Because the District Court granted

Merck’s motion to dismiss, “[w]e must ‘accept as true all

allegations in the complaint and all reasonable inferences that can

be drawn therefrom, and view them in the light most favorable to

the non-moving party.’” Id. (quoting Rocks v. City of

Philadelphia, 868 F.2d 644, 645 (3d Cir. 1989)). The dismissal

must be upheld only “‘if it appears to a certainty that no relief

could be granted under any set of facts which could be proved.’”

Id. (quoting D.P. Enters., Inc. v. Bucks County Cmty. Coll., 725

F.2d 943, 944 (3d Cir. 1984)).

IV.

Discussion

The relevant statutes each contain their own statute of

limitations. A complaint alleging “fraud, deceit, manipulation, or

contrivance” under the Securities Exchange Act “may be brought

not later than the earlier of . . . 2 years after the discovery of the

facts constituting the violation; or . . . 5 years after such violation.”
17

28 U.S.C. § 1658(b). Claims under the Securities Act are subject

to a shorter, one-year limitation period from the time of discovery,

but in no event may be filed later than three years after the public

offering or sale of the security. 15 U.S.C. § 77m. Thus, if

Appellants knew of the basis for their claims prior to November 6,

2001, two years before the first securities complaint was filed, all

of their claims are barred by the statute of limitations. See

DeBenedictis, 492 F.3d at 216.

“Whether the plaintiffs, in the exercise of reasonable

diligence, should have known of the basis for their claims depends

on whether they had ‘sufficient information of possible

wrongdoing to place them on ‘inquiry notice’ or to excite ‘storm

warnings’ of culpable activity.’” Benak ex rel. Alliance Premier

Growth Fund v. Alliance Capital Mgmt., L.P., 435 F.3d 396, 400

(3d Cir. 2006) (quoting In re NAHC, Inc. Sec. Litig., 306 F.3d

1314, 1325 (3d Cir. 2002)). This is an objective question; thus, an

investor is not on inquiry notice until a “‘reasonable investor of

ordinary intelligence would have discovered the information and

recognized it as a storm warning.’” In re NAHC, 306 F.3d at 1325

(quoting Mathews v. Kidder, Peabody & Co., 260 F.3d 239, 252

(3d Cir. 2001)).

“If the existence of storm warnings is adequately established

the burden shifts to the plaintiffs to show that they exercised

reasonable due diligence and yet were unable to discover their

injuries.” DeBenedictis, 492 F.3d at 216 (citations, alterations, and

internal quotation marks omitted). Here, the District Court held

that Appellants were on inquiry notice of their claims no later than

October 9, 2001, the date the New York Times published the article

reporting that defendant Scolnick “acknowledged that Merck knew

that the cardioprotective effect of naproxen was not proven and,

further, that Merck admitted that VIOXX may raise the risk of

heart attack or other thrombotic event.” In re Merck, 483 F. Supp.

2d at 419. The Court also noted what it characterized as the

“overwhelming collection of information signaling deceit by Merck

with respect to the safety of VIOXX [that] had accumulated in the

public realm” by that date, in particular, the FDA warning letter.

Id. In concluding that sufficient storm warnings of fraud existed

more than two years prior to the filing of Appellants’ complaint,
Quoting extensively from Mathews, we recently reiterated 9

the inquiry notice standard for RICO claims in Cetel v. Kirwan

18

the District Court observed that Appellants’ “position that their

claims did not accrue until the existence of fraud was a probability,

as opposed to a possibility . . . is simply not supported by Third

Circuit law.” Id. at 422. Finally, noting that Appellants had “not

argued that they conducted a diligent investigation, and nothing in

the Complaint demonstrates that they were unable to uncover

pertinent information during the limitations period,” the Court

concluded that Appellants’ claims were time-barred and granted

Merck’s motion to dismiss. Id. at 424.

A. Principles of Inquiry Notice

Before reviewing the District Court’s decision, we must

address an ambiguity in our inquiry notice jurisprudence.

Appellants contend that the statute of limitations does not begin to

run until there is sufficient evidence of probable, rather than

possible, wrongdoing by the defendants. Predictably, Merck

supports the latter standard, arguing that inquiry notice may be

triggered by evidence of possible wrongdoing. Both formulations

find support in this court’s precedents. Compare DeBenedictis,

492 F.3d at 216 (Inquiry notice may be established by proof of

“‘financial, legal, or other data that would alert a reasonable person

to the probability that misleading statements or significant

omissions had been made.’”) (quoting In re NAHC, 306 F.3d at

1326-27 n.5) (emphasis added), with Benak, 435 F.3d at 400

(“‘Whether the plaintiffs . . . should have known of the basis for

their claims depends on whether they had “sufficient information

of possible wrongdoing to place them on ‘inquiry notice’ . . . .”’”)

(quoting In re NAHC, 306 F.3d at 1325) (emphasis added). We

therefore take this opportunity to clarify the standard for inquiry

notice in this circuit.

Our first comprehensive discussion of the appropriate

standard for inquiry notice took place in the context of a claim filed

pursuant to the Racketeer Influenced and Corrupt Organizations

Act (“RICO”). See Mathews, 260 F.3d at 241. In Mathews, 9
Financial Group, Inc., 460 F.3d 494, 506-07 (3d Cir. 2006).

 Immediately before using this language regarding a 10

“probability” of fraud, we noted without criticism that the district

court had also framed the first prong of the inquiry notice standard

as “‘whether the plaintiffs knew or should have known of the

possibility of fraud (“storm warnings”) . . . .’” Mathews, 260 F.3d

at 251-52 (quoting unpublished district court opinion). Thus, there

is no basis to conclude that we rejected the notion of a possibility

standard at that time.

19

investors in low-risk securities sued their broker after the securities

had lost more than half their value, alleging that the broker misled

them about the nature of the funds and charged excessive fees and

commissions. We affirmed the district court’s grant of summary

judgment for the broker because the complaint was time-barred.

Id. at 244. In analyzing whether plaintiffs’ suit was filed before

RICO’s statute of limitations had run, we applied a two-pronged

test derived from the inquiry notice standard other courts had

applied in the context of securities fraud claims. Id. at 251-52.

First, we noted the requirement to make an objective inquiry

into whether the defendant had met its burden “to show the

existence of ‘storm warnings.’” Id. at 252. We explained that

storm warnings “may take numerous forms,” such as “‘any

financial, legal or other data that would alert a reasonable person

to the probability that misleading statements or significant

omissions had been made.’” Id. (quoting unpublished district court

opinion). Second, we described an inquiry, “both subjective and 10

objective,” into whether the plaintiffs had met their burden “to

show that they exercised reasonable due diligence and yet were

unable to discover their injuries.” Id. We then noted our

agreement with the Court of Appeals for the Seventh Circuit that

courts should be “mindful of the dangers in adopting too broad an

interpretation of inquiry notice.” Id. at 253 (citing Law v. Medco

Research, Inc. (“Medco II”), 113 F.3d 781, 786 (7th Cir. 1997);

Fujisawa Pharm. Co. v. Kapoor, 115 F.3d 1332, 1335 (7th Cir.

1997)).

A year later, we applied this standard to claims pleaded
 In a footnote of the same opinion, however, we stated that 11

inquiry notice could be established on the basis of “‘data that

would alert a reasonable person to the probability that misleading

statements or significant omissions had been made.’” See In re

NAHC, 306 F.3d at 1325-26 n.5 (quoting Mathews, 260 F.3d at

252).

20

under the federal securities laws. See In re NAHC, 306 F.3d at

1318. The shareholders’ claims in that case arose from a health

care provider’s collapse after the federal government enacted

regulations that negatively impacted the provider’s long-term care

services business. Id. at 1318-21. In formally adopting the inquiry

notice standard for securities claims, we stated that “[w]hether the

plaintiffs, in the exercise of reasonable diligence, should have

known of the basis for their claims depends on whether they had

‘sufficient information of possible wrongdoing to place them on

“inquiry notice” or to excite “storm warnings” of culpable

activity.’” Id. at 1325 (quoting Gruber v. Price Waterhouse, 697 11

F. Supp. 859, 864 (E.D. Pa. 1988)). We explained that “[p]laintiffs

need not know all of the details or ‘narrow aspects’ of the alleged

fraud to trigger the limitations period; instead, the period begins to

run from ‘the time at which plaintiff should have discovered the

general fraudulent scheme.’” Id. at 1326 (quoting In re Prudential

Ins. Co. Sales Practices Litig., 975 F. Supp. 584, 599 (D.N.J.

1997)).

In affirming the district court’s dismissal of the plaintiffs’

claim arising from the impact of the federal regulations on the

defendants’ long-term care services business, we held that a series

of disclosures, which accompanied a drastic decline in the

company’s stock price, id. at 1319, and culminated with the

defendants’ announcement that they were writing off goodwill and

selling their business for nominal consideration, put the plaintiffs

on inquiry notice that previous valuations of goodwill had been

inflated, id. at 1326-27. This holding was bolstered by the

plaintiffs’ admission that the market had written off that business

even before the defendants’ announcement. Id. at 1327.

More recently, in 2006, we considered whether a suit filed
21

by mutual fund investors against fund advisors who had invested

heavily in Enron was barred by the statute of limitations. Benak,

435 F.3d at 397. In our decision, we dispensed with the probability

language altogether, instead holding that storm warnings could be

triggered by “‘sufficient information of possible wrongdoing . . . .’”

Id. at 400 (quoting In re NAHC, 306 F.3d at 1325). Applying our

inquiry notice standard to the facts of that case, we distinguished

mutual fund investors from direct investors on the ground that

mutual fund investors rely on an intermediary to learn about the

companies in which they have invested. Id. at 401-02.

Nonetheless, because the investors in Benak had access to media

reports about their fund’s large holdings in Enron after that

company went bankrupt, we concluded that the plaintiffs were on

inquiry notice of the fraud by the time the media reported the

bankruptcy. Id. at 402-03.

Finally, in a case decided just last year, we considered

investors’ claims that Merrill Lynch misled them by failing to

disclose that a certain class of mutual fund shares was “never a

rational choice of investment for them and that Merrill brokers

received larger commissions on sales of such shares.”

DeBenedictis, 492 F.3d at 210. Merrill argued that news articles,

National Association of Securities Dealers (“NASD”) press

releases, and the mutual funds’ registration statements put the class

on inquiry notice more than two years before the complaint was

filed and that it should therefore be dismissed as time-barred. Id.

at 214. After quoting the “probability” language first used by the

district court in Mathews, we addressed each category of storm

warnings alleged. We noted that Merrill’s registration statements

disclosed the fee structure for the different classes of shares, which

allowed investors to determine the relative costs and benefits of the

different shares, and the different commissions applying to those

shares. Id. at 216-17. We further concluded that storm warnings

existed because the news reports and press releases identified by

the defendants revealed that many brokers had been disciplined by

the NASD for recommending the very class of shares that

undergirded the plaintiffs’ claims. Id. at 217. Accordingly, we

concluded that the plaintiffs’ claims were time-barred.

As this review of our precedent makes clear, although we
22

have occasionally stated that inquiry notice may be triggered by

evidence alerting an investor to the probability of wrongdoing, we

have just as often emphasized that inquiry notice may be triggered

by sufficient information of possible wrongdoing. This implies

that a probability, in the sense of a nearly certain likelihood, of

wrongdoing is not necessary to trigger storm warnings in this

circuit. Therefore, we reaffirm that “whether the plaintiffs, in the

exercise of reasonable diligence, should have known of the basis

for their claims depends on whether they had sufficient information

of possible wrongdoing to place them on inquiry notice or to excite

storm warnings of culpable activity.” Benak, 435 F.3d at 400

(citations, alteration, and internal quotation marks omitted). In so

holding, we note that the majority of courts of appeals to have

addressed the question employ a possibility standard when

evaluating the likelihood of wrongdoing sufficient to constitute

storm warnings. See, e.g., GO Computer, Inc. v. Microsoft Corp.,

508 F.3d 170, 179 (4th Cir. 2007); Tello v. Dean Witter Reynolds,

Inc., 494 F.3d 956, 970 (11th Cir. 2007); Wolinetz v. Berkshire

Life Ins. Co., 361 F.3d 44, 48 (1st Cir. 2004); Ritchey v. Horner,

244 F.3d 635, 639 (8th Cir. 2001); Berry v. Valence Tech., Inc.,

175 F.3d 699, 705 (9th Cir. 1999); Sterlin v. Biomune Sys., 154

F.3d 1191, 1196 (10th Cir. 1998); LaSalle v. Medco Research, Inc.

(“Medco I”), 54 F.3d 443, 444 (7th Cir. 1995); Jensen v. Snellings,

841 F.2d 600, 607 (5th Cir. 1988). But see Newman v. Warnaco

Group, Inc., 335 F.3d 187, 193 (2d Cir. 2003) (“The [existence of]

fraud must be probable, not merely possible.”).

Nonetheless, simply repeating the word “possibility” or

“probability” with ever-increasing frequency and intensity (as both

parties did in their briefs and at oral argument) is hardly useful.

Rather, we review the information set forth by the parties with an

eye toward the practical effect of drawing the inquiry notice line at

a particular date. In this vein, we have emphasized that

“[u]ndergirding the inquiry notice analysis is the assumption that

a plaintiff either was or should have been able, in the exercise of

reasonable diligence, to file an adequately pled securities fraud

complaint as of an earlier date.” Benak, 435 F.3d at 401.

Similarly, the Court of Appeals for the Seventh Circuit, which has

also applied a possibility standard, see Medco I, 54 F.3d at 444, has

reasoned that “[t]he facts constituting [inquiry] notice must be
The PSLRA requires plaintiffs pleading securities fraud 12

to “specify each statement alleged to have been misleading, [and]

the reason or reasons why the statement is misleading,” 15 U.S.C.

§ 78u-4(b)(1), and to “state with particularity facts giving rise to a

strong inference that the defendant acted with the required state of

mind,” i.e., scienter, id. § 78u-4(b)(2).

23

sufficiently probative of fraud–sufficiently advanced beyond the

stage of a mere suspicion, sufficiently confirmed or

substantiated–not only to incite the victim to investigate but also to

enable him to tie up any loose ends and complete the investigation

in time to file a timely suit,” Fujisawa, 115 F.3d at 1335. In other

words, simply stating that a smattering of evidence hinted at the

possibility of some type of fraud does not answer the question

whether there was “sufficient information of possible wrongdoing

. . . to excite storm warnings of culpable activity” under the

securities laws. Benak, 435 F.3d at 400 (citations and internal

quotation marks omitted) (emphasis added).

This concern is reenforced by the heightened pleading

requirements of the Private Securities Litigation Reform Act of

1995 (“PSLRA”), 15 U.S.C. § 78u-4(b). Surely, Congress did not 12

envision a statute of limitations that would open the floodgates to

a rush of premature securities litigation when its primary foray into

this field in recent decades has been to deter poorly pleaded

allegations of securities fraud. See DeBenedictis, 492 F.3d at 217-

18 (noting that “‘the level of particularity in pleading required by

the PSLRA is such that inquiry notice can be established only

where the triggering data “relates directly to the misrepresentations

and omissions” alleged.’”) (quoting Lentell v. Merrill Lynch &

Co., 396 F.3d 161, 171 (2d Cir. 2005)); cf. Mathews, 260 F.3d at

253 (expressing concern about “a flood of untimely litigation” were

we to “adopt[] too broad an interpretation of inquiry notice”).

B. Basis of Appellants’ Claims

Appellants argue that the District Court mischaracterized the

gravamen of their fraud allegations, thereby undermining the

Court’s conclusion that Appellants were on inquiry notice of the
24

alleged wrongdoing. We have repeatedly stated that the

fundamental concern of our analysis is whether plaintiffs were “‘on

inquiry notice of the basis for [their] claims’” prior to the relevant

date triggering the statute of limitations. Benak, 435 F.3d at 400

(quoting In re NAHC, 306 F.3d at 1325). Therefore, we must

carefully scrutinize the District Court’s characterization of the basis

for Appellants’ claims and consider how this characterization

affected the Court’s inquiry notice analysis.

First, Appellants contend that the Court mischaracterized the

basis for their claims by focusing on alleged misrepresentations

about Vioxx’s safety profile. In concluding that sufficient storm

warnings existed to put Appellants on inquiry notice, the District

Court considered the “overwhelming collection of information

signaling deceit by Merck with respect to the safety of VIOXX

[that] had accumulated in the public realm” by October 9, 2001. In

re Merck, 483 F. Supp. 2d at 419. Appellants argue that the true

nature of their claims is that Vioxx “was so dangerous that it lacked

any meaningful commercial prospects, or that [Merck’s]

representations in this regard were materially false and misleading

when made . . . .” Appellant’s Br. at 35. The difficulty with this

contention is that Merck’s representations about Vioxx’s

commercial viability are not unrelated to the company’s

representations about the drug’s safety profile. If public

information undermined Merck’s representations about Vioxx’s

safety, a reasonable investor would also likely see such information

as undermining Merck’s representations about Vioxx’s commercial

viability. Indeed, some professional investors connected concerns

about the safety of COX-2 inhibitors to their commercial viability.

Nonetheless, the fact that many securities analysts continued

to maintain strong growth ratings for Vioxx at the same time that

its safety was being questioned is certainly relevant to whether such

questions constituted sufficient information of possible

wrongdoing to trigger storm warnings. Even though there were

analysts who connected Vioxx’s safety to its commercial viability,

it appears that they were not so worried about Vioxx’s safety after

the FDA warning letter was made public that they felt it necessary

to retract their opinions about Vioxx’s future profitability or
A September 25, 2001 report by a CSFB analyst illustrates 13

the interrelatedness of the two propositions: “Recent prescription

trends have indicated that adverse publicity and cardiovascular

concerns have contributed to erosion in Vioxx (as well as

Celebrex) market share within the collective COX-2/NSAID

market.” App. at 2757. On the other hand, the same CSFB report

also “project[ed] Vioxx revenues will increase 42% year over year

to $3.06 billion for 2001, with growth moderating to the +14%

level in 2002 to $3.49 billion. We maintain our Buy rating.” App.

at 2757.

25

Merck’s market position. In any event, Appellants argue that 13

even if their claims are properly characterized as alleging

misrepresentations about Vioxx’s safety, the District Court

misinterpreted their claims in another respect.

Appellants contend that their complaint challenges the

veracity of Merck’s statements of opinion and belief regarding the

naproxen hypothesis whereas the District Court analyzed whether

Merck misrepresented the fact that the results of the VIGOR study

could support multiple hypotheses (i.e., that naproxen lowers the

risk of CV events or that Vioxx raises that risk). Thus, they argue

that the District Court mischaracterized their claims by considering

whether there were storm warnings that put them on notice of a

fraud different from that which they have asserted in their

complaint.

We have explained that for “misrepresentations in an

opinion” or belief to be actionable, plaintiffs must show that the

statement was “‘issued without a genuine belief or reasonable

basis’ . . . .” Herskowitz v. Nutri/System, Inc., 857 F.2d 179, 185

(3d Cir. 1988) (quoting Eisenberg v. Gagnon, 766 F.2d 770, 776

(3d Cir. 1985)); accord Va. Bankshares, Inc. v. Sandberg, 501 U.S.

1083, 1095 (1991) (“A statement of belief may be open to

objection . . . as a misstatement of the psychological fact of the

speaker’s belief in what he says.”). Thus, to trigger “storm

warnings of culpable activity,” Benak, 435 F.3d at 400 (citations

and internal quotation marks omitted), in the context of a claim

alleging falsely-held opinions or beliefs, investors must have
26

sufficient information to suspect that the defendants engaged in

culpable activity, i.e., that they did not hold those opinions or

beliefs in earnest. Appellants’ theory in the complaint is that

Merck’s statements about the validity of the naproxen hypothesis

were falsely-held statements of opinion or belief and that there was

no information available to investors prior to November 6, 2001

that would have led them to suspect that such statements were not

held in earnest. The District Court rejected this argument,

concluding that “[i]t is prepost[e]rous for Plaintiffs to argue that

because they did not have a ‘smoking gun’ that demonstrated that

Defendants’ misrepresentation was even more egregious than the

[FDA] Warning Letter charged, they were not on inquiry notice of

a general fraudulent scheme regarding the safety of VIOXX.” In

re Merck, 483 F. Supp. 2d at 422-23. We disagree.

It is true that “[p]laintiffs cannot avoid the time bar simply

by claiming they lacked knowledge of the details or narrow aspects

of the alleged fraud. Rather, the clock starts when they should

have discovered the general fraudulent scheme.” Benak, 435 F.3d

at 400 (citations and internal quotation marks omitted). The

“fraudulent scheme” referred to must be one “in connection with

the purchase or sale of any security . . . .” 15 U.S.C. § 78j(b).

Appellants have brought a securities fraud action, not a consumer

fraud action, against Merck. See Gavin v. AT & T Corp., 464 F.3d

634, 640 (7th Cir. 2006) (recognizing that securities fraud suits and

consumer fraud suits are not interchangeable); cf. Marine Bank v.

Weaver, 455 U.S. 551, 556 (1982) (“Congress, in enacting the

securities laws, did not intend to provide a broad federal remedy

for all fraud.”). Thus, the fact that the FDA sent a letter to Merck

about its possible misrepresentations in connection with its

promotion of Vioxx to health care professionals would not have

provided a storm warning unless it put Appellants on inquiry notice

of actionable misrepresentations under the securities laws. See

DeBenedictis, 492 F.3d at 218 (finding storm warning where

disclosure was “directly applicable to the representations or

omissions” challenged by plaintiffs). The asserted basis of

Appellants’ claims is that Merck defrauded investors by proposing

and reasserting the naproxen hypothesis at the same time that it

knew the hypothesis was false. We must analyze the existence of

storm warnings relative to that allegation in order to determine
 We have recognized that “reassurances can dissipate 14

apparent storm warnings if an investor of ordinary intelligence

would reasonably rely on them to allay the investor’s concerns.”

Benak, 435 F.3d at 402 n.16 (citation, alteration, and internal

quotation marks omitted). “‘Whether reassuring statements justify

reasonable reliance that apparent storm warnings have dissipated

will depend in large part on how significant the company’s

disclosed problems are, how likely they are of a recurring nature,

and how substantial are the “reassuring” steps announced to avoid

their recurrence.’” DeBenedictis, 492 F.3d at 218 (quoting LC

27

whether Appellants were on inquiry notice of the alleged fraud.

C. Existence of Storm Warnings

Because the District Court believed that “[t]he wrongdoing

charged in the [FDA] Warning Letter is . . . the same alleged

misconduct on which the securities fraud claims in this case are

predicated,” the Court asserted that it “might arguably conclude

that the FDA Warning Letter alone excited storm warnings

sufficient to put Plaintiffs on inquiry notice of their claims against

Merck,” but it decided that it “need not make that conclusion,

because the FDA Warning Letter was not issued in a vacuum of

information.” In re Merck, 483 F. Supp. 2d at 419. The Court then

took notice of the JAMA article, the lawsuits filed against Merck

in 2001, and various articles discussing competing explanations for

the results of the VIGOR study. Id. at 419-21. The Court reasoned

that the New York Times article following the FDA warning letter

was especially probative because Scolnick “admitted that Merck

recognized the possibility that VIOXX may increase a user’s risk

of heart attack. It therefore represents a significant departure from

Merck’s company line as to the explanation for the VIGOR study

results.” Id. at 420. The Court then rejected Appellants’ argument

that positive information issued by Merck during this period

dissipated any storm warnings. Id. at 421.

Appellants argue that to the extent the disclosures identified

by Merck might be seen as triggering storm warnings, such storm

warnings were dissipated by Merck’s reassuring statements, and 14
Capital Partners, LP v. Frontier Ins. Group, Inc., 318 F.3d 148, 155

(2d Cir. 2003)).

28

are undermined by the failure of the identified disclosures to have

any significant impact on Merck’s stock price or the projections of

securities analysts covering Merck. Merck argues that stock price

movement is irrelevant to the inquiry notice analysis. We cannot

agree. Our past inquiry notice decisions have taken into account

the market reaction to disclosures that purportedly constitute storm

warnings. See, e.g., In re NAHC, 306 F.3d at 1319 (discussing

drastic decline in stock price accompanying disclosures in period

leading up to date of inquiry notice); cf. Benak, 435 F.3d at 403

(noting that Enron’s collapse and subsequent bankruptcy triggered

inquiry notice); Mathews, 260 F.3d at 254 (explaining that 30%

drop in funds’ net asset values and 60% decline in distributions

triggered inquiry notice). In Mathews, we explained that “in most

securities fraud actions, the plaintiffs’ [losses] are inextricably

intertwined with the defendant’s misrepresentations. Discovery of

one leads almost immediately to discovery of the other.” Mathews,

260 F.3d at 251. Similarly, in the context of materiality, we have

stated that in “an efficient market, ‘information important to

reasonable investors . . . is immediately incorporated into the stock

price.’” Oran v. Stafford, 226 F.3d 275, 282 (3d Cir. 2000)

(quoting In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410,

1425 (3d Cir. 1997)). “If the disclosure of certain information has

no effect on stock prices, it follows that the information disclosed

was immaterial as a matter of law.” In re NAHC, 306 F.3d at 1330

(citing In re Burlington Coat Factory, 114 F.3d at 1425).

Because information that is material to reasonable investors

is immediately incorporated into the stock price, the effect of a

purported storm warning on the market, while insufficient on its

own to compel the conclusion that inquiry notice has not been

triggered, is, contrary to Merck’s position, relevant to our inquiry.

See Newman, 335 F.3d at 195 (asserting that the court’s “holding

is further supported by the fact that [defendant]’s stock price did

not have any significant movement following” the identified

disclosure); Berry, 175 F.3d at 705 (concluding that the lack of

significant stock movement “bolster[ed]” the conclusion that
29

inquiry notice had not been triggered).

The District Court (and Merck on this appeal) emphasized

five classes of information, each of which was disclosed on or

before October 9, 2001, which purportedly triggered storm

warnings: (1) articles and reports commenting on the hypothetical

explanations for the results of the VIGOR study; (2) the JAMA

article, which asserted that available data (i.e., VIGOR and a

Celebrex study) raised a “cautionary flag” about the risk of CV

events in COX-2 inhibitors, App. at 748; (3) the FDA warning

letter, which charged Merck with “engag[ing] in a promotional

campaign for Vioxx that minimizes the potentially serious

cardiovascular findings that were observed in the [VIGOR] study,

and thus, misrepresents the safety profile for Vioxx,” App. at 713;

(4) the consumer fraud, product liability, and personal injury

lawsuits filed against Merck throughout 2001; and (5) the New

York Times article, in which Scolnick stated there were “two

possible interpretations” for the VIGOR results, App. at 654.

Because the disclosures in each of these categories ultimately arise

from the results of the VIGOR study, we briefly recap the details

of the study.

VIGOR compared Vioxx to naproxen in the hopes of

establishing that Vioxx had a better GI profile than traditional

NSAIDs. Although those hopes were realized, Merck also learned,

and subsequently notified the public, that “significantly fewer

thromboembolic events were observed in patients taking naproxen”

than patients taking Vioxx. App. at 765. Merck suggested that

naproxen’s effect on platelet aggregation was responsible for this

difference, but conceded that this hypothetical effect “had not been

observed previously in any clinical studies . . . .” App. at 765.

Merck also stated that all other Vioxx trials “showed no indication

of a difference in the incidence of thromboembolic events between

Vioxx, placebo and comparator NSAIDs.” App. at 766.

Securities analysts and the press duly reported the results of

VIGOR and the naproxen hypothesis. For instance, an article

published in Bloomberg News a month after the VIGOR results

were released reiterated Merck’s hypothesis about naproxen’s

effect on platelet aggregation, but noted that “[n]aproxen doesn’t
30

have documented protective effects on the heart,” and quoted an

analyst who stated, “that Vioxx increases cardiac risk . . . may be

true, but it is far too soon to make that kind of judgment.” App. at

2292. Similarly, a J.P. Morgan report from April 2000 noted the

intuitive appeal of the theory that “the thromboembolic event issue

is an ‘NSAID-issue,’” but explained that the “theoretical

cardiovascular protective benefits of Naprosyn . . . have not been

clinically proven . . . .” App. at 2376. In another article, a

spokesperson for the makers of Naprosyn stated, “[t]o our

knowledge, naproxen does not prevent heart attack or stroke . . . .”

App. at 2288. In our view, this category of disclosures does not

constitute storm warnings that Merck misrepresented Vioxx’s

safety profile to investors in a manner that might give rise to a

securities fraud claim. On the contrary, securities analysts and the

press recognized the naproxen hypothesis for what it was, an

unproven hypothesis, and recognized that there was an alternative

hypothesis, “that Vioxx increases cardiac risk . . . .” App. at 2292.

Shortly before the AAC hearing, during which the FDA

considered how Vioxx’s labeling should be modified to incorporate

the results of the VIGOR study, a J.P. Morgan research report

described the effect of NSAIDs such as naproxen on CV events as

“poorly proven” and explained that there was “no way to

retrospectively slice the data to prove the NSAID benefit vs. Vioxx

risk argument . . . .” App. at 2547. At that hearing, defendant

Reicin, the Executive Director of Clinical Research at Merck

Research Laboratories, who argued in support of the naproxen

hypothesis, admitted at the outset that the explanation for the

results of the VIGOR study was uncertain. The first Vioxx product

liability lawsuit (which, incidentally, charged the makers of

Celebrex with identical wrongdoing) followed shortly thereafter,

seeking “additional medical labeling which is presently being

considered by the FDA [in conjunction with the AAC hearing.]” 

App. at 1748. Of course, investors, unlike Vioxx patients, were

presumed to be aware of the publicized outcomes of research

studies, such as VIGOR, which underlay the allegations of that

product liability lawsuit. See Benak, 435 F.3d at 401 (explaining

that “a direct investor . . . can be deemed to have consistent

knowledge of his or her securities holdings”).
31

The JAMA article evaluated Vioxx and Celebrex, both

COX-2 selective inhibitors, together; its findings were not limited

to Vioxx. The article concluded, based in part on VIGOR, that

“[c]urrent data would suggest that use of selective COX-2

inhibitors might lead to increased cardiovascular events.” App. at

752. Of course, this is simply the alternative to the naproxen

hypothesis. The JAMA article did not present any data that would

suggest that Merck did not have reason to propose that hypothesis.

Accordingly, it is of little surprise that a Deutsche Banc securities

analyst described the types of questions raised in the JAMA article

as “not new news . . . .” App. at 2749. Moreover, Merck issued

reassuring statements the day before and the day after the article

was published. Again, we are of the view that the JAMA article,

taken on its own, did not constitute sufficient information of

possible wrongdoing under the securities laws so as to raise a storm

warning of culpable activity under the securities laws.

The FDA warning letter demands more scrutiny. In

analyzing the effect of that letter through the prism of inquiry

notice, we must not lose focus of the nature of the allegations in the

letter and the scope of the FDA’s regulatory authority. The FDA

targeted Merck’s “promotional campaign for Vioxx,” App. at 713,

under its authority to regulate prescription drug advertisements, see

21 U.S.C. § 352(n); see generally Pa. Employees Benefit Trust

Fund v. Zeneca Inc., 499 F.3d 239, 248-49 (3d Cir. 2007)

(discussing the FDA’s authority over prescription drug

advertising). The letter focused on three distinct components of the

promotional campaign that the FDA found of concern: (1) six

promotional audio conferences, presumably aimed at health care

professionals such as doctors and pharmacists; (2) a press release

dated May 22, 2001 entitled “Merck Confirms Favorable

Cardiovascular Safety Profile of Vioxx,” App. at 718; and (3) oral

representations made by Merck sales representatives, again,

presumably to health care professionals. The FDA chastised

Merck’s promotional campaign for “discount[ing] the fact that in

the VIGOR study, patients on Vioxx were observed to have a four

to five fold increase in myocardial infarctions (MIs) compared to

patients on” naproxen, and “selectively present[ing]” the naproxen

hypothesis as the reason for the incidence of increased CV events.

App. at 713. The FDA stated that Merck’s promotional campaign
32

“fail[ed] to disclose that [its] explanation is hypothetical, has not

been demonstrated by substantial evidence, and that there is

another reasonable explanation, that Vioxx may have prothrombotic properties.” App. at 713. For a number of reasons, we

are hesitant to conclude that the FDA warning letter was sufficient

to trigger inquiry notice.

To begin with, the FDA was acting as a regulator of drug

advertising, rather than as a regulator of the securities markets.

Thus, contrary to Merck’s contention at oral argument, the FDA’s

actions are hardly analogous to allegations of accounting fraud

issued by the SEC, which regulates the securities markets. Indeed,

the FDA’s drug advertising regulations and the securities laws

provide wholly different standards with respect to what constitutes

a misrepresentation. FDA regulations provide that advertisements

must not be “lacking in fair balance,” 21 C.F.R. § 202.1(e)(6), and

prohibit advertisements that “[c]ontain[] a representation or

suggestion that a drug is safer than it has been demonstrated to be

by substantial evidence or substantial clinical experience . . . or

otherwise selects information from any source in a way that makes

a drug appear to be safer than has been demonstrated,” id. §

202.1(e)(6)(iv). In contrast, under the securities laws, “a fact or

omission is material only if ‘there is a substantial likelihood that it

would have been viewed by the reasonable investor as having

significantly altered the “total mix” of information’ available to the

investor.” In re NAHC, 306 F.3d at 1330 (quoting Basic Inc. v.

Levinson, 485 U.S. 224, 231-32 (1988)).

Second, the FDA’s description of the truth about the

VIGOR study is quite similar to the evidence that Merck had long

acknowledged and which the market had incorporated.

Specifically, the FDA stated that the naproxen hypothesis “is

hypothetical, has not been demonstrated by substantial evidence,

and that there is another reasonable explanation, that Vioxx may

have pro-thrombotic properties.” App. at 713. This information is

implicit in Merck’s long-standing admission that the posited anticoagulant effect of naproxen “on [CV] events had not been

observed previously in any clinical studies for naproxen.” App. at

765. On the basis of Merck’s public announcements, securities

analysts discussed the existence of “a ‘Vioxx risk’ hypothesis” over
33

seven months before the FDA warning letter was issued. App. at

2547. Indeed, the FDA did not charge that the naproxen hypothesis

was wrong or that Merck did not believe in the validity of its

hypothesis; rather, the agency simply directed Merck to be more

clear about the widely known alternative hypothesis in its dealings

with health care professionals and, presumably, consumers.

Third, two of the three components of the promotional

campaign subject to the FDA’s reprimand consisted of statements

made to health care professionals in the course of targeted audio

conferences and personal conversations. The third component of

the promotional campaign targeted by the FDA was the press

release, but that press release merely repeated the same information

that was first contained in the VIGOR press release, i.e.,

“significantly fewer heart attacks were observed in patients taking

naproxen . . . compared to the group taking Vioxx,” “the VIGOR

finding is consistent with naproxen’s ability to block platelet

aggregation by inhibiting COX-1,” “[t]his is the first time this

effect of naproxen on cardiovascular events has been observed in

a clinical study,” and “[o]ther potential explanations” for the results

were possible. Press Release, Merck & Co., Inc., Merck Confirms

Favorable Cardiovascular Safety Profile of Vioxx(R) (May 22,

2001) (available on PR Newswire and LexisNexis).

Finally, we consider the effect the FDA warning letter had

on the market. Merck’s stock price dipped slightly following the

disclosure of the FDA warning letter before closing higher than it

did before that disclosure just a week and a half later. Although the

lack of significant movement in Merck’s stock price following the

FDA warning letter is not conclusive, it supports a conclusion that

the letter did not constitute a sufficient suggestion of securities

fraud to trigger a storm warning of culpable activity under the

securities laws. See, e.g., Berry, 175 F.3d at 705 (asserting that the

“negligible impact” of an alleged storm warning on defendant’s

stock price bolstered conclusion that inquiry notice was not

triggered). This conclusion is also supported by the fact that more

than a half-dozen securities analysts continued to maintain their

ratings for Merck stock and/or project increased future revenues for

Vioxx after the warning letter was made public.
The New York Times article also explained that “[t]he 15

risk is hypothesized, not proved,” and that “leading arthritis

specialists . . . say that they are not concerned and that they

prescribe the drugs for patients who may have heart disease.” App.

at 653.

34

Merck also emphasizes the three additional lawsuits filed

after the FDA warning letter. Of course, none of these lawsuits

alleged securities fraud. Rather, they alleged consumer fraud,

product liability, and personal injury claims. The claims in those

lawsuits alleged that Merck failed to provide publicly available

information to Vioxx consumers, rather than to Merck investors.

Cf. In re Ames Dep’t Stores, Inc. Note Litig., 991 F.2d 968, 980

(2d Cir. 1993) (stating that the different concerns of debt and

equity holders may call for distinct inquiry notice dates for the two

classes of investors).

Finally, we question the District Court’s conclusion that the

New York Times article constituted a storm warning. The District

Court reasoned that defendant Scolnick’s statements in that article

constituted “a significant departure from Merck’s company line as

to the explanation for the VIGOR study results.” In re Merck, 483

F. Supp. 2d at 420. But Scolnick did not abandon the naproxen

hypothesis; rather, he reiterated that Merck “found no evidence that

Vioxx increased the risk of heart attacks” when it looked back at

its data comparing Vioxx to other drugs and placebos and “that ‘the

likeliest interpretation of the data is that naproxen lowered . . . the

thrombotic event rate’ . . . .” App. at 654. Even in the wake of 15

the FDA warning letter, then, Merck continued to reassure the

investing public that Merck stood behind the naproxen hypothesis,

while acknowledging that another explanation (i.e., that Vioxx

causes CV events) remained a possibility. See Benak, 435 F.3d at

402 n.16 (“Reassurances can dissipate apparent storm warnings if

an investor of ordinary intelligence would reasonably rely on them

to allay the investor’s concerns.”) (citation and internal quotation

marks omitted). It is also notable there was no “significant

movement” of Merck’s stock price following the article’s

publication. Newman, 335 F.3d at 195. Thus, we cannot conclude

as a matter of law that this article constituted a storm warning.
There are two statements in the dissent, although arguably 16

going to minor issues, that call for a response. The dissent states

that Scolnick’s statement quoted in the October 9, 2001 New York

Times article was “the first time [the statement that the VIGOR

results could be explained by either the effect of naproxen or

Vioxx] had been made by the company.” Dissent Typescript op. at

46-47. In fact, as noted above, Alise Reicin, the Executive

Director of Clinical Research at Merck Research Laboratories, had

testified as to that possibility at the FDA’s hearing before the AAC

as early as February 8, 2000, more than eight months before the

New York Times article. See supra p. 7.

Second, to the extent that the dissent suggests that the

majority holds that fluctuations in stock price and analysts’ ratings

and projections are necessary to a finding of storm warnings,

Dissent Typescript op. at 47, a rereading of the majority opinion

will make clear that the majority agrees with the dissent that such

factors are relevant to the storm warnings inquiry, but not required.

35

In summary, we conclude that the District Court acted

prematurely in finding as a matter of law that Appellants were on

inquiry notice of the alleged fraud before October 9, 2001. As of

that date, market analysts, scientists, the press, and even the FDA

agreed that the naproxen hypothesis was plausible, at the very least.

None suggested that Merck believed otherwise. Accordingly, in

April 2002, the FDA approved a labeling change for Vioxx which

stated that “[t]he significance of the cardiovascular findings [from

the VIGOR study] is unknown.” App. at 553. Merck continued to

reassure the investing public at this time, explaining that the

naproxen hypothesis was “a position Merck has always had and

now its [sic] quite clearly laid out in the labeling.” App. at 559.

On the record before us, there is no reason to suspect that Merck

did not believe the naproxen hypothesis until the Harvard study in

2003 revealed an increased risk of heart attack in patients taking

Vioxx compared with patients taking Celebrex and placebo. This

study for the first time belied Merck’s repeated assurances that

naproxen was responsible for the disparity in CV events in VIGOR

and that Vioxx did not have a higher incidence of CVs compared

to placebo or comparator NSAIDs, such as Celebrex.16
See supra p. 28.

It is ironic that the dissent, although noting what might be

viewed as Merck’s misrepresentations, would apply the statute of

limitations to deprive plaintiffs of the opportunity to prove a viable

case against Merck for such misrepresentations.

 Because we have concluded that the District Court erred 17

in finding Appellants on inquiry notice of the alleged fraud at this

stage of the litigation, we do not address Appellants’ remaining

arguments regarding the claims of plaintiffs who purchased stock

after October 9, 2001 and the viability of Appellants’ section 20A

claims.

36

V.

Conclusion17

For the reasons set forth, we will reverse the judgment of

dismissal and remand to the District Court for further proceedings

consistent with this opinion.
37

In re: Merck & Co., et al. 

Nos. 07-2431/2432

 

ROTH, Circuit Judge, dissenting.

I believe “storm warnings” alerting a reasonable investor

of possible culpable activity on the part of Merck were evident

more than two years prior to the filing of appellants’ complaint.

In particular, I believe that the FDA’s September 17, 2001,

warning letter, in and of itself, provided sufficient “storm

warnings” to put the appellants on inquiry notice of their claims

regardless of any significant change in stock price or analysts’

stock ratings or projections at that time. I therefore respectfully

dissent. 

Under the “inquiry notice” test, the statute of limitations

for securities claims “begins to run when the plaintiffs

‘discovered or in the exercise of reasonable diligence should

have discovered the basis for their claim’ against the defendant.”

Benak v. Alliance Capital Management L.P., 435 F.3d 396, 400

(3d Cir. 2006) (quoting In re NAHC, Inc. Securities Litigation,

306 F.3d 1314, 1325 (3d Cir. 2002) (citations omitted)). In

order to establish that plaintiffs were on inquiry notice, a

defendant must demonstrate that, as of a particular date, there

existed “storm warnings” sufficient to alert “a reasonable

investor of ordinary intelligence” to “possible wrongdoing” on

the part of defendants. Id. (quoting In re NAHC, 306 F.3d at

1325) (explaining that the question is whether plaintiffs had
38

“sufficient information of possible wrongdoing to place them on

‘inquiry notice’ or to excite ‘storm warnings’ of culpable

activity”) (emphasis added). 

Furthermore, it is well established that “[t]he existence of

storm warnings is a totally objective inquiry[,]” that is based on

whether a “reasonable investor of ordinary intelligence would

have discovered the information and recognized it as a storm

warning[,]” Mathews v. Kidder Peabody & Co., Inc., 260 F.3d

239, 252 (3d Cir. 2001) (emphasis added); see also In re NAHC,

306 F.3d at 1325. We do not require that plaintiffs “know all of

the details or ‘narrow aspects’ of the alleged fraud to trigger the

limitations period[,]” but rather “the period begins to run from

the time at which plaintiff should have discovered the general

fraudulent scheme.” In re NAHC, 306 F.3d at 1326 (internal

quotations and citations omitted). Most importantly, we

recognize that triggering data for “storm warnings” may include

any information that would alert a reasonable investor to the

possibility that the defendants engaged in the “general

fraudulent scheme” alleged in the complaint. Id. (emphasis

added). Finally, such triggering data must “relate[] directly to

the misrepresentations and omissions alleged.” DeBenedictis,

492 F.3d at 217-18 (quoting Lentell v. Merrill Lynch & Co.,

Inc., 396 F.3d 161, 171 (2d Cir. 2005)).

In applying the above inquiry notice standard to the

instant case, I am reminded of a classic fairytale: The

Emperor’s New Clothes, by Danish author and poet, Hans
In the story, two swindlers approached the Emperor, 18

falsely claiming the ability to make beautiful clothes from cloth

that could be seen only by those individuals fit for their positions

or who were not imbecils. The Emperor immediately hired them.

Word spread throughout the city about the unique quality of the

cloth and the personal characteristics that an individual must

possess to see clothes made of such material. After the swindlers

finished weaving the Emperor’s new clothes and presented them to

him, neither the Emperor nor his most trusted servants would admit

that they could not see the clothes for fear of appearing unfit or

stupid. Instead, each exclaimed that the clothes were beautiful.

Donning his new clothes, the Emperor walked in a procession

through the city’s streets. The townspeople also feared looking

stupid in their neighbors’ eyes. Like the Emperor and his servants,

they proclaimed that the clothes were the most beautiful they had

ever seen. It wasn’t until a child exclaimed, “But, Daddy, he has

nothing on!” that the crowd realized that the child spoke the truth.

39

Christian Anderson. As the child in The Emperor’s New 18

Clothes saw – that the Emperor walked naked down the street –

any reasonable investor reading the FDA’s September 17, 2001,

warning letter could see the problem with Vioxx – the

misrepresentation of its safety profile and the “possibility” that

Merck had fraudulently misrepresented the cardiovascular safety

of its “blockbuster” product. The warning letter to Merck,

which was published on the FDA’s public website, stated in

pertinent part:

You have engaged in a promotional campaign for
40

Vioxx that minimizes the potentially serious

cardiovascular findings that were observed in the

[VIGOR] study, and thus, misrepresents the safety

profile for Vioxx. Specifically, your promotional

campaign discounts the fact that in the VIGOR

study, patients on Vioxx were observed to have a

four to five fold increase in myocardial infarctions

(MIs) compared to patients on the comparator

[NSAID], Naprosyn (naproxen).

Although the exact reason for the increased rate

of MIs observed in the Vioxx treatment group is

unknown, your promotional campaign selectively

presents the following hypothetical explanation

for the observed increase in MIs. You assert that

Vioxx does not increase the risk of MIs and that

the VIGOR finding is consistent with naproxen’s

ability to block platelet aggregation like aspirin.

That is a possible explanation, but you fail to

disclose that your explanation is hypothetical, has

not been demonstrated by substantial evidence,

and that there is another reasonable explanation,

that Vioxx may have pro-thrombotic properties.

...

Your minimizing these potential risks and

misrepresenting the safety profile for Vioxx raise

significant health and safety concerns. Your

misrepresentation of the safety profile for Vioxx

is particularly troublesome because we have

previously, in an untitled letter, objected to
 Also in the warning letter, the FDA identified specific 19

statements made by Merck in promotional audio conferences and

by Merck’s sales force demonstrating Merck’s minimization and

misrepresentation of the increased heart attack rates of Vioxxtaking participants in the VIGOR study and several unsubstantiated

superiority claims made by Merck about Vioxx. App. at 715-16,

718-19. Finally, the warning letter concluded with a corrective

action plan which required Merck to issue a “‘Dear Healthcare

provider’ letter to correct false or misleading impressions and

41

promotional materials for Vioxx that also

misrepresented Vioxx’s safety profile. 

...

We have idenitified a Merck press release entitled,

“Merck Confirms Favorable Cardiovascular Safety

Profile of VIOXX,” dated May 22, 2001, that is also

false or misleading for similar reasons stated above.

Additionally, your claim in the press release that VIOXX

has a “favorable cardiovascular safety profile,” is

simply incomprehensible, given the rate of MI and

serious cardiovascular events compared to naproxen.

The implication that Vioxx’s cardiovascular profile is

superior to other NSAIDs is misleading; in fact, serious

cardiovascular events were twice as frequent in the

VIOXX treatment group (101 events, 2.5%) as in the

naproxen treatment group (46 events, 1.1%) in the

VIGOR Study.

App. at 713-14, 718 (emphasis added).19
information.” App. at 719. 

42

The warning letter clearly and explicitly reprimanded

Merck for its (1) deceptive and misleading conduct in publicly

endorsing the naproxen hypothesis as the sole explanation for

the higher rate of cardiovascular events in VIGOR study

participants taking Vioxx, despite knowing that any purported

cardiovascular protective effect of naproxen was unproven, and

(2) downplaying of potential safety problems in failing to

disclose the possibility that Vioxx increases the risk of heart

attack. As the letter explained, this was not the first time the

FDA had charged Merck with misrepresenting Vioxx’s safety

profile. The language used in the letter was particularly strong

and indicated the FDA’s significant concern for the public’s

health. Also, the warning letter cannot be said to have

constituted mere speculation, but was rather a formal report of

“objective wrongdoing.” See Benak, 435 F.3d at 402

(explaining that, in determining whether a plaintiff has inquiry

notice, “[s]peculation should not be given the same weight as

reports of objective wrongdoing”). Furthermore, the warning

letter was published on the FDA’s website where it would have

been discovered by a reasonable Merck investor. See In re

NAHC, 306 F.3d at 1325. 

Moreover, the charges in the warning letter relate directly

to the misrepresentations and omissions alleged in the appellants’

complaint: that the company and certain of its officers and

directors intentionally misrepresented the cardiovascular safety

of Vioxx and, consequently, the impact that Vioxx would have

on Merck’s financial health. See DeBenedictis, 492 F.3d at 217-
It is important to note that Merck’s reliance on its 20

naproxen hypothesis was proved to be unfounded from the

beginning. Even before the FDA’s warning letter was issued, an

April 27, 2000, Reuters article reported that (1) a spokesperson for

leading naproxen manufacturer, Roche Holding Ltd., explained that

“[t]o [their] knowledge, naproxen does not prevent heart attack or

stroke” and (2) an ABN Amro analyst indicated that “[m]edical

authorities [he had] spoken to don’t see any special reduction of

such cardiovascular events in people taking naproxen.” App. at

2288. Additionally, an August 21, 2001, Bloomberg News Article,

reported a Merck representative’s comment that “[Merck] already

ha[s] additional data beyond what [the JAMA article] cite[s], and

the findings are very, very reassuring. VIOXX does not result in

any increase in cardiovascular events compared to placebo.” App.

at 539. Even if this “additional data” included evidence that could

43

18; see e.g., Amended Complaint, App. at 468 (stating that

“Defendants made... materially false and misleading statements

and omissions concerning... the safety profile of... VIOXX”);

App. at 470 (stating that “Defendants misrepresented the safety

profile of VIOXX, including concealing and minimizing the

significantly increased risk of heart attacks in patients taking the

drug”); App. at 482 (describing a “wrongful scheme... which

included the dissemination of materially false and misleading

statements and concealment of material adverse facts”); App. at

497 (stating that “Defendants falsely conditioned the market to

believe VIOXX was safe”). Accordingly, I believe that the

FDA’s warning letter to Merck sufficiently alerted a reasonable

investor to the possibility that Merck fraudulently misrepresented

the cardiovascular safety of Vioxx – its “blockbuster” product.20
support Merck’s naproxen hypothesis, Merck never revealed the

details of its purported “additional data.”

44

Even assuming that the FDA’s warning letter alone did

not sufficiently excite “storm warnings,” the total mix of

information in the public realm which followed the warning

provided more than adequate “storm warnings” to put appellants

on inquiry notice. 

In response to the FDA’s warning letter, there was

widespread media and financial analyst coverage commenting on

the FDA’s charges against Merck, with some reports noting that

such warnings are reserved for the more serious offenders. See

e.g., App. at 2353 (Reuters, September 24, 2001) (reporting that

“U.S. Regulators have charged... Merck... with misleading

doctors about its blockbuster painkiller Vioxx with promotions

that downplayed a possible risk of heart attacks”); App. at 2752

(Merrill Lynch, September 24, 2001) (stating that “[t]he FDA

issued a warning letter to Merck... [and] is looking for Merck to

cease all violative promotional activities... . We do not see how

this... can be helpful to Merck in promoting Vioxx”); App. at

2355 (USA Today, September 25, 2001) (reporting that “Merck’s

marketing efforts... have minimized Vioxx’s known and potential

cardiovascular risks, the FDA wrote in an eight-page ‘warning

letter’... . So far this year, the FDA has sent drug companies

fewer than a dozen warning letters, which the agency reserves for

activities that raise significant public health concerns”); App. at

2768 (UBS Warburg, September 25, 2001) (stating that the “FDA

[has] issue[d] [a] warning to Merck for marketing only one side

of the Vioxx safety argument... . Merck was cited several times
45

for promoting the story that the outcome of the VIGOR study

was due to Naproxen being cardioprotective and that there is no

unusual cardiovascular safety risk with Vioxx.”); App. at 2360

(Associated Press, September 25, 2001) (reporting that “Merck

has argued that [the VIGOR study results make] Vioxx falsely

look[] risky because naproxen thins the blood... and thus

protect[s] against heart attacks... . ‘In fact, the situation is not all

that clear,’ [according to] the FDA”); App. at 2757 (Credit Suisse

First Boston, September 25, 2001) (stating that “the FDA [has]

issued a warning letter citing Merck with making misleading

statements in the promotion of... Vioxx”); App. at 2361 (The

Wall Street Journal, September 25, 2001) (reporting that

“Federal regulators warned Merck & Co. for improper marketing

of its blockbuster arthritis drug Vioxx, saying the company had

misrepresented the drug’s safety profile and minimized its

potential risks[,]” and “[w]hile the FDA sends out dozens of

routine citations annually, it issues only a handful of these moreserious warning letters each year”); App. at 2363 (The New York

Times, September 26, 2001) (stating that “[t]he [FDA] has

ordered Merck & Company to cease promotions intended to

persuade doctors to prescribe its arthritis painkiller Vioxx, saying

the promotions minimize potential risks”). Even appellants

themselves recognized in their complaint that “FDA Warning

Letters are sent only to address serious circumstances.” App. at

1280. 

Furthermore, in addition to the first lawsuit filed before

the FDA’s warning letter, three product liability and consumer

fraud actions had been filed in September and October 2001, all

alleging that Merck had misrepresented the cardiovascular safety

of Vioxx. See App. at 1748 (May 29, 2001, product liability
46

class action alleging that “Merck’s own research [demonstrated

that] users of Vioxx were four times as likely to suffer heart

attacks as compared to other less expensive medications..., [but

that] Merck... [took] no affirmative steps to communicate this

critical information to class members”); App. at 1557 (September

27, 2001, consumer fraud class action alleging that “Merck [had]

omitted, suppressed, or concealed material facts concerning the

dangers and risks associated with the use of Vioxx, including...

cardiovascular problems... [and] purposely downplayed and/or

understated the serious nature of the risks associated with

Vioxx”); App. at 1574 (September 28, 2001, product liability and

consumer fraud action alleging that Merck had “misrepresented

that Vioxx was... safe and effective..., when in fact the drug

causes serious medical problems such as an increased risk of

cardiovascular events, including strokes, heart attacks and

death”); App. at 1611 (October 1, 2001, product liability action

alleging that Merck failed to “[]disclose[]” that “Vioxx causes

heart attacks”). While these law suits did not allege securities

fraud, the general allegations contained within these complaints

relating to Merck’s intentional misrepresentation with regard to

Vioxx’s safety similarly formed the basis of appellants’

complaint. 

 

Moreover, The New York Times article, dated October 9,

2001, quoted defendant Scolnick as explicitly stating that

“[n]aproxen lowers the heart attack rate, or Vioxx raises it.”

App. at 2367 (emphasis added). Based on my review of the

record, this express acknowledgment by a Merck representative

of the possibility that Vioxx actually raises the risk of heart attack

appears to be not only the first time such statement had been

made by the company, but also in stark contrast to Merck’s prior
47

representations. Therefore, because of what I perceive to be

significant media and financial analyst attention directed at the

explicit and serious nature of the FDA’s warning letter, the

allegations in the multiple lawsuits which followed, and Merck’s

change of tone in the October 9, 2001, article, I cannot see how

a reasonable investor could not be aware of the possibility that

Merck had been fraudulently misrepresenting the cardiovascular

safety of Vioxx. 

Because the objective evidence indicated the possibility of

culpable activity on the part of Merck, a lack of significant stock

movement and decreases in analysts’ stock ratings and

projections do not negate a finding of “storm warnings” under

our inquiry notice standard. Appellants argue that “storm

warnings” could not have existed prior to the 2003 Harvard

Study because the total mix of public information did not have a

negative effect on the price of Merck stock or cause analysts to

drop their ratings for Merck or lower their projections for Vioxx

sales. It is true, as the majority points out, that our past inquiry

notice decisions have taken into consideration the market’s

response to disclosures alleged to constitute “storm warnings.”

However, I do not believe the law requires that, in order to make

a determination that “storm warnings” in fact exist, the total mix

of public information (purported to constitute “storm warnings”)

must have a negative effect on stock prices or cause analysts to

drop their ratings or lower their projections. See Benack, 435

F.3d at 400 (“information [need only suggest] possible

wrongdoing... to excite ‘storm warnings’”) (quoting In re NAHC,

306 F.3d at 1325) (emphasis added). As we recognized in In re

NAHC:
 Regardless, Merck’s stock price did decline sharply in the 21

months leading up to October 9, 2001, as the public controversy

about Vioxx raged. From January 1, 2001, to October 9, 2001,

Merck’s stock price declined by $24.32 or 27.4% App. at 1770-73.

As appellants themselves alleged, “Merck’s stock price began its

slide in approximately January of 2001, and continued and

48

[S]torm warnings may take numerous forms, and

we will not attempt to provide an exhaustive list.

They may include, however, substantial conflicts

between oral representations of the brokers and the

text of the prospectus, ... the accumulation of

information over a period of time that conflicts

with representations that were made when the

securities were originally purchased, or any

financial, legal or other data that would alert a

reasonable person to the probability that

misleading statements or significant omissions had

been made.

306 F.3d at 1326 n.5 (quoting Mathews, 260 F.3d at 252 (internal

citations and quotations omitted)) (emphasis added). In my

view, fluctuations in stock price and analysts’ ratings and

projections, although relevant, are not a required consideration

in this circuit’s objective “storm warnings” analysis. Here, the

lack of a significant response from the market to the FDA’s

warning letter does not mean that the Emperor was not walking

down the street with no clothes on. It merely means that the

analysts saw the emperor’s new clothes as Merck described them

– not as reality presented. 

21
worsened after August of 2001 when the VIGOR cardiovascular

data was presented more fully in the [JAMA article].” App. at

1225 (emphasis added). 

49

Based on the foregoing, I submit there were sufficient

“storm warnings” more than two years prior to the filing of

appellants’ complaint. At a minimum, I believe the FDA’s

September 17, 2001, warning letter constituted more than

sufficient “storm warnings” to put appellants on inquiry notice of

their claims, particularly since appellants fail to demonstrate

either that they conducted a diligent investigation within two

years of the accrual of such “storm warnings” or that they were

unable to uncover pertinent information during that time period.

Accordingly, because appellants waited over two years to bring

suit, I conclude that their claims were filed out of time and were

properly dismissed by the District Court.