MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL.
No. 09-1156
Supreme Court of the United States
Argued January 10, 2011—Decided March 22, 2011
563 U.S. 27
SOTOMAYOR, J.
SOTOMAYOR, J., delivered the opinion for a unanimous Court.
Jonathan D. Hacker argued the cause for petitioners. With him on the briefs were Matthew Shors, Irving L. Gornstein, Michael G. Yoder, and Amy J. Longo.
David C. Frederick argued the cause for respondents. With him on the brief were Scott H. Angstreich, Gregory G. Rapawy, Eric Alan Isaacson, and Joseph D. Daley.
Pratik A. Shah argued the cause for the United States as Amicus Curiae in support of respondents. With him on the brief were Acting Solicitor General Katyal, Deputy Solicitor General Stewart, David M. Becker, Mark D. Cahn, Jacob H. Stillman, Michael A. Conley, Luis de la Torre, Jeffrey A. Berger, and Ralph S. Tyler.*
*Briefs of amici curiae urging reversal were filed for the Advanced Medical Technology Association by Steven G. Bradbury, Steven A. Engel, James M. Beck, and David A. Kotler; for BayBio by Deanne E. Maynard, Brian R. Matsui, and Marc A. Hearron; for the Consumer Healthcare Products Association et al. by Robert A. Long, Jr., and Richard F. Kingham; for DRI—The Voice of the Defense Bar by James C. Martin and Colin E. Wrabley; for the Natural Products Association by Scott Bass and Jonathan F. Cohn; for the Pharmaceutical Research and Manufacturers of America et al. by David W. Ogden and Mark C. Fleming; for the Product Liability Advisory Council, Inc., by Anne E. Cohen; for the Securities Industry and Financial Markets Association et al. by Lyle Roberts, Jonathan E. Richman, Kevin M. Carroll, Robin S. Conrad, and Amar D. Sarwal; and for the Washington Legal Foundation by Daniel J. Popeo and Richard A. Samp.
Briefs of amici curiae urging affirmance were filed for AARP et al. by Jay E. Sushelsky and Michael R. Schuster; for Robert E. Litan et al. by Merrill G. Davidoff and Lawrence J. Lederer; for Tonia M. Young-Fadok et al. by Jonathan S. Massey, Jay W. Eisenhofer, Geoffrey C. Jarvis, David Kessler, Darren J. Check, and Benjamin J. Sweet; for Professors at Law and Business
JUSTICE SOTOMAYOR delivered the opinion of the Court.
This case presents the question whether a plaintiff can state a claim for securities fraud under
I
A
Through a wholly owned subsidiary, Matrixx develops, manufactures, and markets over-the-counter pharmaceutical products. Its core brand of products is called Zicam. All of the products sold under the name Zicam are used to treat the common cold and associated symptoms. At the time of the events in question, one of Matrixx‘s products was Zicam Cold Remedy, which came in several forms including nasal spray and gel. The active ingredient in Zicam Cold Remedy was zinc gluconate. Respondents allege that Zicam Cold Remedy accounted for approximately 70 percent of Matrixx‘s sales.
Respondents initiated this securities fraud class action against Matrixx on behalf of individuals who purchased Matrixx securities between October 22, 2003, and February 6, 2004.1 The action principally arises out of statements that Matrixx made during the class period relating to revenues and product safety. Respondents claim that Matrixx‘s statements were misleading in light of reports that Matrixx had received, but did not disclose, about consumers who had lost their sense of smell (a condition called anosmia) after using Zicam Cold Remedy. Respondents’ consolidated amended complaint alleges the following facts, which the courts below properly assumed to be true. See Ashcroft v. Iqbal, 556 U. S. 662, 678 (2009).
In 1999, Dr. Alan Hirsch, neurological director of the Smell & Taste Treatment and Research Foundation, Ltd., called Matrixx‘s customer service line after discovering a possible link between Zicam nasal gel and a loss of smell “in a cluster of his patients.” App. 67a-68a. Dr. Hirsch told a Matrixx employee that “previous studies had demonstrated that intranasal application of zinc could be problematic.” Id., at 68a. He also told the employee about at least one of his patients who did not have a cold and who developed anosmia after using Zicam.
In September 2002, Timothy Clarot, Matrixx‘s vice president for research and development, called Miriam Linschoten, Ph.D., at the University of Colorado Health Sciences Center after receiving a complaint from a person Linschoten was treating who had lost her sense of smell after using Zicam. Clarot informed Linschoten that Matrixx had received similar complaints from other customers. Linschoten drew Clarot‘s attention to “previous studies linking zinc sulfate to loss of smell.” Ibid. Clarot gave her the impression that he had not heard of the studies. She asked Clarot whether Matrixx had done any studies of its own; he responded that it had not but that it had hired a consultant
By September 2003, one of Linschoten‘s colleagues at the University of Colorado, Dr. Bruce Jafek, had observed 10 patients suffering from anosmia after Zicam use. Linschoten and Jafek planned to present their findings at a meeting of the American Rhinologic Society in a poster presentation entitled “Zicam® Induced Anosmia.” Ibid. (internal quotation marks omitted). The American Rhinologic Society posted their abstract in advance of the meeting. The presentation described in detail a 55-year-old man with previously normal taste and smell who experienced severe burning in his nose, followed immediately by a loss of smell, after using Zicam. It also reported 10 other Zicam users with similar symptoms.
Matrixx learned of the doctors’ planned presentation. Clarot sent a letter to Dr. Jafek warning him that he did not have permission to use Matrixx‘s name or the names of its products. Dr. Jafek deleted the references to Zicam in the poster before presenting it to the American Rhinologic Society.
The following month, two plaintiffs commenced a product liability lawsuit against Matrixx alleging that Zicam had damaged their sense of smell. By the end of the class period on February 6, 2004, nine plaintiffs had filed four lawsuits.
Respondents allege that Matrixx made a series of public statements that were misleading in light of the foregoing information. In October 2003, after it had learned of Dr. Jafek‘s study and after Dr. Jafek had presented his findings to the American Rhinologic Society, Matrixx stated that Zicam was “‘poised for growth in the upcoming cough and cold season‘” and that the company had “‘very strong momentum.‘”2 Id., at 72a-74a. Matrixx further expressed its expectation that revenues would “‘be up in excess of 50% and that earnings, per share for the full year [would] be in the 25 to 30 cent range.‘” Id., at 74a. In January 2004, Matrixx raised its revenue guidance, predicting an increase in revenues of 80 percent and earnings per share in the 33- to 38-cent range.
In its Form 10-Q filed with the SEC in November 2003, Zicam warned of the potential “‘material adverse effect‘” that could result from product liability claims, “‘whether or not proven to be valid.‘” Id., at 75a-76a. It stated that product liability actions could materially affect Matrixx‘s “‘product branding and goodwill,‘” leading to reduced customer acceptance.3 Id., at 76a. It did not disclose, however, that two plaintiffs had already sued Matrixx for allegedly causing them to lose their sense of smell.
On January 30, 2004, Dow Jones Newswires reported that the Food and Drug Administration (FDA) was “looking into
“All Zicam products are manufactured and marketed according to FDA guidelines for homeopathic medicine. Our primary concern is the health and safety of our customers and the distribution of factual information about our products. Matrixx believes statements alleging that intranasal Zicam products cause anosmia (loss of smell) are completely unfounded and misleading.
“In no clinical trial of intranasal zinc gluconate gel products has there been a single report of lost or diminished olfactory function (sense of smell). Rather, the safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established in two double-blind, placebo-controlled, randomized clinical trials. In fact, in neither study were there any reports of anosmia related to the use of this compound. The overall incidence of adverse events associated with zinc gluconate was extremely low, with no statistically significant difference between the adverse event rates for the treated and placebo subsets.
“A multitude of environmental and biologic influences are known to affect the sense of smell. Chief among them is the common cold. As a result, the population most likely to use cold remedy products is already at increased risk of developing anosmia. Other common causes of olfactory dysfunction include age, nasal and sinus infections, head trauma, anatomical obstructions, and environmental irritants.” Id., at 77a-78a (internal quotation marks omitted).
The day after Matrixx issued this press release, its stock price bounced back to $13.40 per share.
On February 6, 2004, the end of the class period, Good Morning America, a nationally broadcast morning news program, highlighted Dr. Jafek‘s findings. (The complaint does not allege that Matrixx learned of the news story before its broadcast.) The program reported that Dr. Jafek had discovered more than a dozen patients suffering from anosmia after using Zicam. It also noted that four lawsuits had been filed against Matrixx. The price of Matrixx stock plummeted to $9.94 per share that same day. Zicam again issued a press release largely repeating its February 2 statement.
On February 19, 2004, Matrixx filed a Form 8-K with the SEC stating that it had “‘convened a two-day meeting of physicians and scientists to review current information on smell disorders‘” in response to Dr. Jafek‘s presentation. Id., at 82a. According to the Form 8-K: “‘In the opinion of the panel, there is insufficient scientific evidence at this time to determine if zinc gluconate, when used as recommended, affects a person‘s ability to smell.‘” Ibid. A few weeks later, a reporter quoted Matrixx as stating that it would begin conducting “‘animal and human studies to further characterize these post-marketing complaints.‘” Id., at 84a.
On the basis of these allegations, respondents claimed that Matrixx violated
Matrixx moved to dismiss respondents’ complaint, arguing that they had failed to plead the elements of a material misstatement or omission and scienter. The District Court granted the motion to dismiss. Relying on In re Carter-Wallace, Inc. Securities Litigation, 220 F. 3d 36 (CA2 2000), it held that respondents had not alleged a “statistically significant correlation between the use of Zicam and anosmia so as to make failure to public[ly] disclose complaints and the University of Colorado study a material omission.” App. to Pet. for Cert. 50a. The District Court similarly agreed that respondents had not stated with particularity facts giving rise to a strong inference of scienter. See
The Court of Appeals reversed. 585 F. 3d 1167 (CA9 2009). Noting that “‘[t]he determination [of materiality] requires delicate assessments of the inferences a “reasonable shareholder” would draw from a given set of facts and the significance of those inferences to him,‘” id., at 1178 (quoting Basic Inc. v. Levinson, 485 U. S. 224, 236 (1988); some internal quotation marks omitted; alterations in original), the Court of Appeals held that the District Court had erred in requiring an allegation of statistical significance to establish materiality. It concluded, to the contrary, that the complaint adequately alleged “information regarding the possible link between Zicam and anosmia” that would have been significant to a reasonable investor. 585 F. 3d, at 1179, 1180. Turning to scienter, the Court of Appeals concluded that “‘[w]ithholding reports of adverse effects of and lawsuits concerning the product responsible for the company‘s remarkable sales increase is “an extreme departure from the standards of ordinary care,“‘” giving rise to a strong inference of scienter. Id., at 1183.
We granted certiorari, 560 U. S. 964 (2010), and we now affirm.
II
To prevail on their claim that Matrixx made material misrepresentations or omissions in violation of
A
We first consider Matrixx‘s argument that “adverse event reports that do not reveal a statistically significant increased risk of adverse events from product use are not material information.” Brief for Petitioners 17 (capitalization omitted).
1
To prevail on a
Basic involved a claim that the defendant had made misleading statements denying that it was engaged in merger negotiations when it was, in fact, conducting preliminary ne-
gotiations. See 485 U. S., at 227-229. The defendant urged a bright-line rule that preliminary merger negotiations are material only once the parties to the negotiations reach an agreement in principle. Id., at 232-233. We observed that “[a]ny approach that designates a single fact or occurrence as always determinative of an inherently fact-specific finding such as materiality, must necessarily be overinclusive or underinclusive.” Id., at 236. We thus rejected the defendant‘s proposed rule, explaining that it would “artificially exclud[e] from the definition of materiality information concerning merger discussions, which would otherwise be considered significant to the trading decision of a reasonable investor.” Ibid.
Like the defendant in Basic, Matrixx urges us to adopt a bright-line rule that reports of adverse events5 associated with a pharmaceutical company‘s products cannot be material absent a sufficient number of such reports to establish a statistically
adverse event reports provide only “anecdotal” evidence that “the user of a drug experienced an adverse event at some point during or following the use of that drug.” Brief for Petitioners 17. Accordingly, it contends, reasonable investors would not consider such reports relevant unless they are statistically significant because only then do they “reflect a scientifically reliable basis for inferring a potential causal link between product use and the adverse event.” Id., at 32.
As in Basic, Matrixx‘s categorical rule would “artificially exclud[e]” information that “would otherwise be considered significant to the trading decision of a reasonable investor.” 485 U. S., at 236. Matrixx‘s argument rests on the premise that statistical significance is the only reliable indication of causation. This premise is flawed: As the SEC points out, “medical researchers . . . consider multiple factors in assessing causation.” Brief for United States as Amicus Curiae 12. Statistically significant data are not always available. For example, when an adverse event is subtle or rare, “an inability to obtain a data set of appropriate quality or quantity may preclude a finding of statistical significance.” Id., at 15; see also Brief for Medical Researchers as Amici Curiae 11. Moreover, ethical considerations may prohibit researchers from conducting randomized clinical trials to confirm a suspected causal link for the purpose of obtaining statistically significant data. See id., at 10-11.
A lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events. As Matrixx itself concedes, medical experts rely on other evidence to establish an inference of causation. See Brief for Petitioners 44-45, n. 22.7 We note that courts frequently permit expert testi-
mony on causation based on evidence other than statistical significance. See, e. g., Best v. Lowe‘s Home Centers, Inc., 563 F. 3d 171, 178 (CA6 2009); Westberry v. Gislaved Gummi AB, 178 F. 3d 257, 263-264 (CA4 1999) (citing cases); Wells v. Ortho Pharmaceutical Corp., 788 F. 2d 741, 744-745 (CA11 1986). We need not consider whether the expert testimony was properly admitted in those cases, and we do not attempt to define here what constitutes reliable evidence of causation. It suffices to note that, as these courts have recognized,
The FDA similarly does not limit the evidence it considers for purposes of assessing causation and taking regulatory action to statistically significant data. In assessing the safety risk posed by a product, the FDA considers factors such as “strength of the association,” “temporal relationship of product use and the event,” “consistency of findings across available data sources,” “evidence of a dose-response for the effect,” “biologic plausibility,” “seriousness of the event relative to the disease being treated,” “potential to mitigate the risk in the population,” “feasibility of further study using observational or controlled clinical study designs,” and “degree of benefit the product provides, including availability of other therapies.”8 FDA, Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment 18 (2005) (capitalization omitted), http:// www.fda.gov/downloads/RegulatingInformation/Guidances/UCM126834.pdf (all Internet materials as visited Mar. 17, 2011, and available in Clerk of Court‘s case file); see also Brief for United States as Amicus Curiae 19-20 (same); FDA, The Clinical Impact of Adverse Event Reporting 6 (1996) (similar), http://www.fda.gov/downloads/safety/MedWatch/UCM168505.pdf. It “does not apply any single metric for determining when additional inquiry or action is necessary, and it certainly does not insist upon ‘statistical significance.‘” Brief for United States as Amicus Curiae 19.
Not only does the FDA rely on a wide range of evidence of causation, it sometimes acts on the basis of evidence that suggests, but does not prove, causation. For example, the FDA requires manufacturers of over-the-counter drugs to revise their labeling “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”
This case proves the point. In 2009, the FDA issued a warning letter to Matrixx stating that “[a] significant and growing body of evidence substantiates that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who
Given that medical professionals and regulators act on the basis of evidence of causation that is not statistically significant, it stands to reason that in certain cases reasonable investors would as well. As Matrixx acknowledges, adverse event reports “appear in many forms, including direct complaints by users to manufacturers, reports by doctors about reported or observed patient reactions, more detailed case reports published by doctors in medical journals, or larger scale published clinical studies.” Brief for Petitioners 17. As a result, assessing the materiality of adverse event reports is a “fact-specific” inquiry, Basic, 485 U. S., at 236, that requires consideration of the source, content, and context of the reports. This is not to say that statistical significance (or the lack thereof) is irrelevant—only that it is not dispositive of every case.
Application of Basic‘s “total mix” standard does not mean that pharmaceutical manufacturers must disclose all reports of adverse events. Adverse event reports are daily events in the pharmaceutical industry; in 2009, the FDA entered nearly 500,000 such reports into its reporting system, see FDA, Reports Received and Reports Entered in AERS by Year (as of Mar. 31, 2010), http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm. The fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event. See FDA, Annual Adverse Drug Experience Report: 1996, p. 2 (1997), http://druganddevicelaw.net/Annual%20Adverse%20Drug%20Experience%20Report%201996.pdf. The question remains whether a reasonable investor would have viewed the nondisclosed information “‘as having significantly altered the “total mix” of information made available.‘” Basic, 485 U. S., at 232 (quoting TSC Industries, 426 U. S., at 449; emphasis added). For the reasons just stated, the mere existence of reports of adverse events—which says nothing in and of itself about whether the drug is causing the adverse events—will not satisfy this standard. Something more is needed, but that something more is not limited to statistical significance and can come from “the source, content, and context of the reports,” supra, at 43. This contextual inquiry may reveal in some cases that reasonable investors would have viewed reports of adverse events as material even though the reports did not provide statistically significant evidence of a causal link.10
Moreover, it bears emphasis that
2
Applying Basic‘s “total mix” standard in this case, we conclude that respondents have adequately pleaded materiality. This is not a case about a handful of anecdotal reports, as Matrixx suggests. Assuming the complaint‘s allegations to be true, as we must, Matrixx received information that plausibly indicated a reliable causal link between Zicam and anosmia. That information included reports from three medical professionals and researchers about more than 10 patients who had lost their sense of smell after using Zicam. Clarot told Linschoten that Matrixx had received additional reports of anosmia. (In addition, during the class period, nine plaintiffs commenced four product liability lawsuits against Matrixx alleging a causal link between Zicam use and anosmia.)11 Further, Matrixx knew that Linschoten and Dr. Jafek had presented their findings about a causal link between Zicam and anosmia to a national medical conference devoted to treatment of diseases of the nose.12 Their presentation described a patient who experienced severe burning in his nose, followed immediately by a loss of smell, after using Zicam—suggesting a temporal relationship between Zicam use and anosmia.
Critically, both Dr. Hirsch and Linschoten had also drawn Matrixx‘s attention to previous studies that had demonstrated a biological causal link between intranasal application of zinc and anosmia.13 Before his conversation with Linschoten, Clarot, Matrixx‘s vice president of research and development, was seemingly unaware of these studies, and the complaint suggests that, as of the class period, Matrixx had not conducted any research of its own relating to anosmia. See, e. g., App. 84a (referencing a press report, issued after the end of the class period, noting that Matrixx said it would begin conducting “‘animal and human studies to further characterize these post-marketing complaints‘“).
We believe that these allegations suffice to “raise a reason-able expectation that discovery will reveal evidence” satisfying the materiality requirement, Bell Atlantic Corp. v. Twombly, 550 U. S. 544, 556 (2007), and to “allo[w] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged,” Iqbal, 556 U. S., at 678. The information provided to Matrixx by medical experts revealed a plausible causal relationship between Zicam Cold Remedy and anosmia. Consumers likely would have viewed the risk associated with Zicam (possible loss of smell) as substantially outweighing the benefit of using the product (alleviating cold symptoms), particularly in light of the existence of many alternative products on the market. Importantly, Zicam Cold Remedy allegedly accounted for 70 percent of Matrixx‘s sales. Viewing the allegations of the complaint as a whole, the complaint alleges facts suggesting a significant risk to the commercial viability of Matrixx‘s leading product.
It is substantially likely that a reasonable investor would have viewed this information “‘as having significantly altered the “total mix” of information made available.‘” Basic, 485 U. S., at 232 (quoting TSC Industries, 426 U. S., at 449). Matrixx told the market that revenues were going to rise 50 and then 80 percent. Assuming the complaint‘s allegations to be true, however, Matrixx had information indicating a significant risk to its leading revenue-generating product. Matrixx also stated that reports indicating that Zicam caused anosmia were “completely unfounded and misleading” and that “the safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established.” App. 77a-78a. Importantly, however, Matrixx had evidence of a biological link between Zicam‘s key ingredient and anosmia, and it had not conducted any studies of its own to disprove that link. In fact, as Matrixx later revealed, the scientific evidence at that time was “‘insufficient . . . to determine if zinc gluconate, when used as recommended, affects a person‘s ability to smell.‘” Id., at 82a.
Assuming the facts to be true, these were material facts “necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading.”
B
Matrixx also argues that respondents failed to allege facts plausibly suggesting that it acted with the required level of scienter. “To establish liability under
Under the PSLRA, a plaintiff must “state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind.”
Matrixx argues, in summary fashion, that because respondents do not allege that it knew of statistically significant evidence of causation, there is no basis to consider the
inference that it acted recklessly or knowingly to be at least as compelling as the alternative inferences. “Rather,” it argues, “the most obvious inference is that petitioners did not disclose the [reports] simply because petitioners believed they were far too few . . . to indicate anything meaningful about adverse reactions to use of Zicam.” Brief for Petitioners 49. Matrixx‘s proposed bright-line rule requiring an allegation of statistical significance to establish a strong inference of scienter is just as flawed as its approach to materiality.
The inference that Matrixx acted recklessly (or intentionally, for that matter) is at least as compelling as, if not more compelling than, the inference that it simply thought the reports did not indicate anything meaningful about adverse reactions. According to the complaint, Matrixx was sufficiently concerned about the information it received that it informed Linschoten that it had hired a consultant to review the product, asked Linschoten to participate in animal studies, and convened a panel of physicians and scientists in response to Dr. Jafek‘s presentation. It successfully prevented Dr. Jafek from using Zicam‘s name in his presentation on the ground that he needed Matrixx‘s permission to do so. Most significantly, Matrixx issued a press release that suggested that studies had confirmed that Zicam does not cause anosmia when, in fact, it had not conducted any studies relating to anosmia and the scientific evidence at that time, according to the panel of scientists, was insufficient to determine whether Zicam did or did not cause anosmia.15
These allegations, “taken collectively,” give rise to a “cogent and compelling” inference that Matrixx elected not to disclose the reports of adverse events not because it believed they were meaningless
*
*
*
For the reasons stated, the judgment of the Court of Appeals for the Ninth Circuit is
Affirmed.