The day after this press release, Matrixx stock price bounced back. Shortly thereafter, however, the TV
show Good Morning America reported that more than a dozen patients had suffered from anosmia after
using Zicam and that some had filed lawsuits against Matrixx. The company’s stock price plummeted.
A group of shareholders filed suit alleging that Matrixx had violated §10(b) and Rule 10b-5. The trial
court granted Matrixx’s motion to dismiss on the grounds that, without a statistical correlation between
the use of Zicam and anosmia, the reported incidents were not material. The Court of Appeals reversed.
The Supreme Court granted certiorari.
Issues: Was Matrixx required to disclose allegations of harm for which there was not statistical
correlation? Did Matrixx violate §10(b) and Rule 10b-5?
Excerpts from Justice Sotomayor’s Decision: To prevail on a §10(b) claim, a plaintiff must show that
the defendant made a statement that was misleading as to a material fact. [T]his materiality requirement is
satisfied when there is a substantial likelihood that the disclosure of the omitted fact would have been
viewed by the reasonable investor as having significantly altered the “total mix” of information made
available.
[M]edical researchers consider multiple factors in assessing causation. 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. 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.
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 a
result, assessing the materiality of adverse event reports is a fact-specific inquiry that requires
consideration of the source, content, and context of the reports.
Application of [the] “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. The
fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug
caused that event. Something more is needed, but that something more is not limited to statistical
significance.
Moreover, it bears emphasis that §10(b) and Rule 10b-5(b) do not create an affirmative duty to disclose
any and all material information. Disclosure is required under these provisions only when necessary to
make statements made, in the light of the circumstances under which they were made, not misleading.
Even with respect to information that a reasonable investor might consider material, companies can
control what they have to disclose under these provisions by controlling what they say to the market.
[W]e conclude that respondents have adequately pleaded materiality. Matrixx received information that
plausibly indicated a reliable causal link between Zicam and anosmia. Importantly, Zicam Cold Remedy
accounted for 70 percent of Matrixx’s sales.
It is substantially likely that a reasonable investor would have viewed this information as having
significantly altered the “total mix” of information made available. Matrixx told the market that revenues
were going to rise 50 and then 80 percent. [H]owever, Matrixx had information indicating a significant
risk to its leading revenue-generating product.
For the reasons stated, the judgment of the Court of Appeals for the Ninth Circuit is Affirmed.
ETHICS Matrixx learned that its products were potentially causing a loss of smell, which is no minor
matter. People with anosmia cannot properly taste food so often lose interest in eating, which can lead to
malnutrition and depression. Did the company have an ethical obligation to alert the public to this issue?
What about its obligation to its shareholders?
Question: What was the holding?
Answer: The plaintiffs have stated a claim for securities fraud under § 10(b) of the Securities and