/f3d/928/0151-01

United States Court of Appeals for the First Circuit · 2019-06-27

Original case on neochart.com

Case and law context

15 U.S.C. § 78j

Role: applied; posture: private Biogen securities class action; Rule 12(b)(6) dismissal under PSLRA; claim-preclusion issue expressly reserved; result: claimant-lost; claim:

Instances and excluded annotation blocks

Annotation blocks, including explicitly excluded context
CaseElementHolding and scopeVariantExact source quotations
/f3d/928/0151-01 — United States Court of Appeals for the First Circuit · 2019Intent to deceive, manipulate, or defraudnot
Counted merits instance
applied / merits

basis: pleaded; party: individual executives; count: safety-profile statements; subject: party=individual executives; count=safety-profile statements

The research report did not contradict the limited effectiveness/data statement; the later statement was evaluated against the already revised safety disclosures. Plausible misleadingness was assumed, not decided.
disclosure-context/drug-safety-research
The complaint alleges that Sandrock made this statement before Biogen's October announcement of the PML-related death, and the plaintiffs do not contend that any of the individual defendants knew about that death before Sandrock made this statement. The plaintiffs nevertheless contend that the District Court erred in concluding that the complaint failed adequately to allege that Sandrock made the statement with the "intentional or willful" design to deceive investors.
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Evidence kind: fact; polarity: cuts-against; absent flag: 1; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

To make this case, the plaintiffs point out that, in August and September of 2014, Dr. Ben Thrower, the medical director at the Shepherd Center in Atlanta, notified Keith Ferguson, the company's senior sales director, and Eric Hall, the medical science liaison for Biogen, that his research showed that patients who were taking Tecfidera had a higher risk of developing low lymphocyte counts than Biogen had originally disclosed. The complaint further alleges that, for this reason, Dr. Thrower chose to discontinue Tecfidera prescriptions for approximately 200 of his patients and to stop issuing new prescriptions for the drug. The complaint also alleges that he told Ferguson and Hall about this development.
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Evidence kind: fact; polarity: supports; absent flag: 0; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

By April of 2015, according to the complaint, Biogen had already disclosed the PML death and updated the drug's label to account for the increased understanding of its risk.
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Evidence kind: fact; polarity: cuts-against; absent flag: 0; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

"For an inference of scienter to be strong, 'a reasonable person would [have to] deem [it] cogent and at least as compelling as any opposing inference one could draw from the facts alleged.' "
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Evidence kind: rule; polarity: not recorded; absent flag: 0; quoted-rule flag: 1 (1 = tagged; 0 = not tagged)

And thus, the allegations regarding Sandrock fail to establish a "strong inference" of scienter as to even him, let alone as to any individual defendant.
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Evidence kind: held; polarity: not recorded; absent flag: 0; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

/f3d/928/0151-01 — United States Court of Appeals for the First Circuit · 2019Intent to deceive, manipulate, or defraudnot
Counted merits instance
applied / merits

basis: pleaded; party: Stuart Kingsley; count: usage-rate statements; subject: party=Stuart Kingsley; count=usage-rate statements

The missing information is what Kingsley learned from monitoring metrics and whether it conflicted with his public statements. Access to metrics plus confidential witnesses several levels below management did not supply the strong inference.
disclosure-context/usage-rates-and-management-metrics
We first address the January 29, 2015 statement by Kingsley that "Tecfidera [was] on track to become the most prescribed therapy for MS worldwide." The plaintiffs argue that this statement was misleading and creates the "strong inference" of scienter on Kingsley's part, because at the time of the statement, Kingsley knew about both the PML death and about Tecfidera's declining sales and discontinuation rates.
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Evidence kind: fact; polarity: supports; absent flag: 0; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

At the time that Kingsley made the statement, however, Biogen had already disclosed to the public the news of the PML death, had already changed the drug's label, had already publicized that it expected the drug's growth rate to "slow," and had already disclosed that the drug's discontinuation rates were higher than expected.
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Evidence kind: fact; polarity: cuts-against; absent flag: 0; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

Yet, the complaint alleges no facts that are illuminating in that regard.
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Evidence kind: fact; polarity: cuts-against; absent flag: 1; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

But, we find no basis for concluding that any of these statements permit us to infer the necessary intent to deceive that could suffice to create the "strong inference" of scienter that the PSLRA requires.
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Evidence kind: held; polarity: not recorded; absent flag: 0; quoted-rule flag: 0 (1 = tagged; 0 = not tagged)

Court interpretations recorded from this case

interpretation

"For an inference of scienter to be strong, 'a reasonable person would [have to] deem [it] cogent and at least as compelling as any opposing inference one could draw from the facts alleged.' "

/f3d/928/0151-01 — United States Court of Appeals for the First Circuit · 2019

"For an inference of scienter to be strong, 'a reasonable person would [have to] deem [it] cogent and at least as compelling as any opposing inference one could draw from the facts alleged.' "
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Pleading specificity and strong inference govern private complaint sufficiency Metzler applies PSLRA/Tellabs to dismiss insufficient scienter allegations even assuming statements plausibly misleading. Pleading is not proof at trial.