Bradley v. ARIAD Pharmaceuticals, Inc.

842 F.3d 744, 2016 WL 6933788, 2016 U.S. App. LEXIS 21235
CourtCourt of Appeals for the First Circuit
DecidedNovember 28, 2016
Docket15-1491P
StatusPublished
Cited by49 cases

This text of 842 F.3d 744 (Bradley v. ARIAD Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bradley v. ARIAD Pharmaceuticals, Inc., 842 F.3d 744, 2016 WL 6933788, 2016 U.S. App. LEXIS 21235 (1st Cir. 2016).

Opinion

' HOWARD, Chief Judge.

When a company’s stock declines, a shareholder lawsuit often follows. This case is no exception. Following a drop in the share price of ARIAD Pharmaceuticals, Inc., investors filed suit against the company and four corporate officers (together “ARIAD”), alleging securities fraud in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (“Exchange Act”), 15 U.S.C. §§ 783(b) and 78t(a), as well as the Securities and Exchange Commission’s (“SEC”) Rule 10b-5, 17 C.F.R. § 240.10b-5. The complaint also raised claims under Sections 11 and 15 of the Securities Act of- 1933 (“Securities Act”), 15 U.S.C. §§ 77k and 77o, against ARIAD, its directors, and‘various under: writers involved in the company’s January 2013 offering of common stock. The district court stopped the- litigation in its tracks by dismissing the complaint in its entirety. See In re ARIAD Pharm., Inc., 98 F.Supp.3d 147 (D. Mass. 2015). The plaintiffs timely appealed.

We affirm the district court’s dismissal of the securities fraud -counts, except with respect to,one particular alleged misstatement for which we find the allegations set forth in the complaint sufficient to state a claim. We also affirm the disposition of the plaintiffs’ claims under Sections 11 and 15, albeit on different grounds than those articulated by the district court.

I. Facts

Fairly read, the complaint alleges the following. ARIAD Pharmaceuticals, Inc. is a publicly traded company headquartered in Cambridge, Massachusetts. At all times relevant to this litigation, Defendant-Ap-pellee Harvey Berger served as ARIAD’s Chairman and Chief Executive Officer (“CEO”), Defendant-Appellee Edward Fitzgerald served as the company’s Executive Vice .President and,. Chief Financial Officer, (“CFO”), Defendant-Appellee Frank Haluska served as its Senior Vice President and Chief Medical Officer, and Defendant-Appellee Timothy Clackson served as its President of Research and Development, Senior Vice President, and Chief Scientific Officer.

In 2008, ARIAD embarked on the development of ponatinib, 1 a tyrosine kinase *749 inhibitor (“TKI”) designed to treat patients suffering from chronic myeloid leukemia (“CML”). As with any experimental drug, the development process entailed a series of clinical trials. See N.J. Carpenters Pension & Annuity Funds v. Biogen IDEC Inc., 537 F.3d 35, 39 (1st Cir. 2008) (discussing typical three-phase trial.structure). The first trial, dubbed “PACE 1,” was intended to determine the maximum tolerable dose (“MTD”) of ponatinib. After settling on 45mg as the MTD, ARIÁD began a second trial, “PACE 2.” The purpose of this follow-on study was to determine the safety, efficacy, and durability of ponatinib, in order to support its limited approval for CML patients who are resistant to or intolerant of other TKI treatments. In November 2012, with PACE 2 on-going, ARIAD began to screen subjects for its third clinical trial, “EPIC,” which was designed to compare ponatinib directly against the leading CML drug on the market, Gleevec.

In July 2012, ARIAD began the process of submitting a rolling application to the FDA for limited approval to market pona-tinib. In conjunction with the application, ARIAD submitted a July 2012 Interim Report consisting of data from the on-going PACE 2 trial, with a cut-off date of July 23, 2012. The Center for Drug Evaluation and Research (“CDER”), located within the FDA, subsequently analyzed the data and issued a series of reports of its own (collectively the “CDER Report”).

By October 2Q12, ARIAD and the FDA began corresponding in earnest about potential approval of ponatinib for limited applications. As part of this process, AR-IAD submitted a proposed label. The FDA, however, rejected ARIAD’s proposal, citing concerns about adverse cardiovascular events and dosage reductions. On December 14, 2012, after some additional back-and-forth, ARIAD announced that the FDA had approved the marketing of ponatinib on a limited basis. It was not all good news, however, as the FDA required ARIAD to include a “black box” warning on ponatinib’s label about the risk of adverse cardiovascular events. Following disclosure of these developments, ARIAD’s per share stock price fell from $23.88 to $18.93.

In the wake of the black box warning, ARIAD nevertheless continued to publicly project confidence in ponatinib. But more troubling news arose' in October 2013. First, on October 9, ARIAD informed investors that, based on additional data from an August 2013 Interim Report, it was pausing enrollment in all clinical studies of ponatinib due to increased instances of medical complications in the PACE 2 trial. Days later, on October 18, ARIAD issued a Form 8-K and accompanying press release indicating that it had agreed to halt the EPIC trial entirely. Finally, on October 31, ARIAD announced that it was “temporarily suspending the marketing and commercial distribution” of ponatinib at the direction of the FDA. The market reacted harshly, and ARIAD’s stock price fell to $2.20 per share. The instant shareholder lawsuit followed.

II. Procedural History

On the defendants’ motion, the district court dismissed the complaint in its entirety. As to the Exchange Act claims, the court found that the complaint sufficiently alleged material misrepresentations or omissions about ponatinib, but that it failed to give rise to a “strong inference” of scienter as required by the Private Securities Litigation Reform Act of 1995 (“PSLRA”). For the Securities Act claims, *750 the district court held that the complaint did not plausibly allege any material misrepresentations or omissions in relation to AKIAD’s January 2013 common stock offering.

We review the grant of a motion to dismiss for failure to state claim de novo. 2 See Aldridge v. A.T. Cross Corp., 284 F.3d 72, 78 (1st Cir. 2002). In doing so, we assume the truth of “the raw facts” set forth in the complaint. In re Bos. Sci. Corp. Sec. Litig., 686 F.3d 21, 27 (1st Cir. 2012). By contrast, we need not credit the plaintiffs’ “legal conclusions or characterizations.” Id.

III. Exchange Act Claims

Section 10(b) of the Exchange Act “forbids the ‘use or employ, in connection with the purchase or sale of any security ..., [of] any manipulative or deceptive device ....”’ Tellabs Inc. v. Makor Issues & Rights, Ltd., 651 U.S. 308, 318, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007) (alteration in original) (quoting 15 U.S.C.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Untitled Case
D. Maryland, 2026
Fagen v. Enviva Inc.
D. Maryland, 2024
CIARCIELLO v. BIOVENTUS INC.
M.D. North Carolina, 2023
Shash v. Biogen Inc.
84 F.4th 1 (First Circuit, 2023)
Slack Technologies, LLC v. Pirani
598 U.S. 759 (Supreme Court, 2023)
Thant v. Karyopharm Therapeutics Inc.
43 F.4th 214 (First Circuit, 2022)
Leung v. Bluebird Bio, Inc.
D. Massachusetts, 2022
Lin v. CGIT Systems, Inc.
D. Massachusetts, 2021
Awad v. Cutone
D. Massachusetts, 2021

Cite This Page — Counsel Stack

Bluebook (online)
842 F.3d 744, 2016 WL 6933788, 2016 U.S. App. LEXIS 21235, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bradley-v-ariad-pharmaceuticals-inc-ca1-2016.