Life Sciences Litigation & Enforcement Team

In re: Ocular Therapeutix, Inc. Sec. Litig. 2019 WL 1950399 (D. Mass. Apr. 30, 2019)

Judge George O’Toole of the U.S. District Court for the District of Massachusetts dismissed a putative securities class action complaint filed against a biopharmaceutical company, Ocular Therapeutix, Inc., and certain of its officers, holding that plaintiffs failed to adequately allege an actionable misstatement or omission concerning manufacturing issues related to an eye pain reliever drug.

Continue Reading D. Mass Holds Plaintiffs Failed to Plead Securities Law Violation Regarding Company’s Statements Concerning Manufacturing of Eye Drug

Nguyen v. New Link Genetics Corp., 2019 WL 591556 (S.D.N.Y. Feb. 13, 2019)

On February 13, 2019, Judge William H. Pauley, III of the Southern District of New York dismissed a proposed investor class action against New Link Genetics Corporation.

Plaintiffs’ allegations arose out of a disclosure by New Link that a Phase 3 trial of its drug candidate for patients with resected pancreatic cancer did not achieve its primary endpoint, which plaintiffs alleged triggered a 30% drop in its stock value.

Continue Reading S.D.N.Y. Dismisses Investor Suit Concerning Pancreatic Cancer Drug Study

Shanawaz v. Intellipharmaceutics Int’l Inc., No. 17-CV-5761 (JPO), 2018 WL 6605426 (S.D.N.Y. Dec. 17, 2018)

On December 17, 2018, Judge J. Paul Oetken of the Southern District of New York partially denied defendants’ motion to dismiss a putative shareholder class action concerning development of an OxyContin alternative, but dismissed claims based on defendants’ non-actionable opinions.

The case, Shanawaz v. Intellipharmaceutics Int’l Inc., arose out of the disclosure by Intellipharmaceutics International Inc. that an FDA committee had found that the Company had not demonstrated that its drug candidate, Rexista, had properties that could be expected to deter abuse, and that there was not sufficient data to support inclusion of language regarding abuse-deterrent properties on the product label for the drug.

Continue Reading S.D.N.Y. Partially Dismisses Shareholder Class Action Claims Based on Pharmaceutical Company’s Nonactionable Statements of Opinion

Dougherty v. Esperion Therapeutics, Inc., 905 F.3d 971 (6th Cir. 2018)

A recent Sixth Circuit opinion demonstrates the critical importance of accurately describing interactions with the FDA when making statements on that topic.

In Dougherty v. Esperion Therapeutics, Inc., the Sixth Circuit held that plaintiffs adequately pleaded the scienter element (i.e., fraudulent intent) of their securities fraud claims against Esperion, a clinical stage pharmaceutical corporation, and its CEO, and reversed the district court’s order granting a motion to dismiss.

Continue Reading Unanimous Sixth Circuit Reverses Dismissal, Finding Plaintiffs Plausibly Alleged Defendants Knew Statements Summarizing FDA Meeting Were False