In re Novan, Inc., 2018 WL 6732990 (M.D.N.C. Nov. 30, 2018), adopted by, No. 1:17CV999 (M.D.N.C. Jan. 28, 2019).

On January 28th, 2019, United States District Judge Catherine C. Eagles of the Middle District of North Carolina adopted a recommendation from a magistrate judge granting the defendants’ motion to dismiss a putative securities class action brought against pharmaceutical company Novan, Inc. and its officers, directors, and underwriters.

The plaintiffs alleged that defendants made false statements and omissions about the Company’s leading drug candidate in connection with an initial public offering of its stock and in the weeks subsequent to the offering.


Continue Reading District Judge Dismisses Securities Class Action Against Novan, Inc. Relating To Disclosure of FDA Recommendations About Clinical Trials

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