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As an associate in Ropes & Gray’s Litigation and Enforcement practice group, Anne’s practice focuses on complex commercial litigation, shareholder disputes, regulatory matters, and civil and criminal government enforcement matters. She has represented clients in matters involving securities laws, the False Claims Act, shareholder actions, and general commercial disputes.

A recently-published report from NERA Economic Consulting provides a mid-year look back at securities class actions and demonstrates the continued focus by the plaintiffs’ securities litigation bar on health care and life science firms, particularly those focused on the development and commercialization of drugs and devices.

The report found that approximately half of all COVID-19-related

Shanawaz v. Intellipharmaceutics Int’l Inc., No. 17-CV-5761 (JPO) (S.D.N.Y. July 30, 2020)

On July 30, 2020, Judge J. Paul Oetken of the Southern District of New York preliminarily approved a settlement in a putative shareholder class action concerning development of an OxyContin alternative, Rexista.  The parties agreed to a settlement amount of $1.6 million.

Mehta v. Ocular Therapeutix, Inc., 955 F.3d 194 (1st Cir. 2020)

On April 9, 2020, the First Circuit affirmed the dismissal of an action brought against a biopharmaceutical company, Ocular Therapeutix, Inc., and certain of its officers, regarding statements concerning the Company’s manufacturing processes.  The Court held that plaintiffs failed to allege facts giving rise to a strong inference of scienter (i.e., fraudulent intent) and thus failed to adequately plead a securities law violation.


Continue Reading First Circuit Affirms Dismissal of Action Regarding Statements Concerning Manufacturing of Eye Drug

A recently-published annual report from Cornerstone Research demonstrates the continued focus by the plaintiffs’ securities litigation bar on pharmaceutical, healthcare, and biotechnology firms.

The report notes that 2019 federal securities filings (excluding merger objections), against Consumer Non-Cyclical companies, primarily composed of pharmaceutical, healthcare, and biotechnology firms, were at record levels.  Specifically, federal filings in the biotechnology, pharmaceuticals, and healthcare sectors increased from 56 in 2018 to 63 in 2019.


Continue Reading Cornerstone Research Report Shows Continued Rate of Federal Securities Litigation Filings Targeting Pharmaceutical Industry

In re Celgene Corp. Sec. Litig., 2019 WL 6909463 (D.N.J. Dec. 19, 2019)

On December 19, 2019, Judge John Michael Vazquez of the District of New Jersey partially denied a motion to dismiss a putative securities class action complaint filed against biopharmaceutical company Celgene and certain of its executives.

Plaintiff’s allegations relied heavily on purported information from former Celgene employees, consultants, and scientists, and arose out of Celgene’s statements concerning three drugs that Celgene was developing as revenue replacements for its blockbuster multiple myeloma drug, Revlimid, which has a patent set to expire in 2022.  Judge Vazquez analyzed allegations relating to each drug in turn.


Continue Reading District Court Judge Partially Dismisses Claims Against Celgene, But Allows Allegations Regarding Misleading Statements About Sales Projections and FDA Approval to Proceed

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