Smith v. Antares Pharma, Inc., 2020 WL 2041752 (D.N.J. Apr. 28, 2020)

Judge Michael A. Shipp of the District of New Jersey dismissed a putative class action complaint filed against Antares Pharma, Inc., and certain of its officers, holding that the plaintiff failed to adequately allege an actionable misrepresentation or omission concerning certain adverse events observed in two Phase 3 clinical studies of Antares’s lead product, QuickShot Testosterone (“QST”), an auto injector product for testosterone replacement therapy.  Plaintiff alleged that Antares made eight materially false or misleading statements concerning the safety of the product and likelihood of FDA approval.

Continue Reading District of New Jersey Dismisses Action Regarding Company’s Statements Concerning Drug Delivery System’s Safety

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

Hou Liu v. Intercept Pharm., Inc., 2020 WL 1489831 (S.D.N.Y. Mar. 26, 2020)

On March 26, 2020, Judge Lewis A. Kaplan of the Southern District of New York granted a motion to dismiss an action against Intercept Pharmaceuticals, Inc. and certain of its executives regarding twenty-one statements made about safety, dosing, and effects of Ocaliva, a drug approved to treat patients with primary biliary cholangitis (“PBC”), a rare liver disease.  The complaint alleged that Intercept’s stock dropped after it issued a Dear Healthcare Provider Letter (the “HCP Letter”) and again after the FDA issued a drug safety communication and a corresponding safety alert on Ocaliva.

Continue Reading S.D.N.Y. Dismisses Action due to Plaintiffs’ Failure to Link Occurrences of Serious Adverse Events to Liver Disease 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

Biondolillo v. Roche Holding AG, 2019 WL 2498928 (D.N.J. June 17, 2019)

On June 17, 2019, Senior Judge Anne E. Thompson granted a motion to dismiss an action alleging that Roche Holding AG and four executives misled investors by failing to disclose a conflict of interest on the part of a study’s trial investigator.

Plaintiffs alleged that Roche’s statements regarding one of its drug trials were misleading because Roche failed to disclose that it had paid millions of dollars in consulting fees and other payments to a doctor who served as one of the trial investigators and co-authored a publication of the study.

Continue Reading District of New Jersey Dismisses Action For Failure to Allege Materiality of Non-Disclosure of a Conflict of Interest

Forman v. Meridian Bioscience, 2019 WL 2177030 (S.D. Ohio May 20, 2019)

On May 20, 2019, Judge Susan J. Dlott of the Southern District of Ohio granted plaintiff’s motion to reconsider and amend a prior order dismissing an action against Meridian Bioscience, Inc. and two of its executives.

Plaintiff brought claims under Section 10(b) of the Exchange Act and SEC Rule 10b-5, alleging that defendants had misrepresented the efficacy of, and concealed known regulatory problems with, blood lead level testing products manufactured by Meridian’s subsidiary, Magellan Diagnostics.

Continue Reading District Judge Finds Error in Previous Dismissal of Action Against Acquirer of Blood Testing Manufacturer

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

The recent annual report from NERA Economic Consulting 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, excluding merger objections, the Health Technology and Services sector accounted for 25% of all filings.  While this represented a slight drop in filings against the health care sector in general compared to 2016 and 2017, there was no such drop for firms in the “Drugs” industry (using the Standard Industrial Classification to identify such firms).  In the Drugs industry, 5% of firms were targeted with securities class actions, “mostly related to misleading announcements regarding future performance.”  Indeed, the NERA Report found that, as in recent years, across securities litigation cases in general, “most allegations related to misleading firm performance in 2018 were against firms in the health care sector” and, of those cases, firms in the Drugs industry accounted for two-thirds of such cases.

Despite the continued trend represented by such cases, the NERA Report found that filings targeting foreign companies saw a stark decrease in 2018 compared to 2017, especially in the Health Technology and Services sector.  Whether that trend continues remains to be seen—but the NERA report makes clear that firms in the health care sector in general—and firms focused on the development and commercialization of new drug therapies in particular—will likely continue to face disproportionate rates of securities litigation filings.