Cases & Deals

Major Indian pharmaceutical company defends against securities fraud class action relating to FDA warning letter

Clients Major Indian pharmaceutical company

Jones Day is defending a class action lawsuit filed against a major Indian pharmaceutical company in federal court, alleging violations of the federal securities laws in connection with a warning letter issued by the U.S. Food and Drug Administration ("FDA") to the company.

The amended complaint alleges that the defendants violated anti-fraud provisions of the Securities Exchange Act of 1934 and SEC Rule 10b-5 by making false or misleading statements (1) prior to the warning letter, about the company's compliance with FDA regulations, and inspectional observations issued by the FDA to the company; and (2) after the warning letter, about the impact of that letter, the company’s remediation efforts, and resultant impact on production. The company filed a motion to dismiss the amended complaint in 2018. In 2019, the court partially granted the defendants' motion to dismiss, holding that the lead plaintiff lacked standing to bring claims related to the vast majority of the alleged misstatements.

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