iRhythm Technologies, Inc.

On November 1, 2022, iRhythm released its revised fourth quarter and full year 2022 financial guidance, issuing an “Advisory Notice” to customers of its real-time heart monitor, Zio AT, and lowered its Zio AT forecast for the quarter from 40% to 20%. On this news, iRhythm’s stock price fell $19.67, or 15.5%, over two consecutive trading days to close at $107.10 per share on November 3, 2022, thereby injuring investors.

Then, on November 4, 2022, iRhythm elaborated on its Customer Advisory Notice, revealing that it had initiated it on September 28, 2022 as a result of its “assessment of topics raised in an FDA inspection focused on Zio AT,” after which the FDA issued an inspection observation report on Form 483, typically issued in cases involving violations of the Food Drug and Cosmetic Act and related Acts. On this news, iRhythm’s stock price fell $2.43, or 2.4%, to close at $100.44 per share on November 7, 2022.

Then, on May 4, 2023, iRhythm disclosed that it had received a subpoena from the Civil Division of the U.S. Department of Justice (“DOJ”), requesting documents related to certain products and services. On this news, iRhythm’s stock price fell $9.25, or 6.9%, to close at $124.79 per share on May 5, 2024.

Then, on May 30, 2023 iRhythm disclosed that it had received a warning letter from the FDA detailing several serious issues with the Zio AT device, including the device having only been approved for non-critical patients and unreliable for high-risk patients, despite the Company’s marketing of the device to high-risk patients. On this news, iRhythm’s stock price fell $7.41, or 6.1%, to close at $114.27 per share on May 31, 2023, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) iRhythm failed to comply with the FDA’s marketing regulations and prohibitions against the promotion of products for uncleared and unapproved uses contrary to the representations it made to investors; (2) iRhythm failed to report adverse events to the FDA in violation of the reporting requirements of Medical Device Reporting regulations; and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.