SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action Against iRhythm Technologies, Inc. - IRTC

Then, on November 4, 2022, iRhythm revealed that on September 28, 2022, it initiated the Customer Advisory Notice 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.  Notably, a Form 483 is issued in cases where an FDA investigator observes conditions that constitute violations of the Food Drug and Cosmetic Act and related Acts.  Although iRhythm did not expand on the concerns the FDA raised, it did assure investors that the Company did "not expect this Zio AT labeling correction or the activities associated with the topics raised in the FDA inspection to present a material risk to [its] business at this time[.]" 

On this new, iRhythm's stock price fell $4.23 per share or 3.95%, to close at $102.87 per share on November 4, 2022. 

Then, on May 4, 2023, iRhythm announced that a month earlier, it had received a subpoena from the Civil Division of the U.S. Department of Justice (the "DOJ"), requesting the production of documents related to certain of its products and services.  Although the Company did not reveal the scope of the DOJ's requests, analysts noted that one of iRhythm's competitors also received a subpoena from the DOJ regarding its wearable real-time monitoring product, and thus presumed that the DOJ inquiry was likely related to Zio AT.  Analysts additionally noted "uncertainty" and cited to "an overhang" on iRhythm in light of the DOJ inquiry.  

On this news, iRhythm's stock price fell $9.25 per share, or 6.9%, to close at $124.79 per share on May 5, 2023. 

Finally, on May 30, 2023, iRhythm disclosed the receipt of a warning letter from the FDA that detailed several serious issues with the Zio AT device (the "Warning Letter").  Among other things, the Warning Letter criticized iRhythm's marketing of the Zio AT as a "mobile cardiac telemetry monitor" that provides "near real-time monitoring" and is approved for use in "high-risk patients" as false.  In truth, the Zio AT device was only approved for non-critical patients and suffered from critical flaws that imperiled high-risk patients.  The Warning Letter also outlined other serious issues with the Zio AT device that iRhythm had known of since at least 2017 yet failed to disclose to the FDA, patients, or investors.  

On this news, iRhythm's stock price fell $7.41 per share, or 6.1%, to close at $114.27 per share on May 31, 2023.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.  

Attorney advertising.  Prior results do not guarantee similar outcomes.   

CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980

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SOURCE Pomerantz LLP