PHILADELPHIA, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it is investigating iRhythm Technologies, Inc. ( IRTC) (“iRhythm”) on behalf of the company’s long-term shareholders.
https://kaskelalaw.com/case/irhythm-technologies/
Recently a securities fraud complaint was filed against iRhythm on behalf of investors who purchased shares of the company’s stock between November 5, 2021 and May 30, 2023 (the “Class Period”). According to the complaint, during the Class Period iRhythm and certain of the company’s senior executive officers made a series of materially false and/or misleading statements concerning iRhythm’s premium wearable heart monitoring device: the Zio AT.
As detailed in the complaint, and according to repeated public statements by iRhythm, the Zio AT supposedly would provide “near real-time” and “continuous” transmissions of significant arrhythmias to a patient’s doctor and was thus expressly marketed to “high-risk” patients. These claims allowed iRhythm to expand into the lucrative Mobile Cardiac Telemetry (“MCT”) space and to bill Medicare and Medicaid for millions more in reimbursement than it otherwise could.
On May 4, 2023, iRhythm disclosed that it had received a subpoena from the Civil Division of the U.S. Department of Justice (“DOJ”), which “sought communications and other documents concerning potential issues related to the Company’s Zio Systems, including that the Zio Systems were failing to timely transmit patient cardiac data to physicians for review after the occurrence of a cardiac event.”
Then, on May 30, 2023, investors learned the full extent of iRhythm’s stunning failure to properly market and warn of the dangers of the Zio AT. On that day, iRhythm disclosed it had received a Warning Letter from the U.S. Food and Drug Administration (“FDA”), which “alleges non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the Company’s Zio AT System and medical device quality system requirements.”
The Warning Letter also stated, among other things, that iRhythm had falsely marketed the Zio AT as approved for use in “high-risk” patients that require “real-time cardiac monitoring,” when, in truth, the Zio AT is approved only for “long-term monitoring of arrhythmia events for non-critical care patients where real-time monitoring is not needed.” Further, the Warning Letter revealed that iRhythm “has been aware of customer complaints related to this [transmission limit] issue since at least 2019” and that “[s]ince at least 2017, [iRhythm] has been aware of this [registration] issue where your clinical care team cannot access the patient’s data.”
In total, iRhythm’s stock price declined a total of $53.74 per share, or 32% in value, from its Class Period high price of $168.01 to close on May 31, 2023 at $114.27 per share.
The investigation seeks to determine whether the members of iRhythm’s board of directors violated the securities laws and/or breached their fiduciary duties in connection with the above alleged misconduct.
iRhythm shareholders who purchased or acquired their IRTC shares prior to November 5, 2021 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750 for additional information about this investigation and their legal rights and options. Alternatively, investors may submit their information to the firm by clicking on the following link (or by copying and pasting the link into your browser):
https://kaskelalaw.com/case/irhythm-technologies/
Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about Kaskela Law LLC please visit www.kaskelalaw.com.
CONTACT:
KASKELA LAW LLC
D. Seamus Kaskela, Esq.
([email protected])
Adrienne Bell, Esq.
([email protected])
18 Campus Blvd., Suite 100
Newtown Square, PA 19073
(888) 715 – 1740
(484) 229 – 0750
www.kaskelalaw.com
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