iRhythm (IRTC) Zio AT FDA Warning Letter Case

N.D. California

Court

3:24-cv-00706

Case number

11 Jan 2022

Class period Start

30 May 2023

Class period End

08 Apr 2024

Lead Plaintiff motion deadline

$IRTC stockholder filed a claim vs. iRhythm for misrepresenting Zio AT prospects and falsely marketing it. 
The news about the Zio AT and the FDA letter caused $IRTC to fall 6% and lose over $227M of shareholder value.
On November 1, 2022, iRhythm Technologies revised its guidance due to "Zio AT utilization," lowering its growth forecast from 40% to 20%.

Three days later, on November 4, 2022, iRhythm disclosed issuing a Customer Advisory Notice following FDA inspection issues. Despite this, iRhythm sought to reassure investors and promoted Zio AT growth.

On May 4, 2023, iRhythm disclosed receiving a subpoena from the U.S. DOJ. Later, iRhythm received an FDA warning letter regarding the marketing of the Zio AT device. The FDA highlighted that iRhythm falsely marketed Zio AT for high-risk patients needing real-time cardiac monitoring, contrary to its approved use.

On this news, $IRTC fell 6.09% and lost over $227M of its market capitalization, seriously damaging shareholders.

Based on these events, $IRTC stockholder filed a claim against iRhythm and its leaders, accusing them of the following:
iRhythm repeatedly promoted Zio AT's growth potential in the market for real-time monitoring, which investors viewed positively due to the premium price for devices.
Considering all the information, investors suspect iRhythm of violating federal regulations, which led to their losses.

Case Status

Lead Plaintiff Appointed

Alleged Offence

Misleading Statements,

Failure to Disclose,

Omissions

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

31 May 2023

Filing date

06 February 2024

Lead Plaintiff Deadline

08 April 2024

iRhythm (IRTC) Zio AT FDA Warning Letter Case

Collecting participants…