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OM.US
id: 992

Outset Medical (OM) FDA Warning Letter Case

N.D. California
Court
5:24-cv-06124
Case number
08/01/2022
Class period Start
08/07/2024
Class period End
10/28/2024
Lead Plaintiff motion deadline
  • $OM stockholders filed a claim against Outset Medical for marketing Tablo products for unapproved uses, which could lead to sales delays and revenue issues.
  • After the news on August 7, 2024, $OM dropped by over 68%.
  • Outset Medical investors can join this case to be notified about potential recovery.
Case Details:

On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the FDA asserting that continuous renal replacement therapy (CRRT) promoted on its website requires prior 510(k) clearance for marketing authorization.

Then, on August 2, 2023, Outset announced a delay in shipping TabloCart due to pending 510(k) clearance. On this news, $OM fell by 10.18% the next day.

After that, on October 12, 2023, Outset announced that an FDA warning letter hurt revenue growth and lowered its 2023 revenue forecast. This caused $OM to drop 50% on October 13, 2023.

On August 7, 2024, Outset Medical missed earnings estimates and cut its 2024 revenue forecast by $39 million.

After that, $OM plummeted 68.5% the next day.

Based on these events, $OM investors filed a claim against Outset Medical, accusing the company of the following:
  • Outset Medical marketed Tablo products for unapproved uses, likely needing new FDA approval.
  • This risked sales delays and revenue issues.
Considering all the representations, investors suspect Outset Medical marketed Tablo products for unapproved uses, which could lead to sales delays and revenue issues.
Case Status
Lead Plaintiff Submission
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
07/10/2023
Filing date
08/29/2024
Lead Plaintiff Deadline
10/28/2024
Judge
Hon. Edward J. Davila
Collecting participants…

Outset Medical Inc

Outset Medical, Inc., a medical technology company, engages in the development of a hemodialysis system for hemodialysis in the United States. The company offers Tablo Hemodialysis System, a compac...

    Ticker
    OM.US
    ISIN
    US6901451079
    CIK
    1484612
    Sector
    Healthcare
    Industry
    Medical Devices
    Country
    USA
    Address
    3052 Orchard Drive, San Jose, CA, United States, 95134