The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Outset Medical, Inc. (NASDAQ: OM) who purchased common stock between September 15, 2020, and June 13, 2022. The action, which was filed in the United States District Court for the Northern District of California, alleges that the Company violated federal securities laws.
In particular, the Outset Medical lawsuit alleges that (1) the Company’s flagship product, Tablo Hemodialysis System (“Tablo”), would require an additional 510(k) application to be filed with The United States Food and Drug Administration (“FDA”), as defendants had “continuously made improvements and updates to Tablo over time since its original clearance”; (2) as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) the Company’s inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a “shipment hold” and marketing suspension, leaving the Company unable to sell Tablo for home use; and (4) as a result, defendants’ positive statements about the Company’s business, operations, and prospects were materially false and misleading and /or lacked a reasonable basis at all relevant times.
Shareholders have until September 6, 2022 to petition the court for lead plaintiff status. Your ability to share in any recovery does not require that you serve as lead plaintiff. You may choose to be an absent class member.
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