Outset Medical is facing a class action lawsuit alleging that the Company made materially false and/or misleading statements and/or failed to disclose 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.
If you incurred a loss on OM common stock purchased between September 15, 2020, and June 13, 2022, this lawsuit is on your behalf. The lawsuit was filed in the United States District Court for the Northern District of California, and our firm is reaching out to investors to discuss their legal rights.
If you wish to act as a representative of the shareholders harmed by this misconduct, you may ask the court to appoint you as lead plaintiff. A lead plaintiff directs the litigation and participates in important decisions, including whether to accept a settlement for the class in the action.