In June, Outset announced that it was holding shipments of its Tablo hemodialysis system for home use as a result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance.
Last month, it was revealed that the company would face a shareholder lawsuit claiming that the company and its top executives made false and misleading positive statements leading up to the shipment hold announcement. In announcing its quarterly results earlier this week, though, the company said that it received the FDA 510(k) clearance and is resuming shipments of Tablo.
According to a news release from the law firm, the lawsuit seeks to recover losses on behalf of Outset Medical investors who were “adversely affected by alleged securities fraud.” The suit is on behalf of all persons or entities who purchased Outset Medical common stock between Sept. 15, 2020, and June 13, 2022.
The filed complaint alleges false statements and/or concealing that Outset’s Tablo system would require the additional 510(k) application, which, as a result, allegedly led to the company not being able to conduct a human factors study on a cleared device in accordance with FDA protocols.
Additionally, the suit alleges that the inability to conduct the human factors study subjected the company to the likelihood of the FDA imposing a shipment hold and marketing suspension, making the company’s positive statements about its business, operations and prospects “materially false and misleading and /or lacked a reasonable basis at all relevant times.”
Shares of OM were down 1.3% at $19.15 per share in mid-morning trading today.