Outset Medical, Inc. Class Action Lawsuit - OM
Case Summary
Investors who suffered a loss and would like to learn more, click here to contact us.
The Outset Medical class action lawsuit seeks to represent purchasers or acquirers of Outset Medical, Inc. (NASDAQ: OM) securities between August 1, 2022 and August 7, 2024, inclusive (the “Class Period”). Captioned Porcelli v. Outset Medical, Inc., No. 24-cv-06124 (N.D. Cal.), the Outset Medical class action lawsuit charges Outset Medical and certain of Outset Medical’s top executives with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the Outset Medical class action lawsuit, please provide your information in the form on this page. You can also contact attorney J.C. Sanchez or Jennifer N. Caringal of Robbins Geller by calling 800/449-4900 or via e-mail at info@rgrdlaw.com. Lead plaintiff motions for the Outset Medical class action lawsuit must be filed with the court no later than October 28, 2024.
CASE ALLEGATIONS: Outset Medical is a medical technology company. According to the Outset Medical class action lawsuit, Outset Medical’s primary products are the Tablo series devices used in dialysis care, including the Tablo Hemodialysis System and the TabloCart.
The Outset Medical class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) the Tablo products were marketed for continuous renal replacement therapy, which is not one of the indications approved by the U.S. Food and Drug Administration (“FDA”); (ii) as a result, Outset Medical was reasonably likely to submit an additional 510(k) application for the Tablo products; (iii) there was a substantial risk that Outset Medical would cease sales of the Tablo products pending FDA approval of additional indications; (iv) Outset Medical lacked the sales team and process to execute on the ramp of Tablo sales; and (v) as a result of all the above, Outset Medical’s revenue growth would be adversely impacted.
The Outset Medical class action lawsuit further alleges that on July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the FDA which “assert[ed] that certain materials . . . promote continuous renal replacement therapy (CRRT), a modality outside of the current indications for the Tablo Hemodialysis System” and “assert[ed] that the TabloCart with Prefiltration . . . requires prior 510(k) clearance for marketing authorization,” and that Outset Medical would “work collaboratively with the FDA to resolve this observation, including potentially submitting a 510(k) on TabloCart.” On this news, the price of Outset Medical stock fell nearly 6%, according to the complaint.
Then, on August 2, 2023, the Outset Medical class action lawsuit further alleges that Outset Medical announced a “Shipment Pause of TabloCart with Prefiltration Pending 510(k) Clearance.” On this news, the price of Outset Medical stock fell more than 10%, according to the complaint.
Thereafter, on October 12, 2023, Outset Medical revealed preliminary third quarter 2023 financial results, as well as updated guidance for 2023 revenue, which reflected that “‘[g]rowth in the quarter was dampened by a larger-than-expected impact in the field from the recent FDA warning letter,’” according to the complaint. On this news, the price of Outset Medical stock nearly 50%, according to the Outset Medical class action lawsuit.
Finally, on August 7, 2024, the Outset Medical class action lawsuit further alleges that Outset Medical released its second quarter 2024 financial results, significantly missing consensus estimates and lowering its full year 2024 revenue guidance by $39 million at the midpoint. The complaint further alleges that Outset Medical further disclosed that: (i) it would be forced to take “‘clear steps to improve our execution’” including “sales team and process restructuring”; and (ii) Outset Medical would be unable to deliver on a post-approval sales ramp of TabloCart previously forecast. On this news, the price of Outset Medical stock fell nearly 69%, according to the Outset Medical class action lawsuit.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Outset Medical securities during the Class Period to seek appointment as lead plaintiff in the Outset Medical class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Outset Medical class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Outset Medical class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Outset Medical class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud cases. Our Firm has been #1 in the ISS Securities Class Action Services rankings for six out of the last ten years for securing the most monetary relief for investors. We recovered $6.6 billion for investors in securities-related class action cases – over $2.2 billion more than any other law firm in the last four years. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.