The Law Offices of Timothy L. Miles Launches Investigation of the Board of Directors of Outset Medical, Inc.
The Outset Medical class action lawsuit seeks to represent purchasers or acquirers of Outset Medical, Inc. (NASDAQ: OM) common stock between September 15, 2020 and June 13, 2022, inclusive (the “Class Period”). The Outset Medical class action lawsuit – captioned Plymouth County Retirement Association v. Outset Medical, Inc., No. 22-cv-04016 (N.D. Cal.) – charges Outset Medical and certain of its top executive officers with violations of the Securities Exchange Act of 1934 and is brought on behalf of investors who purchased Outset Medical stock during the Class Period.
Allegations in the Outset Medical Class Action Lawsuit
Outset Medical’s flagship product is the Tablo Hemodialysis System, a dialysis machine that purifies tap water and then artificially purifies and removes toxins from the blood of patients suffering from kidney failure.
Throughout the Class Period, Outset Medical touted that Tablo can “serve as a dialysis clinic on wheels” that had been “cleared by the [U.S.] Food and Drug Administration (FDA) for use in the hospital, clinic or home setting.” However, devices used by non-professionals outside of a clinical setting and that can present serious health consequences like Tablo are subject to heightened scrutiny by the FDA, including post-market surveillance studies. Thus, though cleared by the FDA for sale, Tablo for use in the home setting was subject to additional studies, the results of which could require additional applications for clearance and approvals. And while performing further regulatory studies during the Class Period, Outset Medical assured investors that it was conducting the studies “in accordance with the FDA approved protocol,” which required an appropriate demonstration of “real-world” human testing given that the device would be used at home by non-professionals.
But as the Outset Medical class action lawsuit alleges, undisclosed to investors, Outset Medical continuously made significant changes to Tablo for use in the home setting. The nature of these undisclosed changes: (i) made it likely that the FDA would order Outset Medical to cease all marketing and selling of Tablo for use in the home pending additional applications and approvals; and (ii) prevented Outset Medical from performing the requisite “real-world” human testing on a device cleared for sale, contrary to representations to investors.
On May 4, 2022, Tablo Medical announced disappointing results for the first quarter of 2022, which analysts attributed, among other things, to the untested nature of Tablo in the home setting. On this news, the price of Outset Medical common stock declined more than 40% over the three trading days that followed.
Then, on June 13, 2022, Outset Medical announced that the FDA had forced it to hold all shipments of Tablo for use in the home until Tablo received proper regulatory clearance. During a “Business Update” conference call held that day with analysts, Outset Medical CEO Leslie Trigg acknowledged the “ship hold” had already been in place for weeks before investors were provided this material information. Importantly, CEO Trigg disclosed for the first time that, rather than conducting studies using “real-world data” gathered in the “home environment” as Outset Medical previously stated was required by the FDA, in reality, Outset Medical had “run with a protocol that involves a simulated use environment at a human factors lab.” On this news, the price of Outset Medical stock fell an additional 34%, further damaging investors who suffered losses in Outset Medical stock.
Investigation of the Outset Medical Board
The investigation of the Outset Medical board focuses on whether the board of directors of Outset Medical have breached their fiduciary duties to the company in light of the serious allegations raised in the Outset Medical class action lawsuit filed against the Company. The firm urges long-term stockholders of Outset Medical to call an Outset Medical Stock Loss Lawyer Timothy L. Miles today or simply submit the form at the bottom of the link if you have questions about the investigation of the Outset Medical Board.
Long-Term Stockholders Urged to Contact Outset Medical Stock Loss Lawyer Timothy L. Miles
If you are a long-term stockholder of Outset Medical, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Outset Medical Stock Loss Lawyer, Timothy L. Miles, by email at email@example.com, or telephone at (858) Tim-MLaw, or by filling out the contact form at the bottom of the link and someone will promptly call you back. There is no cost or obligation to you, so go ahead and call and see what an Outset Medical Lawyer can do for you.
Timothy L. Miles, Esq,
Timothy L. Miles is a nationally recognized shareholder rights attorney raised in Nashville, Tennessee. Mr. Miles was recentely selected by Martindale-Hubbell® and ALM as a 2022 Top Ranked Lawyer, 2022 Top Rated Litigator. and a 2022 Elite Lawyer of the South. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Mr. Miles has published over sixty articles on various issues of the law, including class actions, whistleblower cases, products liability, and more.
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