Baxter International, Inc.

On April 7, 2025, a Missouri news outlet reported serious safety issues relating to inaccurate infusion rates with Baxter’s Novum IQ Large Volume Pump (“Novum LVP”), a device used for the controlled delivery of intravenous fluids, based on information from a whistleblower at a local hospital system. The whistleblower claimed that “patients should not be being treated with these pumps. These pumps are not safe.” The report led to the hospital system’s removal of all Novum LVPs.

Then, on April 24, 2025, Baxter sent warning letters to customers regarding a potential underinfusion risk associated with the Novum LVP, disclosing only one serious injury linked to this issue. On July 14, 2025, the Company issued a second warning letter repeating the underinfusion risk along with an additional overinfusion risk, revealing that it had received 79 reports of serious injury and two reports of patient deaths related to the Novum LVP. The FDA subsequently classified these issues as a Class I recall, its most serious designation, reflecting a risk of severe injury or death.

Then, on July 31, 2025, Baxter announced that it was “voluntarily and temporarily [pausing] shipments and planned installations of the Novum LVP” and that the Company was “unable to currently commit to an exact timing for resuming shipment and installation for Novum LVPs.”

On this news, Baxter’s stock price fell $6.24, or 22.4%, to close at $21.61 per share on July 31, 2025, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the Novum LVP suffered systemic defects that caused widespread malfunctions, including underinfusion, overinfusion, and complete non-delivery of fluids, which exposed patients to risks of serious injury or death; (2) Baxter was notified of multiple device malfunctions, injuries, and deaths from these defects; (3) Baxter’s attempts to address these defects through customer alerts were inadequate remedial measures, when design flaws persisted and continued to cause serious harm to patients; (4) as a result, there was a heightened risk that customers would be instructed to take existing Novum LVPs out of service and that Baxter would completely pause all new sales of these pumps; and (5) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.