Baxter International Inc. (NYSE: BAX) is a global medtech company. Its segments include Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. The Medical Products and Therapies segment includes sales of its sterile IV solutions, infusion systems, administration sets, parenteral nutrition therapies and surgical hemostat, sealant, and adhesion prevention products. The Healthcare Systems and Technologies segment includes sales of its connected care solutions and collaboration tools, including smart bed systems, patient monitoring systems and diagnostic technologies, respiratory health devices, and advanced equipment for the surgical space, including operating room integration technologies, precision positioning devices, and other accessories. The Pharmaceuticals segment includes sales of specialty injectable pharmaceuticals, inhaled anesthesia, and drug compounding. It provides a portfolio of diagnostic, critical care, nutrition, hospital and surgical products.

A recently filed securities fraud class action complaint alleges that Baxter International Inc. (NYSE: BAX), through certain of its officers and directors, made material misrepresentations to investors by portraying its Novum LVP as safe, while concealing systemic issues that put patients at risk of severe injury and death. Prior to launching the Novum LVP in the United States, Defendants assured investors that Baxter “[was] able to address all of [the] issues” that came up with the initial rollout in Canada, and that the U.S. launch would not be subject to the same issues. While the Novum LVP was rolling out in the United States, Defendant Jose Almeida, Baxter’s former Chief Executive Officer, further assured investors that the launch was “going extremely well” and “one of the best launches that [he’s] seen in [his] career.” In reality, the launch was on the brink of failure due to recurring life-threatening defects in the devices that Baxter could not adequately correct.

The underlying securities class action complaint alleges that, throughout the Class Period, Defendants failing to disclose that: (a) 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; (b) Baxter was notified of multiple device malfunctions, injuries, and deaths from these defects; (c) 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; (d) 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 (e) based on the foregoing, Baxter’s statements about the safety, efficacy, product rollout, customer feedback and sales prospects of the Novum LVPs were materially false and misleading.

Safety concerns regarding Novum LVP began to surface on April 7, 2025. On that date, a Missouri news outlet reported serious safety issues relating to inaccurate infusion rates with the Novum LVPs based on information from a whistleblower at a local hospital system. According to the whistleblower, “patients should not be being treated with these pumps. These pumps are not safe.” When asked if any potential fixes to the safety issues had been sufficient, the whistleblower replied, “no, they have all been Band-Aid solutions.” This report prompted the hospital system to take all its Novum LVPs out of service. Notwithstanding the whistleblower report, Baxter did not formally respond to multiple requests for comments and instead continued to tout the Novum LVPs as safe products with a successful launch. Major national news outlets did not pick up the story, allowing Baxter to contain the fallout and continue misleading investors about the success of the Novum LVP rollout.

Just weeks after the whistleblower report, on April 24, 2025, Baxter sent customers a warning letter about a potential underinfusion risk associated with the Novum LVP, disclosing only one serious injury linked to this issue. Then, on July 14, 2025, Baxter issued a second warning letter reiterating an underinfusion risk along with an additional risk of overinfusion. In the second letter, Baxter revealed that it had received 79 reports of serious injury and two reports of patient deaths related to the Novum LVP. Despite these serious hazards, Baxter did not instruct hospitals to remove the Novum LVP from service but instead told hospitals to implement correction steps while continuing to use the devices. The FDA subsequently classified these issues as a Class I recall, its most serious designation, reflecting a risk of severe injury or death.

Finally, on July 31, 2025, the true extent of the safety issues was revealed to the market when Baxter announced the suspension of all new Novum LVP sales.

Current Baxter shareholders who have held Baxter shares since prior to February 23, 2022, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to them whatsoever. Alternatively, if you purchased Baxter shares between February 23, 2022 and July 30, 2025, you can participate in the class action.

If you would like to learn more about this matter, you are encouraged to contact Joshua Grabar at jgrabar@grabarlaw.com, or call 267-507-6085.