Item 3. LEGAL PROCEEDINGS
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Item 3. LEGAL PROCEEDINGS
Abbott is involved in various claims, legal proceedings, and investigations, including (as of January 31, 2026) those described below. While it is not feasible to predict the outcome of such pending claims, proceedings, and investigations with certainty, management is of the opinion that their ultimate resolution should not have a material adverse effect on Abbott’s financial position, cash flows, or results of operations.
Abbott is a defendant in numerous lawsuits involving certain of its specialty infant formula products administered to preterm infants. The lawsuits allege that preterm infants developed necrotizing enterocolitis as a result of being administered a cow’s milk-based preterm infant formula product, which resulted in personal injuries or death. As of January 31, 2026, there were 1,760 lawsuits pending in federal and state courts in which Abbott is a party. The plaintiffs seek various damages, including punitive damages. In April 2022, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal court cases consolidated for pretrial purposes in the U.S. District Court for the Northern District of Illinois. In May 2025, the U.S. District Court for the Northern District of Illinois granted summary judgment in favor of Abbott on all claims in the first "bellwether" case and entered judgment for Abbott. The plaintiff has filed an appeal. The U.S. District Court for the Northern District of Illinois granted summary judgment in favor of Abbott in each of the second and third "bellwether" cases in August and October 2025, respectively. In addition, in December 2021, a purported class of Canadian preterm infants filed suit in British Columbia that makes similar allegations as those made in the United States against Abbott. These plaintiffs seek various damages. Many of the lawsuits name another infant formula manufacturer as a co-defendant. In a trial held in July 2024, a jury in a Missouri state court awarded a plaintiff $495 million in damages. Abbott stands by its products and the information it provided about them, and it appealed this jury’s verdict to the Missouri Court of Appeals in December 2024. In a trial held in October 2024 involving Abbott and another infant formula manufacturer and the treating hospital as co-defendants, a jury in a Missouri state court returned a unanimous verdict for Abbott and its co-defendants. In December 2024, the plaintiff filed a motion for a new trial. In March 2025, the Missouri state court granted the plaintiff's motion for a new trial, and Abbott appealed the ruling to the Missouri Court of Appeals.
In November 2022, Abbott learned that the United States Department of Justice (DOJ), through the United States Attorney’s Office for the Western District of Michigan, is conducting a criminal investigation related to Abbott’s manufacturing of powdered infant formula. In January 2023, Abbott received a civil investigative demand from the United States Federal Trade Commission seeking information in connection with its investigation of companies who participate in bids for WIC infant formula contracts. In addition, multiple civil lawsuits have been filed against Abbott relating to Abbott’s manufacturing of certain powdered infant formula products. Six shareholder derivative lawsuits against certain of Abbott’s current and former directors and officers are pending in a consolidated proceeding, In re Abbott Laboratories Infant Formula Shareholder Derivative Litigation, in the U.S. District Court for the Northern District of Illinois. The consolidated lawsuit seeks monetary damages from the defendants to Abbott. In re Abbott Laboratories Infant Formula Shareholder Derivative Litigation includes: Thomas P. DiNapoli, Controller of the State of New York, as Administrative Head of the New York State and Local Retirement System, and as Trustee of the New York State Common Retirement Fund, and International Brotherhood of Teamsters Local No. 710 Pension Fund and Southeastern Pennsylvania Transportation Authority, both filed in June 2023; David Hamilton filed in April 2023; Matthew Steele filed in February 2023; Ilene Lippman filed in January 2023; and Leon Martin filed in October 2022. In August 2024, the court granted in part and denied in part the defendants’ motion to dismiss, allowing the securities and breach of fiduciary duty claims to move forward. In September 2024, Abbott’s Board of Directors established an independent and disinterested special litigation committee to investigate and evaluate the asserted claims. In November 2024, the special litigation committee filed a motion to stay the case in order to conduct its investigation. In February 2025, the court granted in part and denied in part the committee's motion, allowing written discovery to proceed. In November 2025, the DOJ intervened, in part, in a civil qui tam lawsuit previously filed under seal against Abbott by three private individuals in the U.S. District Court for the Western District of Michigan. The DOJ’s intervention is related to Abbott’s manufacturing of powdered infant formula products at its facility in Sturgis, Michigan. The DOJ alleges certain violations of the Federal False Claims Act and unjust enrichment, and it seeks various damages, including statutory penalties and disgorgement of profits. In December 2025, the Attorneys General of several states filed a consolidated complaint-in-intervention in the same lawsuit alleging violations of certain state laws, including false claims acts, and seeking damages and penalties.
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