There are currently over a thousand lawsuits before state and federal courts alleging a link between the consumption of preterm infant formula and increased risks of a life-threatening condition called necrotizing enterocolitis (NEC), and that manufacturers have failed to sufficiently warn parents of this risk. Despite some plaintiff successes, with three massive jury awards, other recent court proceedings point to a fundamental disagreement on how courts should handle the claims underpinning the lawsuits.

A Cook County jury awarded four families $70 million in damages on April 10, finding that Abbott Laboratories failed to warn that using its baby formula for premature infants instead of human milk can lead to NEC. In a statement following the verdict, Sean Grimsley, a lawyer for the plaintiff, said: “This verdict reveals the truth that Abbott hid from the public: cow’s milk– based baby formula causes NEC in premature infants.” Juror Jim Schmidt expressed a similar sentiment: “I would like a label on their product so any risk is out there.” But just last month, a similar lawsuit against Abbott in the Circuit Court of Broward County, Florida, was dismissed, as Circuit Court Judge Carol-Lisa Phillips leaned heavily on the learned intermediary doctrine to establish that there was no failure to warn the plaintiff of alleged NEC risks.

Judge Phillips reasoned that the doctrine recognizes that neonatologists are in “the best position to evaluate the risks and benefits of a drug for a particular patient,” so the duty to warn is directed to the medical team—the “learned intermediary”—rather than to the patient. The court’s final order quotes three of the neonatologists who treated the infant to establish that the duty to warn was in fact satisfied. The doctors noted that research shows “‘human milk is associated with a significant reduction’ in NEC compared to formula,” but each also stated that they would have made the same feeding decisions regardless of warnings about a higher risk of NEC.

Judge Phillips also dismissed the plaintiff’s claims for intentional and negligent misrepresentation and constructive fraud, rejecting the claim that any of the marketing materials submitted in support of their claims were factually incorrect. The doctors testified that they “relied on their training and expertise,” and not any marketing materials or labels, to make feeding decisions for their patient.

NEC is a gastrointestinal condition that mainly affects premature infants. It is a potentially deadly disease that involves a bacterial invasion of the intestinal lining, leading to tissue necrosis and potential perforation. NEC develops within 2–6 weeks after birth, almost always while the infant is being treated in neonatal intensive care units (NICUs).

Since 2021, over a thousand lawsuits have been filed against Abbott and Mead Johnson, the only two companies that manufacture the specialized products that are, in almost all cases, dispensed in NICUs. The lawsuits commonly allege that the companies failed to warn about alleged NEC risks associated with cow’s milk–based formula for premature infants and that they misleadingly market the products as safe and effective.

The question of the role of science remains a central point of contention as these NEC lawsuits progress through state and federal courts. The medical community has long noted that human milk, whether from the infant’s mother or pasteurized donor milk, is the preferred source of nutrition for all babies, and especially for premature infants. Scientific evidence has consistently shown that it is the absence of human milk, and not the exposure to formula, that increases the risk of NEC. In a January 2026 clinical report, the American Academy of Pediatrics continues to recommend preterm infant formula for very low birthweight infants when breast milk or donor milk is unavailable or declined by the parents.

Abbott stated its plan to appeal the Cook County verdict, with a spokesperson remarking that “science was ignored in this case.” The company noted: “This verdict, and the continued pursuit of a theory at odds with regulators and the medical community, risks eliminating vital options for doctors and the most vulnerable of infants.”

The first of the NEC lawsuits reached the courtroom in 2024. There were two jury verdicts that separately found Abbott and Mead Johnson liable for damages—a St. Louis jury awarded $495 million in damages against Abbott, and an Illinois jury awarded $60 million in damages against Mead Johnson. Following those verdicts, which are being appealed by the defendants, many in the medical community feared that NEC lawsuits could threaten the availability of the very products needed to nourish and sustain premature infants.

Later in 2024, and likely a response to those jury verdicts, three federal agencies—the NIH, FDA, and CDC—issued a consensus statement that outlined the scientific community’s understanding of NEC risk factors: “preterm birth is the primary factor for developing NEC.” The report acknowledges that there is strong evidence that human milk protects against NEC, but also emphasizes that “there is no conclusive evidence that preterm infant formula causes NEC.” 

The 2024 verdicts raised alarms in the marketplace as well. Analysts saw Mead Johnson as a drag on its parent company, Reckitt, noting that the potential litigation risk from the NEC fallout was turning off investors and spurring calls to sell off its Mead Johnson Nutrition business. In a July 2024 investor call, Abbott CEO Robert Ford first suggested the possibility that preterm products could be discontinued in light of the ongoing litigation.

Following this month’s Cook County verdict, Abbott underscored the safety and the vital role of their products in the healthcare of premature infants, but also acknowledged the business challenge: “As we have consistently said, if well-established science and the regulatory framework governing these products are disregarded, it will become extraordinarily difficult for any company to continue providing these medically necessary products in the United States.” Experts in pediatric medicine have warned that babies could die, noting that formula is a vital life-saving product, especially when human milk is unavailable or insufficient.

While there have been mixed results for these NEC lawsuits in state courts, the four bellwether cases in federal courts have been more skeptical of the plaintiffs’ cases. The first three multidistrict litigation (MDL) lawsuits proceeding in the federal courts have been victories for Abbott. In each, the courts determined that the plaintiffs failed to establish causation and summarily dismissed the lawsuits.

The fourth bellwether case, Inman v. Mead Johnson & Company, consolidates over 780 plaintiffs and is tentatively scheduled to be heard in the U.S. District Court for the Northern District of Illinois this summer. Although the defense is awaiting a final ruling on its motion to dismiss, as well as rulings on additional Daubert motions, this would be the first MDL lawsuit to make it before a jury if the rulings go in favor of the plaintiffs.

The NEC lawsuits that have proceeded to trial in state courts have asked juries to weigh in on questions that scientists still don’t understand—what causes NEC. Bellwether cases are meant to help guide how hundreds of other cases in federal courts may proceed and even how to settle the cases. To date, the federal courts have declined to allow juries a similar opportunity to fill the gaps that science cannot answer.