Abbott settles US$670M lawsuits over preterm infant formula safety claims

USA – Abbott has reached agreements with three law firms over claims relating to the company’s speciality formulas for preterm infants, in a settlement worth approximately US$670 million.

The agreements cover a 2024 verdict in Missouri, where the courts ruled in favour of the Gill family, who were awarded damages in a brain damage case related to necrotising enterocolitis (NEC), a serious inflammatory intestinal disease that primarily affects premature infants, as well as additional claims alleging that preterm infant formula is associated with NEC.

Abbott appealed the verdict to the Missouri Court of Appeals in December 2024, but the appeal was denied. The company said it subsequently chose to settle rather than continue the appeals process or pay approximately $600 million, including the Gill judgment and accrued interest.

In a statement on its website, Abbott said the agreements are a compromise of disputed claims and do not constitute an admission of liability. The company continues to maintain that its preterm infant formulas are safe and that there is no reliable scientific evidence that the products cause NEC.

The settlement comes against a backdrop of mixed litigation outcomes for manufacturers of preterm infant formula. Abbott highlighted a series of recent favourable court rulings, including victories in all three federal Multidistrict Litigation (MDL) bellwether cases.

In July 2026, the US Court of Appeals for the Seventh Circuit affirmed a pretrial judgment for Abbott in the first federal MDL bellwether case involving its preterm infant formulas.

In June, the Illinois Appellate Court reversed a $60 million verdict, finding that the trial court had not properly applied the learned intermediary doctrine. A Florida state court similarly dismissed claims involving preterm infant formula in March 2026.

The learned intermediary doctrine generally recognises that, where products are administered under the direction of medical professionals, manufacturers’ warnings are communicated to healthcare providers rather than directly to patients because clinicians are responsible for assessing risks and benefits.

Despite those rulings, Abbott said it believes resolving the latest claims is in the company’s long-term interests and represents a constructive step toward substantially reducing the overall litigation.

Following the agreements, Abbott said roughly 1,700 lawsuits remain pending in federal and state courts, involving claims on behalf of approximately 12,700 individual infants. The company said that figure includes cases with potentially overlapping or disputed circumstances.

Preterm infant formulas are specialised nutritional products designed for premature and low-birth-weight infants, whose nutritional requirements differ from those of full-term babies. Unlike conventional infant formula sold directly to consumers, these products are primarily used in neonatal intensive care settings.

Abbott said it is one of only two companies in the US supplying preterm infant formulas and stressed their role where a mother’s own milk or donor human milk is unavailable or insufficient.

The company cited guidance from the US Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health and American Academy of Pediatrics, among others, arguing that there is no conclusive evidence that preterm formula causes NEC and that such products remain an important component of neonatal care.

In an October 2024 statement, the FDA, CDC and NIH said available evidence supports the hypothesis that an absence of human milk, rather than exposure to formula, is associated with increased NEC risk.

The American Academy of Pediatrics has likewise said speciality formulas and fortifiers provide an essential source of nutrition for premature infants, while noting that breast milk does not eliminate the risk of NEC and that sufficient parental or donor milk is not always available.

The AAP and other medical organisations have also stressed that feeding decisions for premature infants should be made by clinicians and families based on individual circumstances, rather than through litigation.

The company said it remains confident in the safety of its products and the scientific evidence supporting their use.

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