The illness in question, necrotizing enterocolitis, or NEC, is poorly understood outside of neonatal intensive care units, but it is extremely clear to the families who live there. It has a mortality rate of over 20% in the small, underdeveloped bodies of premature infants and causes the intestinal lining to become inflamed and start to die. All four of the trial’s participants, who were born before 32 weeks gestation in Chicago-area hospitals between 2012 and 2019, survived, but three of them needed surgery, and they all still have gastrointestinal issues. One of the four mothers, Eboni Williams, sobbed during the courtroom reading of the verdict.

IMPORTANT INFORMATION TABLE — ABBOTT LABORATORIES INFANT FORMULA LAWSUIT

Hariklia Karis of Kirkland & Ellis handled Abbott’s defense, which was based on a scientific counterargument with regulatory support. According to a 2024 joint statement from the FDA, CDC, and NIH, there is evidence to support the theory that exposure to formula is not linked to an increased risk of NEC, but rather the absence of human milk. Throughout the trial, Karis relied on this, claiming that the four infants’ NEC diagnoses were explained by a number of additional risk factors, including prematurity itself, antibiotic use, and other medical conditions. She informed the jury, “These infants would have gotten NEC regardless of what they were fed.” Additionally, she contended that since parents of hospitalized preemies submit to physicians who are already well-versed in NEC and the protective benefits of breast milk, a warning label would have had no real impact.

Sean Grimsley, the plaintiffs’ lawyer, provided a clearer explanation. He informed the jury that Abbott was aware that the formula “increases the risk of NEC” but neglected to label it. He argued that Abbott’s product contributed to the injuries of these vulnerable infants in these particular circumstances and that the company had a duty to warn that it might, rather than that formula is generally dangerous. He contended that the mothers would have fought more for access to breast milk if they had been aware of the danger. Judge John Ehrlich of Cook County Circuit Court, who presided over the case, was particularly critical of an Abbott expert witness who testified that alerting parents to the NEC risk associated with formula would be “cruel.” Ehrlich described the testimony as “nothing short of astounding” and stated that doctors frequently discuss serious medical risks, including frightening ones, with patients.

The underlying tension in this situation is difficult to ignore. In 2024, Abbott CEO Robert Ford made a public suggestion that if the lawsuit persisted, the company might completely stop producing preterm formula products. From a business standpoint, that threat wasn’t insignificant because the legal risk is growing. Currently, Abbott is the target of about 1,700 lawsuits nationwide, with over 700 of those cases being consolidated in a Chicago federal court. In 2024, Mead Johnson, a Reckitt subsidiary that produces Enfamil, was hit with a $60 million verdict in Illinois due to similar litigation. Almost nothing the infant nutrition industry has encountered is comparable to the combined wave.

The fact that the product in question is not a consumer product in the traditional sense is the medical reality that makes this so challenging. Grocery stores do not sell this formula. For infants in neonatal intensive care units—babies who are frequently too young and too delicate for their mothers to produce enough breast milk—it is a specialized, hospital-only product. When a mother’s own milk and donor breast milk are unavailable, the American Academy of Pediatrics advises using it as the standard of care. In this trial, both the defense and plaintiff’s lawyers agreed that the formula is a last resort. Whether it’s necessary is not the point of contention. It concerns whether Abbott should have made it obvious to families that there is a risk and whether failing to do so cost the intestinal health of four children.

The 2024 Missouri verdict of $495 million has been appealed. There will be an appeal of the $70 million Cook County verdict. The trial of the fourth federal bellwether case is set for July. This is far from over.

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