Baby Formula Lawsuits Rising

Santa Clara, CAThe first lawsuit to go to trial against baby formula maker Abbott last month resulted in a Missouri state court jury awarding $495 million to a family who claimed their infant daughter developed necrotizing enterocolitis (NEC) after receiving Similac while in a neonatal intensive care unit. The first trial against the Enfamil formula maker in March 2024 ended with a $60 million verdict to the mother of a premature baby who died of NEC. 

The lawsuits claim that the infant formula makers failed to warn that infants given their products are at greater risk of NEC compared to infants who are breast-fed or given donor milk or human milk-derived formula.

NEC causes the death of bowel tissue and mostly affects premature newborns with a fatality rate of between 15% and 40%. Babies who develop NEC are at risk for intestinal perforations, which can lead to sepsis, a leading cause of death. The exact cause of NEC isn’t known, but premature babies have a more challenging time fighting off infections and digesting food, which could put them at higher risk. According to the U.S. National Institutes of Health (NIH) there is evidence that formula increases the risk of NEC in premature infants compared with breast milk. A NIH-funded study published in February 2024 found that, compared to their formula-fed counterparts, extremely preterm infants fed donated human milk had half the rate of NEC.

Margo Gill’s child, Robynn Davis, was given Abbott’s premature infant formula while in a neonatal intensive care unit in 2021. Robynn survived but she suffered irreversible neurological damage because of her illness and will require long-term care. The verdict includes $95 million in compensatory damages and $400 million in punitive damages.

The earlier baby formula trial -- Watson vs. Mead Johnson -- against the Enfamil formula maker Reckitt Benckiser unit Mead Johnson, ended with an Illinois jury awarded $60 million to a plaintiff whose child died from NEC. The verdict includes compensation for Jasmine Watson's loss and grief, and for the pain and suffering of her baby, Chance Dean. (Reckitt acquired Mead Johnson Nutrition for $16.6 billion back in 2017, with the intention to firmly place Reckitt's foothold in the infant formula market.)

Plaintiffs in both cases say that the companies concealed the fact that their formula, including products made specifically for premature infants and others, was riskier than alternatives like donor milk. Gill’s attorneys argued that Abbott failed to warn that its formula could increase NEC risk, while Abbot countered that the infant’s injuries were due to a traumatic birth process. Reckitt is appealing, claiming Watson’s attorneys based their case on unreliable evidence.

Almost 1,000 lawsuits filed against baby formula makers over NEC involve formula and products made for fortifying mother's milk given to infants in hospital settings, and not the regular formula available to consumers in stores. Most all lawsuits have been filed against Abbott Laboratories' Similac and various Mead Johnson’s Enfamil formulas.

Of the approximately 1,000 lawsuits filed, and according to the most recent MDL statistics report, over half of these cases are part of federal multidistrict litigation (MDL) in Illinois. The NEC baby formula lawsuits were consolidated into multidistrict litigation in 2022. In April 2024 about 500 lawsuits had been filed. The initial bellwether trial is scheduled for May 2025. Whatever the outcome, these trials will impact the scrutiny and regulation of infant formula products.

Gill v. Abbott Laboratories marked the first NEC case brought against Abbott. It was the second trial behind Watson vs. Mead Johnson, both alleging that cow's milk-based baby formula given to premature infants can cause NEC. Analysts predict these verdicts could affect many other lawsuits awaiting litigation in state and federal courts throughout the U.S. and Abbott and Reckitt may face substantial settlement costs.