Infant Formula Makers Closed Internal Files on Reported Baby Deaths Without FDA Notification

Mead Johnson received an email in September 2016 from a mother who said the company's infant formula caused her baby's death from necrotizing enterocolitis. An internal company memo stated there was "not a reasonable possibility" the formula caused the death and closed the file without further investigation.

Federal rules require manufacturers to investigate and report to the FDA when a complaint indicates a possible health hazard. The FDA's Human Foods Program stated it received no such notifications from any infant formula manufacturer between January 1, 2000, and March 2025.

Wallingford, a paid expert witness for Abbott, testified in October 2024 that Abbott had never reported a single death under regulations for preterm infant formula. Christina Valentine, Mead Johnson's former medical director for North America, testified she never sent the FDA a report of death from NEC during her seven years in the role.

Mead Johnson spokesperson Jen O'Neill stated the company treated physician reports linking its products to NEC as a "reasonable possibility of a causal relationship" and submitted adverse event reports to the FDA. O'Neill did not specify when those reports were filed or whether they related to cases that later appeared in litigation.

About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023. As of late January, 1,760 NEC lawsuits were pending against Abbott. Three cases reached trial in 2024. Watson v. Mead Johnson produced a $60 million judgment later reversed on appeal.

Gill v. Abbott produced a $495 million judgment. Whitfield v. St. Louis Children's Hospital resulted in a defense verdict that a judge set aside for a new trial. An Illinois appeals court reversed the Mead Johnson judgment in June, ruling the trial court improperly admitted evidence of the company's finances and gave the jury erroneous instructions.