Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.

Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File describes a legal dispute involving Mead Johnson and allegations related to necrotizing enterocolitis in a premature infant. The article recounts that in September 2016 a mother emailed Mead Johnson demanding removal from its lists, saying her son died from NEC after receiving the company’s pre-term infant formula in a NICU. In an internal memo, the manufacturer said it conducted extensive quality and safety checks and concluded there was “not a reasonable possibility” that the formula caused the death, closing the file without further investigation. The email and memo were later used as evidence in Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital. The reporting also says federal rules require investigation of adverse event complaints, and FDA notification within 15 days only if the company finds a reasonable possibility of a causal relationship. An FDA search requested by KFF Health News reportedly found no notifications since Jan. 1, 2020, and none from Jan. 1, 2000 onward. The article cites court testimony by an Abbott expert witness in October 2024, stating Abbott had never reported a death under preterm formula regulations.