Infant Formula: A Cover-Up of Deadly Risks?

Infant formula manufacturers may not be adequately reporting infant deaths potentially linked to their products to the government. A mother's 2016 complaint to Mead Johnson regarding her son's death from necrotizing enterocolitis (NEC) was dismissed internally, highlighting a pattern.

Federal regulations require companies to investigate adverse events and report deaths to the FDA within 15 days if a "reasonable possibility" of a causal link is found. However, records indicate that since January 1, 2020, the FDA has not received any such notifications from infant formula manufacturers.

Court cases, including Watson v. Mead Johnson and Gill v. Abbott, have alleged that formulas from Abbott and Mead Johnson contributed to NEC deaths in preterm infants. While over 1,760 NEC lawsuits were pending against Abbott as of January, and Mead Johnson faced a $60 million judgment (later reversed for a new trial), both companies deny fault.

Internal documents from companies like Abbott scientists in 2010 suggested a link between cow's milk-based formulas and NEC. Mead Johnson documents also cited a reduction in NEC risk with human milk. However, companies maintain that correlations do not prove causation.

The FDA, CDC, and NIH have stated there is no conclusive evidence that preterm infant formula causes NEC, while emphasizing the protective benefits of human milk. Despite this, some judges have found the companies' conduct "significantly reprehensible."