Baby Formula and NEC

Baby Formula Linked to Necrotizing Enterocolitis Infections

Cow’s milk-based infant formula, a staple of the diet of newborns from birth to age six months, has received recent scrutiny due to the development of gastrointestinal conditions such as necrotizing enterocolitis (NEC). Cases appear among preterm newborns who are provided with this form of nutrition. NEC is a serious bacterial infection that can develop in the gastrointestinal system of newborn infants.


Although the precise origins of NEC are poorly understood, the relationship between this condition and cows’ milk formula has been observed for at least 40 years; de Peyer et al.’s 1978 case report on this topic points to how “cow’s milk protein played a major role in the pathogenesis of necrotizing enterocolitis.”

While theories abound, absolutely clear mechanisms behind how cow’s milk might cause NEC has yet to be explained. Regardless, such a correlation is well-established.

Studies have linked NEC to the use of certain infant formulas derived from cow milk. In a 1990 study, scientists found that in exclusively formula-fed babies, NEC was 6-10 times more common than in those fed breast milk alone and three times more common in those who received formula plus breast milk.

In 2011, Johns Hopkins Medical Institution found that extremely premature babies fed human donor milk were less likely to develop NEC than those fed a standard premature infant formula derived from cow’s milk. Of course, it has yet to be determined whether cow’s milk-derived formula increases the risk of NEC or if a preemie already has a significant risk for NEC and human donor milk can combat that risk.

Litigation Status

Regardless, parents and their preemies who were fed cow’s milk products and subsequently developed NEC started filing product liability lawsuits against formula manufacturers for negligent failure to warn despite knowledge of the risks.

In April 2022, the MDL Panel certified the Formula NEC multidistrict litigation (In re: Abbott Laboratories, et al., Preterm Infant Nutrition Prod. Liab. Lit.– MDL No. 3026) in the Northern District of Illinois under Judge Rebecca Pallmeyer. To date, there is a total of 97 NEC formula lawsuits pending in the MDL, representing the total plaintiff population. There is no claim registry in this MDL; therefore, this litigation will be small relative to other mass torts. This also means that defendants will be better able to make settlement payouts without cutting profitability.

Meanwhile, the American Academy of Pediatrics (AAP) recently issued new guidelines that recommend avoiding infant formula entirely for newborns, urging hospitals to stop promoting infant formula and focus on breastfeeding. It’s not yet clear whether these changes have inflicted a large enough blow to the MDL defendants to change their ways.

One of the potentially culpable manufacturers is also facing legal woes regarding the cleanliness of its facilities. Last month, the Department of Justice opened a criminal investigation into an Abbott Laboratories plant in Michigan over unsanitary workplace conditions in its production of baby formula. This will only add fuel to the fire of formula safety concerns.

Expert Witness Opportunities

As litigation develops, many specialties will be in demand to provide expert testimony. Areas of expertise range from practicing medical providers and hospital administration to scientists studying neonatology and epidemiology. FDA drug safety experts would have a unique knowledge of acceptable medical practices and could interpret what is standard medical knowledge and procedure. Pediatric surgeons would also have an important story to tell as they are the ones in direct contact with affected intestinal systems and related medical histories.

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