Researchers and health care companies say plaintiffs’ attorneys are engaged in a feeding frenzy of litigation and scientific questioning about the safety of certain types of formula for infants and toddlers.
The law firm Miller and Zois reports that lawsuits targeting Mead Johnson’s Enfamil and Abbott Laboratories’ Similac specialized baby formulas now number 571 in multidistrict litigation (MDL) taking place in the Northern District of Illinois. Such lawsuits generally argue that some scientific research has shown that cow’s milk ingredients heighten the risk of premature newborn babies developing necrotizing enterocolitis (NEC), a serious gastrointestinal condition.
Cases from throughout the nation, including California, are included in the Illinois MDL.
Baby formula litigation, however, can involve issues other than NEC. Earlier this month in the Eastern District of California, a plaintiff challenged an Abbott product, Similac Go & Grow 360 Total Care for toddlers, as deceptively marketed, alleging that the formula misleads consumers into thinking that it has health benefits for children under 2 years old.
“In fact, the product is harmful both nutritionally and developmentally for children under 2,” the lawsuit states.
The lawsuit cites the World Health Assembly’s position that specialty formula milks for older infants are unnecessary. But Abbott has said that the case is simply without merit.
In the NEC cases, which don’t involve formula sold in grocery stores but instead products used by neonatal professions, Abbott said the plaintiffs’ attorneys’ scientific pronouncements are baseless.
“There is no scientific evidence showing Abbott’s preterm infant products cause or contribute to causing NEC,” the company said in a statement emailed to the Southern California Record. “These specialized formulas are considered a part of the standard of care by the medical community and, along with mother’s milk and donor human milk, are the only available options to feed premature infants.”
Such formulas have not been the subject of recalls and have been used by the medical community for decades. The American Association of Pediatrics has concluded that such formulas provide essential nutrition to preterm babies and that research shows human breast milk can only decrease – but not eliminate – the risk of NEC.
“The American Academy of Pediatrics recognizes the role these products play, and top neonatal intensive care units (NICUs) around the country include them in their feeding protocols as part of the standard of care,” the Abbott statement says.
Plaintiffs’ attorneys argue that the dispute could be solved by formula manufacturers such as Abbott simply providing warnings to doctors and consumers about NEC risks so that people can make informed choices. Abbott, however, views the attorneys’ scientific evidence as lacking merit.
“These cases seek to advance a theory promoted by plaintiffs’ lawyers that has no basis in science and is not supported by the medical community,” the company’s statement says.
Plaintiffs’ attorneys suggest otherwise, pointing to a number of studies conducted over recent decades. A 2019 study by Cochrane, a health care research group, offers comprehensive evidence pointing to a causal relationship between formulas containing cow’s milk and NEC in premature infants, the attorneys argue.
They also point to a 2021 British Medical Journal study raising questions about the clinical trials underpinning the safety of specialized infant formulas.
Attorney advertising has fueled the number of such infant formula cases in recent years, critics of such litigation say.