Verdicts against formula companies may jeopardize the U.S. supply of a specialized formula essential to premature infants, according to AAP President Benjamin D. Hoffman, M.D., FAAP.
A Missouri jury Friday ruled in favor of a claim that a preterm infant developed necrotizing enterocolitis (NEC), because of a specialized cow’s milk formula manufactured by Abbott Laboratories. The jury awarded $95 million in compensatory damages and $400 million in punitive damages. In March, an Illinois jury ruled against Mead Johnson in a similar case, awarding $60 million in damages.
The lawsuits alleged the formula companies failed to warn of the risk of NEC posed by its product. Both formula makers said there is no evidence its preterm infant products cause or contribute to causing NEC, according to news reports.
“Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences,” Dr. Hoffman said.
These special formulas provide an essential source of nutrition for preterm infants. Using human breast milk to feed preterm infants may reduce the risk of NEC, but it does not eliminate this risk.
“This condition can be devastating to infants and their families,” Dr. Hoffman said. “Part of what is so challenging about NEC is that the causes are multifaceted and not completely understood. Our science does not tell us exactly how to prevent it."
Dr. Hoffman said Friday’s verdict – and possible verdicts in hundreds of pending cases like it – may jeopardize the availability of this formula, which is produced by just two U.S. companies.
NEC primarily affects the intestines of preterm infants and can present with feeding intolerance, abdominal distension and/or tenderness, bloody stools or lethargy. In 2022, one in 10 infants in the U.S. were born premature, according to the Centers for Disease Control and Prevention.
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