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Lawsuits regarding NEC & Specialized Preterm Hospital Nutrition Products

Our position on NEC lawsuits in the United States regarding specialized preterm hospital nutrition products:

Specialized preterm hospital nutrition products for premature babies provide essential, lifesaving nutrition to the most vulnerable infants when mother’s or donor milk is unavailable or insufficient. We stand behind the safety and efficacy of our specialized preterm hospital nutrition products, which neonatologists recommend when clinically appropriate as a crucial part of the standard of care in neonatal intensive care units. Indeed, the FDA, CDC, and NIH issued a consensus statement reinforcing that “For infants where the supply of human milk is insufficient, these formulas are part of the standard of care for premature infants.”1 

Claims by plaintiffs’ lawyers that these products cause NEC are not supported by the science or the medical consensus and are irresponsible. The FDA, CDC, and NIH jointly stated: “There is no conclusive evidence that preterm infant formula causes NEC.”1  The NIH Working Group on NEC found that “the best way to prevent NEC is the prevention of preterm birth.”2  And the American Academy of Pediatrics (AAP) stated, “the causes [of NEC] are multifaceted and not completely understood. Our science does not tell us exactly how to prevent it.”3  We will continue to vigorously defend ourselves against plaintiff lawyers’ allegations in the interest of safeguarding the health of premature babies. 


1 FDA, CDC, NIH Consensus Statement on Recent Advisory Council Report on Premature Infants and Necrotizing Enterocolitis (U.S. Department of Health and Human Services, October 3, 2024)

Necrotizing Enterocolitis (NEC) in Preterm Infants Working Group of the National Advisory Council of Child Health and Human Development (NACHHD) Report to Secretary, Department of Health and Human Services, page iv (September 16, 2024)

3  American Academy of Pediatrics Statement In Response to NEC Lawsuit Verdicts (July 27, 2024)

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