On March 14, 2024, an Illinois jury returned its verdict against Enfamil baby formula manufacturer Mead Johnson, a unit of Reckitt Benckiser, in the amount of $60 million for the death of baby Chance Dean, who was born premature, from necrotizing enterocolitis (NEC) after being fed Enfamil formula. The jury found that Mead Johnson failed to warn the plaintiff about the risk of NEC associated with Enfamil baby formula and was otherwise negligent.
The plaintiff’s attorney stated after the verdict, “This verdict confirms what Mead Johnson has known for years: cow’s-milk based baby formula causes NEC in preterm infants, often with fatal consequences.” Mead Johnson responded to the verdict, “We continue to believe that the allegations from the plaintiff’s lawyers in this case were not supported by the science or experts in the medical community.”
A recent study found: “Compared to their formula-fed counterparts, extremely preterm infants fed donated human milk had half the rate of necrotizing enterocolitis, a common life-threatening condition of the intestines, according to a study funded by the National Institutes of Health (NIH). There were no differences in neurological development between infants fed donated human milk and those fed formula. Infants who received formula also grew slightly faster than those receiving donor milk.”
Researchers randomly assigned 483 infants born before 29 weeks of pregnancy or who weighed less than 1,000 grams (about 2.2 pounds) at birth to receive formula or donated human milk. Some infants in each group were given their mothers’ milk. Necrotizing enterocolitis developed in 10 infants (4.2%) in the donor milk group, compared to 22 infants (9%) in the formula group.
NEC And Premature Babies
Necrotizing enterocolitis is a potentially devastating condition, affecting approximately 10% of prematurely born neonates. The main risk factor for development of NEC is prematurity. Well-accepted secondary risk factors are intrauterine growth retardation, the presence of pathogenic organisms in the gastrointestinal tract, bowel ischemia, enteral feeding and variations in clinical practice regarding feeding (e.g., breast milk vs donor breast milk or formula) and antibiotic treatment protocols. The administration of antenatal maternal magnesium sulphate (MgSO4), intended as a neuroprotective measure, has been suggested to be an additional risk factor for the development of NEC.
The threshold for active treatment of preterm neonates is currently considered to be 22 weeks gestational age and there is currently not much data on surgical outcomes for this cohort.
The most consistent finding in published reports of NEC is that the incidence has been relatively stable over time in very low birth weight (VLBW) infants (<1500 g at birth). One study reported an incidence of 10% for NEC within this cohort in 1994, which is still commonly cited.
The mortality rate of VLBW infants with surgical NEC is between 50% and 72%, and neurodevelopmental impairment is highly likely to occur in survivors. In live-born infants of 22 or 23 weeks gestational age, survival has been reported to reach almost 50% where active care is offered. Similar outcomes were observed in a single center study in Iowa, with a reported survival to hospital discharge of 78% among NICU admissions at 22 or 23 weeks gestational age.
Given the fragility and high mortality of babies born under 24 weeks gestation, the appropriateness of undertaking surgical intervention in this cohort for NEC or other abdominal emergency remains unclear. Anecdotally, many neonatal surgeons would not offer surgery for a baby under 24 weeks gestation on the grounds of futility. Others, however, would be prepared to attempt a laparotomy in these babies.
If your premature baby developed NEC after being fed Enfamil or other baby formula, you should promptly find a medical malpractice lawyer in your state who may investigate your Enfamil NEC claim for you and represent you and your baby in a premature baby NEC malpractice case, if appropriate.
Visit our website or call us on our toll-free number in the United States (800-295-3959) to find baby formula NEC attorneys in your state who may help you.
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