Necrotizing Enterocolitis (“NEC”) is caused when a preterm baby (born before 37 weeks of pregnancy) or low birth weight baby is fed infant formula based on cow’s milk. (The “gold standard” for safety is, of course, mother’s breast milk.) NEC’s symptoms include blood in the stool, vomiting, lethargy, inability to maintain normal baby temperature, apnea, and low blood pressure.
In 2023, approximately 3.39 million babies were born in the U.S., and about 11 percent were born pre-term. Of these 380,000 pre-term babies, approximately 9,000 will develop NEC. This disease is a serious gastrointestinal condition that involves inflammation and bacterial invasion of the intestinal wall, which can lead to tissue death and, in severe cases, perforation of the intestine. NEC results from a combination of factors, including immature intestinal development, abnormal bacterial colonization, and an exaggerated inflammatory response.
The two primary defendants are Mead Johnson (manufacturer of Enfamil) and Abbott Laboratories (manufacturer of Similac). The legal claims against these two manufacturers include defective design, failure to warn, negligence, and misleading marketing (such as “Human Milk Fortified,” while in fact no human milk is added).
As of December 2024, there have been two verdicts in favor of plaintiffs. The first was against Mead Johnson for $60 million in Illinois. In that case, the verdict was solely for compensatory damages, and the jury made no award for punitive damages. The second case, which was in Missouri, was against Abbott Laboratories for $495 million: $95 million in compensatory damages and $400 million in punitive damages.
Because of these two verdicts and because juries are usually sympathetic to babies that need life-time medical care, Paragon expects settlement values for NEC cases to be quite high.