Proliferation of Formula Lawsuits In Necrotizing Enterocolitis

Posted on by

AAP Statement 7/27/24: AAP Statement In Response to NEC Lawsuit Verdict

Yesterday, the AAP put out a statement (see below) regarding the numerous lawsuits related to necrotizing enterocolitis. The lawsuits allege that formula companies did not provide physicians and patients warning that their products could increase the risk of necrotizing enterocolitis relative to breast milk or donated human milk.

This has led to huge verdicts. In March, a jury in Illinois awarded a mother $60 million (3/15/24 Reuters: Reckitt unit hit with $60 million verdict in Enfamil baby formula case in Illinois). This past week, a jury in Missouri awarded a women $95 million in compensatory damages and $400 million in punitive damages (CNBC 7/26/24: Abbott must pay $95 million in premature infant formula trial, jury finds).

Currently, when one searches for “NEC and lawsuits,” it is difficult to find these news reports due to dozens of law firm websites trying to attract clients. Per CNBC article, “close to 1,000 lawsuits have been filed against Abbott, Enfamil formula maker Reckitt Benckiser or both in federal or state courts.”

My take: These lawsuits are likely to exponentially increase the cost of formulas for all infants with little justification. It has been well-recognized for decades that there are many factors contributing to NEC; infants receiving human milk also develop NEC. For many infants in the NICU, sometimes there is no availability of human milk. What is going to happen to them if formula companies stop making premature formulas?

The most promising therapeutic to try to reduce the risk of NEC would be a safe probiotic. However, the FDA closed off this avenue (see: End of the Line for Probiotics for Preterm Infants). Even if the FDA reversed its position, no company would be willing to try to develop these products due to fear of litigation.

Related blog posts: