A jury in St. Louis, Missouri was recently asked to award over $6 billion in damages against baby formula manufacturers defendants in a lawsuit that alleged the defendants’ specialized infant formulas for premature babies caused the development of necrotizing enterocolitis (NEC), a potentially fatal condition. NEC is a severe gastrointestinal condition that primarily affects premature babies, leading to inflammation and bacterial invasion of the intestine, which can cause significant health issues and lead to death. After three hours of deliberations, the jury found the defendants not liable for Plaintiffs’ product defect, failure to warn and negligence claims.

The U.S. Consumer Product Safety Commission (CPSC) announced a new rule on September 18, 2024, which will implement the first-ever federal safety standards for infant nursing pillows.[1] This rule comes in response to 154 infant deaths and 64 serious injuries believed to be caused by these products between 2010 and 2022.[2] These deaths commonly involved infants under 3 months old who were sleeping with the nursing pillows in locations such as adult beds, cribs, playpens, or couches.[3]

Inflated jury verdicts in the first two preterm infant formula cases tried in the country have raised significant concerns for manufacturers and the broader medical community. These cases not only spotlight the legal challenges faced by manufacturers of highly specialized products, such as the formulas involved in these cases, but also underscore the potentially devastating effects on the availability and use of essential formula to provide preterm infants with adequate nutrition. In response to these bloated jury verdicts, the president of the American Academy of Pediatrics, Benjamin Hoffman, M.D., issued a statement declaring that preterm infant formula “is a routine and necessary part of care of these preterm infants” and warning that “[c]ourtrooms are not the best place to determine clinical recommendations for the care of infants . . . we must take steps to protect the supply of infant formula for those who need it.”