A jury in Chicago on Thursday ruled that Abbott Laboratories must pay $53 million in compensatory damages to a group of families who alleged the company failed to warn that its formula for premature infants could lead to a potentially life-threatening bowel disease.
The verdict was delivered at the conclusion of a lengthy trial in the Cook County Circuit Court, marking the latest development among hundreds of lawsuits claiming that Abbott Laboratories’s cow’s milk-based formulas for premature infants can lead to necrotizing enterocolitis (NEC). The case combined lawsuits from four families into a single trial.
The jury will meet again on Friday to determine how much Abbott must pay in punitive damages.
A spokesperson for Abbott did not immediately respond to a request for comment.
Abbott Laboratories has denied that its products used when mothers are unable to produce sufficient breast milk cause harm, maintaining that they are essential for the care of premature infants.
Necrotizing Enterocolitis (NEC), a serious condition that leads to the death of bowel tissue, primarily affects premature newborns and carries an estimated mortality rate of over 20%.
The children born in hospitals in and around Chicago between 2012 and 2019 developed NEC but survived. Three of them required surgery, and all continue to experience ongoing health complications, as detailed in court filings.
HUNDREDS MORE LAWSUITS
Nearly 1,000 lawsuits have been filed against Abbott Laboratories, the maker of Similac formulas, as well as Mead Johnson, a unit of Reckitt. More than 700 of these cases have been consolidated in a federal court in Illinois, while others are ongoing in state courts across Illinois, Missouri, and Pennsylvania.
The products at the center of these lawsuits include specialized cow’s milk-based formulas and fortifiers designed for premature infants in hospital settings, rather than standard infant formula sold in retail stores.
Abbott Laboratories, which is headquartered in Illinois, also produces medical devices, nutritional products for both adults and children, and a range of medicines.
Both companies have maintained that although breast milk is known to help protect against necrotizing enterocolitis (NEC), their formula products do not cause the condition. They emphasize that the benefits of breast milk have long been recognized within the medical community. In 2024, Abbott CEO Robert Ford indicated that the company’s preterm infant products could potentially become unavailable due to the ongoing litigation.
U.S. regulatory agencies, along with a group of scientists convened by the National Institutes of Health, stated in a joint 2024 report that current evidence supports the view that an increased risk of necrotizing enterocolitis (NEC) is linked more to the absence of breast milk rather than exposure to infant formula.
TRIAL RESULTS MIXED
In 2024, a jury in St. Clair County ordered Mead Johnson to pay $60 million to the mother of a premature infant who died after being fed the company’s Enfamil formula. A few months later, a jury in St. Louis directed Abbott Laboratories to pay $495 million in damages in a separate case. Both rulings are currently under appeal.
The American Academy of Pediatrics filed a brief supporting Mead Johnson in its appeal, stating that infant formula is considered part of the standard care for premature babies.
Abbott Laboratories and Mead Johnson secured a favorable outcome in a Missouri state court trial in October 2024, but the judge later ordered a new trial after determining that defense attorneys had engaged in improper conduct. That decision is currently under appeal.
In March, a state judge in Florida dismissed a necrotizing enterocolitis (NEC) case that had been scheduled for trial, concluding that an additional warning to the family’s doctors would not have altered their decision to use the formula.
No cases have yet gone to trial in federal court, as the judge overseeing the litigation has dismissed three of the four cases selected as bellwether trials. In the most recent dismissal in October, the judge found that Abbott had presented substantial evidence supporting the necessity of its formula products and determined that the alternative proposed by the plaintiffs was not feasible.
