Abbott set to face trial over claims premature infant formula caused deadly disease

By Diana Novak Jones

CHICAGO, March 4 (Reuters) - A trial is set to begin on Wednesday in Chicago in a case brought by four families who allege that baby formula made by Abbott Laboratories ABT.N caused their premature infants to develop a dangerous bowel disease.

The trial in Cook County circuit court is the latest of hundreds of lawsuits accusing Abbott of failing to warn that its cow's milk-based formula products for preterm infants can cause a potentially deadly disease called necrotizing enterocolitis, or NEC.

Abbott, which declined to comment on the trial, has denied that the formula causes NEC and says the products are essential for premature babies when their mothers cannot produce enough breastmilk.

A lawyer for the plaintiffs declined to comment.

The children, who were born in Chicago-area hospitals between 2012 and 2019, developed NEC but survived, according to their lawsuits. Three required surgery, and all live with ongoing health problems, according to the filings.

The trial, which begins with jury selection on Wednesday consolidates the families’ four separate lawsuits and is expected to last several weeks.

WAVE OF LAWSUITS

Nearly 1,000 lawsuits have been filed against Abbott, which makes Similac formulas, and Enfamil manufacturer Mead Johnson, a unit of Reckitt. More than 700 of the cases are centralized in an Illinois federal court, with others pending in state courts in states including Illinois, Missouri and Pennsylvania.

The products in question are cow's milk-based formula and products for fortifying mother's milk that are specially made for infants in hospital settings, not ordinary formula available to consumers in stores.

The lawsuits say the company did not warn doctors that infants receiving formula have a greater risk of NEC compared to infants who are breast-fed or given donor milk or human milk-derived formula.

NEC, which causes the death of bowel tissue, mostly affects premature newborns and has an estimated mortality rate of more than 20%.

The companies have said that while breast milk protects against NEC, their formulas do not cause it, and that the benefits of breast milk have long been known to clinicians.

U.S. regulatory agencies and a working group of scientists convened by the National Institutes of Health said in a joint report in 2024 that current evidence supports the hypothesis that it is the absence of breast milk rather than exposure to formula that is associated with an increase in the incidence of NEC.

MIXED TRIAL RESULTS

The companies have had a mixed record in the few cases to go to trial thus far.

In 2024, a jury in St. Clair County ordered Mead Johnson to pay $60 million to the mother of a premature baby who died after being fed the company's Enfamil baby formula. A few months later, a St. Louis, Missouri, jury ordered Abbott to pay $495 million in damages in another case. Both verdicts have been appealed.

The American Academy of Pediatrics filed a brief supporting Mead Johnson in its appeal of the verdict against it last year, saying that formula is part of the standard of care for premature babies.

Abbott and Mead Johnson prevailed in one trial in Missouri state court in October 2024, but the judge in that case ordered a new trial after finding that lawyers for the defendants had acted improperly. That ruling is also on appeal.

No cases have proceeded to trial in federal court, as the judge overseeing that litigation has dismissed three of the four cases selected for bellwether trials. In the most recent dismissal in October, the judge said that Abbott had presented substantial evidence on the need for the formula and shown the plaintiffs' proposed alternative was infeasible.