Lawsuit Alleges Premature Infant NEC Death Caused by Similac Formula

Mother says Abbott Laboratories knew for decades that their cow’s milk-based infant formula increased the risk of NEC and death for preterm babies.

An Alabama woman has filed a wrongful death lawsuit alleging that Similac infant formula caused her newborn daughter to develop necrotizing enterocolitis (NEC), leading to her death at just 10 days old.

NEC is a devastating condition that occurs when harmful bacteria cause damage to the lining of a newborn’s intestines, resulting in inflammation, tissue death, and in many cases intestinal perforation. Infants who develop NEC often require emergency surgery while still in the neonatal intensive care unit, and many, like Miller’s daughter, do not survive.

Infant Cow’s Milk-Based Formula NEC Concerns

Research has regularly shown that cow’s milk-based infant formula products do not confer the same benefits as breast feeding, and may increase the risk of premature infants developing NEC. However, a growing number of parents are now pursuing lawsuits against Abbott and Mead Johnson, the manufacturers of Similac and Enfamil, alleging that the companies have long been aware of the risks associated with their products for premature infants, yet continued to market the products to maximize profits.

The litigation emerged after a January 2022 study, which found that nutrients in breast milk help the intestinal epithelial layer mature in preterm infants, strengthening their resistance to the disease. However, these nutrients are not present in cow’s milk-based infant formula marketed for premature babies. As a result, the American Academy of Pediatrics (AAP) issued a policy statement later that same year, calling for hospitals and the government to promote breastfeeding as the primary form of nutrition for newborns.

Another study published last March found that infants who were breastfed or received human milk products saw better outcomes than those given infant formula or fed through other means. The researchers found that children who were breastfed for at least six months were 25% less likely to be diagnosed with developmental delays.

There are now nearly 800 Similac lawsuits and Enfamil lawsuits being pursued by families nationwide, each raising similar allegations that the companies placed a desire for profits before the health and safety of children by concealing information about the link between cow’s milk-based formula and NEC.

Infant NEC Wrongful Death Lawsuit

In a complaint (PDF) filed on January 9, Mary Kate Miller indicates her daughter, Helen, died after developing complications allegedly linked to cow’s milk-based formula products that Abbott Laboratories marketed as safe for premature infants.

Miller indicates that Helen was born at only 30 weeks gestation and weighed only 1,015 grams. According to the lawsuit, she was sent to the Neonatal Intensive Care Unit where the newborn was fed Similac Special Care Formula.

Shortly afterward, Helen developed necrotizing enterocolitis, which the lawsuit alleges was caused by consumption of Similac formula.

“Despite the knowledge of the significant health risks posed to preterm infants ingesting Cow’s Milk-Based Products, including the significant risk of NEC and death, Defendants did not warn parents or medical providers of the risk of MEC in preterm infants, nor did Defendant provide any instructions or guidance on how to properly use its Cow’s Milk-Based Products so as to lower the risk or avoid NEC or death.”

– Mary Kate Miller et al. v Abbott Laboratories Inc. et al

The lawsuit notes that Abbott and other infant formula manufacturers began referring to the cow’s milk-based products as “human milk fortifiers” as health experts and pediatricians grew increasingly critical of using non-human milk products in the face of mounting scientific evidence.

Miller presents claims of negligence, manufacturing and design defect, inadequate warning and non-conformity to express warranty. She seeks both compensatory and punitive damages.

Infant Formula NEC Lawsuits

Miller’s complaint will join similar premature infant NEC death lawsuits consolidated in the Northern District of Illinois, as part of a federal multidistrict litigation (MDL) pending before U.S. District Judge Rebecca R. Pallmeyer. 

Over the past few years, Judge Pallmeyer has worked with plaintiffs, Abbott and Mead Johnson to prepare a series of bellwether trials designed to see how juries respond to evidence and testimony likely to be repeated throughout the litigation. 

The first federal NEC infant formula bellwether trials were initially expected to begin in April 2025. However, those trials were canceled after the judge determined that the plaintiffs lacked sufficient evidence to support their claims. Judge Pallmeyer and the parties are now readying a second wave of bellwether selections, each of which involve infants given Similac products. Judge Pallmeyer anticipates those trials will begin in August 2026.

While the results of these bellwether lawsuits are not binding on other claims, the outcomes will be closely watched, as they are likely to affect any NEC infant formula lawsuits settlements reached to resolve the litigation. However, if there is no settlement after the bellwether trials, Judge Pallmeyer could start remanding each individual claim back to the U.S. District Courts where it originated for separate trial dates.

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