Lawsuit Claims Cow’s Milk-Based Baby Formula Use Resulted in Infant Suffering Devastating NEC Symptoms

Mother indicates her newborn required bowel surgery as a result of developing necrotizing enterocolitis, after formula makers failed to warn about known risks.

A product liability lawsuit alleges that a premature infant developed necrotizing enterocolitis (NEC) and required bowel surgery after being fed cow’s milk-based infant formula in a neonatal intensive care unit.

The complaint (PDF) was filed by Linnette Perez, individually and as the guardian of her child G.V., in the U.S. District Court for the Northern District of Illinois on May 1. It names Abbott Laboratories, Abbott Laboratories Inc., Mead Johnson Nutrition Company and Mead Johnson & Company LLC as defendants.

Perez claims the companies’ cow’s milk-based formulas, Similac and Enfamil, caused G.V. to suffer severe and life-threatening gastrointestinal injuries as a newborn.

Cow’s Milk-Based Formula NEC Risks

Abbott and Mead Johnson face hundreds of Similac lawsuits and Enfamil lawsuits brought by families nationwide. Most of the filings claim the baby formula manufacturers failed to warn parents and the medical community about risks of preterm infants developing NEC after being fed the cow’s milk-based products.

NEC is a serious and life-threatening condition caused by harmful bacteria infiltrating the walls of a newborn’s intestines, resulting in portions of the tissue becoming inflamed or dying. It presents a much higher risk for preterm infants whose gastrointestinal tracts may not be fully developed.

Infants who develop NEC often require emergency surgery in a hospital’s neonatal intensive care unit (NICU). Many of the infants do not survive the disease, or the operations meant to address it, and those who do live often have health complications that they have to deal with for the rest of their lives.

Infant Formula NEC Allegations

According to the lawsuit, G.V. was born prematurely on August 18, 2009, and was placed in a NICU shortly after birth. The complaint indicates he was fed Enfamil and Similac cow’s milk-based formulas soon thereafter.

On or around September 5, 2009, the infant began exhibiting symptoms consistent with NEC, including bloody stools and vomiting. Doctors halted feedings and initiated treatment with antibiotics, yet his condition worsened.

By September 15, 2009, G.V. required bowel surgery to treat the condition, highlighting the severity of the illness.

The lawsuit alleges that G.V.’s mother was unaware that cow’s milk-based formulas could increase the risk of NEC and relied on the defendants’ marketing, which promoted the products as safe and necessary for premature infants.

According to the complaint, the manufacturers have long known that their products significantly increase the risk of NEC, as well as the likelihood that premature infants may require surgery or die, yet failed to provide warnings to parents, doctors or hospitals.

The lawsuit further claims the companies engaged in misleading marketing practices, promoting their formulas as safe or superior alternatives to human breast milk, despite medical evidence indicating that human milk is protective against NEC and should be the preferred feeding option for premature infants.

“No parent would reasonably expect that an infant formula or fortifier could be extremely dangerous to their baby unless properly warned and informed of the extreme dangers and risk of NEC, serious injury, surgery, or death.”

– Linnette Perez v. Abbott Laboratories et al

The lawsuit presents allegations of strict products liability, defective design, negligent products liability, failure to warn and negligent failure to warn. It seeks compensatory and punitive damages.

Infant Formula NEC Lawsuits

The majority of Enfamil and Similac NEC lawsuits have been consolidated in the Northern District of Illinois, where U.S. District Judge Rebecca R. Pallmeyer is overseeing coordinated discovery and pretrial proceedings as part of a federal multidistrict litigation (MDL).

Judge Pallmeyer has ordered the parties to prepare a group of claims to serve as bellwether trials. These are designed to observe how juries respond to the strengths and weaknesses of the parties’ arguments and evidence. While not binding on other cases, the trials will be closely observed, as the outcomes could significantly influence any infant formula NEC lawsuit settlements.

Originally scheduled to begin in April 2025, the first batch of bellwether trial prospects were dismissed due to a lack of evidence. However, a second wave of potential bellwether trials are now undergoing case-specific discovery, with the first trial expected to be held this August.

Three Similac-related cases have already been tried in state courts, producing mixed outcomes. A Missouri jury returned a verdict of nearly $500 million during a summer 2024 trial. However, a second case in the same court later that year ended in a defense verdict. This was subsequently set aside after the judge determined Abbott introduced improper evidence, resulting in a new trial being ordered. In a more recent proceeding in Cook County, Illinois, four mothers were awarded a combined $70 million in damages.

In addition, a lawsuit involving Mead Johnson’s Enfamil formula resulted in a $60 million award in Cook County court in 2024.

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