Premature Infant Formula Lawsuit Alleges Enfamil Caused Necrotizing Enterocolitis (NEC)

Lawsuit notes parents are rarely informed that their premature newborn is being fed cow’s milk-based infant formulas like Enfamil or Similac.

A Colorado mother has filed a lawsuit claiming years of deceptive advertising has misled parents and healthcare professionals about the true risks of cow’s milk-based premature infant formula, after her own daughter developed necrotizing enterocolitis (NEC) days after birth.

The complaint (PDF) was brought by Nicole Schneider on behalf of herself and her minor child, identified only as K.M. She names Mead Johnson & Company LLC and Mead Johnson Nutrition Company as the defendants.

Schneider indicates her newborn daughter developed NEC as the result of being fed the defendant’s Enfamil Premature infant formula in the hospital’s neonatal intensive care unit (NICU), starting the day the child was born. The mother claims the manufacturer knew its cow’s milk-based premature infant formula products were dangerous, and often deadly, to newborns.

Premature Infant Formula NEC Risks

Necrotizing enterocolitis is a condition that occurs when harmful bacteria infiltrates the walls of the intestines, causing portions of the tissue to become inflamed and potentially die. Infants in general, and especially preterm infants, face an increased risk of NEC after birth as their intestines continue to develop.

The condition often results in newborns needing emergency surgery. This can sometimes include major alterations to the infant’s intestinal tract and surgical complications leading to life-long health problems. Many infants do not survive the condition.

Hundreds of premature infant formula lawsuits have been filed against both Mead Johnson and its competitor, Abbott Laboratories, the makers of Similac, which is also made using cow’s milk. Each complaint raises nearly identical claims that the manufacturers placed their desire for profits ahead of the safety of newborns, aggressively marketing their products despite the knowledge that their cow’s milk-based formula carries a higher NEC risk.

Infant NEC Injury Allegations

According to Schneider’s lawsuit, K.M. was born on June 20, 2009 at only 34 weeks gestation and weighing just 1.93 kg. She was placed in the NICU shortly after birth where the newborn was fed Enfamil Premature 20 Cal that same day.

Six days later, K.M. was diagnosed with NEC Stage 2 and had to be placed on antibiotics until July 3 of that year.

Schneider claims she relied on the manufacturers’ marketing, which promoted the formula and fortifier as products specifically developed to meet the nutritional needs of premature infants, leading her to believe they were safe and necessary for her daughter’s growth and development.

Hospital staff carried the same false beliefs due to years of misleading advertising about the safety and efficacy of cow’s milk-based infant formula, the lawsuit alleges. However, the filing also claims the manufacturers have known of the products’ dangers for years.

Numerous studies by scientists and researchers worldwide, some stretching back decades, have warned that feeding cow’s milk-based products to newborns increases the risk of NEC, and recommend that infants, particularly those born preterm, be fed breast milk from their mother or a donor as much as possible.

Additionally, Schneider’s complaint notes that even if parents knew about the risks, they are very seldom informed what brand of premature infant formula will be fed to their child, particularly when they are transferred to NICU immediately after birth.

“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. To this day, Defendants have never warned the public about the extreme danger its cow’s milk-based products pose for preterm infants like K.M.”

– Nicole Schneider v. Mead Johnson & Company LLC. et al.

Schneider presents claims of defective design, negligent defective design, failure to provide adequate warnings and instructions, negligent failure to provide adequate warnings and instructions, and seeks both compensatory and punitive damages.

Premature Infant Formula Lawsuits

Both Mead Johnson and Abbott Laboratories face hundreds of premature infant formula lawsuits filed in state and federal courts nationwide. Those at the federal level have been consolidated as part of a multidistrict litigation (MDL) in the Northern District of Illinois for coordinated discovery and pretrial proceedings before U.S. District Judge Rebecca R. Pallmeyer.

The judge intends to hold a series of bellwether trials based on representative claims that will give the parties more jury assessments of the strengths and weaknesses of claims that will be repeated throughout the litigation.

The first federal trial is set to begin on July 6, with a lawsuit filed by Alexis Inman. A second trial is scheduled to start on August 10, focusing on claims brought by Mary Kelton.

However, several trials have already been held at the state level. In a 2024 NEC trial, a Missouri jury ordered Abbott Laboratories to pay nearly $500 million to Margo Gill, whose infant daughter suffered brain damage after surviving NEC. Later that year, another Missouri case initially ended in a defense verdict. However, the judge ordered a new trial after finding Abbott improperly introduced certain evidence.

In April, a Cook County, Illinois, jury awarded four mothers a combined $70 million in damages in a lawsuit involving Similac products. In a separate Cook County trial, another jury returned a $60 million verdict against Mead Johnson in a lawsuit involving Enfamil formula, but an appeals court threw out that verdict on June 12 and ordered a new trial.

While the bellwether trial outcomes are not binding on other pending claims, they are being closely watched by both sides. The verdicts may help shape future negotiations by showing how juries respond to the evidence, expert testimony and damages arguments in premature infant formula lawsuits.

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