Enfamil Infant Formula Lawsuit Filed Over Preemie’s Serious NEC Injuries

A mother claims Enfamil infant formula caused NEC (necrotizing enterocolitis), resulting in partial blindness and cerebral palsy.

A West Virginia mother has filed a lawsuit against Enfamil infant formula manufacturers, indicating her premature child developed NEC (necrotizing enterocolitis) after being fed the cow’s milk-based product in the hospital.

Sandra Hayes filed the complaint (PDF) last month in the U.S. District Court for the Southern District of Indiana, pursuing damages on behalf of herself and her son, Adam.

The Enfamil infant formula lawsuit alleges that Mead Johnson & Company, LLC has known about the serious health risks their product posed for premature newborns, but continued to promote the product for use by hospitals and parents, while withholding safety warnings to maximize profits.

In recent years, there has been a growing body of independent medical research which has established cow’s milk-based infant formula like Enfamil and Similac may cause vulnerable infants to develop NEC, which results in portions of the intestines suddenly becoming inflamed or dying. This often results in the need for emergency surgery while the preterm newborn is still in the NICU us, and can lead to death or long-term complications for the remainder of the child’s life.

Hayes now joins other families of preterm infants nationwide who are now pursuing NEC infant formula lawsuits against Mead Johnson and Abbott Laboratories, which manufacturers competing Similac products.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


Hayes indicates her son Adam was born extremely premature in April 2003, at just 24 gestational weeks. He was only about a foot long and weighed just 610 grams.

Days after his birth, the hospital began to feed Adam four times a day with Enfamil Premature 24, a cow’s milk-based infant formula. However, just two days after the feedings began, Adam began throwing up bile, which is an early sign of NEC.

As a result of the complications, he was taken off Enfamil temporarily. However, the child was placed back on Enfamil just a few days later, leading to the development of an esophageal perforation. This once again caused feedings to be discontinued, only to be resumed days later, along with intravenous nutrition.

Once again, in just a couple days, it was determined the preemie had developed abdominal distension, dilated bowel looks, ileal perforation; and observable free air in abdominal x-rays.

Adam was diagnosed with Stage IIIA necrotizing enterocolitis from the Enfamil infant formula, which has left him with partial blindness and cerebral palsy, the lawsuit claims.

The lawsuit points out that the manufacturers have known for years that their products increase the risk of NEC for premature infants, compared to use of human breast milk. However, Mead Johnson and Abbott Laboratories have continued to promote the products as safe for prematurely born infants.

“These companies continue to aggressively market because it works, especially since they consistently employ unfair and deceptive tactics from the inception of a mother’s use of Cow’s Milk Products,” the lawsuit states. “In addition to perpetuating the myth that these Cow’s Milk Products are similar to breast milk, the Mead Defendants have also intentionally deceived the public into believing that health care providers believe these products are superior to breast milk or even ideal, and that physicians and institutions endorse Cow’s Milk Products.”

In February 2023, researchers working with the World Health Organization released a report blasting infant formula manufacturers for the use of “predatory” marketing to sell potentially unsafe cow’s milk-based formula products to parents, increasing infant health risks and driving down healthier breastfeeding habits worldwide.

May 2023 NEC Infant Formula Lawsuit Update

There are currently about 200 Similac lawsuits and Enfamil lawsuits filed throughout the federal court system against Abbott and Mead Johnson by families of children diagnosed with a NEC injury after being fed the infant formula, which have been centralized before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois, for coordinated discovery and pretrial proceedings.

Each of the NEC injury lawsuits raise similar allegations, indicating that manufacturers of cow’s milk-based infant formula and human milk fortifier specifically marketing products for use by preterm newborns, without providing warnings to hospitals, doctors or families. However, as lawyers continue to investigate and file claims in the coming year, it is ultimately expected that several thousand lawsuits will be brought by families of infants diagnosed with NEC.

In November 2022, a group of 12 cases were selected for a NEC lawsuit bellwether pool, which will go through case specific discovery and prepared for a series of early trial dates expected to begin in 2024.

Although the outcome of these early bellwether trials will not have any binding impact on other claims, they are expected to have a substantial impact on any baby formula NEC injury settlements the manufacturers may offer to avoid the need for each individual case to be remanded back to U.S. District Courts nationwide for separate trial dates in the future.


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