Similac, Enfamil NEC Side Effects Led to Newborn Undergoing Bowel Resection: Lawsuit

Studies have shown that side effects of Similac and Enfamil formula substantially increase the risk of NEC for premature newborns, lawsuit notes.

Just a month after being born, a mother says her premature child had to undergo bowel resections, laparoscopic surgery, blood transfusions and other surgeries due to the development of necrotizing enterocolitis (NEC), which she indicates in a recently filed lawsuit was a direct result of the Similac and Enfamil infant formula fed to the newborn in the hospital.

The complaint (PDF) was brought by Meghan Stewart earlier this month in the U.S. District Court for the Northern District of Illinois, alleging that Abbott Laboratories and Mead Johnson failed to adequately warn parents or the medical community about the potential Similac and Enfamil NEC side effects that premature infants may face from the cow’s milk-based formula products.

NEC is a life-threatening gastrointestinal injury, which can occur when harmful bacteria breach the walls of the intestines, causing portions of the tissue to become inflamed or die. The condition often results in the need for emergency surgery while the baby is still in the NICU, and many infants diagnosed with NEC infections do not survive.

Following a number of studies published in recent years that have confirmed premature infants face an increased risk of developing the condition if they are fed formula products, Stewart now joins more than 1,000 other families currently pursuing Similac NEC lawsuits and Enfamil NEC lawsuits, alleging that the manufacturers knew or should have known about the risk, but have been providing false and misleading information for years about the safety of their products.

Stewart indicates that her child, identified only as F.L.S. in the lawsuit, was born prematurely in December 2016. The child had only gestated for 33 weeks, and was born preterm weighing only 2 pounds and 10 ounces.

The premature infant was transferred to the neonatal infant care unit (NICU) and fed either Similac or Enfamil within the first month of its life, and F.L.S. developed severe NEC only days later.

“F.L.S.’s medical interventions included multiple surgeries including bowel resections, jejunostomy, mucous fistula creation, and laparoscopic gastrostomy insertion, and extensive use of antibiotics and blood transfusions,” the lawsuit notes. “To this day, F.L.S. continues to suffer from injuries related to the NEC diagnosis.”

Stewart’s lawsuit alleges those injuries could have been avoided if the manufacturers had been honest about the risks of NEC linked to their products, particularly those for prematurely born infants. The lawsuit points to the 2011 “Surgeon General’s Call to Action to Support Breastfeeding”, which warned of a 138% increase in the risk of NEC when premature infants are fed infant formula.

Numerous other studies in recent years have also warned of the link between NEC and infant formula, yet the makers of Similac and Enfamil have continued to engage in aggressive marketing tactics that promoted use of the products among premature infants.

“A multicenter, randomized, controlled trial found that premature and low birthweight infants fed an exclusive breast milk-based diet suffered NEC only 3% of the time while premature and low-birth-weight infants receiving cow’s milk-based formula suffered NEC 21% of the time,” the lawsuit states. “Another study conducted a randomized comparison of extremely preterm infants who were given either (a) a diet of breast milk fortified with a breast milk-based fortifier or (b) a diet containing variable amounts of cow’s milk-based products. The babies given exclusively breast milk products suffered NEC 5% of the time. The babies given cow’s milk products suffered NEC 17% of the time.”

Stewart’s lawsuit indicates that, despite this knowledge, Abbott Laboratories and Mead Johnson still market their products to hospitals and mothers as safe for newborns and preemies, placing their desire for profit over children’s safety.

October 2024 Similac NEC Lawsuit Update

Stewart’s complaint will be consolidated with similar Similac and Enfamil lawsuits being pursued in the federal court system, which have been centralized as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Illinois under U.S. District Judge Rebecca R. Pallmeyer, who is presiding over the infant formula lawsuit MDL’s coordinated pretrial proceedings.

In addition to claims pending in the federal MDL, there are also several hundred additional cases pending in various state courts nationwide, where at least two juries have returned massive damage awards after considering evidence that will likely be repeated throughout the litigation. However, the first federal jury trial is not expected to begin until next year.

Earlier this month, lawyers proposed a series of baby formula NEC lawsuit trial dates in the federal MDL, indicating that four bellwether cases will be ready to go before juries on May 5, 2025, August 11, 2025, November 3, 2025 and February 2, 2026.

While the outcomes of these MDL bellwether trials will not have any binding impact on other infant formula NEC lawsuits brought by Stewart and other parents, the average payouts awarded will likely have a substantial impact on the amount that Abbott and Mead Johnson may be required to pay in NEC settlements to avoid hundreds of additional claims going before juries.

If the parties fail to resolve the litigation following the federal bellwether trials, Judge Pallmeyer may start remanding dozens of individual claims back to U.S. District Courts nationwide for separate trial dates in the future.