Infant Formula Lawsuit Links Similac and Similac Special Care to Newborn’s NEC Injuries

Premature infant faces permanent, life-long bowel problems after being fed Similac Special Care, lawsuit claims.

A New York mother says feeding her prematurely born child Similac Special Care led to the child developing necrotizing enterocolitis (NEC), which caused the infant to endure intestinal rupturing.

The complaint (PDF) was filed by Vanessa Yates on behalf of herself and her minor child, identified only as P.W., against Abbott Laboratories in the U.S. District Court for the Northern District of Illinois.

The lawsuit raises allegations of “negligent, willful, and wrongful conduct” by the company in relation to the design, development, manufacturing, testing, packaging, promotion, marketing, distribution, labeling, and sale of its bovine-based formulas and fortifiers, specifically Similac Special Care, which are marketed for use in premature infants.

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 in many cases, is often fatal.

For infants that do survive NEC, like P.W., ongoing health challenges are common, including lifelong gastrointestinal injuries and other complications that require continuous medical treatment and care.

Similar to more than 1,000 other plaintiffs who have filed Similac and Enfamil lawsuits, Yates maintains that there is overwhelming evidence that cow’s milk formula dramatically raises NEC risks for premature newborns, claiming that children could have avoided severe and often fatal injuries if accurate information had been provided by the baby formula manufacturers.

The lawsuit indicates that P.W. was born at only 26 weeks gestation and weighed only two pounds and two ounces at the time of birth. Due to his underdevelopment, P.W. was transferred to the Neonatal Intensive Unit, where he was fed Similac Special Care, his mother claims.

“Shortly after receiving the formula enterally, P.W. began to suffer from gastrointestinal issues, including intestinal rupturing and was diagnosed with NEC,” the lawsuit states. “This injury led P.W. to develop bowel problems and infection.”

Yates’ lawsuit indicates that Abbott Laboratories knew for years that its cow’s milk-based formulas increased the risk of NEC for preterm infants, but decided to risk the newborns’ lives in order to maintain its profit margins. The company has chosen to ignore numerous studies that have warned about the increased NEC risks over the years, particularly when compared with breast milk from mothers or human donors, the lawsuit claims.

“Despite the aforementioned science confirming the dangers of Defendant’s bovine product in causing NEC and death in premature infants, Defendant took no action to change its product, packaging, guidelines, instructions, and warnings,” Yate’s complaint notes. “Defendant continues to sell its bovine formulas and/or fortifiers commercially at retail locations and online.”

Yates presents claims of failure to warn, strict liability for defective product, negligence, negligent misrepresentation, breach of implied warranty, design defect and violation of Illinois consumer fraud and deceptive trade practices laws. She seeks both compensatory and punitive damages.

January 2025 Similac NEC Lawsuits Update

Yates’ lawsuit will be consolidated with other Similac NEC lawsuits and Enfamil NEC lawsuits being pursued in the federal court system, which have been centralized as part of an MDL, or multidistrict litigation, before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois.

As part of the coordinated management of the federal litigation, Judge Pallmeyer previously established a “bellwether” program, where a small group of representative claims are being prepared for a series of early trial dates to help evaluate the strengths and weaknesses of the cases, and facilitate potential NEC settlement discussions.

The first baby formula NEC bellwether trial is set to go before a jury on May 5, 2025. That will be followed by additional trials expected to begin on August 11, 2025, November 3, 2025, and February 2, 2026.

While the outcome of these early trials will not have any binding impact on NEC injury lawsuits being pursued by other families, the average payouts awarded by juries will likely have a substantial impact on the amount that Abbott and Mead Johnson may be required to pay in NEC injury 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.