NEC infant formula lawsuits involve legal claims brought by parents and families of premature infants who developed necrotizing enterocolitis (NEC) after being fed certain cow’s milk–based baby formulas. NEC is a serious and often life-threatening gastrointestinal disease that primarily affects premature and low-birth-weight infants. These lawsuits allege that formula manufacturers failed to adequately warn healthcare providers and parents about the increased risk of NEC associated with their products.

The lawsuits primarily target manufacturers of popular cow’s milk–based formulas, including Similac and Enfamil, which are commonly used in neonatal intensive care units (NICUs). Plaintiffs claim that these companies aggressively marketed their formulas as safe and beneficial for premature infants while knowing, or having reason to know, that medical research showed a significantly higher risk of NEC compared to human breast milk or donor milk.

Families bringing NEC lawsuits allege that exposure to these formulas led to devastating outcomes for their infants, including severe intestinal damage, emergency surgery, long-term digestive problems, developmental delays, and, in some cases, death. As a result, parents seek compensation for medical expenses, ongoing care needs, pain and suffering, emotional distress, and wrongful death when applicable.

A key issue in NEC infant formula lawsuits is the allegation that manufacturers failed to provide proper warnings despite decades of published medical studies linking cow’s milk–based formula to NEC in premature infants. Plaintiffs argue that if adequate warnings had been provided, doctors and hospitals may have chosen safer feeding alternatives, potentially preventing serious injury or loss of life.

Due to the growing number of cases filed nationwide, NEC infant formula lawsuits have been consolidated into multidistrict litigation (MDL) in federal court. This consolidation allows similar cases to proceed together during pretrial proceedings, streamlining evidence review and addressing common legal and scientific questions. The MDL focuses on whether manufacturers knew of the risks, whether warnings were insufficient, and whether the formulas were defectively marketed for use in premature infants.

The formula manufacturers named in these lawsuits deny wrongdoing and maintain that their products meet regulatory standards and are safe when used as intended. They also argue that NEC is a complex condition with multiple contributing factors. Plaintiffs, however, continue to present scientific research, expert testimony, and internal company documents to support claims that stronger warnings and safer marketing practices were necessary.

NEC infant formula lawsuits remain ongoing and represent a significant area of product liability litigation involving infant health and safety. For families affected by NEC, these lawsuits provide a legal pathway to seek accountability and financial recovery while also raising broader questions about transparency, informed medical decision-making, and the protection of vulnerable premature infants.