Similac NEC Lawsuit Filed Over Preterm Infant’s Sepsis and Gastrointestinal Injuries

Michigan mother claims that Abbott Laboratories has known for years about the risk that cow’s milk-based Similac formula may cause NEC in premature infants.

According to allegations raised in a lawsuit brought by a mother from Michigan, her premature newborn developed sepsis and other complications from necrotizing enterocolitis (NEC), after being fed Similac infant formula shortly after birth.

The complaint (PDF) was filed by Shalona Smith in the U.S. District Court for the Northern District of Illinois on October 7, on behalf of herself and her minor son, identified only with the initials R.S.J.

The lawsuit seeks damages from Abbott Laboratories for negligent, willful and wrongful conduct in connection with the development and sale of Similac Special Care, which was marketed for use among premature infants, despite known risks that NEC may result from the cow’s milk formula product.

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.

Babies that do survive NEC often face life-long gastrointestinal injuries and other adverse health effects, which require continuing treatment and care.

Amid a growing body of research finding that cow’s milk formula products like Similac and Enfamil increase the risk of NEC for premature infants, Smith now joins more than 1,000 other families currently pursuing lawsuits alleging that manufacturers placed their desire for profit before the health and safety of babies, by providing false and misleading information for years about the safety of their products.

According to Smith’s complaint, her son was born prematurely at 28 weeks gestation, weighing only two pounds and eight ounces.

Due to his premature development, the newborn was transferred to the Neonatal Intensive Care Unit (NICU), where the lawsuit indicates he was fed Similac Special Care.

“Shortly after receiving the formula enterally, R.S.J. began to suffer from gastrointestinal issues, including intestinal rupturing and was diagnosed with NEC,” the lawsuit states. “This injury led R.S.J. to develop bowel problems, abdominal pain and sepsis.”

Sepsis is a life-threatening infection that requires urgent medical care to prevent tissue damage, organ failure and death. Symptoms can include decreased blood pressure, fever, increased heart rate, confusion, shortness of breath and weakness. The condition is responsible for one in five deaths worldwide.

Roughly 20% of children who get sepsis will develop other severe medical conditions in the months following the diagnosis. Some of those conditions include chronic respiratory failure, nutritional dependence, chronic kidney disease, worsened epilepsy, and the progression of other existing medical conditions.

According to the lawsuit, giving preemies cow’s milk-based, or bovine, infant formula is known to increase the risks of NEC and its various potential complications, such as sepsis. The lawsuit claims that, despite this knowledge, Abbott Laboratories continued to promote Similac as safe for premature infants.

“Defendant knows that its bovine formulas and/or fortifiers are causing NEC, devastating injuries, and death in premature infants, yet Defendant has taken no action to change its product, packaging, guidelines, instructions, and warnings to make them safe,” Smith’s lawsuit states. “Despite Defendant’s knowledge of the numerous studies establishing that its products increase the risk of NEC in premature infants, Defendant never informed Plaintiffs of the studies establishing that bovine formula and/or fortifier were extremely dangerous to their baby.”

October 2024 Similac NEC Lawsuit Update

The lawsuit filed by Smith 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, given similar questions of fact and law presented in the claims.

To help manage the pretrial proceedings, U.S. District Judge Rebecca R. Pallmeyer was appointed to preside over pretrial proceedings for the infant formula lawsuit MDL in 2022, where a small group of claims are being prepared for a series of early trial dates next year.

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 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 Smith 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.