Lawsuit Alleges Similac Caused NEC Injury After Mother Advised Not to Breastfeed Newborn

A Massachusetts couple has filed a lawsuit against Similac manufacturers, indicating their newborn daughter developed a severe and life threatening condition, known as necrotizing enterocolitis (NEC), shortly after after the mother was advised not to breastfeed and switched to use of the cow’s milk-based infant formula.

The complaint (PDF) was filed by Andrew Coulombe and Kensie Sheehan in the U.S. District Court for the District of Massachusetts on March 1, pursuing claims against Abbott Laboratories on behalf of themselves and their minor child, Autumn Coulombe, who has been left with long-term disabilities after Similac caused NEC.

According to the lawsuit, the child was given Similac due to Abbott’s failure to warn about the potential side effects associated with their infant formula, and decision to withhold information from families and the medical community for decades about the risks associated with the use of cow’s milk-based formula among premature newborns.

For decades, Abbott Laboratories and other infant formula manufacturers have marketed formula products like Similac specifically for preterm newborns, despite a growing body of medical research that the products may cause vulnerable infants to develop NEC, which can cause portions of the intestines to suddenly become inflamed or die. This often results in the need for emergency surgery while the preterm newborn is still in the NICU us, and can result in death or long-term complications for the remainder of the child’s life.

Autumn’s parents now join other families of preterm infants nationwide who are now pursuing NEC injury lawsuits against the Similac makers, with a number of similar claims also being pursued against Mead Johnson over problems linked to their competing cow’s milk infant formula products, marketed under the brand name Enfamil, alleging that the desire for profits has been placed ahead of the safety of babies, and driven many families away from safer breastfeeding or donor milk alternatives.

The lawsuit indicates Autumn was born prematurely in July 2022, weighing only 4 pounds, 5.8 ounces and suffering respiratory distress. Doctors advised her mother not to breastfeed due to her epilepsy and the potential side effects of epilepsy drugs she was prescribed to take to control the condition.

Instead, the baby was fed Similac NeoSure premature infant formula, which made up most of her diet for several days. However, just five days after Autumn was born, healthcare professionals she appeared jaundiced, mottled, and was crying in pain. She also had bloody stool and a tender abdomen, leading them to diagnose the newborn with NEC.

“As a result of developing NEC, Baby Autumn was forced to undergo fourteen (14) days of antibiotic therapy, which included no food or liquid for that time, with solely intravenous nutrition, an extended hospitalization at the time of her birth, and she suffered long-term health effects,” the lawsuit states. “At the time of her diagnosis and hospitalization, Baby Autumn’s parents were unaware of the fact that the Defendant’s Cow’s Milk-Based Products that Autumn was fed caused or substantially contributed to her development of NEC.”

Last month, 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.

March 2023 NEC Baby Formula Lawsuit Update

There are currently about 100 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 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.