Enfamil Lawsuit Claims Premature Infant Required Partial Intestine Removal From NEC Side Effects

Lawsuit alleges Mead Johnson had scientific evidence for decades indicating that cow’s milk-based infant formula products increased the risk of NEC.

A lawsuit filed by a New York woman says feeding her newborn infant Enfamil led to serious and life-threatening side effects, causing the premature child to develop a devastating condition known as necrotizing enterocolitis (NEC), which will result in life-long gastrointestinal issues.

The complaint (PDF) was brought by Quadria Breaker, on behalf of herself and her infant, identified only as Baby Z.L., last month in Cook County Circuit Court in Illinois. The case was later removed to the U.S. District Court for the Northern District of Illinois on March 10 by the defendant, Mead Johnson & Company LLC, the maker of Enfamil infant formula.

Mead Johnson already faces hundreds of similar Enfamil lawsuits brought by families nationwide, each involving similar allegations that the infant formula manufacturer failed to warn parents and the medical community that its cow’s milk-based formula products increased the risk of necrotizing enterocolitis (NEC) among preterm infants. The company’s competitor, Abbott Laboratories, faces even more Similac lawsuits over the same issue.

NEC is a serious and life-threatening condition, occurring when harmful bacteria infiltrate the walls of a newborn’s intestines, causing portions of the tissue to become inflamed or die. In many cases, infants who develop NEC from infant formula require emergency surgery while still in the neonatal intensive care unit (NICU), and many newborns do not survive. Those who do are often left with health complications for the rest of their lives.

Despite years of scientific evidence indicating that there is a connection between cow’s milk-based infant formula like Enfamil and preterm infant NEC side effects, lawsuits allege the manufacturers have continued to aggressively market their products for use among this vulnerable population, placing profits ahead of the safety of newborns.

According to Breaker’s lawsuit, Baby Z.L. was born prematurely in November 2020, at 23 weeks gestation. Weighing 650 grams at birth, the infant was transferred to the hospital’s NICU unit and fed Enfamil.

Shortly afterward, Baby Z.L. began suffering from gastrointestinal problems, leading to a NEC diagnosis. As a result, the newborn went into surgery, where doctors removed part of the distal lower intestine.

Breaker indicates the manufacturer had access to decades of research warning of the potential health risks, particularly when compared to feeding preemies human-based milk products. However, even armed with that information, Mead Johnson still promoted feeding preterm infants Enfamil, and obscured the risks through misleading marketing and safety claims, Breaker argues.

“Despite knowing NEC’s risks arising from the use of its bovine-based products, including its Enfamil product, Defendant failed to design its bovine-based products to make them safe and deceived the consuming public, including parents and healthcare providers of premature infants, into believing that the products were safe and necessary alternatives, supplements, and/or substitutes to human milk.”

– Quadria Breaker v. Mead Johnson & Company LLC

The lawsuit presents claims for failure to warn, strict liability for defective product, negligence, negligent misrepresentation, breach of implied warranties, design defect, and violation of the Illinois Consumer Fraud and Deceptive Trade Practices Act. She seeks both compensatory and punitive damages.

Enfamil NEC Lawsuits

Now that the case has been transferred to federal court, Breaker’s complaint will be consolidated with similar Enfamil NEC lawsuits and Similac NEC lawsuits in the Northern District of Illinois under U.S. District Judge Rebecca R. Pallmeyer as part of an infant formula NEC lawsuit multidistrict litigation, where it will go through pretrial proceedings and coordinated discovery with similar claims.

For the last several years, Judge Pallmeyer has been directing the parties through preparations for a series of bellwether trials, designed to see how juries respond to evidence and testimony likely to be repeated throughout the litigation. The first federal trial was originally scheduled to begin in April 2025, but it and several other bellwether cases were dismissed due to lack of evidence.

A second wave of potential bellwether trials is currently undergoing preparations and are expected to begin this August.

In the meantime, infant formula NEC lawsuits have proceeded to trial in some state courts, with one Similac trial currently ongoing in Chicago as of present time. Although the Chicago case and other trials have no legal bearing on other claims, they are being closely watched as indicators for how juries are interpreting and weighing both sides’ arguments.

However, if the parties fail to reach a settlement or other resolution after the federal bellwether trials are concluded, Judge Pallmeyer would likely begin remanding cases back to their originating court districts for individual dates.