NEC Lawsuits Could Disrupt Preterm Formula Supply, AAP President Cautions

Recent NEC lawsuits have shaken the infant formula industry, raising concerns over the future of preterm formula availability. As legal battles escalate, could these lawsuits trigger a major disruption in the essential supply chain for vulnerable newborns?

Let us find out in this article.

Why are Parents Filing NEC Lawsuits?

Some parents have filed lawsuits against baby formula companies because their infants developed necrotizing enterocolitis (NEC) after consuming certain formulas. NEC is a severe gastrointestinal illness that results in intestinal tissue death and can cause death or major health problems.

Studies have shown premature infants fed formulas containing cow's milk protein have an increased risk of NEC. In NEC lawsuits, parents argue formula makers knew of the risks but failed to warn the public and continued selling potentially dangerous products.

In April 2022, judges consolidated numerous NEC lawsuits involving Similac and Enfamil formulas across the US into large-scale litigation in Illinois federal court.

The NEC Infant Formula MDL brings multiple lawsuits against Abbott Laboratories and Mead Johnson & Company, the Similac and Enfamil premature infant formula producers. TorHoerman Law says that these cases are currently centralized in the U.S. District Court for the Northern District of Illinois, overseen by Judge Rebecca R. Pallmeyer. This consolidation aims to streamline pre-trial proceedings and discovery.

According to court filings, formulas sold under the Similac and Enfamil brands "have a greater likelihood to cause NEC in infants born prematurely than other, supposedly safer alternatives." This information is based on the claims made in the filings as per the Consumer Notice.

One such case involved Chance Dean, who tragically passed away after only 25 days. His mother filed a lawsuit against a major formula company. She argued that switching from donor breast milk to a cow's milk-based formula was responsible for Chance's NEC. She told ABC News that this switch led to his untimely death.

After a three-week trial, the jury found the company negligent for failing to adequately warn of higher NEC risks in formula-fed preemies. They awarded the family $60 million in damages to compensate for their loss and the suffering endured by Chance.

The case highlights why some parents of infants who developed NEC after using certain formulas have pursued legal action.

Do Court Decisions Impact the Supply of Specialized Formulas?

Some recent court rulings against formula companies could impact the availability of specialized preterm infant formulas in the US. According to the president of the American Academy of Pediatrics (AAP), large damages awards may jeopardize this vital supply.

In one case, a Missouri jury found that a premature infant's NEC was caused by a specialized cow's milk-based formula made by Abbott Laboratories. The jury awarded nearly $500 million in damages. In another case, an Illinois jury ruled against Mead Johnson, awarding $60 million related to a similar claim.

Both lawsuits alleged the companies failed to warn of NEC risks. However, the formula makers say no evidence links their premature products to NEC. The AAP president said courtrooms may not be best for determining clinical infant feeding recommendations, as individual circumstances vary.

These specialized formulas are an essential nutrition source for preemies, as human breast milk alone does not always meet their needs. While breast milk can reduce NEC risk, it does not eliminate it. NEC causes are not fully understood, making prevention challenging.

The AAP president noted that only two US companies produce these specialized preterm formulas. With hundreds more lawsuits pending and the potential for large damages, the formula supply could be jeopardized.

According to the CDC, about 1 in 10 US infants are born prematurely each year. Therefore, maintaining access to these specialized nutritional products is important. However, some question whether lawsuits are the appropriate way to address NEC risks.

Bellwether Trial Schedule Announced

Counsel for both plaintiffs and defendants in the MDL have agreed upon a proposed schedule for the first four bellwether trials, pending court approval. These dates provide the first glimpse at the trajectory of the consolidated litigation moving forward.

The following are the suggested trial dates as per the Lawsuit Information Center:

Mar v. Abbott Laboratories, May 5, 2025

K.B. v. Abbott Laboratories, August 11, 2025

Brown v. Abbott Laboratories, November 3, 2025

Inman v. Mead Johnson & Company, LLC, et al., February 2, 2026.

The first trial date is set for just over seven months from now. This schedule sets the stage for key test cases to potentially aid in settlement discussions. However, observers note previous assumptions that defendants would settle major lawsuits have not always proven correct.

The plaintiffs' counsel remains optimistic an overarching settlement can be reached before individual trials are held. If no agreement is made, these bellwether proceedings will provide important insights into both sides' arguments. This could shape the broader resolution of the consolidated litigation.

FAQs

1. What compensation do NEC legal cases typically provide?

A: Legal experts indicate that individual settlements in NEC cases typically fall in a broad range from approximately $50,000 to $500,000+. However, every case is unique, and these figures are estimates only, not guaranteed amounts.

2. How severe is NEC, and what are the survival rates?

A: NEC impacts between 2-5% of babies born prematurely and accounts for roughly 8% of all neonatal intensive care unit cases. The condition has a mortality rate of 10-50% overall. In complex cases with complications like intestinal perforation and widespread infection, the survival rate becomes extremely low.

3. Which infants have the highest NEC risk?

A: NEC predominantly affects premature infants, occurring in approximately 1 per 1,000 preterm births. Babies born weighing under 2 pounds face the highest risk. The condition rarely develops in babies carried to full term.

The future of the preterm infant formula industry hangs in the balance as these legal battles play out. No matter the outcome, vulnerable babies remain caught in the middle. Both parents seeking justice and companies demanding the protection of innovation have valid perspectives. As courts deliberate damages and defenses, let us hope all parties prioritize the most fragile lives that depend on this specialized nutrition.

Through open dialogue among all who wish to help preemies, a solution might be found that considers both medical and legal viewpoints. This approach would ensure that this vulnerable population continues receiving the lifesaving sustenance they need.