Introduction
Necrotizing enterocolitis (NEC) is a serious, often fatal gastrointestinal condition that primarily affects premature infants. As more research links cow’s milk-based baby formulas to increased NEC risk, families and legal teams across the country are demanding answers and accountability. Lawsuits against major formula manufacturers, including Abbott Laboratories (Similac) and Mead Johnson/Reckitt (Enfamil), allege failure to warn, misleading marketing, and preventable harm. This blog aims to clearly explain the science, legal background, current litigation, and next steps for families and attorneys involved or considering legal action.
Understanding NEC and Formula Risks
NEC is a severe condition where portions of a baby’s intestine become inflamed, infected, and can die. It can lead to long-term complications or death. Premature and low-birth-weight infants are especially at risk. Symptoms often emerge within the first few weeks of life and may include abdominal swelling, bloody stools, and feeding intolerance.
Studies show a significant link between cow’s milk-based formulas and increased NEC risk. Research published in the Journal of Pediatrics and other medical journals, including Cochrane Reviews, indicates that premature infants fed cow’s milk formula are six to ten times more likely to develop NEC than those fed human milk. Human milk, including donor milk, contains protective antibodies and nutrients that help guard the infant’s fragile gut.
The Legal Claims Against Formula Manufacturers
The lawsuits center around claims that Abbott and Mead Johnson:
- Knew or should have known that their products significantly increase the risk of NEC in preemies.
- Failed to warn doctors and parents about this danger.
- Marketed their products as safe and appropriate for premature infants, despite contrary evidence.
Families argue that had they been properly warned, they would have chosen safer feeding options, like donor human milk. The lawsuits seek compensation for medical expenses, long-term care, emotional distress, and in some cases, wrongful death.
Multidistrict Litigation (MDL) and State Court Actions
Federal MDL
As of mid-2025, over 740 cases have been consolidated into Multidistrict Litigation (MDL 3026) in the Northern District of Illinois under Judge Rebecca Pallmeyer (Reuters). The MDL allows for coordinated pre-trial proceedings, helping streamline evidence collection and expert witness testimony.
In May 2025, Judge Pallmeyer ruled that expert testimony linking formula to NEC is admissible in court. This decision is significant because it allows scientific and medical experts to present their findings, strengthening plaintiffs’ claims.
State Courts
Hundreds more lawsuits are proceeding in state courts, particularly in Illinois (Madison and St. Clair Counties), Missouri, and Pennsylvania. In June 2025, an Illinois appellate court ruled that thousands of NEC lawsuits could remain in Madison County, a favorable venue for plaintiffs.
Bellwether Trials and Verdicts
Several bellwether trials (test cases) have already occurred:
- In March 2024, a jury awarded $60 million against Mead Johnson in an Illinois case.
- A Missouri jury delivered a $495 million verdict against Abbott, later partially overturned.
- A $6.2 billion case resulted in a defense verdict, but the court ordered a retrial due to procedural misconduct.
These early outcomes help gauge jury responses and may influence future settlements.
Who Qualifies for an NEC Formula Lawsuit?
Families may qualify if:
- The infant was born prematurely or had low birth weight.
- The baby was fed cow’s milk-based formula (Similac or Enfamil).
- The child developed NEC, required surgery, suffered long-term complications, or died.
Required Documentation
To file a claim, families should gather:
- Medical records (birth, diagnosis, surgery)
- NICU feeding logs
- Product packaging or receipts
- Proof of formula type and use during NICU stay
Preserving any remaining formula containers can also be helpful.
What Families Should Do Next
- Collect Evidence: Start gathering medical records, feeding logs, and any formula-related documentation.
- Preserve Packaging: Hold onto any used or unopened formula packaging.
- Contact an Attorney: Reach out to a law firm with experience in mass tort or product liability cases. Many offer free consultations.
- Join MDL or File in State Court: Your attorney can help determine the best venue based on your circumstances.
What Law Firms Need to Know
Attorneys representing NEC victims should:
- Screen clients for prematurity, formula use, and NEC diagnosis.
- Coordinate with MDL leadership for shared discovery and expert strategies.
- Monitor bellwether trial outcomes to adjust legal tactics.
- Retain medical experts who can testify on causation and standard of care.
With expert testimony now allowed in MDL, law firms must build strong, scientifically-backed cases.
Ongoing Litigation and What Lies Ahead
The NEC baby formula litigation is evolving rapidly. With hundreds of cases pending and millions already awarded in damages, the next few years could see:
- More bellwether trials
- Potential global settlements
- New labeling or regulatory changes
The key advantage now is that judges have recognized the validity of expert opinions linking formula to NEC. This increases pressure on manufacturers and enhances the strength of plaintiffs’ cases.
Summary
NEC is a devastating condition with life-changing consequences for families. The science shows a clear risk associated with cow’s milk-based formulas, especially in premature infants. Yet, manufacturers failed to provide adequate warnings, leading to widespread harm.
If your family has been affected, you may be entitled to significant compensation. And if you’re a mass tort firm, now is the time to take these cases seriously, build a strong evidentiary foundation, and push for justice.
The NEC baby formula litigation is not just about money—it’s about truth, accountability, and preventing future harm to our most vulnerable patients.
