If your newborn is in a neonatal intensive care unit, you may have heard the term “NEC” — or you may have heard nothing at all, which is increasingly part of what parents and courts say is the problem.
Necrotizing enterocolitis is a life-threatening condition in which intestinal tissue becomes inflamed, begins to die, and can allow infection to spread through the body of a premature infant. It is among the leading causes of death in very premature babies, particularly those born at less than 32 weeks of gestation and those with very low birth weight. It requires surgical intervention in a significant percentage of cases, and survivors can face lifelong gastrointestinal complications.
A growing body of research — and now more than 780 active federal lawsuits — centers on a specific finding: NEC occurs more commonly in premature infants who receive cow’s milk-based formula rather than human breast milk. This is not a contested fringe claim. It is reflected in policy statements from the American Academy of Pediatrics, in peer-reviewed research, and increasingly in jury verdicts finding that formula manufacturers failed to adequately warn parents and physicians about this elevated risk.
For parents of premature infants in the NICU today, this information should prompt immediate, specific conversations with the neonatal team.
Why This Matters
The standard of care for very premature infants — particularly those born before 32 weeks — is to provide human milk whenever possible. The American Academy of Pediatrics recommends that very low birth weight infants receive human milk, preferably from their own mother. When the mother’s own milk is not available, pasteurized donor human milk is the next recommended option. Cow’s milk-based premature infant formula is typically the third option — used when human milk is unavailable or insufficient.
The distinction between these options is not minor. Research from multiple clinical settings has found that NEC rates can fall dramatically when NICUs prioritize human milk — in one documented initiative, the NEC rate fell from 4.1% to 0.4% after implementing a program to increase human milk and donor milk use while reducing early formula exposure.
What the litigation now alleges is that companies, including Abbott (maker of Similac) and Mead Johnson (maker of Enfamil), had access to evidence linking their cow’s milk-based NICU formulas to NEC risk and failed to communicate that risk adequately to parents or physicians — leaving families unable to make informed decisions about what their premature infants were fed.
What We Know So Far
From court records, KFF Health News investigative reporting, and published medical and regulatory data:
What Necrotizing Enterocolitis Actually Is
NEC typically develops in a premature infant’s first two to four weeks of life, often after enteral (oral) feedings have begun. It begins with inflammation in the intestinal wall that, if not caught and treated quickly, progresses to tissue death and potentially perforation — allowing intestinal contents to enter the abdomen and cause life-threatening sepsis.
Symptoms that may indicate NEC in a NICU infant include:
- Sudden abdominal distension or bloating — the belly becomes visibly swollen and rigid
- Feeding intolerance after previously tolerating feeds — the infant is suddenly vomiting, having large residuals, or showing discomfort with feeding
- Bloody stool — blood in the stool is a warning sign that requires immediate evaluation
- Temperature instability — an infant who had been maintaining temperature begins fluctuating
- Lethargy or decreased responsiveness — unusual quietness, decreased movement, or difficulty arousing
- Skin changes near the abdomen — redness, bruising-like discoloration, or visible loops of bowel through the abdominal wall
Parents of NICU infants should know these signs and ask nurses to explain how they would be monitored and what the escalation protocol is if they appear.
The Questions Every NICU Parent Should Ask Today
The neonatal team is your primary resource — and they are obligated to answer these questions honestly. You should ask them directly:
1. “Is my baby receiving cow’s milk-based formula, human milk from a donor bank, or my own breast milk?” If your baby is receiving cow’s milk-based formula, ask whether donor human milk is available at this facility and whether your baby would be eligible to receive it.
2. “What is this baby’s NEC risk, based on gestational age and birth weight?” Very premature infants (less than 32 weeks) and very low birth weight infants (under 1,500 grams) are at the highest risk. Understanding your baby’s specific risk profile puts subsequent conversations in context.
3. “Does this NICU have a standardized human milk feeding protocol?” Facilities that have implemented human milk feeding protocols have documented lower NEC rates. This is a fair question about care quality, not an accusation.
4. “If donor human milk is not available, what fortifiers are being used, and are they human milk-based or cow’s milk-based?” Even when babies receive human milk, cow’s milk-based fortifiers — added to increase caloric and nutritional density — may be used. Human milk-based fortifiers exist and may reduce NEC risk, though they are more expensive.
5. “How are we being monitored for early NEC signs, and what should I tell the nursing staff if I notice something has changed in my baby?” Understanding the monitoring protocol — including how often abdominal exams are performed and what triggers escalation to a neonatal physician — helps parents be effective advocates.
What Doctors and Experts Say
The AAP’s policy on human milk for premature infants is explicit: “[P]reterm infants should only receive their own mother’s milk or pasteurized human donor milk when their own mother’s milk is not available,” the National Institute of Child Health and Human Development summarized in a 2024 working group report.
Research teams have also found that human milk feeding can reduce NEC incidence substantially, though the precise dosage effect and the relative contributions of the mother’s own milk versus pasteurized donor milk remain active research areas.
Court filings in the NEC multidistrict litigation allege that both Abbott and Mead Johnson had internal documents acknowledging the elevated NEC risk from cow’s milk formula fed to premature infants but chose not to provide explicit warnings on packaging or to physicians. A Kansas City family’s lawsuit stated that they were never warned about the increased risk of NEC and were never informed about safer alternatives like donor breast milk.
Both companies deny liability and argue the scientific evidence does not establish causation. Litigation is ongoing.
What the Evidence Shows — and What It Does Not
MedicalDaily Evidence Check
- Study type: Multiple peer-reviewed studies, systematic reviews, clinical outcome data, AAP policy statements
- What the research shows: Premature infants fed cow’s milk-based formula have higher rates of NEC than those receiving human milk. Human milk, including pasteurized donor milk, is associated with reduced NEC incidence.
- What remains debated: The precise causal mechanism; the relative risk of different formula types and different cow’s milk-based fortifiers; whether the association constitutes legal liability for manufacturers
- What is settled: The AAP recommends human milk as the feeding standard for very low birth weight and very premature infants; donor human milk is recommended when the mother’s own milk is not available
- What readers should know: This does not mean formula use in the NICU caused NEC in any individual child — NEC is multifactorial. However, parents have the right to know about feeding options and to ask about their baby’s specific risk profile.
Who Faces the Greatest Risk?
NEC primarily affects:
- Infants born before 32 weeks of gestation
- Infants with very low birth weight (under 1,500 grams, or approximately 3.3 pounds)
- Infants born before 28 weeks of gestation face the highest risk — estimates of NEC incidence in this group range from 5% to 12%
Infants born at full term or near-term are far less likely to develop NEC, though rare cases do occur.
What You Can Do Now
- Ask the neonatal team today the five questions listed above. Write them down and bring them to your next conversation with the neonatologist or attending physician.
- If you are able to pump breast milk, speak with the NICU lactation consultant about how to maximize your milk supply. Even small amounts of your own milk may provide protection. NICUs can assist with pumping schedules and equipment.
- Ask whether pasteurized donor human milk is available at the facility and whether your insurance covers it. Not all NICUs have milk bank access, and not all insurance plans cover donor milk costs.
- Take notes during medical conversations — ask if you can record them or bring a support person who can help document discussions about your baby’s care plan.
- If you feel your concerns about NEC risk are not being taken seriously, you can request a meeting with the attending neonatologist or the hospital patient advocate. Hospitals have formal care escalation pathways.
Cost and Access: What Patients Should Know
Donor human milk from milk banks is typically more expensive than cow’s milk-based formula, and insurance coverage varies. Many NICUs absorb the cost for the highest-risk infants; others charge families the difference. Ask your neonatology team and hospital billing department specifically about donor milk coverage under your plan.
NEC treatment — including surgery when required — is covered under standard insurance and under Medicaid. The cost of NEC treatment and its long-term consequences for the child can be substantial; families who believe their child’s NEC resulted from inadequate warnings about formula risk may wish to consult an attorney about their legal options, given the active multidistrict litigation and the recent jury verdicts.
What Happens Next
The federal multidistrict litigation in the Northern District of Illinois is expected to continue through 2026, with additional bellwether trials that may shape eventual settlement discussions. State court litigation is proceeding separately in multiple jurisdictions.
Families affected by NEC remain in contact with neonatal and surgical follow-up care; long-term outcomes for NEC survivors depend on the extent of intestinal involvement and whether surgical resection was required.
MedicalDaily will continue reporting on NEC litigation developments, policy changes related to human milk access in NICUs, and new research on premature infant nutrition.
The Bottom Line
If your premature baby is in the NICU and receiving cow’s milk-based formula, the medical evidence and existing AAP guidance support asking direct questions about whether human donor milk is available and whether your baby’s NEC risk has been explicitly communicated. You do not need to be adversarial — but you do have both the right and the medical rationale to ask these questions. NEC is often preventable, and the most powerful tool parents have right now is an informed conversation with their neonatal care team before symptoms appear.
