Case Type: Mass Tort / Product Liability

Products Involved: Similac (Abbott Laboratories), Enfamil (Mead Johnson)

Alleged Harm: Necrotizing Enterocolitis (NEC) in premature infants

Status: Ongoing — Lawsuits Growing

Who May Qualify: Families of premature infants diagnosed with NEC after consuming cow's milk-based formula

NEC Baby Formula Lawsuits: What Families of Premature Infants Need to Know

Lawsuits against the makers of Similac and Enfamil continue to grow as more families of premature infants come forward with claims that cow's milk-based baby formula contributed to a life-threatening bowel condition known as necrotizing enterocolitis, or NEC.

According to reporting on the NEC baby formula litigation, families across the country are pursuing legal action against Abbott Laboratories, the maker of Similac, and Mead Johnson, the maker of Enfamil, alleging that these companies failed to adequately warn parents and healthcare providers about the risks their products may pose to premature newborns.

Here is what families should understand about the current state of these lawsuits.

1. What Is NEC and Why Are Lawsuits Being Filed?

Condition: Necrotizing Enterocolitis (NEC)

Products at Issue: Similac and Enfamil cow's milk-based formulas

Who May Be Affected: Premature infants who consumed these products in hospital neonatal intensive care units (NICUs)

Necrotizing enterocolitis is a severe gastrointestinal condition that predominantly affects premature infants. The condition involves inflammation that can destroy intestinal tissue and, in serious cases, can be fatal.

The lawsuits allege that Abbott Laboratories and Mead Johnson knew or should have known that their cow's milk-based formulas posed an elevated risk of NEC in premature infants but continued to market and sell these products without sufficient warnings. According to the complaints, research has long suggested an association between cow's milk-based formula and increased NEC risk in preterm babies, particularly when compared to human breast milk.

Plaintiffs allege that had families and medical providers been adequately warned, different feeding choices might have been made for vulnerable premature infants.

How to learn more: Families can review current information on the litigation through Top Class Actions' NEC lawsuit investigation page.

2. Who the Lawsuits Name as Defendants

Defendants: Abbott Laboratories (Similac) and Mead Johnson (Enfamil)

Legal Claims Include: Failure to warn, negligence, strict product liability

Venue: Cases have been consolidated in federal multidistrict litigation (MDL)

The lawsuits target two of the largest infant formula manufacturers in the United States. Abbott Laboratories produces the Similac line of products, while Mead Johnson manufactures Enfamil. Both companies have produced cow's milk-based formulas widely used in hospital NICUs for premature and low-birth-weight infants.

The litigation alleges that both companies had access to scientific literature indicating a potential link between their products and NEC in preterm infants, yet the complaints allege neither company took adequate steps to update warning labels or restrict marketing of these products to the most vulnerable patient populations.

A significant portion of these cases have been centralized in a federal multidistrict litigation (MDL) proceeding, which is intended to streamline pretrial proceedings for cases involving common questions of fact.

3. What the Science Suggests

The lawsuits draw on a body of published research that, according to the filings, indicates premature infants fed cow's milk-based formula may face a higher risk of developing NEC compared to those fed human breast milk or donor milk. Studies cited in various complaints suggest this association has been documented in medical literature for years.

Neither Abbott nor Mead Johnson has conceded liability, and both companies have disputed the plaintiffs' characterization of the scientific evidence. The defendants argue that their products are safe and that NEC is a complex condition with multiple contributing factors.

The scientific community continues to study the mechanisms behind NEC, and research indicates that premature infants are inherently at elevated risk for the condition due to their underdeveloped digestive and immune systems.

4. Who May Be Eligible to Pursue a Claim

Potential Claimants: Families of premature infants who:

• Were born prematurely or at low birth weight
• Were fed Similac or Enfamil cow's milk-based formula, often in a NICU setting
• Were subsequently diagnosed with NEC

Families whose premature infants were diagnosed with NEC following the use of Similac or Enfamil formula in a hospital setting may be eligible to pursue an individual lawsuit. Because these are individual injury claims — not a class action seeking a shared refund — each case is evaluated on its own facts and circumstances.

Potential compensation, if cases are resolved, could include damages related to medical expenses, pain and suffering, and in cases of wrongful death, additional losses. Outcomes vary significantly by case, and only a qualified attorney can assess whether a specific family's situation meets the legal requirements for a claim.

Key Takeaways

• Lawsuits are ongoing and growing — Families continue to file claims against Abbott and Mead Johnson, and the litigation is expected to develop further through 2026 and beyond.
• These are individual injury cases — Unlike consumer class actions seeking product refunds, NEC lawsuits involve serious personal injury or wrongful death claims and are evaluated individually.
• Medical records matter — Families considering whether to explore a claim should gather medical records documenting prematurity, formula use, and an NEC diagnosis, as this documentation is typically central to any case evaluation.
• The MDL continues to evolve — Consolidation of cases in federal court is ongoing, and how bellwether trials proceed could significantly influence the broader litigation landscape.
• No settlement has been announced — As of publication, no global settlement has been reached in the NEC baby formula litigation. Families should be cautious of any claims suggesting otherwise.

This article is for informational purposes only and does not constitute legal or medical advice. Families with questions about a potential NEC claim should consult a licensed attorney. If you have concerns about your infant's health or feeding, speak with a qualified healthcare provider.