NEC Baby Formula Lawsuit: Similac and Enfamil Preterm Formula Claims

Necrotizing enterocolitis is a serious intestinal disease that mostly affects premature infants. Part of the intestine becomes inflamed and can die, and babies may need surgery. The lawsuits say that cow's milk-based preterm formulas and fortifiers raise the risk of NEC compared with breast milk or donor human milk, and that the manufacturers failed to warn doctors and parents.

These are individual injury and wrongful death claims, grouped as a mass tort. They are not consumer class actions, and there is no refund class.

Similac (Abbott Laboratories)

Claims against Abbott center on its specialty preterm products, including Similac Special Care 24. Abbott says regulators and clinicians recognize the products as safe and necessary, and that there is no reliable scientific evidence they cause NEC.

Enfamil (Mead Johnson)

Claims against Mead Johnson, owned by Reckitt, center on Enfamil products designed for premature infants, including Enfamil Premature formula and human milk fortifiers. Mead Johnson also denies the claims. It was not part of Abbott's August 2026 agreements.

Federal agencies have weighed in. On October 3, 2024, the FDA, CDC, and NIH said there is no conclusive evidence that preterm infant formula causes NEC, and strong evidence that human milk protects against it. The agencies said formulas remain a critical option when human milk is not available. Plaintiffs argue the companies should have warned that human milk options carry a lower NEC risk.

Necrotizing enterocolitis is a condition in which the tissue lining a baby's intestine becomes inflamed and can die, which can cause a life-threatening infection. It mainly affects premature babies, especially those born at very low birth weight, and it usually develops in the neonatal intensive care unit during the first weeks of life.

The FDA, CDC, and NIH estimate that one baby dies every day in the United States from NEC. Babies who survive may need surgery to remove damaged intestine, and some face long-term problems, including neurodevelopmental impairment. That severity is why these lawsuits involve large damage claims and why jury verdicts have been high in some cases.

Preterm babies often cannot get enough of their mother's milk in the first days, so hospitals use pasteurized donor human milk, human milk-based fortifiers, or cow's milk-based formulas and fortifiers. The lawsuits focus on the last category. The federal agencies describe mother's milk as the preferred source, with donor milk as the next best alternative, and say preterm formulas remain a critically important option when human milk is not enough. Families should not read the lawsuits as medical guidance; feeding decisions for a premature baby belong with the NICU team.

On April 8, 2022, the Judicial Panel on Multidistrict Litigation created MDL No. 3026, In re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, and sent federal cases to Judge Rebecca R. Pallmeyer in the Northern District of Illinois. Thousands more claims are in state courts, especially in Illinois and Missouri.

Trial results so far

In the federal MDL, Abbott won pretrial judgment in its first bellwether case, and the Seventh Circuit affirmed that judgment in July 2026, according to Abbott. The Illinois appellate court reversed the Watson verdict because the trial judge mishandled the learned intermediary doctrine (the rule that a manufacturer's duty to warn generally runs to the prescribing doctor) and let jurors hear repeated evidence of Mead Johnson's wealth.

On August 20, 2026, Abbott announced agreements with three law firms resolving the Gill case and claims for about 2,000 other infants for approximately $670 million, without admitting liability. Abbott said about 1,700 lawsuits involving roughly 12,700 infants remain pending. There is no public claim form; those agreements cover specific clients of the settling firms.

Attorneys handling these cases generally look for a premature baby, a documented NEC diagnosis, and hospital feeding records showing cow's milk-based formula or fortifier from Abbott or Mead Johnson. Many cases involve babies born before 37 weeks and fed in a neonatal intensive care unit.

• Babies who needed surgery, developed short bowel syndrome, or died have the most serious claims.
• Cases where the hospital records do not name the brand can still be investigated, but proof becomes harder. Abbott noted some pending claims name both companies without identifying which formula was used.
• Babies fed exclusively breast milk or pasteurized donor milk do not fit these lawsuits.

Because the medical records are central, see how mass torts differ from class actions and how an MDL works.

Every case is valued individually. Jury verdicts have ranged from zero to hundreds of millions, and several large verdicts have been reversed or set aside. Abbott's $670 million for the Gill case plus about 2,000 other claims works out to roughly $335,000 per claim on a simple average, before attorney fees and costs, though actual individual amounts are not public and will vary widely. That average includes the $495 million Gill verdict, which Abbott said had grown to about $600 million with interest, so most other claims likely resolved for much less.

Damages in NEC cases can include medical costs, future care for complications, pain and suffering, and in death cases, wrongful death damages under state law. Mead Johnson has not announced any global settlement. No one can promise a payout, and the defense has won several recent trials.

For how fees affect net recovery, see who pays the lawyers.

Keep in mind that published verdicts are the exceptions that went to trial. Most individual NEC claims that resolve do so privately, and the terms are rarely public. Factors that usually push value up include documented use of a specific brand, surgery, lasting bowel or developmental problems, and death. Factors that push value down include missing feeding records, strong evidence that human milk was offered and declined, and a state whose courts apply the learned intermediary doctrine strictly.

Most NEC complaints plead failure to warn, design defect, and negligence under state product liability law. The key defense is the learned intermediary doctrine: because preterm formula is given in hospitals under medical supervision, the companies argue their duty ran to doctors, and that doctors already knew human milk lowers NEC risk.

That argument has carried weight. In June 2026, the Illinois Fifth District reversed the $60 million Watson verdict, and Abbott said a Florida state court dismissed claims in March 2026 under the same doctrine. Plaintiffs counter that the companies marketed formula as comparable to breast milk and never disclosed the NEC risk data. How each state applies this doctrine can decide a case.

NEC cases are built almost entirely on hospital records, so the first job for any attorney is to get the complete NICU chart. Key questions include:

• Which products were used? Feeding logs and pharmacy records usually name the formula or fortifier, such as Similac Special Care or an Enfamil premature product. Some records list only generic terms, which makes it harder to tie the case to one manufacturer.
• When did feeding start, and when did NEC appear? The timing between cow's milk-based feeding and the NEC diagnosis is central to causation.
• Was human milk available? The defense often argues that the hospital's choices, not the product, drove the outcome, and the learned intermediary doctrine focuses on what doctors knew.
• What were the outcomes? Surgery, short-term and long-term complications, and death all affect the value of a claim.

Because the manufacturers' duty to warn is judged largely by what physicians were told, expert testimony from neonatologists and pediatric gastroenterologists is common on both sides. In the federal MDL, Abbott won pretrial judgment in its first bellwether, and the Seventh Circuit affirmed that result in July 2026, according to Abbott. Cases that reach juries with strong experts have produced both large verdicts and defense wins, which is why settlement values are hard to predict. See how MDL bellwethers work.

Each state sets a statute of limitations. Personal injury deadlines usually run 1 to 3 years, and many states extend deadlines for minors. Wrongful death deadlines often run just 1 to 3 years from the date of death, and many states do not extend them for minors. Some states start the clock when a family knew or should have known the formula might be connected. Because the rules vary so much, a family whose baby had NEC years ago should get an answer from a licensed attorney rather than assume it is too late or that there is plenty of time.

1. Request your baby's complete NICU records, including feeding logs, medication records, and nursing notes. Hospitals must provide them, but it can take weeks.
2. Keep surgical and follow-up records for any complications.
3. Write down what you were told about feeding options and when.
4. Do not sign anything from a manufacturer or insurer without legal advice.

Independent attorneys who handle NEC cases can review the records to see whether the formula and timeline fit. A free case review takes about two minutes. Related pages: toxic baby food and autism and prenatal vitamin lawsuits.

Under the HIPAA Privacy Rule, 45 CFR 164.524, a hospital generally must act on a written request for your records within 30 days, with one possible 30-day extension if it explains the delay in writing. As a parent or legal guardian, you can usually request your child's records, and a personal representative can request records for a baby who died. Ask specifically for the complete chart, including nursing flowsheets and feeding records, not just a discharge summary, because the feeding details are what these cases turn on.