The baby formula lawsuits are product liability claims against Abbott Laboratories and Mead Johnson alleging that their cow’s-milk-based formulas for premature infants, primarily Similac Special Care and Enfamil Premature Infant Formula, cause necrotizing enterocolitis (NEC), a often-fatal intestinal disease. More than 1,700 cases are pending in federal and state courts as of mid-2026. Juries have delivered verdicts ranging from a defense win to $495 million against Abbott, and no global settlement exists.
What Families Are Alleging
The claims target cow’s-milk-based formula and fortifier products fed to premature infants in neonatal intensive care units. Plaintiffs argue three things: the products are defectively designed, the manufacturers knew they significantly raised the risk of NEC in preterm babies, and neither Abbott nor Mead Johnson warned parents or hospitals about that risk. Families also contend that safer options, including human donor milk and human-milk-based fortifiers such as those made by Prolacta Bioscience, should have been disclosed as alternatives.
At their core, the suits accuse the companies of prioritizing hospital market share over infant safety by marketing aggressively while minimizing evidence that cow’s-milk protein can trigger NEC in the most vulnerable newborns.
What NEC Is and Why the Science Matters
Necrotizing enterocolitis is a gastrointestinal disease that primarily strikes premature infants. It inflames and kills intestinal tissue and can progress to bowel perforation, sepsis, and organ failure. Mortality runs 30 to 50 percent. Survivors often live with short bowel syndrome, malnutrition, or neurodevelopmental problems.
The disease is understood to arise from a combination of an immature intestinal lining, abnormal bacterial colonization, and an unregulated inflammatory response, with premature birth itself as the leading risk factor. The scientific fight at the heart of the litigation is whether cow’s-milk-based formula actively causes NEC or whether the real variable is the absence of protective human milk. A joint statement from the FDA, NIH, and CDC in October 2024 said there is “no conclusive evidence that preterm infant formula causes NEC” but acknowledged “strong evidence that human milk is protective against NEC.”1FDA. FDA Roundup That framing is contested in every trial.
Verdicts So Far
State-court juries have driven the numbers in this litigation. Results have gone both ways.
Mead Johnson, $60 Million (March 2024)
The first NEC formula case to reach a jury concluded in St. Clair County, Illinois. Jasmine Watson alleged Enfamil caused her son, Chance Dean, to develop NEC and die. The jury found Mead Johnson negligent and awarded $60 million.2Law.com. Mead Johnson Hit With $60M Verdict in First NEC Trial Over Preterm Infant Formula The company said it was “surprised and deeply disappointed” and announced an appeal.
Abbott, $495 Million (July 2024, Affirmed May 2026)
A Missouri jury in Gill v. Abbott Laboratories awarded $95 million in compensatory damages plus $400 million in punitive damages after finding Similac Special Care caused a premature infant to develop NEC. In May 2026, the Missouri Court of Appeals for the Eastern District upheld the full $495 million award, citing “compelling evidence” that Abbott knew its formula posed significant risks to premature infants weighing under 1,500 grams and failed to take remedial steps.3CaseMine. Missouri Appellate Court Affirms $495M NEC Verdict Against Abbott The court also rejected Abbott’s “learned intermediary” defense, ruling that preterm formula is classified as a food rather than a medical product, so liability could not be shifted to treating physicians.
Defense Verdict, Then a Do-Over (October 2024 to March 2025)
Abbott and Mead Johnson won their first jury trial in Whitfield v. Abbott and Mead Johnson on October 31, 2024.4CVN. Abbott and Reckitt Land First NEC Baby Formula Defense Verdict The win did not hold. In March 2025, St. Louis Circuit Court Judge Michael Noble threw out the verdict and ordered a new trial, finding that defense attorneys had engaged in “pervasive prejudicial conduct.”5Keller Postman. Keller Postman Secures Retrial in NEC Case According to the court, defense counsel introduced excluded evidence (including the October 2024 FDA/NIH/CDC statement), told jurors premature babies would “starve to death” without formula, and made false claims against the plaintiff. Abbott’s lead attorney was sanctioned during trial and barred from delivering closing arguments.6Atlanta Legal Examiner. New Twist in NEC Baby Formula Lawsuits: Judge Overturns Verdict Both companies said they would appeal the retrial order.
Abbott, $70 Million (April 2026)
A Cook County, Illinois, jury handed down the most recent verdict in April 2026. Four mothers, Antonia Mendez, Casie Thompson, Kara Sharpe, and Eboni Williams, alleged Similac Special Care caused their premature infants (all born before 32 weeks) to develop NEC. After a month-long trial, the jury found Abbott liable for product defect, failure to warn, and negligence, awarding $53 million in compensatory damages plus $17 million in punitive damages after finding Abbott’s conduct “willful and wanton.”7Chicago Tribune. Abbott Punitive Damages Infant Formula8Manufacturing Chemist. Abbott $70 Million Damages Verdict Preterm Infant Formula Abbott said it would appeal.
The Federal MDL
Federal cases were consolidated in April 2022 into MDL No. 3026 before Judge Rebecca R. Pallmeyer in the Northern District of Illinois. Roughly 797 cases were pending in the MDL as of May 2026, with hundreds more in state courts, especially Illinois and Missouri.9Lawsuit Information Center. NEC Baby Formula Lawsuits10Top Class Actions. Baby Formula NEC Lawsuit Each case is handled individually; the MDL is not a class action.
The federal cases have been rougher for plaintiffs. In May 2025, Judge Pallmeyer granted Abbott summary judgment in the first scheduled bellwether trial days before it was set to begin, finding the plaintiff had not established a feasible alternative design because human-milk-based products had not been shown to be a practical, scalable substitute Abbott could have offered at the time.11Expert Institute. Abbott Bellwether NEC Baby Formula Case The judge said Abbott “could have made more forceful warnings” but found no causal link between the missing warning and this plaintiff’s outcome. She limited her ruling to that case and declined to exclude plaintiffs’ key experts from the broader MDL.12U.S. District Court Northern District of Illinois. MDL 3026 Details
A second bellwether was dismissed in August 2025 after the court excluded the plaintiff’s causation expert. The Seventh Circuit heard oral arguments in May 2026 on one of these dismissed cases, focused on whether plaintiffs must identify a specific alternative warning that would have changed doctors’ behavior.13Law360. 7th Circ Weighs if Abbott Warning Would Change NEC Care That appeal was pending as of mid-2026.
Two new federal bellwether trials are set: an Enfamil case on July 6, 2026, and a Similac case on August 10, 2026. These will be the first federal NEC cases to actually reach a jury.9Lawsuit Information Center. NEC Baby Formula Lawsuits
How the Companies Are Responding
Abbott and Mead Johnson maintain their products are safe and that the science does not support the causation claim, pointing to the October 2024 federal joint statement. Defense experts testify that cow’s-milk-based formulas provide critical nutrition to infants already at high risk simply because they were born too early.
There is no global settlement and no public framework for valuing claims. Individual settlements have been confidential. Abbott CEO Robert Ford said on a July 2025 earnings call that the company was not open to settlement talks and would defend its products in court.9Lawsuit Information Center. NEC Baby Formula Lawsuits The upcoming federal bellwether trials in summer 2026 are widely seen as the next inflection point: a plaintiff win before a federal jury would sharply raise settlement pressure, while another defense success could push the litigation into a long run of individual state-court trials.
Who Can File
Families are still filing new cases. To qualify, an infant generally must have:
- been born prematurely,
- received cow’s-milk-based formula or fortifier made by Abbott (Similac) or Mead Johnson (Enfamil) during a NICU stay, and
- been diagnosed with NEC during or shortly after receiving the product.10Top Class Actions. Baby Formula NEC Lawsuit
Medical records showing the feeding history and NEC diagnosis are essential, along with expert testimony linking the formula to the disease. Statutes of limitations vary by state, typically two to four years from injury or discovery, though many states extend deadlines for minors. Because each case is individual rather than a class action, damages are assessed separately based on the severity of the child’s injuries, whether the child survived, whether surgery was required, and whether lasting disabilities or ongoing care are involved.
What the FDA Has and Hasn’t Done
The FDA has not recalled cow’s-milk-based preterm formulas and has not required manufacturers to add NEC warnings. The agency does not pre-approve infant formulas; it sets nutrient standards and can intervene on safety, but it has not done so here.14Sullo Law. NEC Baby Formula Lawsuits and the FDA The October 2024 joint statement with NIH and CDC acknowledged gaps in the science and called for more research but stopped short of recommending against formula, stating that “all infants should be fed as soon as is medically feasible through whatever appropriate nutritious food source is available.”1FDA. FDA Roundup So the litigation, not the regulator, is currently driving whatever accountability exists for these products.