The Similac lawsuit is not one case but hundreds of individual product liability claims accusing Abbott Laboratories of causing necrotizing enterocolitis (NEC) in premature infants fed its cow’s-milk-based preterm formulas. As of mid-2026, roughly 780 to 800 federal cases sit in a multidistrict litigation in the Northern District of Illinois, hundreds more are in state courts, and juries in Missouri and Illinois have hit Abbott with verdicts of $495 million and $70 million. No global settlement has been announced, and trials are ongoing.1
What Parents Are Claiming
The core allegation is that Similac Special Care, NeoSure, and Similac Human Milk Fortifier significantly raise the risk of necrotizing enterocolitis when fed to premature or very low birth weight infants in neonatal intensive care units. NEC is a serious and sometimes fatal intestinal disease. Tissue in the bowel becomes inflamed and begins to die. Babies who survive often need emergency surgery and can face lifelong complications, including short bowel syndrome.
Families argue that Abbott knew its cow’s-milk-based formulas posed an elevated NEC risk compared to human breast milk and donor milk, but did not warn parents or adequately inform doctors. The complaints generally raise three theories: defective design, negligence, and failure to warn. These are individual mass tort claims, not a single class action. Each family files on behalf of its own child.
Similar cases are pending against Mead Johnson, the Reckitt subsidiary that makes Enfamil, and the two sets of cases are being handled together in the federal litigation.
Where the Cases Are Being Heard
In April 2022, the Judicial Panel on Multidistrict Litigation consolidated the federal NEC formula cases into MDL No. 3026 before Judge Rebecca Pallmeyer in the Northern District of Illinois. More than 1,700 cases are pending across federal and state courts combined.
The federal MDL has been slow going for plaintiffs. No family has won a verdict in federal court so far. The first three bellwether cases chosen for trial were all dismissed on summary judgment after Abbott successfully attacked the plaintiffs’ causation experts. In Diggs v. Abbott Laboratories, Judge Pallmeyer excluded the plaintiff’s specific causation expert in July 2025, citing a lack of “factual fit” between the expert’s opinion and the infant’s gestational profile, and then granted summary judgment for Abbott.
Plaintiffs have done better on the broader science. In May 2025, Judge Pallmeyer denied defense motions to exclude two general causation experts, Dr. Logan Spector and Dr. Sucre, keeping alive the argument that cow’s-milk-based formulas substantially increase NEC risk in preterm infants. In August 2025, the court struck a defense expert for relying on inaccurate figures.
The next federal bellwether, Inman v. Mead Johnson, was scheduled for July 6, 2026. It involves Enfamil rather than Similac, and centers on a premature infant named Daniel, born at 29 weeks, who developed NEC after being fed Enfamil Premature and died in June 2020. The court found sufficient evidence that the mother’s own breast milk was an available alternative, which created a genuine dispute about whether a warning would have changed the feeding decision. A second bellwether involving a Similac case was set for August 2026, with more trials proposed through early 2027.
Because the federal track has been unfavorable, plaintiffs’ lawyers have increasingly moved cases into state courts. That is where the biggest verdicts have come from.
The Verdicts So Far
Three verdicts have shaped the litigation.
- In July 2024, a St. Louis jury awarded Margo Gill $95 million in compensatory damages and $400 million in punitive damages in Gill v. Abbott, finding that Abbott’s preterm formula caused her daughter Robynn Davis to develop NEC. Davis, born at 26 weeks in 2021, lost roughly 75 percent of her intestine and suffered severe brain damage, and will need lifelong care. A Missouri appellate court affirmed the full $495 million verdict on May 5, 2026.
- In April 2026, a Cook County jury ordered Abbott to pay $53 million in compensatory damages and $17 million in punitive damages to four families whose children, all born before 32 weeks, developed NEC after consuming Similac Special Care. Three of the children required surgery, and all four continue to experience gastrointestinal complications. The jury found Abbott liable for product defect, failure to warn, and negligence, and found the company’s conduct “willful and wanton.”
- In March 2024, an Illinois jury awarded $60 million to a mother whose baby died from NEC after consuming Enfamil, in a case against Mead Johnson.
Not every trial has gone against the manufacturers. In October 2024, a Missouri jury returned a complete defense verdict for Abbott and Mead Johnson in a case seeking more than $6.2 billion. Judge Michael Noble vacated that verdict in March 2025, finding that defense counsel engaged in “pervasive prejudicial conduct,” including intentionally violating court orders and misleading the jury. A new trial was ordered but not yet scheduled. In March 2026, a Broward County, Florida judge dismissed an NEC case against Abbott, ruling that Abbott could not be sued for failure to warn because it provided its formula to doctors in hospitals rather than directly to consumers.
Abbott says it will appeal the $70 million Chicago verdict, arguing “science was ignored,” and “strongly disagrees” with the Missouri appellate court’s decision affirming the $495 million Gill award, which it plans to challenge further.
The Learned Intermediary Ruling
The most consequential legal development came from the Missouri appellate opinion in Gill. Abbott had argued that because its preterm formula is used in hospital NICUs under a doctor’s supervision, the “learned intermediary” doctrine should apply. Under that doctrine, a manufacturer’s duty to warn runs only to the prescribing physician, not to the patient or parent. If accepted, that theory could have shielded Abbott from many of the failure-to-warn claims driving the litigation.
The appellate court rejected it. It ruled that preterm infant formula is food, not a prescription drug or medical device, so the learned intermediary doctrine does not apply. The court also found that Abbott had internal knowledge of the elevated NEC risk for very low birth weight infants but did not communicate it clearly. The ruling weakens a defense Abbott has relied on across the broader litigation.
How Abbott Is Fighting Back
Abbott and Mead Johnson maintain that NEC is fundamentally a “disease of prematurity” and that no scientific evidence proves their formulas cause it. They point out that preterm formula has been on the market for more than 45 years, is FDA-regulated, and has been the subject of hundreds of clinical trials. They call it an essential medical resource for premature babies when breast milk is unavailable.
They also argue that NICU feeding decisions are made by neonatologists, not by parents reading a label, and that doctors already understand the risks of formula feeding in preterm infants. A large part of the defense strategy has been to challenge plaintiffs’ expert witnesses under Daubert, which asks courts to exclude expert testimony that fails scientific reliability standards. That approach worked in Diggs but failed against the plaintiffs’ broader general-causation experts.
The underlying science is genuinely contested. A 2024 report from the National Advisory Council of Child Health and Human Development concluded that “available evidence supports the hypothesis that it is the absence of human milk — rather than the exposure to formula — that is associated with an increase in the risk of NEC.” A peer-reviewed article in Nature‘s Journal of Perinatology noted that research supporting the idea that “toxic components in infant formula cause NEC is limited to preclinical data while data from human infants are lacking.” Plaintiffs respond with internal Abbott documents they say show the company knew of elevated risks, along with studies showing higher NEC rates with bovine-based milk fortifiers than with exclusive human milk-based diets.
Abbott has also moved outside the courtroom. In late 2025, the company launched a lobbying campaign threatening to stop making its preterm formula products unless Congress and federal health officials provide protection from NEC-related lawsuits.
Do You Have a Claim
Families considering a case generally need to show that the child was born prematurely or at low birth weight, was fed a cow’s-milk-based formula such as Similac or Enfamil in the NICU, and was later diagnosed with NEC. Medical records confirming the specific formula administered and its timing relative to NEC onset are critical. Expert testimony is required to establish causation.
Statutes of limitations vary by state, typically running two to four years for product liability claims. Illinois, where the manufacturers are headquartered, has a general two-year deadline. Many states apply a “discovery rule” that starts the clock when the connection between formula and NEC is discovered, rather than when the injury occurred. In most jurisdictions, the limitations period on a claim brought for a minor does not begin to run until the child turns 18, though parents’ own claims for associated damages may face a shorter deadline.
Bloomberg Intelligence has estimated combined liability exposure of roughly $3 billion for Abbott and Mead Johnson across pending and anticipated cases, though the real figure depends heavily on trial and appellate outcomes. Most individual settlements that have occurred are confidential, and no global settlement has been announced.
The 2022 Recall and Heavy Metals Case Are Separate
Two other Similac matters sometimes get folded into the “Similac lawsuit” question, but they are distinct from the NEC litigation. In February 2022, Abbott voluntarily recalled Similac, Alimentum, and EleCare powdered formulas made at its Sturgis, Michigan plant after reports of four infant Cronobacter sakazakii infections, two of which the FDA said may have contributed to the infants’ deaths. Abbott entered a consent decree with the DOJ and FDA in May 2022 and resumed production later that year. The DOJ opened a criminal investigation into conduct at the plant in January 2023; as of mid-2026, no charges have been filed.
Separately, in March 2025, two mothers filed a putative class action, Huggins v. Abbott Laboratories, in the Northern District of Illinois, alleging that Similac powdered formulas contained undisclosed arsenic, cadmium, lead, and mercury. In April 2026, the court granted summary judgment for Abbott, ending the case.
What to Watch Next
The Inman federal bellwether is widely viewed as a possible inflection point. A plaintiff verdict in federal court would meaningfully change settlement dynamics after a string of defense wins on summary judgment. The Seventh Circuit is also weighing whether five Pennsylvania cases belong in the federal MDL at all, a ruling that could shrink the scope of the federal consolidation. Abbott, for its part, is appealing the large state verdicts and has publicly floated exiting the preterm formula market without legislative protection from liability. Where the litigation heads next depends heavily on how those three fronts resolve.