Juries Punish Baby Formula Makers Over Hidden Killer That Stalks Premature Infants

Four Illinois mothers went into labor prematurely between 2012 and 2019. Each delivered at a Chicago-area hospital, and each watched as her newborn wass transferred to the neonatal intensive care unit, where nurses fed the babies Similac Special Care 24 — Abbott Laboratories’ cow’s milk-based formula designed for premature infants.Each developed necrotizing enterocolitis, better known as NEC, a devastating bowel disease that kills the intestinal tissue of premature babies. Three needed surgery shortly after birth. All four survived, but in a lawsuit in April the jury heard about disfigurement, emotional distress, and the loss of a normal life.After roughly 10 hours of deliberation, the Cook County jury ordered Abbott to pay the families $53 million in compensatory damages, $1 million more than their own attorney had asked for, with each family receiving between $7 million and $16 million.The next day, jurors added $17 million in punitive damages, bringing the total to $70 million. The jury found Abbott liable for defectively designing the product, for failing to warn of the risk, and for negligence. Company shares fell 2.4 percent on the news.The verdicts are piling up, and the baby formula industry is running out of places to hide.A bellwether trial against Reckitt Benckiser subsidiary Mead Johnson, maker of Enfamil, is scheduled for July 6 in the federal multidistrict litigation; three more federal bellwether trials against Abbott are slotted for August and November of this year and for February 2027; and a Missouri appellate court in May upheld a $495 million verdict against Abbott with no reduction in the total.For an industry that built its fortune in the neonatal intensive care unit, the courtroom has become the most dangerous room in America. So, is the case against formula closed? Not so fast. Many of the physicians who treat these infants say the juries have it wrong.“There is no evidence that the formulas cause NEC,” the division chief of pediatric gastroenterology, hepatology and nutrition at the University of Tennessee Health Science Center, Dr. Mark Corkins, tells The New York Sun. “That is why these court cases make no sense to the folks who understand the actual science.”The disease mothers were never warned aboutNecrotizing enterocolitis, or NEC, causes the tissue lining a newborn’s intestine to become inflamed and die. The condition, among the most feared diagnoses in any NICU, mostly strikes premature babies and carries a death rate that the medical literature places between 20 and 30 percent, rising to as high as 50 percent in surgical cases.Federal health data attributed hundreds of infant deaths to the disease in a single recent year. Survivors often face a lifetime of complications, from short bowel syndrome to neurological damage.“Being premature creates a risk for NEC,” Dr. Corkins tells the Sun. “However, if you feed breastmilk, the NEC risk goes down but doesn’t eliminate it. Feeding the premie formulas has a higher risk of NEC than getting breastmilk. Of course, one of the crucial factors for premature infants is getting them to grow, which requires nutrition.”Premature, by medical definition, means born before 37 completed weeks of gestation. That is three or more weeks before a full-term pregnancy concludes at 40 weeks, when organs are fully developed. It is the population for which Similac Special Care 24 was designed, and the one at the center of more than 775 federal lawsuits consolidated against Abbott and Mead Johnson — with hundreds more pending in state courts across the country.The plaintiffs argued that Abbott had known the danger since at least the 1990s, when peer-reviewed studies began showing NEC was six to 10 times more common in formula-fed preemies than in those receiving breast milk. Yet the company continued marketing its formula to hospitals as safe and necessary while disclosing the NEC risk to nobody — not the medical staff administering it, and not the parents of the babies receiving it.After the jury returned the compensatory verdict in the Cook County case, Judge John Ehrlich found sufficient evidence that Abbott had hidden those risks to allow the punitive phase to proceed.The jury agreed. Jurors found that Abbott marketed Similac Special Care 24 directly into neonatal intensive care units, while declining to place any warning on its packaging, even as evidence aired at trial pointed to decades of internal awareness of the elevated danger.The verdict held Abbott to account not for making the formula, but for selling it into the NICUfor selling it into the NICU without adequately warning the medical staff or parents of the risks it knew. Abbott disputed their product’s responsibility at every turn. It argued that the infants’ extreme prematurity and very low birthweights — not its formula — drove their disease; and that Similac Special Care has been on the market for decades, backed by research that it says shows the product does not cause NEC.The company also insisted that because the formula is not sold over the counter, Abbott maintained it had no legal duty to warn parents at all — only doctors, a standard that it argued was already satisfied by its product labeling and the existing medical literature.Still, the verdict is part of a larger pattern.In March 2024, a St. Clair County, Illinois, jury delivered a landmark $60 million verdict against Mead Johnson, the first trial ever to hold a cow’s milk-based formula manufacturer accountable for a premature infant’s NEC.Months later, a Missouri jury ordered Abbott to pay $495 million, including $400 million in punitive damages, to the mother of a girl who was born at 26 weeks and developed the disease after a neonatal intensive care unit switched part of her feeding from human milk to Abbott’s preterm formula. A state appellate court upheld the verdict in full in May.Abbott has not backed down. The company has put the medical community on notice that if the verdicts keep coming, pulling its preterm formula from the market entirely becomes a real possibility. It characterizes the litigation not as a consumer protection matter but as a threat to a product that doctors need and regulators have deemed safe.It has won where the cases reached federal judges rather than state juries. But in a fresh blow, a St. Louis Circuit Court judge vacated the manufacturers’ only favorable jury verdict in any state court after finding that Abbott repeatedly introduced inadmissible evidence and violated court orders.A billion-dollar reckoning and ongoing controversiesWhat Abbott faces in court now is unlike anything the formula industry has seen. More than 1,700 lawsuits have been filed nationally over whether its cow’s milk-based preterm formula causes NEC — roughly 780 of them consolidated before a federal judge in the Northern District of Illinois, with hundreds more working throughstate courts across the country.Together, Abbott and Reckitt control roughly 80 percent of the specialty preterm formula market in the United States.The financial fallout is already reshaping the sector. Reckitt is exploring a sale of its Mead Johnson nutrition division amid mounting liabilities. Abbott has gone further: CEO Robert Ford has warned investors it will become “extraordinarily difficult for any company to continue providing these medically necessary products” if the verdicts keep mounting. The company has proposed transferring control of its preterm formula sales to the federal government to keep them on the market.The industry and Washington push backThe controversy reaches into Washington, too.A Lancet analysis found that the six largest American formula manufacturers — led by Abbott, Mead Johnson, and Nestlé — spent $184.2 million lobbying the federal government between 2007 and 2018, targeting Congress, the FDA, the State Department, the White House, and the Department of Agriculture. Of the $55.1 million declared as formula-related lobbying, Abbott alone accounted for nearly 80 percent.Among other things, industry groups lobbied against expanded parental leave, prompting criticism that the manufacturers fear more paid leave would give mothers the latitude to breastfeed for longer. America is the only OECD country without legislated paid maternity leave. This gap pushes millions of mothers back to work within weeks of giving birth and toward formula out of necessity rather than choice.The formula makers have friends in high places. After the 2024 verdicts sent shockwaves through the industry, three of the country’s most powerful health agencies — the FDA, the CDC, and the NIH — issued a joint statement saying they find no conclusive evidence that preterm infant formula causes NEC. They did concede that human milk protects against the disease, but stopped well short of implicating formula as the cause.Even the NEC Society, a patient-led nonprofit fighting the illness, has criticized the litigation, arguing that “feeding decisions should be made at patients’ bedsides, not in courtrooms.”An emeritus professor of pediatrics at the UC Davis School of Medicine, Dr. Mark Underwood, tells the Sun the protective power of breast milk is real; however, that does not make formula the culprit.“It is clear that human milk, especially mom’s milk that is not pasteurized, contains many bioactive molecules, cells and even healthy bacteria that are protective against NEC,” he says. But “I cannot find any compelling evidence that infant formula contains anything that causes NEC.”A professor of pediatrics at the Dell Medical School at the University of Texas at Austin, Dr. Steven Abrams, concurs that preterm formulas and bovine-based human milk fortifiers “are an essential part of neonatal care for many infants, such as larger preterm infants, those who need extra nutrients after they go home and those with chronic illnesses such as chronic lung disease.”“Without these products caring for these infants would be difficult and it would be more difficult to provide optimal care,” Dr. Abrams tells the Sun.That is the fear haunting neonatologists as the verdicts mount: that the products could vanish altogether.“That is a very real worry that it will drive the premie formulas off the market,” Dr. Corkins surmises. “If you don’t have breast milk but want to start feeding a premature infant, what do you use?”Some nurseries, he notes, are now documenting parental consent before using any premature formula. Dr. Underwood warns that the fallback, standard term formulas, would leave the smallest babies worse off, “resulting in more osteopenia, aka metabolic bone disease, and less robust growth.”Federal judges have proven to be a tougher audience than state juries.Judge Rebecca Pallmeyer, who oversees the multidistrict litigation, has granted Abbott summary judgment in all three federal bellwether cases tried so far — each dismissed before a jury ever heard the evidence, largely because plaintiffs could not establish that a human milk-based alternative was feasible at the scale NICUs require.A separate appeal before the Seventh Circuit could prove more consequential: the court is weighing whether hundreds of NEC cases were improperly pulled into federal court in the first place, and a ruling against the manufacturers could send them back to state courts — where three juries have already delivered verdicts worth more than $625 million.For the families who have already prevailed in court, the verdicts speak for themselves.“Four families walked into that courtroom asking for justice,” he said Ben Whiting, a senior partner at Keller Postman and lead counsel for the four Chicago families who won the $70 million verdict in April. . “And four families received it.”

Juries Punish Baby Formula Makers Over Hidden Killer That Stalks Premature Infants

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