The Baby Formula Wars: When Science, Law, and Grief Collide

Four mothers in Illinois watched their premature newborns get wheeled into the NICU. Each baby was fed Similac Special Care 24 — Abbott Laboratories’ cow’s milk-based formula engineered for preemies. Each developed necrotizing enterocolitis, or NEC: a devastating bowel disease that destroys intestinal tissue in premature infants and carries a death rate of up to 50 percent in the most severe cases.

Three of those babies needed surgery. All four survived. Yet their lives were changed forever.

Earlier this year, a Cook County jury ordered Abbott to pay the four families $70 million. The jury found the company liable for defective design, failure to warn, and negligence.

It was not an outlier verdict. However, it may not tell the whole story either.

The Verdicts Keep Coming

More than 1,700 lawsuits have been filed nationally. A $495 million verdict against Abbott in Missouri was upheld by a state appellate court in May. A separate $60 million verdict against Mead Johnson, maker of Enfamil, came down in 2024. Together, Abbott and Reckitt, Mead Johnson’s parent company, control roughly 80 percent of the specialty preterm formula market in the United States.

The financial fallout is already reshaping the industry. Reckitt is exploring a sale of its Mead Johnson nutrition division. Abbott 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.

That warning is not just corporate self-interest. It points to a genuine dilemma at the center of this litigation, one that the verdicts alone don’t resolve.

What the Plaintiffs Argue

The core of the litigation is not simply that babies got sick. It is that Abbott knew the risks and said nothing.

Peer-reviewed studies dating to the 1990s showed NEC was six to ten times more common in formula-fed preemies than in those receiving breast milk. Plaintiffs argue Abbott continued marketing Similac Special Care 24 directly into NICUs for decades — with no warning on the packaging and no disclosure to parents.

Judge John Ehrlich found sufficient evidence of concealment to allow punitive damages. The jury agreed, adding $17 million on top of the compensatory award.

“Four families walked into that courtroom asking for justice,” said Ben Whiting, lead counsel for the Chicago families. “And four families received it.”

Photo by Visualss on Unsplash

What Abbott Argues And Where It Has Won

Abbott has not been losing everywhere.

The company argues that extreme prematurity and very low birthweight, not its formula, drove these outcomes. It also maintains that because Similac Special Care is not sold over the counter, it had no legal duty to warn parents directly, only physicians — a standard it says was already met through labeling and the existing medical literature.

Federal judges have been more receptive to that argument than state juries. Judge Rebecca Pallmeyer, overseeing the federal multidistrict litigation, has granted Abbott summary judgment in all three federal bellwether cases tried so far — each dismissed before a jury heard evidence, largely because plaintiffs could not establish that human milk alternatives were available at the scale NICUs require.

A pending Seventh Circuit ruling could prove decisive. If the court finds these cases were improperly moved to federal court, hundreds could return to state courts — where juries have already delivered more than $625 million in verdicts.

The Science Is Genuinely Contested

This is where the story gets complicated and where the courtroom narrative diverges most sharply from the clinical one.

“There is no evidence that the formulas cause NEC,” Dr. Mark Corkins, division chief of pediatric gastroenterology at the University of Tennessee Health Science Center, tells me. “That is why these court cases make no sense to the folks who understand the actual science.”

Dr. Mark Underwood, emeritus professor of pediatrics at UC Davis, agrees that breast milk is protective, yet draws a critical distinction: “I cannot find any compelling evidence that infant formula contains anything that causes NEC.”

Dr. Steven Abrams, professor of pediatrics at the Dell Medical School at the University of Texas at Austin, goes further. Preterm formulas and bovine-based human milk fortifiers, he tells me, “are an essential part of neonatal care for many infants, 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.”

After the 2024 verdicts, the FDA, CDC, and NIH issued a rare joint statement: no conclusive evidence that preterm formula causes NEC. They acknowledged human milk is protective. They stopped well short of calling formula the culprit.

Even the NEC Society, a patient-led nonprofit fighting the disease, has criticized the litigation, arguing that feeding decisions “should be made at patients’ bedsides, not in courtrooms.”

The Real Fear

What neonatologists fear most is not the verdicts themselves. It is what happens if the products disappear.

“That is a very real worry that it will drive the premie formulas off the market,” Dr. Corkins tells me. “If you don’t have breast milk but want to start feeding a premature infant, what do you use?”

The fallback, standard term formula, would leave the smallest babies worse off, Dr. Underwood warns, increasing rates of metabolic bone disease and stunting growth. Some NICUs are already requiring documented parental consent before administering preterm formula, a precaution that adds complexity to some of the most time-sensitive decisions in medicine.

Premature babies need calories to survive. That is not in dispute. The question, still unresolved, is whether the warning labels on the products delivering those calories should have said more.

The Influence Question

The industry has not been passive in shaping the policy environment around these debates.

A Lancet analysis found the six largest American formula manufacturers spent $184.2 million lobbying the federal government between 2007 and 2018, targeting Congress, the FDA, the State Department, the White House, and the USDA. Abbott alone accounted for nearly 80 percent of the $55.1 million declared as formula-related lobbying.

Among the targets: expanded parental leave. Critics argue the industry has long understood that longer paid leave means more breastfeeding and less formula dependency. The United States remains the only OECD country without legislated paid maternity leave, a policy gap that pushes millions of mothers toward formula out of economic necessity rather than choice. The formula industry has denied that opposition to parental leave is motivated by market considerations.

A Longer History And a Global One

The domestic litigation is damning enough on its own terms. Nevertheless, it sits within a much longer and darker history of formula marketing, one that played out most lethally not in American courtrooms but in the clinics and villages of the developing world.

Beginning in the 1970s, aggressive formula marketing across Sub-Saharan Africa, Southeast Asia, and Latin America contributed to a wave of infant deaths that drew global condemnation. The mechanics were well-documented: mothers in maternity wards were given free samples, enough to suppress lactation and establish dependency. When the samples ran out, families who couldn’t afford to keep buying formula mixed powder with contaminated water. Babies died of malnutrition and waterborne disease at scale. Nestlé bore the brunt of international criticism, triggering a boycott that remains active today. The practice, however, was industry-wide.

The WHO responded with the International Code of Marketing of Breast-milk Substitutes in 1981 — prohibiting free samples in health facilities, banning direct-to-consumer advertising, and requiring honest labeling. More than 100 countries have since incorporated elements of the Code into national law.

Compliance, however, has remained inconsistent.

A 2020 investigation by the Bureau of Investigative Journalism found formula companies, including Nestlé, using Instagram to market to consumers in Southeast Asia in ways that raised concerns over potential violations of the WHO Code. A separate 2024 report by the Swiss watchdog Public Eye and the International Baby Food Action Network found Nestlé adds sugar and honey to infant milk and cereal products sold in dozens of low- and middle-income countries — products sold with no added sugar in Switzerland, where the company is headquartered. The implication is straightforward: regulatory asymmetry allows standards to vary based on what markets can and cannot enforce.

Defenders of the industry point out that formula has also saved lives in contexts where mothers cannot breastfeed due to illness, malnutrition, or death, and that blanket condemnation of formula marketing ignores the genuine public health role the products play in resource-limited settings. UNICEF and the WHO both acknowledge that formula remains essential when breastfeeding is not possible, and that the goal is informed choice, not prohibition.

The tension between those positions, formula as lifesaver versus formula as commercial product marketed without adequate guardrails, is the same tension animating the American litigation, just playing out on a global scale and without the benefit of a jury.

Where This Leaves Us

The litigation will continue for years. The science will remain contested. And somewhere in the middle are the families, and the neonatologists, trying to make the best decisions possible with incomplete information.

What is clear is that premature infants are among the most vulnerable patients in medicine. What is less clear is who bears responsibility when they get sicker — the disease, the biology of prematurity, the products feeding them, or the institutions that marketed those products without fuller disclosure.

The courts are working through that question one verdict at a time. The answers, so far, depend heavily on which courtroom you’re in.

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