Jury Orders Abbott to Pay $53 Million in Landmark Preterm Formula NEC Case

CHICAGO — In a legal decision with far-reaching implications for neonatal care and the multi-billion dollar infant formula industry, a Cook County jury on April 9, 2026, ordered Abbott Laboratories to pay $53 million in compensatory damages to four families. The jury found the healthcare giant liable for failing to warn parents and medical providers that its cow’s milk-based preterm infant formula significantly increases the risk of Necrotizing Enterocolitis (NEC)—a devastating and often fatal intestinal disease. This verdict marks a pivotal moment in a mounting wave of litigation involving over 1,000 lawsuits against formula manufacturers, raising urgent questions about informed consent in the Neonatal Intensive Care Unit (NICU).

The Heart of the Case: Vulnerable Infants and Hidden Risks

The lawsuit focused on the experiences of four Chicago-area mothers whose premature infants developed NEC after being fed Abbott’s Similac Special Care or similar cow’s milk-based products while in the NICU.

NEC is a severe medical condition characterized by the inflammation and death of intestinal tissue. In its most critical stages, the bowel can perforate, leading to sepsis and, in 20% to 30% of cases, death. The disease primarily strikes very low birth weight infants (under 1,500 grams), affecting approximately 5-10% of this population.

Plaintiffs argued that Abbott was well aware of the link between cow’s milk-based formula and NEC but chose to aggressively market its products to hospitals as a “standard of care” without adequate warnings. Jurors agreed, determining that the company prioritized market share over the safety of the most vulnerable patients. The $53 million award is intended to cover medical expenses, lost quality of life, and the profound emotional trauma suffered by the families.

Scientific Evidence and the “Gold Standard” of Milk

The scientific crux of the litigation rests on decades of research comparing human milk to bovine-based formula. A landmark 1990 study published in The Lancet found that NEC was six to 10 times more common in formula-fed preterm infants than those fed exclusively breast milk. In some cases, the risk was 20 times higher for infants who received formula alone.

More recent data continues to support these findings:

• 79% Risk Reduction: Meta-analyses show that breast milk—specifically when supplemented by donor milk if maternal supply is low—can reduce NEC risk by nearly 80%.

• Biological Protective Factors: Human milk contains bioactive components, such as immunoglobulins and oligosaccharides, that help develop a healthy gut microbiome and protect the delicate intestinal lining of a preemie.

• The “Modifiable” Factor: While prematurity and low birth weight are unavoidable risks, medical experts identify the type of enteral feeding (what the baby is fed) as one of the few factors doctors and parents can actually control.

The Defense: Complexity and Necessity

Abbott’s legal team, led by attorney Karis Clark, maintained that the company’s products are safe and essential. The defense argued that NEC is a “multifactorial” disease, meaning it is caused by many variables including prematurity itself, respiratory distress, and necessary antibiotic use.

“These infants were born with significant health challenges,” the defense contended during the trial, suggesting that the babies would likely have developed NEC regardless of their diet. Furthermore, Abbott highlighted that the American Academy of Pediatrics (AAP) recognizes preterm formula as a necessary nutritional option when human milk is unavailable or insufficient to meet the extreme caloric needs of a growing preemie.

Expert Perspectives: A Divided Medical Landscape

The verdict has sparked intense discussion among pediatric experts. Dr. Mark Underwood, a pediatric gastroenterologist at UC Davis not involved in the litigation, suggests the relationship is nuanced.

“Human milk clearly lowers NEC risk through bioactive factors protecting the gut microbiome, but formula’s role is often associative,” Dr. Underwood noted. “While litigation pushes for better warnings which could save lives, we must be careful not to label formula as ‘toxic’ in every context.”

Dr. Stephanie Prescott, a Chicago-based neonatologist, emphasized the practical reality of the NICU. “We prioritize donor milk banks whenever possible, but currently, about 20% to 30% of preemies still require formula for growth when milk is unavailable. Stronger labeling would provide the informed consent parents deserve during a very stressful time.”

Public Health and Industry Implications

The preterm infant formula market was valued at $2.1 billion in 2024, with North America accounting for 38% of that share. As preterm birth rates remain high—roughly 12% of all U.S. deliveries—the demand for neonatal nutrition is constant.

This verdict may trigger several shifts in public health policy and hospital protocol:

1. Informed Consent: Hospitals may be required to provide more explicit warnings to parents regarding the comparative risks of formula versus donor milk.

2. Donor Milk Infrastructure: There is growing pressure to expand the nation’s donor milk banks. Currently, U.S. supply meets only about 1% of the potential demand.

3. Regulatory Review: The FDA may face renewed calls to review labeling requirements for specialized preterm formulas to include specific NEC risk disclosures.

Balancing Growth and Safety

While the jury’s decision provides a sense of justice for the plaintiffs, it also highlights a delicate balance. Medical ethicists, including Dr. Annie Janvier, have cautioned that if manufacturers exit the market due to liability concerns, the resulting shortage of specialized nutrition could inadvertently harm infants who cannot tolerate or access human milk.

For now, the legal battle continues. Abbott is expected to appeal the verdict, mirroring its strategy in other jurisdictions. However, with punitive damages deliberations on the horizon, the financial and reputational pressure on formula manufacturers is reaching an all-time high.

For parents of preterm infants, experts recommend having an open dialogue with their neonatology team about “exclusive human milk diets” and the specific protocols their NICU has in place to mitigate the risks of NEC.

Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.

References

• Reuters. “Jury orders Abbott to pay $53 million in preterm infant formula trial.” April 10, 2026. [DOI/Link: reuters.com/legal/litigation/2026-04-10]