Jury findings raise new questions about risk communication, labeling, and regulatory expectations for neonatal nutrition products

A Chicago jury has ordered Abbott Laboratories to pay $70 million in damages after finding that its cow’s milk-based premature infant formula, Similac Special Care, contributed to the development of necrotizing enterocolitis (NEC) in four preterm infants.

The verdict includes $53 million in compensatory damages and $17 million in punitive damages, with jurors determining that Abbott was liable for product defect, failure to warn, and negligence. Three of the affected infants required surgery, and all continue to experience long-term gastrointestinal complications.

Abbott has stated it will appeal the decision, asserting that the ruling contradicts the prevailing scientific and regulatory understanding of NEC risk.

A Rapidly Expanding Litigation Landscape

This case is part of a broader wave of litigation involving preterm infant formulas manufactured by Abbott and Mead Johnson (maker of Enfamil). Nearly 1,000 lawsuits have been filed, and more than 700 cases are consolidated in federal court in Illinois. Prior verdicts include a $495 million judgment against Abbott in Missouri that is under appeal, and a $60 million against Mead Johnson in Illinois that is under appeal.

To date, no federal bellwether trial has been completed, making state court verdicts particularly influential in shaping litigation strategy and settlement expectations.

The Science Remains Contested

NEC is a serious and often fatal gastrointestinal disease that primarily affects premature infants. The central legal question is whether cow’s milk-based formula increases NEC risk relative to human milk.

A 2024 working group supported by the National Institutes of Health concluded that the absence of breast milk, rather than the presence of formula alone, is associated with increased NEC risk for a uniquely vulnerable population requiring careful nutritional management. Evidence remains incomplete and evolving.

Clinical practice continues to reflect this uncertainty. Maternal breast milk is preferred for newborns and donor milk is often used when maternal supply is unavailable. And formula remains a critical alternative in neonatal intensive care units (NICUs)

Regulatory Classification: Food, Not Drug or Device

Despite their use in highly vulnerable patients, preterm infant formulas are regulated by the U.S. Food and Drug Administration as food products.

Exempt Infant Formula

These products, intended for infants with low birth weight or special medical needs are regulated under Section 412 of the FD&C Act and 21 CFR Part 107 and subject to pre-market notification, not pre-market approval.

FDA oversight includes nutritional adequacy requirements, ingredient safety (food additive or GRAS status), manufacturing controls and inspections, and labeling and use instructions.

Importantly, FDA does not “approve” infant formula in the same way it approves drugs or other healthcare products.

Where Litigation and Regulation Collide

The Abbott verdict highlights a critical disconnect. The regulatory framework is food-based and focused on nutrition and safety standards. Prenatal formulas are a clinical use case of a high risk, ICU-level application in premature infants. And their legal exposure is based on product liability standards more typical of drugs or devices.

The jury’s findings, particularly failure to warn and punitive damages, signal increased scrutiny in areas such as risk communication to clinicians and caregivers, labeling language and adequacy of warnings, internal safety assessments and decision-making, and postmarket surveillance and adverse event awareness.

Implications for Industry

This litigation is likely to drive significant changes across the neonatal nutrition sector.

Enhanced Labeling and Risk Disclosure

Manufacturers may face pressure to expand NEC-related warnings, clarify relative risks of formula vs. human milk, and improve clinician-facing safety communications.

Elevated Evidence Expectations

Even without formal FDA causation findings, companies may need to strengthen clinical and epidemiological evidence, conduct additional postmarket studies, and maintain more robust scientific justification files.

Convergence Toward MedTech-Level Rigor

Although regulated as food, these products may increasingly require structured risk management approaches, formal benefit-risk analyses, and enhanced complaint handling and signal detection. In practice, this begins to resemble medical device or pharmaceutical-level oversight discipline.

Potential Market Disruption

Abbott leadership has previously indicated that ongoing litigation could lead to withdrawal of preterm formula products, and neonatal clinicians have warned that such actions could limit critical feeding options in NICUs and create supply and care challenges for vulnerable infants.

MDP Perspective

This case represents a pivotal moment in the intersection of consumer product regulation, clinical risk in vulnerable populations, and product liability law.

While preterm infant formula remains classified as a food product, its real-world use in high-risk medical settings is driving expectations toward a much higher standard of evidence generation, risk communication, and lifecycle safety management.

Conclusion

The Abbott verdict underscores a fundamental reality. Products regulated as food may still carry the clinical risk, and legal exposure, of far more tightly regulated categories when used in vulnerable populations.

For manufacturers, the path forward will require not only regulatory compliance, but proactive, defensible strategies for safety, labeling, and evidence development.

Read more about food risk in vulnerable populations.