Illinois Appellate Court Extends Learned Intermediary Doctrine, Overturns $60 Million NEC Verdict That Threatened Access to Preterm Infant Formula

A recent Illinois appellate ruling could help reshape failure-to-warn liability for infant formula and other physician-directed products, while also offering manufacturers new evidentiary protections at trial. The decision has immediate implications for necrotizing enterocolitis (“NEC”) litigation nationwide and for the broader supply of preterm infant formula.

Key Takeaways

• The Illinois Fifth District Appellate Court reversed a $60 million jury verdict against Mead Johnson, holding that the learned intermediary doctrine applies to infant formula administered in a NICU under physician direction, meaning the manufacturer’s duty to warn ran to treating physicians, not parents.
• The decision signals that courts may focus on the clinical context of product administration rather than formal regulatory classification, potentially expanding the learned intermediary doctrine to other products used under physician direction in hospital settings.
• NEC litigation poses a serious threat to the preterm formula supply; the vast majority of U.S. preterm infant formula comes from two manufacturers, and unchecked litigation pressure could deprive neonatologists of an essential instrument of care.
• The case is expected to be retried, and related proceedings, including a certified question before the Connecticut Supreme Court and a cert petition before the U.S. Supreme Court, may further shape the legal landscape.

What Happened?

On June 12, 2026, the Illinois Fifth District Appellate Court reversed a $60 million jury verdict against Mead Johnson & Company, LLC, in a case brought under Illinois products liability law alleging that the company failed to warn of risks associated with its cow-milk-based infant formula, Enfamil Premature 24 (“EPF24”), which the plaintiff alleged caused a premature infant to develop NEC.

In Watson v. Mead Johnson & Co., the mother of premature twins alleged EPF24 caused her infant to develop NEC, resulting in the child’s death at 25 days old. A St. Clair County jury awarded $60 million on failure-to-warn and negligence claims.

The appellate court reversed on two grounds. First, it held the learned intermediary doctrine applies because EPF24 was administered in a NICU under physician direction, meaning Mead Johnson’s duty to warn ran to treating physicians, not the infant’s mother. Second, it found the trial court improperly admitted corporate financial evidence in a compensatory-damages-only case.

Why This Matters for Healthcare, Life Sciences, and Infant Nutrition Companies

This decision carries significant implications across the healthcare and life sciences spectrum and raises broader policy concerns about continued access to infant formula for the most vulnerable patient populations in the United States.

Expansion of the Learned Intermediary Doctrine Beyond Prescription Products

The Illinois Appellate Court’s extension of the learned intermediary doctrine to a product that is neither a prescription drug nor a medical device marks a potentially significant shift in product liability law. Under the doctrine, a manufacturer satisfies its duty to warn by adequately informing the prescribing or treating physician — who acts as an intermediary exercising independent medical judgment — rather than warning the patient directly; a plaintiff can only overcome the defense by showing the doctrine does not apply (for example, if the patient retained independent choice over the product) or that the warning given to the physician was itself inadequate. By prioritizing physician-directed use, hospital procurement, and individualized medical judgment over regulatory classification, the court opened the door for manufacturers of medical foods, specialty nutrition products, and similar items to invoke the doctrine as a defense to failure-to-warn claims.

The court’s ruling does not extend the doctrine to all consumer or nutritional products, but instead turns on a fact-intensive inquiry into both the nature of the product and the context in which it is administered. The appellate court emphasized that EPF24 was ordered by the infant’s treating neonatologists based on hospital protocols, medical literature, and individualized professional judgment, that the formula was administered entirely within the NICU, and that mother did not select, purchase, or administer the product herself. The court also cited with approval authority declining to apply the doctrine where a physician merely recommended a product that the patient could have obtained and used without that recommendation. Accordingly, manufacturers should expect the expanded defense to be available primarily where a medical professional orders and directs the specific use of a product in a closely supervised clinical setting that leaves the patient, or in this case the patient’s parent, without a meaningful independent choice, and should be cautious about extending this reasoning to products marketed for, or readily obtained in, general consumer or retail settings, even where a physician has recommended the product.

Impact on NEC Litigation and the Preterm Formula Supply

NEC litigation has expanded rapidly, with hundreds of lawsuits and verdicts totaling hundreds of millions of dollars. This wave raises a critical policy concern: few companies in the United States produce formula for premature infants, and because preterm formula is medically essential when breast milk and donor milk are unavailable, unchecked litigation pressure coupled with questionable scientific analyses in the courts could threaten access to these products entirely. Loss of this supply would deprive neonatologists of an essential instrument of care, with foreseeable consequences including increased infant mortality and impaired neurological development.

Against this backdrop, the Watson decision offers manufacturers a new, though limited, defense framework that could help relieve some of the litigation pressure that has built up over time. By establishing that the warning obligation runs to NICU physicians who already understand and weigh NEC risks as part of routine clinical care, rather than to parents directly, the ruling gives manufacturers a viable path to defeat failure-to-warn claims arising from formula administered under close physician supervision. This defense is not a blanket shield, however; as discussed above, it applies only where the fact-intensive inquiry into the product’s nature and clinical context supports application of the doctrine, meaning its impact on the broader wave of NEC litigation will likely play out case by case rather than through wholesale dismissal of pending claims.

Evidentiary Guardrails for Compensatory Damages Cases

The Illinois Appellate Court’s ruling on financial evidence sends a clear signal: corporate revenue, executive compensation, and marketing budgets are generally inadmissible when only compensatory damages are at stake. The state appellate court observed that the $60 million verdict appeared “more punitive than compensatory,” driven by testimony about Mead Johnson’s wealth rather than evidence of defect, causation, or inadequacy of warnings. On retrial, such evidence is inadmissible unless directly relevant to an issue the jury must decide.

Implications for Affected Companies

The Watson decision carries several practical takeaways that manufacturers, litigators, and supply-chain stakeholders should factor into their planning.

• Learned intermediary doctrine. The Watson decision establishes that the learned intermediary doctrine applies to products administered in a NICU under physician direction, meaning the manufacturer’s duty to warn runs to treating physicians, not parents. This framework may be relevant to pending and anticipated NEC claims.
• Related proceedings. The Watson case is expected to be retried. The Connecticut Supreme Court is considering a certified question in Hunte v. Abbott Laboratories on the same learned intermediary issue, and the U.S. Supreme Court is considering a cert petition in a related NEC case.
• Supply-chain considerations. The vast majority of U.S. preterm infant formula comes from two manufacturers. Unchecked litigation pressure could threaten access to these essential products, with foreseeable consequences including increased infant mortality.
• Scope of the holding. The Watson decision addresses only failure-to-warn claims and does not address other products liability theories, such as manufacturing defect or design defect claims, which turn on different legal standards and evidentiary showings. Companies should not read the decision as providing guidance on, or otherwise influencing, the analysis of manufacturing defect or design defect claims.

Looking Ahead

The Watson ruling marks an important, if still developing, shift in how courts may evaluate failure-to-warn liability for products administered under close physician direction. With a retrial pending in Illinois and parallel proceedings before the Connecticut and U.S. Supreme Courts, the full scope of this defense, and its ability to ease pressure on the preterm formula supply, will continue to take shape over the coming months. Manufacturers and counsel should monitor these developments closely and assess how the fact-intensive standard articulated in Watson applies to their own products and clinical use contexts.