Baby formula is not a prescription drug. No doctor hands you a slip of paper for it. The FDA does not regulate it that way. And yet — when a premature newborn receives cow-milk-based preterm formula through a tube in a neonatal intensive care unit, administered by hospital staff, ordered by neonatologists, selected after individualized review of the infant’s gestational age, birth weight, comorbidities, and the risks and benefits of every available feeding option — what is that if not a prescription? Watson v. Mead Johnson & Company, LLC, 2026 IL App (5th) 240936, 2026 WL 1706992 (Ill. App. Ct. June 12, 2026), answers that question. In what we believe is the first ruling by any appellate court on the issue, an Illinois intermediate appellate court reversed a multi-million-dollar verdict and held that the learned intermediary doctrine applies to infant formula used exclusively in a hospital setting under physician oversight. The formal absence of an FDA prescription requirement does not determine the analysis. The clinical context does.

Plaintiff’s son was born more than two months premature. He spent his entire 25-day life in neonatal intensive care. His physicians discussed the risks of prematurity with his mother, including necrotizing enterocolitis (NEC), a potentially fatal inflammatory intestinal disease, before and after birth. During his hospitalization, the baby’s neonatologists ordered his feedings be supplemented with defendant’s cow-milk-based formula for preterm infants. The child developed NEC and underwent three unsuccessful surgeries. Plaintiff sued the formula manufacturer for strict liability design defect, strict liability failure to warn, and negligence. The jury found for plaintiff on the failure-to-warn and negligence counts. Defendant’s posttrial motions were denied.  Id. at *1-3.

Before the appellate court could reach the learned intermediary question, it had to address plaintiff’s threshold procedural argument—the general verdict rule. The general verdict rule provides that when a jury returns a general verdict on multiple theories of liability, the verdict will be upheld if there was sufficient evidence to support any one of those theories—and a defendant who failed to request special interrogatories cannot complain on appeal. Id. at *17. Plaintiff argued that the learned intermediary doctrine applied only to her strict-liability failure-to-warn claim, not to her four theories of negligence, and that because the jury returned a general verdict encompassing negligence as well, defendant was foreclosed from raising the issue on appeal.

The court was not persuaded. It reviewed plaintiff’s four negligence theories: (a) defendant knew or should have known its formula significantly increased NEC risk; (b) it placed a harmful product into commerce; (c) it marketed the product for premature infants despite the risk; and (d) it failed to disclose NEC risks to parents and healthcare providers. The court dissected each in turn. Theory (a) mirrored the strict-liability failure-to-warn claim. Theory (b) was a reframing of the design-defect theory. Theory (c) was a restatement of the failure-to-warn claim—Illinois does not recognize negligent marketing as an independent cause of action. Theory (d) was “effectively identical” to the strict-liability failure-to-warn count. Id. at *19. In the court’s words, plaintiff’s “negligence theories materially overlap with, and in several instances merely restate, the same factual grounds underlying her strict liability design-defect and failure-to-warn claims.” Id. at *18. The negligence count did not set forth four distinct theories but rather “repeated iterations of the same operative facts framed under multiple labels.” Id. at *20. Where negligence is re-packaged strict liability, it is not treated as a separate basis for recovery, and the general verdict rule does not bar appellate review.

With that threshold cleared, the central question was to whom defendant’s duty to warn ran. Defendant said: to the physicians. Plaintiff said: to the mother.

Plaintiff’s position had surface appeal. Baby formula is not an FDA-regulated prescription drug. Parents can, in principle, purchase it online. The learned intermediary doctrine, the argument went, belongs to prescription drugs and prescription devices. Baby formula is a food.

The appellate court disagreed. It started with the rationale underlying the learned intermediary doctrine as articulated by the Illinois Supreme Court—prescription drugs are complex; the prescribing physician weighs a drug’s propensities against the patient’s susceptibilities; the choice the physician makes is an “informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.” Id. at *21. That rationale, the court observed, does not turn on whether the FDA has stamped “prescription only” on a label. It turns on whether individualized medical judgment was exercised in selecting and administering the product.

The undisputed evidence put the point beyond argument. The formula was obtained by the hospital directly from defendant. No infant in the NICU could receive it without a physician’s order. The neonatologists who ordered it for plaintiff’s son did so after evaluating his gestational age, birth weight, comorbidities, growth trajectory, the NEC risk associated with formula versus human milk, and the available alternatives. That is exactly “the individualized medical judgment of the type upon which the learned intermediary doctrine is based.” Id. at *22. The formal absence of a prescription requirement did not change what was actually happening in that NICU. The formula was, in the court’s words, “squarely within the class of products for which the learned intermediary doctrine applies.” Id.

Plaintiff pointed to the online availability of the product as evidence that the doctrine should not apply. The court dispatched that quickly. Plaintiff’s son never left the hospital. Plaintiff did not purchase the formula. “Considering the nature of [the formula] and the context in which the product was administered,” id., the court held that the learned intermediary doctrine applied as a matter of law. The duty ran to the physicians. We agree.

The trial court’s refusal to give the learned intermediary instruction was therefore reversible error. “By rejecting the doctrine, the trial court fundamentally skewed the legal lens through which jurors evaluated the evidence because the jury instruction misstated to whom [defendant’s] duty was owed.” Id. at *23. The error was not a technicality. It directed the jury to evaluate whether plaintiff was adequately warned when, as a matter of law, the duty ran to her son’s physicians. Illinois precedent is clear that when a case is tried under an erroneous theory of law, reversal and a new trial are required. Id.

The court also addressed one evidentiary issue it expected to recur on remand—the admission of extensive financial evidence regarding defendant’s revenues, profit margins, and executive compensation, despite the fact that plaintiff sought only compensatory damages and asserted no claim for punitives.

Plaintiff had argued the evidence was relevant to motive, knowledge, and corporate priorities. The trial court agreed and admitted it. The appellate court did not. Under Illinois law, when only compensatory damages are recoverable, a party’s financial condition is irrelevant and often prejudicial — it appeals to the jury’s sympathy and invites a verdict based on the defendant’s ability to pay rather than on evidence of liability. Id. at *24. The financial evidence here was anything but incidental. It was introduced before the first witness was called, highlighted repeatedly during trial, and emphasized in opening statements and closing argument. The jury heard about defendant’s revenues, its parent company’s billions in global sales, and executive compensation packages — none of which bore on whether the product was defective, whether the warnings were adequate, or what the compensatory damages should be. Motive, in any event, was not an element of plaintiff’s burden of proof. On remand, such evidence is inadmissible absent a punitive damages claim. Id.

The learned intermediary doctrine has never been a creature of FDA classifications. It is a doctrine built on clinical reality—a medical professional stands between the manufacturer and the patient, exercises independent expert judgment, and makes an individualized decision to use a product for a specific patient. When a preterm infant formula is ordered by a neonatologist in a NICU, administered through a tube, and selected through precisely that kind of individualized medical assessment, calling it “food” rather than a “prescription drug” does not change the analysis. The label on the can does not determine the law.