Background
Jasmine Watson brought suit as administrator of the estate of her son Chance Dean, a premature infant born at 31 weeks and 2 days who died at 25 days old in March 2020. While in the neonatal intensive care unit (NICU) at Barnes-Jewish Hospital and later at Children’s Hospital in St. Louis, Chance initially received intravenous nutrition followed by donor milk and his mother’s expressed breast milk. Because Memorial Hospital in Shiloh, Illinois—where the family sought a transfer to be closer to home—did not stock donor milk, Chance’s care team transitioned him to Enfamil Premature 24 Cal/fl oz with iron (EPF24), a cow-milk-based preterm formula manufactured by Mead Johnson, before the transfer. Days after the transfer, Chance developed necrotizing enterocolitis (NEC), underwent three surgeries, and died.
Watson alleged strict liability based on design defect, strict liability for failure to warn, and negligence. The design-defect count did not reach the jury. Following a jury trial in St. Clair County, Illinois, the jury found for Watson on the failure-to-warn and negligence counts and awarded $60 million in damages. The trial court denied Mead Johnson’s motions for directed verdict, judgment notwithstanding the verdict, and a new trial.
On appeal, Mead Johnson argued that the trial court erred by refusing to apply the learned intermediary doctrine, by improperly instructing the jury, by admitting extensive and prejudicial internal Mead Johnson documents (including marketing presentations, CEO compensation materials, and financial records unrelated to EPF24), and that Watson failed to prove proximate or medical causation.
The Court’s Holding
The Fifth District reversed the judgment and remanded for a new trial. The appellate court identified multiple trial-court errors warranting reversal, including the failure to properly apply the learned intermediary doctrine, erroneous jury instructions, and improper evidentiary rulings. The court found that the trial record raised significant concerns about whether Watson had proved proximate causation.
On the evidentiary front, the court was troubled by the admission of hundreds of internal Mead Johnson documents—marketing presentations, competitive analyses, financial records, and CEO compensation materials—that post-dated Chance’s death, concerned products he never received, or bore no connection to EPF24 or the clinical decisions of his treating physicians. None of Chance’s treating physicians had ever seen Mead Johnson marketing materials or the EPF24 label, and Watson herself had never seen any promotional materials from the company before Chance was placed on the formula. The court found that admitting this evidence risked unfair prejudice without illuminating whether EPF24 caused Chance’s NEC.
On causation, Mother’s expert witnesses—board-certified neonatologists Dr. Brian Sims and Dr. Jonathan Swanson—both acknowledged that NEC occurs in infants fed exclusively human milk, that the precise causal mechanism linking cow-milk-based formula to NEC remains unknown, that neither could identify a specific ingredient in EPF24 causing NEC, and that none of Chance’s treating physicians attributed his NEC to EPF24. Chance’s twin brother, Chase, received the same feedings under the same protocol but did not develop NEC.
Key Takeaways
- The learned intermediary doctrine can be a dispositive defense in pharmaceutical and medical-product failure-to-warn cases: where a sophisticated physician intermediary makes the prescribing or feeding decision, a manufacturer’s duty to warn runs to the physician, not the ultimate patient or family member.
- Admission of internal corporate documents—marketing materials, financial records, executive compensation data—that are unconnected to the plaintiff’s specific product, treating physicians, or clinical events can constitute reversible error, particularly where they risk portraying a defendant as profit-driven without bearing on causation.
- Plaintiff’s experts conceding that NEC arises even in exclusively human-milk-fed infants, that the exact causal mechanism is unknown, and that no treating physician attributed the injury to the defendant’s product creates a difficult causation record that courts will scrutinize carefully.
- The “twin discordance” problem—where an identical sibling received the same formula under the same protocol yet did not develop NEC—is a significant obstacle to specific causation arguments in infant-formula NEC litigation.
Why It Matters
This decision is the latest in a growing body of appellate rulings addressing NEC litigation against infant-formula manufacturers. The Fifth District’s reversal of a $60 million verdict on multiple grounds—including the learned intermediary doctrine and the scope of permissible corporate-conduct evidence—provides meaningful guidance to both plaintiffs and defendants in the wave of NEC cases pending in Illinois and other jurisdictions. Courts are signaling that, where the clinical record shows highly trained neonatologists made independent, evidence-based feeding decisions untouched by manufacturer marketing, failure-to-warn claims face structural obstacles that pre-trial motions should address.
The decision also highlights the ongoing scientific uncertainty surrounding NEC causation. Both sides’ experts acknowledged an association between cow-milk-based formula and elevated NEC risk in premature infants, yet neither could pinpoint a specific causal mechanism or ingredient. As NEC litigation expands nationally, this opinion underscores that association evidence alone—particularly from studies involving patient populations smaller or more medically vulnerable than the plaintiff infant—may be insufficient to carry a plaintiff’s burden of proving specific causation at trial.