Products Liability Law Daily Wrap Up, WARNINGS ISSUES—BABY PRODUCTS—7th Cir.: Formula maker wins dismissal of mother’s claims in bellwether infant death case, (Jul 28, 2026)

By Pankhuri Bhatnagar, B.A. LL.B.

A lower court properly denied the mother’s reconsideration motion because her proposed witnesses were available beforehand and their testimonies did not qualify as “newly discovered evidence.”

In an action brought against a formula manufacturer by a mother whose premature infant died from necrotizing enterocolitis (NEC) after being fed a cow's-milk-based infant formula, the U.S. Court of Appeals for the Seventh Circuit upheld a lower court’s grant of summary judgment to the manufacturer in the first of four bellwether cases. Although the mother proposed a warning stating that human milk carries a lower risk of NEC than formula, there was insufficient proof that such a warning would have prompted the hospital to establish a donor milk program, changed the infant’s treatment plan, or prevented her death (In re Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, No. 25-2587 (7th Cir. July 24, 2026)).

Background. On New Year’s Day 2014, a baby girl was born 12 weeks prematurely and admitted to the neonatal intensive care unit at Charleston Area Medical Center. Initially, she was fed intravenously and later received her mother's breast milk through a feeding tube. After the mother could no longer produce usable milk and the hospital had no donor breast milk available, the infant's physicians began feeding her Similac Special Care 24, a cow's-milk-based formula manufactured by Abbott Laboratories (Abbott). Hours after the first ingestion of formula, the infant was diagnosed with surgical NEC, a serious gastrointestinal disease that disproportionately affects premature infants. She died the following day. Approximately eight years later, the mother filed suit alleging that Abbott failed to warn healthcare providers and consumers that its formula carried a greater risk of NEC than human breast milk. The suit became part of a multidistrict litigation involving hundreds of similar claims against Abbott and was selected as one of the four bellwether cases. A district court granted summary judgment to Abbott, concluding that the mother failed to establish that her proposed alternative warning would have prevented the infant's death because the hospital had no donor milk available and formula was the only feasible source of nutrition [see Product Liability Law Daily’s May 5, 2025, analysis]. Her motion for reconsideration was also denied.

Legal standard. West Virginia holds manufacturers liable for not warning consumers about their products’ dangers. Morningstar v. Black and Decker Mfg. Co., 253 S.E.2d 666, 682 (W. Va. 1979). Liability for failure to warn under strict liability or negligence theories requires a claimant to prove that “it was reasonably foreseeable that the product would be unreasonably dangerous if distributed without a warning” Church v. Wesson, 385 S.E.2d 393, 396 (W. Va. 1989), and the manufacturer’s failure to warn was the cause in fact of the injuries. Tracy v. Cottrell ex rel., 524 S.E.2d 879, 890 n.9 (W. Va. 1999).

Analysis. The court rejected each of the mother's theories that her proposed warning would have altered the infant's treatment. First, she argued that a warning stating that "human milk has a lower risk of NEC than formula" would have prompted the hospital to establish a donor milk program. Although one treating physician testified that the hospital might have tried to obtain donor milk sooner than it did, the mother overread this statement. The full transcript of his testimony established that creating such a program would have required years of planning, substantial financial resources, institutional approval, specialized personnel, and appropriate storage and transportation systems. The hospital in fact did not establish a donor milk program until approximately five years after the infant's death. Moreover, the treating physicians were already aware of published medical literature recognizing the association between formula feeding and NEC, yet no donor milk program existed when the infant was treated. The court therefore concluded that any inference that Abbott's proposed warning would have prompted the immediate creation of such a program was speculative.

Next, the mother argued that she was barred from receiving breast milk offered by another patient, an action which would not have occurred had the hospital seen her proposed warning. However, hospital policy prohibited the use of untested, unpasteurized donor milk because of the risk of transmitting infectious diseases and there was no evidence that that policy would have been abandoned based on a different warning. Third, she claimed she was told to discard her breast milk as it contained blood from excessive pumping, and if Abbott had used her alternative warning, she would have declined the formula and retained her blood-tainted milk instead. This argument also failed because she admittedly never read Abbott's original warning label and failure-to-warn claims under West Virginia law generally require proof that the existing warning was read before a claimant may establish that a different warning would have changed her conduct. Howard v. Eaton Corp., No. 16–0055, 2016 WL 6651592, at *4 (W. Va. Nov. 10, 2016). The claimant relied on Cloutier v. GoJet Airlines, LLC, 996 F.3d 426 (7th Cir. 2021), for the proposition that counterfactual inferences are for a jury to decide. While true, only those counterfactuals that have supporting record evidence and have not been undermined by a defendant’s evidence may reach the jury. Since the inferences here were speculative and did not show that the proposed warning would have prevented the infant's death, summary judgment was proper.

Rule 59 motion. A reconsideration motion may be filed by presenting “newly discovered evidence or a manifest error or law or fact” as per Oto v. Metro. Life Ins., 224 F.3d 601, 606 (7th Cir. 2000). The mother sought to introduce testimony from the child’s father explaining that had he known about the risk of NEC from Abbott’s formula, he would have pursued different feeding options such as a donor breast milk system or taken her to a different hospital. Another physician asserted that donor milk could be sent from her milk bank to the infant’s hospital within 24 hours. But these proposed testimonies did not qualify as “newly discovered evidence” because both witnesses were known and available before summary judgment. Even if admitted, they would not have cured the speculative nature of the mother's causation theory. Therefore, the district court did not abuse its discretion in denying the Rule 59 motion.

The case is No. 25-2587.

Judge: Brennan, C.J.

Attorneys: Jose M. Rojas (Levin, Rojas, Camassar & Reck, LLC) for Ericka Mar. Linda T. Coberly (Winston Taylor LLP) for Abbott Laboratories.

Companies: Abbott Laboratories

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