The Evolving Legal Landscape of Necrotizing Enterocolitis in Neonatology: What Years of Litigation Inform us About the Future.

Abstract

To analyze publicly available federal and state court records involving necrotizing enterocolitis (NEC)-related litigation related to bovine milk-based formulas and fortifiers in the US, examining litigation trends, causes of action, geographic patterns, and case outcomes. A retrospective descriptive analysis was performed using Westlaw Precision data. Search terms were used to identify NEC-related cases across US federal and state jurisdictions as of January 2026. Cases were classified into three groups: group A (product liability), group B (medical Malpractice), and group C (equipment/other). This study characterized the legal landscape and lack of clear scientific data for causal relationship between bovine milk-based fortifiers and formulas and NEC. A total of 951 unique lawsuits were identified. Of these, 829 (87.2%) were consolidated within Multi District Litigation (MDL) No. 3026. Product liability accounted for 86%, medical malpractice 12% and other issues 2%. Filing rates remained low through 2021, accelerating after 2022, with 898 cases (94.4%) filed between 2022 and 2025. Landmark verdicts included $495 million against Abbott Laboratories, upheld on appeal in May 2026, and $60 million against Mead Johnson, reversed on appeal in June 2026. Two appellate courts have now reached opposite conclusions on the same legal question, whether a formula company must warn parents or doctors, confirming that these verdicts are not based on scientific evidence. NEC remains an imprecisely defined diagnosis, and the evidence on bovine milk-based formulas is contested. A documented consent may not reliably protect clinicians. The underlying uncertainty remains, no matter what any single court decides. Until scientific evidence resolves this issue, the logical step is to share this uncertainty with families as plainly as possible.