Necrotizing enterocolitis lawsuits are product liability claims against infant formula manufacturers, alleging that cow’s milk–based formulas increased the risk of NEC in premature infants without adequate warnings to healthcare providers or parents.
These cases depend heavily on complete and well-organized medical documentation, particularly NICU records that establish feeding history, symptom progression, diagnosis timing, and treatment decisions during extended hospitalizations.
This guide examines the medical background of NEC, the legal framework governing these lawsuits, current litigation status, eligibility criteria, and the types of evidence commonly used to evaluate and pursue NEC claims.
What Is Necrotizing Enterocolitis (NEC)?
Necrotizing enterocolitis is a severe gastrointestinal disease affecting neonates, particularly premature infants. According to the National Library of Medicine (NIH), NEC involves inflammation and necrosis of intestinal tissue that can progress to intestinal perforation, peritonitis, sepsis, and death.
The condition disproportionately affects premature and low-birthweight infants, with NIH data indicating nearly 70% of NEC cases occur in infants born before 36 weeks of gestation. The NICHD reports that NEC occurs in approximately 5-10% of NICU patients.
Clinical staging follows the Modified Bell's Criteria, which stratifies NEC severity.
- Stage I (Suspected NEC) is characterized by nonspecific systemic signs, including temperature instability, apnea, bradycardia, and feeding intolerance.
- Stage II (Definite NEC) includes specific radiographic findings such as intestinal pneumatosis, metabolic acidosis, and thrombocytopenia.
- Stage III (Advanced NEC) represents the most severe classification, characterized by intestinal perforation with pneumoperitoneum, peritonitis, and severe systemic illness.
Clinical management protocols generate substantial documentation as a direct result of standard of care requirements. According to clinical practice guidelines from major academic centers, standard care requires:
- Serial abdominal examinations every 4-8 hours.
- Continuous vital sign monitoring.
- Frequent laboratory testing multiple times daily.
- Serial imaging studies with formal radiologist interpretations.
What Is a Necrotizing Enterocolitis Lawsuit?
NEC lawsuits are product liability actions filed against infant formula manufacturers. These cases allege that cow's milk-based formulas marketed for premature infant use increased the risk of NEC development, and that manufacturers failed to adequately warn healthcare providers and consumers of this risk.
The legal framework encompasses three primary theories:
- Strict Product Liability—design defect and failure to warn.
- Negligence—breach of duty to warn and design safely.
- Misrepresentation—fraudulent and negligent misrepresentation.
Failure to Warn
The predominant theory alleges manufacturers possessed knowledge of elevated NEC risks but failed to provide adequate warnings on product labels or inform NICU personnel and parents of comparative risks between formula and human milk.
Design Defect
This theory alleges cow's milk-based formulas are inherently dangerous when used as intended for premature infants, making the products defectively designed for the vulnerable population.
According to the Illinois Appellate Court opinion in Toles v. Mead Johnson & Company, LLC, causation requires establishing both general causation (scientific evidence linking formula use to NEC risk) and specific causation (evidence that the particular infant's NEC resulted from formula exposure).
NEC litigation divides into personal injury claims (filed by or on behalf of surviving infants for medical expenses, pain and suffering, and long-term care costs) and wrongful death claims (filed by surviving family members for funeral expenses, loss of companionship, and emotional distress).
Baby Formula and NEC Allegations
NEC product liability litigation centers on allegations that cow’s milk–based infant formulas marketed for premature infants increase the risk of necrotizing enterocolitis. Federal complaints allege that manufacturers knew or should have known of this association based on decades of scientific and clinical research but failed to provide adequate warnings to clinicians or parents.
The consolidated federal litigation focuses on two manufacturers and their widely used NICU products:
- Abbott Laboratories, manufacturer of Similac cow’s milk–based formulas.
- Mead Johnson Nutrition Company / Reckitt Benckiser, manufacturer of Enfamil cow’s milk–based formulas.
Plaintiffs advance a consistent causation framework across filings. Complaints typically allege that:
- The increased risk of NEC associated with cow’s milk–based formula was known or reasonably knowable from published research.
- Medical records document formula feeding during the NICU stay before NEC onset.
- Absent warnings deprived healthcare providers and parents of the ability to make informed feeding decisions for premature infants.
Court filings frequently reference comparative feeding studies involving extremely preterm infants. A randomized clinical trial published in the Journal of the American Medical Association reported that necrotizing enterocolitis (NEC) occurred in 9.0% of formula-fed extremely preterm infants, compared with 4.2% in those receiving donor human milk, among 483 infants studied.
Manufacturers have relied heavily on regulatory defenses in response. The FDA has not issued formal warnings or recalls specifically linking cow’s milk–based infant formula to NEC, and defendants argue that this regulatory posture undermines failure-to-warn claims. Plaintiffs counter that the absence of FDA action does not negate independent duties to warn when product risks are supported by scientific evidence.
Current NEC Litigation and Verdicts
Federal NEC litigation is consolidated in MDL 3026 (In re: Abbott Similac and Mead Johnson Enfamil Marketing, Sales Practices and Products Liability Litigation) before Judge Rebecca R. Pallmeyer in the U.S. District Court for the Northern District of Illinois. As of December 2025, 774 active cases are pending. MDL consolidation enables coordinated pretrial proceedings for cases with common factual questions.
Federal Bellwether Outcome
On May 2, 2025, Judge Pallmeyer granted Abbott Laboratories' motion for summary judgment in the first federal bellwether trial (Mar v. Abbott Laboratories, Case No. 1:22-cv-00232), resulting in a complete defense victory. The court established that failure-to-warn liability was diminished because no alternative feeding options were available at the time of the infant's birth.
State Court Verdicts
In March 2024, an Illinois jury awarded $60 million against Mead Johnson/Reckitt Benckiser for failing to warn about NEC risks. In July 2024, a Missouri jury awarded $495 million against Abbott Laboratories, including $400 million in punitive damages.
Upcoming Trials
Pursuant to Case Management Order No. 15, second-wave bellwether trials are scheduled for August 3, 2026, November 2, 2026, and February 1, 2027.
In May 2025, Judge Pallmeyer denied defendants' motions to exclude general causation expert testimony, though specific methodologies remain under Daubert scrutiny.
Who May Qualify for a Necrotizing Enterocolitis Lawsuit
Eligibility for a necrotizing enterocolitis lawsuit depends on a combination of gestational age, documented formula exposure, NEC severity, and resulting injury. Courts and plaintiffs’ firms evaluate these factors together rather than relying on any single criterion.
1. Gestational Age
Infants born at less than 32 weeks of gestation represent the core at-risk population in NEC litigation. Some claims involve infants born between 32 and 36 weeks, but case strength generally declines as gestational age approaches full term.
2. Formula Exposure During NICU Care
Successful claims typically rely on documentation showing that the infant received cow’s milk–based formula before NEC onset. Records commonly reviewed include:
- Birth and admission records confirming premature status.
- NICU feeding logs identifying Similac or Enfamil formula use.
- Progress notes and orders reflecting feeding decisions and changes
3. NEC Diagnosis Severity
Most litigation requires a diagnosis meeting Bell’s Stage II (Definite NEC) or Bell’s Stage III (Advanced NEC) criteria. Cases limited to Stage I (Suspected NEC) generally do not meet qualification thresholds absent additional complications.
4. Injury Severity and Long-Term Outcomes
Cases most often accepted for litigation involve serious clinical outcomes, such as:
- Surgical intervention (including bowel resection or ostomy creation).
- Systemic complications, including sepsis or multi-organ involvement.
- Long-term conditions such as short bowel syndrome.
- Death directly attributable to NEC.
Because NEC cases often involve overlapping medical factors, qualification assessments depend heavily on complete NICU records and clearly documented timelines linking formula exposure, symptom progression, diagnosis, and treatment.
Evidence Commonly Used in NEC Lawsuits
NEC product liability cases require comprehensive medical documentation spanning multiple healthcare facilities and extended time periods. Extensive medical documentation spanning weeks or months of NICU hospitalization challenges paralegal capacity and case preparation timelines.
Core Medical Record Categories:
- Birth Records: Documentation confirming premature birth status and exact gestational age.
- NICU Records: Daily nursing notes, physician progress notes, vital sign monitoring, and treatment records spanning the entire hospitalization.
- Feeding Logs: Detailed documentation of formula type, brand, dates, quantities, and feeding frequencies.
- Diagnostic Records: NEC diagnosis with Bell's Stage classification, laboratory abnormalities, and clinical findings.
- Imaging Studies: X-rays and ultrasounds showing diagnostic indicators with radiologist interpretations.
- Surgical Records: Operative notes, anesthesia records, and post-operative care documentation.
- Pathology Reports: Tissue analysis and diagnostic testing confirming NEC diagnosis.
Volume and Complexity
NEC cases routinely involve hundreds to thousands of pages of medical records resulting from multiple healthcare facility involvement, extended NICU stays, multi-disciplinary documentation, and established clinical protocols requiring serial examinations and imaging studies. Judges in NEC litigation have emphasized that incomplete or disorganized medical records submitted early in litigation can delay case progression and weaken settlement positions.
Expert Testimony Requirements
Expert witnesses must establish both general and specific causation with medical specialization in neonatology, pediatric gastroenterology, or pediatric surgery, clinical experience with NEC diagnosis and treatment, and familiarity with infant formula composition effects on premature infant intestinal development.
Documentation Completeness
Accurate case preparation requires date-stamped entries for every medical event, clear feeding timelines, symptom progression documentation, and treatment intervention timing, establishing temporal relationships between formula exposure and NEC onset.
Building the Evidentiary Foundation in NEC Cases
Necrotizing enterocolitis lawsuits hinge on detailed medical evidence linking premature birth, formula exposure, and NEC diagnosis to specific clinical outcomes. Eligibility and case strength depend on gestational age, documented feeding practices, disease severity, and resulting complications, with outcomes varying across jurisdictions and venues.
Because these claims rely on extensive NICU records and precise feeding timelines, firms evaluating NEC cases often focus on early access to complete records and clear chronology development.
Tavrn supports this process by helping legal teams obtain, organize, and review neonatal medical records in a way that preserves clinical detail and supports causation analysis. Learn more with a demo.
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