NEC Baby Formula Litigation: What Attorneys Need From Medical Experts
Necrotizing enterocolitis litigation over cow’s milk based preterm infant formula has become one of the most scientifically contested mass torts in the country. As of the August 3, 2026 JPML statistics report, 825 actions are pending in MDL No. 3026 in the Northern District of Illinois, out of 1,035 total historical actions. Plaintiffs allege that Abbott Laboratories and Mead Johnson failed to warn that their preterm formulas and fortifiers increased the risk of necrotizing enterocolitis in premature infants. With a federal bellwether trial underway and a second wave of bellwether trials already scheduled through February 2027, demand for credible neonatology, pediatric gastroenterology, pediatric surgery, and NICU nursing experts is high on both sides.
The Litigation Landscape
The Judicial Panel on Multidistrict Litigation centralized these cases on April 8, 2022, creating In re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, MDL No. 3026, Master Docket No. 1:22-cv-00071, before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois. The August 3, 2026 JPML report lists 825 actions now pending and 1,035 total actions historically.1
Plaintiffs allege that Abbott, maker of Similac preterm products, and Mead Johnson, maker of Enfamil preterm products, knew or should have known that bovine milk based formula and human milk fortifiers carried an elevated risk of necrotizing enterocolitis in premature and very low birth weight infants, and that neither company adequately warned treating clinicians or parents. The defendants deny the allegations, maintain that their products are safe and medically necessary, and argue that no reliable science supports a causal link.
This litigation is unusual because the state courts moved faster than the MDL, and the results have run in both directions. Juries in 2024 returned a $495 million verdict against Abbott in Missouri’s 22nd Judicial Circuit Court in St. Louis and a $60 million verdict against Mead Johnson in St. Clair County, Illinois. In April 2026, a Cook County jury awarded $53 million in compensatory damages and $17 million in punitive damages to the families of four premature infants in a consolidated trial against Abbott. Abbott has said it will appeal.2 On the other side of the ledger, the Illinois Fifth District Court of Appeal reversed the $60 million Mead Johnson verdict on June 16, 2026, holding that the trial court failed to apply the learned intermediary doctrine, which directs the duty to warn to the prescribing clinician rather than the patient. A St. Louis jury then returned a defense verdict for Mead Johnson on July 2, 2026, finding against the plaintiff on specific causation.3 No verdict in this litigation is final, and no global settlement has been announced.
Inside the MDL, the early record favored the defense. Judge Pallmeyer declined to exclude plaintiffs’ general causation experts, Dr. Logan Spector and Dr. Jennifer Sucre, in her May 2, 2025 general causation order, finding their methodology reliable, and denied the related defense motion for summary judgment.4 Several individual bellwether cases were nonetheless dismissed on summary judgment on case-specific grounds, most prominently Mar v. Abbott, where the Seventh Circuit affirmed on July 24, 2026, holding that the plaintiff had not shown that a different warning would have changed the clinical decision.5
The first federal case to reach a jury is Inman v. Mead Johnson. Judge Pallmeyer denied Mead Johnson’s summary judgment motion on May 8, 2026, and on August 5, 2026 declined to dismiss the design defect claim on Infant Formula Act preemption grounds, noting that the argument arrived on the eve of trial. Jury selection began August 13, 2026, with opening statements expected August 17, 2026.6
Case Management Order No. 15, entered October 28, 2025, set a second wave of bellwether trials in cases where Abbott is the sole defendant, drawn from Kelton, Cresap, and McCarthy. Those trial settings are August 3, 2026, November 2, 2026, and February 1, 2027, each with its own expert report, expert deposition, and Rule 702 briefing track.7
The Injuries at Issue
Necrotizing enterocolitis is an inflammatory and ischemic disease of the intestine that occurs almost exclusively in premature infants. Portions of the bowel wall become inflamed, then necrotic, and in severe cases perforate, spilling intestinal contents into the abdomen. It remains one of the leading causes of death and long term disability in the neonatal intensive care unit.
Acute Disease and Surgical Injury
Cases are typically staged using the modified Bell criteria, from suspected disease through definite disease to advanced disease with perforation and shock. Infants with advanced disease frequently require laparotomy with resection of the affected bowel, or placement of a peritoneal drain when the infant is too unstable for surgery. Many require a temporary ostomy and a later takedown procedure.
Short Bowel Syndrome and Intestinal Failure
When extensive bowel is resected, the remaining intestine may be unable to absorb enough nutrition, a condition known as short bowel syndrome. Affected children may depend on parenteral nutrition for months or years, with the associated risks of central line infection, venous thrombosis, and intestinal failure associated liver disease. Some are evaluated for intestinal transplantation.
Neurodevelopmental Injury
Surgical necrotizing enterocolitis is associated in the published literature with an increased risk of cerebral palsy, cognitive impairment, and developmental delay, attributed in part to the systemic inflammatory response and to periods of hypotension and hypoxia during acute illness. Plaintiffs allege lifelong injuries including feeding intolerance, growth failure, developmental delay, repeated hospitalizations, and, in the most severe cases, death.
The Science Behind the Claims
The scientific dispute in this litigation is not about whether human milk is associated with lower rates of necrotizing enterocolitis. It is about whether formula can be said to cause the disease in a specific infant given the many other risk factors of extreme prematurity.
Donor Human Milk Versus Formula
The 2024 update of the Cochrane systematic review on formula versus donor human milk for feeding preterm or low birth weight infants pooled 12 randomized trials involving 2,296 infants. The reviewers concluded that feeding very preterm or very low birth weight infants donor human milk rather than formula reduces the risk of necrotizing enterocolitis by roughly half, while probably making little or no difference to in-hospital mortality or infection.8 Because the underlying trials are randomized, this review is central to plaintiffs’ general causation showing.
Fortifier Composition
A 2025 systematic review and network meta-analysis in the International Breastfeeding Journal compared bovine, human, and donkey milk derived fortifiers in NICU populations. Compared with human milk derived fortifier, bovine milk derived fortifier was associated with an increased risk of necrotizing enterocolitis, with a relative risk of 2.33, 95% CI 1.22 to 4.44. The authors cautioned that the analysis rests on a small number of studies with small sample sizes.9
Mechanism
A 2026 review in Frontiers in Nutrition examined the mechanistic case, arguing that preterm formulas in which roughly half to sixty percent of the lactose is replaced by glucose polymers increase necrotizing enterocolitis risk in the immature intestine, and that the absence of protective components found in human milk contributes as well.10 Defense experts respond that animal models and observational NICU data cannot establish causation in an individual human infant, and that necrotizing enterocolitis occurs in exclusively human milk fed infants as well.
Why Expert Witnesses Are Critical
The verdicts and reversals in this litigation have turned less on general causation than on warning causation and specific causation, both of which are decided almost entirely on expert testimony. Four specialties carry the weight.
Neonatology
Neonatologists are the anchor experts in these cases. They address the differential diagnosis, whether the clinical course and imaging are consistent with necrotizing enterocolitis rather than spontaneous intestinal perforation or feeding intolerance, and how feeding decisions were actually made in the NICU. Under the learned intermediary doctrine, which the Illinois Fifth District applied in reversing the Watson verdict, the decisive question is often what the treating neonatologist knew and whether a different label would have changed the feeding order. Attorneys need neonatologists who practice or recently practiced in a level III or level IV NICU, who can speak to feeding protocols, milk banking availability, and the realities of caring for an infant whose mother cannot produce enough milk.
Pediatric Gastroenterology
Pediatric gastroenterologists address the downstream course: feeding intolerance, malabsorption, short bowel syndrome, parenteral nutrition dependence, intestinal failure associated liver disease, and the long term nutritional prognosis. Their testimony frequently drives the damages model, because life care planning depends on whether the child is expected to achieve enteral autonomy.
Pediatric Surgery
Pediatric surgeons testify to the operative findings, which are often the strongest objective evidence in the record. Operative notes describing pneumatosis intestinalis, necrotic segments, and perforation help distinguish necrotizing enterocolitis from spontaneous intestinal perforation, a distinction the defense presses hard because spontaneous intestinal perforation is generally not attributed to feeding. Surgeons also address the extent of resection, the need for staged procedures, and surgical complications.
NICU Nursing
NICU nurses provide the feeding record. They explain charting conventions, feeding advancement protocols, residual checks, human milk handling and labeling, and how orders for donor milk or formula were carried out at the bedside. In cases where the volume and timing of formula exposure are contested, a qualified NICU nurse expert is often the only witness who can walk a jury through the flow sheets.
Supporting Specialties
Cases also draw on neonatal or pediatric neurology and developmental pediatrics for neurodevelopmental sequelae, pediatric radiology for interpretation of abdominal films, pathology for resected specimens, epidemiology for general causation, and life care planning and economics for damages.
Key Dates
| Date | Event |
|---|---|
| April 8, 2022 | JPML centralizes MDL 3026 in N.D. Illinois before Judge Rebecca R. Pallmeyer |
| May 2, 2025 | Court declines to exclude plaintiffs’ general causation experts and denies related summary judgment |
| October 28, 2025 | Case Management Order No. 15 sets second-wave bellwether protocol |
| May 8, 2026 | Summary judgment denied in Inman v. Mead Johnson |
| June 16, 2026 | Illinois Fifth District reverses the $60 million Watson verdict on learned intermediary grounds |
| July 2, 2026 | Defense verdict for Mead Johnson in St. Louis on specific causation |
| July 24, 2026 | Seventh Circuit affirms summary judgment in Mar v. Abbott on warning causation |
| August 3, 2026 | First second-wave bellwether trial setting under CMO No. 15 |
| August 13 and 17, 2026 | Jury selection and opening statements in Inman v. Mead Johnson |
| August 28 to October 2, 2026 | Summary judgment and Rule 702 briefing for the November trial setting |
| November 2, 2026 | Second second-wave bellwether trial setting |
| November 25 to December 30, 2026 | Summary judgment and Rule 702 briefing for the February 2027 setting |
| February 1, 2027 | Third second-wave bellwether trial setting |
Deadlines in an active MDL move. Counsel should confirm every date against the current docket before relying on it.
How Med Legal Pro Helps
Necrotizing enterocolitis cases are won and lost on the quality of the medical testimony, and the specialties that matter here are small. There are far fewer practicing neonatologists and pediatric surgeons willing to serve as experts than there are cases pending. Med Legal Pro screens, credentials, and prepares physician and nurse experts for medical-legal work, and matches attorneys with experts whose clinical background actually fits the record in front of them, including NICU level, era of practice, and feeding protocol familiarity.
If you are a neonatologist, pediatric gastroenterologist, pediatric surgeon, or NICU nurse interested in expert witness work, or an attorney who needs a qualified reviewer for a necrotizing enterocolitis file, contact Med Legal Pro. The Expert for Experts.
Sources
- U.S. Judicial Panel on Multidistrict Litigation, MDL Statistics Report, Distribution of Pending MDL Dockets by Actions Pending, report date August 3, 2026. jpml.uscourts.gov
- Law.com, “Abbott Loses $70M Verdict in Multi-Plaintiff Formula Trial,” April 10, 2026.
- Law.com, “Mead Johnson Wins Defense Verdict in Latest NEC-Related Infant Formula Trial,” July 2, 2026.
- In re Abbott Laboratories, et al., Preterm Infant Nutrition Prods. Liab. Litig., No. 22 C 00071, 2025 WL 1283927 (N.D. Ill. May 2, 2025), general causation order.
- Law.com, “Federal Appeals Court Won’t Reinstate Would-Be Bellwether Case in Infant Formula MDL,” July 27, 2026, reporting the Seventh Circuit opinion in Mar v. Abbott Laboratories.
- Memorandum Opinion and Order, Inman v. Mead Johnson & Co., No. 1:22-cv-03737 (N.D. Ill. May 8, 2026); Law.com, “Bellwether Infant Formula Trial to Proceed After Besting Mead Johnson’s Preemption Challenge,” August 6, 2026.
- Case Management Order No. 15, Protocol for Selection of Second-Wave Bellwether Trial Cases, In re Abbott Laboratories, et al., MDL No. 3026, Dkt. 724 (N.D. Ill. Oct. 28, 2025).
- Cochrane Database of Systematic Reviews, “Formula versus donor human milk for feeding preterm or low birth weight infants,” 2024 update, 12 trials, 2,296 infants. Cochrane
- International Breastfeeding Journal, “Impact of three mammalian milk-derived fortifiers on morbidity and mortality in preterm infants: a systematic review and network meta-analysis,” 2025. doi.org/10.1186/s13006-025-00801-w
- Frontiers in Nutrition, “Preterm infant formulas with glucose polymers and reduced lactose content increase the risk of necrotizing enterocolitis,” 2026. doi.org/10.3389/fnut.2026.1768510
By Tracy L. Liberatore Esq, PA-Emeritus. This article is provided for informational purposes for attorneys and medical professionals and is not legal or medical advice. All claims described are allegations that remain contested in ongoing litigation.
