NEC Infant Formula Litigation: Verdicts, MDL 3026 and Status

Necrotizing enterocolitis (NEC) is a serious intestinal disease that primarily affects premature infants. Since 2021, hundreds of lawsuits have alleged that cow’s milk-based preterm formulas sold as Similac and Enfamil caused NEC and that their manufacturers failed to warn of the risk. Federal claims are consolidated in MDL 3026 in the Northern District of Illinois before Judge Rebecca R. Pallmeyer, listed at 847 pending actions as of September 1, 2026 by the Judicial Panel on Multidistrict Litigation. Juries returned plaintiff verdicts in two 2024 state cases, an appellate court has since reversed one, and the first federal bellwether cases ended in defense verdicts. The 2022 Abbott Nutrition recall of powdered formula made at a Sturgis, Michigan plant concerned Cronobacter and Salmonella contamination, a separate matter from the NEC claims.

What the lawsuits allege

The cases concern specialized preterm hospital nutrition products, not retail formula for full-term babies. Plaintiffs contend that cow’s milk-based preterm formula marketed under the Similac and Enfamil names has a higher propensity to cause NEC in infants born prematurely than allegedly safer alternatives, according to the JPML’s April 8, 2022 transfer order that created MDL 3026. Claims are typically pleaded as negligence and strict liability, including failure to warn, per a Congressional Research Service insight. The article on how mass tort litigation works explains how claims of this kind are organized, and how an MDL differs from a class action explains why they are consolidated for pretrial purposes.

What is established vs. what is alleged

Established by the record. The FDA began a for-cause inspection of Abbott Nutrition’s Sturgis, Michigan facility on January 31, 2022 and identified Cronobacter sakazakii there along with significant operational deficiencies. Abbott recalled certain powdered formulas on February 17, 2022 after four consumer complaints and expanded the recall on February 28, 2022. The FDA’s investigation page records four adverse events, four hospitalizations and two reported deaths, with illness onset from September 6, 2021 to January 4, 2022. The Western District of Michigan entered a consent decree between the FDA and Abbott Nutrition on May 16, 2022, and the JPML created MDL 3026 on April 8, 2022.

Alleged, not decided. It remains an allegation that the products caused any individual infant’s NEC, and no court has entered a general finding that preterm formula causes NEC. In September 2024 a working group of the National Advisory Council of Child Health and Human Development, convened by the NICHD at the request of the Department of Health and Human Services, concluded that NEC is a multifactorial disease and that available evidence supports the hypothesis that the absence of human milk, rather than exposure to formula, is associated with increased NEC risk. The Congressional Research Service states that a 2024 FDA, CDC and NIH consensus statement drew on that report, recommended further research, and found the evidence generally inconclusive.

Where the claims stand procedurally

MDL 3026, In re Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, sits in the Northern District of Illinois before Judge Rebecca R. Pallmeyer. The JPML’s September 1, 2026 statistics report lists 847 actions pending and 1,057 filed in total. Consolidation covers pretrial proceedings only; each case keeps its own trial forum.

State and federal results have diverged. In 2024 an Illinois jury returned a $60 million verdict against Mead Johnson and a St. Louis jury returned a $495 million verdict against Abbott. In June 2026 the Illinois Appellate Court reversed the $60 million verdict, holding that the trial court had not properly applied the learned intermediary doctrine, which places a manufacturer’s duty to warn on the prescribing physician rather than the patient. Abbott states that the St. Louis verdict was affirmed on appeal and that it then agreed to resolve that case plus claims on behalf of approximately 2,000 other individuals for approximately $670 million. In July 2026 the Seventh Circuit affirmed a pretrial judgment for Abbott in the first federal MDL bellwether, and on August 31, 2026 a federal jury in the Northern District of Illinois returned a unanimous defense verdict for Mead Johnson in Inman, the first bellwether against it tried in the MDL.

Key dates

• January 31, 2022: FDA begins a for-cause inspection of the Sturgis, Michigan plant (FDA).
• February 17, 2022: Abbott recalls certain powdered formulas made at Sturgis after four consumer complaints (FDA).
• February 28, 2022: Abbott expands the recall to one lot of Similac PM 60/40 (FDA).
• April 8, 2022: The JPML creates MDL 3026 in the Northern District of Illinois (JPML).
• May 16, 2022: The Western District of Michigan enters the FDA consent decree with Abbott Nutrition (FDA).
• 2024: An Illinois jury awards $60 million against Mead Johnson; a St. Louis jury awards $495 million against Abbott (Abbott).
• June 2026: The Illinois Appellate Court reverses the $60 million verdict (Abbott).
• July 2026: The Seventh Circuit affirms a pretrial judgment for Abbott in the first federal MDL bellwether (Abbott).
• August 20, 2026: Abbott announces agreements covering the St. Louis case and about 2,000 other claims (Abbott).
• August 31, 2026: A federal jury returns a defense verdict for Mead Johnson in Inman (Reckitt / Mead Johnson).
• September 1, 2026: The JPML reports 847 actions pending in MDL 3026 (JPML).

What this does not establish

Nothing in the record decides whether preterm formula caused any particular infant’s NEC. The 2022 recall and the consent decree concerned bacterial contamination at one plant, not the allegations in these lawsuits; the recall notice describes Cronobacter sakazakii and Salmonella Newport, environmental findings in non-product contact areas, and no positive test on distributed product. A verdict binds the parties to that case and creates no general rule, and one of the 2024 plaintiff verdicts has been reversed. Abbott’s August 2026 agreements state that they are not an admission of liability and cover only part of the pending claims. The consent decree resolved FDA findings about manufacturing conditions and contains no finding about NEC, and the NICHD report describes the state of the science rather than ruling on any claim. The time limits that apply to injury claims vary by state.

Frequently asked questions

Do these lawsuits involve the formula sold in grocery stores?

No. They concern specialized preterm hospital nutrition products used in neonatal intensive care units, which Mead Johnson states are administered by a medical team rather than sold at retail.

Has a court found that preterm infant formula causes NEC?

No. Plaintiffs have won individual state-court verdicts, one of which was reversed on appeal. The Congressional Research Service states that the 2024 FDA, CDC and NIH consensus statement found no conclusive evidence that preterm infant formula causes NEC.

What was the 2022 Abbott recall about?

It concerned bacterial contamination at the Sturgis, Michigan plant. The FDA identified Cronobacter sakazakii in the facility and recorded four adverse events and two reported deaths. Abbott recalled certain powdered formulas in February 2022 and entered an FDA consent decree in May 2022.

Which companies are named in the NEC litigation?

The principal defendants are Abbott Laboratories (Similac) and Mead Johnson (Enfamil). Both deny that their preterm nutrition products cause NEC.

Sources

1. United States Judicial Panel on Multidistrict Litigation: “IN RE: ABBOTT LABORATORIES, ET AL., PRETERM INFANT NUTRITION PRODUCTS LIABILITY LITIGATION, MDL No. 3026, Transfer Order” (link, accessed 2026-10-13)
2. United States Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending (September 1, 2026)” (link, accessed 2026-10-13)
3. U.S. Food and Drug Administration: “FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility in Sturgis, Michigan” (link, accessed 2026-10-13)
4. U.S. Food and Drug Administration: “Abbott Voluntarily Expands Recall of Powder Formulas Manufactured at One Plant” (link, accessed 2026-10-13)
5. U.S. Food and Drug Administration: “FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)” (link, accessed 2026-10-13)
6. U.S. Food and Drug Administration: “FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula” (link, accessed 2026-10-13)
7. Eunice Kennedy Shriver National Institute of Child Health and Human Development: “Necrotizing Enterocolitis (NEC) in Preterm Infants Working Group of the National Advisory Council of Child Health and Human Development: Report to the Secretary, Department of Health and Human Services” (link, accessed 2026-10-13)
8. Congressional Research Service: “Preterm Infant Formula and Necrotizing Enterocolitis Litigation (CRS Insight IN12591)” (link, accessed 2026-10-13)
9. Abbott Laboratories: “Abbott reaches agreements to resolve a portion of litigation involving its specialty formulas for preterm infants” (link, accessed 2026-10-13)
10. Reckitt / Mead Johnson Nutrition: “Mead Johnson Welcomes Defense Verdict in Inman Case” (link, accessed 2026-10-13)

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