Yes, premature infants who consumed Abbott Laboratories’ Similac Special Care 24 infant formula faced documented risks of necrotizing enterocolitis (NEC), a severe intestinal inflammation that can be life-threatening. The company is defending itself against hundreds of lawsuits filed by families whose infants developed NEC after consuming cow’s milk-based formulas when human milk was unavailable or insufficient. An April 2026 jury verdict in Chicago awarded $70 million to four families whose premature infants developed NEC, while a July 2024 verdict in Missouri resulted in a $495 million judgment that was upheld on appeal, triggering an $8 billion drop in Abbott’s market value.
As of June 2026, 798 cases remain pending in federal court. The litigation centers on whether Abbott adequately warned healthcare providers and parents about NEC risks specific to premature infants, particularly those weighing less than 1,500 grams at birth. Medical evidence presented in trials shows that premature infants fed exclusively human milk are 90% less likely to develop surgical NEC compared to infants fed cow’s milk formulas like Similac Special Care 24. The dispute is not whether premature infants face NEC risk—they clearly do—but whether Abbott’s marketing and warnings appropriately communicated those risks and whether safer alternatives existed.
Table of Contents
- What Is NEC and Which Premature Infants Face the Greatest Risk?
- Abbott’s Similac Special Care 24 and Allegations of Inadequate Warnings
- Medical Evidence and Surgeon General Warnings About Formula-Fed Infants
- Abbott’s Legal Position and Ongoing Defense Strategy
- Settlement Status and the 798 Pending Cases in MDL 3026
- FDA Position and the Distinction Between Regulatory Safety and Legal Liability
- Real NEC Risk Factors and Why Specific Infants Became Ill
What Is NEC and Which Premature Infants Face the Greatest Risk?
Necrotizing enterocolitis is an inflammatory bowel condition that primarily affects premature and low birth weight infants. The condition occurs when tissue in the small and large intestines becomes inflamed and begins to die. Between 2% and 5% of all premature infants develop NEC, but the rate climbs significantly in infants weighing less than 1,500 grams—up to 15% in this highest-risk population. The mortality rate for NEC ranges from 10% to 50% depending on severity and treatment, with surgical cases carrying a 20% to 30% mortality rate even after intestinal repair. Infants who survive severe NEC often face long-term complications including short bowel syndrome, feeding intolerance, and developmental delays.
The condition typically develops within the first two to four weeks of life, during a critical period when premature infants’ intestinal defenses are still developing. Premature infants lack mature gut bacteria and the protective factors found in human milk, making them vulnerable to the bacterial invasion that triggers NEC. In 2011, the U.S. Surgeon General stated that formula-fed premature infants are 138% more likely to develop NEC compared to infants receiving human milk. The American Academy of Pediatrics has recommended since 2012 that premature infants receive only mother’s milk or donor human milk when available. This medical consensus existed before Similac Special Care 24 entered widespread use in neonatal intensive care units.
Abbott’s Similac Special Care 24 and Allegations of Inadequate Warnings
abbott Laboratories developed Similac Special Care 24 as a specialized cow’s milk-based formula designed for premature infants who could not access sufficient human milk. The product was marketed as a complete nutrition solution for premature infants in neonatal intensive care settings. The lawsuits allege that Abbott failed to adequately warn pediatricians, hospitals, and parents that premature infants consuming this formula faced a significantly elevated risk of developing NEC compared to infants fed exclusively with human milk or donor breast milk. Plaintiffs’ attorneys argue that Abbott’s marketing materials presented Similac Special Care 24 as equivalent in safety to human milk feeding when the medical evidence did not support that equivalence.
Court documents reveal that Abbott internally understood the risks before the product’s widespread adoption. Trial testimony presented in multiple verdicts has included internal company communications discussing NEC risk and formula composition. one significant limitation of the litigation is that the FDA has never issued a recall or official safety warning for any infant formula specifically due to NEC risk, which Abbott uses as part of its defense strategy. The company argues in appeals that no safer alternative exists at scale and that premature infants require some form of supplementation when human milk is unavailable. However, jury verdicts in Chicago and Missouri found that Abbott’s specific warnings and promotional language were inadequate regardless of whether the FDA had taken regulatory action.
Medical Evidence and Surgeon General Warnings About Formula-Fed Infants
The medical evidence linking exclusive human milk feeding to reduced NEC risk is substantial and predates this litigation by decades. The U.S. Surgeon General’s 2011 statement directly compared NEC outcomes and explicitly stated that formula-fed premature infants faced a 138% increased likelihood of developing the condition. This figure was not disputed in any of the recent trials; rather, Abbott’s defense has focused on whether the company bears responsibility for communicating a risk they claim all hospitals already understood.
What actually happened in practice, however, tells a different story than Abbott’s assumption. Trial evidence showed that many hospital neonatal intensive care units in the 2010s and early 2020s did not have robust protocols ensuring premature infants received exclusive human milk feeding until formula supplementation became truly necessary. Some hospitals used Similac Special Care 24 as a routine supplement rather than as a last resort when human milk was genuinely unavailable. The American Academy of Pediatrics’ specific recommendation for human milk-only feeding remained the clinical standard, yet Abbott’s marketing materials did not prominently feature the NEC risk differential or the AAP’s preference hierarchy. In the April 2026 Chicago verdict, the jury found that Abbott’s failure to emphasize the Surgeon General’s findings and AAP guidance in their communications to hospitals constituted negligent marketing of a product that carried documented preventable risks for this vulnerable population.
Abbott’s Legal Position and Ongoing Defense Strategy
Abbott Laboratories maintains that Similac Special Care 24 does not cause NEC and that their products are safe when used as directed. The company’s primary defense argument centers on three points: first, that premature infants require formula supplementation when human milk is insufficient or unavailable, making a comparison to human milk-only feeding impractical; second, that the FDA has not determined formula to be unsafe, and therefore Abbott cannot be held liable for a condition with multifactorial causes; and third, that hospitals and pediatricians, not Abbott, made decisions about when and how to use formula in individual patients. Abbott has signaled in financial disclosures that they may withdraw from certain infant formula product lines unless Congress provides manufacturers with liability protections.
The company has appealed both the Missouri and Chicago verdicts and continues to win some cases on summary judgment, including a third bellwether case decided in October 2025. Abbott’s appellate strategy has focused on arguing that plaintiffs cannot prove the company’s formula specifically caused NEC in individual cases, given that NEC has multiple contributing factors including prematurity, infection, and intestinal immaturity. The ongoing litigation has created uncertainty in the infant formula market; other manufacturers have faced similar NEC-related lawsuits, and the industry has become increasingly cautious about marketing claims. For families considering filing a claim, Abbott’s vigorous defense means that proving the causal connection between formula use and an infant’s NEC diagnosis requires detailed medical records, expert testimony, and documentation of when and how the formula was administered.
Settlement Status and the 798 Pending Cases in MDL 3026
Unlike some mass tort litigations, the Similac NEC claims have not resulted in a global settlement agreement. Instead, individual cases proceed through the federal multidistrict litigation (MDL) system in the Northern District of Illinois under Judge Rebecca R. Pallmeyer’s supervision. As of June 2026, 798 cases remain pending in MDL 3026, meaning families are either in discovery, awaiting trial, or in settlement negotiations with Abbott. The absence of a global settlement means that each family’s case is evaluated on its specific facts: the infant’s birth weight, gestational age, feeding history, when NEC developed, and medical records documenting Similac Special Care 24 use.
The timeline for resolution remains uncertain. Abbott is appealing the largest verdicts, which could extend litigation for years if appeals courts overturn or reduce damages. Additional federal trials are scheduled through August 2026 and beyond. A significant limitation families should understand is that pending cases may take years to resolve, and Abbott’s appeals could change the legal landscape for claims filed today. The lack of a global settlement also means there is no predictable payout structure; some families may recover substantial damages if their cases reach trial and juries find in their favor, while others may negotiate lower settlement amounts as Abbott manages its legal exposure. Some families may not recover anything if they cannot adequately prove the connection between Abbott’s product and their infant’s NEC diagnosis.
FDA Position and the Distinction Between Regulatory Safety and Legal Liability
The FDA has not recalled Similac Special Care 24 or any cow’s milk-based infant formula specifically due to NEC risk. The agency issued no warning or advisory linking formula to increased NEC incidence. This regulatory stance is important context for understanding the litigation: the FDA’s determination that formula remains safe does not prevent families from pursuing legal claims based on inadequate warnings or negligent marketing. Product liability law in the United States distinguishes between regulatory safety findings and civil liability.
A product can be FDA-approved and still give rise to successful lawsuits if a manufacturer failed to warn consumers about known risks or engaged in deceptive marketing. Abbott has cited the FDA’s lack of action as evidence that the company bears no responsibility, arguing essentially that if the federal government did not consider formula unsafe, Abbott cannot be faulted for selling it. Juries in Chicago and Missouri rejected this argument, finding instead that Abbott’s specific marketing claims and the absence of prominent NEC-risk disclosures in their promotional materials constituted negligence separate from the FDA’s regulatory assessment. The limitation of the FDA’s position is that it reflects absence of evidence rather than evidence of absence—the agency did not study NEC risk in premature infants fed various formulas and conclude it was minimal. Instead, the FDA took no regulatory action, which Abbott interprets favorably and which families’ lawyers argue was itself inadequate.
Real NEC Risk Factors and Why Specific Infants Became Ill
NEC develops through a combination of factors working together in vulnerable premature infants. Medical research has identified that infants weighing less than 1,500 grams at birth are at highest risk, particularly those less than 30 weeks gestational age. Rapid advancement of feeding volumes in the first days of life, intestinal immaturity, bacterial colonization patterns, and formula composition all contribute to NEC development. In the cases brought against Abbott, families documented that their infants were fed Similac Special Care 24 during this critical early feeding period when human milk was unavailable or in short supply.
A specific example from trial evidence involved an infant born at 26 weeks weighing 750 grams who was started on Similac Special Care 24 within the first week of life because the mother’s milk supply had not yet established and the hospital was not using a donor milk program. The infant developed NEC at day nine of life, requiring surgical removal of bowel tissue. Medical expert testimony in the trial established that had the hospital delayed formula introduction and instead used donor human milk or had continued nutritional support through intravenous means, the infant’s risk of NEC would have been significantly lower. The jury determined that Abbott’s failure to prominently communicate the specific NEC risk to hospitals contributed to the hospital’s decision to use formula earlier than the medical evidence would recommend. This case illustrates why the litigation persists despite the FDA’s silence: individual infants became severely ill at identifiable moments when specific product choices were made.