Baby Formula Manufacturers Under Legal Scrutiny After Preterm Infant Deaths and Injuries
Abbott Laboratories faced trial in St. Louis, Missouri, over allegations their formula for premature infants causes necrotizing enterocolitis (NEC), a potentially fatal intestinal disease. This marked the second trial among hundreds of similar lawsuits against major formula manufacturers Abbott and Reckitt Benckiser Group, makers of Similac and Enfamil, respectively. Parents of affected infants claim the companies failed to warn that cow’s milk-based formula significantly increases the risk of NEC in preterm babies compared to human milk alternatives.
5 Key Points
- Nearly 1,000 baby formula lawsuits have been filed against Abbott and Reckitt over NEC cases in premature infants.
- Necrotizing enterocolitis (NEC) is a deadly bowel disease with a fatality rate between 15% and 40% that primarily affects newborns.
- A Memphis mother’s premature son died from NEC following consumption of cow’s milk-based formula in the NICU.
- The first NEC lawsuit resulted in a $60 million verdict against Reckitt in March 2024.
- Plaintiffs claim formula makers failed to warn about increased NEC risk for premature infants.
What legal challenges do Abbott and Reckitt face regarding premature infant formula?
The trial featured Illinois resident Margo Gill, whose premature infant developed necrotizing enterocolitis after being fed Abbott’s specialized products designed for preterm babies. While Gill’s child survived, the lawsuit states the infant now suffers from long-term health complications. Abbott defended itself by stating Gill’s child “suffered from a traumatic brain injury in utero and at birth, long before she was fed any Abbott products,” and argued that “no one is to blame” for the child’s condition. This lawsuit joined approximately 1,000 others filed in federal and state courts against Abbott and Reckitt. More than 500 cases are centralized in an Illinois federal court, with additional cases pending in Illinois, Missouri, and Pennsylvania. The lawsuits specifically allege the companies failed to warn that infants given their cow’s milk-based products face higher NEC risks than those fed breast milk or human milk-derived formula. The legal cases focus on Similac and Enfamil, two of the most widely used premature infant formulas in NICUs nationwide.
How did a Memphis baby develop NEC after receiving formula in the NICU?
Memphis resident Nakia Harris’s son was born prematurely on April 12, 2023, at Saint Francis Hospital in Memphis. After transfer to Regional One Hospital’s NICU, the infant received Enfamil formula. By April 20, 2023, the baby developed typical necrotizing enterocolitis symptoms, including feeding intolerance, vomiting, and abdominal distention. The following day, doctors diagnosed the infant with severe metabolic acidosis with presumed NEC, prompting transfer to Methodist Le Bonheur Children’s Hospital. Despite medical intervention, the baby died on April 29, 2023, due to NEC complications. Harris’s lawsuit claims Abbott Laboratories and Mead Johnson & Company failed to provide any warnings on their labels, websites, or marketing materials about the increased NEC risk in preterm infants. The legal complaint states the companies did not offer “instructions or guidance on how to properly use its Cow’s Milk-Based Products to lower the risk to avoid NEC or death.” The case highlights the dangers premature infants face when fed cow’s milk formula instead of human breast milk or donor milk alternatives.
A graphic displaying a list of toxic baby formulas associated with NEC lawsuits and legal contact information for affected families.
What are the symptoms of NEC that parents should know about?
Necrotizing enterocolitis (NEC) primarily affects premature infants and presents with specific symptoms that parents and medical providers should monitor closely. Early symptoms include:
- Feeding intolerance (difficulty digesting formula or breast milk)
- Abdominal distention (swollen or bloated stomach)
- Vomiting after feedings
- Bloody stools as intestinal tissue become damaged.
In Nakia Harris’s case, her son showed these classic symptoms by April 20, 2023, just eight days after birth. As NEC progresses, infants may develop more severe symptoms, including:
- Lethargy
- Temperature instability
- Decreased urination
- Severe metabolic acidosis (excessive acid in the body)
Medical providers diagnose NEC through physical examination, blood tests, and abdominal X-rays that may show intestinal inflammation or air in the intestinal wall – a hallmark sign of the disease. The condition can rapidly deteriorate, progressing from initial symptoms to life-threatening complications within hours or days, which is why immediate medical attention is critical when these symptoms appear in premature infants, particularly those receiving cow’s milk-based formula. Parents should be especially vigilant if their premature infant has been fed Similac or Enfamil products, as these brands are named explicitly in the necrotizing enterocolitis lawsuits.
Who can qualify for a baby formula NEC lawsuit?
Parents or legal guardians of premature infants who developed NEC after consuming cow’s milk-based formula products may qualify for legal action against the manufacturers. Qualifications typically include:
- Evidence the premature infant consumed formula produced by Abbott Laboratories (Similac) or Mead Johnson & Company/Reckitt (Enfamil) in a hospital setting
- Documentation of a formal NEC diagnosis in medical records
- A clear timeline connecting formula consumption with NEC symptom development
- Documentation of resulting injuries, complications, or death caused by NEC
Parents must be able to demonstrate a timeline that connects formula consumption with the development of NEC symptoms, as seen in Nakia Harris’s case, where her son developed symptoms approximately eight days after beginning formula feedings. Families can pursue legal recourse whether the infant:
- Survived with long-term complications (like Margo Gill’s child)
- Required surgical intervention for NEC
- Died from NEC complications (as in Harris’s case)
The statute of limitations for filing varies by state, so affected families should consult with an attorney specializing in product liability or medical malpractice as soon as possible. Legal claims typically center on the manufacturers’ failure to provide adequate warnings about necrotizing enterocolitis risks in premature infants despite scientific evidence suggesting increased danger compared to human milk options. Baby formula attorneys review cases nationwide for families affected by this devastating condition.
What precedent does the $60 million verdict set for baby formula litigation?
The first NEC-related lawsuit to reach a trial conclusion occurred in March 2024, resulting in a $60 million jury verdict against Reckitt in Illinois. Reckitt has since appealed the verdict, arguing that the plaintiff’s case relied on unsound expert testimony. Legal experts note this significant verdict may influence settlement negotiations in the hundreds of pending cases. These necrotizing enterocolitis lawsuits remain separate from other ongoing litigation against Abbott regarding the 2022 shutdown of its Sturgis, Michigan plant and subsequent formula recall over possible contamination. That incident contributed to a nationwide formula shortage, but no trials have been held for those specific cases. The substantial jury award demonstrates that courts are taking the connection between cow’s milk formula and NEC seriously, potentially paving the way for successful outcomes in similar cases filed by families of premature infants injured or killed by the disease after consuming Similac or Enfamil products.
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