NEED TO KNOW
- A Missouri appeals court upheld a $495 million NEC verdict against Abbott Laboratories over claims that its Similac Special Care 24 formula caused a premature infant to develop necrotizing enterocolitis (NEC).
- The court rejected Abbott’s “learned intermediary” defense, ruling that preterm infant formula is considered food, not a prescription medical product.
- The decision is expected to strengthen ongoing NEC preterm infant formula lawsuits filed by families nationwide involving cow’s milk-based preterm formulas.
A Missouri appellate court has upheld one of the largest verdicts yet in the ongoing NEC formula litigation, affirming a $495 million judgment against Abbott Laboratories over claims that its cow’s milk-based preterm infant formula caused a premature baby to develop necrotizing enterocolitis (NEC).
The Missouri Court of Appeals for the Eastern District upheld the July 2024 jury verdict awarding $95 million in compensatory damages and $400 million in punitive damages to the family of a severely premature infant who suffered catastrophic injuries after being fed Abbott’s Similac Special Care 24 formula in a neonatal intensive care unit (NICU).
NEC is a serious intestinal disease that primarily affects premature infants and can lead to severe infection, intestinal tissue death, and long-term complications. This case is just one of thousands of lawsuits alleging that manufacturers of cow’s milk-based preterm infant formulas failed to adequately warn hospitals and parents about the increased risk of NEC in vulnerable premature babies.
Premature Infant Developed NEC After Formula Feeding
According to trial evidence, the infant was born at just 26 weeks of gestation in August 2021. Although initially fed human milk, the infant was later given Abbott’s Similac Special Care 24 High Protein formula while still under 1,500 grams — a weight range associated with an elevated risk of NEC in many studies.
Within days of receiving the formula, the infant developed NEC. The condition resulted in the removal of approximately 75% of the child’s intestine, and the child now suffers permanent and debilitating injuries, including cerebral palsy, seizures, brain damage, inability to eat normally, and the need for lifelong around-the-clock care.
Missouri Appeals Court Rejects Abbott’s NEC Formula Defense Arguments
In affirming the verdict, the appellate court rejected several arguments raised by Abbott during the appeal process.
One of the most significant rulings involved Abbott’s attempt to invoke the “learned intermediary” defense. The company argued that because the formula was used in NICUs under physician supervision, it should be treated similarly to prescription medical products, meaning Abbott needed to warn only doctors, not parents, about potential risks.
The appeals court disagreed, concluding that the preterm infant formula is legally considered food rather than a prescription drug or medical device. As a result, Abbott could still be held directly responsible for allegedly failing to provide adequate warnings regarding NEC risks.
The ruling could have significant implications for future NEC lawsuits because it limits one of Abbott’s key liability defenses in preterm formula litigation.
Evidence Focused on NEC Risks in Low Birthweight Infants
During the trial, jurors heard testimony regarding medical studies linking cow’s milk-based formula to significantly increased NEC risks in very low birthweight premature infants.
Plaintiffs argued Abbott knew or should have known about the heightened danger for infants weighing less than 1,500 grams but failed to include stronger NEC warnings on its formula labeling.
Jurors were shown examples of warning language that plaintiffs argued should have appeared on the product, specifically referencing the risks of necrotizing enterocolitis. Current labeling for Similac Special Care 24 states that human milk is recommended and advises users to follow physicians’ instructions, but does not specifically warn about NEC.
The jury ultimately concluded that Abbott’s conduct warranted substantial punitive damages in addition to compensation for the child’s lifelong injuries. The ruling is expected to influence future NEC cases as similar claims continue advancing in courts nationwide.
NEC Baby Formula Litigation Continues Nationwide
The Missouri appellate court ruling comes as NEC preterm infant formula lawsuits in both state and federal courts continue to move forward against manufacturers, including Abbott and Mead Johnson.
Earlier this year, an Illinois jury awarded $70 million to four families who alleged their premature infants developed necrotizing enterocolitis after being fed Abbott’s Similac Special Care 24 formula. The verdict included claims involving negligence, product defect, and failure to warn.
As more families learn about the risks associated with cow’s milk-based formula products used in NICUs, many are speaking with an NEC preterm infant lawyer to better understand their legal options and whether they may qualify to pursue compensation.
Childers, Schlueter & Smith, led by founding partner C. Andrew Childers, represents families nationwide in NEC preterm infant formula litigation and continues to monitor developments as additional cases move through the courts. Families with questions about premature infant formula injuries, NEC diagnoses, or potential legal claims can contact the firm online, use the live chat feature, or call 1-800-641-0098 to discuss their situation with an experienced attorney.
