
Abbott Laboratories must pay $495 million in damages in the case of a girl who developed a serious gastrointestinal disease as a premature infant after consuming Abbott formula, a Missouri jury decided Friday evening.
The jury awarded the girl $95 million in compensatory damages and said the company must pay $400 million in punitive damages, half of which will go to the girl and half of which will go to the state of Missouri, said attorneys representing the family.
The lawsuit is one of more than a thousand against north suburban-based Abbott and Mead Johnson alleging that their formulas for premature infants cause necrotizing enterocolitis, a disease of the intestinal tract, in which tissue lining the intestine becomes inflamed and dies.
This was the first case against Abbott over the issue to go to trial. In a similar case that went to trial earlier this year in Illinois against Mead Johnson, a jury awarded $60 million in damages to a woman whose son died of NEC after consuming Mead Johnson’s cow’s-milk-based premature infant formula.
The Abbott trial began earlier this month in Missouri Circuit Court in St. Louis after Illinois resident Margo Gill sued the company. Gill alleged her daughter Robynn Davis was given Abbott’s cow’s-milk-based infant feeding products as a premature infant, which caused her to develop NEC. Davis, who was born in 2021, had to undergo extensive surgery because of her NEC diagnosis and continues to suffer from long-term health issues.
“Despite knowing of the risk of NEC, Abbott did not warn of the significantly increased risk of NEC (and resulting medical conditions, and/or death) associated with its products, or of the magnitude of this increased risk,” the lawsuit alleged.
Abbott lawyers argued that the girl’s condition was caused by trauma at birth, before she consumed the formula, Reuters reported.
Abbott said in a statement Friday evening: “We strongly disagree with the verdict which was not unanimous, and continue to believe that Robynn’s condition is a tragedy for which no one is to blame. We will pursue all avenues to have the erroneous decision overturned.”
Abbott said in the statement that there is no scientific evidence showing that Abbott’s preterm infant products cause or contribute to NEC.
“Specialized formulas and fortifiers, like the one in this case, are part of the standard of care by the medical community and, along with mother’s milk and donor human milk, are the only available options to feed premature infants,” Abbott said in the statement.
Abbott also said the verdict “has no bearing on any future cases.”
According to the National Institutes of Health, preterm and low-birth-weight babies are at higher risk of developing NEC, potentially because of their immature digestive systems, and about 15% to 40% of infants with the disease die.
Davis, who is now 2 years old, had about 75% of her intestine removed after she was diagnosed with NEC, and she suffered brain damage from the illness, according to a news release from the office of Tor Hoerman, one of the attorneys representing the family. She has spastic quadriplegic cerebral palsy, cannot walk or talk and is fed through a tube, according to the release.
The U.S. surgeon general has acknowledged that formula feeding is associated with higher rates of NEC for premature infants.
But this weekend, after the verdict, the president of the American Academy of Pediatrics, Dr. Benjamin Hoffman, cautioned in a statement that the causes of NEC “are multifaceted and not completely understood.”
He noted that though breast milk may reduce the risk of preterm infants developing NEC, it does not eliminate the risk. He called formulas designed for preterm infants an “essential source of nutrition” and said there is not enough donated human milk to feed preterm infants without the use of formula.
“Recent court cases, however, may jeopardize the availability of these formulas,” Hoffman said, noting that only two companies in the U.S. make such formulas, and both are facing lawsuits. “Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families.
“More than 300,000 infants are born prematurely every year, and we must take steps to protect the supply of infant formula for those who need it,” Hoffman said in the statement.