Abbott Labs Ordered To Pay $495 Million Over Formula For Premature Infants

NORTH CHICAGO, IL — A jury found that an Abbott Laboratories' formula made for premature infants caused an Illinois girl to develop a severe bowel disease and ordered the company to pay nearly half a billion dollars in damages.

The St. Louis, Missouri, state court trial that ended Friday was the the first of hundreds of similar lawsuits against Abbott in state and federal court to have made it to a jury trial.

The verdict, awarding of $95 million in compensatory damages and $400 million in punitive damages, was supported by nine of the 12 jurors, who found the North Chicago-based company liable for allegations of negligent design, failure to warn and strict liability.

Margo Gill, the plaintiff, alleged that Abbott failed to warn that its formula could cause necrotizing enterocolitis, or NEC, a potentially deadly disease that primarily affects babies who are born prematurely.

The disease, which causes bowel tissue to die, has a fatality rate of 15 to 40 percent, according to the National Institutes of Health. Its exact cause is not fully understood, but it is believed to involve a combination of factors, including immature intestines, bacterial infections and formula feeding.

Gill's child, Robynn Davis, who developed NEC after being given Abbott formula in 2021, survived but suffered irreversible brain damage and spastic quadriplegic cerebral palsy, which requires lifelong intensive care.

According to Gill's law firm, Abbott's internal documents that became evidence at trial showed that Abbott company officials knew that their Similac Special Care 24, a cow’s milk-based formula for premature infants, could contribute to cases of NEC but never told doctors or consumers.

“Justice was served for Margo Gill and her daughter Robynn, who suffered severe, irreversible brain damage due to Abbott’s misconduct," Tor Hoerman, Gill's lead attorney, said in a statement. "We thank the judge and jury for their diligent consideration in this case, and we will continue to hold Abbott accountable on behalf of the other families we represent."

Following the verdict, an Abbott spokesperson said in a statement there is no scientific evidence that its formula contributed to NEC and characterized Gil's daughter's condition as "a tragedy for which no one is to blame."

The company spokesperson noted that the verdict was not unanimous, described formulas like the one at issue in the Gill case as part of the medical community's standard of care and said the verdict has "no bearing" on other cases.

"We will pursue all avenues to have the erroneous decision overturned,” the company's statement said.

The NEC Society, a nonprofit advocacy group working to prevent the disease, has argued that litigation over formula could lead to intensive care units changing their policies and cause unintended harms.

"In the ICU, feeding decisions are medical decisions. It is imperative for medical decisions to be made by those who practice medicine in partnership with patient-families," the society said in a statement following an April verdict against Enfamil formula-maker Mead Johnson in a similar case in St. Clair County.

"Neonatal feeding decisions should be made at patients’ bedsides, not in courtrooms," it said.

The earlier trial against Mead Johnson parent Reckitt Benckiser resulted in a a $60 million verdict, which is currently under appeal.

The litigation has impacted the stock prices of the health care company's, with Reckitt's share price falling 15 percent after the verdict and remaining low. On Monday, Abbott's stock dropped 4.5 percent to just over $100.50.

Dr. Benjamin Hoffman, the president of the American Academy of Pediatrics, said in a statement that public policy should expand access to donor milks and the protect the supply of infant formula for those who need it.

“Recent court cases, however, may jeopardize the availability of these formulas. Only two companies in the U.S. produce formula for premature infants; both are the subject of lawsuits similar to one that recently returned extremely high punitive damages," Hoffman said following Friday's verdict.

The lawsuits over specialized premature infant formulas are separate from ongoing litigation over the shutdown of its Sturgis, Michigan, plant and a 2022 recall of baby formula batches for possible bacterial contamination, which triggered a nationwide shortage. Those cases have yet to make it to trial.

“Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families," Hoffman said on behalf of pediatrician organization. "These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences."

According to Gill's law firm, another major, multi-district federal trial of similar claims is currently scheduled for early 2025.