$495 Million Verdict Against Abbott Laboratories for Disease-Causing Baby Formula

A Missouri jury recently found that the specialized baby formula, Similac Special Care 24, which is frequently used in neonatal intensive care units for premature babies, caused a dangerous bowel disease in a newborn and rendered a $495 million verdict against the manufacturer, Abbott Laboratories. The jury verdict is the second case to go to trial this year over the dangers of specialized formula, with Abbott’s competitor, Mead Johnson (acquired by Reckitt Benckiser) also facing similar claims over its Enfamil formula. All of these lawsuits involve products that are specially made for babies in hospital settings and are not products that are available to consumers in retail stores.

What Happened?

When babies are born prematurely, they are often given specialized cows’ milk formulas while in the neonatal intensive care units to increase their weight. When Margo Gill gave birth to her daughter, Robynn Davis, at only 26 weeks gestation in August 2021, Davis began taking Abbott’s Similac formula in October. Within 72 hours, Davis developed necrotizing enterocolitis (NEC), a gastrointestinal disease that affects low birth weight and preterm infants. NEC, which causes the necrosis of bowel tissue, has a fatality rate between 15% to 40%. Although Davis survived, she needed to have 75% of her intestines removed. She cannot eat normally, relies on a wheelchair for mobility, and suffers from brain damage. Her injuries will require permanent, around-the-clock care for the rest of her life.

The Trial

Represented by Jake Plattenberger of TorHoerman Law LLC, Davis filed a lawsuit on her daughter’s behalf, alleging that Abbott was aware of the risk of necrotizing enterocolitis but failed to warn the public and medical community. According to the lawsuit, as well as other similar lawsuits against Abbott and Reckitt, the risk of developing NEC is starkly greater in their formula than with breast milk, donor milk, or human milk-derived formula. At trial, the plaintiff’s attorney presented evidence that formula should not have been given to Davis if she remained under 1,500 grams, citing studies that indicate an increase in NEC for babies under that weight. Counsel also asserted that at least one defense expert had learned, for the first time during the trial, that Abbott had “worked behind the scenes” to influence Duke University Hospital’s standards and protocols in connection to preterm newborns.

Defense attorney, James Hurst of Kirkland & Ellis LLP, argued that Davis’s permanent injuries were caused by brain trauma she suffered at birth after her brain was deprived of oxygen.

The jury rendered a verdict in favor of Gill and Davis, with nine out of the 12 jurors in agreement, as Missouri civil law does not require unanimity – only three-fourths of jurors must agree on the verdict. The jury awarded the plaintiffs $95 million in compensatory damages and $400 million in punitive damages.

What’s Next?

This case is just one of nearly 1,000 lawsuits that are pending against Abbott as well as Reckitt Benckiser, the makers of Enfamil formula, throughout the country. More than 500 of these lawsuits were centralized in multidistrict litigation before an Illinois federal court, with others pending in state courts in Illinois, Missouri and Pennsylvania. The first MDL lawsuit is scheduled to proceed to trial in May 2025.

The first state court lawsuit to proceed to trial against Reckitt was in Illinois this past March and resulted in a $60 million jury verdict which Reckitt is appealing on the basis of “unsound expert testimony.” In response to the verdict, Reckitt's share price fell about 15% and has since continued to suffer from market losses. A similar result happened to Abbott – with stock prices falling the Monday after the verdict. A spokesperson for Abbott has stated that it strongly disagrees with the verdict and would try to have it overturned. Abbott spokesperson, Scott Stoffel, released a statement commenting, "[w]e 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." Stoffel also added that, "[t]here is no scientific evidence showing Abbott's preterm infant products cause or contribute to causing” NEC and that its products 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."

Aside from the NEC formula lawsuits, Abbott is also facing litigation over the shutdown of its Sturgis, Michigan plant and the subsequent recall of possibly contaminated batches of formula, which led to the nationwide shortage in 2022. Thus far, no trials have occurred in those cases.