A little more than two years after infant formula produced by Abbott Laboratories was thought to be behind an infant death, the company has been ordered to pay nearly $500 million. The payment resolves allegations that the company concealed the risk that its infant formula for premature babies could cause serious illness.
The case – Gill v. Abbott – was brought on behalf of Robynn Gill, a premature baby girl who developed necrotizing enterocolitis (NEC) and apparently suffered brain damage after being fed Abbott’s cow’s milk-based formula Similac Special Care 24.
The family’s lawyers argued that Abbott failed to disclose the NEC risks on the product label and did not inform parents that their children could face brain damage or death from the formula.
TorHoerman Law, the legal firm representing the Gill family, stated on LinkedIn after the verdict: "Robynn Gill suffered severe, irreversible brain damage due to Abbott’s misconduct. Abbott has known for years that its cow’s milk-based formula significantly increases the risk of necrotizing enterocolitis (NEC) in premature babies. Families like the Gills had their lives changed forever due to the company’s refusal to warn families and physicians."
In its defense, Abbott’s lawyers claimed the formula does not cause NEC and that Robynn Gill had pre-existing health issues. Following the verdict, an Abbott spokesperson stated that the company “strongly disagreed” with the decision and noted it was not unanimous. “We will pursue all avenues to have the erroneous decision overturned,” the spokesperson added.
This could set a bad precedent
Following the verdict, Benjamin Hoffman, president of the American Academy of Pediatrics (AAP) raised the point that verdicts against formula companies may jeopardize the U.S. supply of fortified formulas such as Abbott’s – formulas that are essential to premature infants.
“Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences,” Hoffman said.
In Hoffman's opinion, special formulas such as these provide essential nutrition for preterm infants. Preterm infants may be less likely to develop NEC when breast milk is used, but it is not guaranteed to be safe.
“This condition can be devastating to infants and their families,” Hoffman said.
“Part of what is so challenging about NEC is that the causes are multifaceted and not completely understood. Our science does not tell us exactly how to prevent it," he said.