Abbott Laboratories Secures Court Victory Amid NEC Lawsuits
A federal judge has dismissed a significant lawsuit against Abbott Laboratories, which could influence numerous similar cases concerning its specialized formula for premature infants. The ruling came from U.S. District Judge Rebecca Pallmeyer in Chicago, who granted Abbott’s motion for summary judgment in a case brought by Keosha Diggs, a Maryland resident. Diggs alleged that her son developed a life-threatening condition known as necrotizing enterocolitis (NEC) after consuming Abbott’s cow’s milk-based formula designed for preterm babies.
Diggs’ son, born at just 32 weeks of gestation, required surgery to remove part of his intestine as a result of the illness. The case was initially scheduled for trial this month but has now been resolved in favor of Abbott. This dismissal serves as a bellwether, indicating potential outcomes for over 1,400 similar lawsuits filed against Abbott and its competitor, Mead Johnson, which have been consolidated in federal court in Chicago.
The implications of this ruling are profound. Judge Pallmeyer’s opinion, issued on March 1, 2024, noted that key expert testimony regarding the risks associated with cow’s milk formulas could not be included in the case. This testimony related to infants born earlier and weighing less than Diggs’ son, rendering it irrelevant to the specific circumstances of the case. Without this expert evidence, the judge concluded Diggs could not establish a direct link between the formula and her son’s illness.
In her ruling, Judge Pallmeyer highlighted deficiencies in Diggs’ claims that echoed issues seen in a previous bellwether case she also dismissed earlier this year. Analysts at Wells Fargo commented that the ruling, along with others, suggests the challenges facing plaintiffs in these lawsuits, noting that Abbott and Mead Johnson possess robust defenses.
Abbott expressed appreciation for the court’s decision, emphasizing that it aligns with their belief that the lawsuits contradict scientific understanding and legal principles. James Hurst, an attorney representing Abbott, stated, “We remain confident that Abbott will continue to prevail when the science is properly evaluated.” Efforts to reach Diggs’ attorneys for comments were unsuccessful.
Diggs’ lawsuit claimed that Abbott failed to adequately warn parents and medical providers about the risks of NEC associated with their products. Although research indicates a correlation between formula feeding and higher rates of NEC among premature infants, establishing a causal relationship remains complex.
In a statement from three federal agencies—the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health—it was noted, “There is no conclusive evidence that preterm infant formula causes NEC.” Medical professionals recognize the necessity of these formulas for some infants, expressing concern that ongoing litigation could lead Abbott to withdraw these products from the market altogether.
Despite the controversies, these specialized formulas represent a small fraction of Abbott’s overall sales. Neonatologists advocate for breast milk as the optimal choice for very premature infants, but acknowledge that this is not always available, and donated breast milk is not universally accessible.
Currently, three additional cases related to this issue have been adjudicated in state courts, yielding mixed verdicts. One case resulted in a substantial award of $60 million against Mead Johnson, while another concluded with a $495 million ruling against Abbott, which the company is appealing. A third case initially found no liability for Abbott or Mead Johnson regarding a boy who developed NEC after consuming their products. However, a St. Louis judge later granted a new trial, citing errors in the original proceedings.
As Abbott Laboratories continues to navigate these legal challenges, the outcomes of the remaining cases may shape the future of specialized nutrition for premature infants and the corporate strategies of both Abbott and Mead Johnson.
