A federal court has dismissed a significant case against Abbott Laboratories, which could influence over 1,400 similar lawsuits regarding its formula for preterm infants. The ruling, issued by U.S. District Judge Rebecca Pallmeyer, addresses allegations from Maryland resident Keosha Diggs, who claimed her son developed a severe intestinal condition, known as necrotizing enterocolitis (NEC), after being fed Abbott’s specialized cow’s milk formula.
Diggs’ son was born at just 32 weeks gestation and underwent surgery to remove a part of his intestine due to the illness. The judge’s decision to grant Abbott’s motion for summary judgment means that the case, initially set for trial this month in Chicago, will not proceed. This case was particularly noteworthy as it was one of the first bellwether trials aimed at guiding the outcomes of similar claims consolidated in federal court.
As the legal landscape unfolds, Abbott faces over 1,400 lawsuits across the United States, all centered on the safety of its cow’s milk-based formula for preterm infants. The judge’s recent ruling follows another bellwether case that was also dismissed earlier this year. The court is still scheduled to hear two additional bellwether cases regarding this issue.
In a statement, James Hurst, an attorney representing Abbott, expressed appreciation for the court’s thorough examination of the case. “Abbott has always believed these lawsuits are contrary to both the science and the law,” Hurst commented, adding that the company remains confident in its position as the science is properly assessed.
Diggs’ allegations included claims that Abbott failed to adequately inform parents and healthcare providers about the risks of NEC when using its products. She contended that the formula was “unreasonably dangerous.” In her ruling, Judge Pallmeyer determined that the testimony of an expert witness, who argued that cow’s milk formulas could contribute to NEC, was not relevant to Diggs’ case as it dealt with infants born at earlier gestational ages and with different health conditions.
Without this expert testimony, the judge concluded that Diggs could not establish a causal link between the formula and her son’s condition. Judge Pallmeyer also noted several other deficiencies in Diggs’ case that mirrored those in the prior bellwether ruling, suggesting similar issues could arise in future consolidated cases.
Analysts at Wells Fargo commented that the recent decision indicates challenges for plaintiffs in making their cases credible in light of the court’s concerns. They noted that both Abbott and Mead Johnson, another formula manufacturer, have robust legal defenses.
The ongoing litigation has seen parents from across the nation challenge Abbott and Mead Johnson, claiming their infants became ill after consuming these specialized formulas. Parents assert that the companies should have provided clearer warnings about the potential dangers of cow’s milk-based products for preterm infants.
While research indicates a correlation between formula feeding and increased rates of NEC in premature infants, establishing a direct causative relationship remains complex. In a joint statement released last year, three federal agencies—the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health—stated, “There is no conclusive evidence that preterm infant formula causes NEC.”
Healthcare professionals emphasize the importance of these formulas as a critical nutritional source for some infants, expressing concern that continued litigation could lead Abbott to withdraw these products from the market. Although breast milk is widely regarded as the best option for very premature babies, it is not always available, and donated milk may also be scarce.
The situation remains fluid, with three other related cases having been adjudicated in state courts, yielding mixed outcomes. One case resulted in a $60 million verdict against Mead Johnson, while another saw Abbott ordered to pay $495 million. Abbott is currently appealing this decision. In a separate case, a jury found both companies not liable for a child’s NEC development, but a St. Louis judge later granted a new trial due to identified errors and misconduct.
As the legal proceedings continue, the implications of these rulings may shape the future of infant nutrition products and the responsibilities of manufacturers in ensuring the safety of their formulas.
