Abbott Laboratories has achieved a significant legal victory as a federal judge dismissed a second lawsuit concerning the safety of its formula designed for preterm infants. The ruling, issued by U.S. District Judge Rebecca Pallmeyer on March 15, 2024, could have far-reaching implications for numerous similar cases pending against Abbott and other formula manufacturers.
The lawsuit was brought forth by Keosha Diggs, a Maryland mother, who claimed that her son developed a severe intestinal disease known as necrotizing enterocolitis (NEC) after consuming Abbott’s specialized cow’s milk formula. Born at just 32 weeks gestation, her son underwent surgery to remove a section of his intestine. This case was scheduled to go to trial this month, marking it as the first case to be heard in federal court in Chicago regarding the potential link between Abbott’s formula and NEC.
The ruling comes amidst a backdrop of over 1,400 lawsuits filed against Abbott across various jurisdictions, related to the safety of its products for premature infants. The consolidated cases are being overseen in federal court in Chicago, where hundreds of similar claims have been grouped together. The recent decision to dismiss the Diggs case is considered a bellwether, as it may influence the trajectory of the remaining lawsuits.
In her ruling, Judge Pallmeyer concluded that the expert testimony suggesting a link between cow’s milk-based formulas and NEC in preterm infants was inadmissible. The judge noted that the testimony pertained to infants who were born at an earlier gestational age and weighed less than Diggs’ child. Consequently, without this testimony, the plaintiff could not establish a causal connection between the formula and her son’s illness.
In a statement following the ruling, James Hurst, an attorney for Abbott, expressed appreciation for the court’s thorough examination of the matter. “Abbott has always believed these lawsuits are contrary to both the science and the law,” he stated.
Diggs’s lawsuit accused Abbott of failing to provide adequate warnings to parents and medical professionals regarding the risks of NEC associated with the use of their products. The judge’s opinion indicated that other deficiencies in the Diggs case echoed issues identified in a previous bellwether case, which was also dismissed earlier in the year.
Analysts at Wells Fargo noted in a report to investors that the court’s decision demonstrates the challenges plaintiffs face in effectively addressing the judge’s concerns. They believe that both Abbott and Mead Johnson, another formula manufacturer, have robust defenses against these claims.
The legal battles surrounding these specialized formulas have sparked intense debate within the medical community. While some research indicates a correlation between formula feeding and increased rates of NEC in preterm infants, the causal relationship remains complex. In a joint statement released last year, three federal agencies, including the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), asserted that there is “no conclusive evidence that preterm infant formula causes NEC.”
Medical professionals emphasize the importance of these formulas, which provide essential nutrition for vulnerable infants when breast milk is not available. They caution that ongoing litigation could deter Abbott from continuing to produce these vital products. Currently, these formulas account for only a small fraction of Abbott’s total revenue.
While three other cases have been litigated in state courts with varying outcomes, the recent dismissals in federal court may signal a challenging path ahead for plaintiffs. One case resulted in a substantial $60 million verdict against Mead Johnson, while another awarded $495 million to plaintiffs against Abbott. However, Abbott is appealing that ruling. In a third case, a jury initially found no liability for Abbott and Mead Johnson after a child developed NEC. Yet, a judge later granted a new trial due to alleged “errors and misconduct” during the original proceedings.
The legal landscape surrounding Abbott Laboratories and its specialized formulas for preterm infants continues to evolve, with implications for both the company and the families involved in these lawsuits.