Business

/

ArcaMax

Abbott Laboratories scores a win in federal court, as it faces hundreds of suits over formula for preterm babies

Lisa Schencker, Chicago Tribune on

Published in Business News

A federal judge has thrown out a second case against Abbott Laboratories over the safety of its formula for babies born prematurely — a decision with potential implications for hundreds of other similar cases.

In the case, Maryland woman Keosha Diggs alleged that her son developed a life-threatening intestinal disease called necrotizing enterocolitis (NEC) after being fed specialized cow’s milk formula made by Abbott. Her son, who was born at 32 weeks gestation, then had to undergo surgery to remove a section of his intestine.

U.S. District Judge Rebecca Pallmeyer issued an opinion and order granting Abbott’s motion for summary judgement in the case Friday, several weeks after indicating at a hearing that she would do so.

The case had been scheduled to go to trial this month, and would have been the first to be heard in federal court in Chicago over whether Abbott’s specialized cow’s milk-based formula for preterm babies causes NEC.

Hundreds of cases over specialized formulas for preterm infants — filed against Abbott, which is based in Chicago's northern suburbs, and formula maker Mead Johnson, which is basd in Chicago — have been consolidated in federal court in Chicago. In total, Abbott has said that it faces more than 1,400 lawsuits over the issue in courts across the country.

The newly resolved case was a bellwether case, meaning its outcome was meant to help guide how the hundreds of other cases in federal court in Chicago might proceed, and/or how to settle those cases. Another bellwether case was also thrown out earlier this year by the same judge. The court is still scheduled to hear two other bellwether cases about the issue.

James Hurst, an attorney for Abbott, said in a statement Monday that Abbott appreciates the court’s decision and the “careful attention it gave to this matter.”

“Abbott has always believed these lawsuits are contrary to both the science and the law,” Hurst said. “We remain confident that Abbott will continue to prevail when the science is properly evaluated.”

Attempts to reach attorneys for Diggs were not immediately successful Monday afternoon.

In her lawsuit, Diggs alleged that Abbott did not adequately warn parents or medical providers about the risk of NEC in preterm babies when using their products. She also alleged that the products were “unreasonably dangerous,” among other allegations.

In her opinion released Friday, the judge wrote that the testimony of an expert who has said that cow’s milk-based formulas can contribute to preterm infants developing NEC could not be included in the case. Pallmeyer agreed with Abbott that the expert’s testimony would not fit the case because it pertained to babies who were born earlier and weighing less than Diggs’ son. Without the expert’s testimony, Diggs couldn’t show that the formula caused her son’s illness, the judge wrote.

 

The judge also noted in her opinion that there were other “deficiencies” in the Diggs case that were similar to problems she saw in the previous bellwether case that she also threw out. She noted that such issues “may continue to recur in the future” in the consolidated cases.

Analysts at Wells Fargo said in a note to investors Sunday that their legal consultant believes the decision, along with others, shows “that it will be difficult in every case to credibly respond to the judge’s practical concerns” and that Abbott and Mead Johnson have strong defenses in the cases.

For years, Abbott and Mead Johnson have been facing off in court with parents across the country who say their premature babies fell ill after consuming the special formulas. The parents say that the companies should have done more to warn parents and providers of the dangers associated with feeding preterm babies cow’s milk-based products.

But the science behind the issue is complicated. Though research has shown that formula feeding is associated with higher rates of NEC for premature infants, that doesn’t necessarily mean the formulas cause the disease.

Amid the legal battle, three federal agencies — the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health — released a statement last year saying, “There is no conclusive evidence that preterm infant formula causes NEC.”

Medical professionals have argued that the products are a necessary source of nutrition for some babies, and they worry that if the lawsuits continue, Abbott might eventually decide to pull the formulas altogether. The formulas, which are typically given in hospitals, make up a very small portion of Abbott’s total sales.

Neonatologists agree that mothers’ breast milk is best for babies born very prematurely, but they caution that it’s not always available, and donated breast milk is also not always an option.

Three other cases about the issue have been heard in state courts with mixed results.

One of those cases resulted in a verdict of $60 million against Mead Johnson and another ended with a $495 million verdict against Abbott Laboratories. Abbott has said it is appealing that decision. In the third case, a jury initially decided Abbott and Mead Johnson were not liable for a boy developing NEC after he was fed the companies’ cow’s milk-based products for premature infants. But a St. Louis judge in March granted a motion for a new trial citing “errors and misconduct” in the original trial, and Abbott is also appealing that decision.


©2025 Chicago Tribune. Visit at chicagotribune.com. Distributed by Tribune Content Agency, LLC.

 

Comments

blog comments powered by Disqus