In a win for Abbott Laboratories, a federal judge in Chicago sided with the company Friday in the case of a woman who alleged that Abbott’s formula for preterm infants led to her daughter’s death.
The case had been scheduled to go to trial this week, and was supposed to be the first to be heard in federal court in Chicago over the issue of whether Abbott’s specialized cow’s milk-based formula for preterm babies causes a life-threatening intestinal disease called necrotizing enterocolitis (NEC).
North suburban-based Abbott and formula-maker Mead Johnson are facing hundreds of lawsuits in federal court in Chicago over the issue, and Abbott is facing more than 1,400 lawsuits total in courts across the country. The case dismissed Friday was a bellwether case, meaning its outcome was meant to help determine how the hundreds of other cases in federal court in Chicago proceeded, and/or how to settle those cases. The court is still scheduled to hear three other bellwether cases about the issue, with the next trial slated to begin in August.
An Abbott spokesperson declined to comment Monday. An attorney for the plaintiff did not immediately respond to a request for comment Monday.
In the case, Kentucky woman Ericka Mar contended that her daughter RaiLee, who was born at 28 weeks gestation in 2014, died when she was about 2 weeks old after being fed a cow’s milk-based product made by Abbott. Mar alleges in her lawsuit that the formula was defective or unreasonably dangerous, that Abbott was negligent in selling it and that Abbott failed to warn health care providers and consumers of its dangers.
But on Friday, U.S. District Court Judge Rebecca Pallmeyer granted Abbott’s request for summary judgment and sided with the company.
In her order, Pallmeyer wrote that Mar had not been able to present evidence that Abbott could have designed the formula differently to be safer, nor that her daughter’s illness would have been prevented if Abbott had provided warnings about the higher risk of NEC in preterm babies who consume cow’s milk-based formulas.
Pallmeyer wrote that her decision in the case has “limited direct application” to the hundreds of other cases against the formula-makers in federal court in Chicago. She wrote that it’s possible plaintiffs in those other cases will be able to overcome the issues that led her to rule in favor of Abbott, depending on what evidence and testimony they provide.
In a bright spot for the other cases, Pallmeyer also decided Friday to deny Abbott’s request to exclude from those cases testimony from two expert witnesses on the link between cow’s milk-based formulas and NEC. And she denied Abbott’s motion for summary judgment in the other cases.
Wells Fargo analysts said in a note Sunday that their legal consultant “believes that it is likely that most, if not all, of the pending cases will fail on these same theories,” though it’s possible different state laws might give other plaintiffs more “breathing room,” the analysts wrote.
The ruling on Friday was the latest twist in a yearslong legal battle between Abbott and families of babies who became ill after consuming the company’s specialized formula for preterm infants — a battle that has potential implications for both Abbott and families with babies born very prematurely.
Research has shown that formula feeding is associated with higher rates of NEC for premature infants, but that’s not to say that cow’s milk-based formulas cause the disease. Some premature babies who are fed only breast milk also develop NEC.
Last year, three major 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 saying, “There is no conclusive evidence that preterm infant formula causes NEC.”
Some medical professionals are concerned about the many cases against Abbott and Mead Johnson, saying juries should not be deciding questions that scientists can’t even answer. They also worry that large verdicts against Abbott could lead the company to pull its cow’s milk-based products for preterm infants off the market, leaving some families who depend on the products in a bind.
Though neonatologists agree that mothers’ breast milk should always be the first choice of nutrition for babies born very prematurely, it’s not always available, and donated breast milk is not always an option.
Abbott Chairman and CEO Robert Ford warned in an earnings call last year, “If the regulatory process is disregarded, if the science is disregarded, it’s going to be very difficult for any company to remain on the market with these products, taking on that indefinite liability here, at least in the United States.” The specialized formulas, which are generally given in hospitals, represent a very small portion of Abbott’s overall sales.
Though Mar’s case was supposed to be the first one to go to trial in federal court, three other cases about the issue have already been heard in state courts. 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 — an outcome Abbott is appealing.
In the third case, Abbott initially prevailed, with a jury deciding 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 in a setback for Abbott and Mead Johnson, a St. Louis judge in March granted a motion for a new trial citing “errors and misconduct” in the original trial.
