Abbott Laboratories, facing hundreds of lawsuits over safety of formula for premature babies, notches a win in federal court
Published in Business News
A federal judge handed Abbott Laboratories another win this week in its yearslong battle over the safety of its formulas for babies born prematurely — a decision that could have implications for hundreds of other cases.
In the case, Deondrick Brown Sr. and Rebekah Etienne alleged that Abbott’s formula for premature babies was “unreasonably dangerous” and caused their son, Deondrick Brown Jr., to develop the intestinal disease necrotizing enterocolitis (NEC) that led to his death.
Their son was born 24 weeks into his mother’s pregnancy, but because his mother was unable to produce breast milk, he was fed fortified donated breast milk for about two months, according to an opinion and order issued Thursday by U.S. District Judge Rebecca Pallmeyer.
Doctors then began transitioning the baby onto Abbott’s cow’s milk-based formula designed for preterm infants, and within days he died from NEC, according to the opinion and order.
On Thursday, Pallmeyer granted Abbott’s motion for summary judgment in the case, siding with the company.
The win is Abbott’s third in a row in federal court in Chicago where hundreds of cases over specialized formulas for preterm infants — filed against north suburban-based Abbott and formula maker Mead Johnson — have been consolidated.
All three cases, including the one decided Thursday, have been bellwether cases, meaning their outcomes are meant to help guide how the hundreds of other cases in federal court in Chicago might proceed, and/or how to settle those cases. The court is slated to hear one more bellwether case over the issue.
“We appreciate the federal court’s thoughtful consideration of the scientific evidence and its decisions in the first three bellwether cases,” Abbott said in a statement Friday. “Abbott has consistently maintained that the claims are unsupported by both science and law, and that our preterm infant nutrition products are safe and vital to the care of premature infants.”
Attorneys for the plaintiffs did not immediately respond to a request for comment Friday afternoon.
In her opinion and order Thursday, the judge wrote that she granted the motion for summary judgment and sided with Abbott because no feasible alternative to the formula was available and because the plaintiffs were not able to show that the formula’s risk outweighed its usefulness.
“Even if human milk is always a safer option, (the formula) still has utility by virtue of its widespread availability and important role as a backup nutrition source for an infant who otherwise has no feeding option,” Pallmeyer wrote. “A lifeboat is not as safe as a cruise ship, but that fact alone does not render the lifeboat defective.”
In addition to the hundreds of cases consolidated in federal court in Chicago, many other cases over the issue have also been filed in state courts. Many parents who filed lawsuits 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.
Though neonatologists agree that mothers’ breast milk is best for babies born very prematurely, they caution that it’s not always available, and donated breast milk is also not always an option.
Research has shown that formula feeding is associated with higher rates of NEC for premature infants, but that doesn’t necessarily mean the formulas cause the disease. 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.”
A number of medical professionals have expressed worry that if Abbott were to fare poorly in court over the cases, it might eventually decide to stop distributing the formulas. The formulas are typically given in hospitals and make up a very small portion of Abbott’s total sales.
Though the decision Thursday was the third win for Abbott in federal court, it’s had more mixed results in state courts.
One case in state court resulted in a verdict of $60 million against Mead Johnson. Another case ended with a $495 million verdict against Abbott — a decision that Abbott is appealing. In a 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. Abbott is appealing that decision.
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