Judge: Benefits of feeding babies beat risk claims in NEC lawsuits

Audio By Carbonatix

Saying trial lawyers have not yet shown evidence of an alternative to cow's milk-based infant formula that would not leave tens of thousands of babies unfed, a Chicago federal judge has again flushed another lawsuit against pharmaceutical and nutritional supplement maker Abbot Laboratories.

The ruling marks another significant victory for Abbott and, potentially, some of its co-defendants, as they seek to defend against thousands of lawsuits that seek to make Abbott and frequent co-defendant Mead Johnson & Co. pay potentially billions of dollars for selling baby formula the companies allegedly knew substantially increased the risk of babies developing the illness known as necrotizing enterocolitis, or NEC.

NEC is a condition that results in the death of bowel tissue and can lead to severe illness and death in newborns, particularly if they are born premature. NEC carries a fatality rate of around 15-40% in infants suffering from the condition.

In the ruling, U.S. District Judge Rebecca Pallmeyer said the lawsuits fell short in backing up their claims that Abbott Labs, among other companies, improperly chose to promote cow's milk-based formula rather than formulas based on human milk, despite the alleged enhanced NEC risks from their cow's milk products.

In her ruling, Pallmeyer said the plaintiffs must do more than argue that human milk is safer and better.

She noted expert testimony that estimated relying on human milk alone would have left at least 62,000 babies unfed over the period of 2010-2022 alone.

"... Even if Plaintiffs are correct, and formula can cause NEC, those risks cannot outweigh (Abbott's formula's) utility unless Plaintiffs put forward some evidence that shows that cow’s milk formula is unnecessary - which they have not done," Pallmeyer wrote.

"A lifeboat is not as safe as a cruise ship, but that fact alone does not render the lifeboat defective."

The lawsuits, which have poured into court since the end of 2020, claim Mead Johnson and Abbott Labs, the makers of Similac and Enfamil infant formulas, should be made to pay families with infants who died or were injured by NEC because the companies failed to warn the public about the alleged enhanced NEC risks posed by their cow's milk-based formulas, compared to human breast milk.

According to court documents, there are "thousands" of lawsuits pending in state and federal courts in Madison County, Chicago and elsewhere in the U.S., all leveling the same claims against Mead Johnson and Abbott Labs.

At least hundreds of such lawsuits are pending in state courts, including in Madison and St. Clair counties in Illinois.

However, more than 750 of those lawsuits are also pending in a consolidated action before Judge Pallmeyer in Chicago federal district court.

As part of that action, Pallmeyer, in consultation with attorneys for both sides, selected four cases to serve as so-called "bellwether" cases. While pre-trial proceedings would continue to be consolidated for the other 700-plus cases, legal teams would prepare to take those four cases to trial.

However, to this point, none of the four bellwether cases have made it to a jury. Instead, Pallmeyer has granted summary judgment to Abbott Labs in each of the first three bellwether cases.

In a summary judgment ruling, the judge essentially determines that, based on the evidence submitted in the run-up to trial, the evidence favors one side strongly enough that there is no need to empanel a jury and hold a trial.

In all three of the bellwether cases decided thus far, Pallmeyer agreed that evidence overwhelmingly favored Abbott Labs' position that the plaintiffs can't get past the benchmark holding that the benefits of their infant formula products - feeding newborns who would otherwise starve, for instance, in cases in which their mothers not be able to produce milk to feed their babies - outweigh the risks of possibly contracting NEC.

While Abbott and Mead Johnson produce human milk-based formulas, too, the supply of such human milk is not abundant enough to meet the demand, the companies said, noting the commercial supply depends on voluntary milk donations.

In her latest ruling, Pallmeyer again agreed with the companies. The judge noted that any steps the companies might take to increase the supply of human milk would run into strong legal and ethical obstacles. For instance, the judge said, even if the company paid women for their milk, the supply would then come primarily from women in lower income or other vulnerable groups, which could, in turn, jeopardize their own ability to properly nourish their own babies.

And the judge also specifically rejected plaintiffs' lawyers' contention that a so-called human milk-based "fortifier" product made by Abbott Labs should also be considered a viable alternative, because the "fortifier" is an entirely different product.

Plaintiffs in the case involved in the most recent decision were represented by attorneys Anthony D. Irpino and Pearl A. Robertson, of Irpino Avin & Hawkins, of New Orleans.

Abbott is represented by attorneys Linda T. Coberly and Stephen V. D'Amore, of Winston & Strawn, of Chicago; and James F. Hurst and Rebecca Fitzpatrick, of Kirkland & Ellis, of Chicago.

A fourth bellwether case has also yet to advance beyond the summary judgment stage.

It is not yet known what effect Pallmeyer rulings may have on the ultimate resolution of the litigation.