U.S. District Judge Rebecca Pallmeyer
CHICAGO — Mead Johnson, one of the country's largest makers of infant formula, can't use a recent Supreme Court ruling that ended legal claims over weed killer Roundup to similarly pull the plug on an upcoming high stakes trial over claims Mead Johnson's baby formula was defectively designed and caused babies to become severely ill, a federal judge has ruled.
On Aug. 5, U.S. District Judge Rebecca Pallmeyer rejected Mead Johnson & Co.'s bid to bring an abrupt end to a key case that is set to become the first federal court trial over claims that the company's Enfamil-brand infant formula has harmed some babies.
The ruling marks another important procedural win for trial lawyers who are seeking huge potential judgments and settlements in lawsuits against Mead Johnson and its frequent co-defendant and chief baby formula market competitor, Abbott Laboratories, which makes Similac-branded baby formulas.
In those lawsuits, the plaintiffs accuse the companies of allegedly selling baby formula, including under the Similac and Enfamil brand names, despite allegedly knowing consumption of their cow's milk-based formulas increases the risk of babies suffering severe injuries or dying from the illness known as necrotizing enterocolitis, or NEC.
NEC is a condition which 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.
The lawsuits have poured into courts by the thousands in state and federal courts throughout the U.S.
Specifically, they typically accuse the companies of allegedly failing to warn the public about the alleged enhanced NEC risks posed by the baby formulas, compared to human breast milk.
While hundreds of lawsuits are pending in Illinois state courts in Madison and St. Clair counties, more than 750 lawsuits have been consolidated 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 had prepared to take those four cases to trial.
Formula makers had succeeded in ending three of the four cases. In those rulings, Pallmeyer had specifically agreed with the companies that the plaintiffs couldn't prevail on their claims that the companies should be made to pay simply because their products were more dangerous to babies than human breast milk.
Pallmeyer ruled in those other cases that feeding babies formula is better than letting them starve, even with heightened risk of NEC, when human breast milk is in short supply.
However, in the fourth case, Pallmeyer said she believed the plaintiffs could advance to trial over a different question: Whether Mead Johnson could have replaced its current formula with a different product that relied on lactose as "the main source of carbohydrates, rather than corn syrup and maltodextrin."
Pallmeyer noted some studies had shown such a change could reduce the risk of NEC in piglets. And she said communications from scientists employed by Mead Johnson showed the company was at least aware of those studies since at least 2015.
Pallmeyer thus rejected Mead Johnson's attempt to end that case and agreed in May to advance it to trial.
Following that ruling, however, Mead Johnson filed a new request to potentially end the case, this time arguing for the first time that the lawsuits should be disallowed, because they were preempted by federal law.
Specifically, Mead Johnson argued federal oversight of its infant formula production under the federal Infant Formula Act law (IFA) means that the company doesn't have the power to simply switch its formula recipe at will.
To support their claim, Mead Johnson pointed to the U.S. Supreme Court's June ruling in the case known as Durnell v Monsanto. In that case, the Supreme Court ruled that Monsanto and its corporate parent couldn't be sued for alleged harm caused by the company's alleged failure to warn consumers about the alleged cancer risk posed by its glyphosate herbicide, sold under the brand name of Roundup.
In that ruling, the Supreme Court said federal regulation under the Federal Insecticide, Fungicide, and Rodenticide Act meant Monsanto surrendered control of what its label could say to federal government regulators.
In its new filing in the baby formula case, Mead Johnson argued that reasoning should similarly preempt the defective design claims that Pallmeyer had allowed to proceed to trial.
Pallmeyer, however, disagreed. In her Aug. 5 ruling, Pallmeyer noted the IFA law did not include any language preempting lawsuits against formula makers.
And the judge further said she didn't believe the IFA law requires formula makers to secure regulatory approval before taking a new product to market, as do prescription drug makers when releasing a new medication, for instance. Rather, the judge said she believes the law requires formula makers to only notify federal regulators before selling a new product.
Pallmeyer agreed that the law empowers the federal Food and Drug Administration to take action against a manufacturer "if it believes the ... reformulation is unsafe."
"But the mere specter that the FDA might disfavor a potential lactose reformulation is no basis for a holding of preemption, as there is no indication that the FDA would disapprove or impose any additional requirements on Mead," Pallmeyer wrote.
The judge said she would provide Mead Johnson with an additional opportunity to try again, if the company "is able to identify a basis for its apparent belief ... that the FDA’s involvement in infant formula is effectively the same as the pre-market approval process that prescription drugs undergo."
Plaintiffs are represented by attorney Jose M. Rojas, of the firm of Levin Rojas Camassar & Reck, of Hartford, Connecticut.
Other attorneys representing plaintiffs in the consolidated actions and bellwether cases include attorneys from the firms of Levin Papantonio, of Pensacola, Florida; Johnson Becker, of St. Paul, Minnesota; Lieff Cabraser Heimann & Bernstein, of New York; DiCello Levitt, of Chicago and Birmingham, Alabama; and The Dixon Firm, of San Diego.
Mead Johnson is represented by attorney Paul W. Schmidt and others from the firm of Covington & Burling, of New York and Washington, D.C.
