Enfamil Necrotizing Enterocolitis Lawsuit Set for Trial to Begin This Week

MDL judge has cleared the way for jury selection to get underway, after finding that the Enfamil infant formula lawsuit is not preempted by federal law.

A federal judge has rejected a last-minute effort by Mead Johnson to dismiss an Enfamil necrotizing enterocolitis (NEC) lawsuit, which is set for jury selection to begin later this week.

The manufacturer and its competitor, Abbott Laboratories, collectively face more than 800 Enfamil NEC lawsuits and Similac NEC lawsuits filed in federal courts nationwide. Each case argues that the manufacturers provided hospitals with specialized formula products supposedly designed to provide nutrition to premature infants without warning the institutions or parents that the cow’s milk-based products increased risks of the potentially deadly condition.

Necrotizing enterocolitis (NEC) is a condition where harmful bacteria infiltrates and attacks the walls of the intestines. Preterm newborns are particularly susceptible due to their often under-developed gastrointestinal system.

The condition causes necrosis (tissue death) in the intestines, which can lead to severe health complications and death. Treatment can involve heavy use of antibiotics and surgery to remove portions of the newborn baby’s intestines, often leaving those who survive with life-long health problems and the need for continuous medical treatment.

In recent years, numerous studies have linked the use of cow’s milk in infant formula like Enfamil and Similac to a substantially increased risk of the condition. As a result, many researchers have urged hospitals and parents to rely on breast feeding, human donor milk or other human milk substitutes for numerous health reasons, including a reduced risk of contracting NEC.

All federal necrotizing enterocolitis lawsuits brought against the makers of Enfamil and Similarc have been consolidated as part of a federal multidistrict litigation (MDL), where U.S. District Judge Rebecca Pallmeyer is presiding over coordinated discovery and pretrial proceedings in the Northern District of Illinois.

For the last couple years, Judge Pallmeyer has led the parties through the preparation of a series of representative cases to serve as early test trials. These “bellwether” cases will provide an opportunity to see how evidence and testimony likely to be repeated throughout the litigation may be interpreted by juries nationwide. Seeing how the juries respond to these commonalities could provide enough insight for attorneys to hammer out an Enfamil lawsuit settlement agreement.

After several delays, jury selection for the first bellwether trial will begin on Wednesday, involving claims filed by Alexis Inman, whose infant son, Daniel, allegedly died due to necrotizing enterocolitis after being fed Enfamil Premature Formula.

Enfamil Lawsuit Preemption Rejected

According to a memorandum opinion and order (PDF) Judge Pallmeyer issued on August 5, Mead Johnson recently filed a motion to dismiss, claiming Inman’s wrongful death lawsuit was preempted by federal law. The company’s arguments rested on a recent Supreme Court decision known as Monsanto Co. v. Durnell, which provided the manufacturers of the weed killer Roundup immunity from future product liability lawsuits.

However, Judge Pallmeyer rejected the motion, noting that the Monsanto case involved the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which specifically includes a preemption clause.

“In contrast, Mead wields Durnell against Inman’s defective design claim, in a case where the FDA need not approve a design before it goes on the market. Durnell thus does not disrupt this court’s conclusions on preemption.”

– U.S. District Judge Rebecca Pallmeyer, Northern District of Illinois

She noted that Mead Johnson’s defense was based on a new theory that the company should have brought up before, suggesting that if the manufacturer’s attorneys have evidence supporting their theory, they will be allowed to file a post-trial motion.

Necrotizing Enterocolitis Infant Formula Trials

While the decision clears the lawsuit to proceed as the first federal bellwether trial, several cases have already played out in various state courts.

A 2024 trial in Missouri ended in a jury ordering Abbott to pay nearly $500 million to a woman whose daughter suffered brain damage due to the condition. That same year, another Missouri case initially ended in a defense verdict. However, the judge ordered a new trial after finding Abbott improperly introduced certain evidence.

In April, a Cook County, Illinois, jury handed down a $70 million verdict in a Similac lawsuit. Another Cook County jury returned a $60 million verdict against Mead Johnson in a lawsuit involving Enfamil formula, yet an appeals court tossed that verdict out on June 12 and ordered a new trial.

Although none of these bellwether trial results are binding on other cases, the outcomes are being carefully watched since they could help attorneys reach a future Enfamil or Similac infant formula settlement agreement. If the litigation is not resolved by the end of the bellwether trials or pretrial proceedings, Judge Pallmeyer is likely to begin remanding cases back to their originating federal districts for individual trial dates.

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