Discovery Protocols for Baby Formula NEC Lawsuits Outlined for Bellwether and Trial Selections

The protocols are designed to help the parties select and prepare the first baby formula NEC lawsuits for trial.

With a growing number of families pursuing baby formula NEC lawsuits against the makers of Similac and Enfamil over failure to warn about the risks associated with use of the products with premature infants, an agreement has been reached regarding discovery protocols which will help prepare a small group of representative claims for early trial dates.

Necrotizing enterocolitis (NEC) is a devastating gastrointestinal disease, which primarily impacts premature babies, occurring when harmful bacteria breaches the walls of the intestines, causing portions of the tissue to become inflamed or die. The condition often results in the need for emergency surgery while the baby is still in the NICU, and many infants do not survive NEC.

Several hundred families are now pursuing Similac lawsuits and Enfamil lawsuits against the makers of cow’s milk-based infant formula products, alleging that Abbott Laboratories and Mead Johnson failed to warn families and the medical communities that premature infants faced an increased risk of developing NEC following use of the powdered formula, compared to infants fed human milk.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


In the federal court system, a baby formula MDL (multidistrict litigation) was established last year, centralizing all lawsuits over NEC caused by Similac or Enfamil before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois, for coordinated discovery and pretrial proceedings.

As part of the management of the litigation, Judge Pallmeyer has established a “bellwether” program, where a group of 12 NEC lawsuits brought against the two infant formula manufacturers are going through case-specific discovery, and will be prepared for a series of early trial dates, which are designed help gauge how juries will respond to certain evidence and testimony that will be repeated throughout the litigation.

On April 18, the parties submitted a listed of stipulated discovery protocols (PDF), which will govern the exchange of information in the bellwether cases. The parties laid out plans for completing fact discovery in trial selections, including conducting deposition of fact witnesses, defendants’ case-specific fact witnesses, and treating healthcare providers.

The protocols include a limit on bellwether discovery, which is meant to balance the needs of being able to determine the best cases for early trials, while not undergoing full discovery at this time. The protocols limit the number of depositions on each side, with plaintiffs agreeing not to depose any of the Defendants case-specific fact witnesses at this stage.

The protocols also cover discovery search terms, depositions of defendants’ current or former employees and health care providers.

Baby Formula NEC Bellwether Case Selections

In October 2022, Judge Pallmeyer identified the first eight cases that will serve in the initial bellwether pool, including four claims selected by plaintiffs and another four randomly selected by the Court. In December, another order was issued identifying four additional claims selected by the infant formula manufacturers.

Fact discovery is scheduled to be completed for those 12 bellwether cases by April 28. The parties will then select a smaller group of four claims that will be eligible for trial two weeks later, and conduct expert discovery over the remainder of 2023.

As part of the pretrial schedule, a series of court-ordered infant formula NEC settlement talks will be held between October 15 and October 27, 2023, at which time the parties will participate in mediation on the Bellwether selections, which may also lay the ground work for negotiating an agreement that would settle all claims pending against the two manufacturers.

If NEC settlements are not reached, the Court will consider challenges to the admissibility of expert witness testimony in early 2024, and a final pretrial conference has been set for March 11, 2024, at which time the parties will establish the schedule for initial trials.


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