Enfamil NEC Lawsuits Must Meet Strict Product Identification Requirements Before Filing

As a growing number of families throughout the U.S. continue to file necrotizing enterocolitis (NEC) lawsuits against the makers of Similac and Enfamil, alleging that premature infants developed the devastating gastrointestinal illness after receiving the cow’s milk-based infant formula, the federal judge presiding over the litigation has issued an order outlining requirements for plaintiffs to establish the specific product involved in certain claims.

NEC occurs when harmful bacteria invades the intestinal walls, leading to inflammation and tissue death. This often results in the need for emergency surgery while the child is still in the neonatal intensive care unit (NICU), and many premature babies do not survive NEC.

Although Similac and Enfamil have been widely promoted as safe, and specific variations have been sold for use among premature infants, the litigation emerged following the publication of multiple studies establishing that preterm infants fed cow’s milk formula face a substantially greater risk of developing the condition compared to use of human breast milk.

There are currently about 500 Similac NEC lawsuits and Enfamil NEC lawsuits pending in the federal court system, each raising similar allegations that manufacturers placed their desire for profits before consumers safety, by withholding information from families and the medical communities, and engaging in misleading marketing that has driving mothers away from breast feeding.

Given common questions of fact and law raised in the complaints, consolidated pretrial proceedings have been established in the federal court system, where all complaints are currently centralized before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois for coordinated discovery and a series of early bellwether trials designed to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout large numbers of claims.

The litigation includes lawsuits against Abbott Laboratories, which manufactures Similac, as well as Mead Johnson, which manufactures Enfamil. However, many of the lawsuits have been brought against both manufacturers, failing to specifically identify the product that was fed to the child.

Enfamil Proof of Consumption Requirements for NEC Lawsuits

In a case management order (PDF) issued on May 6, Judge Pallmeyer established a procedure for identifying the specific preterm infant formula products involved in each case, as part of an effort to ensure that Mead Johnson is only named as a defendant in claims where Enfamil was actually ingested by the infant.

Under this new order, all lawsuits naming Mead Johnson as a defendant must now include detailed allegations that Enfamil products were indeed ingested by the infants who developed NEC. The court mandates that Plaintiffs’ counsel conduct pre-suit due diligence to identify the specific products ingested, including a thorough review of the infant’s hospital and feeding records from birth through discharge to confirm that a Mead Johnson product was used.

In cases where these records do not specify the exact preterm infant formula used, plaintiff attorneys have been given a window of 21 to 30 days after filing the lawsuit to issue targeted subpoenas to request documents that reveal the manufacturer, brand, type, item number, lot number, NDC Format Code, and any other identifying details of the nutrition product, which could also include feeding orders, nurses’ notes, and records from any feeding tracking systems used.

Moreover, the order allows for a “partial lift of discovery stay” in certain cases, enabling plaintiffs to gather necessary product identification details swiftly. Should the investigation conclude that the infant was not fed with Mead Johnson products or if the product cannot be precisely identified, plaintiffs must either dismiss Mead Johnson from the complaint or amend it accordingly.

June 2024 Enfamil and Similac NEC Lawsuit Update

As part of the coordinated management of the litigation, Judge Pallmeyer has established a bellwether program in which a small group of 12 NEC lawsuits were selected for detailed case-specific discovery. Late last year, the parties narrowed the claims down to four individual lawsuits that are expected to be ready to go before juries by the end of 2024, with cases spaced about 12 weeks apart.

Following the early trial dates, if the parties fail to negotiate infant formula NEC lawsuit settlements, it is then likely that Judge Pallmeyer will start remanding dozens of individual claims back to U.S. District Courts nationwide for separate trial dates.

As the bellwether trial process continues, baby formula lawyers are continuing to review and file new claims for families nationwide, and the size of the litigation is expected to continue to grow throughout 2024.