Enfamil Formula Should Carry NEC Warnings for Premature Infants, Mother’s Lawsuit Alleges

An Arizona mother says feeding her prematurely born daughter Enfamil infant formula led to the development of necrotizing enterocolitis (NEC); a risk she says the manufacturer was well aware of, but has failed to adequately disclose to parents or the medical community for decades.

The complaint (PDF) was filed by Case Stansell and her daughter, Kiara Sedwick, on June 12 in the U.S. District Court for the Northern District of Illinois, pursuing damages from Mead Johnson & Company, LLC, and Mead Johnson Nutrition Company, the makers of Enfamil formula, as the defendants.

NEC is a devastating condition, which occurs when an infants intestinal tissue becomes inflamed and dies, often resulting in the need for emergency surgery or fatal injuries.

Due to a growing body of research that has found that cow’s milk-based products like Enfamil and Similac greatly increase the risk among premature infants, Stansell’s lawsuit calls for more stringent warnings to be provided to medical staff and new parents about the NEC risks from infant formula.

“As early as 1990, a prospective, multicenter study on 926 preterm infants found that NEC was six to ten times more common in exclusively formula-fed babies than in those fed breast milk alone and three times more common than in those who received formula plus breast milk,” her lawsuit notes. “Despite knowing for decades that their Cow’s Milk Products are associated with and are significantly increasing NEC and death in premature infants, and are far more dangerous than most prescription drugs, Defendants have done nothing to stop or lessen NEC or death.”

Stansell and Sedwick now join a number of other parents of preterm infants nationwide who are pursuing NEC infant formula lawsuits against Mead Johnson and Abbott Laboratories, which manufactures competing Similac products. Both Enfamil and Similac are cow’s milk-based formula, which have been linked to the development of NEC among preterm infants.

According to the complaint, Sedwick was born prematurely in November 2004, and was fed Enfamil Premature Infant Formula and Enfamil Human Milk Fortifier shortly after her birth. As a result of exposure to the cow’s milk formula, the lawsuit indicates Sedwick developing NEC, leading to the need for additional surgeries to save her life.

Stansell says her daughter still suffers from severe complications, injuries and negative health consequences from NEC nearly 20 years later. However, since Mead Johnson continues to hide the risks associated with Enfamil infant formula products, the pair only recently discovery the cause of Sedwick’s life-long injuries.

“Plaintiffs were not informed that Defendants’ Cow’s Milk Products carried the risk of NEC (and resulting medical conditions and/or death),” the lawsuit states. “If Plaintiff Stansell had been informed that Defendants’ Cow’s Milk Products were associated with health risks, including NEC, she would not have allowed Plaintiff Sedwick to be fed Defendants’ Cow’s Milk Products.”

Their lawsuit presents claims of design defect, negligence, failure to warn, and negligent misrepresentation, and seeks both compensatory and punitive damages.

July 2024 Enfamil and Similac NEC Lawsuits

There are currently more than 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 pretrial proceedings.

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. However, as baby formula lawyers continue to review and file new claims for families nationwide, the size of the litigation is still expected to continue to grow throughout 2024.