Enfamil and Similac NEC Lawsuit Overview

Similac and Enfamil are two popular types of infant formula that have been marketed as safe and effective for premature babies. As a result, the baby formula is often fed to preemies or low birth weight infants in the NICU or hospital before discharge. However, cow’s milk-based products like Enfamil and Similac have been linked to necrotizing enterocolitis (NEC) among premature infants, which can result in serious injuries, lifelong health complications and death.

A number of studies published over the past three decades have highlighted the link between NEC and Similac, Enfamil or other cow’s milk formula fed to premature infants. However, false and misleading information has been provided to parents, hospitals and medical providers about the risks associated with baby formula and the benefits of breast milk.

Families are now pursuing Enfamil and Similac lawsuits in state and federal courts nationwide, alleging that the manufacturers placed their desire for profits before consumer safety.

Who Can File an Infant Formula NEC Lawsuit?

Enfamil NEC Lawsuits

Parents of infants who developed NEC are filing Enfamil NEC lawsuits against Mead Johnson Nutrition Company after consuming the following Enfamil products;

• Enfamil NeoPro EnfaCare Infant Formula
• Enfamil Premature Infant Formula 24 Cal High Protein
• Enfamil Premature Infant Formula 30 Cal with Iron
• Enfamil Premature Infant Formula 24 Cal with Iron
• Enfamil Premature Infant Formula 20 Cal with Iron
• Enfamil 24 Cal Infant Formula
• Enfamil Human Milk Fortifier (acidified liquid and powder)

Similac NEC Lawsuits

Parents of infants who developed NEC are filing Similac NEC lawsuits against Abbott Laboratories after consuming the following Similac products;

• Similac NeoSure
• Similac Special Care 20
• Similac Special Care 24
• Similac Special Care 24 High Protein
• Similac Special Care 30
• Similac Alimentum Expert Care
• Similac Human Milk Fortifier (which is actually a cow’s milk product)
• Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
• Similac Liquid Protein Fortifier

Free consultations and claim evaluations are provided to help determine if a family may be eligible for a baby formula NEC settlement, and there are no fees or expenses unless a recovery is obtained.

2025 Similac and Enfamil NEC Lawsuit Updates: MDL 3026

All Similac lawsuits and Enfamil lawsuits over NEC have been centralized as part of an MDL before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois since April 2022, where parties are preparing a small group of representative claims for early trial dates. While the outcomes of these “bellwether” trials will not be binding on other families, the average NEC lawsuit payout amount may influence the amount of any settlement offers Abbott or Mead Johnson may offer to resolve claims in the future.

• November 3, 2025 Update: The number of Enfamil and Similac NEC lawsuits continues to rise at a slow pace, with only five new cases added to the federal MDL in recent weeks, bringing the total number of cases to 755, each alleging that premature infants developed necrotizing enterocolitis after being fed cow’s milk-based baby formulas.
• October 15, 2025 Update: U.S. District Judge Rebecca Pallmeyer has ordered a second wave of NEC infant formula bellwether trials to be prepared for August 2026, after earlier cases were dismissed before reaching juries. The new round of trials will focus on claims that Similac and Enfamil cow’s milk-based formulas caused necrotizing enterocolitis in premature infants. More than 750 lawsuits remain pending in the federal MDL, with discovery for the new cases to be completed “as soon as reasonably possible.”
• July 9, 2025 Update: U.S. District Judge Rebecca Pallmeyer has ruled that Mead Johnson must face an NEC lawsuit in Missouri state court, rejecting the company’s attempt to remove the case to the federal MDL. The lawsuit, filed by an Illinois mother over her child’s NEC diagnosis after being fed Enfamil, was originally brought in St. Louis Circuit Court. While most claims remain consolidated in the federal court system, with 744 lawsuits currently pending, the ruling means this case will proceed separately in Missouri state court.
• June 24, 2025 Update: Opening arguments in the first federal NEC formula bellwether trial are scheduled to begin August 8, 2025, involving a Maryland child who suffered lifelong injuries after being fed Similac and Enfamil. The outcome of this trial may heavily influence future settlement negotiations, as manufacturers face more than 700 similar claims nationwide.
• June 2, 2025 Update: Following the dismissal of the first NEC bellwether trial, lawyers will meet with the MDL judge on June 11 to discuss next steps in the litigation. The lawsuit was dismissed due to facts unique to that case and is not expected to affect the broader claims. A second bellwether trial remains scheduled for August 11, 2025. There are currently 740 Similac and Enfamil NEC lawsuits pending in the MDL.
• May 6, 2025 Update: The first baby formula NEC bellwether trial was dismissed after the court found insufficient evidence in the individual case to support claims that Similac caused the infant’s death. However, in a major win for plaintiffs, Judge Pallmeyer denied motions to exclude expert witnesses who link cow’s milk-based formula to NEC, allowing the science behind the claims to be presented in upcoming trials. With the next bellwether scheduled for August 11, the litigation remains on track, and jury outcomes are expected to heavily influence potential Similac and Enfamil NEC settlement talks.
• May 1, 2025 Update: As new Enfamil and Similac NEC lawsuits continue to be filed by parents of children who have suffered severe gastrointestinal injuries caused by the manufacturers failure to warn about NEC risks, the JPML reports there were an additional 47 claims added to the litigation since March, marking a steady incline of new cases.
• March 5, 2025 Update: The JPML has recently issued an updated docket, indicating there are now 663 baby formula lawsuits filed against the makers of Enfamil and Similar over their alleged failure to warn about NEC side effects.
• January 14, 2025 Update: As the NEC lawsuit bellwether trials approach in the coordinated proceedings, Judge Pallmeyer has reappointed the group of 32 attorneys previously selected to lead the litigation. According to a case management order issued on January 13, these attorneys will continue handling key pretrial tasks, such as arguing motions, conducting depositions, and managing discovery on behalf of all plaintiffs. Their ongoing leadership aims to streamline the process and ensure consistent representation of common issues across the cases.

Enfamil and Similac NEC Risks

Necrotizing enterocolitis (NEC) is a serious health condition that may be caused by toxic baby formula, where an infant’s intestinal tissues becomes inflamed. If left untreated, it can cause that tissue to die, resulting in perforations in the intestines, which allow bacteria to leak into the abdomen or infiltrate the bloodstream. This can lead to life-threatening infections, narrowing of the intestines, short bowel syndrome, developmental delays and a failure to thrive.

About 90% of NEC cases occur among babies born in the 37th week of pregnancy and about 1 out of every 1,000 premature infants may be effected. It is usually diagnosed through a blood test for bacterial infections, fecal tests looking for blood in the stool, or by x-rays revealing air bubbles in the abdomen or around the intestines.

Symptoms can include:

• Abdominal pain
• Abdominal swelling
• Changes in heart rate, blood pressure, breathing and temperature
• Bloody diarrhea
• Green or yellow vomit
• Inability to gain weight
• Lack of appetite
• Lethargy

Although numerous studies published in recent years have linked Similac and Enfamil to an increased risk of NEC, the manufacturers have failed to provide adequate warnings about the potential risk to infants, and in fact still promote their products as a preferred, premium formula for premature infants.

Some studies have indicated babies fed cow’s milk formula exclusively are six to 10 times more likely to be diagnosed with NEC than infants given only breast milk.

Studies Linking Cow’s Milk Formula to NEC and Supporting Breastfeeding for Preemies

Years of research have consistently shown that cow’s milk-based infant formulas like Similac and Enfamil significantly increase the risk of necrotizing enterocolitis (NEC) among premature infants, compared to human breast milk. The studies below highlight the protective role of breast milk, the dangers associated with formula feeding in preemies, and the growing medical consensus that exclusive human milk diets should be the standard of care in NICUs.

Human Milk Diet Cuts NEC Risk and Mortality in Preemies, Study Confirms

In a study published in Advances in Neonatal Care on February 13, 2025, researchers from Memorial Hospital in Savannah and Troy University in Alabama compared the outcomes of extremely premature infants fed either an exclusive human milk diet (EHMD) or cow’s milk-based formula such as Similac and Enfamil. The study found that infants given bovine-based formulas were more than twice as likely to develop NEC and six times more likely to die in infancy than those fed human milk.

The trial evaluated 201 infants born before 32 weeks gestation and weighing less than 1,250 grams. Among those fed Similac or Enfamil formula, 10.5% developed NEC, compared to only 4.8% of infants given breast milk. Additionally, the mortality rate was 6% in the formula group, while it was only 1% in the human milk group.

The human milk-fed infants also gained weight more effectively, suggesting stronger overall health outcomes. The study’s authors urged NICUs to adopt exclusive human milk diets as standard practice, further highlighting how formula companies have downplayed the known dangers of cow’s milk products for this vulnerable population.

Mother’s Milk Contains Bioactive Nutrients That Protect Against NEC

In a study published in Nutrients on October 28, 2021, researchers from Washington University School of Medicine analyzed breast milk samples from mothers of preterm infants to assess how different components of human milk influenced NEC risk.

They found that key nutrients such as lipids and fatty acids played a role in neonatal growth and gut development, factors critical to preventing necrotizing enterocolitis (NEC). The study reinforced prior findings that human milk offers a protective advantage over cow’s milk-based formula in premature infants.

The research team studied samples collected in a NICU setting from mothers whose babies either did or did not develop NEC, and confirmed that while individual milk composition varied, breast milk consistently provided antimicrobial and bioactive compounds essential for infant health. These compounds help regulate intestinal function and immune response—benefits not replicated in formulas like Similac and Enfamil. The authors concluded that human milk is the “gold standard” for preterm nutrition, and its absence leaves infants vulnerable to diseases like NEC, particularly when substituted with formula aggressively promoted for NICU use.

Meta-Analysis Identifies Breastfeeding as Key Protective Factor Against NEC

In a study published in BMC Pediatrics on March 22, 2024, Chinese researchers conducted a comprehensive meta-analysis of 8,616 premature infant NEC cases, identifying breastfeeding as one of the most effective protective measures against the condition.

While 16 factors were found to increase NEC risk, including respiratory failure, infections, congenital heart disease, and blood transfusions, the researchers concluded that breast milk, oral probiotics, and prenatal glucocorticoids significantly reduced the risk of NEC, with breastfeeding lowering it by roughly one-third.

The study emphasized that breast milk provides a biological defense system not present in cow’s milk-based formulas like Similac and Enfamil. Specifically, it contains secretory IgA, lactoferrin, and other antimicrobial substances that help protect the gut lining from harmful bacteria.

The researchers noted that breast milk’s lower osmolality also helps reduce intestinal stress in premature infants. In contrast, cow’s milk formula can increase osmotic load and bacterial imbalance that can contribute to NEC development. These findings add further weight to allegations that formula manufacturers ignored known protective science in favor of aggressive product promotion in neonatal care units.

Breastfeeding Linked to Lower Risk of Developmental Delays in Infants

In a study published in JAMA Network Open on March 24, 2025, researchers analyzed the developmental outcomes of over 500,000 children born in Israel between 2014 and 2020. The study found that infants who were breastfed for at least six months were significantly less likely to experience delays in achieving language, motor, and social milestones compared to infants breastfed for shorter periods or not at all. The data showed that breastfeeding for six months reduced the likelihood of developmental delays by more than 25%.

Importantly, the researchers also compared sibling pairs, where one child was breastfed and the other was not, and found consistent results: the breastfed child was less likely to develop neurodevelopmental conditions. These findings reinforce the idea that breast milk provides essential nutrients and protective factors that are not replicated in cow’s milk-based infant formula products like Similac and Enfamil. While manufacturers have promoted their formulas as safe and nutritionally complete, this and other research demonstrates that they are inferior substitutes, especially for vulnerable infants during critical developmental periods.

Similac & Enfamil NEC Settlements

As of March 2024, there have been no global settlements in the Enfamil and Similac NEC lawsuits currently pending in the federal court system, where the claims have been consolidated before U.S. District Judge Rebecca Pallmeyer in the Northern District of Illinois.

In 2023, Judge Pallmeyer ordered the parties to select four infant formula NEC lawsuits for an initial bellwether trial pool, to serve as early test cases to see how juries will respond to common evidence and arguments likely to be repeated in hundreds of similar claims.

While the date the first NEC bellwether trial in the federal court system not yet been scheduled, Judge Pallmeyer has previously indicated the cases will be spaced about 12 weeks apart, and prior scheduling orders suggested the claims would be ready to go before juries by the end of 2024.

Bellwether trials serve a strategic purpose in mass tort litigation by providing a sample of jury responses to evidence and arguments that are common across a large number of similar cases. The outcomes of these Enfamil and Similac NEC trials can significantly influence the course of the litigation for several reasons, potentially encouraging a global settlement offer.

How much is an infant formula NEC lawsuit worth?

In March 2024, the first Enfamil NEC lawsuit to go before trial resulted in an Illinois jury awarding $60 million in damages to the mother of a premature infant who died of necrotizing enterocolitis (NEC) after being fed Enfamil formula shortly after birth.

Although the case was filed in an Illinois state court and not included in the MDL, the lawsuit was being closely watched, since it was the first Enfamil NEC lawsuit to go to trial in the United States, and may signal how juries will respond to similar evidence and testimony during the upcoming Enfamil and Similac NEC bellwether trials.

Free Similac or Enfamil Lawsuit Evaluation

NEC lawyers provide free consultations and claim evaluations to help determine if financial compensation and settlement benefits may be available as a result of the manufacturers’ failure to warn about the link between Similac, Enfamil and necrotizing enterocolitis.

Toxic baby formula Lawsuits are being investigated nationwide for parents of infants who were left severely injured, or who died, due to an NEC diagnosis after being fed Similac or Enfamil while hospitalized.