Enafmil & Similac's Potential Link to NEC Infant Death

spilled baby formula with backdrop of canisters; hand holding a full scoop next to baby bottle

When you purchase baby formula for your infant, you expect it to be safe. However, numerous lawsuits have recently been filed after baby formula brands Similac and Enfamil were linked with higher rates of a serious gastrointestinal infection called necrotizing enterocolitis (NEC). While these formulas have been marketed as being safe for premature and low birth weight babies, multiple studies have shown that they may be directly associated with this disease, which can cause serious, lifelong complications and even death.

An Overview of NEC in Babies

NEC is a serious bacterial infection that affects the gastrointestinal system of infants. Once it takes hold, NEC can cause rapid tissue decay of the baby’s intestinal walls. This typically creates pain and severe bowel inflammation. Without treatment, it can lead to a perforation in the intestinal wall. Once a perforation occurs, intestinal bacteria can leak into the abdominal cavity. This often causes widespread internal infection and can cause sepsis, a potentially deadly bloodstream infection.

In some cases, an infant will survive, but lose a significant portion of their intestines due to life-saving surgery. This can lead to long-term effects such as malabsorption, growth failure, and developmental delays. It may also put infants at risk for other potentially life-threatening conditions.

Research Linking Similac, Enfamil, and Similar Products to NEC

Similac and Enfamil are both popular brands of infant formula made from cow milk. These formulas are commonly given to newborns as a substitute for human breast milk. However, clinical studies and medical research have shown that giving cow milk formula to premature infants can significantly increase their chances of contracting NEC.

The scientific evidence linking Similac and NEC dates back over 30 years. This includes a 1990 study published in The Lancet, which first indicated the link between cow’s milk baby formula and NEC and suggested that babies fed with formula faced up to ten times greater risk of developing this condition. In 2012, a study in the Journal of Pediatric Research found that premature infants that were fed formula were more likely to develop NEC than those who were breastfed.

In 2021, a report published in the British Medical Journal found that manufacturers of baby formulas such as Enfamil and Similac had funded “biased and unreliable” clinical trials and may have downplayed the potential risks associated with their formulas. 

The American Academy of Pediatrics and many other prominent public health organizations have now issued warnings strongly cautioning against feeding cow-milk formula to premature infants.

Allegations Against the Manufacturer of Similac and Enfamil

The Similac brand of infant formula is manufactured and sold by Abbott Laboratories Inc., while Enfamil is manufactured by Mead Johnson. Despite being aware of the connection between their products and high rates of NEC in premature infants, these companies are alleged to have failed to include a warning label cautioning parents, hospitals, and healthcare providers against the increased risk associated with the use of these types of baby formula.

As product manufacturers, both Abbott and Mead Johnson have a legal obligation to warn users about any known dangers and risks associated with their products. Lawsuits allege that the companies made a deliberate choice not to include these vital warnings, presumably to avoid any negative impact on their products' marketability. This failure to warn is the basis of virtually every Similac and Enfamil baby formula lawsuit.

One recent wrongful death claim against Abbott Labs alleges that although Similac did have a few warnings included in their product labeling, they were “overly broad and vague, and do not ever mention that the product significantly increases the risk of NEC and death, nor provide any detailed instructions or evidence on when and how to feed the infants and how to avoid NEC and death when feeding its products.”

It went on to say that the company “did nothing to change their product, packaging, guidelines, instructions, and/or warnings” after becoming aware of the research linking products like theirs to increased risk of developing NEC among premature and other at-risk infants.

Additionally, although there are many other alternatives to cow’s milk formulas, the lawsuit points out that the manufacturers have elected to continue to promote and sell their current products instead of making changes to their formula.

Toxic Baby Formula Lawsuits

Similac litigation is still in the early stages, with new lawsuits being filed against Abbott in courts across the United States. These suits are based on strict product liability and negligent failure to warn. As plaintiffs continue to file NEC baby formula lawsuits against Abbott, all pending Similac cases in federal court will be consolidated into a “class action MDL” (multidistrict litigation) under Chief Judge Rebecca R. Pallmeyer in the Northern District of Illinois. This means that regardless of the state where you file your case, your claim will be transferred to Illinois. 

In mass tort product liability litigations, MDLs are similar to traditional class-action lawsuits. While none of the baby formula NEC lawsuits have gone to trial or been settled yet, historically, solid cases with high damages and clear evidence of the defendants’ responsibility have led to global settlements.

There's also the potential for state court cases to be consolidated into a single baby formula class-action lawsuit in Madison County since both Abbott Laboratories & Mead Johnson are based in the Chicago area. As of this writing, the Illinois Supreme Court has yet to rule on consolidation requests. However, if granted, this could be advantageous as the state of Illinois has favorable laws for victims claiming injuries like NEC. 

Request a Free Case Evaluation

If your infant suffered from NEC after consuming Similac, Enfamil, or other cow’s milk formulas, you may be entitled to significant compensation. Our firm is committed to holding manufacturers accountable for their negligence or wrongdoing and getting victims the compensation they deserve.

To learn more about whether you may be eligible to file a claim, complete our free case evaluation request form. Our experienced and compassionate attorneys will review your information and contact you to discuss your options. There are no upfront costs, no obligation, and you won't pay any attorneys fees unless we recover compensation for you.