Baby Formula Failure to Warn: The Core Allegation in the Toxic Baby Formula Lawsuits

The lawsuits allege that manufacturers of cow’s milk-based formulas, specifically Abbott Laboratories (maker of Similac®) and Mead Johnson (maker of Enfamil®), knew for decades that their products significantly increased the risk of necrotizing enterocolitis (NEC) in premature infants but failed to warn parents and doctors.

Necrotizing enterocolitis (NEC) is a serious and often life-threatening intestinal disease that primarily affects premature and low-birth-weight infants. It causes severe inflammation that can destroy intestinal tissue, leading to a hole (perforation) in the gut, which can cause overwhelming infections like sepsis.

The lawsuits primarily name cow’s milk-based products from Similac and Enfamil that are designed for premature infants. These include specialized formulas and “human milk fortifiers” (which are also bovine-based) such as Similac Special Care, Similac NeoSure, Enfamil NeuroPro EnfaCare, and Enfamil Human Milk Fortifier.

A premature baby’s digestive system is underdeveloped and can’t easily digest the proteins in cow’s milk. This is believed to trigger an inflammatory response that damages the fragile intestinal lining, leading to NEC. Human breast milk contains protective antibodies and immune cells that help a preemie’s gut mature and fight infection.

No. As of late 2025, there has not been a recall of these formulas specifically for the risk of NEC. The lawsuits are based on the manufacturers’ “failure to warn” about the known risks, not a specific contamination or manufacturing defect that would typically trigger a recall.

Symptoms can appear suddenly and include a swollen, hard, or discolored (red or blue) abdomen, bloody stools, green or yellow vomit, difficulty feeding, lethargy (sluggishness), and changes in heart rate, breathing, or body temperature.

You may be eligible to file a lawsuit if your child was born prematurely or with a low birth weight, was fed a cow’s milk-based formula (like Similac or Enfamil), and was subsequently diagnosed with necrotizing enterocolitis.

Not necessarily. Most states have a “discovery rule,” which means the time limit (statute of limitations) may not start until you discovered the link between the formula and your child’s NEC, which for many parents was only recently. It is crucial to speak with a lawyer immediately to understand the deadline in your state.

The deadline, or statute of limitations, varies by state but is typically two to three years. However, the “discovery rule” and special exceptions for injuries to minors can extend this deadline, so you should not assume it’s too late.

Yes. If you tragically lost your child to NEC, your family may be able to file a wrongful death lawsuit. This type of claim seeks compensation for medical and funeral expenses, as well as for your family’s emotional distress and suffering.

This is very common, and you can still have a case. An experienced NEC lawyer can obtain and review your child’s hospital medical and feeding records to identify the exact products that were used.

It is less common, but you may still have a case. While the vast majority of NEC cases affect premature infants, full-term babies with other health issues can also develop NEC. It is best to consult an attorney to evaluate your specific situation.

The first step is to get a free case review from a law firm that specializes in these cases. They will listen to your story, review the basic facts, and determine if you may be eligible to file a claim. There is no cost or obligation for this consultation.

There are no upfront costs. Reputable law firms handle these cases on a contingency-fee basis, which means they only get paid if they successfully recover compensation for you through a settlement or verdict.

No, it is a mass tort, which is handled through a Multidistrict Litigation (MDL). In a mass tort, each family’s case remains individual, and compensation is based on the specific harm your child suffered. This is different from a class action, where all plaintiffs typically receive the same settlement amount.

MDL stands for Multidistrict Litigation. The NEC MDL (MDL 3026) is a process that consolidates all federal lawsuits into a single court in Illinois to streamline pretrial proceedings like evidence gathering. This makes the process more efficient for everyone involved.

Bellwether trials are “test cases” selected from the larger group of lawsuits in the MDL to be tried first. The outcomes of these trials help both sides understand how juries might respond to the evidence and often guide negotiations for a global settlement for the remaining cases.

These cases can take several months to a few years to resolve. The timeline depends on the complexity of the case and the progress of the larger MDL, including the results of the bellwether trials.

As of late 2025, there has not been a global settlement for all the cases in the federal MDL. However, individual state court trials have resulted in massive verdicts for families, including a $60 million verdict against Enfamil’s maker and a $495 million verdict against Similac’s maker.

The value of each case is unique and depends on the severity of the injury. Legal experts estimate that potential payouts could range from $50,000 for cases with a full recovery to over $500,000 or even millions for cases involving wrongful death or severe, lifelong disabilities like short bowel syndrome.

Compensation can cover both economic and non-economic losses. This includes medical expenses (past and future), lost wages for parents, pain and suffering for both the child and family, and in tragic cases, wrongful death damages like funeral costs.

Survivors of severe NEC can face lifelong challenges, including short bowel syndrome, intestinal scarring (strictures), growth failure, and neurodevelopmental delays like cerebral palsy.

Short bowel syndrome (SBS) is a serious condition that can occur after surgery for NEC, where a large portion of the intestine is removed. The remaining bowel is too short to absorb enough nutrients and fluids, often requiring lifelong intravenous nutrition (PN).

Doctors diagnose NEC based on symptoms like a swollen belly and bloody stools, combined with an abdominal X-ray. The X-ray may show a bubbly appearance in the intestinal wall (pneumatosis intestinalis) or air that has leaked into the abdomen, which are key signs of the disease.

Colic is a pattern of intense crying in an otherwise healthy baby, while reflux is simple spitting up. NEC is a medical emergency with severe, systemic symptoms like a hard, discolored belly, bloody stools, and green vomit. A baby with NEC is visibly and seriously ill, which is very different from a “happy spitter” or a colicky but healthy infant.

The most important evidence is your child’s medical records. These records should show that your baby was born prematurely, was fed a cow’s milk-based formula, and was diagnosed with NEC. Your lawyer will help you gather all necessary documentation.

Under HIPAA, you have a legal right to your child’s medical records. You can request them by contacting the hospital’s Medical Records or Health Information Management (HIM) department and filling out an “Authorization to Release Health Information” form. Your lawyer can also handle this entire process for you.

The primary defense strategy for Abbott and Mead Johnson is to deny that their formulas cause NEC. They argue that NEC is a multifactorial disease of prematurity and that there is no “conclusive” scientific proof of causation.

Bellwether trials are “test cases” selected from the larger group of lawsuits in the MDL to be tried first. The outcomes of these trials help both sides understand how juries might respond to the evidence and often guide negotiations for a global settlement for the remaining cases.

No. Because the NEC lawsuits are a national mass tort, with many cases consolidated in a federal MDL, you can hire the best and most experienced law firm in the country, regardless of where you live. They can file a claim for you in the appropriate court.