NEC/Infant-Formula Litigation

No child should have to endure a diagnosis of necrotizing enterocolitis (NEC) at the beginning of their life. It is a serious condition that causes the death of intestinal tissue. Babies with NEC may need one or more surgeries to survive inflamed or ruptured intestines, or they may not survive at all.

As a parent or guardian, you may be shocked to learn that your child’s cow’s milk-based infant formula or fortifier is linked to NEC. If your family suffered the horrible consequences of that disease, you have our sympathy. Although we can’t reverse the harm, the attorneys at Keller Postman are here to fight for your family and see that the formula manufacturers are held responsible.

A Groundbreaking Victory

On March 14, 2024, Keller Postman achieved a monumental victory, securing a $60 million jury verdict in the very first trial to hold manufacturers of cow’s-milk based formula accountable for causing NEC in premature infants. In this landmark case, a St. Clair, Illinois jury unanimously found in favor of our client, proving that Mead Johnson’s Enfamil formula caused her son to tragically die from NEC. This victory not only provides meaningful compensation for the Watson family but also sets a precedent for holding manufacturers accountable for the safety of their products.

At Keller Postman, we are leading the state-side litigation against Abbott and Mead Johnson, the makers of Enfamil and Similac infant formula and fortifiers, for their role in causing preterm infants to develop NEC. We are bringing claims on behalf of families in state courts across the country, with cases filed in Illinois, as well as in state courts in California, Pennsylvania, and Missouri.

The lawsuits allege that defendants falsely marketed their infant formulas as “medically endorsed” and “nutritionally equivalent” to mother’s breast milk when the formulas are linked to the development of necrotizing enterocolitis.

Despite mounting scientific evidence of the harm caused by their products, as well as the existence of safer alternatives like donor milk and human-milk based formula, these defendants have continued to encourage distribution of their products to premature infants across the country. Through this litigation, we hope to shed more light on the dangers of defendants’ products and equip parents with the information they need to avoid putting their infants’ health at risk.

Strong Scientific Evidence Supports a Link Between Cow’s Milk-Based Formula & NEC in Pre-Term and Low-Birth-Weight Infants

Preterm and low-birth-weight infants are especially susceptible to NEC because of their underdeveloped digestive systems. Extensive scientific research, including numerous randomized controlled trials, has confirmed that cow’s milk-based feeding products cause NEC in preterm and low-birth-weight infants, which in turn may lead to other medical complications, surgeries, long-term health problems, and death.

In one randomized, multicenter study of 926 preterm infants, NEC was six to ten times more common in babies exclusively fed cow’s milk formula than in babies exclusively fed breast milk and three times more common in babies who received a combination of formula and breast milk. For babies born at more than 30 weeks gestation, NEC was 20 times more common in those only fed cow’s milk formula than in those fed breast milk. (1)

Nevertheless, Abbott Laboratories and Mead Johnson have manufactured, marketed, and sold multiple cow’s milk-based formula and fortifier products specifically billed for premature infants. Not only do these products pose a threat to infants’ health, but they also displace the breast milk that the children could otherwise receive.  This displacement only increases infants’ vulnerability to NEC, as studies show that breast milk protects against the disease.

Roughly a quarter of NEC-diagnosed infants die. And even those who survive may face significant lifelong health effects: To treat the NEC, many of these infants undergo surgery to cut out and remove dead portions of their intestines. In addition to significantly taxing the premature infant’s body at a time when it needs to be focused on growing as it would in the womb, removing intestines often leads to long-term inability to absorb food and nutrients, lifelong gastrointestinal troubles, and other long-term consequences, including short-gut syndrome and cystic fibrosis. Research has also connected NEC to neurological issues ranging from learning disabilities to cerebral palsy.

(1) A. Lucas & TJ Cole, Breast milk and neonatal necrotising.  enterocolitis, 336 Lancet 1519 (1990). (2) Alan Lucas, John Boscardin & Steven A. Abrams, Preterm Infants Fed Cow’s Milk-Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother’s Own Milk, 15 Breastfeeding Medicine 297 (2020).

Qualifications for an NEC/Infant-Formula Lawsuit

If you meet the following criteria, you may qualify for an NEC/infant-formula lawsuit:

• Your child was born prematurely.
• Your child received Similac, Enfamil, or any other cow’s milk-based formula.
• Your child was subsequently diagnosed with necrotizing enterocolitis, dead bowel, or gut rot.

Necrotizing Enterocolitis (NEC) Explained: Symptoms & Diagnosis

Symptoms

• Difficulty feeding (unable to digest food)
• Stomach bloating or swelling (also called abdominal distention)
• Discoloration of the stomach (generally a blueish or reddish color)
• Pain when the stomach/abdomen is touched
• Blood found in stool or a change in stool volume/frequency
• Diarrhea, which may often contain blood
• Lethargy/reduction in activity
• Vomiting (usually a greenish/yellowish liquid)
• Unable to maintain a normal temperature
• Low heart rate/apnea episodes

(Source)

Diagnosis

To confirm a diagnosis of necrotizing enterocolitis, an abdominal X-ray is often performed. The healthcare professional will look at the wall of the intestine for a bubbled appearance or for air in the peritoneal cavity (outside of the infant’s intestine, which confirms the diagnosis. Other signs of necrotizing enterocolitis that the X-ray may reveal include air in the portal vein of the liver, lack of gas in the abdomen, or swollen intestines.

(Source)

Facts About the Number of Yearly Necrotizing Enterocolitis Cases

Approximately 9,000 infants per year develop NEC, and approximately 90% of them were born prematurely.

The saddest reality is that approximately 25% of infants with NEC die, according to a recent meta-analysis. This means that, each year, more than 2,250 infants, including 2,025 premature infants, die as a result of NEC.

Approximately 25 – 61% of NEC survivors have neurodevelopmental disabilities. And approximately 15 – 35% of NEC survivors have severe intestinal problems.

Assuming that 50% of survivors (roughly 37.5% of all infants) have an NEC-inflicted injury, approximately 3,375 infants—including 3,035 premature infants—each year are NEC survivors with long-term complications.