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.

At Keller Postman, we are leading the state-side litigation against Abbott and Mead, 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.

Our Team

Meet the attorneys leading the necrotizing enterocolitis/infant-formula litigation.

Amelia Frenkel
Partner
Ashley Keller
Senior Partner
Ben Whiting
Partner
Ellyn Gendler
Associate
Julia Jones
Attorney
Bridget Hamill
Attorney
Michele Rose
Attorney
Patrick Etchingham
Attorney
Leighton Miller
Attorney
Michael Bullerman
Attorney
Polina Kueber
Attorney
Karla Rangel
Attorney
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Working with Keller Postman

We understand the harm you and your family may have experienced and the seriousness of your claims, and we are committed to providing excellent representation on your behalf.

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Our team has the skills and resources to go head-to-head with the largest, most well-resourced corporations in the country. Plus, our lawyers have experience on both sides of the courtroom, allowing us the unique ability to anticipate our opponents’ moves.

FAQs

Has Enfamil and/or Similac been recalled?

They have not been recalled. The lawsuits argue that manufacturers of Enfamil and Similac should include adequate label warnings about the specific potential risk of necrotizing enterocolitis for premature babies.

Necrotizing enterocolitis (NEC) occurs when the lining of the intestinal wall dies and the tissue falls off. NEC develops when harmful bacteria breach the walls of the intestine, causing portions of the intestine to become inflamed and often die. Once NEC develops, the condition can progress rapidly from mild feeding intolerance to systemic and fatal sepsis.

It is possible for a full-term baby to receive a necrotizing enterocolitis diagnosis, but it is rare. A NEC diagnosis is more likely in premature or low-birth-weight babies whose digestive systems are more underdeveloped (and more vulnerable).

Unfortunately, we cannot currently make an accurate prediction at this moment in time. The amount of any potential settlement or damages award would depend on factors such as how severe a plaintiff’s injuries are and treatment history. As the litigation progresses, we may learn more about the range of possible outcomes and will keep our clients updated.

We unfortunately cannot predict with any certainty how long it will take for cases to resolve, as litigation is unpredictable. There is no way to know just yet. But we will keep this page updated and also ensure that our clients are notified with any key developments.

We will pursue your claim on a contingency fee basis, meaning that there is no upfront payment, fees, or expenses unless we win your case and recover money on your behalf.

Resources

About Necrotizing Enterocolitis by NICHD: Information provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), an organization that investigates human development throughout the entire life process. They have curated helpful information about necrotizing enterocolitis (NEC), such as an overview of the disorder, information about how many infants are affected by or at risk of NEC, how it is diagnosed, and more.

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