Baby Formula Lawsuits – Enfamil and NEC

There have been a growing number of lawsuits around the country against makers of infant formula based on bovine milk (cow’s milk), in particular Mead Johnson, the makers of Enfamil. Bovine-based formulas have been shown to significantly increase the risk of necrotizing enterocolitis (NEC), a potentially deadly condition. Conversely, infant formulas based on human milk show a significant reduction in the risk of NEC. 

What is NEC? What babies are susceptible?

NEC is a bacterial infection of the intestine that can cause symptoms ranging from mild to severe, and tragically, sometimes deadly. These symptoms can include diarrhea or constipation, vomiting, distended stomach, difficulty eating or gaining weight, sleep apnea, lethargy, and shock.

Ninety percent of all cases of NEC are in premature babies. Studies show that if a premature baby is fed exclusively on cow-milk formula, that baby is ten times more likely to develop NEC than a baby fed on breast milk. The American Academy of Pediatrics and other health organizations have strongly advocated against feeding preemies on bovine-based formulas. 

Is there evidence of an NEC/bovine-based formula connection?

As early as 1990, a study published in the highly-respected research journal Lancet found that NEC was 6-10 times more common in formula-fed babies. Over the past ten years, study after study has shown both that babies fed with bovine-based formulas have a significantly higher rate of NEC and that babies fed with human-milk formulas have a significantly lower rate of NEC. 

For example, in 2010, the Journal of Pediatrics reported that premature babies fed exclusively on mother’s milk, donor milk, and human milk fortifier were 90% less likely to develop NEC. In 2011, the Surgeon General’s report concluded that premature infants who are not breastfed are 138% more likely to develop NEC. Additional studies over the years showed similar results. In 2021, a study in the Journal of the American Academy of Pediatrics concluded: “Meta-analyses of 4 randomized clinical trials performed over the period 1983 to 2005 support the conclusion that feeding preterm infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis (NEC). A more recent study of preterm infants fed an exclusive human milk diet compared with those fed human milk supplemented with cow-milk-based infant formula products noted a 77% reduction in NEC.” 

Did the manufacturers know about the connection to NEC?

It is impossible to believe that a company in the business of making baby formula would not know about the many studies regarding babies’ health after being fed baby formula. To not be aware of such studies would itself be an argument for negligent ignorance. But the manufacturers’ own marketing suggests they knew. 

For instance, Mead Johnson claims “Enfamil Enspire brings formula closer to breast milk than ever before.” Several of their new additives are prebiotics, which are known to promote intestinal health. NEC is the growth of harmful bacteria in the intestines, which prebiotics would combat. 

Even with so many studies, along with the warnings from the American Academy of Pediatrics and the Surgeon General of the United States, Enfamil has still refused to admit their formula is connected to NEC in premature babies and has not placed any warnings on their labels. Many doctors and nurses, unaware of the studies, have fed babies in the NICU with Enfamil and other cow’s milk-based formulas, possibly due to a lack of warning labels.

In what ways could the manufacturers be sued?

Mead Johnson and other manufacturers of cow’s milk formulas could be sued for a variety of causes:

  • Negligence
  • Failure to warn
  • Strict product liability
  • Negligent misrepresentation
  • Intentional misrepresentation (if the discovery process finds that they did, indeed, know of the connection to NEC)
  • Breach of warranty
  • Wrongful death (if an infant dies from NEC or complications from NEC)

What is the likely outcome of all these lawsuits?

Because there are many lawsuits, possibly growing to many thousands, it is likely they will be joined into a multi-district litigation (MDL). This differs from a class-action lawsuit, in which all litigants receive the same compensation upon settlement or award by the court. In an MDL, many individuals have varying levels of harm caused by the product, and therefore their compensation would also vary. 

If your child has received bovine-based baby formula and you believe he or she was harmed by it, contact me from anywhere in Florida. As a Florida-based personal injury attorney, I will fight for your child and for compensation for your family. It is the responsibility of companies to produce safe, effective products and the responsibility of our medical professionals to know the science and use those products appropriately. We trust them. They owe us a duty of care. When they breach that duty, I am there to fight for you. Call today at (954) 448-7288 for a free consultation.

Contact Information