Lawsuits Allege Cow’s Milk-Based Formula Causes NEC, Other Deadly Conditions in Preterm Infants

powder milk baby formula blue spoon

Recently, cow’s milk-based baby formula products have come under fire as a growing number of lawsuits allege such products can lead to the development of necrotizing enterocolitis (NEC) — a potentially deadly intestinal disease among preterm infants.

Lawsuits claim the makers of certain Similac® and Enfamil™ products failed to adequately warn consumers about the risks of NEC, which are well-documented in medical literature.

Marketed for decades as safe alternatives to breast milk for infants, cow’s milk-based “baby formula” products rose in popularity in the 1960s. Such products were once believed to be good for the growth of premature babies.

However, an extensive — and growing — body of scientific research has shown that cow’s milk-based infant feeding products can greatly increase the risks of NEC developing in preterm and low-birth-weight babies.

Conditions like NEC can turn deadly fast. Inflammation and damage to the intestinal tissues can lead to perforations in the intestines, and, as a result, allow bacteria normally present in the intestinal tract to leak into the abdomen, resulting in severe infection and potentially even death.

Infants born prematurely are at particularly high risk for developing NEC as a result of using cow’s milk-based formula, as they are more likely to have underdeveloped digestive systems. According to the NEC Society, the mortality rate among infants who develop NEC is roughly 40% — a frighteningly high number for thousands of parents of preterm babies.

Symptoms of NEC may include:

  • Bloating or swelling of the belly (abdominal distention)
  • Poor tolerance of feeding (not being able to digest food)
  • Greenish-colored fluid (bile) in the stomach
  • Bloody stool
  • Decreased activity (lethargy)
  • Temperature instability

Parents whose infants are displaying any of the above symptoms should contact their child’s physician right away.

Deceptive Marketing Puts Infants’ Lives at Risk

While alternatives to cow’s milk-based formula products are available for premature infants, the companies that sell cow’s milk-based formula products have engaged in aggressive marketing tactics that specifically target parents of premature and low birth weight infants. Often, these products are marketed as being medically endorsed, equally safe, and nutritionally equivalent to regular breast milk.

The warnings that come with such products are often overly broad, and avoid mentioning any increased risk of NEC or death. Ingredients, too, can be misleading. For example, products listed with ingredients such as “human milk fortifier” may mislead consumers into thinking the product is derived from breast milk when, in fact, it is cow’s milk-based.

Despite the large body of research highlighting the increased risks of infants developing NEC who use these products, companies selling cow’s milk-based formula have not made changes to their product’s ingredients, packaging, or warnings, continuing to use cow’s milk as the foundation of their products.

Seeking Help for NEC

No infant should be needlessly put at risk for the benefit of a company’s bottom line.

If your child has developed NEC as a result of cow's milk-based formula, you may be able to file a NEC lawsuit to seek compensation.

To learn more about your options, contact Sokolove Law today for a free, no-obligation legal consultation.

Sokolove Law Team

Contributing Authors

The Sokolove Law Content Team is made up of writers, editors, and journalists. We work with case managers and attorneys to keep site information up to date and accurate. Our site has a wealth of resources available for victims of wrongdoing and their families.

Last modified: January 26, 2022

  1. Good, Misty, et al. “Evidence based feeding strategies before and after the development of necrotizing enterocolitis.” Expert Review of Clinical Oncology, 5 June 2014. Retrieved Jan. 20, 2022, from 
  2. Johns Hopkins Medical Institutions. “Formula-fed preemies at higher risk for dangerous GI condition than babies who get donor milk.” Science Daily, 1 May 2011. Retrieved Jan. 20, 2022, from
  3. Meinzen-Derr, J., et al. “Role of human milk in extremely low birth weight infants’ risk of necrotizing enterocolitis or death.” Journal of Perinatology, Vol. 29, pp. 57–62 (2009). Retrieved Jan. 20, 2022, from
  4. NEC Society. “What Is NEC?” NEC Society, n.d. Retrieved Jan. 20, 2022, from