The first few months of life are critical for babies’ health and development, especially when an infant is born prematurely. While health experts widely recommend that infants be fed breast milk exclusively for the first six months of life, many preterm infants are unable to breastfeed. As an alternative, they may be fed infant formula breast milk substitutes.

The use of formula in place of mother’s milk is associated with short and long-term infant health risks. For premature infants, the administration of cow-based formulas instead of breast milk is associated with a higher risk of developing necrotizing enterocolitis (NEC), a life-threatening gastrointestinal disease. Science dating back to the 1990s links cow-based formula products and NEC in premature infants. 

Yet despite the strong medical evidence connecting these products to NEC in preemies, manufacturers do not disclose this risk on product packaging or other materials. In fact, some manufactures market cow-based infant formula as equally safe alternatives to breast milk, even going so far as to promote their products as necessary for optimal infant nutrition and growth. 

If your child developed complications from NEC after being fed formula containing cow’s milk, you may qualify for a legal claim against the product manufacturer. Contact us, the nation’s largest injury law firm, for a free case review. 

What Is Necrotizing Enterocolitis?

Necrotizing enterocolitis (NEC) is a serious gastrointestinal illness that primarily affects premature babies. According to the Cleveland Clinic, 90% of babies who get NEC are born prematurely. Usually, it afflicts babies born before 28 weeks of pregnancy and has a sudden onset, with no warning signs. 

NEC is a serious inflammatory condition of intestinal tissue. It can advance to tissue death (necrosis) and, in some cases, a hole in the gut (perforation) develops that can allow bacteria to leak into the abdomen or bloodstream through the hole. Infants with NEC are also at risk for:  

• Longer hospital stays
• Abdominal infection
• A narrowed intestine that makes digestion difficult (intestinal stricture)
• Short bowel (short gut) syndrome, which can make it hard to absorb fluids and nutrients
• Growth failure, developmental delays, and poor neurodevelopmental outcomes
• Systemic sepsis
• Organ failure
• Death 

What is the Treatment for NEC? 

Surgery may be necessary for severe forms of NEC. About 20 to 40% of cases require surgery, says a paper published in the journal Advances in Nutrition. Health care costs associated with NEC are high. Data indicate that treating an infant with NEC costs nearly $200,000. If surgery is required, costs can increase to more than $300,000. NEC survivors have healthcare costs that are about $100,000 more, on average, than infants without a diagnosis of NEC. 

Does Cow-Based Baby Formula Cause NEC? 

The links between cow-based infant formulas and NEC in premature infants is well-established. Researchers writing in the Expert Review of Clinical Immunology note, “There is general consensus in the field that the administration of breast milk is the most effective for protecting against the development of NEC.” Conversely, the administration of formula is associated with a higher risk of developing NEC versus milk either from the infant’s own mother or from a donor source. 

Research on this topic first appeared in the Lancet in 1990, with researchers finding that exclusively formula-fed infants were 6 to 10 times more likely to develop NEC than infants receiving breastmilk. 

In 2010, a study was published establishing that premature babies fed an exclusive diet of mother’s milk, donor milk, and human milk fortifier were 90% less likely to develop NEC requiring surgery. 

The following year, the U.S. surgeon general, in a call to action to support breastfeeding, published a report warning that, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC).” 

A year later, the American Academy of Pediatrics came out with a policy statement that all preterm infants should be fed an exclusive diet of human milk due to the risk of NEC from consuming cow-based formula. 

Do Formula Manufacturers Know About the Risks of NEC to Premature Babies?

At the very least, they should know, given the numerous policy statements and studies showing the protective qualities of breastmilk against NEC. Nevertheless, some manufacturers have specifically marketed their cow-based infant formulas and fortifiers as necessary to the growth and development of preterm infants, ignoring the medical evidence against giving these formulas to preemies. 

Indeed, they have not failed to address NEC risks in product literature, but actively tried to get more moms to choose toxic baby formula over breast milk. This aggressive marketing of formula products has led to what a review in The BMJ calls, “the cultural normalisation of formula feeding.” 

BMJ reviewers found lack of transparency, selective reporting, and bias in favor of formula in formula trials. They concluded that, “The formula industry is closely involved in formula trials, findings are almost always reported as favourable, and little transparency exists about the aims of the trial or reporting of results.”

Which Formulas May Lead to an Infant Developing NEC?

Around 80% of toxic baby formulas are cow milk-based, including products made by the following brands: 

• Baby’s Only
• Bobbie
• Earth’s Best
• Enfamil
• Gerber
• Go & Grow
• Happy Baby
• Holle
• Kendamil
• Lebenswert
• Louloka
• Parent’s Choice
• Similac

Some of these brands offer alternatives that don’t contain cow’s milk. Although breast milk is shown to be safer for premature infants than formula, if you are unable to provide breast milk, talk to your pediatrician about which formulas are best for your child. 

Do I Qualify for an NEC Toxic Baby Formula Lawsuit? 

Lawsuits are being filed against cow milk-based formula makers Abbott Laboratories, maker of Similac, and Mead Johnson, manufacturer of Enfamil. 

The plaintiffs in these cases are parents whose premature babies suffered or died from NEC after taking one of these toxic baby formulas. They claim that Abbott and Mead Johnson were aware of the scientific evidence linking their formulas to NEC in premature infants, but did not include product warnings about this risk. Their lawsuits seek compensation to pay for infant deaths and injuries they say were caused by the negligence of Abbott and Mead Johnson.

You may qualify for a similar NEC toxic baby formula lawsuit if your premature baby was fed Similac, Enfamil, or another cow milk-based infant formula, and the child subsequently was diagnosed with NEC. For a full explanation of your legal rights and options, contact the award-winning injury attorneys at Morgan & Morgan and tell us your story.