Several studies have found an association between cow’s milk-based infant formulas and necrotizing enterocolitis. As a result, plaintiffs have filed NEC infant formula lawsuits against Mead Johnson and Abbott Laboratories, the manufacturers of Enfamil and Similac, respectively. They allege that these formulas cause necrotizing enterocolitis.
This is what you need to know about infant formulas, necrotizing enterocolitis, the studies on the relationship between the two, and the recently filed baby formula lawsuits.
Infant formula types
- Cow’s milk-based formulas: Most infant formulas comprise altered cow’s milk that resembles breast milk. It is nutritious and easily digestible. Many babies can handle cow’s milk-based formulas. However, some babies, especially those with protein allergies, need different infant formulas.
- Soy-based formulas: If you want your baby’s diet to exclude animal products, you can use soy-based infant formulas. They are an option for babies with cow’s milk formula allergies or lactose intolerance. However, some babies are allergic to soymilk.
- Protein hydrolysate formulas: These formulas contain hydrolyzed proteins. They are intended for babies who cannot tolerate cow- and soymilk-based formulas. Protein hydrolysate formulas are an alternative for babies with protein allergies.
Necrotizing enterocolitis (NEC) is a gastrointestinal issue that primarily affects premature infants who weighed under five and a half pounds at birth and underwent enteral nutrition. It causes intestinal tissue inflammation, resulting in necrosis. Perforations may form in the intestine. Bacteria can travel to the abdomen or bloodstream through the perforations. NEC’s side effects range from mild in some infants to life-threatening in others. It can affect 1 in 1,000 premature infants. Babies with a birth weight of under two pounds have the greatest risk. NEC rarely affects full-term babies.
Thankfully, NEC is pretty rare. Only 1 in 10,000 full-term infants get NEC. This could be baby formula makers thought they could get by without warning about the NEC risk.
Necrotizing enterocolitis symptoms include:
- Abdominal swelling and pain
- Heart rate, body temperature, blood pressure, and breathing changes
- Bloody diarrhea
- Yellow or green vomit
- Diminished appetite
- Weight gain difficulties
- Abdominal infections: Some infants may sustain intestinal wall perforations. Bacteria can enter the abdominal cavity through these perforations. Peritonitis may result, which increases the sepsis risk.
- Intestinal strictures: Up to one-third of infants with NEC develop intestinal strictures. This occurs within a few months after recovering from NEC. Narrowed intestines make it difficult to pass food. Surgery may be needed to open the intestine up.
- Short gut syndrome: If NEC causes small intestine damage, the infant may develop short gut syndrome. This condition causes malabsorption. Children suffering from short bowel syndrome require lifelong care for adequate nutrition. Some children require enteral feedings.
- Developmental delays and growth failure: Developmental delays, growth failure, and poor neurodevelopment can occur, especially in infants who need surgery.
What causes NEC?
Healthcare providers do not know what causes NEC. However, premature babies have weakened immune systems, which negatively impacts their bodies’ ability to fight infections. They also have weakened digestive systems, which affects their ability to fight an intestinal infection. In premature babies, oxygen-rich blood cells have a difficult time reaching the intestines. Reduced blood flow damages intestinal tissue. As a result, bacteria leaves the intestine and enters the bloodstream or abdominal cavity.
Necrotizing enterocolitis types
- Classic: The most common NEC type occurs in premature babies within three to six weeks after birth. In many cases, the baby appears stable. Then, NEC occurs without warning.
- Transfusion-associated: Some babies sustain anemia at birth. They will require blood transfusions. About one-third of premature babies who undergo this procedure develop NEC after three days.
- Atypical: While rare, infants can develop NEC within a week of being born or before their first feeding.
- Term infants: Full-term babies with NEC usually have birth defects, including gastroschisis, congenital heart conditions, and persistent pulmonary hypertension.
NEC management and treatment
Treating and managing NEC requires time for your infant’s intestines to heal. The first step is to cease oral or tube feedings. Your baby will undergo IV nutrient therapy instead. Other treatments include:
- Antibiotics: Antibiotics combat bacterial infections.
- Nasogastric tube: A thin, long tube will be inserted into your baby’s nose or mouth. It suctions out fluids and gas from the stomach.
- Surgery: Around one-fourth of babies with NEC require surgery to repair a perforation and remove necrotic intestinal tissue. An ostomy may be required.
- Catheterization: Your baby may require catheterization if they are too ill or weigh less than a pound. Draining infected or unhealthy gas and fluids alleviates symptoms. Your baby may require surgery when they are bigger and healthier.
Cochrane study finds that infant formulas increase NEC risk
The British medical research non-profit Cochrane looked at the outcome differences between premature and low birth weight babies who received infant formula compared to breast milk. Its researchers examined 12 trials that involved 1,871 babies. Their data analysis showed that infant formula increased overall growth rates during hospitalization. However, the researchers also found that it significantly increased the necrotizing enterocolitis risk. They found no evidence that infant formula affects long-term development or survival. The researchers concluded that replacing breast milk with infant formula would increase growth rates in low birth weight and premature babies but dramatically increase the NEC risk.
Breastfeeding Medicine-published study finds association between infant formula and adverse outcomes
A May 2020 Breastfeeding Medicine-published study examined cow’s milk-based infant formula’s effects on babies compared to breast milk. They reanalyzed a randomized trial that involved varying diets, including donor milk, mother’s only milk, human milk-based formulas, and cow’s milk-based formulas. The researchers narrowed their study to mother’s only milk and cow’s milk-based formulas. They found that cow’s milk-based formulas were associated with a higher NEC risk, especially NEC surgery and death. The researchers also found that babies who received cow’s milk-based formulas had lower head circumference increases than those who received mother’s only milk. They concluded that cow’s milk-based formulas were associated with significant adverse health effects compared to mother’s only milk.
May 2021 wrongful death lawsuit in California federal court
On May 14, 2021, an Oregon man and woman filed suit in California federal court. They alleged that the cow’s milk-based infant formulas Enfamil and Similac contributed to their child’s death. Their baby boy was born at 31 weeks weighing two pounds two ounces. He was transferred to the NICU, where he developed necrotizing enterocolitis. The boy died during his stay. He was only 16 days old. The boy’s parents claimed he developed NEC from being fed cow’s milk-based infant formulas. They alleged that the formulas’ manufacturers, Mead Johnson and Abbott Laboratories, failed to warn the public of their products’ toxicity, designed a defective product, and misrepresented its safety to the public.
August 2021 lawsuit in Illinois state court
Two Louisiana residents, a young woman and her mother, filed a lawsuit against Mead Johnson and Abbott Laboratories in Illinois state court on August 27, 2021. They alleged that their cow’s milk-based formulas, Mead Johnson’s Enfamil and Abbott’s Similac, caused the young woman’s necrotizing enterocolitis.
The woman was born prematurely on August 25, 2001. Her mother fed her both formulas. The then-baby girl developed NEC. She underwent surgery. The now-woman was left with permanent side effects. She and her mother alleged defective design, failure to warn, misrepresentation, and loss of consortium against Mead Johnson and Abbott.