Lawsuits against Baby Formulas Allege That Cow’s Milk-based Formulas are Dangerous and Potentially Fatal

Recently, the discussion around Necrotizing Enterocolitis in infants, due to baby formulas containing cow milk, has been at an all-time high. Many lawsuits have been filed against makers of baby formulas by parents of infants whose children have had a rare gastrointestinal problem called Necrotizing Enterocolitis.

These lawsuits say that the formulas contain cow’s milk which can result in serious gastrointestinal problems and could be potentially fatal in premature babies. This is a somewhat concerning allegation considering that according to the March of Dimes, 380,000 babies—nearly 1 in 10 babies overall—are born prematurely annually in the United States.

What is Necrotizing Enterocolitis (NEC)?

Infant Necrotizing Enterocolitis (NEC) is a gastrointestinal emergency where the infant’s intestines are inflamed. There are also areas of the intestines that may contain dead/necrotic tissue, and some parts may become perforated. If a perforation does occur, the intestine’s contents, including the bacteria, leak into the abdomen. This could lead to multiple complications, including but not limited to septicemia. These complications may then be fatal.

In 2017 an article was published in the Journal Advances in Nutrition that reported that somewhere between 25 and 50 percent of cases of Necrotizing Enterocolitis are fatal.

The link between NEC and Cow’s Milk-Based Formulas

Research has shown a correlation between neonatal NEC risk and formula administration. Many parents, and even many NICU healthcare workers—are not aware that many popular baby formula brands are fortified with or contain cow’s milk. Cow’s milk is not recommended for premature newborns.

The Journal of Pediatrics published a study back in 2010 that concluded that when premature babies were fed mother’s milk, donor milk, and human milk fortifiers exclusively, they were 90% less likely to develop surgical NEC.

Premature infants who are not breastfed are 138% more likely to develop NEC than those that are, was the conclusion of a report published in 2011 by the U.S. Surgeon General.

Symptoms of NEC

NEC can present with a variety of signs and symptoms. These are the more commonly seen ones:

  • Abdominal pain and distension
  • Diarrhea and blood in the stool
  • Green or yellow vomit
  • Feeding intolerance
  • Decreased activity

California Lawsuit

There are currently multiple lawsuits against baby formula manufacturers, such as Abbott Laboratories Inc. and Mead Johnson & Company. Their formulas, Similac and Enfamil, are currently the ones that are in the limelight the most.

One such lawsuit is related to the death of a 34-day infant. The lawsuit is filed in the United States District Court for the Central District of California.

The plaintiff’s child, referred to in the lawsuit as “Baby Sanders”, was born prematurely on December 25th, 2020. He was then intravenously fed Similac Special Case 20F, manufactured by Abbott Laboratories, and Enfamil HMF High Protein, Enfamil Premature, and Enfamil Premium manufactured by Mead Johnson & Company, LLC.

Baby Sanders then developed Necrotizing Enterocolitis (NEC) on January 25th, 2021, and unfortunately passed away on the 27th of January 2021.

According to the lawsuit, Baby Sanders’ NEC diagnosis and consequent death were the “direct or proximate result of consumption of [the] defendants’ unreasonably dangerous cow’s milk-based products.” The lawsuit also mentioned that studies had shown a link between the consumption of cow’s milk-based formulas and NEC. Despite all this, Abbott and Mead have not made any changes to their products or added any instructions or warnings in this regard.

Abbott and Mead have also been accused of promoting their cow’s milk-based products despite the development of human milk and non-bovine-based products by the lawsuit.

Who Can File a Lawsuit for Infant Necrotizing Enterocolitis?

Attorney Jon Ostroff of Ostroff Injury Law has looked into cases and explains: “In the lawsuits that are moving forward, the baby must have been born prematurely, or before 37 weeks of gestation. It is a critical part of the case that the infant has consumed a formula that contains cow’s milk or is fortified with cow’s milk. There should also be a diagnosis of Necrotizing Enterocolitis by a medical practitioner if there is a potential connection between your baby’s illness and the baby formula they consumed.”

Use of Cow Milk in Baby Formulas

Similac Special Care, Enfamil NeuroPro EnfaCare Infant Formula, and Enfamil Human Milk Fortifier are some baby formulas currently either being investigated or that have claims filed against them.

According to NPR, roughly 80 percent of baby formula products contain cow’s milk. Although the extensive use of cow’s milk is not a bad thing, it can be harmful to premature babies, so parents must be aware of its components. However, products containing cow’s milk are considered safe for consumption in babies who are not born prematurely.