Tennessee Mom Files Baby Formula NEC Lawsuit Following Newborn Son’s Death

A Tennessee mom has filed a wrongful death lawsuit against big-name infant formula manufacturers Abbott Laboratories and Mead Johnson, alleging that her son developed a fatal case of necrotizing enterocolitis (NEC) after consuming cow’s milk-based formula. This latest baby formula NEC lawsuit sheds additional light on the dangers allegedly associated with popular cow’s milk-based formulas like Enfamil and Similac, particularly for premature infants.

Newborn Baby Developed NEC After Consuming Enfamil Formula

According to Nakia Harris’ lawsuit, her son was born prematurely at Saint Francis Hospital on April 12, 2023. He was transferred to the neonatal intensive care unit (NICU) at Regional One Hospital in Memphis, where he was fed Enfamil formula. Within days, the baby began exhibiting symptoms indicative of necrotizing enterocolitis (NEC), including feeding intolerance, vomiting, and abdominal distention. He then developed severe metabolic acidosis and was ultimately diagnosed with NEC. He was transferred to Methodist Le Bonheur Children’s Hospital, where he died on April 29, 2023.

What is Necrotizing Enterocolitis?

Necrotizing enterocolitis (NEC) is a serious and life-threatening gastrointestinal condition that primarily affects premature infants. It is characterized by the inflammation and death of intestinal tissue, which can lead to a perforation in the intestine. This allows bacteria to leak into the abdominal cavity or bloodstream, causing severe infections like peritonitis and sepsis. NEC is a medical emergency, and early recognition and aggressive treatment are crucial to improve outcomes, as the condition has a mortality rate as high as 50%. Premature infants, especially those with low birth weight and those fed cow’s milk-based formula products, are at the highest risk of developing this devastating condition.

Allegations Raised in Baby Formula NEC Lawsuits

Abbott Laboratories and Mead Johnson face serious allegations in lawsuits focusing on the companies’ alleged failure to adequately warn families of the risks associated with their cow’s milk-based infant formulas. Plaintiffs argue that the manufacturers knew or should have known about the dangers of NEC and deliberately misled consumers by promoting Similac and Enfamil as akin to breast milk. 

According to her lawsuit, Harris “successfully pumped her own breast milk for her baby’s nutrition,” and “Enfamil formula made up a significant portion of (his) diet between April 12, 2023 and April 21, 2023.” Harris alleges that Mead Johnson, the maker of Enfamil, and Abbott Laboratories, the maker of Similac, “mislabel and misrepresent the contents” of their products “both to the public at large and to the health care community, passing off these deadly products as something like or even superior to human breast milk.” Harris’ lawsuit was transferred to federal court on July 12, 2024.

Potential Health Risks and a Lack of Infant Formula NEC Warnings

Despite evidence linking cow’s milk-based formulas like Similac and Enfamil to an increased risk of necrotizing enterocolitis (NEC) in preterm infants, there have been no recalls, and the products continue to lack explicit warnings about this risk on their labels. This omission occurs even though studies have demonstrated that NEC can lead to severe medical complications, including infections, intestinal perforation, and potentially death, in up to 30% of affected infants. The absence of specific warnings and guidelines for the use of these formulas in vulnerable populations like preterm or low-birth-weight infants raises critical concerns about consumer safety and informed choice.

Alternative Feeding Options for Preterm Infants

The risks associated with cow’s milk-based formulas highlight the importance of alternative feeding options for preterm infants. Human breast milk is strongly recommended as it not only supports the developmental needs of these infants but also provides protection against NEC. Studies have shown that preterm infants fed exclusively with breast milk or human milk have significantly lower risks of developing NEC compared to those fed with cow’s milk-based formulas. 

In situations where the mother’s milk is not available, pasteurized donor human milk (PDHM) is considered a safer alternative than cow’s milk-based formulas. This approach aligns with prevention strategies that emphasize early feeding with human milk to promote intestinal maturation and decrease the risk of intestinal inflammation.

Scrutinizing the Safety of Infant Formula Products

The ongoing infant formula NEC litigation and its outcomes could prompt a reevaluation of marketing and labeling practices within the baby formula industry. With trials set to start this year, the stakes are high for both Abbott Laboratories and Mead Johnson, as these NEC injury and wrongful death lawsuits could influence public and regulatory scrutiny surrounding the safety of infant formula products.