Cow’s Milk-Based Infant Formula Necrotizing Enterocolitis (NEC) Lawsuit Lawyers
Did your baby develop Necrotizing Enterocolitis (NEC)?
Cow’s milk protein allergy (CMPA) is a very common food allergy in newborns, infants, and young children. A milk allergy can produce a range of serious symptoms and adverse health events. The reactions also range in intensity amongst infants and can involve several different organ systems but primarily affects the gastrointestinal tract. Milk allergies in infants are the leading cause of food-protein-induced enterocolitis syndrome (FPIES) in newborns.
The symptoms include recurrent vomiting, pallor, hypoalbuminemia, lethargy, dehydration with metabolic acidosis in the acute setting, diarrhea with blood and/or mucus, and chronic “failure to thrive.” Delayed diagnosis or misdiagnosis of food-protein-induced enterocolitis syndrome (FPIES) is common. If untreated, or the infant is not taken off of the cow’s milk-based infant formula, the child may develop Necrotizing Enterocolitis (NEC).
Which Baby Formula Brands May Contain Cow’s (Bovine) Milk?
Depending on which stage of infant formula is used, the amount of cow’s milk protein used can change. The following brands offer a bovine-based formula:
- Baby’s Only
- Earth’s Best
- Go & Grow
- Happy Baby
- Parent’s Choice
What is Necrotizing Enterocolitis (NEC)?
Necrotizing Enterocolitis (NEC) is a very serious and life-threatening medical condition, which the intestines become inflamed. The persistent inflammation and infection destroy the infant’s bowel walls resulting in stool leaking into the infant’s abdomen. The Children’s Hospital of Los Angeles (CHLA) has stated that NEC is the most prevalent cause of gastrointestinal mortality and morbidity in neonatal intensive care units (NICUs).
A premature baby’s risk of developing NEC is substantially increased when the infant consumes cow’s milk-based formulas. NEC can lead to severe and potentially fatal medical conditions such as sepsis. If an infant develops NEC, they may suffer a range of health complications leading to emergency surgery.
Premature babies typically need special nutrition plans, including the mother’s milk, milk donated by other lactating mothers, or a supplemental formula that is not based on cow’s milk. Human milk is ideal as the proteins are easier for premature babies to digest, and human milk contains constituents that help intestinal cells mature and fight infection. Pediatricians or neonatologists may prescribe the supplementation of cow’s milk formula or fortifier with human breast milk. The most popular brands of infant formula containing cow’s milk are Similac and Enfamil.
A study published by the Imperial College in London found that “enteral feeding with cow’s milk formula is associated with neonatal necrotizing enterocolitis (NEC) and sepsis.” The study found that dietary antigen sensitization likely plays a part in “promoting and/or sustaining inflammation.” The study focused its investigation on how cytokine, a cow’s milk protein (CMP), responds in preterm infants without NEC or sepsis as compared to preterm babies suffering from NEC and sepsis and preterm babies with NEC. The study found that during the acute phase of NEC, there was a high level of cytokine secretion when stimulated and unstimulated by CMPs: casein and beta-lactoglobulin (-lg) and mitogen [phytohaemagglutinin (PHA)]. Cytokine responses also during sepsis, although in much lower levels. The group of healthy infants showed the least about of Cytokine response.
When the body produces a sudden high cytokine level, this severe immune response or immunity manifestation is called a “cytokine storm.” During a cytokine storm, the body can start to attack its own healthy cells and tissues rather than fighting the foreign substance, bacteria, or a virus. Cytokine storms can lead to life-threatening organ damage, and this immune response can increase the risk of death.
According to investigative research conducted at the Johns Hopkins Children’s Center, “extremely premature babies” who were fed human donor milk were less likely to develop necrotizing enterocolitis (NEC) as compared to infants fed the standard premature baby formula based on cow’s milk. The research studies showed that premature infants who are fed “bovine” based infant formulas are more likely to develop necrotizing enterocolitis (NEC) than babies fed only human breast milk. There have been numerous studies that have confirmed these conclusions.
How Deadly is Necrotizing Enterocolitis (NEC)?
Necrotizing Enterocolitis (NEC) can be a fatal medical condition. Severe NEC cases result in death or intestinal resection. According to published research studies on pubmed.ncbi.nlm.nih.gov, NEC occurs in between 5–12% of very low birth weight babies. In about 20 to 40% of NEC cases, surgery was required, while 25% to 50% of NEW cases were fatal.
What Are the Signs and Symptoms of Necrotizing Enterocolitis (NEC)?
The signs and symptoms of Necrotizing Enterocolitis (NEC) begin to surface within a few days to a couple of weeks. The clearest sign of NEC is swelling of the abdomen, also known as abdominal distension. Other signs and symptoms of bloating of Necrotizing Enterocolitis (NEC) include:
- Abdominal wall erythema
- Apnea (Breathing pauses)
- Bloody or dark stools
- Bradycardia (Slowed heart rate)
- Cardiovascular collapse
- Decreased bowel sounds
- Decreased peripheral perfusion
- Delayed gastric emptying and constipation
- Hypotension (Low blood pressure)
- Low or unstable body temperature
- Tender, red, or painful abdomen
- Trouble feeding
- Vomiting, particularly green vomit containing bile
Necrotizing Enterocolitis (NEC) usually required medication to treat. However, severe cases of NEC will require surgery and surgery carries the risk of permanent injury.
Who is Liable For My Baby’s NEC Injury or Death?
Many infant formula manufacturers have not listed the potential risks of preterm infant necrotizing enterocolitis on their cow’s milk-based formula packaging. In addition, pediatricians and neonatologists may have not been aware or have not properly explained the risks associates with cow’s milk-based formulas to parents. If your baby developed necrotizing enterocolitis because they were being fed a cow’s milk-based formula, you could be able to file a product liability lawsuit against the maker(s) of the infant or file a medical negligence lawsuit against the hospital or doctor.
SPEAK WITH ONE OF OUR NECROTIZING ENTEROCOLITIS (NEC) LAWSUIT LAWYERS TODAY FOR FREE
If your child was fed a cow’s milk-based infant formula and developed intestinal injuries such as NEC or tragically passed away, contact Parker Waichman LLP to receive your free case evaluation. An attorney from our law firm will listen to you and investigate your child’s case to determine if there are grounds to file a lawsuit.
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 Abdelhamid, A., Chuang, SL., Hayes, P. et al. In Vitro Cow’s Milk Protein-Specific Inflammatory and Regulatory Cytokine Responses in Preterm Infants With Necrotizing Enterocolitis and Sepsis. Pediatr Res 69, 165–169 (2011). https://doi.org/10.1203/PDR.0b013e31820263e7
 Johns Hopkins Medical Institutions. “Formula-fed preemies at higher risk for dangerous GI condition than babies who get donor milk.” ScienceDaily. ScienceDaily, 1 May 2011. <www.sciencedaily.com/releases/2011/04/110430171122.htm>.
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