The Link Between Infant Formula and Necrotizing Enterocolitis

by | May 17, 2023 | Defective Children's Product, Personal Injury, Safety

Necrotizing enterocolitis (NEC) is a serious medical condition that primarily affects premature infants, although it can occur in full-term babies as well. It is characterized by inflammation and damage to the intestinal tissue.

One of the primary risk factors for NEC is feeding cow’s milk-based infant formulas. Premature and low birth weight infants’ bodies cannot properly process formula, which results in residue building up in the intestines. Without immediate diagnosis and treatment, infants can suffer devastating illness or even death.

At Kherkher Garcia, LLP, we believe that no infant should suffer illness due to products that healthcare providers and parents trust to bring them wellbeing. Below, we provide insight into the link between infant formula and NEC, and provide information for parents about the illness and how to get help.

Does Infant Formula Cause Necrotizing Enterocolitis?

Formula feeding is a known risk factor for NEC, a serious gastrointestinal condition that affects, primarily, premature babies. The exact mechanism by which formula feeding increases the risk of NEC is not fully understood, but it is thought to be due to a combination of factors, including:

  • The composition of formula: Formula contains cow’s milk, which is more difficult to digest than breast milk. This can lead to an increased risk of bacterial infection in the intestines.
  • The immaturity of the gut: Premature babies have immature digestive systems, which makes them more susceptible to NEC.
  • The use of antibiotics: Antibiotics can disrupt the normal balance of bacteria in the intestines, which can increase the risk of infection.

It is important to note that not all formula-fed babies will develop NEC. The risk of NEC is highest in premature babies who are born before 32 weeks of gestation and who have other risk factors, such as low birth weight or congenital heart defects.

Formula Manufacturers Fail to Warn about NEC Risks

In recent years, research has suggested that cow’s milk-based formulas greatly increase the risk of NEC, especially in preterm or low birth weight infants. Numerous lawsuits have been filed against formula manufacturers alleging that companies like Enfamil and Similac failed to warn healthcare providers, and consequently parents, about the risk of NEC.

Neonatal intensive care units (NICU) routinely use cow’s milk-based formulas to feed, supplement, or fortify feedings. Lawsuits claim that manufacturers knew about the risks but still did not warn healthcare providers or parents, or include labeling on their products related to NEC. In fact, some manufacturers directly targeted preterm infants in their marketing, despite knowing the risk existed.

As a result, parents had no idea that NEC was a risk factor until their babies developed the horrible illness.

What Causes Necrotizing Enterocolitis?

The exact cause of NEC is unknown, but it is thought to be caused by a combination of factors, including:

  • Prematurity: NEC is most common in premature babies, especially those born before 32 weeks of gestation.
  • Formula feeding: NEC is more common in babies who are fed formula than in breastfed babies.
  • Bacterial infection: NEC may be caused by an infection with bacteria that normally live in the intestines.

Necrotizing Enterocolitis

Necrotizing Enterocolitis Risk Factors

Several factors can increase the risk of developing necrotizing enterocolitis (NEC) in infants. The exact cause of NEC is not fully understood, but the following are known risk factors:

  • Prematurity: NEC primarily affects premature infants, particularly those born before 32 weeks of gestation. The risk of NEC decreases as gestational age increases.
  • Low Birth Weight: Infants with a low birth weight, especially those weighing less than 1,500 grams (3.3 pounds), have a higher risk of developing NEC.
  • Enteral Feeding: The introduction of enteral feeding (feeding through the gastrointestinal tract) is associated with an increased risk of NEC. The premature digestive system may be immature and more susceptible to injury.
  • Formula Feeding: Exclusive formula feeding, especially with cow’s milk-based formula, has been identified as a risk factor for NEC. Breast milk is known to have protective factors against NEC.
  • Intestinal Ischemia: Insufficient blood flow to the intestines can lead to tissue damage and increase the risk of NEC. Conditions that can cause intestinal ischemia include hypotension (low blood pressure), respiratory distress, congenital heart disease, and sepsis.
  • Infection: Infections, particularly bacterial infections, are associated with an increased risk of NEC. Bacteria can cause inflammation and damage to the intestinal tissue.
  • Prenatal Factors: Maternal factors such as maternal hypertension, preeclampsia, and chorioamnionitis (inflammation of the fetal membranes) have been linked to an increased risk of NEC.
  • Use of Certain Medications: The use of certain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and indomethacin, used to treat certain medical conditions in preterm infants, may increase the risk of NEC.

It’s important to note that while these factors increase the likelihood of developing NEC, not all infants with these risk factors will develop the condition. Additionally, NEC can still occur in infants without any identifiable risk factors. Close monitoring and appropriate medical care are crucial for infants at higher risk of NEC.

What are the Signs and Symptoms of Necrotizing Enterocolitis?

The symptoms of NEC can vary depending on the severity of the condition. The signs and symptoms of necrotizing enterocolitis can vary but often include the following:

  • Feeding Intolerance: Infants with NEC may have difficulty tolerating feedings. They may refuse to eat, vomit, or have significant gastric residual volumes.
  • Abdominal Distension: The abdomen may appear swollen and distended, which can be caused by an accumulation of gas and fluid in the intestines.
  • Bloody Stools: Blood may be present in the stools, which can appear red or have a dark, tarry appearance.
  • Abdominal Tenderness: The baby’s abdomen may be sensitive to touch, and the infant may show signs of discomfort or pain.
  • Respiratory Problems: NEC can affect the lungs, leading to breathing difficulties or a need for respiratory support.
  • Temperature Instability: The baby may have fluctuations in body temperature, with episodes of fever or hypothermia (low body temperature).
  • Lethargy or Irritability: Infants with NEC may be unusually inactive, sleepy, or difficult to console. They may also display signs of distress, such as fussiness or inconsolable crying.
  • Apnea or Bradycardia: NEC can cause episodes of apnea (pauses in breathing) or bradycardia (slowed heart rate).
  • Poor Weight Gain: Infants with NEC may have difficulty gaining weight or may experience weight loss.

It is important to note that these signs and symptoms can be nonspecific and may overlap with other conditions. If you suspect your child may have NEC, it is crucial to seek immediate medical attention. NEC is a medical emergency, and early diagnosis and treatment are critical for a better prognosis.

How Quickly Does Necrotizing Enterocolitis Develop?

The development of NEC can vary from case to case, and there is no fixed timeline for its onset. However, NEC is generally seen within the first few weeks of life in premature infants. The majority of cases occur within the first 2 to 4 weeks after birth, with the highest risk period being between the second and fourth weeks.

The onset of NEC can be sudden or progress gradually. In some cases, it may develop rapidly over a few hours, while in others, it may take a couple of days for symptoms to manifest fully. The symptoms can worsen rapidly once they appear.

How is Necrotizing Enterocolitis Treated?

The treatment of necrotizing enterocolitis (NEC) involves a combination of medical and surgical interventions, depending on the severity of the condition. The specific approach may vary based on the infant’s overall health, gestational age, and the extent of intestinal damage. Here are some common treatment strategies:

NPO (Nothing Per Oral)

The infant’s feeding is temporarily stopped to rest the intestines and reduce the workload on the digestive system. Parenteral nutrition, which involves delivering nutrients through intravenous fluids, is provided to meet the baby’s nutritional needs.

Gastric Decompression

A nasogastric or orogastric tube may be inserted to remove gas and fluid from the stomach and relieve abdominal distension.


Broad-spectrum antibiotics are administered to treat or prevent infection, which often accompanies NEC. Commonly used antibiotics include ampicillin, gentamicin, and metronidazole.

Intravenous Fluids

Fluids are given intravenously to maintain hydration and electrolyte balance, especially if the infant is unable to tolerate oral feedings.

Monitoring and Supportive Care

Close monitoring of vital signs, blood tests, and imaging studies (such as X-rays or ultrasounds) is essential to assess the progression of NEC and guide treatment decisions. Supportive care measures, including temperature regulation, respiratory support, and pain management, are provided as needed.

Surgical Intervention

In severe cases of NEC, surgical intervention may be necessary. Surgery aims to remove damaged or necrotic bowel segments and repair any perforations or leaks. Surgical procedures can range from limited bowel resections to more extensive interventions, such as bowel resection with an ostomy or primary anastomosis.

Early diagnosis and treatment are crucial for a better prognosis in NEC. The treatment approach should be individualized and carried out by a multidisciplinary team, including neonatologists, pediatric surgeons, and other specialists, to provide comprehensive care to the affected infant.

What is the Standard of Care for Necrotizing Enterocolitis?

The standard of care for NEC involves a combination of medical and surgical interventions, along with supportive care. The specific treatment plan may vary depending on the severity of the condition and individual patient factors. The following outlines the general standard of care for NEC:

Early Recognition and Diagnosis:

Prompt recognition and diagnosis of NEC are crucial for initiating timely treatment. Close monitoring of high-risk infants, such as premature or low birth weight babies, is essential to identify early signs and symptoms.

Medical Management:

  1. NPO (Nothing Per Oral): Stopping enteral feedings temporarily to rest the intestines and reduce the risk of further injury.
  2. Gastric Decompression: Insertion of a nasogastric or orogastric tube to remove gas and fluid from the stomach and relieve abdominal distension.
  3. Antibiotics: Administration of broad-spectrum antibiotics to treat or prevent infection. Commonly used antibiotics include ampicillin, gentamicin, and metronidazole. Antibiotic therapy is usually continued for a specific duration.
  4. Intravenous Fluids: Provision of intravenous fluids to maintain hydration and electrolyte balance, especially if oral feedings are not tolerated.

Surgical intervention:

  1. Surgical Consultation: Early involvement of a pediatric surgeon for assessment and consideration of surgical intervention in severe cases or when medical management fails.
  2. Surgical Procedures: The surgical approach depends on the extent of intestinal damage. It may involve bowel resection, removal of necrotic tissue, repair of perforations or leaks, and, if feasible, re-establishment of intestinal continuity.

Supportive care:

  1. Close Monitoring: Frequent assessment of vital signs, abdominal examination, and laboratory tests to monitor the progression of NEC and response to treatment.
  2. Nutritional Support: Parenteral nutrition (intravenous delivery of nutrients) to provide essential nutrition while the intestines are healing. Gradual reintroduction of enteral feeding is initiated once the baby’s condition improves.
  3. Infection Control: Stringent infection control measures to prevent the spread of bacteria and minimize the risk of sepsis.

Multidisciplinary Approach:

Collaboration among a team of healthcare professionals, including neonatologists, pediatric surgeons, nurses, and other specialists, to provide comprehensive care and make informed treatment decisions.

Management of NEC should be individualized, taking into account the specific needs and condition of each infant. The standard of care may also evolve as new evidence and guidelines emerge in the field of neonatology.

Do I Have an NEC Infant Formula Lawsuit?

As of April, 2023 there are more than 150 lawsuits in Multidistrict Litigation (MDL). Parents who believe their infant developed NEC as a result of infant formula should contact a skilled product liability attorney to learn more. Every case is different, and it is important to have all the facts before determining if a viable case exists.

Get a Free NEC Infant Formula Consultation

At Kherkher Garcia, we can help parents carefully assess the circumstances surrounding their child’s illness, formula feeding, and related medical care. Our goal is to help injured victims and their families get justice and compensation from manufacturers whose products cause them harm.

If you would like a free consultation with one of our attorneys, call us at 713-333-1030 or contact us via our online form.


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Kevin Haynes

Kevin Haynes

Firm Partner and Trial Lawyer

This article was written and reviewed by Injury Trial Lawyer and Firm Partner Kevin Haynes. Kevin has been a practicing injury lawyer for more than 15 years. He has won $150 Million+ in Settlements and Verdicts for his clients. Kevin is powerful and effective in the courtroom and the trial lawyer you want on your side if you or a loved one have been seriously injured at work or on the road.

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