The birth of a premature infant is a profound experience, a journey marked by incredible hope and often, unexpected fragility. These tiny warriors fight for every breath, every ounce, and every milestone. When such a precious life is suddenly imperiled by a severe and aggressive condition like necrotizing enterocolitis (NEC), the world can tilt on its axis for a family.

The discovery that certain cow’s milk-based infant formulas, products often provided in neonatal intensive care units (NICUs), may be significantly linked to this devastating intestinal disease transforms anxiety and fear into a quest for answers, accountability, and justice. For numerous West Virginia families, this path is fraught with medical complexities and daunting legal questions.

At Powell & Majestro, P.L.L.C., we have long stood with West Virginia families navigating the turbulent waters of personal injury and product liability litigation. Our commitment is to provide not only robust legal representation but also compassionate support and clear, understandable information.

The Pathophysiology: How NEC Develops

The exact cascade of events leading to NEC is multifactorial and not entirely understood, but it’s believed to involve an immature intestinal barrier, an abnormal microbial colonization of the gut, an exaggerated inflammatory response, and compromised blood flow to the intestines.

1. Intestinal Immaturity: Premature infants have an underdeveloped intestinal lining that is more permeable than that of a full-term baby. This “leaky gut” can allow bacteria and toxins to pass from the intestinal lumen into the bowel wall and potentially the bloodstream. Their ability to digest and absorb nutrients, especially complex ones found in cow’s milk, is limited.
2. Abnormal Bacterial Colonization: The gut microbiome of a premature infant is different and often less diverse than that of a healthy, breastfed full-term infant. The introduction of formula, particularly cow’s milk-based products, can promote the growth of pathogenic bacteria.
3. Inflammatory Cascade: When bacteria invade the intestinal wall, they trigger a powerful inflammatory response. In the immature gut of a preemie, this response can be overwhelming and uncontrolled, leading to the release of damaging cytokines and other inflammatory mediators. This inflammation further damages the intestinal tissue.
4. Ischemia and Necrosis: The inflammation can compromise blood flow (ischemia) to sections of the intestine. Without adequate oxygen and nutrients, the intestinal cells begin to die (necrosis). This can affect small patches or extensive portions of the bowel.
5. Gas Formation and Perforation: As bacteria proliferate in the damaged tissue, they can produce gas, which may accumulate within the intestinal wall (pneumatosis intestinalis – a hallmark sign of NEC on X-ray). In severe cases, the necrotic bowel wall can perforate, spilling intestinal contents (bacteria, stool) into the abdominal cavity, leading to peritonitis and life-threatening systemic infection (sepsis).

NEC is often staged based on its severity (e.g., Bell’s staging criteria), ranging from suspected NEC (Stage I) with mild, non-specific symptoms, to definite NEC (Stage II) with clear clinical and radiological signs, to advanced NEC (Stage III) involving intestinal perforation and shock.

Who is Most at Risk? Expanded Risk Factors

While prematurity is the single greatest risk factor, several other elements can contribute:

• Gestational Age and Birth Weight: Infants born before 32 weeks gestation and weighing less than 1500 grams (approximately 3.3 pounds) are at the highest risk. The risk decreases with increasing gestational age and birth weight.
• Type of Feeding: This is a critical factor. As will be discussed extensively, formula feeding, particularly with cow’s milk-based formulas, significantly increases the risk compared to exclusive human milk feeding.
• Difficult Birth or Asphyxia: Infants who experience oxygen deprivation around the time of birth may have reduced blood flow to the intestines, predisposing them to injury.
• Congenital Heart Disease: Certain heart conditions can affect blood flow to the gut.
• Infections: Other infections can increase an infant’s vulnerability.
• Rapid Advancement of Feeds: Introducing or increasing feed volumes too quickly in a premature infant may overwhelm their digestive capacity.

Diagnosing NEC: Uncovering the Threat

Early diagnosis is vital for improving outcomes in NEC. Clinicians look for a combination of signs and symptoms, supported by diagnostic tests:

• Clinical Symptoms: These can be initially subtle and non-specific in premature infants. They include:
  • Feeding intolerance (increased residuals in the stomach before the next feeding, vomiting, especially if bile-stained)
  • Abdominal distension (a swollen, often shiny and tender belly)
  • Bloody stools (visible or occult blood)
  • Lethargy, apnea (pauses in breathing), bradycardia (slow heart rate)
  • Temperature instability (difficulty maintaining body temperature)
  • Signs of shock in severe cases (low blood pressure, poor perfusion)
• Radiological Imaging: Abdominal X-rays are key. They may show:
  • Dilated bowel loops
  • Pneumatosis intestinalis (gas cysts in the bowel wall)
  • Portal venous gas (gas in the veins leading to the liver, a more ominous sign)
  • Free air in the abdomen (pneumoperitoneum), indicating a bowel perforation – a surgical emergency. Abdominal ultrasound may also be used to assess bowel wall thickness, perfusion, and detect fluid collections.
• Laboratory Tests: Blood tests can show signs of infection and inflammation, such as:
  • Elevated white blood cell count (or sometimes a very low count)
  • Low platelet count (thrombocytopenia)
  • Elevated C-reactive protein (CRP)
  • Metabolic acidosis (an imbalance in the body’s acid-base levels)

Treatment Modalities for NEC: A Difficult Battle

Once NEC is suspected or confirmed, treatment is initiated immediately:

• Medical Management (for non-perforated NEC):
  • Bowel Rest: All oral or tube feedings are stopped to allow the intestines to heal. The infant receives nutrition intravenously (Total Parenteral Nutrition – TPN).
  • Gastric Decompression: A tube is inserted through the nose or mouth into the stomach to remove air and fluid, reducing pressure in the gut.
  • Broad-Spectrum Antibiotics: Given intravenously to treat or prevent infection.
  • Supportive Care: This includes IV fluids, monitoring of vital signs, respiratory support (if needed), and management of pain.
• Surgical Intervention: Surgery is required if there is evidence of bowel perforation or if the infant’s condition deteriorates despite medical management. Surgical options include:
  • Exploratory Laparotomy: The surgeon opens the abdomen to directly inspect the intestines, identify and remove any necrotic (dead) bowel tissue.
  • Bowel Resection: The diseased portion of the intestine is removed. The surgeon then attempts to reconnect the healthy ends (anastomosis).
  • Ostomy Creation: If direct reconnection is not possible or safe (often due to widespread inflammation or the infant’s instability), the surgeon may bring an end of the intestine through an opening in the abdominal wall (an ostomy, e.g., ileostomy or colostomy). Stool then collects in a bag outside the body. This is often a temporary measure, with a second surgery planned later to reconnect the bowel.
  • Peritoneal Drain Placement: In very small or unstable infants, a drain may be placed into the abdomen as a less invasive initial step to manage perforation, with a formal surgery to follow when the infant is more stable.

The Devastating and Lasting Consequences of NEC

Surviving NEC is often just the beginning of a long and challenging medical journey. The long-term complications can be profound and lifelong:

• Short Bowel Syndrome (SBS): If a significant portion of the small intestine had to be removed, the infant may develop SBS. This condition impairs the body’s ability to absorb sufficient nutrients and fluids, leading to malabsorption, malnutrition, diarrhea, and dependence on long-term TPN. TPN itself carries risks, including liver disease and infections. Infants with SBS often require multiple hospitalizations and specialized care.
• Intestinal Strictures and Adhesions: As the damaged intestine heals, scar tissue can form, leading to narrowing of the bowel (strictures) or bands of scar tissue that can cause kinking or blockage (adhesions). These can cause recurrent abdominal pain, vomiting, and bowel obstructions, often necessitating further surgeries.
• Neurodevelopmental Delays: A significant percentage of infants who survive severe NEC, particularly those requiring surgery, experience neurodevelopmental delays. These can range from mild learning disabilities to more severe cognitive impairments, motor skill deficits, and conditions like cerebral palsy. The mechanisms are complex and may relate to the systemic inflammation, nutritional deficiencies, prolonged hospitalization, and hypoxic-ischemic insults associated with severe NEC.
• Growth Failure and Failure to Thrive: Due to feeding difficulties, malabsorption, and the high metabolic demands of recovery and chronic illness, many NEC survivors struggle with growth.
• Cholestasis and Liver Disease: Prolonged TPN use, a common necessity for infants with severe NEC and SBS, can lead to cholestatic liver disease, where bile flow from the liver is reduced or blocked. This can progress to liver failure in some cases.
• Increased Risk of Rehospitalization: Children who have had NEC are often re-hospitalized for complications related to their condition.
• Psychological and Emotional Toll: The impact on the infant’s quality of life, as well as the immense emotional and financial strain on the family, cannot be overstated. Parents often face anxiety, stress, and the challenges of caring for a child with complex medical needs.

The Link to Cow’s Milk-Based Infant Formula: A Deeper Scientific Dive

The connection between cow’s milk-based infant formulas and an increased risk of NEC in premature infants is not a recent or speculative notion; it is supported by decades of scientific research and affirmed by leading pediatric health organizations worldwide.

Research and Mounting Evidence

Numerous studies, including observational research, cohort studies, and randomized controlled trials, have consistently shown that premature infants fed an exclusive human milk diet have a significantly lower incidence of NEC compared to those fed cow’s milk-based formulas. Some meta-analyses suggest that formula-fed premature infants may be six to ten times more likely to develop NEC than those fed exclusively human milk, and for extremely premature infants, the risk may be even higher.

Human milk is uniquely suited to the needs of the premature infant. It contains a complex array of components that protect the gut and promote its maturation:

• Immunoglobulins (especially IgA): Provide passive immunity, coating the intestinal lining and preventing bacteria from adhering and invading.
• Lactoferrin and Lysozyme: Have antimicrobial properties.
• Oligosaccharides (Human Milk Oligosaccharides – HMOs): Act as prebiotics, promoting the growth of beneficial bacteria in the gut, and can also act as decoys, preventing pathogens from binding to the intestinal wall.
• Growth Factors: Stimulate the growth and repair of intestinal cells.
• Anti-inflammatory Components: Help to modulate the infant’s immune response.
• Easier Digestibility: The proteins and fats in human milk are more easily digested by the immature gut of a premature infant than those in cow’s milk.

Why Are Cow’s Milk-Based Formulas Problematic for Preemies?

Cow’s milk is designed for calves, not human infants, especially not premature ones. While infant formulas are modified, the fundamental differences remain:

• Foreign Proteins: The proteins in cow’s milk (e.g., casein, beta-lactoglobulin) are different from human milk proteins and can be more difficult for a preemie’s gut to process, potentially triggering inflammatory or allergic-type reactions.
• Osmolarity: Some formulas may have a higher osmolarity (concentration of particles) than human milk, which can draw fluid into the bowel, potentially stressing the intestinal lining.
• Lack of Protective Components: Cow’s milk formulas lack the rich array of bioactive and immunological components found in human milk that actively protect the gut. While manufacturers add some vitamins and nutrients, they cannot replicate the complexity of human milk.
• Impact on Gut Microbiome: Studies show that formula feeding leads to a different gut microbial profile compared to human milk feeding, often with fewer beneficial Bifidobacteria and Lactobacilli and more potentially pathogenic bacteria.

The Stance of Major Health Organizations

Leading health authorities have long recognized the superiority and protective benefits of human milk for premature infants:

• The American Academy of Pediatrics (AAP): Explicitly recommends that all preterm infants be fed human milk. If the mother’s own milk is unavailable or insufficient, pasteurized donor human milk is the next best option. The AAP notes that a human milk-based diet is associated with lower rates of NEC.
• The World Health Organization (WHO): Also advocates for human milk as the optimal nutrition for premature and low-birth-weight infants.

Despite this strong scientific consensus and the recommendations from these authoritative bodies, many cow’s milk-based formulas and fortifiers (products added to human milk to increase caloric and nutrient density, but often derived from cow’s milk) have been aggressively marketed to NICUs and parents of premature infants, often without clear, prominent warnings about the specific and heightened risk of NEC.

The Litigation Landscape: Pursuing Accountability from Manufacturers

The increasing scientific evidence linking cow’s milk-based formulas to NEC has paved the way for legal action by families whose premature infants suffered this devastating disease. Lawsuits filed against major manufacturers like Abbott Laboratories (maker of Similac products) and Mead Johnson (maker of Enfamil products) have been steadily growing.

Core Legal Allegations in Detail

These lawsuits typically center on several key legal theories:

1. Failure to Warn (Strict Liability and Negligence): This is often a central claim. Plaintiffs allege that manufacturers knew or, based on available scientific evidence, reasonably should have known about the significant risk of NEC associated with their cow’s milk-based products when used in premature infants. Despite this knowledge, they allegedly failed to provide adequate warnings to doctors, hospitals, NICUs, and parents about this specific danger. An “adequate warning” would be one that is clear, conspicuous, and accurately conveys the nature and severity of the risk, allowing healthcare providers and parents to make truly informed decisions.
2. Defective Design (Strict Liability and Negligence): This claim argues that the cow’s milk-based formulas were defectively designed for use in the vulnerable population of premature infants, especially when safer alternatives—namely, an exclusive human milk diet, supplemented with human milk-based fortifiers if necessary—were known to significantly reduce the risk of NEC. The argument is that the foreseeable risks of using these cow’s milk-based products in preemies outweighed any potential benefits, particularly given the availability of safer feeding options.
3. Negligence: Beyond specific design or warning defects, negligence claims allege that the manufacturers breached a general duty of care owed to consumers. This could encompass negligent marketing practices (minimizing risks or overstating benefits for preemies), negligent failure to conduct adequate post-market surveillance, or negligent failure to update product formulations or warnings as more scientific evidence about NEC became available.
4. Breach of Implied Warranty: This legal theory suggests that products come with an “implied warranty of merchantability,” meaning they are reasonably fit for their ordinary intended purpose. It’s argued that a formula causing or significantly increasing the risk of a life-threatening condition like NEC in its intended users (premature infants) is not fit for that purpose.

The Role of Multidistrict Litigation (MDL) in NEC Cases

Given the large number of similar lawsuits filed in federal courts across the United States, the Judicial Panel on Multidistrict Litigation (JPML) consolidated many of the NEC infant formula cases into an MDL. This MDL (MDL No. 3026, In re: Abbott Laboratories Preterm Infant Nutrition Products Liability Litigation) is currently centralized in the U.S. District Court for the Northern District of Illinois.

Recent Developments and Settlements

The legal battle surrounding NEC infant formula litigation is dynamic, with significant developments impacting families nationwide.

July 2024: $495 Million Jury Verdict Against Abbott Laboratories

A Missouri jury ordered Abbott Laboratories to pay $495 million in damages on July 26, 2024, after finding the company liable for failing to warn about necrotizing enterocolitis (NEC) risks associated with its Similac Special Care 24 formula. The verdict included $95 million in compensatory damages and $400 million in punitive damages for Margo Gill’s daughter, Robynn Davis, a premature infant who developed NEC in 2021 after consuming the formula. The jury concluded Abbott knew of NEC risks linked to cow’s milk-based formulas as early as 2009 but withheld warnings from parents and healthcare providers.

March 2025: Retrial Ordered in Defense’s Sole Victory

On March 14, 2025, Missouri Judge Michael Noble vacated Abbott and Mead Johnson’s only trial win in the NEC litigation, citing “intentional and repeated misconduct” by defense attorneys during an October 2024 trial. The original case involved Kaine Whitfield, a premature infant who developed NEC after being fed Similac and Enfamil. Judge Noble ruled defense teams violated court orders by introducing inadmissible evidence, making misleading arguments about formula shortages, and improperly referencing FDA approvals. The retrial order erased the defendants’ sole favorable verdict, leaving them without a single trial victory as of May 2025.

Ongoing Litigation as of May 2025

 Federal MDL Status: 710 cases remain active in the federal multidistrict litigation (MDL 3026) before Judge Rebecca Pallmeyer. The first federal bellwether trial (Mar v. Abbott) was dismissed on May 5, 2025, due to insufficient evidence linking Abbott’s warnings to the infant’s death, though expert testimony on the formula-NEC connection was preserved for future cases. Additional bellwether trials are scheduled for August 2025 (K.B. v. Abbott) and February 2026 (Inman v. Mead Johnson).

• State Court Actions: New lawsuits continue to emerge, including cases filed in Arizona in May 2025 alleging NEC-related injuries and deaths from Similac products. State-level verdicts remain influential, such as the $60 million Illinois award against Mead Johnson in March 2024 and the $495 million Missouri verdict.

Scientific and Legal Implications

 Evidence in Dispute: Internal Abbott documents revealed during trials showed the company acknowledged NEC risks tied to formula feeding as early as 2009. Plaintiffs argue studies since the 1990s demonstrate NEC incidence is 6–10× higher in formula-fed preemies compared to breastfed infants. Defense teams counter that NEC has multifactorial causes and that formulas remain critical for preterm infants who cannot access human milk.

• Regulatory Context: Judges have permitted expert testimony on the formula-NEC link despite defense challenges, though some cases (e.g., Mar v. Abbott) have failed on causation grounds.

Contact Powell & Majestro for Knowledgeable and Compassionate Legal Guidance

The legal team at Powell & Majestro, P.L.L.C., has decades of experience fighting for West Virginians who have been harmed by the negligence of others and by dangerous products. We understand the science and the law involved in complex cases like those linking infant formula to NEC.

If your premature infant was diagnosed with necrotizing enterocolitis after being fed a cow’s milk-based formula such as Similac or Enfamil, we are here to help you understand your rights and explore your legal options.

Call Powell & Majestro today at (800) 650-2889 or contact us through our website to learn how we can fight for your family.