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NEC Baby Formula Lawsuit (2024 Update)

Parents of premature infants have begun to file lawsuits against the manufacturers of Enfamil and Similac, claiming that these cow’s milk-based infant formulas have led to cases of necrotizing enterocolitis (NEC). These legal actions assert that the companies failed to adequately warn parents about the increased risks their products pose to preemies.

Understanding Necrotizing Enterocolitis (NEC)

Necrotizing enterocolitis (NEC) is a severe intestinal disease that primarily affects premature infants (born before 37 weeks of gestation). This condition typically arises a few days to weeks after birth and is characterized by the invasion of bacteria into the intestinal wall. In severe cases, the intestines can become inflamed and perforate, allowing bacteria to enter the abdomen or bloodstream, which can be life-threatening.

For parents, an NEC diagnosis is incredibly distressing. Treatment involves halting regular feedings and providing nutrition intravenously. A nasogastric tube is used to remove fluids from the baby’s stomach, and antibiotics are administered to combat infection. Frequent x-rays monitor disease progression, and additional oxygen or mechanical breathing support may be necessary. These interventions, while life-saving, deprive parents of crucial bonding time with their newborns during their initial days and weeks of life.

While many babies recover with these treatments and go on to live healthy lives, severe cases of NEC can be fatal or require surgical intervention to remove damaged sections of the intestines. Approximately 30% of infants with NEC need surgery, and 20-30% of cases result in death. Survivors often face long-term complications.

Long-Term Complications of NEC

Long-term complications from NEC include:

• Parenteral nutrition-associated cholestasis and liver dysfunction
• Poor growth and malnutrition
• Metabolic bone disease
• Short bowel syndrome
• Sepsis and severe infections
• Neurocognitive impairments

Link Between Baby Formula and NEC

Research spanning over 30 years has demonstrated a significant connection between cow’s milk-based formulas and the incidence of NEC in premature infants. Notable studies include:

• A 1990 study in The Lancet revealed that preemies fed cow’s milk-derived formulas were 6 to 10 times more likely to develop NEC compared to those fed exclusively on breast milk. Babies given cow’s milk-based formulas as supplements were three times more likely to develop NEC.
• A meta-analysis combining six studies involving 869 preterm infants found that those fed cow’s milk-based formulas had a 362% increased risk of developing NEC compared to those fed human breast milk.
• A 2011 Johns Hopkins Medical Institutions study showed that extremely premature infants fed human donor milk were significantly less likely to develop NEC than those fed cow’s milk-based formulas.
• The U.S. Surgeon General’s 2011 Call to Action supported breastfeeding, warning that formula feeding is associated with higher rates of NEC in premature infants.

Despite these findings, Enfamil and Similac continue to market their cow’s milk-based formulas without warning parents or healthcare providers about the risks of NEC.

Types of NEC

NEC is categorized into four types based on symptoms and circumstances:

• Classic NEC: Most common, affecting infants born at 28 weeks gestation, typically emerging suddenly 3-6 weeks post-birth.
• Transfusion-associated NEC: Occurs within three days following a blood transfusion for conditions like anemia.
• Atypical NEC: A rare form occurring within the first week of life or before the first feeding.
• Term infant NEC: Affects full-term infants often born with congenital disabilities or other issues like genetic heart conditions or low oxygen levels.

Risk Factors for NEC

According to the National Institutes of Health (NIH), the risk for NEC increases with prematurity and low birth weight. Of the 480,000 premature babies born annually in the U.S., about 9,000 develop NEC. Approximately 80% of those weighing less than 4.5 pounds are affected.

The American Society of Nutrition reports that 5-12% of very-low-birthweight infants (less than 3.3 pounds) develop NEC, with 20-40% requiring surgery and 25-50% dying from the disease. While the majority of NEC cases involve premature infants, full-term and near-term infants can also be susceptible.

Signs and Symptoms of NEC

NEC symptoms typically manifest between two to six weeks after birth and can appear suddenly or gradually. Common symptoms include:

• Abdominal pain and swelling, sometimes with redness
• Changes in heart rate or blood pressure
• Temperature instability
• Apnea
• Bloody stools
• Yellow or green vomiting or gastric discharge
• Lethargy
• Feeding intolerance
• Lack of weight gain

Impacted Baby Formulas

NEC is linked to cow’s milk-based infant formulas and human milk fortifiers. The most common brands involved are:

Similac Products:

• Similac Special Care
• Similac Human Milk Fortifier
• Similac NeoSure
• Similac Alimentum
• Similac Alimentum Expert Care
• Similac Human Milk Fortifier Concentrated Liquid
• Similac Human Milk Fortifier Powder
• Similac Liquid Protein Fortifier
• Similac Special Care 20
• Similac Special Care 24
• Similac Special Care 24 High Protein
• Similac Special Care 30
• Similac Human Milk Fortifier Hydrolyzed Protein-Concentrated Liquid

Enfamil Products:

• Enfamil Human Milk Fortifier Acidified Liquid
• Enfamil Human Milk Fortifier Powder
• Enfacare Powder
• Enfamil Human Milk Fortifier Liquid High Protein
• Enfamil Milk Fortifier Liquid Standard Protein
• Enfamil NeuroPro Enfacare
• Enfamil Premature 20 Cal
• Enfamil Premature 24 Cal
• Enfamil Premature 24 Cal/fl oz HP
• Enfamil Premature 30 Cal
• Enfamil 24 and DHA & ARA Supplement

Commercial Infant Formulas

Infant formulas come in powdered, concentrated liquid, and ready-to-use liquid forms. There are three main types:

• Cow’s milk-based formulas: Altered to resemble breast milk.
• Soy-based formulas: Suitable for parents excluding animal proteins or infants allergic to cow’s milk or lactose.
• Protein hydrolysate formulas: Contain proteins broken down for infants intolerant to cow’s milk and soy-based formulas, often due to protein allergies.

Donor Breast Milk for Preemies

Donor breast milk is available through certified milk banks accredited by the Human Milk Banking Association of North America (HMBANA). This organization ensures donated milk is tested and pasteurized to eliminate harmful bacteria. Since 2006, Prolacta Bioscience, Inc., has offered human milk caloric fortifiers and ready-to-feed human breast milk formulas for NICU preemies.

In 2012, the American Academy of Pediatrics (AAP) recommended that all preterm infants be fed either their mother’s milk or pasteurized human donor milk. Despite this, Enfamil and Similac continue to market cow’s milk-derived formulas for preemies, ignoring these recommendations.

Reasons for Filing Baby Formula Lawsuits

Parents are suing Mead Johnson (Enfamil) and Abbott Laboratories (Similac) for not warning about the NEC risks associated with their cow’s milk-based formulas. These lawsuits seek compensation for extensive financial losses and emotional distress suffered by families and aim to alert other parents to the potential dangers.

Eligibility for an NEC Baby Formula Lawsuit

You may qualify for an NEC baby formula lawsuit if your baby was:

• Born prematurely (fewer than 37 weeks gestation)
• Fed Enfamil and/or Similac infant formula or human milk fortifier
• Diagnosed with NEC
• Suffered any of the following:
  • Intestinal perforation
  • Scarring or strictures in the intestines
  • Cerebral palsy
  • Neurological damage
  • Sepsis
  • Surgery
  • Death

Conclusion

The rising number of NEC baby formula lawsuits highlights the serious concerns regarding the safety of cow’s milk-based formulas for premature infants. With significant research supporting the connection between these formulas and NEC, parents and healthcare professionals must be vigilant in their feeding choices for vulnerable preemies. Legal actions continue to emphasize the need for better warnings and safer alternatives, ensuring the well-being of our most fragile infants.

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