NEC Baby Formula Investigation

Enfamil and Similac baby formulas and milk fortifiers based on cow’s-milk may increase the risk of Necrotizing Enterocolitis (NEC) in a pre-term infant. NEC has resulted in gastrointestinal damage and perforation, need for surgery or even death in some cases.
Parents and caregivers of infants who developed NEC after taking cow’s milk-based formulas or milk fortifiers like Enfamil and Similac may be eligible for compensation.

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  • Similac and Enfamil Formula Linked to NEC in Premature Infants
  • Necrotizing Enterocolitis in Infants
  • Symptoms of NEC
  • Other Conditions Linked to NEC
  • NEC Formula Connection
  • Enfamil and Similac Cow’s Milk Formula NEC Lawsuit

Similac and Enfamil Formula Linked to NEC in Premature Infants

Similac and Enfamil baby formulas have been linked to an increased risk of a life-threatening gastrointestinal disorder known as necrotizing enterocolitis (NEC) in pre-term infants. Similac Special Care and Enfamil NeuroPro Enfacare are milk-based infant formulas designed for use in premature infants.

Infants who are considered pre-term or premature are already at risk of NEC and are at further risk when given Similac and Enfamil milk-based formulas, even those formulated for premature infants.

Necrotizing Enterocolitis (NEC) in Infants

Necrotizing Enterocolitis (NEC) is a serious intestinal condition which affects premature infants, usually in the first two weeks of life. Infants who are born pre-term or premature, are already at increased risk of NEC, but milk-based infant formulas may further increase the risk.

NEC occurs when tissues in the small or large intestine become inflamed and may result in serious injury to the gastrointestinal tract as tissue death may occur or necrotize. This may result in erosion or development of a hole in the intestines which allows bacteria to pass into the abdominal cavity, causing in a severe infection that can also spread into the bloodstream.

Sections of the infant’s intestines which have necrotized will require surgical removal and in severe cases, may result in death.

Symptoms of NEC:

  • Swollen or bloated abdomen
  • Trouble feeding
  • Feeding does not move through intestines but stays in stomach
  • Constipation or diarrhea
  • Bloody or dark poop
  • Bile-containing or green vomit
  • Slow breathing or apnea
  • Low heart rate (bradycardia) or low blood pressure
  • Sluggishness

In most cases, NEC occurs in infants born sooner than 32 weeks of gestation and who are 2-4 weeks of age. Formula feeding with milk-based formula, even when formulated for pre-term infants, may increase the risk of NEC. Breast fed babies or those fed with breast milk have a lower risk of NEC.

Other Conditions Linked to NEC

Development of NEC may increase the risk of other conditions including:

  • Peritonitis (abdominal infection)
  • Sepsis (blood infection)
  • Intestinal stricture (narrowing of intestines)
  • Bowel resection surgery
  • Short bowel syndrome (SBS) or short gut syndrome
  • Developmental delays
  • Neurological damage
  • Death

Up to half (50%) of all infants who develop NEC may die and half (50%) of those who live will likely experience significant developmental delay and disability.

NEC Formula Connection

Results from multiple studies performed since 1990, which examined feeding methods of premature infants show that pre-mature infants who are fed cow’s milk-based formula are at higher risk for developing NEC than those who are fed breast milk. The increased risk for NEC due to cow’s milk formula may be as much as 320% higher.

Researchers believe that human breast milk may help the pre-term infant ward off inflammation and infection which results in development of NEC. Cow’s milk-based formulas are unable to perform in the same way, even when designed for infants. Though human milk-based products have been available for a number of years, baby formula manufacturers have continued to primarily market their bovine or cow’s milk products.

Babies who get breast milk feedings may also be taken off of IV nutrition infusions earlier than those who are fed milk-based formula. This may also reduce the risk of other dangers posed by parenteral or supplemental (IV) nutrition.

In 2012, along with multiple hospital systems, the American Academy of Pediatrics stated that premature infants should only be given mother’s milk or human donor breast milk.

Enfamil and Similac Cow’s Milk Formula NEC Lawsuit

Parents or caregivers whose pre-term infants developed Necrotizing Enterocolitis (NEC) after being given bovine or cow’s milk-based formula may be eligible for compensation for medical costs, lost wages, future medical costs, and pain and suffering or for wrongful death if the infant died due to the condition.



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