NEC Baby Formula

Parents of premature babies are filing lawsuits against the manufacturers of Enfamil and Similac after their babies developed necrotizing enterocolitis (NEC). The parents claim the formula makers failed to warn parents that feeding the companies’ cow’s milk-based infant formulas and human milk fortifiers to their vulnerable preemies put them at increased risk for the devastating intestinal disease.

What is Necrotizing Enterocolitis (NEC)? 

NEC is a distressing disease that affects the intestines of primarily premature infants (less than 37 full weeks of gestation), a few days to a few weeks after birth. It occurs when bacteria invade the wall of the intestines. In more severe cases, the intestines can become inflamed and perforate, allowing bacteria and other substances to leak into the abdomen or bloodstream.  

NEC is an extremely frightening diagnosis for any parent to hear, especially with such a tiny and vulnerable infant. Treatment includes stopping all regular feedings for a period of time and giving the infant nutrients via an intravenous catheter. A nasogastric tube is inserted through the baby’s nose into his stomach to suction any fluids, and antibiotics are given to treat the infection. Frequent x-rays are performed to monitor the progression of the disease, and extra oxygen or mechanically assisted breathing will be provided as needed. Isolation procedures will be taken to prevent the spread of infection. This treatment, while life-saving, robs parents of precious holding and bonding time in the days and weeks after birth. 

These medical interventions resolve symptoms in many cases, and the baby can live a healthy life. But severe cases can be life-threatening and require blood transfusions or surgery to remove the destroyed parts of the intestines. Approximately 30% of babies diagnosed with NEC require surgery. Twenty to thirty percent of cases are fatal. Of those who survive, about half will develop long-term complications. 

NEC Complications

Long-term complications of NEC include: 

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

What is the Connection Between Baby Formula and NEC? 

Research dating back more than 30 years has established that one of the primary causes of NEC in premature infants is feeding them cow’s milk-based formulas (as opposed to human breastmilk).  

  • In 1990, a study published in The Lancet found that premature babies fed cow’s milk- (or bovine-) derived infant formulas were 6 to 10 times more likely to develop NEC than exclusively breast milk babies. Babies fed cow’s milk-based infant formulas as a supplement to breastmilk were three times more likely to develop NEC.

One meta-analysis of six combined studies involving 869 preterm infants suggested babies fed cow’s milk-based infant formula had a 362% increased risk of NEC compared to infants fed human breastmilk either from the infant’s mother or a human donor.  
Source: Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products, Jocelyn Shulhan, Bryan Dicken, Lisa Hartling, and Bodil MK Larsen; American Society for Nutrition; Adv Nutr (2017)

  • A May 2011 Johns Hopkins Medical Institutions study found that extremely premature babies weighing less than 3.3 pounds fed human donor milk were far less likely to develop NEC than babies fed infant formula derived from cow’s milk. Lead investigator Elizabeth Cristofalo, M.D., concluded, “The stark differences in the risk of NEC, its complications and the need for surgery between babies who receive human donor milk and those who get formula signal the need for a change in feeding practices across neonatal intensive care units.” 
  • Research published in the May 2020 edition of the journal Breastfeeding Medicine found that premature babies fed cow’s milk-derived formula had a 4.2-fold increased risk of NEC and a 5.1-fold increased risk of NEC surgery or death.  

In 2011, the U.S. Surgeon General issued a Call to Action supporting breastfeeding and cautioned, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC).”

Despite this knowledge, Enfamil and Similac baby formula manufacturers have refused to warn parents, or medical professionals about the NEC risks its cow’s milk-based formulas pose to babies born prematurely. Both companies continue to market formulas derived from cow’s milk for preemies.  

Types of NEC

NEC is classified into one of four types based on symptoms and the circumstances leading up to the condition: 

  • Classic NEC is the most common type, affecting most infants born at 28 weeks gestation. Symptoms typically come on suddenly, without warning, usually about three to six weeks after birth.  
  • Transfusion-associated NEC occurs within three days after an infant undergoes a blood transfusion, such as anemia.  
  • Atypical NEC is a rare form of NEC. It occurs within the first week of life or before the first feeding.  
  • Term infant NEC occurs in babies born full-term. These infants often have a congenital disability or other problems at birth, such as a genetic heart condition, gastroschisis, or low oxygen levels. 

Which Babies are at Risk for NEC?  

According to the National Institutes of Health (NIH), the smaller the infant or, the more premature the delivery, the greater the risk for NEC. Of the 480,000 babies born prematurely (less than 37 weeks gestation) each year in the United States, 9,000 develop NEC. Approximately 80% of babies born weighing less than 4.5 pounds develop the disease.

According to the American Society of Nutrition, about 5-12% of very-low-birthweight infants—those weighing less than about 3.3 pounds—develop NEC. About 20-40% of those babies require surgery, and 25-50% die.  

While 90% of infants who develop NEC are born prematurely, full-term and near-term infants can also develop the disease.  

NEC Signs & Symptoms

Symptoms of NEC usually present two weeks to six weeks after birth and can either come on suddenly without warning in infants who appear to be doing well or gradually over time.  

Common symptoms include: 

  • Pain and swelling in the abdomen, sometimes accompanied by redness on the belly 
  • Changes in heart rate or blood pressure 
  • Temperature instability 
  • Apnea 
  • Bloody stools 
  • Bile-colored (yellow or green) vomiting or gastric discharge 
  • Lethargy 
  • Feeding intolerance  
  • Lack of weight gain  

What Baby Formulas are Affected? 

NEC is associated with infant formulas and human milk fortifiers derived from cow’s milk. The two most common brands of infant formulas include: 

  • Similac (Abbott Laboratories) 
  • Enfamil (Mead Johnson & Company, LLC) 

Similac Infant Formulas & Human Milk Fortifiers Derived from Cow’s Milk

  • 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 Infant Formulas & Human Milk Fortifiers Derived from Cow’s Milk 

  • 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 

Types of Commercial Infant Formulas

Infant formulas come in powdered and concentrated liquid, which require mixing with water or ready-to-use liquids. There are three major types of commercial formulas:  

  • Cow’s milk-based formulas are altered to resemble breast milk. 
  • Soy-based formulas are helpful for parents who want to exclude animal proteins from their child’s diet or infants who are allergic to cow’s milk or lactose. 
  • Protein hydrolysate formulas contain proteins broken down into smaller pieces for babies who do not tolerate cow’s milk and soy-based formulas, such as infants with a protein allergy. 

Donor Breastmilk for Premature Infants

Donor Breast milk has been readily available in the U.S. for decades. Mothers who cannot supply enough or any of their breast milk can order pasteurized human donor milk (PHDM) from a Human Milk Banking Association of North America (HMBANA) certified milk “bank.” The organization was founded in 1985 to accredit nonprofit milk banks in the U.S. and Canada, setting international guidelines for pasteurized donor human milk. Each Bank tests donated breastmilk to ensure it is free from harmful bacteria and then pasteurizes it to eliminate any infecting organisms that may be present in the milk.  

In 2006, Prolacta Bioscience, Inc., introduced the world’s first and only human milk caloric fortifier for preemies in the neonatal intensive care unit (NICU). Eight years later, the company introduced human breastmilk ready-to-feed formula to the market.  

In 2012, the American Academy of Pediatrics (AAP) issued a statement that “all preterm infants should be fed either their mother’s milk or, if their mother’s milk is unavailable, pasteurized human donor milk.”  

Despite the availability of human breastmilk and recommendations by the AAP, Enfamil and Similac continue to market cow’s milk-derived formulas to vulnerable preemies at increased risk for NEC.  

Why are People Filing Baby Formula Lawsuits? 

Mead Johnson and Abbott Laboratories, makers of Enfamil and Similac, respectively, have no warnings on their cow’s milk-derived infant formulas to alert parents or medical professionals about the risk of necrotizing enterocolitis to premature babies.  

Parents whose babies have developed this devastating disease have endured extensive financial losses and emotional distress watching their infants suffer or die. Many are filing lawsuits against the makers of Enfamil and Similac, seeking compensation and warning other parents of the potentially dire consequences of feeding premature babies infant formulas derived from cow’s milk.

Do I Qualify 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 before diagnosis 
  • Diagnosed with NEC 
  • Suffered at least one of the following injuries:
    • Intestinal perforation 
    • Scarring or strictures in the intestines 
    • Cerebral Palsy 
    • Neurological damage 
    • Sepsis 
    • Resection/surgery 
    • Death 

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