Case Info
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.
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. Breast fed babies or those fed with breast milk have a lower risk of NEC.
Formula manufacturers Abbott and Mead-Johnson are facing numerous lawsuits over GI injuries like NEC in infants who were fed Similac (Abbott) or Enfamil (Mead-Johnson) infant cow-milk based formulas.
Products linked to NEC in premature infants include:
- Enfamil 24 Cal
- Enfamil NeoPro EnfaCare Infant Formula
- Enfamil Premature 20 Cal
- Enfamil Premature 24 Cal
- Enfamil Premature 30 Cal
- Enfamil Premature 20 Cal with Iron
- Enfamil Premature 24 Cal High Protein
- Enfamil Premature 24 Cal with Iron
- Enfamil Premature 30 Cal with Iron
- Enfamil Human Milk Fortifier
- Enfamil Human Milk Fortifier Powder
- Enfamil Human Milk Fortifier Acidified Liquid
- Enfacare Powder
- Enfamil 24 and DHA & ARA Supplement
- Enfamil NeuroPro EnfaCare
- Similac NeoSure
- Similac Special Care
- Similac Special Care 20
- Similac Special Care 24
- Similac Special Care 30
- Similac Special Care 24 – High Protein
- Similac Human Milk Fortifier Concentrated Liquid
- Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
- Similac Liquid Protein Fortifier
- Similac Alimentum
- Similac Alimentum Expert Care
Parents or caregivers of infants who were fed cow-milk based formula and developed NEC, required surgery or who died, may be eligible for compensation.
Necrotizing Enterocolitis (NEC) in Infants
Necrotizing Enterocolitis (NEC) is a serious intestinal condition which affects premature infants, usually in the first two to four 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. Babies who are breast fed or fed only human breast milk have a lower risk of NEC than infants who are fed cow’s milk-based formulas.
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. NEC may result in permanent injury, need for surgery or may be fatal in half of all infants who develop it.
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 6 to 10 times 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 premature 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. In addition, formulas advertised or labeled as “Human Milk Fortifier” may include additional ingredients to mimic breast milk but are actually based on cow’s milk.
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 Recalls
In February 2022, two consumer groups filed petitions asking the FDA to ban certain ingredients known as nanomaterials from infant formulas. Abbott Laboratories was also forced to recall a number of powdered Similac formulas manufactured at Abbott’s plant in Sturgis, Michigan. The recall was issued due to concerns over contamination with Cronobacter sakazakii which may have caused multiple gastrointestinal bacterial infections requiring hospitalization in a number of infants.
The recall was issued after the FDA announced the opening of an investigation into the Sturgis plant. The investigation initially focused on reports of hospitalizations of four infants who had been fed powdered Similac products manufactured in Sturgis. One of these infants died due to complications of the infection.
After confirming the presence of Cronobacter at the facility, the FDA issued a public warning regarding purchases of Sturgis, Michigan products and Abbott recalled affected powdered Similac and other products including Alimentum and EleCare formulas manufactured at the plant.
Enfamil and Similac Cow’s Milk Formula NEC Lawsuits
Infant formula manufacturers Abbott and Mead-Johnson are facing numerous lawsuits over GI injuries and death associated with use of their cow’s milk-based formulas. Lawsuits claim that the manufacturers failed to warn about the risks of their products and that other feeding methods would have been chosen if risks had been known. Neither Similac nor Enfamil products have yet included warnings on any packaging or instructional information.
In early 2022, the Supreme Court of Illinois granted a request to consolidate Formula NEC lawsuits filed in Illinois state court into a class action lawsuit. In April 2022, federal NEC baby formula lawsuits were consolidated into multidistrict litigation (MDL-3026) in the U.S. District Court for the Northern District of Illinois. Abbott also faces a class action lawsuit for the Cronobacter contamination events.
In August 2022, the American Academy of Pediatrics also began encouraging hospitals to discontinue promoting cow’s milk formulas for premature infants and issued a public statement urging parents to discontinue cow’s milk formulas if administration of human breast milk was possible.
In November 2022, a number of Pennsylvania state baby formula NEC lawsuits were allowed to move back to state court because hospitals had been included in the lawsuits. Twelve federal lawsuits were also selected to possibly bellwether cases and an additional four were to be selected in early 2023, with an agreement four bellwether cases would begin in spring 2024. In addition to Illinois state lawsuits, a number of NEC baby formula lawsuits have also been filed in California and the companies are facing nearly 200 federal lawsuits.
Parents or caregivers whose pre-term infants developed Necrotizing Enterocolitis (NEC) after being given Enfamil or Similac 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.