NEC Baby Formula Lawsuit

Baby Formulas Similac and Enfamil have been linked to necrotizing enterocolitis (NEC), a life-threatening condition that mostly affects premature and low-weight infants. NEC lawsuits have been filed against Abbott Laboratories and Mead Johnson for failure to warn parents and medical professionals, and that the manufacturers knew or should have known that their cow-based milk infant formulas posed a serious risk of developing NEC.


Most health professionals advise that preemie babies and infants with low birth weight are given formula if breastfeeding is not possible. Tragically, this is not always a safe choice: recent studies have found that some cow’s milk-based formulas, such as Enfamil and Similac, are associated with NEC.

One study back in 1990 found that Formula-fed preemies were six to ten times more likely to get NEC than preemies who were fed breast milk and were three times more likely to get NEC than preemies who received both breast milk and formula. This disease occurs in nearly 10 percent of premature babies and it affects between one percent and five percent of neonatal intensive care unit admissions.

What is NEC ?

Children’s Hospital Los Angeles describes Necrotizing enterocolitis (NEC) as a devastating disease that affects mostly the intestine of premature infants. The wall of the intestine is invaded by bacteria, which cause local infection and inflammation that can ultimately destroy the wall of the bowel (intestine). Such bowel wall destruction can lead to perforation of the intestine and spillage of stool into the infant’s abdomen, which can result in an overwhelming infection and death.

The exact cause of NEC is not completely understood but medical experts believe that feeding infant formula to premature babies increases their risk of developing the disease while human breast milk decreases the risk.  Because a preemie has immature lungs and intestines, any decrease in oxygen to the intestines—the lungs cannot oxygenate the blood adequately-- will damage the lining of the intestinal wall. This damage to the bowel wall allows bacteria that normally live inside the intestine to invade the wall of the intestine and cause local infection and inflammation (NEC) that can eventually lead to rupture or perforation of the intestine.

Possible consequences of NEC (and/or the surgery to treat NEC ) include:

• Sepsis
• Peritonitis (an abdominal infection)
• Narrowing of the intestinal wall, called intestinal stricture
• Short bowel syndrome, which may cause malabsorption (and may require a bowel transplant)
• Neurodevelopmental problems
• Growth failure
• Scarring
• Death (if the NEC is not treated quickly)

Baby Formula

Because premature babies are not fully-grown in the womb they need extra nutrition once they are born. Sometimes it is delivered via infant formulas, most commonly made out of cow’s milk.  Most all babies benefit from these formulas, which can also be manufactured to mimic breast milk, and they also include vitamins and minerals that babies need to develop.   Many companies produce these formulas and the most popular brands are Enfamil and Similac.  While drug companies such as Abbot and Mead must undergo rigorous testing and development before releasing their product for public use, that doesn’t mean it is perfectly safe for your baby.

Cows’ Milk Formula vs Human Breast Milk

Research has shown that significantly higher rates of NEC have been found in premature babies with very low birth weights who were fed cow’s milk-based formula or fortifier products over those who were fed exclusively with human breast milk. In 2012, the American Academy of Pediatrics stated that premature infants should only be fed human-based milk due to NEC risks from bovine milk formula.

Because studies have shown breast milk can serve as a protective measure, lawsuits claim these formulas have displaced breast milk that infants would have otherwise received, robbing them of a primary defense against NEC.

Studies and Research Linking Cow’s Milk-Based Formula to NEC

A clinical trial published in The Lancet (1990) found that Babies that consumed cow-based formula (such as Enfamil or Similac) are six to ten times more likely to be diagnosed with NEC compared to preemies that drank solely human breast milk.  

Another study determined that feeding preterm or low birth weight infants with formula milk might increase nutrient input and growth rates but feeding with formula milk may be associated with a higher incidence of feeding intolerance and necrotising enterocolitis, and this may adversely affect growth and development.

In 2011, numerous hospitals concluded that NEC was less of a risk for very premature babies fed human donor milk than those fed cow milk.

Baby Formula Lawsuits

A number of parents have filed lawsuits alleging that Abbott and Mead knew or should have known that their cow-based milk infant caused their preterm babies to get sick or die from NEC.  The product liability lawsuits claim failure to warn; if the manufacturers had warning labels disclosing NEC risks and warning on the products’ labels, neonatologists and pediatricians may have chosen human donor milk instead of formula.

A wrongful death lawsuit was filed by parents of a preterm baby who was fed Similac in the NICU, developed NEC and died from the disease. The complaint alleges that the risk of Similac baby formula causing NEC and death in preemies wasn’t properly disclosed on its packaging, in its warnings, or on other materials.  And as recently as 2016, Abbott advertised some Similac formulas as being specifically for premature and low birth-weight infants despite the known dangers. Daniel died from NEC after being given Similac for 16 days of his short life.

The case is Restad et al v. Abbott Laboratories, Inc. et al, Case number 1:2021cv00798, filed May 14,  2021 in the U.S. District Court for the Eastern District of California.

Baby formula lawsuits filed in Ohio, Wisconsin, and Illinois allege that the makers of both Similac and Enfamil knew the dangers their formula products posed to preterm babies. As well, Similac and Enfamil “aggressively marketed” their formulas as being equivalent to breast milk while being fully aware of the risk such products posed to preterm babies and unreasonable danger to premature infants.

One such lawsuit filed by Valerie Flores and Kairi Flores in the Madison County Circuit Court against Mead Johnson and Abbott Laboratories alleges design defect, failure to warn, negligence, intentional misrepresentation and other claims.  Plaintiffs claim that the defendants' cow's milk-based formula caused the babies to develop necrotizing enterocolitis (NEC). The plaintiffs claim the premature infants, who had "underdeveloped digestive systems," suffered death or long-term health effects after being fed Similac and Enfamil formula. 

Further, the lawsuit states that defendants

• Were well aware of the "scientific consensus" on the dangers of their products to premature infants.
• Aggressively marketed their cow's milk-based infant formulas as being "equivalent alternatives" to breast milk and targeted parents of premature babies while knowing their products posed an increased risk of NEC, serious injury and death to premature infants.
• Warnings and instructions were "inadequate, vague and confusing." 

To date, no cow’s milk-based baby formulas have been recalled for their link to NEC. And neither company has posted warnings concerning the risk of feeding cow-based milk formula such as Enfamil and Similac to preemies. 
 

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Published on Dec-3-21