Enfamil Baby Formula Lawsuits

Neither parents nor the medical community were warned that Enfamil increases the risk of necrotizing enterocolitis

Although the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFA) recommend breastfeeding for the first six months of an infant’s life, many parents are unable or simply choose not to breastfeed.

The Centers for Disease Control and Prevention (CDC) reports that more than 83 percent of newborns are fed some breast milk shortly after birth, but that number drops to 55.8 percent by the time they turn six months old.

Babies who do not receive their nutrition from breast milk typically receive it through formula. Enfamil is one of the most popular brands of baby formula, along with Similac.

The United States Food and Drug Administration (FDA) regulates baby formula sold in the United States, but there have nevertheless been lawsuits filed against the manufacturer of Enfamil due to some serious side effects.

What is Enfamil?

Enfamil is a brand of infant formula made by Mead Johnson (a subsidiary of Reckitt).

Enfamil was first put on the market in 1959. The product was marketed as “the nearest approximation of mothers’ milk” for the “physician who prefers a lower protein formula than most infant formulas.”

Since the release of Enfamil in 1959, Mead Johnson has added several different versions of Enfamil to the market (including Enfamil NeuroPro EnfaCare and Enfamil Enspire), all with slightly different ingredients.

Like other brands of baby formula, Enfamil formula is made using cow’s milk. It’s intended to be a substitute or supplement to breast milk.

Does Enfamil cause necrotizing enterocolitis (NEC) in newborns?

A number of lawsuits have been filed by parents against Mead Johnson, claiming that:

• Enfamil causes NEC,
• Enfamil caused their child’s NEC,
• Mead Johnson knew or should have known that Enfamil causes NEC, and
• Mead Johnson failed to warn parents and medical providers that Enfamil causes NEC

Before we address the question of whether Enfamil causes NEC, let’s take a closer look at the condition.

According to the Cleveland Clinic, necrotizing enterocolitis (NEC) is a gastrointestinal condition that primarily affects preterm babies. Roughly 9 percent of newborns are born prematurely in the United States. NEC inflames intestinal tissue, causing it to die. As a result, a hole may form in the intestine of a newborn with NEC. Bacteria can leak into the abdomen or bloodstream through this hole.

Symptoms of NEC include:

NEC is a serious condition with a death rate approaching 25 percent. Infants suspected of having NEC are fed via intravenous fluid and given antibiotics. Surgery may be necessary if there’s a hole in the intestines. Some babies fully recover from NEC, while others have lifelong neurological and nutritional complications.

So, does Enfamil cause NEC?

As far back as 1990, a study published in the peer-reviewed journal Lancet found that NEC was six to ten times more common in exclusively formula-fed preterm babies than in those preterm babies fed breast milk exclusively.

In 2011, the U.S. Surgeon General published a report titled, “The Surgeon General’s Call to Action to Support Breastfeeding.” In the report, the Surgeon General warned that “for vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis.”

Subsequent studies have reached a similar conclusion. In 2016, a study published in the Journal of Pediatrics found that premature babies who consumed cow’s milk-based formula (such as Enfamil and Similac) were more likely to develop NEC than those who consumed only breast milk.

Specifically, researchers found that low-birth-weight infants who consumed breast milk at least 98% of the time had a 1.3% occurrence rate of NEC. When low-birth weight infants had only formula, they had an 11.1% occurrence rate of NEC. Babies who had a combination of breast milk and formula had an 8.3% occurrence rate.

Researchers aren’t certain why premature babies who consume formula are more likely to develop NEC. The prevailing theory is that premature infants have intestines that can’t protect themselves as well as the intestines of more developed infants. While human milk adds protection (reducing inflammation and bacterial invasion), formula encourages the proliferation of bacteria.

Has the FDA recalled Enfamil?

The FDA has not recalled Enfamil even though its packaging does not contain any warning labels about the increased risk of NEC among premature babies.

There have been some isolated store recalls, but these recalls were the result of product tampering. For example, a store recall occurred after a handful of mothers reported that their Enfamil products contained flour instead of formula.

Enfamil lawsuit update

The link between baby formula and NEC is strong enough that the AAP (along with many other health organizations) strongly recommends giving premature babies breast milk whenever possible.

So if health organizations are advising against giving premature babies formula due to the risk of NEC, why isn’t the manufacturer of Enfamil required to warn parents and doctors about the risk? This is precisely the question some parents are asking in their lawsuits against Mead Johnson.

The NEC lawsuits are not the only lawsuits Mead Johnson has faced. Mead Johnson recently settled a class action lawsuit for $8.4 million. The lawsuit alleged that Mead Johnson inflated the number of bottles its Enfamil baby formula products could make. In addition, several manufacturers are facing lawsuits over misleading nutrition claims in toddler’s milk products. These suits argue that products were deceptively marketed as essential for toddler development, despite offering no proven nutritional advantage over regular cow’s milk and containing added sugars not recommended for young children.

We’ll do our best to keep you updated on the Enfamil lawsuits. In the meantime, learn more about unsafe baby foods and product liability lawsuits.

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