Why Didn’t Baby Formula Manufacturers Warn Parents of Preemies? 

If you’ve heard about the lawsuits pending against baby formula manufacturers like Abbott Labs (Similac) and Mead Johnson (Enfamil) in connection with necrotizing enterocolitis (NEC), you may be confused about the fact that these formulas remain on the market. The current lawsuits are focused on a very specific issue: the claim that formulas that include cow’s milk significantly increase the risk of NEC in premature infants–especially smaller, earlier-born infants. 

The NEC baby formula lawsuits allege that manufacturers of many different types of formula knew of the risks formula containing cow’s milk posed to premature infants, but failed to warn parents or medical providers of those risks. 

When Was the Link Between NEC and Cow’s Milk Discovered?

One of the earliest regularly-cited studies identifying a possible link between cow’s milk in formula and NEC was published in 1990. In the years that followed, numerous other studies concluded that preterm babies–especially those born very early or who were very small–were at a significantly greater risk of NEC if they were fed formula containing cow’s milk. 

However, many of these studies also reported a positive outcome: while formula feeding resulted in a higher risk of NEC, it was also linked with better short-term weight gains and growth in preterm infants. So, these formulas were often promoted as a means of helping preemies put on “catch-up weight.”

In fact, a large-scale survey of baby formula trials published in October of 2021 indicated that the majority of these studies and trials reported positive outcomes. But, researchers noted something else that might help explain those positive results: a high potential for bias in many studies.

How Important is the NEC Risk Compared with the Need for Weight Gain?

That’s a question to be answered by the baby’s pediatrician and parents. But, it’s critical that the decision be made with complete and accurate information. Researchers have found that premature infants fed cow’s milk formula are six to 10 times as likely to develop necrotizing enterocolitis than those fed exclusively breast milk.

The seriousness of NEC varies from infant to infant, but researchers have concluded that the condition is fatal in about 30% of significantly preterm babies. 

Who Publishes Baby Formula Studies? 

According to the October, 2021 report, 84% of 117 trials published between 2015 and 2020 reported receiving support from the formula milk industry. 77% of those had one or more authors who worked for or were in some other way professionally affiliated to a baby formula manufacturer. In other words, they were tied to a company that stood to profit from favorable outcomes and suffer financial losses if unfavorable results were reported.

Just 14% of trials published across that six-year period involved low levels of conflict of interest. 

Marketing of Cow’s-Milk Formula for Premature Infants

As of late December, 2021, Similac and Enfamil both continue to market cow’s-milk-based formulas specifically for use with premature infants. A search of the Similac website turns up no mentions whatsoever of necrotizing enterocolitis or NEC, let alone the possible link to formula feeding.

Enfamil’s site contains brief mentions of the condition in two articles geared toward parents of premature infants. One warns of the higher risk of the condition in preemies and lists warning signs. The other says that human milk can help avoid the condition. But, we found no mention of the many studies suggesting that cow’s-milk based formulas increased the child’s risk of NEC. 

Product Liability for Failure to Warn

The key issue in the majority of current cases pending against Similac and Enfamil in connection with NEC in premature infants is legally described as a failure to warn. That means parents are claiming that the manufacturers knew or should have known that their products posed a risk to premature infants, but failed to make parents and pediatricians aware of that risk.

Failure to warn is a common element in product liability cases. For example, many Philips CPAP lawsuits and Zantac lawsuits assert that the manufacturers were aware of the risks for years before recalling products or taking corrective action, and continued to market their products without alerting consumers or medical professionals. 

If your premature infant suffered NEC after being fed formula containing cow’s milk, you owe it to your family to learn more about your rights. Action Matters makes that easy. Just fill out the contact form on this site and we’ll put you in touch with an attorney who handles baby formula litigation in your area.