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Baby Formula Lawsuits Being Filed Over Links to Necrotizing Enterocolitis (NEC)

Updated December 6, 2021.

Baby Formula Lawsuits Being Filed Across the Country Over Links to Necrotizing Enterocolitis (NEC) a Dangerous Condition Affecting Premature Babies

Lawsuits against the makers of Similac® and Enfamil® are being pursued by families nationwide. Similac and Enfamil are popular infant formulas that have been marketed as safe for premature babies. Premature babies, low birth weight babies and infants who have breastfeeding difficulties are often fed or given supplemental feedings with formula. However, cow’s milk-based products like Enfamil and Similac have been linked to necrotizing enterocolitis (NEC) among premature infants, which can result in serious injuries, lifelong health complications and even death.

What is Necrotizing Enterocolitis (NEC)?

NEC is a serious gastrointestinal disease that causes inflammation in the intestines. NEC can cause intestinal strictures; a narrowing of the intestines, a perforation or hole in the intestine, development of intestinal scars, decreased ability to absorb food after damage to or removal of the intestine (short bowel syndrome), and development of severe infections such as peritonitis, an infection in the abdomen, or sepsis when infection becomes systemic throughout the body. Symptoms can range from mild to life-threatening, depending in great part upon how quickly the condition is diagnosed and treated. Unfortunately, around 15 percent of NEC cases result in death. Of those who survive, a significant number of babies will have long-term health complications.

Which Babies are at Risk for NEC?

NEC is mostly associated with preterm babies (around 9 out of 10 NEC cases are found in preterm babies), particularly those born before 28 weeks, but it can also occur after a child has received a blood transfusion or when the child is fed through the stomach (enteral nutrition). While medical experts know who falls into the at-risk category for NEC, there is no consensus as to what exactly causes NEC.

90% of the cases of NEC involve preterm babies, particularly those born before 28 weeks. However, NEC can occur after a child has received a blood transfusion or when the child is fed through a tube into the stomach (enteral nutrition).

While the exact cause of NEC is unknown, medical experts have pinpointed certain conditions where the disease is more likely to develop. Many of these conditions are prevalent in preterm babies. For example, premature babies generally have weaker immune systems, which might affect their ability to fight the disease.  Preemies also are believed to have weaker digestive systems, which may impact their ability to fight off infection of the intestines.

While there are still a lot of unknowns about NEC and its exact cause, low birth weight and preterm delivery are known risk factors.

Diagnosis and Treatment

Symptoms of NEC usually show up in the first two weeks of a baby’s life. Common symptoms of necrotizing enterocolitis include:

  • Stomach pain
  • Stomach swelling
  • Blood in the infant’s stool
  • Lethargy (tiredness)
  • Vomiting, especially when colored green or yellow
  • Change in heart rate, blood pressure, breathing or body temperature
  • Lack of weight gain, refusal of food

The symptoms are not always apparent and, therefore, diagnosis can be delayed or even missed. NEC can range in severity and treatment will depend upon many factors including severity of the disease, the baby’s age, relative health and strength. Treatment can range from IV feeding, stopping of feeding and giving antibiotics to the removal of the intestine or bowels in the most severe cases.

The Link Between Cow’s Milk Based Formulas and NEC

A number of studies published over the past three decades have revealed a link between NEC and Similac, Enfamil or other cow’s milk formula fed to premature infants as compared to breast milk. Unfortunately, studies have demonstrated that premature infants fed formula are more likely to develop necrotizing enterocolitis (NEC) than those who are breastfed. Despite this knowledge, it is alleged that the manufacturers of the baby formulas have done nothing to warn parents and medical professionals about the dangers.

Links to some of the studies linking NEC to Cow’s Milk Baby Formulas can be found at: MDPI: The Impact of Human Milk on Necrotizing Enterocolitis: A Systematic Review and Meta-Analysis (2020), Pediatric Research: In Vitro Cow’s Milk Protein-Specific Inflammatory and Regulatory Cytokine Responses in Preterm Infants With Necrotizing Enterocolitis and Sepsis (2011); and The National Center for Biotechnology: Human milk is the feeding strategy to prevent necrotizing enterocolitis (2015)

NEC Lawsuits

  • NEC Lawsuits have been filed against Abbott Laboratories and Mead Johnson & Company, two of the largest formula manufacturers in the country. The lawsuits claim that Abbott Laboratories’ product Similac and Mead Johnson’s product Enfamil should have carried warning labels to advise parents of the risks to their newborns. The lawsuits allege that the manufacturers knew about the risks, but failed to act to warn the public causing serious injury and even death to preterm babies.
  • Recent lawsuits allege that false and misleading information has been provided to parents, hospitals and medical providers about the risks associated with the use of baby formula.
  • Enfamil and Similac lawsuits brought by families in state and federal courts nationwide, allege that manufacturers ignored the risk to consumers in pursuit of profits. The suits allege that despite known risks, Similac and Enfamil baby formula were marketed for use among preemies in the NICU or hospital.
  • Some of the early claims include a lawsuit filed against both Mead Johnson and Abbott Laboratories by the parents of Daniel Renteria-Hernandez.  The suit, filed in the Eastern District of California in May 2021, alleges that the companies failed to adequately warn parents and medical professionals of the dangers of feeding their formulas to preterm and underweight babies. Daniel was born weighing only 2 pounds, was fed formula and died from NEC just days after his birth in 2019. A claim brought on behalf of the family of baby Aries Peterson was filed in October 2020 in Connecticut. In August of 2021, a federal judge rejected attempts by Abbott Laboratories to dismiss the claim for the baby’s wrongful death. The claim will now move forward after supplementary deliberations by the Connecticut Supreme Court.
  • Abbott Laboratories is a named defendant in a class action lawsuit over Similac Pro-Advance formula. The suit alleges that marketing materials were false and deceptive in making suggestions that cow’s milk formula is comparable to breast milk. The was filed in the U.S. District Court for the Southern District of Illinois in late November of 2021, seeks class action status to pursue damages for all consumers similarly situated, indicating parents were misled that Similac Pro-Advance was “close” to breast milk.

Similac Cow’s Milk Based Baby Formulas 

Similac baby formulas cited in current Similac baby formula lawsuits include:

  • Similac Neosure
  • Similac Human Milk Fortifier
  • Similac Special Care.

Other cow’s milk-based Similac products include:

  • Similac Alimentum
  • Similac Alimentum Expert Care
  • Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
  • Similac Human Milk Fortifier
  • 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

Enfamil Cow’s Milk Based Baby Formulas 

The NEC lawsuits against Mead Johnson allege that cow’s milk-based formulas from the company’s Enfamil line have led to the death or serious injury of premature babies. The Enfamil products include:

  • Enfacare Powder
  • Enfamil 24 and DHA & ARA Supplement
  • Enfamil Human Milk Fortifier Acidified Liquid
  • Enfamil Human Milk Fortifier Liquid High Protein
  • Enfamil Human Milk Fortifier Powder
  • 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

Several of the lawsuits name both Mead Johnson and Abbott Laboratories as co-defendants because many of the injured babies were fed both Similac and Enfamil products.

Should I Contact an Attorney?

The legal proceedings are in their early stages, and it is too soon to determine the outcome. However, anyone who believes they may have been affected by these products should contact an attorney as soon as possible to determine if they might have a claim. It is important to know that injured infants and their families may be able to bring a claim for injuries even many years after the harm. The law provides for extended time periods within which to bring a claim for minor children.

If your baby was born prematurely, diagnosed with NEC and used Enfamil or Similar baby formula attorney Jacqueline M. Thomas may be able to help. The attorneys at Lacy Katzen LLP have proudly represented injured individuals and their families for over 70 years. Please call for a free consultation.


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