Posted On March 31, 2023

Baby Formula Lawsuits

Enfamil and Similac, brands of infant formula given to premature infants, are linked to a growing number of baby formula lawsuits. These baby formulas are known to create a high risk of injury and death for premature infants who develop necrotizing enterocolitis (NEC) due to the cow’s-milk used in the formulas.

Why Are People Filing Baby Formula Lawsuits?

Over the last decade, there has been significant evidence of high injury risks for premature infants who are given baby formula made with cow’s milk, yet manufacturers continue to make their baby formulas with cows’ milk-based ingredients. Furthermore, these companies have failed to disclose the risks of these formulas to the public and the medical community. This has resulted in numerous baby formula lawsuits across the country.

Medical studies dating back to 1990 have underscored the high risk of feeding cow’s-milk-based formula to premature infants. A 1990 study done on 926 preterm infants and published in Lancet medical journal showed that preterm babies who were given cow’s milk formulas were at risk of developing NEC, a life-threatening gastrointestinal disorder, at six to ten times greater than breastfed infants. In 2012, the American Academy of Pediatrics published its findings that a mother’s own breast milk is “optimal” for premature infants, and for mothers who can not breastfeed, donor human milk is an “advantageous option.”

According to a study in 2014, it was established that preterm newborns who were given a cows’-milk-based baby formula had a 320% greater chance of developing necrotizing enterocolitis (NEC) than other premature infants. The study established that the risk of (NEC) is greatly increased by feeding premature infants formula and greatly decreased by feeding them breast milk.

Damages in Baby Formula Lawsuits

If your infant suffers from NEC or other health problems due to being given a baby formula containing cow’s milk, you may be entitled to compensation. Common types of damages awarded in these lawsuits include the following:

  • Cost of medical care for past, current, and future expenses
  • Lost income and diminished earning capacity
  • Compensation for the injured child and the parents (in what are called “consequential damages,” either within their child’s claim or in a separate claim)
  • Pain and suffering
  • Loss of consortium or compensation
  • Wrongful death and survival actions

To qualify for an NEC lawsuit, you must meet the following three conditions: 1- Your infant was born prematurely, 2- Your premature infant received Enfamil or Similar baby formula while in the hospital, and 3- Your premature infant must have received a diagnosis of necrotizing enterocolitis (NEC), bacterial infection, bloody stool, abnormal bleeding, bowel amputation, meningitis, salmonella, sepsis, fatigue, shortness of breath, or death.

To file a product liability claim against the baby formula manufacturers of Enfamil and Similac, your infant does not have to receive an NEC diagnosis. In addition to claims for NEC, parents of a child who received Enfamil or Similac can seek compensation through a baby formula lawsuit for damages due to other types of illnesses, infections, or wrongful death due to any of the symptoms or side effects listed above.

Currently, most product liability cases for baby formula damages are individual cases, rather than class actions, but this may change as more lawsuits are filed. Specific questions on filing baby formula lawsuits should be addressed with your attorney, who can review your claim and advise the best legal options available based on active litigation and the facts of your case. Much of the NEC infant formula litigation is still in the beginning phases, so settlement payments are not established.

What Is Necrotizing Enterocolitis?

Necrotizing Enterocolitis (NEC) is a life-threatening gastrointestinal disorder that can have severe or fatal consequences for premature infants. To better understand this illness, we can look at the medical meaning of specific parts of the words. In medical terms, the prefix “necro-“ typically means dead tissue, and the suffix “-ing” indicates an action. Putting it together, necrotizing is the action of tissue dying. The prefix “entero-” relates to the intestines, and the suffix “-colitis” relates to an inflamed colon. Putting it together, enterocolitis means inflammation in the digestive tract. This gives you a clearer understanding of the meaning of this medical condition, which is when tissue in the digestive tract dies. This can occur in the colon, gut, or intestines, and it is most commonly seen in sick or premature infants.

In premature infants, NEC occurs when the lining in part of the digestive tract or a wall of tissue dies from bacteria found in baby formula. When dead tissue and bacteria infect surrounding tissue, the weakened tissue allows bile, digestive acids, and stomach acids to leak into the infant’s abdomen. Since the bowel, intestines, and stomach are still developing in premature or preterm infants, internal damages occur quickly, and the result is often death.

Premies are usually smaller and underdeveloped, have lower birth weights, and are highly susceptible to internal infections because they are born before their full gestation period. It is difficult for them to fight off infections because their immune systems are not fully developed. This is why premature infants should not be given baby formulas, especially when they contain cow’s milk, which is known to put premature and preterm infants at high risk for developing NEC.

Common signs and symptoms of NEC in infants include:

  • Abdominal pain and swelling
  • Bloody stool or diarrhea
  • Green or yellow vomit
  • Inability to gain weight and refusing to eat
  • Lethargy
  • Unpredictable breathing, blood pressure, and temperature

Although NEC puts premature infants at risk for a variety of health problems if they survive, the most common ones include abdominal infections, decreased development, growth failure, physical and cognitive delays, and sepsis. According to pediatric studies, as many as 50% of infants who develop NEC die from the disorder, often resulting in a wrongful death lawsuit filed by the parents. The other 50% of infants who survive NEC develop severe developmental and cognitive disabilities that usually last throughout their lifetime.

Why are Preterm Infants Given Baby Formulas?

According to a study published in Maternal Fetal Neonatal Medicine, preterm infant formula is given to premature and preterm babies when there is not enough of the mother’s milk or when the mother is not able to breastfeed and there is no access to donor breast milk. Premature babies and those with low birth weights often receive special baby formulas in the Neonatal Intensive Care (NIC) unit because the products contain extra calories and minerals that the infants need.

Currently, there are three types of baby formulas on the market in the United States:

  • Cow’s Milk Protein-Based Formulas – These types of infant formulas are made with cow’s milk that has been altered to resemble breast milk.
  • Soy-based Formulas – These types of infant formulas are commonly used to exclude animal proteins from an infant’s nutrition or when there is a known allergy to cow’s milk.
  • Protein Hydrolysate Formulas – These types of formulas contain protein that has been broken down (hydrolyzed), partially or completely, into smaller sizes than those in cow’s milk and soy-based formulas. Protein hydrolysate formulas are meant for babies who don’t tolerate cow’s milk or soy-based formulas. Extensively hydrolyzed formulas are also a good option for babies who have a protein allergy.

Hospitals often use cow’s-milk-based preterm formula products because they are less expensive than human milk, readily accessible, and do not require refrigeration. Most formulas can be purchased as ready-to-use formulas that do not have to be mixed, concentrated liquid formulas that can be mixed with water, and powdered formulas that must be mixed with water. All of these types of formulas cost hospitals much less than other types of baby formulas.

Brands Involved in the NEC Baby Formula Lawsuits

Enfamil and Similac brands of infant formula are linked to many baby formula lawsuits in the United States. These popular brands are formulated specifically for premature infants, who already face a higher risk of developing NEC. Many infant deaths linked to these brands have caused victims to suffer organ failure.

Most defendants in NEC lawsuits against Enfamil and Similac do not include hospitals and medical providers because they were not informed of the life-threatening risks associated with Enfamil and Similac baby formula products. Legal action and baby formula lawsuits against Enfamil and Similac are primarily focused on product liability and target baby formula manufacturers.

Mead Johnson, the manufacturer of Enfamil, and Abbott Labs, the manufacturer of Similac, allegedly did not provide any warnings or information to hospitals and medical providers about the potential dangers of using these products. Both Enfamil and Similac contain bovine milk, a white liquid food produced by the mammary glands of mammals, which can increase the risk of NEC and death in infants and premature babies.

Enfamil and Similac baby formula lawsuits include the following products:

  • Enfamil – Enfamil NeuroPro EntaCare, Enfamil Premature Infant Formula, Enfamil 20 Cal, Enfamil Premature 24 Cal, Enfamil Premature 30 Cal, Enfacare Powder, Enfamil Human Milk Fortifirer Liquid High Protein, and Enfamil Milk Fortifirer Liquid Standard Protein.
  • Similac – Similac Alimentum, Similac NeoSure, Similac Special Care 20, Similac Special Care 24, Similac Special Care 30, and Similac Human Milk Fortifier, Similac Human Milk Fortifier Powder, and Similac Liquid Protein Fortifier.

Many parents are claiming that Abbott Laboratories and Mead Johnson knew or should have known about the potential risks associated with their products, specifically the component of cow’s milk, called bovine spongiform encephalopathy (BSE), that could cause NEC, as well as failure to thrive, sepsis, and other health risks to premature infants. They also argue that the companies failed to learn more about the potential dangers of their products and neglected to warn the public, despite warnings from numerous influential medical groups.

Important Information About Recalled Baby Formulas

According to recent updates on baby formulas, Enfamil and Similac baby formulas have not been recalled specifically for the link between the formulas and NEC. Most FDA product recalls have been due to isolated incidents of product tampering and the potential for bacterial infections. However, the Federal Food and Drug Administration (FDA) has issued warnings about the potential risks of certain baby formulas that contain cow’s-milk.

On February 17, 2022, the FDA recalled Similac Advance, Similac Sensitive, Similac Total Comfort, Similac for Spit Up, Similac Alimentum, and Similac EleCare powdered infant formulas. Recalled Similac products were removed from store shelves. Similac products that are not included in the recall are considered safe for consumer use.

In 2022, the FDA also issued recalls for powered infant formulas due to bacterial infections. The recall warns that certain Alimentum, EleCare, and Similac products should not be used. This recall was issued after four infants had to be hospitalized. Two of the infants died, and it is believed that their deaths were caused by bacterial infections. All four cases involved Cronobacter sakazakii infection caused by a bacterium that causes severe, life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine).

Cronobacter infections are rare, but are especially high risk for newborns and premature infants. Symptoms related to Cronobacter infection include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements. Parents with infants displaying these symptoms should immediately contact the child’s doctor to report the symptoms and get immediate care.

Most baby formula recalls are due to some kind of manufacturing or processing error that contaminates the product and/or makes the product unsafe for human consumption. FDA does not approve infant baby formulas before they can be marketed and sold to consumers. However, all baby formulas marketed in the United States must meet federal nutrient requirements, and infant formula manufacturers must notify the FDA prior to marketing a new formula. If an infant formula manufacturer does not provide the required assurances for a new or reformulated infant formula, the formula is defined as adulterated and FDA has the authority to take compliance action if the new infant formula is marketed.