Is Enfamil Being Sued?

Lawsuits against Enfamil and Mead Johnson & Company are being pursued by families of premature babies diagnosed with necrotizing enterocolitis (NEC). Enfamil is being sued for failing to warn hospitals, doctors and parents about the risks associated with their cow milk-based baby formula products.

NEC is a serious gastrointestinal complication that can arise suddenly after feeding Enfamil in the NICU, hospital or following discharge, often causing prolonged hospitalization, surgery, life-long injury for the child or wrongful death.

Decades of research and studies have established that premature babies fed Enfamil or other cow’s milk baby formula face a substantially greater risk of NEC. Although Mead Johnson & Company knew or should have known about the problems, NEC baby formula lawsuits allege that the company placed its desire for profits before the safety of premature babies and families.

Does Enfamil Cause NEC ?

Enfamil may cause NEC when harmful bacteria from the cow’s milk formula breaches the wall of the intestines, causing portions to become inflamed or die. This results in intestinal perforations that could allow bacteria to leak into the abdomen and blood stream. Often NEC caused by Enfamil results in:

  • Emergency Surgery
  • Prolonged Treatment in the NICU
  • Life-Long Disabilities; or
  • Wrongful Death

Is Enfamil Toxic?

While the exact mechanism of action is not well understood, researchers have established that Enfamil causes NEC at substantially greater rates for premature babies, compared to infants fed an exclusive diet of human milk.

The U.S. Surgeon General, The American Academy of Pediatrics and other organizations have launched initiatives to encourage breastfeeding or use of donor breast milk.

In July 2022, the American Academy of Pediatrics issued an updated policy statement, calling for hospitals and the government to promote breastfeeding as the primary form of nutrition for newborns, stating;

“There is no need to introduce infant formula or other sources of nutrition for most infants,”

The updated policy statement was accompanied by a supporting technical report which indicates “Mother’s milk for very low birth weight infants in the NICU provides short- and long-term health benefits, including reduction of necrotizing enterocolitis, late-onset sepsis, chronic lung disease, and retinopathy of prematurity in addition to improved neurodevelopment.”

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What types of products are involved in the Enfamil formula lawsuit?

Families are pursuing Enfamil NEC lawsuits against Mead Johnson & Co. (also known as Mead Johnson Nutrition Company) over problems associated with several different type of the baby formula products marketed for premature infants, including:

  • Enfamil NeuroPro EnfaCare Infant Formula is a cow’s milk-based, iron-fortified, post-discharge formula with enriched nutrition and it is advertised and recommended for infants who were born prematurely or with low birth weight
  • Enfamil Premature Infant Formula 24 Cal High Protein is a formula that Enfamil marketes for premature babies and low-birth-weight babies. It is typically sold in ready-to-use Nursette bottles and it is fortified with protein.
  • Enfamil Premature Infant Formula 30 Cal, 24 Cal, and 20 Cal with Iron are other variations of the Enfamil cow milk formula that are marketed to help low-birth-weight or premature babies who can’t breastfeed gain weight. It is typically sold in ready-to-use Nursette bottles and it is fortified with iron.
  • Enfamil Human Milk Fortifier is actually still a cow’s milk-based powder, which is used to fortify breast milk. It is advertised for breast-fed babies who are born prematurely or with a low birth weight, but carries similar risks of causing NEC as other Enfamil formula.

The Enfamil NEC lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations for families throughout the United States, to help determine whether Enfamil lawsuit settlement benefits may be available. There are no fees or expenses unless a recovery is obtained for your family.

Did Your Child Suffer NEC from Enfamil?

Can my family get an Enfamil settlement for NEC?

Substantial settlement benefits and financial compensation may be available for families of preemie babies diagnosed with necrotizing enterocolitis (NEC) through an Enfamil lawsuit against Mead Johnson.

As the makers of Enfamil, Mead Johnson had a duty to disclose the risks associated with their baby formula. Based on years of research and reports of NEC in premature infants, Mead Johnson knew or should have known about the Enfamil NEC side effects, yet withheld this information from consumers and the medical community.

If warnings about the link between Enfamil and NEC had been disclosed, infant deaths and life-long injuries may have been avoided by many families.

Why should I sue Enfamil for NEC?

As the parent of a child diagnosed with NEC, an Enfamil formula lawsuit settlement may provide the money needed to pay for long-term care and medical expenses your child will need. Future surgery may be required to correct intestinal scarring, adhesions or bowel resection. In some cases your child may require tube feedings or a colostomy throughout their life. In addition, if your premature baby died from NEC after being fed Enfamil, your family experienced a devastating loss that may have been avoided.

Years of research has established that the risk of NEC is much greater when premature babies are fed Enfamil or another cow’s milk based formula, yet Mead Johnson withheld this information from families, hospitals and doctors.

More than 30 years ago, researchers warned that the risk of necrotizing enterocolitis was 6 to 10 times greater among preterm infants fed baby formula only, and 3 times greater among infants who received formula plus breast milk. However, specific formulations of Enfamil for premature infants continued to be introduced and marketed as safe and effective.

Subsequent studies and independent research have consistently established that feeding premature babies Enfamil formula and Enfamil breast milk fortifiers causes NEC, which may be avoided if a baby is fed the mother’s own breast milk, pasteurized donor breast milk or certain breast-milk formulas and fortifiers.

Your family may be eligible for settlement benefits through an Enfamil NEC lawsuit if the following criteria apply:

  • Enfamil or another cow milk-based infant formula fed to a premature baby born at 34 gestational weeks or less;
  • Baby diagnosed with necrotizing enterocolitis (NEC) in the NICU or shortly after hospital discharge; and
  • NEC resulted in wrongful death, the need for surgical treatment or life-long disabilities.

What is the problem with Enfamil and Necrotizing Enterocolitis (NEC)?

For decades, the makers of Enfamil and other infant formula have engaged in extensive marketing campaigns that targeted not only new parents, but hospitals and doctors as well. The advertisements encouraged increased use of Enfamil for premature babies, but the Enfamil label warnings failed to disclose the serious risk of NEC in premature babies.

Enfamil has ignored the strong medical evidence establishing the extreme dangers that cow’s milk-based products pose for premature infants. Enfamil has marketed their cow’s milk-based products as equally safe alternatives to breast milk, and have promoted their products as necessary for additional nutrition and weight gain before hospital discharge, and medical providers have trusted the Enfamil claims.

Does Enfamil Human Milk Fortifier Cause NEC?

Enfamil fortifiers have also been linked to a risk of causing NEC for preemies, posing similar problems that have been seen with other versions of the baby formula.

Mead Johnson developed Enfamil Human Milk Fortifier in response to a shift in the medical community towards an exclusive breast milk diet for premature infants. Since fortifying a mother’s milk has been promoted as safe and effective, doctors have often recommended Enfamil fortified breast milk for newborns to increase calories and help babies gain weight before discharge. However, incomplete information and warnings were provided about the risk that Enfamil Human Milk Fortifier may cause NEC.

While the product name misleadingly suggests that it is derived from human breast milk, Enfamil fortified breast milk still involves the use of cow’s milk, which may pose the same NEC side effects as Enfamil NeuroPro and Enfamil Premature Infant Formulas. The lawyers at Saiontz & Kirk, P.A. are also pursuing Enfamil Human Milk Fortifier NEC lawsuits for families nationwide.

What are the symptoms or signs of NEC from Enfamil?

Most symptoms of NEC from Enfamil will become apparent within days of a preemie receiving the baby formula, often while still in the NICU. The most obvious sign of NEC caused by Enfamil is swelling of the abdomen (abdominal distension), which may be confused with bloating. However, other signs or symptoms of NEC from Enfamil may include:

  • Vomiting, specifically green/yellow vomit containing bile
  • Severe diarrhea
  • Bloody stools
  • Trouble feeding
  • Delayed gastric emptying and constipation
  • Decreased peripheral perfusion
  • Tender, red, or painful abdomen
  • Decreased bowel sounds
  • Apnea
  • Lethargy
  • Slowed heart rate (bradycardia)
  • Low blood pressure (hypotension)
  • A low or unstable body temperature
  • Abdominal wall erythema (advanced stages)
  • Shock (in advanced stages)
  • Cardiovascular collapse (advanced stages)

What are the long-term risks of Enfamil NEC diagnosis?

Most Enfamil NEC cases will require emergency treatment, medications and often surgery. Unfortunately, for some premature babies diagnosed with NEC after being fed Enfamil formula, they do not survive the injury or are left with life-long disabilities.

Scarring and narrowing of the bowel may develop after Enfamil NEC treatment, which may lead to future intestinal obstruction or blockage. Additionally, the inability of the bowel to absorb nutrients normally, otherwise known as malabsorption may be developed. This is generally more common among babies who require surgical NEC treatment from Enfamil, and for children who lost a large segment of intestine due to the surgical intervention they may be left with short gut syndrome from Enfamil.

If an infant loses so much intestine from the infection caused by NEC that they do not have enough intestine left to survive, a bowel transplant surgery may be necessary. Other long-term complications from an Enfamil NEC diagnosis may include:

  • Neurodevelopmental delay
  • Gastrointestinal problems
  • Cholestasis
  • Strictures and adhesions of the bowel
  • Short bowel syndrome
  • Intestinal failure
  • Failure to thrive
  • Premature death

Why was Enfamil bad for my premature baby?

Infants who are born preterm or prematurely may require specific nutrition plans in order to grow and gain weight at an acceptable rate. These nutrition plans may involve mother’s milk, donor milk (milk donated by another mother), or non-cow’s milk based supplemental formula. These are considered to be the safest plans for premature babies as human milk is easier to digest. Human milk also contains substances and bacterias that help fight infection and help the babies’ intestines mature.

In certain cases, medical providers may recommend supplementing human milk with cow’s based milk or fortifier products, such as Enfamil. However, studies have shown that premature babies who are fed cow’s milk–based formulas are more likely to develop NEC than those who receive only human breast milk.

Enfamil significantly increases the risk of NEC in premature babies compared to the use of breast milk, donor milk or certain breast milk-based formula products. According to one study published in 2017, human milk is the preferred diet for preterm or premature babies, as it protects them against NEC.

Preterm babies are susceptible to NEC due to the immaturity of their gastrointestinal and immune systems. A diet made up exclusively of human milk compensates for the babies’ immature systems in many ways. Health experts now widely recommend that preterm infants be fed human milk and avoid cow’s milk protein.

History of Enfamil Recalls and Problems

Mead Johnson introduced the original Enfamil in the 1950s, and it has aggressively marketed it through hospitals and directly to parents as a substitute for breast milk. Although there has not been any Enfamil recall due to the NEC risk for premature infants, there have been several reported problems with Enfamil baby formula products in recent years.

August 2018

After discovering problems with the protective seal, CVS recalled Enfamil baby formula from store shelves, indicating that the products may have been damaged during the manufacturing process or tampered with

December 2011

Following reports of a baby who died from a rare bacterial infection, Walmart and several major retail chains removed Enfamil powdered infant formula from thousands of stores. The 10 day old baby died after he was infected with Cronobacter sakazakii, which is a bacteria known to cause illness in infants. Mead Johnson maintained at the time that its formula was tested for the bacteria before it was distributed, and no Cronobacter had been found.

Enfamil Lawyers Are Pursuing NEC Lawsuits For Families Nationwide

If your baby was born preterm or premature, was given Enfamil formula while in the Neonatal Intensive Care Unit (NICU), and suffered from a diagnosis of NEC, Enfamil lawsuit settlement benefits may be available for your family.

In addition to lawsuits against Enfamil, Saiontz & Kirk, P.A. is also pursuing Similac NEC lawsuits against the makers of this other cow’s milk-based baby formula, which has been linked to similar problems.

There are no costs to have our Enfamil lawyers review your case and help determine the legal options that may be available. If your family qualifies to pursue a formula lawsuit, there are never any attorney fees or expenses paid unless an Enfamil settlement or recovery is obtained.


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Saiontz & Kirk, PA, Attorneys & Lawyers, Baltimore, MD