Necrotizing Enterocolitis Linked to Enfamil and Similac Infant Formula

Studies show Necrotizing Enterocolitis afflicts premature babies who are fed “cow’s milk-based formula” like Enfamil and Similac. In most cases, baby or infant formula is a safe alternative to breastmilk for newborn babies as long as standard guidelines and feeding practices are used.

The United States Food and Drug Administration (FDA) website hosts a comprehensive report on infant formulas that includes approved manufacturers and individual products. It also highlights the best practices for feeding formula to a baby.

However, one major issue, specifically regarding cow’s milk baby formula, is when a baby is born prematurely. Do not use cow’s milk baby formula to feed your preemie due to the risk of developing NEC.

Cow's milk baby formula fed to your preemie may lead to developing NEC

Why Premature Infants Should Avoid Cow’s Milk Formula

According to most modern studies and evidence, premature babies should not be fed cow’s milk baby formula. Furthermore, a 2020 study by the National Institute of Health’s (NIH) National Library of Medicine found that even milk-based fortifiers in conjunction with a base breastmilk diet negatively impacted premature infants’ health.

The consensus and evidence regarding the use of cow’s milk baby formula on premature babies are pretty clear. It often results in the development of necrotizing enterocolitis (NEC), a severe and potentially deadly condition.

If your premature baby was diagnosed with necrotizing enterocolitis (NEC), you may have a case if your baby was fed a cow’s milk formula. The experienced birth injury lawyers at The Yost Legal Group are here to help you and hold the manufacturers accountable for their negligence.

Necrotizing Enterocolitis Afflicts Premature Babies Fed Cow’s Milk Formula from Enfamil and Similac

What are premature birth risks, and how can They be identified?

People frequently talk about human pregnancy in terms of months and say that it lasts about nine months. However, doctors and other medical professionals talk about human pregnancies in terms of weeks.

The average length of a full-term human pregnancy is 40 weeks, which is a little longer than just “nine months.” However, as long as the pregnancy lasts at least 37 weeks, it is still considered a “full-term pregnancy.”

Anything under 37 weeks is considered a “premature birth,” i.e., the baby is born too early. However, not all premature births are the same. The earlier the birth, the greater the health risk to the baby, outcomes that can be long-term, lifelong, or even fatal.

According to the Mayo Clinic, a newborn can be:

  • Late Preterm: born between 34 and 36 completed weeks of pregnancy
  • Moderately Preterm: born between 32 and 34 weeks of pregnancy
  • Very Preterm: born between 28 and 32 weeks of pregnancy
  • Extremely Preterm: born before 28 weeks of pregnancy

The Mayo Clinic does note, however, that “most premature births happen in the late-preterm stage.” The Cleveland Clinic states that about 10% of births in the United States are premature.

What are the Health Risks Associated with Premature Birth?

As mentioned, the earlier the birth in terms of the number of weeks completed, the higher the risk of health issues for the newborn. It is entirely possible that a late-preterm newborn is as healthy as any baby born after 37 weeks of gestation.

If health factors are present, symptoms can range from mild to serious. However, it is always advised to follow professional medical advice after premature birth, even if symptoms are not readily apparent or seem mild.

Symptoms of premature birth include, but are not limited to, the following:

  • Small-sized/underweight baby
  • Smaller/less-developed brain
  • Problems breathing
  • Problems feeding
  • Low body temperature
  • Newborn jaundice

Cow's milk based infant formula leads to Necrotizing Enterocolitis

What is Necrotizing Enterocolitis (NEC)?

In a 2023 study, the National Library of Medicine (NLM) stated that “infant necrotizing enterocolitis is caused by bacterial invasion into the intestinal wall.”

When a baby is born prematurely, they have not had the full gestational period to develop safely in the womb.

Though the exact mechanism that causes the bacterial invasion that leads to NEC in premature babies has not yet been determined, the 2023 NLM study found that “gastrointestinal tract immaturity [in premature neonates] is believed to play a role in the pathogenesis of necrotizing enterocolitis.”

An NEC preemie with NEC symptoms is frightening to new parents.

Additional studies, even ones dating back to 2011, have shown a link between premature babies fed with cow’s milk formula and the development of NEC.

Although it is possible for babies who are exclusively fed breast milk to develop neonatal necrotizing enterocolitis, the incident rate is much lower.

The Cleveland Clinic also supports this data with its findings that NEC affects 1 in 1,000 premature babies. In comparison, “the condition only rarely affects full-term infants,” about 1 in 10,000 full-term babies.

While it is possible to diagnose NEC disease clinically, doctors often require diagnostic imaging to determine the condition’s stage. Radiography is the most commonly used tool because it can show the intestines and areas affected by rogue bacteria.

There are three Bell’s stages of NEC:

  • Bell’s stage 1 (suspected disease)
  • Bell’s stage 2 (definite disease)
  • Bell’s stage 3 (advanced disease)

What are the Health Risks Associated with Necrotizing Enterocolitis?

NEC in preterm infants is a severe condition that affects the gastrointestinal tracts of premature babies, leading to bacterial infections of the intestinal wall.

If diagnosed and treated immediately, the effects of NEC preemie symptoms can be minimized. However, doctors can miss symptoms, leading to untreated NEC.

When untreated, bacteria that enter the gastrointestinal tract can cause severe infections that kill the intestinal tissue and cause bacterial leakage to other internal organs. Bell’s stage 3 means the presence of dead tissue or bowel perforations.

In the United States alone, NEC caused 355 deaths per 100,000 live births in 2013, and the mortality rate for Black Americans was three times higher than for the White population.

Symptoms of NEC include, but are not limited to, the following: (signs of necrotizing enterocolitis)

  • Abdominal swelling
  • Bloody stools
  • Green vomit
  • Poor feeding
  • Inability to gain weight
  • Organ failure
  • Death

If your baby was born premature and diagnosed with necrotizing enterocolitis after it was fed cow’s milk baby formula, there is no time to delay. Learn about filing an NEC lawsuit and get NEC lawsuit updates.

Call or text our experienced product liability lawyers today for a free consultation regarding your potential case. We must hold these companies accountable for their negligence and dangerous products. We are available at no cost to you at 410-659-6800.

Do you Qualify to File a Necrotizing Enterocolitis Lawsuit?

At The Yost Legal Group, we understand the sensitivity of this subject. We are talking about children’s health, life, and wellbeing—and not just any children, but your children or grandchildren.

For years, we have pursued claims against Abbott Laboratories and Mead Johnson related to this NEC litigation, and the fight is just getting started.

It is time to hold these multinational, billion-dollar companies accountable for their negligence in developing and marketing dangerous products.

These products are being fed to newborn and premature babies and, in some instances, causing grave harm, if not death.

If NEC is not caught and treated in time, the damage done to the premature baby might never be fully healed. It could require a lifetime of care. And those affected deserve compensation.

Contact The Yost Legal Group, a wrongful death law firm.

Already, we are seeing cases go to court and settlements being reached. The manufacturers of cow’s milk formula fed to premature infants, leading to NEC, must be held accountable. The Yost Legal Group will continue to fight.

Call or text our experienced defective product lawyers today for a free consultation. We will discuss filing an NEC baby formula lawsuit or a Similac infant formula lawsuit, which will allow us to hold the manufacturers of these dangerous products accountable.

We will help you recover financial compensation for medical treatments, pain and suffering, and whatever your NEC newborn requires.

Contact a baby formula lawyer at 410-659-6800. There is no charge or fee unless you recover. We are here to help you get the justice you deserve.

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Baby Formula Linked to Increased Risk for NEC in Premature Infants

More and more parents across the country are filing suit against manufacturers of cow-milk formula designed for preterm infants. Studies have provided evidence that cow-milk formula has been linked to a condition called necrotizing enterocolitis (NEC) in premature babies, the result of which can be deadly. Despite evidence of the risk posed by these products, they were still marketed as a safe, and even superior alternative to breast milk. As a result, many premature newborns developed NEC and have suffered serious injury and even death.

What is NEC?

Necrotizing Enterocolitis (NEC) is a deadly bacterial infection that affects primarily premature newborn infants. This condition, caused by the inability of the infant to digest food properly, leads to inflamed intestinal tissue, which causes the tissue to die. This can lead to holes in the intestinal walls, which allows harmful bacteria from the intestines to leak into the abdominal cavity, which can rapidly cause a very dangerous infection of the blood stream called sepsis.

While NEC cases can range in severity, with some only causing mild discomfort, others can quickly turn deadly for a newborn. For newborns weighing less than 3 pounds 5 ounces the mortality rate for NEC can be 50% or more. Nearly 9 out of 10 infants diagnosed with NEC are premature.

What Causes NEC?

In 1990, a multi-center study was performed in which 926 pre-term newborns were observed. Of the 926 newborns, 51, or roughly 5.5% developed necrotizing enterocolitis. The mortality rate for those diagnosed with NEC was 26%. This study found that infants that were fed cow milk formula only were 6-10 times more likely to develop NEC. Infants fed a mixture of human milk and formula were 3 times more likely to develop NEC. Among infants born 30 weeks or later, NEC was exceedingly rare among infants whose diet included breast milk. It was 20 times more likely in those fed formula only.

Formula Manufacturers Failed to Warn Consumers

For over 30 years, it has been known that formula poses a threat of increasing a preterm newborn’s risk of developing NEC, yet brands such as Similac and Enfamil, which are known for their cow-milk based formulas, continue to be produced and marketed as intended specifically for pre-term infants. Furthermore, they have failed to provide any warning of the harm that cow-milk formula can cause to pre-term babies.

By failing to warn consumers of the risks posed by their product, Similac and other cow-milk based formula companies deprive parents and caregivers the ability to make informed health decisions on behalf of their premature child. By advertising their products as being specifically designed for premature infants, these companies falsely lead parents to believe that they are safe for their baby to consume, even going so far as to market their products as being safer for a preterm infant than breast milk! As a result, many families have been devastated by the onset of NEC in their newborns, leading to severe and even fatal consequences.

Call Now.

If your baby has been diagnosed with NEC, The Yost Legal Group is here to help you through this difficult time. No parent should be left uninformed of the risks these cow-milk based products pose to their preterm newborns by manufacturers they trust to provide safe formula for their child. Act today by calling us at 1 (800) YOST LAW (967-8529) to hold these manufacturers accountable.

Link Between Necrotizing Enterocolitis and Cows’ Milk-Based Baby Formula and Fortifiers Exposed

The Yost Legal Group has produced an important educational video about the alarming link between certain types of baby formula and fortifiers (those that are specifically manufactured for premature infants) made with cows’ milk and Necrotizing Enterocolitis (NEC) in premature babies (babies born prior to 37 weeks gestation).

NEC is a serious gastrointestinal condition with a high morbidity rate that may require emergency intestinal surgery. It could lead to what is known as Leaky Gut Syndrome, where holes form in the intestinal wall and harmful toxins and fecal matter leak out, potentially leading to sepsis or even death.

Shortly after birth, when a premature infant is unable to breast and/or bottle feed, they are often fed cows’ milk-based formula and/or fortifiers through a feeding tube. However, researchers have concluded that the underdeveloped gastrointestinal tracts of premature babies have a difficult time digesting the proteins in cows’ milk. As a result, preterm infants that receive formula and/or fortifiers made using cows’ milk through their feeding tubes are much more likely to develop NEC. Unfortunately, this condition can be fatal, or require a lifetime of care.

“The manufacturers of Similac or Enfamil failed to warn parents and healthcare providers of the risks of premature infants ingesting their cows’ milk-based formulas and fortifiers – even though suitable alternatives were available.”

  • Tom Yost, Founder, The Yost Legal Group

Symptoms of NEC in Premature Infants Include:

  • Pain and swelling of the abdomen
  • Changes in a baby’s heart rate and blood pressure
  • Diarrhea and blood in the stool (sometimes not visible)
  • Vomiting that is yellow or green in color
  • Feeding intolerance or residuals
  • Inability to gain weight
  • Unusual lethargy

Manufacturers of Cows’ Milk-Based Formula and Fortifiers Withheld Information About Harm to Premature Infants

The manufacturers of cows’ milk-based formula and fortifiers, Similac and Enfamil, failed to warn parents and healthcare providers of the risks of premature infants ingesting their products. Despite suitable alternatives being available such as preterm infant formula and fortifiers made using human milk, mothers’ own breast milk, and human donor breast milk, the manufacturers of Enfamil and Similac continue to market their cows’ milk-based formulas and fortifiers for premature babies with feeding tubes, putting them at significant risk.

If you or a loved one’s premature infant has been diagnosed with NEC due to being fed cows’ milk-based formula and/or fortifiers, they may be entitled to compensation. Contact the defective product lawyers at The Yost Legal Group by filling out and submitting a contact form online or calling our office at 1-800-YOST-LAW (1-800-967-8529) for a free legal consultation today.