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Did Similac or Enfamil Hurt Your Premature Baby?

Baby formula

Nothing else can produce the joy or broken heart that parenthood allows. Having a new baby should be an extremely exciting time. However, when a baby is born prematurely, this happy event may also be filled with stress, fear, and worry. Babies born prematurely require extra nutrition to boost their development and growth. Many premature infants, however, are not physically able to breastfeed feed so they are generally given baby formula instead. Similac and Enfamil are the two leading brands of infant formula. But cow milk is the problem. Most baby formulas, such as Similac and Enfamil, are made from cow milk with various nutrients and ingredients added to mimic human breast milk. Recent scientific research has shown that cow-milk-based formulas such as Similac and Enfamil can make infants more likely to develop a dangerous neonatal digestive disease called necrotizing enterocolitis (NEC). NEC occurs in about 10% of all premature babies (born 37 weeks or earlier). Unfortunately, nobody has bothered to warn already over-stressed mothers and fathers about this.

What Is Necrotizing Enterocolitis (NEC)?

Necrotizing enterocolitis (NEC) is a devastating disease that mostly affects the intestines of premature and low-weight infants. NEC is caused by bacteria that attack the wall of the baby’s intestine which leads to local infection and inflammation. This can ultimately destroy the intestinal wall. Once the wall is destroyed by the bacteria, it can cause a tear which leads to spillage of stool into the infant’s abdomen. This can result in an overwhelming infection, organ failure, and death. To hear that a baby dies from formula use is shocking, to say the least.

Symptoms of NEC

Premature babies who are suffering from NEC may experience:

  • Swollen, red, or tender stomach
  • Abdominal pressure
  • Diarrhea
  • Refusal to eat or hold down food
  • Tiredness
  • Fluctuations in temperature
  • Vomiting
  • Abnormal breathing patterns
  • Slowed heart rate
  • Low blood pressure

NEC can also cause serious injuries like permanent blindness, loss or removal of the small and/or large intestines, and cerebral palsy. In most cases, the baby survives but suffers catastrophic injuries. In rare cases, the infection can lead to death.

Treatment for NEC

Treatment for NEC begins, of course, with stopping the infant's formula regiment the newborn infant is on. Then, excess stomach gas can be relieved from the bowels by inserting a small tube into the stomach. This usually allows doctors to begin antibiotic treatment and assess whether or not surgery is needed. Next, excess stomach gas is relieved from the baby’s bowels by inserting a small tube in the stomach.

The infant’s condition will then be monitored around the clock with x-rays, blood tests, and other assessments.

If doctors find that the baby has a hole in their intestine or inflammation of the abdominal wall then surgery will be necessary. During surgery to treat NEC, the dead bowel tissue is removed and a colostomy or ileostomy is performed.

A colostomy is a surgical procedure in which a part of the colon is rerouted to an artificial opening in the abdominal wall to bypass the damaged part of the colon.

An ileostomy is a surgical procedure that creates an opening at the surface of the skin which allows the small intestine to move intestinal waste into an external ostomy system. The baby's bowel may then be reconnected several weeks or months later when the infection and inflammation have healed.

Treatments for NEC do not cure the condition, and infants who experience NEC will have lifelong neurological and digestive issues. As if birthing a premature baby is not traumatic enough, NEC treatment is also extraordinarily traumatic for both the baby and the whole family.

Baby Formula Has Been Linked to NEC

A new study published on October 14, 2021, in the British Medical Journal suggests that the makers of infant formulas such as Similac and Enfamil have funded biased and unreliable clinical product trials. The researchers found that the infant formula trials showed a “universal lack of transparency” and may have downplayed the risks of NEC associated with their cow-milk formula products.

The scientific evidence establishing a causal link between cow milk-based infant formula and NEC has been developing for the last 30 years. Below is a chronology of the studies establishing that cow-milk formula increases the risk of NEC in premature or low-weight infants.

1900 The Lancet - Breast milk and neonatal necrotizing enterocolitis: research study on 926 preterm infants finds that those who were given cow-milk formula were 6-10 times more likely to develop NEC.
2010 Journal of Pediatrics - infants fed with breast milk or human milk fortifiers were 90% less likely to develop NEC compared to those fed with traditional formula made from cow milk.
2011 U.S. Surgeon General's Call to Action to Support Breastfeeding premature infants who are not feed with human breast milk are 138 times more likely to develop NEC.
2014 Expert Review of Clinical Immunology - noting and reviewing the established scientific evidence showing higher rates of NEC with formula compared to breast milk.
2015 Pediatria - Portuguese study finding 50% reduction in NEC rates for babies given breast milk rather than formula.
2016 Breastfeeding Medicine - Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet: study of over 1,500 newborns finding lower incidence of NEC in those who received only human breast milk.
2019 Cochrane study of over 1,900 premature infants found those with cow-milk-based formulas and had 7 times higher rates of NEC
2021 Journal of The American Academy of Pediatrics - premature infants given exclusively human breast milk showed 77% reduction in NEC.

Medical research links cow milk-based infant formulas such as Similac and Enfamil to a dangerous neonatal medical condition known as necrotizing enterocolitis. The makers of these formulas knew of the risk of NEC and did nothing to warn families and give them a choice.

Makers of Similac and Enfamil Failed to Warn About the NEC Risks

Unfortunately, it seems already over-stressed mothers and fathers have not been warned about this. Abbott Laboratories and Mead Johnson & Company (the makers of Similac and Enfamil respectively) have not added any warning labels to their products regarding the potential risks of a premature baby developing NEC as a result of cow’s milk. It’s unclear if any hospitals or doctors were aware of this risk and failed to warn new parents.

Similac is manufactured and sold by Abbott Laboratories Inc., a large medical device and health care product company based in Illinois. You have likely heard of them. You are less likely to have heard of Mead Johnson Nutrition Company, the company that makes Enfamil. But it is a 16 billion-dollar company.

Both Abbott and Mead were well aware of the scientific evidence establishing that their cow-milk-based formulas caused a significantly increased risk of NEC in premature infants. Despite being well aware of the link between their formulas and the risk of NEC, Abbott and Mead deliberately chose not to include a warning label about the NEC risk on their product labeling.

In the face of growing scientific proof that their formulas presented an increased risk for premature infants to develop NEC, Mead and Abbott continue to market their products as safe and failed to warn consumers about this risk.

What You Can Do Next

No parent should have to worry that the food, medicine, or toys they are giving their child is going to seriously injure or kill them. This is especially true when a parent is already dealing with a sick and at-risk infant. Premature babies already have enough problems. By definition, a premie baby is usually small, lacks body fat, and has trouble suckling and swallowing. This means that because they did not grow fully in the womb, they need extra nutrition and assistance once they are born. This is why advanced infant formulas have been developed.

If a product is intended to provide a benefit, it should do that. It definitely shouldn’t cause unnecessary and avoidable harm.

A growing number of parents and infants who were fed with Similac and Enfamil formula and subsequently developed NEC are filing product liability lawsuits against the formula manufacturers (Abbott and Mead) for negligent failure to warn.

If your preterm infant was injured or died because of NEC caused by infant formula, you need the help of legal experts who understand what it takes to hold large corporations accountable. You may be owed compensation and our compassionate case managers are available to chat. You are not alone, we can help.

What Settlement Amounts are Expected in NEC Infant Formula Lawsuits?

The NEC infant formula lawsuits are just getting started. But we can estimate settlement amounts and compensation payouts from juries at trial by looking at NEC medical malpractice lawsuits. Let's look at a few:

  • New York: $5 million verdict
  • New York: $1.35 million settlement
  • California: $10 million settlement
  • Michigan: $50,000 settlement
  • Louisiana: $347,000 settlement
  • Florida: $900,000 settlement
  • Massachusetts: $7 million verdict

Was your baby born prematurely?

Were they fed Enfamil, Similac, or another formula made out of cow’s milk while they were in the NICU?

Was your baby diagnosed with the bowel disease Necrotizing Enterocolitis (NEC) and the devastating complications of NEC?

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