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Premature newborn baby girl in the hospital incubator

Are There Side Effects to Premature Baby Formulas?

Having a baby should be one of the happiest days of your life. Unfortunately, about 10 percent of newborns come much too soon before a full-term pregnancy. Premature babies, or “preemies,” may need to stay for weeks or months in the neonatal intensive care unit (NICU). 

Many preemies are not strong enough to fight infections, get the nutrition they need, or even breathe independently. They can develop brain hemorrhages, low blood pressure, gastrointestinal problems and more. One of the most serious conditions for preemies is necrotizing enterocolitis (NEC), an illness that inflames the intestines. While uncommon – affecting just one out of every 1,000 preemies – NEC has up to a 50 percent mortality rate. 

Premature babies fed formula rather than breast milk could be more at risk for NEC. Dozens of NEC lawsuits began popping up last year from parents whose newborns died from NEC. One such preemie lived just 16 days after consuming Similac, a popular cow’s milk brand. Studies have shown a correlation between NEC, Similac and Enfamil, another bovine brand. Parents allege that the companies withheld the risk of NEC and death from any of its warnings or packaging.  

What Can Cow’s Milk Formula Do To Preemies?

Premature babies in the NICU are often given baby formula; not as beneficial as breast milk but contains the essential nutrients a baby needs. The formula is generally safe for healthy infants but can be dangerous for preemies, especially those under three pounds. One study found that formula-fed preemies are twice as likely to develop necrotizing enterocolitis as those fed breast milk. The risk increases further with cow’s milk-based formula. Approximately 10 percent of preemies will develop NEC

Manufacturers of Similac, Enfamil, and other brands market preemie-specific versions of their formulas inside hospitals and stress that they are safe for struggling newborns. Overwhelmed parents often readily accept their word. 

Preemies are already susceptible to intestinal problems because they have underdeveloped organs and difficulty digesting nutrients. Natural breast milk is more easily broken down than cow milk and boosts immunity, but parents can’t always provide it. A mother may struggle to produce breast milk or be unable to afford donated human-based breast milk, and it’s also possible her baby could be too weak to breastfeed.  

If a baby has an adverse or allergic reaction to baby formula, it could be time to try something else. Side effects of baby formula can include:

  • Nausea and gas
  • Constipation or diarrhea
  • Black stool
  • Hives or rash
  • Wheezing or trouble breathing
  • Coughing and sneezing
  • Stomach cramps
  • Low blood pressure
  • Fussy behavior

Switching formulas is usually a simple process for healthy babies, but pediatricians may suggest that slowly combining the old and new formulas before phasing out the old one will be easier on a preemie’s digestive system. 

What Is Necrotizing Enterocolitis?

Necrotizing enterocolitis causes inflammation in the intestines, which kills healthy colon tissue and can tear a hole in the intestinal wall. About eight out of ten patients recover if treated quickly; many may need multiple surgeries or experience chronic health problems down the road. But if NEC goes untreated, bacteria will begin to leak into the abdomen, which can quickly lead to sepsis and death.

Other complications from NEC can include narrowing intestines that must be corrected with surgery, permanent short gut syndrome that causes malabsorption, and delays in brain development and growth. 

NEC has indicators and symptoms already present in preemies, making it crucial to monitor them closely. Preemies have poor blood and oxygen circulation, which, along with their digestive issues, increases the risk of NEC even before introducing formula.

NEC symptoms usually appear within two weeks and can include:

  • Breathing problems 
  • Low heart rate or blood pressure
  • Swollen abdomen
  • Food not moving through intestines
  • Bloody or green-colored stool
  • Stomach bile

Many of these symptoms are found in other common health problems, so it’s best to have any of them evaluated immediately. Sleep apnea, slow heartbeat and lethargy can indicate infection rather than just symptoms.

NEC may be diagnosed using an abdominal X-ray or by inserting a needle into the abdomen. These tests can detect intestinal fluid in the stomach and air inside or outside of the intestines or in the liver. 

After NEC is confirmed, formula is replaced with a nutritional IV and sometimes a stomach tube for antibiotics. Babies who are struggling to breathe may be placed on a ventilator. Severe cases may require surgery, such as draining the abdomen or repairing the intestinal hole. The surgeon may perform an ostomy by threading the large intestine through the belly so stool can exit into a bag outside the body. This will be corrected when your baby is stronger and has had time to heal.

NEC can mentally, emotionally and financially devastate a new family. Some families with NEC babies are fighting back against the formula companies whose negligence may have ruined their lives.

Lawsuits Filed Against Similac and Enfamil 

Dozens of preemie parents whose infants developed NEC after being fed Similac and Enfamil are filing lawsuits against their manufacturers, Abbott Laboratories and Mead Johnson Nutrition. The parents claim that the formulas were heavily marketed to them as even safer than breast milk, with no mention of the risk of NEC or other health problems. The lawsuits allege selling a defective product, negligence, wrongful death and more.  

More than 30 of these lawsuits were filed in Illinois, where both companies are based. Last month, a motion was filed for the lawsuits to be consolidated into multidistrict litigation (MDL). The cases were filed on behalf of a heartbreaking 85 preemies, and more are anticipated. 

Multidistrict litigation would allow discovery and pretrial proceedings to be conducted in one Madison County courtroom. Five cases are already scheduled for trial, the first in March 2023, and those may also be consolidated. 

Abbott called the allegations “without merit,” and both they and Mead Johnson insist their products are safe. 

The research on the connection between the bovine formula and NEC is clear. Parents with a preemie who was fed Similac or Enfamil and developed NEC have options for legal recourse. Whether you lost your baby or are facing years of surgeries and care, you may have a lawsuit for medical negligence, product liability or wrongful death. It is important to seek out a lawyer experienced in these areas. You could recover damages for pain and suffering, medical bills and funeral expenses, lost wages and more – even if your child made a full recovery.