NEC Baby Formula Lawsuits: The Dangers

What Are the Potential Dangers of Cow’s Milk-Based Baby Formulas? Since the late 19th century, infant formula that is based on cow’s milk has been offered in the U.S. There are also cow’s milk-based fortifiers which are sometimes added to breast milk as a method of upping the nutrition for babies who need this added nutrition. These fortifiers include protein and mineral supplements. Pre-term infants, in particular, have been given fortifiers and formula based on cow’s milk, yet over the past few decades NICU doctors and nurses—as well as researchers—have identified a potential link between necrotizing enterocolitis (NEC) and cow’s milk-based formula and fortifiers.

In fact, according to PubMed, preemies who are fed formulas or fortifiers that are cow-based are at a risk of NEC which is two to ten times higher than other babies who were fed non-cow-based formulas or fortifiers. The WHO released a review in 2006 that found “strong and consistent evidence” that feeding breast milk to preemies was associated with a much lower incidence of necrotizing enterocolitis and infections. Today, it is well known among those in the medical field that premature infants who are fed cow’s milk-based formulas or fortifiers are significantly more likely to develop NEC than breastfed babies.  

Necrotizing enterocolitis is a disease in the intestines that causes injury and inflammation to the intestines and gut. Premature babies are often born with bowels that have not fully developed, making them more prone to an infection like NEC when fed with a formula or fortifier based on cow’s milk, a much higher risk of NEC exists. When taken in conjunction with inadequate oxygen flow at birth, the baby’s intestinal wall is unable to fight infection.

Formula and fortifiers based on cow’s milk can result in bowel inflammation in a premature infant, potentially causing a rupture. Once the bowel is ruptured, harmful bacteria can leak into the abdominal cavity. While the goal for premature infants is to address the nutritional deficiencies by substituting or adding cow’s milk-based fortifiers, this can have adverse outcomes.

A 2019 Pub Med study found that between 20 and 40 percent of all infant NEC cases will result in surgical intervention. The long-term side effects associated with moderate to severe NEC are significant, including neurodevelopmental and gastrointestinal issues, as well as failure to thrive and grow. Neurological impairment and conditions like cerebral palsy that begin in the intestinal wall can spread to other organs, with NEC survivors at a 45 percent higher risk of cerebral palsy, psychomotor impairments, and hearing, cognitive, and visual impairments by 20 months.

These neurological issues are unlikely to improve as the child gets older; by school age, NEC survivors may experience poor attention span, issues with visual perception, and even a lower IQ than their peers. When you consider that ten percent of all infants born in the U.S. are preemies (born before 37 weeks), thousands of babies will be diagnosed with NEC each year. 

What is Necrotizing Enterocolitis (NEC)? Necrotizing enterocolitis is the death of intestinal tissues. Premature infants, as well as newborns who have other medical conditions, are those primarily affected by NED. When the lining of the intestinal wall dies, the tissues fall off. NEC typically begins within the first 2-3 weeks after birth in preterm infants who otherwise appear to be getting healthier. It is believed that the blood flow to the bowel prevents the bowel from producing mucus that protects the gastrointestinal tract, although bacteria in the intestine may also be a cause. In addition to infants who are fed cow’s milk-based formula, infants in a nursery where an outbreak has occurred, or infants who have received blood exchange transfusions are also at risk.  

  • Symptoms—The symptoms of necrotizing enterocolitis may include the following:
  • Abdominal pain
  • Swelling of the abdomen
  • Rapid or unusual changes in body temperature
  • Changes in heart rate
  • Vomit that is green or yellow
  • Lethargy
  • Refusing to eat
  • Lack of weight gain
  • Diarrhea with bloody stool
  • Metabolic acidosis
  • Tender stomach
  • Jaundiced appearance
  • Low blood pressure
  • Abnormal breathing patterns
  • Lack of appetite
  • Sleep apnea
  • Diagnosis—Diagnosing necrotizing enterocolitis may begin when the parent or the infant’s doctor notices redness, swelling, or tenderness in the belly. Sometimes, a mass can be felt during a belly examination that can indicate a perforation. The physician may order an abdominal X-ray. If the X-ray shows small bubbles in the intestinal wall, this is an indicator of bacteria in the wall of the bowel and a diagnosis of NEC may be made. Serial films help assess the progression of NEC; in severe cases of the disease, the x-ray can reveal gas or air in the large veins of the liver, produced by bacteria in the bowel wall. Other diagnostic tools include a blood test to check for bacteria and other signs of infection and a fecal test that checks for blood in the baby’s stool.
  • Prognosis—Most infants who develop NEC will recover and will have no further feeding issues, however, in some cases, scarring and narrowing of the bowel can develop. This could lead to future intestinal blockages or obstructions. A residual medical issue associated with infant NEC is malabsorption, which is the inability of the bowel to absorb nutrients. Malabsorption is more common among children who undergo surgery for NEC in which a large piece of the intestine is lost. Some infants can require a bowel transplant when they do not have sufficient intestines left to survive.
  • Treatment—Pediatric patients can require medical or surgical treatments for their enterocolitis. If only a small area of the intestine is affected, surgery may not be necessary, and 60-80 percent of infants with necrotizing enterocolitis will not be required. Medical treatments may involve one or more of the following:
  • Providing all nutrients through an IV catheter while halting regular feedings
  • Administration of antibiotics
  • A nasogastric tube that extends from the nose into the stomach, suctioning air and fluids from the baby’s stomach, relieving swelling and inflammation
  • Frequent blood tests
  • Oxygen or mechanically assisted breathing when the abdominal swelling interferes with breathing
  • Checking stools for blood
  • A platelet and red blood cell transfusion

If these medical treatments do not have the desired effect, or if the intestine is perforated, surgery is necessary. The goal is to remove only the destroyed parts of the intestines, leaving as much as possible in order for the intestines to regain function. For some infants, an abdominal drain will remove the infected fluids. A diagnosis of necrotizing enterocolitis can be extremely frightening to parents as it is frustrating to be unable to feed your baby or even to hold and bond with the baby. Babies with a higher birth weight are more likely to have a good outcome to necrotizing enterocolitis.

What Are the Potential Short-Term and Long-Term Injuries Related to NEC Baby Formula? As one of the most severe—and most common--intestinal diseases among premature babies, necrotizing enterocolitis causes the infant’s intestines to no longer be able to hold waste. This allows bacteria to pass into the bloodstream and can potentially be life-threatening. The short-term symptoms include lethargy, lack of appetite, diarrhea, constipation, pauses in the baby’s breathing, vomit containing bile, low blood pressure, a slowed heart rate, red, swollen, or tender belly, and difficulty feeding.

Some infants may recover fully from NEC, with no further feeding problems. Others will have long-term feeding issues related to NEC. Malabsorption is one of these long-term issues, occurring when the intestines cannot absorb nutrients from food. Babies who have had a piece of their intestine removed are more likely to have malabsorption and feeding issues. Those who are diagnosed with malabsorption may need to have nutrition delivered directly into a vein until the intestine is healed sufficiently to return to normal feeding. Other long-term effects of necrotizing enterocolitis include short bowel syndrome, cholestasis, neurodevelopmental delays, failure to thrive, strictures, and adhesions.

Parents of infants who were diagnosed with NEC after the hospital fed them cow’s milk-based formula and/or fortifier may want to speak to an experienced NEC baby formula lawsuit attorney. If you have questions regarding a potential Similac lawsuit or Enfamil lawsuit, your NEC lawyer can answer all your questions related to a necrotizing enterocolitis lawsuit. Your baby’s necrotizing enterocolitis symptoms may have been extremely serious.

Necrotizing enterocolitis causes are not entirely known, however, research has shown that certain baby formulas that are based on cow’s milk can lead to NEC. Since many hospitals routinely give these cow’s milk-based formulas to babies—particularly preemies who are already at a higher risk of developing NEC—necrotizing enterocolitis symptoms can appear within the first two to six weeks. Although no amount of money can restore your baby’s health, you deserve compensation for injuries your baby incurred as a result of cow milk-based baby formula.

Remember, there is a statute of limitations in every state that limits the amount of time you have to act. Speak to a qualified NEC baby formula lawsuit attorney from Sullo & Sullo to determine your options. If your baby was injured or died as a result of formula-induced NEC, our experienced baby formula attorneys can provide a free consultation where we will explain your legal rights and the next steps.

DISCLAIMER: Statutes of Limitations limit the amount of time that an individual has to file a lawsuit, and not only vary from state to state, but also vary by cause of action. The information provided above and in the state-specific pages in this section is meant as a general guide, and is for informational purposes only. Each client’s case is unique, and the specific circumstances of any individual case can have significant bearing on the applicable statute of limitations. Any person who believes they may have a viable cause of action is strongly encouraged to consult with an attorney about the statute of limitations for his or her case. Attorney Andrew Sullo is licensed to practice law in Texas, and can prosecute cases that are part of a federal multi-district litigation. Andrew Sullo does not practice law in any other state, and is not certified by the Boards of Legal Specialization in any state. Not all states have board certifications. This information is not intended to solicit clients for matters outside of the State of Texas. Our firm is not accepting cases in any state where it would be impermissible for it to do so. Sullo & Sullo, LLP maintains its principal office in Houston, Texas.

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