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Baby Formula Litigation – Necrotizing Enterocolitis (NEC)

The Baby Formula lawsuits claim that premature or preterm babies who were fed Similac or Enfamil formula while in neonatal intensive care units are at an increased risk for developing necrotizing enterocolitis (NEC).

Our law firm is representing the parents of infants who were fed Similac or Enfamil formula while they were in neonatal intensive care units and who subsequently developed necrotizing enterocolitis (NEC).

What Do We Know About the Baby Formula Lawsuits?

Similac and Enfamil brands of infant formula are linked to an increased risk of causing premature infants to develop necrotizing enterocolitis (NEC), a life-threatening gastrointestinal disorder. These baby formula brands are formulated specifically for premature infants, who already suffer a higher risk of developing NEC. When this disorder results in intestinal necrosis, it can ultimately cause the infant to suffer organ failure and possibly lead to death.

The list of defendants in NEC lawsuits excludes medical providers and hospitals, as they were not informed of the life-threatening risks of Similac and Enfamil formula products, like Similac Special Care and Enfamil NueroPro Enfacare. Rather, these legal actions target the formula manufacturers.

Examples of Baby Formula Lawsuits Filed to Date

Parents of premature babies who were given Similac and/or Enfamil infant formulas and developed NEC have begun pursuing legal action against manufacturers.

In May 2021, the Madison-St. Clair Record reported that a premature male infant had been fed Enfamil and/or Similac cow’s-milk-based baby formula in the hospital. The baby developed NEC and required surgical removal of a large portion of his intestines. The infant’s parents filed a lawsuit seeking financial relief and a trial by jury.

Another lawsuit was filed that same month in the U.S. District Court for the Eastern District of California. In the complaint, the parents of a boy born at 31 weeks are suing Abbott Laboratories and Mead Johnson & Company for the boy’s death from NEC at only 16 days old. The infant had been given Similac infant formula in the NICU at Valley Children’s Hospital in Merced, California.

Studies Indicating Baby Formula Risk in Preterm Babies

Study after study has underscored the risk of feeding cow’s-milk-based formula to premature infants. As far back as 1990, a study on 926 preterm infants published in Lancet medical journal showed that preterm babies who were formula-fed had a risk of developing NEC at six to ten times greater than their breast-fed counterparts.

In 2012, the American Academy of Pediatrics published its findings that a mother’s own milk is “optimal” for premature infants, and in cases where this is not an option, donor milk would be “advantageous.”

In the case of profoundly preterm newborns, the risk of developing NEC on a diet of cow’s-milk-based formula was 320% greater than that of other premature infants, according to one 2014 study. As the published study states, “…it is well established that the risk of [NEC] is increased by the administration of infant formula and decreased by the administration of breast milk.”

Formula products and fortifiers based on human milk have been available since 2014, but manufacturers continue manufacturing their products on cows’ milk. Furthermore, these companies have failed to disclose the risks of NEC to the public or the medical community.

Baby Formula Injuries & Side Effects

Merck Manual states that NEC is the most common gastrointestinal emergency among newborn infants. According to this professional medical resource, more than 90% of NEC occurrences develop in premature infants — and in up to 8% of infants admitted to the NICU. Mayo Clinic reports that premature newborns who consume only breast milk experience a significantly lower risk of developing NEC.

As explained by the Cleveland Clinic, NEC causes a baby’s intestinal tissue to inflame, which leads to the tissue dying. This can prompt the formation of perforations in the infant’s intestine, enabling leakage of bacteria into the belly or bloodstream. Because premature infants have weaker immune systems and digestive systems, they struggle to fight off infections. Premature babies also have a diminished blood flow, and the resulting damage of oxygen not reaching the intestinal tissue can permit bacteria to enter into the belly or bloodstream.

Indications That Your Baby Has Developed NEC

Symptoms and signs of NEC include:

  • Abdominal swelling and pain
  • Bloody stool
  • Diarrhea
  • Lack of weight gain
  • Lethargy
  • Unpredictable body temperature, blood pressure, breathing, and heart rate
  • Refusing to eat
  • Yellow or green vomit

NEC puts an infant at risk for multiple other health problems, including:

  • Developmental delays
  • Growth failure
  • Intestinal stricture (narrowing of the intestines)
  • Peritonitis (abdominal infection)
  • Poor neurodevelopment
  • Sepsis
  • Short bowel/gut syndrome

According to Pediatrics Nationwide, as much as 50% of babies who develop NEC perish from the disorder, and nearly 50% of the infants who survive, develop “significant developmental and cognitive disability.”

What Compensation is Recoverable in a Baby Formula Lawsuit?

If your infant was fed Similac or Enfamil formula while in a neonatal intensive care unit and developed necrotizing enterocolitis (NEC), we will be seeking the following damages:

  • Past and future medical expenses to treat your child’s injuries.
  • Past and future pain and suffering that results from your child’s injuries, both from a physical and mental standpoint.
  • Wage loss, if any.
  • Other economic losses experienced because of your child’s injuries.
  • Punitive damages, if appropriate.

Learn more about your options during a free consultation. At Hill, Peterson, Carper, Bee & Deitzler, we have extensive experience fighting for justice when you or your child is injured. Call us at 304-205-1810 or toll-free at 800-797-9730 to get started.

Baby Formula Lawsuit Settlements

As of this time, there have been no large groups of mass torts settlements involving Baby Formula and the link to necrotizing enterocolitis. However, litigation like this generally takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.

Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (known as an MDL).

What Is the Purpose of Feeding Formula to a Preterm Baby

Often, premature babies lack the energy or coordination to manage the “suck-swallow-breathe” process required for breastfeeding.

According to a study published in Maternal Fetal Neonatal Medicine, preterm infant formula (PTF) is given to preterm babies when there is not enough of the mothers’ milk or when mothers cannot breastfeed and there is no access to donor breast milk.

Premature babies and those with low birthweights receive these special formulas in the NIC unit because the products contain extra calories and minerals that the infants need, reports Medline Plus.

Hospitals often use cow’s-milk-based preterm formula products because they are:

  • Less expensive than human milk
  • Readily accessible
  • Shelf-stable, not requiring refrigeration

Baby Formula Necrotizing Enterocolitis Lawsuit News

Researchers Define Chain of Events Leading to Dangerous Intestinal Disorder in Preemies

A research team has provided what may be the most definitive view to date of the biological process leading to necrotizing enterocolitis (NEC), a dangerous inflammatory disease that can destroy a premature infant’s intestinal lining and causes death in up to a third of the cases. Read more at New Food Magazine.

New Nonprofit Breast Milk Bank Launches in San Diego

Every year, about 260 of the tiniest premature babies in California hospitals develop an often-fatal bowel disease known as necrotizing enterocolitis, or NEC. Nobody knows what causes NEC, but a common factor in many cases is the use of formula to feed these very low-birth-weight babies because the mother’s breast milk is not available. Replacing that formula with pasteurized breast milk in every California hospital’s newborn intensive care unit could be a positive step in reducing NEC cases. Read more at San Diego Tribune.

What’s Next for NEC?

Most premature babies are initially placed on total parenteral nutrition (TPN) intravenously until their immature intestines are capable of tolerating feeds. Giving breast milk orally is the first step in preventing NEC, according to Dr. Talavera. “Just a drop of breast milk – preferably mom’s but possibly from a donor – can start the process of coating the digestive tract with all the good things that will help the baby thrive,” she says. “We can even just paint the mouth with a little breast milk from day zero. Getting more oral feeds as early as possible is an important goal for preventing NEC.”  Read more at Pediatrics Nationwide.

New York Parent Charges SimplyThick Infant Food Thickener Caused Catastrophic Injuries to Her Baby

In May 2011, the FDA warned that SimplyThick may cause the life-threatening condition of necrotizing enterocolitis (“NEC”) and that the product should not be fed to prematurely-born infants. Soon thereafter, the FDA conducted an inspection of Thermo Pac, LLC’s Stone Mountain, Georgia, facility, where SimplyThick was manufactured, and found numerous problems at the manufacturing plant. Read more at Business Wire.

Scientific Studies Regarding Baby Formula & NEC

The Effect of Donor Human Milk on the Length of Hospital Stay in Very Low Birthweight Infants: A Systematic Review and Meta-Analysis

This systemic review set out to determine the degree to which hospital stays reduce when donor human milk (DHM) is used as an alternative to preterm infant formula in cases where the mother’s milk is not available. The researchers concluded that the randomized controlled trials (RCT) revealed neither a shortening nor a lengthening in hospital stay for DHM-fed preterm babies as compared with those who were fed preterm infant formula. However, DHM did lower the incidence of NEC. Meta-analysis of the 8 observational studies (n=2,496) found a significant reduction in the occurrence of NEC in the DHM group compared to the formula group (RR 0.48; 95% CI 0.35-0.66; p<0.05).  Read more at International Breastfeeding Journal.

Safety of Cow’s-Milk-Derived Fortifiers Used with an All-Human Milk Base Diet in Very Low Birthweight Preterm Infants

The objective of this meta-analysis was to determine whether cow’s milk-derived fortifiers (CMDF) link to a heightened risk of major morbidities, even when paired with a 100 percent human milk (HM) based diet. The researchers concluded that very low birthweight (VLBW) preterm infants who ingested CMDF with a 100 percent HM base diet experienced significant increases in major morbidities. Specifically, CDMF was associated with a higher risk of NEC compared to HMDF: 19/220 vs 7/233 (RR 3.31; 95% CI 1.36-8.07; p=0.008). Read more at Neonatology Today

The Impact of Human Milk on Necrotizing Enterocolitis: A Systematic Review and Meta-Analysis

This meta-analysis included six randomized control tests and 18 observational studies, which found a reduced risk of NEC in infants who were fed human milk compared with those who received formula. Specifically, the study comprised the following:

  • 6 RCTs enrolling 1626 infants found a reduced risk of NEC with human milk compared to formula: RR 0.62; 95% CI 0.42–0.93; p=0.02
  • 18 observational studies including 6,405 infants found a reduced risk of NEC with human milk compared to formula: RR 0.45; 95% CI 0.32-0.62; p<0.001
  • 7 observational studies found a reduced risk NEC in 2,453 infants with high (>50th quantile) vs low proportional consumption of human milk: RR 0.51; 95% CI 0.31-0.85; p=0.001
  • 3 observational studies found a reduced risk NEC in infants exclusively breastfed compared to mixed-fed infants: RR 0.74; 95% CI 0.63–0.91; p=0.003
  • 4 observational studies found an increased risk of NEC in mixed-fed infants compared to infants exclusively fed preterm formula: RR 1.37; 95% CI 1.13–1.65; p=0.001

Read more at MDPI.

Formula Milk Versus Donor Breast Milk for Feeding Preterm or Low Birth Weight Infants

The objective of this study was to identify the comparative effects on growth and development in preterm or low birthweight (LBW) babies when fed donor breast milk vs formula. Based on the main results of 12 trials with 1,879 infants, the authors concluded that feeding with formula resulted in higher rates of head growth, weight gain, and linear growth—but also a higher risk of developing NCE—as compared to rates experienced in donor breast milk-fed infants. Read more at Cochrane Library.

Availability of Donor Milk for Very Preterm Infants Decreased the Risk of Necrotizing Enterocolitis Without Adversely Impacting Growth or Rates of Breastfeeding

This observational study takes into account the fact that human milk facilitates maturation of a baby’s intestines and protects them from inflammatory and infectious conditions. The researchers aimed to measure the incidence of NEC and late-onset sepsis (LOS) in very preterm infants (VPI) after DM had been introduced. The study also measured breastfeeding rates and growth as secondary outcomes. Two groups totaling 227 VPI had been admitted to the NICU. One group was admitted when only formula was available for feeding the babies. The second group was admitted during a period when donor milk had become available. Group 1 experienced a higher occurrence rate of NEC (9.1 percent) compared with the DM group (3.4 percent). Surgical NEC dropped from 55.6 percent in the formula group compared with 25 percent in the DM group. Read more at MDPI.