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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).
We have been handling lawsuits against product manufacturers since 1955. Each year we teach 1,500 attorneys how to successfully handle these cases. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
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.
September 2023
The NEC infant formula MDL grew by 80 cases, bringing the total number of filed cases to 263. This is almost three times the number of cases since the beginning of 2023.
July 2023
The statute of limitations has surfaced as an issue with some of the infant formula NEC lawsuits. Parents whose infants suffered injury assert that the 2-year timeframe for filing their complaints should start from the time they determined that the formula caused the alleged problems with their children.
May 2022
The Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order on April 8, 2022, establishing MDL 3026, In Re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation. Cases were transferred to the U.S. District Court Northern District of Illinois under the Honorable Rebecca R. Pallmeyer, Chief Judge.
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.
Study after study have 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.
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.
Symptoms and signs of NEC include:
NEC puts an infant at risk for multiple other health problems, including:
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.”
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:
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:
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
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 newborn intensive care unit could be a positive step in reducing NEC cases. Read more at San Diego Tribune
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
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
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
The objective of this meta-analysis was to determine whether cow’s milk-derived fortifiers (CMDF) links to a heightened risk of major morbidities, even when paired with a 100 percent human milk- (HM) base 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
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:
Read more at MDPI
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
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 who 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
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