Status of NEC (necrotizing enterocolitis) Litigation

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Updated: January 2022

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    According to the Cleveland Clinic, necrotizing enterocolitis (NEC) is a “serious gastrointestinal problem that mostly affects premature babies. The condition inflames intestinal tissue, causing it to die.” Holes can form in the intestine of premature infants, which allows bacteria to leak through the intestinal wall or intestinal tract and into the abdomen or bloodstream. NEC can lead to severe complications and send preterm infants to neonatal intensive care units with life-threatening symptoms.

    The Centers for Disease Control and Prevention (CDC) lists NEC as the 10th leading cause of death for preterm babies and infants under one year of age. The CDC study from 2019 also shows an increase of 19% from 2018. According to the American Academy of Pediatrics, NEC is also the most common life-threatening surgical emergency in newborns and preterm infants.

    Families of newborn babies with NEC have filed multiple baby formula lawsuits against Mead Johnson, makers of Enfamil, and Abbot Laboratories, makers of Similac. Legal actions filed by several personal injury attorneys and other lawyers claim that manufacturers should have known their products could lead to an increased risk for necrotizing enterocolitis (NEC) in premature infants and that they failed to warn parents and medical professionals about the higher risk.

    Both baby formula brands’ products contain cow’s milk. Studies published by the National Institutes of Health have shown that cow’s milk in baby formula leads to a higher incidence of NEC in a newborn baby than in human breast milk. A study published in The Lancet — dated 1990 — showed that a child exclusively fed formula derived from cow’s milk was 6-10 times more likely to contract NEC than those fed human milk alone.

    The NEC lawsuits not only claim manufacturers failed to provide the proper warnings of risks to child immune systems and potentially serious injuries but that they targeted parents of premature infants with advertising for baby formula products even though the company knew or should have known about the potential increased risk for severe medical problems from necrotizing enterocolitis.

    The condition of infants with NEC can be life-threatening in severe cases, especially in those children with low birth weight. NEC has a mortality rate ranging from 30% or 50%, according to studies published in the National Library of Medicine at the National Institutes of Health.

    Latest update on NEC litigation : January 2022

    Headquartered in Illinois, Abbott and Mead Johnson are facing 33 lawsuits. In December 2021, the plaintiffs made a motion to consolidate cases in the Illinois Supreme Court.

    Abbott Laboratories faces a separate class-action suit in the U.S. District Court for the Southern District of Illinois, filed in November 2021. The suit alleges that marketing falsely suggested that Similac Pro-Advance formula (bovine formula) is comparable to breast milk. The complaint seeks class-action lawsuit status to pursue damages for all consumers in similar situations.

    In this suit, attorneys list that the product label contains language claiming “our closest formula to breast milk.” Yet, no reliable scientific studies provide scientific evidence that shows similarities between baby formula and human milk. Further, lawyers point out that the World Health Organization’s International Code of Marketing of Breast-milk Substitutes prohibits claims that idealize infant formula according to the legal action.

    As such, the lawsuit alleges marketing claims for the baby formula products are “false, deception, and misleading.”

    Previous NEC litigation

    Other lawsuits from across the United States allege that:

    Baby formula manufacturers knew about the risks of formula but failed to warn the public or place warning labels on products.

    Manufacturers marketed false and misleading information about the risks to parents, hospitals, and medical teams.

    Manufacturers of these popular infant formulas ignored known risk factors in favor of profit, knowing the high risk of health problems, such as NEC, yet still marketed the products to premature birth infants and families.

    Some of the more notable lawsuits filed previously include baby Daniel Renteria-Hernandez and baby Aries Peterson.

    Restad et al v. Abbott Laboratories Inc. et al.

    Plaintiffs Alicia Restad and Daniel Renteria-Hernandez filed a personal injury product liability action against Abbott Laboratories, Mead Johnson Nutrition Company, and Mead Johnson & Company, LLC in the U.S. District Court for the Eastern District of California.

    According to the lawsuit, baby Daniel was born prematurely on April 29, 2019, in Merced, California. With a birth weight of two pounds and two ounces, his treatment required a stay in the neonatal intensive care unit (NICU). Daniel died 16 days later from NEC.

    According to the lawsuit, “Science and research have advanced in recent years confirming the dangers of the defendant’s cow’s milk-based product in causing NEC and death in premature infants, yet the Defendant did nothing to change its product, packaging, guidelines, instructions, and warnings.”

    Further, the suit states: “warnings and instructions are overly broad and vague, and do not ever mention that the product significantly increases the risk of NEC and death, nor provide any detailed instructions or evidence on when and how to feed the infants and how to avoid NEC and death when feeding its products.”

    Hunte v. Abbott Labs

    Plaintiff Anika Hunte filed a product liability case against Abbott Laboratories after the death of her infant son, Aries Peterson, in U.S. District Court in Connecticut.

    According to the lawsuit, baby Aries was born prematurely and spent three months in the NICU at Yale New Haven Hospital, where caregivers used three of Abbott Lab’s cow-milk-based infant formula products. The plaintiff alleges the formula caused Aries to develop NEC.

    Abbott Labs moved to have the suit dismissed in August 2021. Still, U.S. District Judge Stefan Underhill denied the company’s motion to dismiss and allowed legal proceedings in the infant formula lawsuits to continue.

    The connection between infant formula and NEC

    While the exact cause of NEC remains undetermined, according to researchers, available information from multiple clinical studies has concluded a connection between cow’s milk or baby formula based on cow’s milk and adverse outcomes.

    The American Academy of Pediatricians (AAP) recognizes that providing breast milk for premature infants may be challenging. However, premature milk is higher in minerals and proteins that make it easier for newborns to digest and avoids exposing a premature infant’s immature intestinal lining to the cow’s milk proteins found in premature infant formula.

    According to the AAP, “Premature babies who are breastfed are less likely to develop intestinal infections than are babies who are formula-fed. The milk you produce in the first few days contains high concentrations of antibodies to help your baby fight infection.”

    Doctors at the AAP recommend breastfeeding (exclusive human milk diet) for about six months. In a policy statement, the group cited that the benefits of breastfeeding can lower the risk of NEC by as much as 77%.

    A study of 926 preterm infants showed that formula-fed babies were six to ten times more likely to show NEC symptoms than those fed break milk alone. Among premature infants born at more than 30 weeks gestation, NEC was 20 times more common in infants fed formula only. Despite treatment options, researchers fear that the growing use of exclusive formula feeding in British neonatal units could account for an additional 500 cases of NEC annually and 100 deaths.

    A 2017 review published by the American Society for Nutrition noted: “Several studies have indicated that bovine milk-based infant formulas lead to a higher incidence of NEC in preterm infants than does human milk (HM).” Another study published at the National Center for Biotechnology Information concluded that “In preterm and low birth weight infants, feeding with formula compared with donor breast milk results in a higher rate of short-term growth but also a higher risk of developing necrotizing enterocolitis.”

    Researchers Alan Mucas, John Soscardin, and Steven Abrams looked at the common practice of feeding preterm infants a base diet of human milk but fortified with a cow’s milk-derived fortifier. Even when the diet was primary human breast milk, the student reported that evidence points to an increase in adverse outcomes, including necrotizing enterocolitis with “severe morbidity comprising NEC surgery or death.”

    Investigators at the Johns Hopkins Children’s Center prompted doctors to call for a change in feeding practices in NICUs. “The stark differences in the risk of NEC, its complications, and the need for surgery between babies who receive human donor milk and those who get formula signal the need for a change,” said Elizabeth Critofalo, MD.

    The study, funded in part by the National Institutes of Health, showed that only one of the babies studied developed NEC and recovered without surgery. By comparison, of those fed exclusively formula, five out of 24 (20.8%) developed symptoms of NEC, and four had complications that required surgery.

    Background on NEC:
    What is it, and what are the risks?

    Necrotizing enterocolitis is a serious intestinal disease. Tissue in the large intestine or small intestine become injured or inflamed and can lead to perforations in the intestinal wall or the death of intestinal tissue.

    When this occurs, the intestine is no longer able to hold waste, which can cause bacteria to pass into the baby’s abdomen and abdominal cavity.

    Stanford’s Children’s Health lists procedures that doctors may need to use to treat NECs, including:

    • Surgery to remove damaged portions of intestines
      or bowels
    • An ostomy, connecting part of the intestine or
      bowel to an opening in the baby’s abdomen
    • Draining of peritoneal (abdominal) cavity

    Even with treatment, Stanford Children’s Health warns that there can be severe complications, including:

    • Hole in the intestinal tract
    • Scars and narrow areas in the intestine
    • Difficulty in absorbing nutrients from food (short
      guy syndrome/short bowel syndrome)
    • Long-term complications, including inhibited
      growth and developmental delays
    • Sepsis and damage to multiple organs
    • Death

    NEC impacts approximately one in 1,000 preterm infants, according to the Cleveland Clinic. The risk is most significant for those most vulnerable, including newborns weighing less than two pounds at birth. NEC is rare in full-term infants. The Cleveland Clinic reports incidents of necrotizing enterocolitis in full-term newborns are about one in 10,000.

    Toxic baby formula lawsuits

    Infant formula lawsuits, sometimes called toxic baby formula lawsuits, are complex cases that require deep legal expertise. If your law firm needs help preparing NEC cases, contact us to learn about our services.