NEC Baby Formula Lawsuits

Necrotizing enterocolitis (NEC) is a condition that mainly occurs in premature babies, affecting the stomach and intestines. Babies with NEC often receive a diagnosis after being fed cow milk-based formula or human milk fortifier instead of breast milk. 

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    NEC is a serious and potentially fatal condition. Infants that survive can require surgery and may have lifelong health problems. If your baby developed NEC after they were fed formula or a fortifier that contained cow’s milk, you might be able to file a lawsuit against the product manufacturer. The birth injury lawyers at Cutter Law P.C. can help you pursue an NEC baby formula case to recover compensation for the losses associated with the condition.

    What is necrotizing enterocolitis (NEC)?

    In necrotizing enterocolitis, the lining of an infant’s intestines becomes diseased, and in some cases, the cells can even die. Harmful bacteria can then pass through the dead tissue, infect the intestine, and enter the bloodstream. Inflammation of the intestines can make it impossible for the infant to digest food properly. NEC typically develops between three and 12 days after birth. In some cases, a baby may appear healthy and stable before symptoms arise.

    Necrotizing Enterocolitis Symptoms

    The following initial symptoms of NEC may appear over several days or develop suddenly:

    • Refusal to eat or tolerate feedings
    • Bloated or swollen stomach
    • Pain when touching the abdomen 
    • Bloody stools or diarrhea
    • Vomit or spit-up that is green or yellow
    • Inability to maintain average body temperature (​​95.9–99.5°F on an oral thermometer)
    • Low heart rate
    • Sleep apnea

    If you notice any of these symptoms in your newborn, you should contact your doctor immediately. NEC can lead to potentially severe complications as the condition progresses, including low blood pressure, a weak pulse, and shock. Additionally, the infant’s abdominal cavity can fill up with fluid, and a hole in the intestinal wall may develop.

    Necrotizing Enterocolitis Diagnosis

    If NEC is suspected, a doctor will first check the infant’s stomach for any swelling that may be present. The doctor will likely perform blood and stool tests next to check for abnormalities. The doctor might also request abdominal X-rays to check for air bubbles, which can be a sign of perforation and other intestinal damage.

    Necrotizing Enterocolitis Treatment

    When a doctor diagnoses a baby with NEC, they usually recommend that the parents stop all feedings. The infant may receive IV fluids while their stomach and intestines heal. The doctor may also insert a tube into the infant’s stomach via the nose to suction out any gas or fluids. Finally, they might prescribe antibiotics to help fight any infections. 

    About 25% of all babies with NEC will need surgery to remove dead tissue or repair a perforation. In extreme cases, some babies require an ostomy, where a hole is created in the abdomen. Instead of passing through the intestines, any bowel movements are rerouted through this hole and into an external pouch. Depending on the severity of the condition, an ostomy may be temporary or permanent.

    Why is NEC dangerous?

    NEC is a leading cause of illness and death in preterm babies and very low birth weight infants. Those born before 37 weeks of gestation and have a low birth weight are at greater risk. The National Institutes of Health (NIH) reports that between 15% and 40% of babies diagnosed with NEC will die from the condition.

    NEC is common among premature infants, affecting about 1 in 1,000. The condition is rarer in full-term babies, at 1 in 10,000. 

    The exact cause of NEC remains unknown, but some studies indicate higher risks in babies who consume cow milk products. Manufacturers of these products failed to make parents and health care providers aware of an increased risk of NEC development in infants consuming their baby formulas.

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    Baby Formula Linked to NEC Development in Premature Babies

    As early as 2011, a connection between infant formula and NEC was noted in a study released by the Johns Hopkins Medical Institutions. In that study, five out of 24 babies who were fed formula developed NEC. Four of those infants required surgery. In comparison, only one out of 29 infants fed human milk developed the condition, and that infant recovered without needing surgery. This data led researchers to recommend a strict breast milk diet when possible for premature babies’ nutritional needs.

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    Which baby formula products cause NEC?

    Any infant formula or human breast milk fortifier that contains cow’s milk can cause NEC. While there are countless brands for sale in the United States, Similac and Enfamil are very popular. According to the USDA’s Economic Research Service, Similac accounts for 43% of all sales, and Enfamil accounts for 40%. The brand Good Start is a distant third, at 15%. 

    These brands market their products to new parents seeking healthy nutritional feeding options for their children. The Enfamil website cited independent clinical studies stating that “babies fed Enfamil saw a 16% improvement in a measure of vocabulary at 5 years old.” The Similac website boasts that the brand is the “#1 Pediatrician Recommended Brand for Immune Support.” They rely on their long history and independent studies to market their claims of safe, healthy products for babies and infants.

    Similac products for premature infants that contain cow’s milk include:

    • Human Milk Fortifier Concentrated Liquid
    • Human Milk Fortifier Powder
    • Special Care® 20
    • Special Care® 24 High Protein
    • Special Care® 24
    • Special Care® 30

    Enfamil products for premature infants that contain cow’s milk include:

    • Premature Infant Formula 20 Cal with Iron
    • Premature Infant Formula 24 Cal High Protein
    • Premature Infant Formula 24 Cal with Iron
    • Premature Infant Formula 30 Cal with Iron
    • Human Milk Fortifier, Acidified Liquid
    • Human Milk Fortifier, Powder

    These products are widely available. In fact, hospitals and neonatal intensive care units (NICUs) often use them. However, this list does not cover all available cow-milk-based formulas and fortifiers. Some products not on this list may include cow milk derivatives such as whey and casein.

    Similac and Enfamil Recalls

    As of late 2021, there have been no NEC-related recalls in the United States. However, Similac products were recalled in 2019 and 2010, and Walmart removed Enfamil from its shelves in 2010 after several babies developed bacterial infections.

    Similac, Enfamil, and other baby formula brands continue to make and advertise cow-milk products for preterm infants.

    Formula Manufacturers Didn’t Warn Parents

    Similac and Enfamil fail to mention the dangers of NEC on their websites and product packaging. Currently, Enfamil only mentions NEC once on their website but with a positive spin rather than addressing its risks: 

    Human milk can help babies avoid infections and sudden infant death syndrome (SIDS) as well as necrotizing enterocolitis (NEC).” 

    Similac’s website makes no mention of NEC. Their packaging for premature infant products only states that at the first signs of intolerance, “feeding should be slowed or discontinued.” These instructions are arguably vague and do not indicate any real dangers or risks to babies using milk-based formulas.

    Is there a history of premature baby formula lawsuits for NEC?

    Yes, multiple lawsuits have been filed on behalf of preterm infants diagnosed with NEC after being fed cow milk-based formulas, including one lawsuit filed in Madison County, Illinois. The defendants are Mead Johnson Nutrition Company, the makers of Enfamil, and Abbott Laboratories, the makers of Similac. Several parents joined together to file this legal case, stating that the injuries to the affected infants were a direct cause of consuming cow’s milk formula. 

    Recently, another premature baby formula case was filed in California. That claim involves one child who sadly passed away from NEC complications. He received care at Valley Children’s Hospital in Madera. The lawsuit alleges that the warnings and instructions on Similac’s formulas are “overly broad and vague.” These instructions fail to mention that the product increases the risk of NEC.

    2021 Baby Formula NEC Lawsuit Status Updates​

    The lawsuits mentioned above against the makers of Enfamil and Similac are still working their way through the court system. However, other companies manufacture cow’s milk formula, and there may be other defendants in the future. Legal cases may continue to grow in number as parents receive more information about the link between cow’s milk formula and NEC.

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    Do I have a baby formula claim?

    You might be eligible for a baby formula claim if your child developed NEC after being fed an infant formula or human breast milk fortifier that contained cow’s milk. Babies who survive NEC often face a long road to recovery and possible lifelong treatment. They may battle complications long after they’re discharged from a neonatal intensive care unit (NICU). NEC can lead to brain development delays, a failure to meet developmental milestones on time, and ongoing stomach and intestinal problems.

    In 2017, the average medical cost for an infant with NEC who needed surgery was greater than $300,000, and health care costs continue to rise each year. On top of an extended NICU stay, NEC-related care can leave parents with a large amount of debt. A settlement can help pay for medical expenses and ongoing care. 

    Contact Cutter Law P.C. for Information About Your Legal Options for an NEC Baby Formula Claim

    In the case of a suspected NEC-related injury or death, Cutter Law P.C. can help parents pursue justice. A personal injury or wrongful death lawsuit can hold the responsible baby formula manufacturers accountable. Additionally, compensation can help ease accompanying financial burdens and provide some semblance of closure for your pain and suffering. Contact us today for more information.

    Photo of Sacramento injury lawyer Brooks Cutter

    Personal injury and civil justice attorney Brooks Cutter is a leading advocate for consumer justice and protecting the rights of the severely injured. Brooks founded Cutter Law, P.C., with offices in Sacramento and Oakland, with a mission of providing injured people with great lawyers to help them get the compensation they deserve and the resources they need.

    November 16, 2021

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    J.R. Parker and the attorneys at the firm founded by Brooks Cutter helped our family through the very difficult loss of our newborn daughter, who died as a result of a medical misdiagnosis. We found the idea of filing suit against such a predominant medical foundation to be extremely intimidating and overwhelming, but J.R. and his team gave us the strength and confidence we needed to obtain justice for our daughter. Their hard work and dedication helped to even further acknowledge our daughter’s life, no matter how short it may have been.
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