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NEC Lawsuit Update – April 27, 2023 Timely Insights on Laws, Issues and New Developements
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Enfamil & Similac Baby Formula Lawsuits

FDAPremature Baby Formula lawsuits involving bovine-based milk products are being filed based on the belief that they are linked with necrotizing enterocolitis (NEC). These cow’s-milk based formulas are believed to raise the risk of necrotizing enterocolitis (NEC) in newborns who are fed them.

When is a Newborn considered Premature ?

Roughly 1 in 10 babies is born premature or preterm in the U.S. each year. That means they are born before a pregnancy has completed 37 weeks of gestation. Most preterm babies eventually thrive into adulthood, but many require some form of feeding support in their early life.

Preterm or low-birth-weight babies often suffer from refusal to eat, lethargy, and an inability to gain weight and thrive. As a result of these problems, preterm and underweight babies are often fed supplemental formula(s). That is unfortunately where problems can start.

Infant Formula Linked to Dangerous Condition Affecting Premature Babies

Studies have shown some cow’s milk-based baby formulas might be harming babies more than helping them. These formulas can be linked to the crippling disease of Necrotizing Enterocolitis (NEC).

We now know that premature infants fed infant formula are more likely to develop NEC than breastfed infants, according to a study published in Pediatric Research. Nevertheless, companies that produce and promote popular baby formula products have failed to warn parents and medical personnel about these dangers.

NEC Lawsuit Updates — April 2023

  • April 1, 2023 – Medical News Today discusses newborns with NEC, a serious condition that affects the intestines and can lead to death. Inflammation from NEC can damage or kill colon tissue.
  • April 1, 2023 – Black babies are especially vulnerable to NEC (study).
  • March 1, 2023 – An NEC lawsuit plaintiff claims Enfamil Premature formula contributed to her baby’s premature death.
  • February 1, 2023 – Parents of a premature baby boy are suing Mead Johnson and Abbott for failure to warn that their infant formula products could cause serious gastrointestinal disorders and other health problems. Dana and Destin Jupiter filed a complaint against Mead Johnson & Company LLC and Mead Johnson Nutrition Company on May 7, 2022. Their causes of action include strict liability for design defects and failure to warn, negligence, intentional and negligent misrepresentation. The Jupiters’ complaint states their son was prematurely born at Woman’s Hospital, Baton Rouge, La on May 9, 2002. He has necrotizing enterocolitis and other long-term health issues caused by his being fed Similac and/or Enfamil cow milk-based products after his birth.
  • January 15, 2023 – β-glucan protects mice from NEC by inhibiting intestinal inflammation and improving the gut barrier.
  • December 1, 2022: Long-term Outcomes of NEC & Spontaneous Intestinal Peforation — National Library of Medicine – National Center for Biotechnology.
  • November 16, 2022 – Families express their grief to raise awareness about a NEC.
  • October 1, 2022 – Prenatal steroids may improve NEC survival, reduce complications.
  • September 1, 2022 – Doctors hopeful new lab work may have found NEC causes.
  • August 1, 2022 – Human milk oligosaccharide composition predicts risk of NEC.
  • July 24, 2022 – Stanford Children’s Health publishes: NEC in the Newborn.
  • July 12, 2022 – The administering of amnion-derived multipotent cell secretome ST266 helps protect against necrotizing enterocolitis in piglets & mice.
  • July 1, 2022 – NEC New Study: Variability in antibiotic duration for necrotizing enterocolitis and outcomes in a large multicenter cohort.
  • June 19, 2022 – National Library of Medicine (The National Center for Biotechnology Information) – New NEC Study: Neurologic consequences of neonatal NEC Children who survive NEC have been shown to demonstrate neurodevelopmental delay.
  • June 12, 2022 – Donor-dependent fecal microbiota transplantation effectiveness against necrotizing enterocolitis in preterm pigs. The development of NEC, a life-threatening inflammatory bowel disease affecting preterm infants, is associated with gut microbiota dysbiosis. NEC is a terrible intestinal inflammation disease primarily affecting infants born preterm with an incidence of up to 7%.
  • June 9, 2022 – National Library of Medicine (National Center for Biotechnology Information) publishes a new NEC study: Evaluation of Risk and Preventive Factors for Necrotizing Enterocolitis in Premature Newborns. A Systematic Review of the Literature.
  • May 19, 2022 – The National Library of Medicine (National Center for Biotechnology Information) publishes a new study: NEC in Very Low Birth Weight Neonates.
  • May 16, 2022 – The FDA issues Powdered Infant Formula Recall – What You Need to Know – Don’t use recalled Similac and Alimentum infant formulas made in Sturgis, MI.
  • February 18, 2022 – FDA warns against powdered infant formula. Abbott recalls products. Three types of baby formula recalled following bacterial infection reports.
  • February 1, 2022 – National Cancer Institute: Probiotics were used for the prevention of NEC in premature infants.
  • January 20, 2022 – In a cohort study, Probiotic Bifidobacterium infantis EVC001, a type of strain of bacteria, was associated with a 73% reduction in NEC.
  • January 1, 2022 – U.S. Dept. of HHS updated NEC causes.
  • A lawsuit complaint was filed in the U.S. District Court for the Eastern District of California on May 14, 2021 by Alicia Restad and Daniel Renteria-Hernandez. The suit alleges Abbott Laboratories and Mead Johnson & Company, LLC are responsible for the death of their newborn child, Daniel Renteria-Hernandez. Born premature on April 29, 2019 at Dignity Hospital in Merced, California, he was immediately placed in the Neonatal Intensive Care Unit (NICU) at Valley Children’s Hospital. Daniel died at 16 days from NEC. His parents allege the death was caused by the Similac fed to him during his short life.
  • December 16, 2021 –  Illinois woman Shandria White claims the makers of Similac and Enfamil formula failed to warn about the risks of premature infants developing NEC after being fed the cow’s milk-based products.
  • November 2, 2021 – Tylea Hundley, born prematurely, developed NEC, an intestinal disease, and died. Hundley’s estate administrator sued the producers of three infant formulas which doctors at Yale New Haven Hospital had fed Tylea before she died: Mead Johnson & Company, Mead Johnson Nutrition Company, Abbott Laboratories, Inc. for violating Connecticut Product Liability law.

NEC Risk Factors

NEC cases most often occur in premature infants born under 32 weeks or underweight.

Other risk factors include:

  • Antibiotic treatment for more than 10 days
  • Abnormal Doppler test (placenta to fetus blood flow test)
  • Congenital heart disease
  • Enteral feeding
  • Ingestion of cow’s milk-based formulas

NEC Lawsuits name Abbott Labs and Mead Johnson

Abbott Laboratories and Mead Johnson & Company, two of the country’s most prominent formula producers, are named in most of the NEC lawsuit petitions. The complaints claim Abbot Laboratories’ Similac and Mead Johnson’s Enfamil should have carried warning labels to alert parents to NEC dangers. Plaintiffs in these lawsuits claim both knew of the risks yet failed to act on the knowledge, which may have caused serious injury and even killed some preterm babies. Litigation on these cases has only just commenced. More parents with injured infants are expected to come forward with suits.

What is Necrotizing Enterocolitis (NEC)?

NEC is a gastrointestinal disease that causes inflammation and intestinal perforations which can lead to more problems as bacteria leaks through the holes and stomach into the bloodstream. While NEC is considered to be a serious illness, its symptoms can range from “mild” to severe and even life-threatening.

NEC Diagnosis and Treatment  

NEC symptoms usually manifest in the first two weeks of life. Since NEC is linked to preterm babies (particularly with low birthweight), doctors are expected to monitor infants in that category for symptoms: blood in the stool, lethargy, vomiting, stomach swelling.

Not all symptoms are apparent. An X-ray of the infant is usually required for a definitive diagnosis. The X-ray can show signs such as intestinal damage or air in liver veins. Doctors might also use a needle to look for signs of abdominal fluid, which is a sign of intestinal perforation. Stool samples and blood tests can also help determine a diagnosis. Since NEC can range in severity, treatment depends on many factors that include the infant’s age, relative health, and strength. Treatment options greatly vary. They range from IV feeding, stopping feeding and giving antibiotics, or removing the intestine or bowels.

RELATED

  • Infant Formula Lawsuit
  • Abbott recalls Similac Infant Formula
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