What do parents need to know about the NEC baby formula lawsuit?
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calendar_month Jun, 20, 2024
In recent years, a growing number of lawsuits have been filed against baby formula manufacturers, alleging a dangerous link between their products and a life-threatening condition known as Necrotizing Enterocolitis (NEC). For parents, the news is both shocking and terrifying. How could something as essential as baby formula pose such a grave risk to their infants? In this article, we’ll explore the details of this lawsuits, the science behind NEC, and what it means for families and the future of infant nutrition.
NEC is a severe gastrointestinal disorder that predominantly affects preterm infants. The disease inflames the intestinal lining, causing damage. The pathogenesis of NEC involves bacterial intestinal inflammation, which in turn causes cell damage, colon necrosis, and cell death. With severe NEC, intestinal perforation may occur, justifying sepsis, peritonitis, and even death. NEC can also cause nonspecific symptoms, including vomiting, poor appetite, fatigue, and abdominal discomfort.
Mead Johnson & Company and Abbott Laboratories are two well-known brands of infant formula in the United States, producing Enfamil and Similac respectively. Similac and Enfamil appear to have similar effects on preterm infants in the development of necrotizing enterocolitis (NEC). According to research, preterm babies who consume these toxic baby formula products are predisposed to NEC at rates seven times higher compared with those fed only human milk. The elements of bovine milk-based nutrition products are capable of inducing an inflamed state among preterm infants thereby resulting in NEC. Breast milk, at the same time, contains antibodies, growth factors and immunocytes that may help prevent this syndrome. Premature newborns, especially those with a gestational age below 37 weeks or with a birth weight below 5.5 lbs are particularly susceptible to developing this condition.
The terrifying potential that Enfamil and Similac, two commonly used products, may be doing more damage than good is now facing parents who entrust these brands with their infants' nutritional needs. There is growing evidence linking the makers' formula to NEC, lawsuits filed against them claim they did not provide enough warning about the risks involved. Both names, long mainstays in the baby formula industry, are now under close examination.
The makers of these formulas are accused in the NEC baby formula lawsuits of knowing about the dangers of NEC but neglecting to warn about any potential risks involved in using them. They have not included enough warnings about potential dangers in their products. It is unknown whether medical facilities, physicians, or other healthcare providers knew about the risks or not, making it impossible for them to have alerted stressed-out parents about the same. Even the FDA website advises against giving cow milk-based formula to preterm babies.
Nevada’s NEC complaint was originally filed in Illinois state court, and an MDL judge upheld that decision in a recent ruling. This story is a traditional NEC story. A premature baby who was given Mead's formula at a hospital in Nevada was diagnosed with a non-essential cerebral edema and underwent major surgery, including a bowel removal. The background is that, based on the assumption that Mead established its principal office in Illinois, NEC initially filed the complaint in federal court where Mead sued in federal court in Nevada, but later moved back to Illinois for pretrial consolidation in MDL No. 3026.
Two years after the lawsuit, plaintiff NEC's counsel discovered new information, raising the possibility that plaintiff's child was negligently treated by Nevada physicians. Due to lack of diversity, this led to an amendment to the case to include these employees as defendants and to send the case back to state court. Around August 2023, a federal judge granted a motion to pursue punitive damages against Abbott Laboratories. Punitive damages are rarely available to plaintiffs in civil proceedings; instead, they are only awarded only in extreme circumstances, when the intention is to punish the aggrieved party and serve as a deterrent to future similar actions.
In this instance, the plaintiff claimed Abbott Laboratories purposefully concealed or omitted crucial information regarding the dangers of providing Similac to newborns from both its clients and the medical community. The plaintiff's child suffered terrible, lifelong injuries as a result.
50 new NEC preterm infant formula cases in December 2023 were added to the class action MDL, marking one of the highest monthly new case volumes ever seen in this MDL. Whether this surge indicates the beginning of a trend remains to be seen in upcoming cases. As of January 2024, there were 342 cases pending in the MDL. This MDL has gained traction in recent months, and new cases may increase more rapidly by 2024.
These problems go back many years, as demonstrated by a case filed by the NEC last week in May, 2024. In this instance, a baby was born at 32 weeks and 6 days gestation at Children’s Memorial Hermann Hospital in Houston, Texas on May 29, 2004. The newborn weighed less than six pounds, and was placed on D10W with minimal medication. The baby was fed Enfamil Premature 20, a cow’s milk formula, continuously. The baby was intubated from June 3 to June 7, 2004, due to abdominal distension, infection, and respiratory failure. The baby was then placed in the NICU at Texas Children's Hospital for permanent care, where he remained till July 23, 2004, until he was discharged. The lawsuit holds the formula producers liable for the serious health issues that resulted, claiming that the infant's mother was unaware that the cow's milk-based formula may induce NEC.
Keller Postman, a leading law firm won a historic $60 million jury award on March 14, 2024, in the first trial in which formula producers based on cow's milk were held liable for inducing NEC in premature infants. At St. Clair, an Illinois jury unanimously decided in its client’s (Watson family's) favour in this historic case, establishing that Mead Johnson's Enfamil toxic baby formula was the reason behind her son's untimely death from NEC. This win not only gives the Watson family substantial compensation, but it also establishes a standard for holding product manufacturers responsible for their safety.
As of May 2024, 496 lawsuits alleging NEC in infant formula were pending in multidistrict litigation. In the Northern District of Illinois, MDL 3026 is in front of U.S. District Judge Rebecca Pallmeyer. The legal process is still in its early phases, and no jury verdicts or accepted settlements have been reached.
Stay tuned as we continue to monitor and report on this critical issue. Your baby's health is paramount, and together, we can advocate for the changes needed to protect our most vulnerable.
