Premature Babies at the Center of a Legal Storm Over Necrotizing Enterocolitis
A surge of NEC lawsuits against major infant nutrition companies has thrust necrotizing enterocolitis (NEC), a devastating intestinal disease primarily affecting premature infants, into the national spotlight. These legal battles allege that cow’s milk-based formulas increase the risk of this life-threatening condition, pitting grieving parents against multinational corporations in a high-stakes showdown that could reshape neonatal care practices.
5 Key Points
- Over 1,000 NEC lawsuits involving 7,000+ families filed against formula makers
- Plaintiffs allege cow’s milk-based formulas increase NEC risk in premature infants
- Companies defend their products as safe and essential for premature infant nutrition
- A recent $60 million verdict in favor of a mother who lost her child to NEC
- Debate over the companies’ duty to warn about potential NEC risks
A Tidal Wave of Litigation Floods Courts
The legal landscape surrounding NEC has dramatically shifted in recent years, with a deluge of lawsuits targeting major infant formula manufacturers like Mead Johnson and Abbott. These NEC lawsuits, now numbering over 1,000 and involving more than 7,000 families, claim that the companies’ cow’s milk-based formulas designed for premature infants substantially increase the risk of developing NEC compared to babies fed with human milk.
Ben Whiting, a partner at Keller Postman representing hundreds of plaintiffs in NEC lawsuits, articulates the core argument: “Our allegation is that these formula manufacturers should be, at minimum, warning moms, doctors, dietitians, nurses, and hospitals of the risk of this horrendous disease that comes with switching preterm infants from human milk to a cow’s milk-based formula.”
This wave of litigation spans across the United States, from Connecticut to California, with hundreds more cases pending in federal court. The sheer volume of cases underscores the widespread impact of NEC and the growing concern among parents and healthcare providers about the potential risks associated with specific infant formulas.
In March 2024, a landmark verdict in St. Clair County, Illinois, sent shockwaves through the infant nutrition industry. A jury awarded $60 million to Jasmine Watson, whose premature son Chance died from NEC after being fed Mead Johnson’s formula. This verdict, believed to be one of the most significant compensatory damages awards in the county’s history, has become a rallying point for plaintiffs in other NEC lawsuits and a cause for concern among formula manufacturers.
The details of the case are heart-wrenching. Chance Dean, born two months early, lived for just 25 days. Unable to produce enough breast milk, his mother initially opted for a combination of her own milk and donor breast milk. However, when transferred to a hospital where donor milk was unavailable, Chance was transitioned to a formula designed for premature infants. Ten days later, he developed NEC and died despite three urgent surgeries.
Stunned by the verdict, Mead Johnson stated they were “surprised and deeply disappointed” and vowed to pursue all options to overturn it. The company maintains that the allegations “were not supported by the science or experts in the medical community.” This case has become a flashpoint in the broader debate over the safety of cow’s milk-based formulas for premature infants and the adequacy of warnings provided to parents and healthcare providers.
Scientific Debate: Formulas Under Scrutiny
At the heart of these NEC lawsuits lies a complex scientific debate about necrotizing enterocolitis’s causes and risk factors. NEC is a multifaceted disease with no single known cause, but studies have consistently shown a higher occurrence in formula-fed preemies. The magnitude of this risk, however, varies widely in scientific literature.
A recent Journal of the American Medical Association study provides compelling data. The research followed 483 extremely preterm infants and found that twice as many formula-fed babies developed NEC compared to those fed only with donor milk (9.0% vs. 4.2%). While this study doesn’t prove causation, it adds to the growing evidence suggesting a link between cow’s milk-based formulas and increased NEC risk in premature infants.
Dr. Ravi Patel, a neonatologist at Children’s Healthcare of Atlanta who has been studying NEC for 14 years, explains the complexity of the issue: “NEC is a multifactorial disease. It’s not just any single factor we can pinpoint why babies develop NEC. We know that babies who only get breast milk are still at risk.”
Nutrition companies, however, argue that no published study has conclusively proven their products cause NEC. They contend that their formulas are “essential, safe, life-saving nutrition products” used successfully in NICUs for decades. This tension between scientific evidence and the companies’ stance forms a central point of contention in the ongoing NEC lawsuits.
Challenging Industry Practices: The Duty to Warn
A pivotal issue in these NEC lawsuits is whether formula manufacturers have a duty to warn parents directly about the potential risks associated with their products. This question cuts to the heart of corporate responsibility and consumer rights in neonatal care.
The formula companies argue that because their products are used under medical supervision, they should be treated similarly to prescription medications. In such cases, warnings are typically given to healthcare providers rather than patients directly. This principle, known as the “learned intermediary doctrine,” has been a cornerstone of their legal defense.
However, this argument has faced significant challenges in court. In at least three cases, judges have rejected the application of the learned intermediary doctrine to preterm infant formula. One judge articulated the reasoning behind this decision, stating that the formula “is not a recognized prescription medication or medical device.”
This legal interpretation could have far-reaching implications for the industry. If upheld, it would require formula manufacturers to communicate potential risks directly to parents, potentially changing the dynamics of decision-making in neonatal care.
Whiting, who represents plaintiffs in NEC lawsuits, argues for the importance of direct warnings: “At the end of the day, it’s the formula manufacturer—it’s their product. And so they are the ones that know the risks of using their product.” This stance reflects a growing demand for transparency and informed consent in medical decision-making, especially when it comes to the care of vulnerable premature infants.
Ripple Effects on Neonatal Care
The ongoing NEC lawsuits have sparked intense debate about their potential impact on neonatal care practices. Some experts worry that fear generated by these legal battles could lead to abrupt changes in feeding practices that may not necessarily benefit all premature infants.
The NEC Society, a nonprofit patient-led advocacy group, urged caution in response to the recent verdict: “Neonatal feeding decisions should be made at patients’ bedsides, not in courtrooms. Verdicts like the Watson case may prompt ICUs to reconsider their approaches to feeding neonatal patients, but not necessarily in a way that better protects infants from NEC.”
This sentiment reflects the complex reality of neonatal care, where decisions often involve balancing various risks and benefits. While human milk has been shown to reduce NEC risk, it’s not always available or sufficient to meet the nutritional needs of all premature infants. Formula, in many cases, plays a crucial role in ensuring adequate nutrition and growth.
Amy Gates, a pediatric nutrition specialist serving as Mead Johnson’s medical director, emphasized this: “Not every baby can sustain himself on just breast milk. And loss of access to these life-saving products would be a tragedy.” This perspective highlights the potential unintended consequences of the NEC lawsuits and the need for a nuanced approach to neonatal nutrition.
Future of Neonatal Care: NEC Lawsuits Set Stage for Change
As more NEC lawsuits progress through the courts, including the first case against Abbott set to begin trial, the legal and medical communities are closely watching for potential impacts on neonatal care practices, formula availability, and corporate liability in cases involving premature infants.
These cases highlight the complex interplay between scientific evidence, medical practice, corporate responsibility, and the legal system in addressing rare but devastating conditions like NEC. The outcomes of these lawsuits could reshape how we approach the nutrition and care of our most vulnerable infants.
For parents like Jasmine Watson, the hope is that these legal actions will lead to greater awareness and improved safety measures. “If I had known the risk of giving my children this formula, absolutely, I would have made a different decision,” she said. “I don’t want any other parents ever to have to go through that. I want them to know that you can ask questions. Make sure you understand.”
As the litigation unfolds, it may catalyze changes in how formula companies communicate risks, how hospitals approach feeding protocols for premature infants, and how the medical community balances formula with human milk in neonatal care. The resolution of these NEC lawsuits could mark a significant turning point in the ongoing effort to reduce the incidence of this devastating disease and improve outcomes for premature infants.
