A few months ago, I shared a Blog Post regarding the Mead Johnson / Reckitt / Enfamil verdict in a NEC lawsuit case: Enfamil / Reckitt / Mead Johnson was recently sued relating to a case of NEC (Necrotizing enterocolitis) - a very serious medical condition that is most often associated with premature infants. Breastfeeding has shown to reduce the risk of NEC in infants. & while this lawsuit was far from the first of it’s kind, one first did occur here... the Plaintiff won. "Enfamil sued in NEC case- Plaintiff awarded $60 million from Reckitt; What Is NEC and What Does This Mean?!"
Necrotizing enterocolitis (NEC) is a serious medical condition that primarily affects premature infants, although it can also occur in full-term infants. It is characterized by inflammation and necrosis (tissue death) of the intestine, particularly the colon and sometimes the small intestine.
Here are some key points about NEC:
Risk Factors: Premature birth is the most significant risk factor for NEC. Infants born prematurely, especially those with very low birth weights, are at the highest risk. Other factors that may contribute to the development of NEC include formula feeding, bacterial colonization of the intestine, and a compromised immune system.
Symptoms: Symptoms of NEC can vary but often include feeding intolerance, abdominal distension, vomiting, diarrhea (which may be bloody), lethargy, temperature instability (hypothermia or fever), and signs of systemic illness such as apnea or bradycardia (slowed heart rate).
Diagnosis: Diagnosis is typically based on clinical symptoms, laboratory tests, and imaging studies such as abdominal X-rays or ultrasounds. In some cases, a diagnosis may be confirmed by examining a sample of intestinal tissue obtained through surgery or a procedure called pneumatosis intestinalis.
Treatment: Treatment for NEC often involves stopping enteral feeding (feeding through the stomach or intestine) and providing intravenous fluids to maintain hydration. Antibiotics are usually administered to treat or prevent bacterial infection. In severe cases, surgery may be necessary to remove necrotic bowel tissue or to repair perforations.
Complications: NEC can lead to serious complications such as intestinal perforation (a hole in the intestine), peritonitis (inflammation of the abdominal lining), sepsis (bloodstream infection), and short bowel syndrome (a condition where insufficient bowel remains for adequate nutrient absorption). These complications can be life-threatening.
Prevention: Strategies to reduce the risk of NEC include promoting breastfeeding, minimizing exposure to unnecessary antibiotics, practicing careful hand hygiene in neonatal units, and avoiding overfeeding or feeding too rapidly.
The causes of Necrotizing Enterocolitis (NEC) can be complex, involving factors like prematurity, intestinal immaturity, reduced blood flow to the intestines, bacterial colonization, and feeding practices. The exact relationship between these factors varies among infants, making it hard to identify a single cause for the condition. This complexity adds challenges to understanding and preventing NEC. It remains a significant issue in premature infants, despite advances in neonatal care. Early recognition and prompt treatment are crucial for improving outcomes.
So Mead Johnson was ordered to pay $60 million in March 2024. In most of these cases, the lawsuits allege that the company failed to warn them of the potential increased risks of NEC in premature infants who consume cow's milk-based formula
& Now,
Abbott / Similac has been ordered to ordered to pay $95 million in compensatory damages and $400 million in punitive damages. A total of $495 million.
A lawsuit was filed in St. Louis on behalf of a child who developed necrotizing enterocolitis (NEC). Now 3 years old, the child has spastic quadriplegic cerebral palsy due to a massive brain injury caused by NEC, is unable to walk or talk, and is fed through a tube. At the time, the child had consumed Abbott's formula.
The suit claims that Abbott was aware of the increased risks of NEC in premature infants who consume cow's milk-based formula but failed to provide adequate warnings. The verdict came through on Friday, July 26.
Something I noticed that felt important in this picture as we move forward..
The jury verdict was not unanimous, and was supported by 9 of the 12 jurors in the case. To return a verdict in a civil case in Missouri, three-fourths of jurors must agree.
The NEC Society Statement on Mead Johnson / Enfamil Verdict + My Personal Thoughts on Both Verdicts
The NEC Society released a statement on the Enfamil / Mead Johnson verdict in April 2024, and it felt like the perfect mix of understanding, empathy, and acknowledgement + concern, frustration, and fear. A mix of emotions that I personally feel regarding this situation as well. While I can truly understand the reasoning behind the lawsuit, my concern regarding medical practices is very real. When we see verdicts like this, it leaves medical practitioners stuck in a tough position. While efforts are most always made to use breastmilk in NICU, there ARE scenarios in which this may not be the feeding route taken. Placing such blame solely on the infant formula is concerning because if an infant does need to use this, it leaves healthcare practitioners fearful.
Even more concerning to me in this case... Only 9 out of 12 jurors agreed with the Abbott verdict. Meaning it only takes 3/4 of a group of citizens to potentially change to trajectory of infant feeding - maybe in a good way? Or... maybe not...
NEC Society Statement from April 2024:
"The NEC Society is the leading nonprofit working to accelerate the science and prevent this disease. "NEC is a complex, multifactorial disease. There is no single cause, no clear etiology, no cure, and no known way to eliminate the risks of NEC for medically fragile infants. We are working tirelessly to advance equity for babies. We are committed to revealing why, even with the protection of MOM and PDHM, some babies still tragically develop and die from NEC. The NEC Society is compelled to advance the science so we can prevent this devastating disease."
"With or without MOM or PDHM, premature and medically fragile infants must receive adequate nutrition to support their complex and exceptional nutritional needs. The ICU is inherently risky for infants, and NEC is one of many devastating health risks. In the ICU, feeding decisions are medical decisions. It is imperative for medical decisions to be made by those who practice medicine in partnership with patient families. The medical team, in collaboration with patient-families, should decide how babies are fed in the ICU. These medical feeding decisions aim to protect against NEC while providing optimal nutrition for discharge and long-term health outcomes. 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. Moreover, such litigation may result in unintended harmful consequences for babies and the elimination of potentially beneficial therapy choices. Accordingly, the NEC Society does not use or support litigation to influence medical care decisions"
I must say, it does create a concern...
In a very similar scenario, this topic of concern was also brought up during the FDA Oversight Congressional Hearing! There is a very fine line when it comes to healthcare and the courts system... and it feels like we are flirting with it a bit too often..
Quick NEC Overview
Risk Factors: Premature birth is the most significant risk factor for NEC. Infants born prematurely, especially those with very low birth weights, are at the highest risk. Other factors that may contribute to the development of NEC include formula feeding, bacterial colonization of the intestine, and a compromised immune system.
Prevention: Strategies to reduce the risk of NEC include promoting breastfeeding, minimizing exposure to unnecessary antibiotics, practicing careful hand hygiene in neonatal units, and avoiding overfeeding or feeding too rapidly.
Several studies have demonstrated the protective effects of breastfeeding against NEC. Infants who are exclusively breastfed or receive predominantly breast milk have been shown to have a lower incidence of NEC compared to those who are formula-fed. Additionally, the duration of breastfeeding may also play a role, with longer durations of breastfeeding associated with a decreased risk of NEC. In neonatal intensive care units (NICUs), efforts are often made to support and promote breastfeeding among premature infants as part of NEC prevention strategies. However, it's essential to acknowledge that breastfeeding may not always be feasible for all infants, particularly those who are critically ill or have specific medical conditions. In such cases, pasteurized donor human milk may be considered as an alternative to formula feeding to provide some of the protective benefits of breast milk.
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Jessica Enderle, R.D., L.D.
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