Studies and lawsuits are connecting necrotizing enterocolitis (NEC)—a potentially fatal condition significantly affecting preterm infants—with cow’s milk formula.
Necrotizing Enterocolitis Explained
NEC is a leading cause of illness among the 480,000 preterm infants born each year in the United States. The National Institute For Child Health and Development estimates that NEC strikes 9,000 newborns annually, with about 9 percent of the cases presenting in full-term babies.
The mortality rate for this rapidly progressing condition can be as high as 40 percent. NEC is a complex issue—symptoms appear suddenly, and progress rapidly,
In just a matter of a few hours, a seemingly thriving preemie may develop a hardened or distended abdomen, bloody stools, diarrhea, vomiting, lethargy, a low heart rate, and respiratory difficulties.
Additional findings may include:
- Abnormal radiological studies
- A low platelet count
- Poor feeding
- Discoloration of the skin on the abdomen
- The inability to maintain a stable body temperature
- A sudden drop in blood pressure
A portion of NEC cases may occur a few days following a blood transfusion given due to bleeding before delivery, anemia( low birth weight infants are at high risk for anemia), or an infection. The International Society of Blood Transfusion reports about one-third of pre-term babies receives blood transfusions.
Infection control plays an important part in reducing NEC cases in hospitals and medical clinics. A report in the Journal of Pediatrics details a connection between NEC cases and norovirus. NEC is not contagious, but the bacteria and viruses that may cause NEC are.
Term infant NEC
NEC in a full-term baby is rare except in an infant with a congenital heart defect or with gastroschisis (a birth defect of the abdominal wall where the intestines are outside the body.) Insufficient oxygen during delivery can also contribute to NEC.
The Causes of NEC
Among the known risk factors of premature birth are:
- A previous history of a preterm birth
- Multiple miscarriages or pregnancy terminations
- Pregnancy with multiples
- Lifestyle indicators such as substance abuse, smoking, and being over or under ideal weight
- Conceiving through in vitro fertilization
- High blood pressure
- Stressful event
In addition to premature birth, or low birth weight, medical experts believe that these scenarios may pose risk factors for contracting NEC:
- Oxygen deprivation during delivery
- Insufficient oxygenation following delivery
- Undeveloped gastrointestinal tract
- The use of cow’s milk-based formula
- Too many red blood cells
- An injury to the intestines
- A viral or bacterial infection
Symptoms Of NEC
Found primarily in premature formula-fed infants within the first few weeks of birth, symptoms include:
- Hardening of the abdomen and swelling
- Bloody stools
- Changes in heart rate and blood pressure
- Respiratory distress
- Changes in body temperature
- Feeding intolerance
- Lack of weight gain
Heightened vigilance, timely diagnosis, and prompt treatment are paramount for infant survival. Radiology studies and blood tests may help a physician definitively diagnose the condition. An X-ray will reveal air bubbles in the veins leading to the liver and abdominal cavity, while blood studies will count platelets and white blood cells. One additional test is to place a needle into the abdominal cavity to check for intestinal fluid—a sure sign of a hole in the intestine.
A treating physician can reduce the possibility of NEC. While we cannot eliminate all the risk factors of NEC, some strategies may help.
Some experts believe that the components of some infant formulas can cause necrotizing enterocolitis. Research indicates increasing the availability and use of human milk feeding alone could cut NEC by half.
Every case of NEC is distinct.
Treatment options will likely depend on the particular circumstances, such as:
- The gestational age of the child
- The presenting symptoms and the extent and severity of each
- Other pertinent medical conditions
The first line of treatments is typically non-surgical if there is no evidence of intestinal perforation.
These might include:
- Using intravenous feeding rather than normal feeding
- The use of a nasogastric tube to remove air from the stomach
- Antibiotic therapy
- Frequent blood tests to check for infection
- Supplemental oxygen or a respirator
- Blood transfusion
Your baby may need surgery if less-invasive medical intervention fails or doctors find a bowel perforation. Doctors may remove the diseased portion of the intestine.
Infants who survive NEC face a likelihood of neurological and developmental issues, nutritional challenges, and other complications such as:
- An abdominal infection
- Intestinal stricture
- Short bowel syndrome—a condition making it difficult for the body to absorb nutrients
The Feasibility of Pursuing Legal Action
It is hard to push emotions aside when dealing with the health, welfare, and possibly the life of a preterm or low birth weight infant. More often than not, the first time parents hear about NEC is when they confront the dire condition of their newborn.
When an infant succumbs to a medical condition or suffers permanent injury because of medical negligence or a manufacturer’s failed responsibility, however, a family may consider legal action. In cases of negligence, or product liability, compensation may include past and future medical bills, parents’ lost wages, and financial considerations for pain and suffering.
You might pursue litigation against healthcare providers that fail to diagnose NEC in time or fail to treat the condition appropriately. Manufacturers of cow’s milk-based formula products may be found liable for failure to provide sufficient warning about the correlation between their product(s) and NEC.
A Product Liability Lawsuit
Vague, misleading, or deceptive packaging, guidelines, instructions, or warnings on the formula that a doctor fed a premature infant can make a claim against the manufacturer of the product possible. A preterm baby that was given cow’s milk-based formula before being diagnosed with NEC, and then worsens, is one scenario that can lead to legal action and financial compensation.
Countless references to medical and academic research show a connection between cow’s milk-based formula, such as Enfamil and Similac, to NEC.
- In 1990 an article was published in The Lancet stating NEC was 6-10 times more common in formula-fed babies
- In 2009 an article in the Journal Of Pediatrics concluded in the case of premature infants, an exclusively human milk-based diet is associated with significantly lower rates of NEC and surgical NEC as compared to a diet of mother’s milk and a cow’s milk-based product.
- In 2016 an article published by Breastfeeding Medicine stated, “Extremely premature infants who received an exclusive HUM (Human) diet had a significantly lower incidence of NEC and mortality.”
And the list can go on and on. A manufacturer of infant formula should know about the dangers of offering certain products to preterm infants.
Yet, due to the preponderance of current litigation, it is likely they failed to warn medical professionals and consumers of the potential risks. Manufacturers still market products containing cow’s milk-based formula as safe and beneficial.
You might file product liability or wrongful death lawsuits against manufacturers of cow’s milk-based formulas, like Mead Johnson Nutrition Company (makers of Enfamil products) and Abbott Laboratories (makers of Similac products).
The evidence suggests that cow’s milk formulas endanger certain newborns, and if the manufacturer does not explicitly reveal this on the product label, deadly results can follow.
A Medical Negligence Lawsuit
This type of litigation can be complicated.
It is possible:
- A doctor gave a newborn a controversial product rather than mother’s breast milk, donor human milk, or non-cow’s-milk-based formula
- A doctor failed to inform the infant’s parents about the dangers of cow’s milk-based formulas for low birth weight babies
- Doctors failed to diagnose
- the infant’s condition
- Doctors misdiagnosed
- the infant’s condition
- Doctors failed to treat
- the infant’s condition in time
- Doctors failed to treat the infant’s condition by following acceptable standards
Any of these case scenarios can cause irreparable harm and may be actionable when a parent relies on the doctor’s skill and judgment.
Medical professionals must know the signs and symptoms of NEC, take precautions to prevent it from causing additional complications, and act quickly. If a physician, or another healthcare provider, fails to meet a standard of care in treating your preterm infant, you might hold them responsible.
In the case of a baby with the possibility of NEC, this may include:
- Stopping the feeding and changing to intravenous nutrition
- Inserting a nasogastric tube to alleviate pain and remove any air in the stomach
- Beginning antibiotic therapy
- Constant monitoring for any sign of infection
- The use of oxygen or a ventilator to assist with breathing
- A blood transfusion
When advising parents about the treatment options and risks of NEC, an overly confusing warning is not acceptable. When this happens, negligence and wrongful death claims and lawsuits may be possible.
Parents of a severely ill newborn have a right to expect:
- A detailed explanation of their child’s condition in terms they can understand
- Full disclosure of the proposed treatment, including potential risks and short and long-term complications
- The expected results and prognosis
- The availability and accessibility of alternative treatments
- What to expect without treatment
During an extremely stressful time, parents will need sufficient time to make an informed decision about their child’s care. Neonatal intensive care units are busy, but that is not an excuse for doctors failing to allow sufficient time to thoroughly explain the situation to the infant’s parents.
A neonatal physician must inform parents facing a difficult situation about the pros and cons of formula feeding and nutritional supplementation. Sadly, parents and their babies devastated by necrotizing enterocolitis know the incredible physical, financial, and emotional toll it takes on a family.
When this happens, a NEC baby formula lawsuit lawyer can help you hold the responsible parties accountable and empower you to ensure that other families don’t suffer the same tragedy you endured.