Lawsuit Update Center
If your premature baby died or suffered serious injuries from necrotizing enterocolitis (NEC) after being fed with formula such as Enfamil or Similac, you may be able to file a product liability lawsuit and get financial compensation.
Infant formula made from cow milk has been linked to NEC, and there is evidence that the formula companies knew about this link but negligently failed to warn consumers and doctors about it.
About Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis (NEC) is a serious and potentially life-threatening condition that primarily affects premature infants. It occurs when harmful bacteria invade the intestinal wall, leading to inflammation and infection. This bacterial invasion can severely damage the intestinal tissue, weakening the wall and potentially causing a tear or perforation. When this happens, bacteria may leak into the abdominal cavity, resulting in further complications.
Essentially, NEC causes the lining of the baby’s intestines to become inflamed, and in severe cases, parts of the intestinal tissue may begin to die. If not promptly treated, the disease can lead to a hole in the intestine and, ultimately, partial or complete destruction of the bowel. Such complications can interfere with the baby’s oxygen supply to vital organs, which may result in permanent and serious injuries.
Why is litigation focused on premature infants? NEC disproportionately affects premature babies, especially those fed formula instead of breast milk—although it can also occur in breastfed infants. While the exact cause of NEC remains unclear, it is widely believed to involve an imbalance of bacteria in the baby’s gut. This increased risk in formula-fed preemies has been known for some time, forming the basis for ongoing litigation.
NEC Treatment and Prognosis
The long-term outlook for infants diagnosed with NEC depends on the severity of the condition and whether surgical intervention was necessary. Survivors may face chronic complications such as short bowel syndrome, developmental delays, and growth problems. Preventive measures include encouraging the use of breast milk, closely monitoring feeding tolerance, and using antibiotics cautiously.
Whenever NEC is first suspected in a premature infant, all oral formula feedings are immediately stopped and a strong course of antibiotics is administered. Nutrients are given by IV while the infection is treated.
In many cases, NEC causes tissue in the infant’s intestine to decay and eventually die. When this occurs, surgery is required to take out the dead tissue sections. Even when this surgery is successful, it can leave the baby with long-term consequences such as “short gut” syndrome.
Short Gut Syndrome
Short gut syndrome (also called short bowel syndrome) is a condition that occurs when a significant portion of the small intestine is missing or has been surgically removed. This part of the digestive tract is responsible for absorbing most of the nutrients and fluids from food. When there’s not enough intestine left, the body can’t absorb what it needs to grow, heal, and function properly.
Babies with short gut syndrome may struggle with malnutrition, dehydration, and failure to thrive. They often require specialized nutrition support, such as intravenous feeding (TPN) or feeding tubes, and long-term care from a team of specialists. While some children adapt over time as their remaining intestine “learns” to absorb more, others may need a bowel transplant in severe cases.
NEC Mortality Rate
Over half of all infants who develop NEC will require surgical treatment (usually to remove decayed intestinal tissue). Even when NEC is diagnosed right away and treatment is immediate, the outlook for this disease is very grim. Nearly 4 out of every 10 babies who develop NEC will die.
NEC Can Be Caused By Cow Milk Based Formula
There is growing scientific and medical evidence linking necrotizing enterocolitis (NEC) to the use of cow’s milk-based infant formula, especially in premature infants.
Multiple studies have shown that premature infants fed cow’s milk-based formula are at a significantly higher risk of developing NEC compared to those fed human breast milk or donor milk. A landmark 1990 study published in The Lancet found that preterm infants fed formula were 6 to 10 times more likely to develop NEC than those who were exclusively breastfed. More recently, in 2021, a pair of studies published in major medical journals found clear evidence that premature infants fed with cow milk formula have a significantly higher risk of NEC.
Cow’s milk contains proteins that can trigger an immune response and disrupt the delicate balance of gut bacteria in premature infants. This increases the risk of inflammation and tissue damage in the intestines—key contributors to NEC. Premature infants have underdeveloped digestive systems, making it difficult for them to properly digest cow’s milk proteins. This impaired digestion can contribute to bacterial overgrowth and inflammation.
Human breast milk contains protective antibodies, anti-inflammatory compounds, and beneficial bacteria that help support gut health and immune function. It has been shown to reduce the risk and severity of NEC compared to cow’s milk-based formula.
NEC Formula Product Liability Lawsuits
In addition to the scientific evidence showing a link between cow milk infant formulas and NEC, there is mounting evidence indicating that formula manufacturers knew that their products could cause NEC but failed to warn anyone about that risk. The two primary manufacturers of infant formula in the U.S. are Abbott Laboratories and Mead Johnson Nutrition.
Abbott Laboratories (“Abbott”) manufactures the Similac brand of infant formula, while Mead Johnson makes the Enfamil brand of baby formula. Nearly all of the Similac and Enfamil formula products are derived from cow’s milk. Product manufacturers have a legal duty to warn consumers about known hazards associated with their products. Abbott and Mead Johnson had an obligation to warn that Enfamil put premature infants at high risk for NEC.
Despite being aware of evidence linking formula to NEC in premature babies, both companies ignored their obligation to warn consumers. They did this in order to maintain the marketability of their products.
The primary legal claim being asserted in the NEC formula lawsuits is negligent failure to warn based on the evidence that Abbott, Mead, and other manufacturers knew about the link between their products and NEC but chose not to put that on the product warning labels.
NEC Formula Litigation
Thousands of NEC formula product liability lawsuits have been filed across the country. Most of these cases have ended up in federal courts, but a large number of NEC lawsuits have also been brought in state court in Missouri.
The NEC formula cases in federal court have been consolidated into a “class action” MDL in the Northern District of Illinois. The NEC formula MDL currently has over 700 pending cases and the fact discovery phase is almost over. A group of 4 cases have been selected for bellwether test trials in the MDL and these cases are currently being prepared for trial.
In July 2024, the first NEC formula case went to trial in Missouri state court. The result was a $495 million verdict against Abbott. The verdict included $400 million in punitive damages and $95 million in compensatory damages. A second NEC formula case went to trial in Missouri and resulted in a defense verdict.
Bellwether Test Trials
4 cases have been selected and prepared for jury trials, known as bellwether trials. The first of these “test” trials is set to begin in a few months. The outcome of these bellwether trials will determine the future course of the litigation. Most mass torts get resolved in global settlements before the bellwether trial phase, but it looks like the defense team is going to roll the dice and try at least 1 or 2. Unfortunately, the first bellwether case scheduled to go to trial is a very weak case that favors the defense. The subsequent bellwether cases are much stronger.
Contact Us About NEC Formula Lawsuits
If you have a potential NEC formula lawsuit, contact our product liability lawyers today at 800-322-3010 or reach out to us online.
