NEC Lawsuit: Premature Baby Formula Risks (November 2024)

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Sarah Edwards

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Reviewed By Adam Ramirez, J.D.

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Summary

  • Premature babies face many challenges, including nutrition
  • Preemies fed formula face a higher risk of necrotizing enterocolitis (NEC)
  • An NEC lawsuit must prove baby formula caused NEC

Pre-term babies do not have the time to mature like full-term babies. As a result, they must complete their development outside of the womb. This type of development raises many challenges because the child is no longer connected to the mother through the umbilical cord for nutrition, oxygen and antibodies.

Doctors and nurses cannot replicate the environment inside the womb. Instead, they have to try to protect and nurture the child in an incubator until they are strong enough to survive without intensive, around-the-clock care. One of the most significant challenges of this process is feeding. Pre-term babies often need gastric tubes because they cannot drink on their own.

Scientific evidence shows that preterm babies fed formula rather than breast milk have an increased risk for NEC. This condition happens when the intestinal tissue dies. Sadly, NEC is often fatal. The goal of an NEC lawsuit is to hold formula manufacturers responsible for causing this condition and the resulting death.

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Grounds for a Baby Formula Lawsuit

There are several risk factors for NEC, including the mother’s health, the baby’s birth weight and gestational age, and the post-birth care provided. Another factor is whether the child was fed baby formula or breast milk.

Pre-term babies have underdeveloped lungs, intestines and immune systems. Researchers believe that something in baby formula causes oxygen levels in the intestinal cells to drop. Since pre-term babies have underdeveloped lungs, they cannot take in enough oxygen to keep these cells alive.

Necrotizing enterocolitis means the intestinal cells die. Dead intestinal cells cannot absorb nutrients. They also cause infection. Since the preterm baby’s immune system has not fully developed, they cannot fight it.

Sadly, the result of the necrotizing enterocolitis baby formula may cause is often death. Specifically, this condition has a 50% mortality rate.

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NEC Lawsuit Challenges

The challenge faced by families when filing an Enfamil lawsuit or Similac lawsuit is proving causation. To win a product liability case, an NEC baby formula lawyer must prove that the baby formula caused the death and was not merely coincident with it.

In other words, there are many risk factors for NEC in preterm babies. To win a lawsuit, the family must prove that baby formula was a significant contributing factor to the death.

Manufacturers will likely point to two alternate explanations. First, the child’s weakened state might have meant that they would suffer NEC regardless of how or what they were fed. To counter this argument, the lawyer would identify a medical expert who can testify that the risk of NEC is significantly higher for formula-fed preemies than breast-fed preemies.

Second, manufacturers might try to shift blame to hospitals, doctors and nurses. They could argue that the risk factors for NEC are well known. They would assert they are not responsible when healthcare providers feed formula to preterm babies despite the known risks and that these cases fall under medical malpractice statistics rather than product liability statistics.

The product liability attorney can counter in two ways. First, the lawyer will often include the hospital and doctors in the NEC lawsuit. Fortunately, many injury attorneys have experience as medical malpractice lawyers. Second, the lawyer could point to the lack of warnings provided by formula manufacturers against the use for preterm babies.

NEC Lawsuit Update

Rather than starting an NEC class action lawsuit, plaintiffs have focused on filing individual lawsuits. These lawsuits have been consolidated into a multidistrict litigation (MDL) in the Northern District of Illinois. The distinction between class actions and MDLs is important.

How to start a class action lawsuit? A class representative gathers class members and has a court certify that the number of class members with similar facts and legal claims makes it more efficient to have only a single lawsuit.

An MDL starts after numerous individual plaintiffs have filed lawsuits and the courts determine that they should share procedural resources in a single district. In the NEC case, all NEC lawsuits are handled in the Northern District of Illinois. They share resources when gathering discovery and handling motions. However, they retain their individual trial dates and compensation claims.

The NEC MDL has proceeded almost to the end of discovery. This means the plaintiffs have collected relevant evidence from the formula manufacturers. They have also turned over their expert witness reports to the manufacturers. The parties have also chosen which cases will reach trial in 2025.

These trials, referred to as bellwether trials, help the parties determine the value of the claims. This, in turn, will spur settlement negotiations.

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Possible NEC Settlement Amounts

There is no sign that the formula makers are ready to offer a global settlement in the MDL. However, a recent verdict in a non-MDL NEC case might push them toward settlement. A family in Missouri won a $495 million verdict against Abbott Labs for NEC. However, that case involved a Similac formula that was specifically marketed for feeding preterm babies.

Contact ConsumerShield for More Information

Losing a child due to someone else’s actions is highly traumatic. ConsumerShield supports your efforts to hold someone responsible. Contact us for a free case evaluation and a referral for legal representation.

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Frequently Asked Questions

  • An NEC lawsuit is a case filed against formula manufacturers and, in some cases, doctors and hospitals, for injury or death to a preterm baby resulting from formula feeding. The Northern District of Illinois is overseeing an MDL involving all federal cases filed against formula makers.


  • The statute of limitations for an NEC lawsuit depends on your state. State law determines the statute of limitations for product liability and medical malpractice cases. Consider speaking to a lawyer quickly if you believe you have a claim against formula makers for NEC because some states have short deadlines.


  • No, Enfamil does not kill babies. However, research shows that feeding formula to preterm babies increases the risk of NEC compared to breastfeeding. Lawsuits allege two types of claims. First, manufacturers should warn against use for preterm babies. Second, doctors should know not to feed formula to preterm babies.


  • Several individual lawsuits have reached trial, resulting in verdicts for families. The first trials in the NEC MDL are scheduled for 2025. Once the manufacturers know the scope of their exposure, they will probably begin to negotiate a global settlement. This settlement will cover any plaintiffs who elect to join.


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