What is the NEC Lawsuit?

Babies that are born prematurely, before 37 weeks, may receive infant formula as recommended by a doctor to help them grow and develop. Should these babies develop NEC, however, parents may be able to hold infant formula manufacturers liable for the damages.

Studies have shown that premature infants who are fed infant formula may have a higher risk of NEC than babies who receive human milk. Infant formula manufacturers have not provided adequate warnings about this risk to doctors or parents. Doctors may believe they are helping premature babies by feeding them infant formula when in truth they could be putting them at risk of a very serious bacterial disease.

NEC is not only frightening and difficult, but it can leave parents with significant medical bills. Filing an NEC lawsuit can help them recover damages while holding manufacturers responsible for their negligence.

What Formulas are in the NEC Lawsuit?

Any infant formula that is fed to a premature infant may be the subject of an NEC lawsuit. Currently, the most common ones that are used in hospital settings include:

• Similac (Abbot Laboratories)
  • Similac NeoSure
  • Similac Alimentum Expert Care
  • Similac Liquid Protein Fortifier
  • Similac Human Milk Fortifier
  • Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
  • Similac Special Care 20
  • Similac Special Care 24
  • Similac Special Care 24 High Protein
  • Similac Special Care 30
• Enfamil (Mead Johnson)
  • Enfamil NeoPro EnfaCare Infant Formula
  • Enfamil Premature Infant Formula 20 Cal with Iron
  • Enfamil 24 Cal Infant Formula
  • Enfamil Premature Infant Formula 24 Cal High Protein
  • Enfamil Premature Infant Formula 24 Cal with Iron
  • Enfamil Premature Infant Formula 30 Cal with Iron
  • Enfamil Human Milk Fortifier

Is There a Lawsuit on Baby Formula?

Currently, several baby formula lawsuits are pending in courts across the country, and every week, new ones are filed. As parents become more aware of the connection between infant formula and NEC, more are seeking compensation for their child’s medical bills, pain, and suffering.

These lawsuits all consist of common questions of fact, mainly, the question of whether infant formula manufacturers acted negligently when it comes to their infant formula products. It’s the manufacture’s responsibility to properly study their products and to warn doctors and parents of any health risks that may be associated with them.

As far back as 1990, there was scientific literature connecting infant formula with an increased risk of NEC in premature infants. Yet the manufacturers failed to alert doctors to this issue, and still haven’t to this day. Instead, they market their products as made to help premature babies.

Some parents have already filed and settled NEC lawsuits, but they typically sued the doctors and/or hospitals where their babies were treated. It has become clear over time, however, that many doctors were unaware of the link between infant formula and NEC, mainly because the manufacturers failed to alert them to the issue.

Today, parents are filing cases against the manufacturers. If the juries agree that the evidence shows these companies were negligent, parents may be able to win not only compensatory but punitive awards as well. It is also our goal to hold these manufacturers responsible for their actions, they will add the warnings needed on their products to prevent any more babies from falling victim to infant-formula-induced NEC.

How is Baby Formula Linked to Necrotizing Enterocolitis (NEC)?

Several studies have suggested that premature infants fed formula are more likely to develop NEC than those who are breastfed.

Researchers pointed out this connection as early as 1990, which is surprising to many parents. Why, then, didn’t the infant formula manufacturers do something back then to make their formulas safer for premature infants?

In a 1990 study published in The Lancet, scientists found that in exclusively formula-fed babies, NEC was 6-10 times more common than in those fed breast milk alone, and three times more common in those who received formula plus breast milk.

Among babies born at more than 30 weeks gestation, NEC was rare in those whose diet included breast milk, yet it was 20 times more common in those fed formula only. The researchers concluded that “exclusive formula feeding could account for an estimated 500 extra cases of necrotizing enterocolitis each year. About 100 of these infants would die.”

What is Necrotizing Enterocolitis (NEC)?

Necrotizing enterocolitis (NEC) is a bacterial disease that infects, inflames, damages, and kills the cells in parts or all of the intestines. This destroys the wall of the intestine and can create cracks or gaps that allow bad bacteria to leak into the abdomen, worsening the infection and sometimes leading to death.

NEC is rare overall, affecting only about one in 2,000 to 4,000 births. But studies have found that it’s more common in premature infants fed cow’s milk-based infant formula. Doctors aren’t sure why, but believe it has to do with the fact that premature babies have underdeveloped, immature bowels that are sensitive to infection.

Research has also found that if the baby has one or more of these characteristics, they may have an increased risk for the disease:

• Premature and weighs less than 3.25 pounds
• Fed infant formula by mouth or tube
• Has an existing gastrointestinal infection
• Has too many red blood cells in circulation
• Experienced a difficult delivery
• Has lowered oxygen levels
• Is seriously ill

The disease typically develops within the first two weeks, usually, after feeding has begun, and creates the following symptoms:

• Swollen or bloated belly
• Green fluid in the stomach or green vomiting
• Feedings that remain in the stomach and don’t flow through the intestines
• Bloody stool
• Trouble breathing
• Low heart rate
• Sluggishness
• Temperature instability

More Studies Suggest Infant Formula Increases Risk of NEC

In a later study, scientists compared over 1,500 premature babies fed cow’s milk-based formula with those fed breastmilk. Those fed breastmilk exclusively had a significantly lower incidence of NEC and mortality.

In another study, researchers reported that the risk of NEC “is increased by the administration of infant formula and decreased by the administration of breast milk.” They suggested that breast milk “may serve to protect against NEC….”

In 2011, Johns Hopkins Medical Institutions found that extremely premature babies fed human donor milk were less likely to develop NEC than those fed a standard premature infant formula derived from cow’s milk. Specifically, only one of the 29 infants who received human milk developed NEC and recovered without surgery. Five of the 24 fed formula developed the disease, and four of them required surgery.

Indeed, the evidence keeps coming in. In 2015, researchers noted that there is a 50 percent reduction in the rate of NEC among extremely low birth weight infants receiving breastmilk only compared to those receiving breastmilk plus formula or formula alone. They added that human milk is better accepted in the infant’s body compared to formula.

And when researchers observed nearly 300 premature infants fed either breastmilk or formula, they found that consumption of higher amounts of mother’s milk in the first few days of life was associated with less infection, including NEC, and less death.

In 2017, researchers reported that NEC “affects 5-12 percent of very low birth-weight infants, leads to surgery in 20-40 percent of cases, and is fatal in 25-50 percent of cases.” They go on to state that the exact cause of NEC is not yet fully understood, but that different types of nutrition may affect its onset and progression, including infant formula. They suggest specialty formulas that are easier to digest and may help reduce the risk of NEC.

Finally, in a 2019 Cochrane review, researchers found that feeding premature infants with formula increases rates of growth during the hospital stay, “but is associated with a higher risk of developing the severe gut disorder called ‘necrotizing enterocolitis.’”

Why Would Infant Formula Increase the Risk of NEC?

As to why formula would increase risk, scientists aren’t sure, but they have some ideas. In a 2012 animal study, they found that infant formula, but not fresh breast milk, contains levels of free fatty acids (FFAs) that can be toxic to intestinal cells.

When subjects digested preterm infant formula, it caused significant death of certain types of cells in the gut.

Scientists also took a look at cow’s milk-based formula in the laboratory. In a 2010 study, they compared intestinal cells exposed to breastmilk to intestinal cells exposed to infant formula. They found that the formula significantly increased oxidation, cell damage, and cell death.

Scientists also note that because premature infants have immature intestines, their intestines can’t protect themselves as well as more developed infants. Whereas human milk is protective, reducing inflammation and bacterial invasion, cow’s milk may encourage the proliferation of damaging bacteria.

Indeed, in a 2004 study, scientists found that breastmilk was protective against inflammation, inhibiting pathways that would normally proceed to damage intestinal cells.

And in a 2020 Cochrane study, scientists noted that artificial formulas “do not contain the antibodies and other substances present in breast milk that protect the immature gut of preterm or low birth weight infants and reduce the risk of infection and severe bowel problems.”

Which Formulas Use Cow’s Milk as a Base?

Almost every major brand and store-brand equivalent infant formula offers a cow’s milk-based formula. These include:

• Similac
• Enfamil
• Earth’s Best
• Happy Baby
• Gerber
• Parent’s Choice
• Go & Grow
• Baby’s Only
• Loulouka
• Holle
• Kendamil
• Bobbie
• Lebenswert

Types of Potential Injuries to Premature Infants Associated with Infant Formula

Premature infants fed infant formula may be at risk for the following injuries:

• Necrotizing enterocolitis (NEC)
• Intestinal damage
• Ongoing digestive problems
• Intestinal failure
• Neurodevelopmental delays
• Death

Can I Recover Damages for My Baby’s NEC Treatment?

As a parent, it’s stressful enough to have a premature baby. It can be even more difficult if your baby is diagnosed with NEC and has to undergo serious surgery to treat it. This can increase medical bills and could lead to lost wages and other expenses.

Despite knowing since at least 1990 that their products could increase the risk of NEC in premature infants, formula manufacturers have not taken action to warn doctors or parents of this danger. They do not list this risk on their product labels, nor do they provide such a warning on any of their advertising materials.

These manufacturers are already defending lawsuits filed by parents seeking to hold them liable for the medical expenses associated with their babies’ NEC diagnoses. The plaintiffs claim that the manufacturers knew that their products posed unique dangers to preterm babies, yet failed to provide the appropriate warnings.

Why Premature Babies May Need Infant Formula

Infants who are born prematurely often have different nutritional needs from babies born fully developed. Their bodies may need more of certain types of nutrients to continue proper growth and development.

They might not be able to suck properly, either, making breastfeeding difficult or even impossible. To continue feeding, doctors will thread a tube from the nose or mouth to the tummy until the baby can start eating on his own.

Healthy mothers can choose to express their breastmilk to feed their premature babies. Alternatively, they can choose to use human donated milk. While in some cases that may be enough, doctors may additionally recommend supplementing that breast milk with infant formula or fortifier.

These formulas can help supplement nutrients that the baby needs to grow, but they may also increase the risk of NEC.

How is NEC Treated?

There are several treatment options for NEC. Less invasive options are typically preferred and include antibiotics and probiotics. Regular feedings through the digestive tract are typically stopped for a short period to allow the bowel to rest.

In more serious cases, surgery may be necessary. Doctors may place a drain in the abdominal cavity to relieve pressure and inflammation. They may remove the damaged part of the bowel, which protects the rest of the bowel and allows it to heal. Or they may place an enterostomy to reroute the stool and keep waste from traveling through the injured section.

In most cases, babies treated for NEC go on to live healthy lives. But in some cases, the condition can cause ongoing problems or may be life-threatening. Typically, the outcome depends on how much of the bowel has to be removed, and how well the remaining sections manage digestion.

What Bacteria Cause NEC?

In a 2008 review, scientists noted that gastrointestinal emergency encountered in the neonatal intensive care unit.”

They went on to analyze how NEC takes hold in the premature gut, stating that first, the intestine is invaded by bacteria. Those bacteria initiate a cascade of inflammation that leads to further destruction and eventually, to systemic infection. This can lead to the infant’s death.

They also found that no individual bacteria, fungus, or virus has been shown to cause NEC. Instead, it can be caused by various microorganisms. The key thing is that they grow, replicate, and cause inflammation, which eventually damages the bowel, creating gaps that can then lead to greater infection.

Infant Formula NEC Lawsuits

Parents shouldn’t have to worry about the products used to treat their premature infants. If your preterm baby was injured or died because of NEC, you may be eligible to file a baby formula lawsuit to recover damages.

Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.