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NEC Baby Formula Lawsuit

Preemie Infant NECFor the parents of babies born prematurely, there are so many dangers to worry about. What might be perfectly safe for newborn babies born at term could potentially lead to life-threatening infections or complications for preemies, especially micropreemies.

Unfortunately, these dangers can even extend to the formula used to feed these tiny newborns and help them begin gaining weight to reach a healthy size. Even the formula provided to the smallest premature infants in a hospital’s neonatal intensive care unit (NICU) by the doctors and nurses who specialize in the care of newborns sometimes contains cow’s milk, an ingredient that research shows may increase the risk of adverse outcomes in preemies.

One particularly worrying condition that preemies are prone to, especially when they consume cow’s milk, is necrotizing enterocolitis (NEC). If your family has been through the nightmare that is a diagnosis of NEC, you know how unbelievably difficult it is to watch helplessly as your small and vulnerable newborn baby battles a potentially life-threatening disease. Your family deserves compassionate support throughout this ordeal, and any company that is responsible for potentially putting your child in danger deserves to be held fully accountable.

The NEC baby formula lawyers at Console & Associates are here to help families going through this unimaginable situation. Our law firm is known for the caring service we provide to families going through circumstances like yours and for fighting to hold responsible the manufacturers of dangerous products. We will listen to the details of your family’s unique situation and begin an investigation into whether a cow’s milk-based baby formula is to blame, all at no upfront cost to your family.

It would be our privilege to assist your family at this difficult time. If we can be of help, please call (866) 778-5500 today for a free, confidential consultation.


What Is Necrotizing Enterocolitis (NEC)?

Necrotizing enterocolitis is a serious disease that affects the intestine. In NEC, bacterial infection, inflammation, and decay of the tissues of the intestine can cause the cells that make up the intestine to die, according to Children’s Hospital of Pittsburgh. If the infection causes holes in the intestine to develop or destroys the wall of the baby’s bowel, stool and bacteria can leak into the abdomen, leading to a systemic infection that can be deadly.

Who Is Affected by Necrotizing Enterocolitis?

NEC primarily affects premature newborns. Overall, the disease affects only in every 2,000 to 4,000 live births, but it is disproportionately common among the most vulnerable of infants—those who are premature and exceptionally small. Just 1 in 10,000 full-term babies will develop NEC, compared to 1 in 1,000 preemies, according to the Cleveland Clinic. In all, 9 out of 10 babies who develop necrotizing enterocolitis are premature.

Prematurity is the term that encompasses birth before the pregnancy is 37 weeks along, but there are degrees of prematurity. Generally, babies born between 32 and 37 weeks of gestation are considered preterm. Babies born between 28 and 32 weeks of gestation are considered very preterm, and babies born before 28 weeks of gestation are extremely preterm, according to the Academy for Continued Healthcare Learning. Babies who are born before the 26th week of pregnancy or who weigh less than 28 ounces at birth fit under the term “micropreemie,” according to the Cook Children’s Health Care System.

Nearly one in 10 babies born in the United States today is premature, according to the March of Dimes—and that amounts to hundreds of thousands of babies born prematurely, and potentially at risk of developing NEC, each year.

Generally, smaller and more premature infants have the highest risk of suffering from NEC. Babies who develop necrotizing enterocolitis are typically born weighing less than five and a half pounds. According to Children’s Hospital of Pittsburgh, around 80 percent of babies diagnosed with NEC weigh less than four and a half pounds, and approximately 10 percent of babies who weigh less than three pounds and five ounces will develop NEC. Babies who weigh less than two pounds face the greatest risk of necrotizing enterocolitis, according to the Cleveland Clinic.

The reason premature infants are at such a higher risk of suffering necrotizing enterocolitis, the Children’s Hospital of Pittsburgh reported, is that their immature bowels are particularly sensitive and susceptible to infections. Having trouble with digestion and with circulating blood and oxygen can compound the potential for complications and raise the risks of developing NEC.

Most cases of necrotizing enterocolitis develop early in the infant’s life—within the first two weeks of life, according to the Children’s Hospital of Pittsburgh, while the Cleveland Clinic reported that “classic” NEC most commonly occurs between three and six weeks following birth.

What Are the Signs of NEC?

Necrotizing enterocolitis can be treated, often successfully, but the condition must be diagnosed first. Some of the most common symptoms doctors look for when diagnosing NEC include:

  • Feeding problems and intolerance, including baby’s refusal to eat
  • Vomiting
  • Diarrhea
  • Blood appearing in the stool
  • Abdominal swelling, bloating, pain, or distention
  • Lack of weight gain
  • Lethargy or lack of energy
  • Unstable breathing, body temperature, blood pressure, or heart rate

If necrotizing enterocolitis is suspected, doctors will usually order tests such as abdominal X-rays, blood tests, and fecal (stool) tests.

How Dangerous Is NEC?

In some instances, the damage caused by necrotizing enterocolitis affects only a small area of the intestine. In other cases, the disease can affect a large area of the intestine or completely destroy the wall of the bowel, allowing large amounts of stool and bacteria to leak into the baby’s abdomen.

The severity of the damage determines not only what the infant’s prognosis is but also what medical interventions will be used to treat this emergency. In 60 to 80 percent of cases of necrotizing enterocolitis, the baby will not need to undergo surgery, the Children’s Hospital of Pittsburgh reported. Instead, the infant may be treated through methods that include stopping feedings, using a nasogastric tube to drain fluids and air from the infant’s stomach and intestine, administering antibiotics, and close monitoring. Some babies who are sick with NEC may require oxygen, mechanical breathing assistance or a transfusion of platelets and red blood cells.

Most babies who develop NEC and who receive prompt and proper medical care for this emergency condition will survive and recover, the Children’s Hospital of Pittsburgh reported. Some infants may develop further complications, such as short bowel syndrome, intestinal strictures, or growth failure and developmental delays, according to the Cleveland Clinic—but approximately 80 percent of babies with necrotizing enterocolitis do survive.

However, for babies in whom NEC has led to perforations of the intestine that are large enough to warrant surgery, the risks are much higher. Among babies who require surgical treatment of NEC, mortality rates between 20% and 67% have been reported, according to Acta Paediatr, the journal of the International Congress of Pediatrics.

What Causes NEC?

It’s still unknown precisely what leads to the development of necrotizing enterocolitis.

The National Library of Medicine’s MedlinePlus identifies potential factors that can contribute to NEC, including:

  • Damage resulting from decreases in blood flow to the baby’s bowel
  • Bacteria in the baby’s intestine
  • The premature baby’s undeveloped immune system that impedes the body’s immune regulation

One other major factor that is consistently present in most cases of necrotizing enterocolitis is the baby’s consumption of formula, as opposed to human breast milk.

“Feeding an infant breast milk may lower the risk of NEC,” reported the Cleveland Clinic.

“Some experts believe that necrotizing enterocolitis causes have to do with the makeup of infant formula,” as well as other factors, the Children’s Hospital of Pittsburgh reported, adding that, although exclusively breastfed newborns can develop NEC, “their risk is lower.”

“The only consistent observations made in infants who develop NEC are the presence of prematurity and formula feeding,” Children’s Hospital Los Angeles reported.

MedlinePlus lists formula feeding as a risk factor for NEC, noting that “human milk contains growth factors, antibodies, and immune cells which may help prevent the problem.” The cow’s milk that is used in around 80 percent of baby formula products on the market doesn’t contain the properties that can help protect babies from developing necrotizing enterocolitis.

Does Formula Cause NEC? What Research Says About NEC and Formula Feeding of Preterm Infants

Numerous research studies have found links between the enteral consumption of formula among premature infants and the development of necrotizing enterocolitis.

“… after 30 weeks of gestation, necrotizing enterocolitis occurred 20 times more among strictly formula-fed babies than babies who consumed breastmilk, either exclusively or supplemented by formula.”
In 1990, an article in the medical journal The Lancet reported that preterm babies who were exclusively fed formula developed NEC at a rate six to 10 times as high as exclusively breastfed babies and three times as high as babies fed both formula and breastmilk. The difference in NEC risk was even more pronounced among infants who were born after 30 weeks of gestation, in whom necrotizing enterocolitis occurred 20 times more among strictly formula-fed babies than babies who consumed breastmilk, either exclusively or supplemented by formula.

Over 20 years later, a 2011 article in the journal Pediatric Research theorized that “dietary antigen sensitization may play a role in promoting and/or sustaining inflammation” in necrotizing enterocolitis and sepsis. Upon investigating the hyperinflammatory immune responses known as cytokine responses that are specific to cow’s milk proteins in babies suffering from NEC, the researchers collected data that “provide further evidence of [cow’s milk protein] sensitization in preterm infants in different disease settings.”

“Several studies have indicated that bovine milk-based infant formulas lead to a higher incidence of NEC in preterm infants than does human milk,” reported an article published in the Advances in Nutrition journal in 2017.

Based on data leading up to 2019, the Cochrane Collaboration summarized study results by saying, “The currently available evidence suggests that feeding preterm infants with artificial formula (rather than donor breast milk when mother’s own breast milk is not available) is associated with faster rates of growth, but with a near-doubling of the risk of developing necrotizing enterocolitis.”

Further evidence suggests that even supplementing preterm infants’ breastmilk feeding with a fortifier made from cow’s milk may increase the risks of NEC. In a 2020 article in the journal Breastfeeding Medicine, researchers conclude that “preterm infants fed cow’s milk-derived fortifier had adverse outcomes despite a base diet of only mother’s own milk.”

Research study after research study has produced data that suggests that the consumption of cow’s milk-based formula in premature infants is associated with an increased risk of necrotizing enterocolitis. This data is the scientific evidence used to support the ongoing premature baby formula lawsuits.

Why Premature Babies End Up Consuming Cow’s Milk in Spite of the Research Findings

In theory, the abundance of research data linking cow’s milk-based formula and fortifiers to NEC could potentially help reduce cases of necrotizing enterocolitis. The problem is that, as things currently stand, avoiding cow’s milk products for preterm infants is easier said than done.

A diet of the infant’s mother’s own milk is generally considered the best and safest option for premature infants, but exclusive feeding with the mother’s own milk may not be possible. Many mothers have trouble with breastfeeding, including low milk supply, and a decreased milk supply is especially common among mothers whose children are born prematurely.

Donor breast milk produced by other lactating women can help meet the special feeding needs of preemies. However, using donor milk “presents significant challenges including the need for pasteurization, nutritional and biochemical deficiencies, and a limited supply,” researchers noted in an article published in the journal Pediatric Clinics of North America.

Even if the mother’s own breast milk or donor milk is available in quantities sufficient for the baby to survive on, some sort of formula or fortifier is often used, as well. Statistically, formula-fed babies gain more weight in less time than breastfed babies, according to NPR. In the case of tiny preemies, gaining the weight needed to grow bigger and stronger is often a high priority. Human milk fortifiers may be made from either bovine (cow’s) milk or human milk, and the majority of baby formula products include cow’s milk in some capacity.

Despite the research data that highlights the NEC risks preterm babies face when fed cow’s milk, many of these vulnerable infants still consume cow’s milk. As the ongoing NEC baby formula lawsuits have alleged, major baby formula brands have marketed their products that contain cow’s milk for preemies. As a result, parents and even NICU care providers have unwittingly fed babies who are already at risk of developing necrotizing enterocolitis due to their prematurity a diet that, because it includes cow’s milk formula or fortifier, could make these risks even greater.

Which Formulas Use Cow Milk as a Base?

“around 80 percent of baby formula products on the market in the United States are cow’s milk-based.”
The reason it is so difficult to avoid cow’s milk baby formulas is because, according to the American Academy of Pediatrics’ website HealthyChildren.org, around 80 percent of baby formula products on the market in the United States are cow’s milk-based.

Some of the baby formula brands that sell products containing cow’s milk (though not necessarily only cow’s milk-based formula products) include:

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

For babies who are born at term and at a healthy birth weight, drinking cow’s milk-based formula is generally safe. The issue on which the ongoing lawsuits are based isn’t that many baby formula products use cow’s milk, but rather that the manufacturers of these products have marketed them as safe for use in preemies who are at an increased risk of necrotizing enterocolitis.

Who Is Liable if My Child Develops NEC From Drinking Cow’s Milk-Based Formulas?

If your preemie child was fed a cow’s milk-based formula at home or while in the NICU and subsequently developed necrotizing enterocolitis, you might be able to hold the formula manufacturer legally accountable for the harm your family has suffered. Doing so would mean pursuing a civil legal claim against the maker of the baby formula product(s) that you are alleging caused your infant’s NEC. A successful NEC baby formula claim would result in financial compensation for your family.

Certain formula products, specifically, are already part of litigation being pursued by NEC formula lawyers. These formulas include:

The makers of Similac and Enfamil—Abbott Laboratories and Mead Johnson & Company, respectively—have been named in baby formula lawsuits, the Madison-St. Clair Record reported in July 2021.

The baby formula lawsuits that have been filed so far have included allegations like the following:

  • That the cow’s milk-based baby formula products increased the likelihood of the baby developing NEC and severe injuries as a result and, specifically, that they “caused the Injured Infants [named in the lawsuit] to develop necrotizing enterocolitis”
  • That the defendants named in the case knew of the “scientific consensus that [their formula products] present a dire threat to the health and development of preterm infants” but nonetheless kept marketing and selling their “their unreasonably dangerous products to unsuspecting parents and healthcare providers”
  • That the “aggressive marketing” of these formula products preys on the fears that parents of preemies have while also failing to warn these parents of the increased risk of necrotizing enterocolitis that comes with the consumption of cow’s milk-based formulas in preterm infants

NEC baby formula litigation is ongoing, and there have been no baby formula lawsuit settlements or trials arising out of this litigation as of December 2021.

Baby formula lawyers are still investigating claims related to NEC cases that may have been caused by the consumption of cow’s milk-based formulas and fortifiers in premature infants. As these investigations proceed, additional baby formula manufacturers may also face legal accountability.

Who Can File a Baby Formula Lawsuit Arising out of an NEC Diagnosis?

If you’re wondering whether your family can move forward with a lawsuit against a baby formula manufacturer, here’s what you need to know. At this time, product liability lawyers can only take on claims in which the baby was born prematurely, was fed with a cow’s milk-based formula or fortifier, and was diagnosed with NEC. If you’re not sure about any of these points, a product liability attorney may be able to investigate the matter and dig into past medical records to confirm whether your family’s situation meets these criteria.

Because there are legal deadlines that affect how long a person has to sue, an NEC baby formula lawyer may ask questions about when the birth and NEC diagnosis happened. Generally, many of the law firms handling claims like these are primarily representing clients (formerly diagnosed with NEC as babies) who are 25 years old or younger. In some cases, the family of the child diagnosed with NEC may be able to pursue a claim.

The types of injuries for which an individual who was diagnosed with NEC as an infant or the family of such an infant may sue include:

  • Gastrointestinal or bowel issues
  • Surgery
  • Cerebral palsy
  • Neurological conditions
  • Death

If you believe that your family may have the grounds for a necrotizing enterocolitis lawsuit against a baby formula manufacturer, you should reach out to an attorney right away to review your case. Even if you’re not sure that your situation meets all of the criteria, it may be worth speaking to a legal professional to discuss your rights and options.

Most attorneys handling NEC baby formula claims offer free consultations, so you can get your questions answered and the legal process explained at no charge. You have nothing to lose by speaking to an attorney about your situation.

Legal Representation From Experienced Baby Formula Lawyers at No Upfront Cost

No Fee PromiseYour family has been through enough as it is. The last thing you need is the additional financial burden of a legal matter to add to your family’s suffering right now. That’s precisely why the products liability lawyers handling NEC baby formula cases are offering no-win, no-fee legal representation.

Under this fee model, individuals and families affected by NEC pay nothing upfront to move forward with a claim. They will only ever have to pay in attorneys’ fees a portion of the money their lawyer succeeds in getting for them, so they won’t owe anything unless and until they actually receive financial compensation.

Pursuing an NEC baby formula lawsuit won’t add to the troubles your family is facing by costing you money upfront or taking up your time. Your attorney will handle every aspect of the claim so you can focus on taking care of your family as best you can in this difficult situation.

Your family deserves accountability for what you have been through and fair compensation for all that you have suffered. Call (866) 778-5500 today for a free, no-obligation case review.

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