Annually, one in every ten newborns nationwide arrive preterm or before the lapse of the 37 weeks gestation. Again, as per the CDC statistics, one out of twelve newborns in the country come weighing less than 2,500 grams. These statistics demonstrate that most preterm infants are born underweight. However, some preterm and underweight babies grow to become healthy adults, several experience many health complications. One common challenge that results in these complications is a refusal to breastfeed, which results in further weight loss and a weaker immune system. Medical experts ensure preemies and underweight infants grow and develop into healthy adults by feeding them supplemental infant formula milk.

Baby Formula Associated with a Health Complication That Affects Preemies

Sadly, many recent scientific studies have shown that some infant formula milk fortified or containing cow milk harm infants instead of providing the nutritional value they should be providing. Particularly, feeding preterm arrivals cow milk-derived formulas increases the risk of developing a necrotizing Enterocolitis (NEC) condition. Recent studies have established a clear link between feeding preemies formula and the risk of developing NEC. When you feed your preterm baby with formula milk, they are at a heightened risk of NEC compared to their counterparts breastfeeding. Unfortunately, the baby formula brands' makers have failed to disclose the product's dangers to medical professionals and families who have welcomed newborns recently, which has resulted in many lawsuits against the companies by the parents whose infants have developed the disease.

Updates on Enfamil and Similac Infant Formula Suits as of January 2022

Many families that have lost a loved one or have a preemie with NEC could file lawsuits against the manufacturers of baby formula if its consumption led to the development of the condition. Additionally, many studies have been conducted confirming the link between baby formula and increased risk of NEC.

One lawsuit that has been recently filed on 2nd November 2021 by Tylea Hundley’s estate. Hundley was a preterm arrival and developed NEC two days after arrival. The estate was suing three infant formula brands because the baby developed the condition and later died after being fed the product by medical experts at Yale-New Haven Hospital. The producers of these baby ormulas are Mead Johnson & Company, Mead Johnson Nutrition Company & Abbott for the violation of Connecticut Product Liability.

On 1st December 2021, a milestone in the medical research on NEC was made after a nurse from Carle Foundation Hospital named Christine Wetzel obtained a national honor for developing equipment used to examine babies’ chances of developing the dangerous NEC.

Similarly, on 16th December 2021, Jo Shandria White of Edwardsville, IL, alleged that Similac and Enfamil baby formulas refused to warn families and doctors adequately of preterm or underweight babies developing necrotizing enterocolitis after exclusive consumption of formulas with cow milk.

On 1st January 2022, the Health and Human Services Department informed NEC causes. Later, on 6th January 2022, a new research release titled: Studying the Influence of Exposure to Maternal Voice on Oral Feeding in Volumes in Preterm Infants released its findings. The Exclusion Criteria adopted in the study was necrotizing enterocolitis requiring treatment.

NEC Poll 2022

Our experts at Consumer Alert Now recently polled parents or families whose preemies have developed necrotizing enterocolitis after feeding baby milk. The poll targeted 173 parents and aimed to establish the number of weeks the pregnancy lasted. From the poll, 8% of the preemies were born before 23 weeks, while 39% of the parents claimed their preterm babies arrived between 24-28 weeks of pregnancy. Another 32% of the parents claimed that the newborn arrived between 29-33 weeks of pregnancy. Additionally, 13% of the NEC parents claimed their children were born 34-37 weeks gestation. Only 10% of these parents had full-term babies.

About Necrotizing Enterocolitis Suits

In the U.S., only a handful of companies manufacture baby formula. Abbott and Mead are the two large formula manufacturers that face NEC lawsuits from parents. The plaintiffs allege that Abbott’s Similac and Mead’s Enfamil failed to warn or inform parents of the deadly condition linked to infant formula consumption by preemies. The companies withheld this information from the public. Their actions resulted in harm or death due to NEC among many preemies nationwide.

And because many babies have been injured or lost their lives from NEC, personal injury attorneys have helped many families to file product liability suits against the manufacturers of the product for the damages caused by their negligence. The window for the injury claims is yet to close. Therefore, you should come out and file a claim if you are among the parents whose preterm newborns have developed NEC or died out of it. Experienced injury counsels are ready to educate you on your rights, evaluate your claim and pursue compensation for your losses.

Overview of Necrotizing Enterocolitis

Necrotizing enterocolitis is a bacterial infection of the gastrointestinal system that causes intestinal tissue inflammation or perforation of the intestinal walls. When the problems go untreated, the perforations in the intestinal walls allow bacteria to leak to the belly and bloodstream, causing a fatal infection. The fatality rate of infants with NEC is 50%, making the disease severe. However, despite the condition’s severity, the symptoms manifest within two weeks of arrival and vary from modest to extreme.

Babies at Risk of Developing NEC

So far, no census has been conducted to corroborate the cause of necrotizing enterocolitis, explaining why doctors and other medical practitioners cannot identify infants in danger of developing NEC. However, most NEC cases are linked with preterm arrivals feeding on formula. Specifically, nine out of ten preterm newborns with NEC were born 28 weeks before gestation, although this does not mean only preemies develop NEC. A baby might develop the condition after a blood transfusion or undergo enteral nutrition, otherwise known as feeding through the belly.

NEC Condition Phases

The Modified Bell Staging Criteria is the standard of practice to diagnose, stage, and treat necrotizing enterocolitis in the Neonatal Intensive Care Unit (NICU). The criteria used to stage NEC condition is as follows:

Stage IB

Stage IB, also called the suspected NEC stage, comprises patients experiencing mild symptoms. NEC diagnosis is usually uncertain, and the doctor suspects it when other tests rule out other gastrointestinal complications. The systematic signs or manifestations include:

  • Lethargy

  • Temperature unsteadiness

  • Bradycardia

  • Apnea

Also, in stage IB, the baby might experience intestinal manifestations like passing stool with bright sore blood. Also, the infant will experience intestinal dilation on radiographic review with light ileus.

Phase IIA

Babies with suspected NEC diagnosis whose condition advances to include radiographic manifestations like ileus are categorized as stage IIA, proven NEC, or mildly ill. The manifestations experienced by infants in this stage are more indicative than those of phase I. The symptoms reveal the NEC condition once other gastrointestinal disorders have been ruled out.

The systematic signs the infant will have include lethargy, temperature variance, apnea, and bradycardia. The intestinal symptoms at this phase include:

  • Heightened pregavage residuals

  • Abdominal distention

  • Persistent occult or bright red lifeblood in the stool without bowel sounds

  • Abdominal tenderness

  • Guaiac-positive stool

  • Emesis

Radiographic manifestations include ileus, intestinal dilation, and pneumatosis intestinal.

Stage IIB

The proven cases and mildly sick infants are classified at stage IIB and mainly include babies showing part or all the manifestations of stage IB and IIA. The systematic symptoms in this phase of NEC include:

  • Apnea

  • Temperature unsteadiness

  • Mild thrombocytopenia

  • Bradycardia

  • Trivial metabolic acidosis

The intestinal manifestations are:

  • Absent bowel sounds

  • Bright blood from the rectum without bowel sound

  • Emesis

  • Definite intestinal tenderness

  • Guaiac-positive stool

  • Increased pregavage residuals

  • Stomach cellulitis

Upon radiographic evaluation, the infant will experience intestinal enlargement, ileus, portal arterial gas with or lacking ascites, and pneumatosis gut.

Stage IIIA

Advanced NEC, Bowel intact or severely ill are categorized as stage IIIA. Infants at this stage portray some or all systematic signs in stage IB, IIA, and IIB, plus other manifestations like:

  • Hypotension

  • Neutropenia

  • Disseminated intravascular coagulopathy

Similarly, intestinal manifestations include some or all those mentioned in the above stages. Other intestinal symptoms are peritonitis inflammation, marked abdominal tenderness, and abdominal distention.

The radiological manifestation for the infant is intestinal enlargement, definite ascites, portal venous gas, using or absence of ascites.

Stage IIIB

Under the modified Bell clinical criteria for necrotizing enterocolitis, the final stage is stage IIIB, classified as advanced NEC where the infant is severely sick and with a perforated bowel. At this phase, the systematic symptoms the infant experiences are the same as those of stage IIIA. They include:

  • Temperature instability

  • Disseminated intravascular coagulopathy

  • Combined respiratory and metabolic acidosis

  • Severe apnea

  • Hypotension

  • Mild metabolic acidosis

  • Lethargy

  • Mild thrombocytopenia

The intestinal signs babies experience in an advanced NEC stage are:

  • Marked tenderness

  • Abdomen distention

  • Definite gut tenderness, with or absence of abdominal cellulitis

  • Amplified pregavage residuals

  • Emesis

  • Bright blood leaving the rectum without stomach sounds, by way of or absence of abdominal tenderness

  • Guaiac-positive stool

  • Generalized peritonitis manifestations

Lastly, the radiological manifestations of this phase are portal vein gas, with or absence of ascites, and Pneumoperitoneum. Also, the infant’s intestines are likely to enlarge.

Currently, there are multiple ongoing kinds of research on NEC that have enabled the amendments or changes in the Bell Staging Criteria for a definite differentiation of diagnosis stages.

2021 Infant Formula Suit Status Update

Recall, infant formula milk lawsuits are still ongoing, and personal injury counsels are urging parents to come out and hold those responsible for the harm or death caused to their babies. Nonetheless, several suits are in court so far. One of these lawsuits filed in May 2021 in the Eastern District of California is that by the family of Daniel Renteria-Hernandez against Mead and Abbott, the manufacturers of the cow’s milk formula associated with increased risk of NEC among preterm newborns. The plaintiffs allege that these two companies declined to adequately inform parents who have recently welcomed infants and hospitals that the consumption of the product is dangerous to premature infants and underweight arrivals.

Daniel was born underweight. He weighed only two pounds. And because many low birthweight babies rely on formula during the early days, Daniel was fed Similac infant formula and died just two days after arrival in 2019. In a death claim, Daniel’s estate presents several incidents of inaction or negligence by the baby formula milk brand maker. They claim that Abbott Laboratories, the formula maker, was negligent, breached warranty, and engaged in negligent misrepresentation of facts. In August 2021, the company tried to have the wrongful death claim against them dismissed, but a federal law court judge rejected the petition.

Another wrongful death claim by the family of infant Aries Peterson was initially filed in 2020, although it will proceed after the Connecticut Supreme Court supplemental debates.

Spotting and Treating Necrotizing Enterocolitis

Signs of NEC begin to manifest within two weeks after the newborns’ arrival. And because the gastrointestinal condition has been heavily associated with exclusive consumption of baby formula among underweight or preterm infants, medics are constantly closely monitoring these infants for NEC signs. The common manifestations doctors lookout for include bloody stool, stomach swelling, lethargy, and vomiting. Nonetheless, some of the symptoms might not be apparent, meaning a diagnosis can only happen if the doctor conducts an abdominal x-ray on the preemie. The procedure looks out for air bubbles in liver veins or bubbly appearance due to bacterial infection damage on the gastrointestinal system. Moreover, the doctor could test blood or stool samples for the condition. In some cases, they inject a needle into the abdomen to detect punctures or holes in the intestinal walls.

After diagnosis, the doctor can opt for multiple treatment options. The procedure to be administered varies from one patient to another because of the variance in the disease severity. Other elements that affect the treatment technique the infant’s doctor will adopt are the preemie’s age, qualified health, and body strength. The prevalent NEC treatments include IV administration, stopping oral feeding, administering antibiotics, and in severe cases, a surgical operation to remove the dead intestinal tissues or bowels.

Necrotizing Enterocolitis Figures

NEC disease is a gastrointestinal condition prevalent among newborns or very young babies. Nevertheless, few cases have been reported in adults. As full-term infants or those arriving after full gestation can develop this medical condition, most of these cases are reported in preterm and underweight newborns. Figures show that 9 out of all ten premature infants develop NEC. On the issue of NEC and its links with low-weight children, statistics show that only 3% of infants arriving with a weight ranging from 1.251-1.5 kilograms develop NEC conditions. The percentage increased to 11% of infants arriving with a highly minimal birth weight of no more than 750g, up from the 3% for those between 1252-1500 grams.

Sources Associating NEC Condition and Cow Milk Infant Formula

You can read more about human milk (HM) effects on NEC by visiting MDPI. The source reports on a systematic review and meta-analysis findings in a 2020 publication by Emma Altobelli, Reimondo Petrocelli, Alberto Verrott & Paolo Matteo Angelotti.

Another 2020 publication by Alan Lucas, Steven A. Abrams & John Boscardin underlines the adverse impact of administering cow milk-based fortifiers on preemies despite being on a breast milk diet from their mother. You can read more about the study on The National Center for Biotechnology.

Also, a 2015 publication by Richard J. Schanler underlines the strategy of preventing NEC through a human milk diet. Visit The National Center of Biotechnology to read more on the publication.

Similarly, Ohio Library and Information reports on a 2014 publication by Sreekanth K. Viswanathan MD regarding standardized slow enteral feeding protocol and incidence of NEC in low birthweight babies. Adel E Abdelhamid, Peter Hayes, Shu-Ling Shuang & John M E Fell highlight the responses of Vitro cow’s milk protein-specific inflammatory and regulatory cytokine on preterm arrivals diagnosed with NEC. Read more at Pediatric Research.

NEC Infant Formula Suit Settlement

No NEC lawsuit has already been settled so far. However, many parents whose children have developed this condition even without a settlement will enter suits because of the increased cognizance of the legal action. So, it is difficult to attach a dollar value to your claim without a ruling on these cases. Nonetheless, makers of this product have in the past compensated millions of dollars to victims for various law violations, although not related to NEC. Additionally, most of the NEC suits already filed against Abbott and Mead allege that the companies are responsible for wrongful demise and severe harm due to feeding Enfamil and Similac baby formula brands. If these parents and families win these lawsuits, then the settlement they obtain from these manufacturers will be millions. So, if you plan to file an NEC lawsuit, it is time to talk to an attorney because the chances of settlement are high.

NEC Infant Formula Attorneys

Nationwide, many attorneys work with many families to build lawsuits against Abbott and Mead for their children's wrongful death or severe injury due to a faulty product. Many publications mentioned above have linked infant Enfamil and Similac with an elevated risk of NEC in preemies. Families call upon these manufacturers to take the necessary action to protect babies.

In one of these NEC lawsuits, the plaintiff wonders why the firms continued to advertise their product as safe regardless of the harm it caused to consumers. The manufacturers were aware of thousands of preemies, and underweight births nationwide depend on their product for additional nutrition. So, if all these families sue these companies, they will face multiple suits in the pending years from all the parents whose children have fallen victims of the defective infant formula. Parents whose children have been harmed or died due to infant formula are encouraged to visit Select Justice for a free case review to determine their eligibility for NEC suits.

NEC Risks

Necrotizing enterocolitis is a severe health condition. The conditions cause inflammation of the colon due to the destruction of the intestinal tissue. You will understand the illness better by breaking down its derivation. Necrotizing stands for tissue destruction; entero means involving the intestines, while colitis means colon inflammation. The cause of the illness is not clear. Still, experts associate it with dangers like intestinal stricture, perforation or development of a hole in the intestinal walls, scarring of the bowels, and bowel syndrome associated with decreased food absorption due to intestine destruction or extraction. Again, the condition increases the danger of peritonitis which is the severe abdomen infection, or the whole body infection, called sepsis. Sadly, some of the infants who develop the condition end up dead.

NEC Manifestations

Necrotizing enterocolitis has several signs, which include but are not limited to:

  • Stomach pain

  • Food refusal

  • Blood pressure

  • Lethargy or fatigue

  • Breathe or body temperature

  • Heart rate variation

  • Green or yellow-colored vomit

  • Privation of weight increase

  • Bloody stool

NEC Causes

NEC cause is unclear, although medical professionals have associated particular conditions with an elevated risk of the NEC. Most of these conditions are expected in preemies and low-weight births. For example, preterm arrivals are associated with a weak immune system that reduces their capacity to combat the illness. Additionally, preemies’ gastrointestinal system is yet to develop fully, resulting in digestion problems and increased danger of gastrointestinal disease, hindering their capacity to combat the illness. Further, preterm arrivals experience blood flow problems. And when blood does not spread to the intestines, the child's risk of developing NEC is high.

The causes mentioned above are yet to be confirmed. Nevertheless, preterm births and underweight infants are at a high risk of developing the disease. Also, many studies have shown that preemies who consume cow milk-based baby formula are likely to develop NEC. For this reason, Abbott and Mead face multiple lawsuits for not adequately warning consumers of the product's dangers despite being aware of them for years.

Necrotizing Enterocolitis Formula Suits

Makers of baby formula continue to market it as a super substitute for human milk, with scientifically proven nutritional benefits. Sadly, the same companies hit the headlines for all the wrong motives. Infant formula makers are being blamed for overstating the nutritional value of their product because, in one case, they claim that the DHA added in the product stimulates the growth and development of the baby’s brain. Still, there is little or no evidence supporting the claims.

Worse, companies are accused of marketing products as safe without warning the public of their dangers. For instance, a 2011 class-action lawsuit against Enfamil maker claimed that the company gave false and deceptive information about DHA infant formula. The class action is not the only lawsuit because Abbott was embroiled in a legal battle as of 1996 for price-fixing in 17 states, paying a settlement of thirty-two and half million dollars. Although leading baby formula makers are embroiled in legal battles, it does not mean they are unscrupulous. The NEC lawsuits aim at ensuring these companies sell safe products to infants and settle the families whose children have been harmed or killed by the default product.

Similac Infant Formula Suits

Similac is a baby formula brand by Abbott, a company that has survived in the industry for more than 90 years. The manufacturer’s motto states, “we promise to keep your baby fed, happy, and healthy.” This is true because Similac brands are safe except for the cow milk formulas intended for preemies and underweight infants. The products mentioned in the suit include Similac Neosure, Similac Human Milk Fortified, and Similac Special Care.

Enfamil Formula Suit

Another baby formula manufacturer engaged in legal battles is Mead. Edward Mead Johnson, a Johnson and Johnson co-founder, founded the company, but left the family venture to establish his company. Today, Mead is famous for child nutrition. One of its products, Enfamil, a cow milk-derived formula, is associated with an increased risk of NEC causing wrongful death and severe harm in preemies.

Like Abbott, the company faces multiple suits, with many of these claims citing Abbott as a co-accused. The reason being many of the harmed or dead children were fed Enfamil and Similac in their early birth stages, making both companies liable.

NEC Suits Frequently Asked Questions (FAQs)

Attorneys and other legal teams helping parents file NEC lawsuits encounter frequent questions about these claims. Some of the FAQs are:

  1. What are the Facts of NEC Suits?

Most parents who have lost infants or whose babies have sustained severe injuries because of the infant formula claim that Enfamil and Similac makers should have taken a more proactive approach in warning them and medical professionals of their products’ risks. In addition, the plaintiffs believe Abbot and Mead are liable for deliberately advertising their product as supplemental feeding for preterm arrivals while knowing of its elevated risk of causing NEC.

  1. Can an Infant Develop NEC At Least Once?

The answer to this question is yes. A baby can develop the condition at least once, requiring surgery for treatment. The surgical operation in itself can lead to other long-term health effects.

  1. Is Enfamil or Similac the Reason for NEC?

The source of NEC is not conclusive yet. Nonetheless, many scientific studies have associated the condition among preemies with exclusive consumption of Enfamil and Similac. Most lawsuits allege the makers of the products were aware of its health effects but continue marketing them as safe.

  1. Can Full-Birth Infants and Adults Develop NEC?

Yes. Infants arriving past 37 weeks of gestation can develop the disease, although 90 percent of the incidents are reported in preemies and low birth weights. In adults, these cases are rarely reported.

  1. Are there Ways to Protect Infants from NEC?

It is unclear the source of NEC, meaning there is no definite answer to keep it at bay. Nonetheless, if you have a preemie, they are at risk of developing the condition, so you should consult with a medical expert for guidance.

  1. Are there Current NEC Lawsuits for Preemies?

Abbott and Mead face several lawsuits today because of the association of their product with the elevated risk of NEC in preterm arrivals. However, these lawsuits are at their early stages, and more parents who have been affected are joining. Consumer Alert Now is available for a free case evaluation if you are a victim.

  1. Are you Qualified For NEC Suits?

Not everyone is eligible for lawsuits. However, if you have a preterm baby and are fed Enfamil or Similac in NICU, you can seek compensation if they have NEC.

Find a Product Liability Professional Near Me

It can be stressful to learn your infant’s health problems result from the consumption of faulty baby formula. Preferably, these products must be processed and packaged according to the set standards to ensure they provide the nutritional benefits intended as supplements for mother’s milk. So, it is only right to seek compensation when your infant develops NEC after feeding baby formula.

At Consumer Alert Now, we have product liability experts and attorneys ready to evaluate your case and help you file an NEC lawsuit. Contact us today at 800-511-0747 to discuss your case.