Many toxic infant formula lawsuits allege that preemies exclusively fed on Similac or Enfamil in the Neonatal Intensive Care Unit (NICU) have a heightened risk of Necrotizing Enterocolitis (NEC).

When you are a parent or family whose preterm arrival fed on any of these baby formula products while in the NICU and was later diagnosed with NEC, you should seek a willing and dedicated attorney to offer legal representation. That way, you can recover compensation for the harm or death caused by the defective product.

Information About Infant Formula Lawsuits

The typical baby formula brands nationwide, Similac and Enfamil, have been associated with an elevated risk of NEC, a dangerous health condition among preterm babies. These two formula milk brands are produced to offer extra nutrition value to underweight babies and preterm infants, who, by being born before 37 weeks gestation, are predisposed to the danger of NEC disease. When this gastrointestinal condition is left untreated, it could lead to intestinal necrosis, resulting in body part failure and perhaps loss of life.

As a parent or family whose infant has been harmed or died due to the condition, it is easy to assume the hospital or medical experts who fed the child Enfamil or Similac while in NICU are to blame for the disease. However, the truth is that medical facilities and experts are innocent because, like you, they were never conversant with the elevated risk of developing NEC after feeding preterm arrivals Enfamil or Similac products. Therefore, NEC lawsuits are not targeting hospitals and doctors but the formula makers.

Examples of Infant Formula Suits Filed So Far

If your preterm baby was fed Similac, Enfamil, or both and later diagnosed with NEC, you should join other claimants in taking legal redress from the product manufacturers.

Many NEC suits have been filed up to date. One of these lawsuits was filed in May 2021 by a parent seeking reimbursement and a jury trial for the injury sustained by their preemie. According to Madison-St. Clair Record, the claimant alleges that their preterm baby consumed cow milk-based Enfamil, Similac, or both while in NICU and was diagnosed with NEC. The baby had to undergo surgery to remove a significant percentage of the intestines whose tissue had been severely damaged beyond repair.

Similarly, another suit was filed in the California Eastern District Court in the same month by a parent of a baby boy who arrived at 37 weeks. The parent argues that their infant was fed Similac baby formula while in NICU at the Valley Children’s Hospital in Merced, CA. Afterwards, the baby developed NEC and died only 16 days after arrival. Therefore, the parent is suing Abbott and Mead for the wrongful death of heir infant.

Scientific Studies Associating Infant Formula With Elevated Danger of NEC

Several studies have underlined the danger of feeding preemies and underweight infants’ cow milk-based baby formula. In 1990, Lancet medical journal published a poll on 926 preemies. As per the publication, premature arrivals who exclusively consumed formula were 6 to 10 times at risk of contracting NEC than their breastfeeding counterparts.

In 2012, the American Academy of Pediatrics emphasized the need to feed preterm arrivals breast milk. In a publication of its findings, the association asserted that human milk is ideal for premature babies. In incidents where it is unavailable, it should be substituted by donor milk.

Another 2014 scientific study asserts that highly premature infants feeding on cow milk-centered formula were at 320% danger of developing NEC than their counterparts feeding on mother’s milk. According to the publication, the development of NEC in preterm arrivals is elevated by feeding on baby formula milk and reduced by the breast milk diet.

The problem with cow milk formulas and fortifiers is that they have been accessible in the market since 2014. Still, the manufacturers continue to use the same cow milk in formula production, despite its apparent dangers. Additionally, these manufacturers have continued marketing the product as safe without warning or disclosing its risks to hospitals, doctors, and parents.

Injuries and Side Effects Stemming from Infant Formulas

According to Merck Manual, a medical resource, NEC accounts for most infant gastrointestinal system emergencies. Ninety percent of NEC cases are reported in preterm arrivals, and 8% of all babies are admitted in the NICU. Additionally,  Mayo Clinic asserts that the rate of contracting NEC among preemies on a mother’s milk diet is significantly low.

Cleveland Clinic reports that the NEC condition causes inflammation and subsequent death of the intestinal tissue. When the tissue dies, holes or perforation begin to form on the intestinal walls, allowing bacteria to leak to the stomach and bloodstream, causing infection. And because preterm arrivals usually have a weak immune and digestive system, they find it challenging to fight the disease, increasing its severity causing abdominal infection and sepsis. Again, premature babies have a reduced blood flow, which is experienced even in the intestines. Low blood flowing to the intestines means low oxygen levels allowing bacteria entry into the bloodstream and the stomach.

Signs of NEC in Infants

Particular manifestations or symptoms can show your infant has NEC. These signs are:

  • Lethargy

  • Diarrhea

  • Blood in the baby’s stool

  • Refusal to eat

  • Inability to gain weight

  • Abdominal inflammation and pain

  • Varying heart rate, body temperature, breathing, and blood pressure

  • Yellow vomit

When your baby develops NEC, they are in danger of experiencing other health-related conditions like:

  • Abdominal infection also called peritonitis

  • Developmental delays

  • Short bowel, also known as the gut syndrome

  • Sepsis

  • Contraction of the bowels commonly referred to as an intestinal stricture

  • Growth failure

As per Pediatrics Nationwide, the mortality rate among preterm arrivals diagnosed with NEC is 50%. Only half of the babies (50 percent) with the condition survive, although these survivors experience significant side effects of the disease like cognitive and developmental disabilities.

Recoverable Damages in Infant Formula Lawsuits

If the diet your premature baby relied on while in NICU was Enfamil or Similac, you can seek damages if they have been diagnosed with NEC. The recoverable damages in these lawsuits include:

  • Past, current, and long term medical costs to cater for the infant’s treatment

  • Loss of income if you quit your job to care for the baby

  • Physical and mental pain and anguish stemming from the baby’s injuries

  • Other financial or monetary losses arising from the baby’s harm

  • Punitive damages, when right

Infant Formula Claim Settlement

So far, there are zero mass tort rulings and settlements for formula milk and its association with an elevated risk of NEC. Nonetheless, the legal redress often takes years before the jury pronounces a verdict, with groups of profound attorneys working around the clock to determine the events that led to the lawsuits and how they can be prevented in the future.

Before large groups receive a settlement from the court, the individual cases must usually go for jury hearing for the companies involved to understand the financial implications. After these small cases have been settled, the Multi-District Litigation (MDL) process happens where the minor issues are consolidated in the federal court for discovery.

The Reasons Premature Infants Stay on Formula Diet

Most preterm arrivals are underweight and lack the coordination and energy necessary to suck-swallow and breathe, making it challenging to breastfeed.

Maternal-Fetal Neonatal Medicine reports that preterm arrivals feed on Preterm Infant Formula (PTF) because the mother has insufficient milk to breastfeed or cannot take breast milk and donor milk is unavailable. In the early days of birth, preemies are placed in the NICU, where they feed on unique formulas to provide the extra nutrition benefit they need to grow, according to MedlinePlus.

Cow’s milk infant formula is preferred for many hospitals because it is readily available, cheaper than human milk, and shelf-stable, eliminating the need for refrigeration.

Infant Formula NEC Lawsuit News

The New Food Magazine explains the biological development that results in necrotizing enterocolitis. The magazine gives an account by researchers on the chain of events that results in this dangerous condition that kills the intestinal tissue and sometimes causes loss of life in nearly a third of the reported cases.

In other news, a new nonprofit breast milk bank has been launched in San Diego to replace baby formula with pasteurized breast milk in NICUs in all California hospitals. In California, two hundred sixty infants develop a nearly fatal gastrointestinal system condition called NEC annually. The condition's cause is not clear, but many scientific studies have associated feeding preemies with cow milk-based baby formula with increased risk of NEC. Therefore, by replacing the cow milk-based with pasteurized breast milk in hospitals, preterm arrivals will feed on breast milk, thus reducing the risk of NEC. For more information on this, visit San Diego Tribute.

Also, medical experts are finding ways of preventing NEC. One technique commonly used is placing the preterm infant in total parenteral nutrition (TPN) exclusively until their digestive system is strong enough to allow feeding. Dr. Talavera opines that feeding the preemie milk through the mouth is the first step towards preventing this condition. The doctor recommends that parents with preterm arrivals feed the baby even a drop of the mother’s or donor milk to help coat the digestive tract with all proper nutrients that allow them to grow healthy. Dr. Talavera adds that even painting the infant’s mouth with breast milk in the early days is good for the baby because oral feeding is critical to prevent the condition. For more information on this news, read Pediatric Nationwide.

Also, if you read the Business Wire, you will come across a New York Parent who alleges that SimplyThick Baby Food Thickener caused her infant catastrophic injuries. The Wire further reports that in May 2011, the FDA had warned that SimplyThick heightened the risk of developing nearly fatal NEC and therefore cautioned parents against feeding the product to preterm arrivals. Later, the FDA investigated the SimplyThick maker, Thermo Pac, LLC’s Stone Mountain, inspecting their Georgia plant. After the inspection, the agency found many glitches that contributed to the defective product.

Scientific Research on Infant Formula and NEC

Different sources have reported many studies linking baby formula with an increased risk of NEC. These studies and their references include:

  1. The Effects of Donor Breast Milk (DHM) on the Length of Hospital Stay in Extremely Low Birth Weights: A Systematic Review and Meta-Analysis

The systematic evaluation aimed at establishing the level to which hospital stay reduces the use of DHM to substitute for the preterm baby formula where breast milk from the mother is unavailable. The Randomized Controlled Trials (RCTs) review showed no variance in the hospital stay length for preemies feeding on DHM compared to their counterparts consuming preterm infant formula. Nonetheless, preemies on the DHM diet had a reduced risk of developing NEC than baby formula.

The meta-analysis of the research (n-2,496) found a massive reduction in the occurrence of NEC in preemies on a DHM diet than in the preterm infant formula group (RR 0.48; 95% CI 0.35-0.66; P>0.05). You can find more information on the study if you read the International Breastfeeding Journal.

  1. Safety of Cow’s milk-derived Fortifiers (CMDF) Used With an All Human-Milk Base Diet Used in Very Low Birthweight, Preterm Infants

This meta-analysis intended to establish the association of CMDF with an elevated danger of significant morbidities, even when combined with a 100% human milk (HM) diet. The study found that highly underweight preterm arrivals on CMDF paired with a 100% HM base diet had significantly heightened significant morbidities. Mainly, CMDF was linked with a heightened risk of NEC than HMDF: 19/220 VS 7/233 (RR 3.31; 95% CI 1.36-8.07; p=0.08). Visit Neonatology Today to read more on the study.

  1. The Impact of Human Milk on Necrotizing Enterocolitis: A Systematic Review and Meta-Analysis

The meta-analysis included 6 RCT and eighteen observation polls, which found a decreased risk of NEC in preemies on the human milk diet than those on the baby formula diet. Remarkably, the study was composed of the following:

  • Six RCTs registering 1,626 babies discovered the reduced danger of developing NEC with HM based diet than a baby formula: RR 0.62;95% CI 0.42-0.93; p=0.02

  • Eighteen observation polls with 6,405 babies discovered a lowered risk of NEC with human milk than a baby formula: RR 0.45; 95% CI 0.32-0.62; P<0.001

  • Seven observation studies concluded that 2,453 babies with elevated (>50th quintile) vs. low relative human milk diet had a lower risk of developing NEC: RR 0.51; 95% CI 0.31-0.85; P=0.001

  • Three observational polls discovered a lowered risk of necrotizing enterocolitis in babies exclusively on breast milk than those on a mixed diet: RR 0.74; 95% CI 0.63-0.91; P=0.003

  • Four observational pieces of research found an elevated danger of NEC in preterm arrivals on a mixed diet than their counterparts on exclusively preemie formula diet: RR 1.37; 95% CI 1.13-1.65; P=0.001

You can visit MDPI to read more about this scientific study.

  1. Formula Milk versus Donor Breast Milk for Feeding Preterm or Underweight Infants

The poll aimed to establish the proportional effects on growth and development in preemies and low birth weight arrivals on breast milk versus baby formula. Twelve trials involving 1,879 babies show that infants on a formula diet had heightened head growth, linear growth, and weight gain. Nonetheless, they were at an increased risk of developing NEC than the risk for their counterparts on human donor milk. More information about the study is available at Cochrane Library.

  1. Availability of DHM for Extremely Low Preterm Arrivals Decreased the Danger of NEC Without Adverse on Growth or Breastfeeding Rate

This scientific study considered that human milk encourages the maturation of an infant’s intestines and shields them from gastrointestinal or infectious conditions. The study aimed to establish late-onset sepsis and NEC incidences on extremely low preterm arrivals after donor milk introduction. Additionally, the research estimated breastfeeding rates and development as secondary results. Two categories of 227 infants in NICU were the focus of the study, with one category admitted exclusively fed on formula milk and the other on a donor milk diet. Category one had a 9.1% rate of developing NEC, while the group on donor milk had a 3.4% rate of developing NEC. Also, the rate of surgical NEC was at 55.6% in babies on a formula diet compared to 25% of the category of donor milk. For more info on the study, visit MDPI.

Find an Experienced NEC Lawsuit Expert Near Me

Toxic baby formula milk has caused many injuries and deaths nationwide. Companies making these products have a responsibility to protect consumers from possible hazards. Further, courts have maintained that the makers of the products have a deeper insight or knowledge of their products and therefore should be financially liable for the injuries, deaths, or losses caused by their product.

When your baby has been diagnosed with NEC because of consuming formula milk, Consumer Alert Now invites you to discuss your case with our experienced formula lawsuits attorneys and experts to claim reimbursement. Reach out to us today at 800-511-0747 for a free case evaluation.