Baby Formula & NEC

NEC Baby Formula Lawsuit – Enfamil & Similac Dangers

​​Baby Formula Linked to Deadly NEC in Premature Infants

For decades research has clearly indicated that formula-fed premature infants are at a higher risk of developing a dangerous and potentially deadly gastrointestinal disease, necrotizing enterocolitis (NEC). Manufacturers of these formulas, including the makers of Similac and Enfamil, have done nothing to warn consumers about the risks associated with their product.

At Fibich, Leebron, Copeland & Briggs, we are fierce advocates for children and their families who have been harmed by dangerous and defective products. We work tirelessly to obtain justice on behalf of those who have been injured by negligent manufacturers.

If your preterm baby was given Enfamil or Similac and suffered NEC, contact our office at (713) 804-6121 for a free consultation.

What Is NEC?

Necrotizing enterocolitis or NEC is a severe and devastating gastrointestinal disease. It almost exclusively affects premature babies. When an infant develops NEC, the intestinal tissue becomes inflamed and may cause tissue decay and death.

While NEC can range in severity, even mild to moderate cases can cause long-term health concerns. NEC can allow bacteria to pass through the intestinal wall into the bloodstream. In advanced cases, bacteria in an infant’s bloodstream can lead to sepsis, a life-threatening, potentially fatal blood infection.

What Are the Signs and Symptoms of NEC?

NEC is diagnosed by a physician through blood or fecal test. NEC may also show up on an abdominal x-ray. It typically presents within the first two weeks of life. According to the Children’s Hospital of Los Angeles (CHLA), the disease occurs in approximately 10% of premature infants.

Generally, NEC presents in premature babies who have been fed formula in lieu of breast milk. Several studies have been conducted linking an increased risk for developing the dangerous infection with a premature infant being exclusively formula-fed. Despite knowing the risks associated with their product, manufacturers of the leading baby formulas have done nothing to warn consumers of the potential health problems. 

Signs and symptoms of NEC as reported by CHLA:

  • Inability to tolerate feedings
  • Abdominal distention (bloating)
  • Vomiting green bile
  • Bloody stools
  • Diarrhea
  • Lethargy or listlessness
  • Low respiratory rate
  • Periodic breathing (apnea)
  • Low heart rate
  • Red, tender abdomen
  • Shock (decreased blood pressure)

Baby in hospital

What Are the Types of NEC?

The Cleveland Clinic notes that NEC is classified into four types depending on when the infant starts exhibiting symptoms and the underlying cause of the condition. Data from the clinic shows that necrotizing enterocolitis affects approximately 1 in 1,000 premature babies and is rare in full-term infants.

The four types of NEC are:

  • Classic – Classic NEC affects infants born prior to 28 weeks of pregnancy and is the most common form of the disease. It generally presents within three to six weeks after a baby is born.
  • Transfusion-associated – Approximately 1 in 3 babies who are born prematurely develop transfusion-associated NEC within three days of getting a blood transfusion.
  • Atypical – Atypical NEC develops within the first week of an infant’s life or prior to a baby’s first feeding. Atypical NEC is rare.
  • Term infant – NEC in a baby that is full-term is rare and may be the result of a birth defect or other condition.

Can NEC Be Fatal?

While many cases of NEC can be resolved through treatment, tragically, some instances of NEC prove fatal. Even in circumstances that are not life-threatening, infants may have to undergo surgery to remove dead or decayed intestinal tissue.

The Cleveland Clinic estimates that 1 in 4 infants with NEC needs surgery as a result of the disease. The condition can cause a hole or perforation in the intestine, allowing bacteria to seep into the bloodstream or abdomen. Surgery is generally required to repair this hole and prevent severe infection, including peritonitis and blood poisoning or sepsis.

If your child was born premature and subsequently diagnosed with NEC, it is strongly recommended that you contact an experienced attorney. NEC baby formula lawsuits are being filed across the country.

What Are the Chances That a Premature Baby Will Develop NEC?

Scientists have been studying the link between necrotizing enterocolitis and preterm infants for over 30 years. 

In one of the most conclusive studies of its kind, researchers found that over 5% of the over 900 preterm infants included in the clinical trial developed NEC. The study, published in the Lancet, found a significantly increased risk of the disease in infants fed cow-milk or bovine-based formulas.

The Lancet study indicated that:

  • Exclusively formula-fed preterm infants were 6-10x more likely to develop NEC compared to those fed breast milk exclusively.
  • Preterm babies fed formula alone were 3x more likely to develop NEC when compared to preterm infants that received a combination of formula and breastmilk.
  • In “stringently confirmed cases,” mortality was 26%.
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What Is the Status of NEC Baby Formula Lawsuits?

Across the country, parents of premature infants are considering or have filed lawsuits against negligent baby formula manufacturers. It is expected that more will be filed.

NEC baby formula lawsuits against the makers of Enfamil and Similac are in the early stages of litigation. No settlement or verdicts have been published. If your premature infant suffered harm as a result of taking cow milk-based formula, contact an experienced product liability lawyer today.

Similac and Enfamil are two of the leading cow milk-based formulas in the world. If your preterm baby developed NEC, a serious bowel disease, after being fed one of these formulas, contact our office to discuss your right to compensation. An NEC baby formula lawsuit may show that the manufacturers knew of the risks to premature infants and failed to warn consumers.

If your child was diagnosed with NEC, please contact Fibich, Leebron, Copeland & Briggs today. We can help you understand your legal rights and whether you qualify to file a lawsuit.

Strong Advocates for Families

At Fibich, Leebron, Copeland & Briggs, our attorneys have extensive experience holding negligent baby product manufacturers liable for their wrongdoing. Defective baby products have caused irreparable damage to countless infants and their families. The companies who make and sell these products must be held legally responsible.

Attorney Erin K. Copeland is a dedicated advocate for women and children. She has been appointed to numerous leadership roles on MDLs across the country. Her pursuit for justice against companies who commit wrongful acts in their design, manufacture, and marketing is evidenced by her involvement in the recent $1.6 billion settlement against Essure manufacturer Bayer.

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Call our office today at (713) 804-6121 to speak with our team.

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What Causes NEC?

While the direct cause may be unknown, health care providers and non-profit organizations like the Cochrane Collaboration are in overwhelming consensus that preterm babies should receive maternal breast milk when available.

Despite having such knowledge, the manufacturers of cow milk-based infant formula failed to adequately warn and heavily marketed usage of their products. Necrotizing enterocolitis (NEC) is almost exclusively present in premature infants who are fed cow milk-based formula. 

NEC can result in any of the following:

  • Perforation of the bowel
  • Bowel blockage
  • Life-threatening infection 
  • Pain and inflammation
  • Developmental delays
  • Intestinal strictures
  • Infant death

A 2011 Johns Hopkins study found that extremely premature babies who were fed human donor milk were less likely to develop NEC. Investigators concluded that these findings “should resolve any residual doubts about the risks and clarify the benefits of human donor milk.” According to their findings, up to 40% of premature babies who develop NEC can die.


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Has Cow Milk-Based Formula Been Recalled?

Despite these findings, formula manufacturers continued to push the safety benefits of cow milk-based formulas. If your infant was fed Similac, Enfamil, or another bovine-based formula after their preterm delivery, contact our office immediately. An NEC baby formula lawsuit may be warranted.

To date, the agency responsible for recalling dangerous products, the U.S. Food and Drug Administration (FDA), has not recalled Similac, Enfamil, or other cow milk-based formulas. These formulas account for nearly 80% of all infant formula sold.

Who Makes Enfamil and Similac?

Enfamil baby formula is made by Chicago-based Mead Johnson & Company (“Mead Johnson”). Similac is manufactured and sold by Abbott Laboratories Inc. (“Abbot”). Neither manufacturer has requested or issued a warning or label change about the potential risks associated with premature infants being fed their product.


Get the Dedicated Legal Representation You Need

If your premature newborn was diagnosed with NEC after being fed Similac or Enfamil, you might have a legal action. Contact our office at (713) 804-6121 for a free consultation. Our experienced legal team has successfully litigated numerous dangerous and defective product cases, obtaining millions of dollars in compensation on behalf of our clients.

The manufacturers of cow milk-based formulas have had ample warning that their product is dangerous if consumed by preterm infants. The risk of developing a bowel infection is at least six times greater than if they had received human breast milk. NEC baby formula lawsuits may prove that the manufacturers knew or should have known of the risk and failed to adequately warn consumers. 

Call Fibich, Leebron, Copeland & Briggs today at (713) 804-6121 to determine if you are eligible to pursue damages against the makers of Enfamil or Similac baby formulas. 

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