Babies born preterm require additional nutrition to encourage their growth and development. However, most premature babies aren’t physically capable of feeding by breastfeeding, so they’re instead fed on infant formula. Similac and Enfamil are the most common brands of baby formula. These two brands have been linked to necrotizing enterocolitis (NEC). So is it true that these two formulas cause NEC? We will find that out in this blog.

What Is NEC?

NEC is a gastrointestinal bacterial infection that mostly occurs in premature babies. This infection leads to inflammation that might result in the death of intestinal tissues. Doctors treat the infection by antibiotics or, if need be, an abdominal repair surgical procedure.

NEC might result in severe health complications and problems, such as cerebral palsy, development problems, intestinal tissue perforation, intestinal strictures, and possible death. NEC symptoms may include:

  • Shock (in progressed cases)
  • Apnea
  • Lethargy
  • Hypotension (low blood pressure)
  • Distended abdomen
  • Vomit that’s green or yellow
  • Ileus
  • Delaying gastric emptying and constipation
  • Dark or bloody stools
  • Trouble gaining weight and eating
  • Diarrhea with blood
  • Painful, red, or tender abdomen
  • Bradycardia (slowed heart rate)
  • Decreased peripheral perfusion
  • An unstable or low body temperature
  • Cardiovascular collapse (progressed stages)
  • Abdominal wall erythema (progressed cases)

About 480,000 babies are born in the United States every year. Out of those, approximately nine thousand develop NEC. And 90 percent of these cases occur in preterm babies. There are four types of NEC— Classic NEC, term infant NEC, Atypical NEC, and transfusion-associated NEC.

Cow Milk Problems

Most infant formulas are derived from cow’s milk with different ingredients and nutrients added to resemble a mother’s breast milk. Latest scientific studies have indicated that baby formula derived from cow milk can put babies at a higher risk of developing a deadly neonatal disease known as NEC.

While reaping profits worth billions, the makers of these baby formulas have ignored the research over the past thirty years that has informed us that formulas derived from cow milk cause an overload of sepsis-causing bacteria in the preterm babies’ stomachs. The bacteria then create holes in the infants’ bowels, leading to infection and bleeding.

NEC in Preterm Babies Caused by Similac and Enfamil

NEC only develops in one out of two thousand full-term babies born in the United States. However, the disease is more common in preterm babies. It occurs in approximately ten percent of all preterm babies (infants born before thirty-seven weeks).

The precise cause of necrotizing enterocolitis isn’t fully understood. However, several clinical and scientific studies definitively prove that infant formulas derived from cow milk, for instance, Similac and Enfamil, substantially increase the possibility of a preterm baby developing NEC. These studies reveal that NEC generally develops in two-to-six week old preemies.

The Lancet-Published Study

One of the first studies showing a possible connection between NEC and cow milk-derived formulas was published in The Lancet in 1990. This study found that babies fed on formulas were ten times highly likely to suffer from NEC.

Study Published In The Journal of Pediatrics

After ten years since the first study, another study published in the Journal of Pediatrics had similar conclusions. The study found that babies fed on human milk fortifiers or breast milk were 90 percent less likely at risk of suffering from necrotizing enterocolitis compared to infants fed on the traditional formula.

Another study conducted several years after followed over nine thousand preemies. It revealed that:

  • The chances of formula-fed preemies suffering from NEC were 6-10 times higher than premature babies who were given breast milk
  • Preterm infants given formula were three times more likely to suffer from NEC than preterm babies fed on both formula and breast milk

In 2011, various hospitals concluded that preterm infants fed on human donor milk were at a lower risk of developing NEC than those fed on cow milk-based formula. Additionally, in the same year, the United States Surgeon General stated that formula feeding is linked to a higher NEC rate for vulnerable premature babies. In 2012, the health professionals representing the American Academy of Pediatrics announced that preterm infants should be given only breast milk since cow milk formula had a significant risk of NEC.

Two more studies published in the Journal of Pediatrics in 2013 drew more conclusive findings on the connection between bovine formulas and NEC. 

New Necrotizing Enterocolitis British Medicine Study

New research findings published in the British Medical Journal on 14th October 2021 mention that the manufacturers of baby formulas like Similac and Enfamil funded unreliable and biased clinical trials for these products. The researchers discovered that the baby formula clinical trials universally lacked transparency and might have downplayed NEC risks linked to their bovine formula products.

Additional Studies Linking Baby Formula to NEC

More studies to prove cow milk-based formula causes NEC are: 

  • A cycle of clinical research findings was published in 2017 (HUM diet is the feeding strategy of preventing NEC— Semin Perinatol) and 2016 (Beyond NEC Prevention— Breastfeeding Medicine). These findings show that extremely preterm babies exclusively fed on Human Milk (HUM) diet registered a substantially lower risk of death and NEC. The group that fed exclusively on human milk also experienced a decrease in BPD (bronchopulmonary dysplasia), ROP (retinopathy of prematurity), and LOS (late-onset sepsis). This multicenter research emphasizes the benefits of exclusively feeding on the human milk diet and shows improved results after implementing the HUM diet feeding protocol.
  • Research findings on Evidence-Based Feeding Strategies Before and After NEC Development (Expert Review of Clinical Immunology. July 2014) stated that NEC is a distressing disease of preterm babies, leading to mortality or significant morbidity. It’s well established that the risk of NEC is increased by infant formula administration.
  • In 2019, an independent medical care research team known as Cochrane released the findings of the most detailed research to date, which compared medical results for preterm infants fed with human milk versus cow milk-derived formulas. The Cochrane study results brought to a close any unsettled debate about whether there’s a relationship between NEC and bovine-based formulas in preterm infants.

Several Parents Have Also Come Forward Claiming Their Babies Developed NEC after Feeding on Baby Formula

An increasing number of parents who fed their babies on Similac or Enfamil baby formula claims that their infants developed NEC afterward. These parents are bringing product liability suits against the baby formula manufacturers for negligently failing to warn. These lawsuits claim that the formula manufacturers had an obligation to warn their consumers about the risk of developing NEC after using their products but intentionally failed to do so and continue to market the formulas as safe.

Similac is made by the Illinois-based Abbott Laboratories, a large company that manufactures healthcare products and medical devices. On the other hand, Enfamil is manufactured by Mead Johnson Company, also based in Illinois. Apparently, Abbott Laboratories and Mead Johnson knew very well that scientific proof existed, deducing that their bovine-based baby formulas presented a significantly higher NEC risk in preterm babies. Despite knowing the connection between their formula products and the NEC risk, the companies intentionally opted not to attach any warning label or tag about the risk of NEC on their formula labeling.

Altering or adding a warning label on infant formula under FDCA (the U.S Federal Food, Drug, and Cosmetic Act) isn’t difficult. In fact, it’s much easier to alter/add a warning label under FDCA than altering or adding, for instance, a warning label on a given medication.

So why did these companies fail to include a warning on their products? Well, it isn’t clear yet. These infant formula suits are just starting. However, depending on existing facts, it isn’t hard to predict that the failure to warn was all for the cash. A warning would lead to decreased sales. Decreased sales would, in turn, result in fewer profits.

Despite the growing scientific evidence that their infant formulas presented a higher risk for preterm babies to suffer from NEC, Abbot and Mead have failed to caution consumers concerning this risk and have continued to market the formulas as safe.

Examples of Lawsuits Claiming the Link between Infant Formula and NEC

On 18th October 2021, plaintiff Abigail Grosshuesch brought a lawsuit in Illinois State against Enfamil manufacturer Mead Johnson Nutrition Company and Mead Johnson & Company, claiming negligence plus other allegations. Mrs. Grossshuesch alleges that she gave birth to a preterm baby in 2013. She says that initially, she fed the baby on her breast milk and the infant was doing okay, progressing normally. Fourteen days after giving birth, she fed that baby Enfamil for some days. The suit alleges that the Enfamil made the baby develop necrotizing enterocolitis, requiring medical intervention.

Unfortunately, the baby passed away seven days later from NEC complications. The lawsuit alleges that the Enfamil manufacturer failed to warn. It alleges that the company was aware of the risk of its cow milk-based formula yet failed to give sufficient warnings about NEC being linked to the formula.

On 22nd November 2021, Jo Shandria White filed a suit in Illinois against Mead Johnson Nutrition Company, Mead Johnson & Company, and Abbott Laboratories. The suit claims strict liability for failure to warn, strict product liability for design defect, negligence, negligent misrepresentation, intentional misrepresentation, loss of consortium, and violation of the consumer fraud and deceptive business practices act.

Per this lawsuit, Mrs. White’s baby, Khelil White, suffered NEC after feeding on the bovine-based Similac and Enfamil infant formula made by the respondents. Mrs. White gave birth to a premature Khelil White on 19th November 2019 in Texas and fed him human milk fortifier, a bovine-derived product. This product led to the baby going through a surgical procedure that he didn’t survive.

White claims that none of the respondents gave warnings, either through marketing or on their product labels, that the products weren’t safe or could harm preterm infants. She further alleges that the respondents didn’t provide statistical data on the link between infant formulas and NEC development. She alleges that the companies’ actions make them negligent.

The lawsuit states that White was made to suffer sorrow, grief, mental suffering, emotional distress, loss of enjoyment of life, and loss of cash, goods, services, society, and benefits. She, therefore, seeks to recover compensatory damages and damages for:

  • Future, present, and past loss of enjoyment of life, emotional distress, mental anguish, pain & suffering, and other non-economic losses
  • Future, present, and past lost wages and out-of-pocket expenses
  • Lost profits, revenue, earning capacity, and business opportunity
  • The cost associated with mental health or medical treatment, attorney’s fees, interest, and the cost of the lawsuits

Since Feb 2012, thirty-three NEC infant formula suits have been filed in Illinois. Consequently, Illinois has become a hot spot for the sprouting NEC formula lawsuits since the headquarters of both Similac and Enfamil manufacturers is in Chicago.

Litigation is still very fresh. New suits come every week against Similac and Enfamil manufacturers for supposedly causing infants to develop NEC. Causes of action in most of these suits are:

  • Wrongful death suits (if the baby died)
  • Breach of warranty
  • Negligent misrepresentation
  • Intentional misrepresentation
  • Negligence
  • Strict liability for failing to warn
  • Strict product liability for design defect

These lawsuits will likely be consolidated into a multi-district litigation (MDL) in a United States District Court. Multidistrict litigations are a means to speed up the pretrial and settlement procedure. They’re similar to class-action suits, except that for an MDL, cases remain separate.

Parents are also filing federal and state court medical malpractice lawsuits against hospitals whose neonatal intensive care unit (NICUs) fed their infants Enfamil or Similac baby formula.

Find a Similac or Enfamil Baby Formula Mass Tort Attorney Near Me

Our duty at Consumer Alert Now is to inform consumers across the country of the dangerous products circulating in the market, which can cause serious medical conditions. Not only that. We also work with legal experts to help consumers find the answers to questions about harmful products and related product liability lawsuits, mass torts, or class-action suits. If a dangerous product has harmed you in any way, we’ll help hold the responsible party liable by linking you up with an experienced attorney to fight for you. Several lawyers are currently investigating potential Similac and Enfamil lawsuits across the country. If your baby took either of these baby formulas and subsequently suffered NEC, contact us at 800-511-0747, and we will connect you to one of these lawyers.