What You Need to Know About the NEC Baby Formula Lawsuit
Parents have filed lawsuits against baby formula makers after their children suffered necrotizing enterocolitis (NEC), a serious and life-threatening condition.
If your newborn was diagnosed with NEC, you might wonder whether this lawsuit affects you and your rights. Naturally, you want to know whether someone is at fault. Don’t hesitate to reach out to Gerling Law to learn more about the Similac lawsuit and whether you have a right to demand compensation for your child.
You can reach us online through our contact form or call to schedule a consultation. We represent families nationwide and throughout Illinois, Indiana, and Kentucky and have offices nearby in Evansville, Indianapolis, Owensboro, and Louisville.
What Is NEC?
NEC is a gastrointestinal disease that primarily affects premature infants. Babies most at risk for the condition are those:
- Born before 37 weeks,
- Fed through a stomach tube (enteral nutrition), and
- Who weigh less than 5.5 lbs. at birth.
While NEC affects about 1 in 1,000 premature infants, it impacts only 1 in 10,000 full-term babies.
NEC is a result of a serious bacterial infection in the gastrointestinal system of infants. This condition leads to inflammation in the intestines, which causes rapid decay and death of tissue in the baby’s inner intestines, starting with the inner lining and progressing to encompass the entire thickness of the intestine.
Cases of NEC can range from mildly uncomfortable to severe and life-threatening. A review of NEC data found NEC continues to be one of the leading causes of illness and death among preterm infants. Fifteen to forty percent of infants with NEC die from the disease.
Fatalities occur when serious cases cause a hole to form in the intestinal wall as the tissue dies. Bacteria leaks into the abdominal cavity through the perforation.
An infection reaching the bloodstream could result in sepsis, which is deadly, especially in newborns. There can be permanent consequences even if the baby survives.
What Are the Signs of NEC?
Between two and six weeks after birth, an infant may show signs of:
- Abdominal pain and swelling,
- Changes in heart rate and blood pressure,
- Changes in body temperature,
- Changes in breathing,
- Diarrhea and bloody stool,
- Green or yellow vomit,
- Refusal to eat and lack of weight gain or weight loss, and
- Sleepiness and unresponsiveness.
A doctor will examine the infant and may run blood and fecal tests and X-rays to diagnose NEC.
How Do Doctors Treat NEC?
Because the infant’s intestines need to heal, doctors will stop oral or tube feedings and give the baby nutrients through an IV. They may insert a long tube through the child’s nose or mouth into the stomach to remove gas and fluid. They may also prescribe antibiotics to fight the infection.
The infant might require surgery to repair a hole in their intestine or remove dead intestinal tissue in more serious cases. Sometimes, doctors surgically place a drain in the baby’s abdomen to remove fluids and gas.
What Causes NEC?
Doctors and scientists don’t know the exact cause of NEC. However, numerous studies and papers have discussed the link between cow-milk-based formula and NEC. It is more common for premature infants with less developed digestive systems.
For example, a study published in 1990 connected NEC to cow-milk-based infant formula. In a study involving 926 preterm infants, NEC was 6 to 10 times more common in formula-fed babies than those given breast milk only or a combination of breast milk and formula.
A more recent study published in 2019 reviewed 12 complete trials involving 1,871 infants. The trials found formula almost doubled the risk of NEC.
Data from a 2021 study following infants in the NICU receiving formula versus pasteurized donated human milk (PDHM) determined that infants receiving formula are at increased risk for transfer for suspected NEC compared to those receiving PDHM.
The American Academy of Pediatrics also found that giving preterm infants human milk reduced the risk of NEC. According to the AAP, “One case of NEC could be prevented if 10 infants received an exclusive human milk diet, and 1 case of NEC requiring surgery or resulting in death could be prevented if 8 infants received an exclusive human milk diet.”
According to 2020 US Census data, 3.22 million Americans used Enfamil baby formulas, and 3.18 million Americans used Similac baby formulas.
Baby Formula Lawsuit Legal Foundation
Baby formula lawsuits have been surfacing for over a decade. Typical causes of action in these lawsuits are:
- Strict product liability for design defect,
- Strict liability for failure to warn,
- Intentional misrepresentation,
- Negligent misrepresentation,
- Breach of warranty, and
- Wrongful death lawsuits (if the infant passed away).
If you suspect that your baby has been impacted by NEC caused by milk replacement formula, you may have the right to file a lawsuit. There are two major components of product liability at play when evaluating the validity of a lawsuit against Similac and other baby formula producers. These are failure to warn and product defectiveness.
The makers of the formula have a duty to warn the public about potential dangers that could arise from product use. Given previous studies, the company knew or should have known that the formulas were flawed or ill-fit for higher-risk infants. Their labeling does not mention the risk of NEC.
An argument could potentially be made that Similac, Enfamil, and similar products were defectively designed. Manufacturers could have used fortified human breast milk as a substitute for cow’s milk, and the manufacturer was aware of the option for this alternative design. The court may or may not take production costs into consideration.
Baby Formula Lawsuit Updates 2022
The first Similac lawsuit of 2022 was filed in January against Abbott Laboratories. For two weeks, a premature infant was fed Similac in the NICU for nearly half of his nutrition. He demonstrated symptoms of gastrointestinal distress, was diagnosed with NEC, and underwent surgery. He could not be saved.
In May 2021, parents filed a wrongful death lawsuit against Abbott Laboratories and Mead Johnson & Company, LLC, the makers of Similac. The parents allege the infant formula caused NEC and their child’s death.
In June 2021, another family filed a lawsuit against Abbott and Mead Johnson, claiming their son suffered serious injuries from developing NEC. Their son was given Similac and Enfamil products at the hospital after his premature birth.
Similac and Enfamil are high-calorie, cow-milk-based formulas. The parents allege the formulas increase the risk of NEC, yet the makers didn’t include warnings on the product labels. These same allegations provoked a class action lawsuit against Similac in 2010 when the product was found to contain insects.
In 2017, a class-action lawsuit was filed for misrepresentation about the non-GMO status of products labeled for non-GMO. The products were found to have GMO soybeans.
Baby Formula Recalls
There has been no recall of formula related to a Similac lawsuit, but there have been isolated store recalls for product tampering. In some instances, mothers reported that their Enfamil products contained flour instead of formula. Some babies reportedly incurred bacterial infections, some of which resulted in death. Despite the reports, the FDA tested the formula and found it to be safe.
In February 2022, Abbott Nutrition recalled certain lots of Similac, EleCare, and Alimentum. All of the recalled products were manufactured at its Sturgis, Michigan facility. Four babies suffered Cronobacter sakazakii infections, and one baby became infected with Salmonella Newport. Two of the babies died, and the FDA and Abbott are still investigating. This recall was unrelated to the Similac formula lawsuit.
Similac and Enfamil products are not the only baby formulas to have been recalled in the last few years.
- In 2019, Perrigo Company voluntarily recalled containers of Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron due to the potential presence of metal foreign matter.
- In 2016, Sammy’s Milk Baby Food Powdered formula was recalled for failure to adhere to federal manufacturing regulations. The product was also not tested for Cronobacter.
- In 2012, Gerber Baby Gentle Start Formula was recalled because of a bad smell in the product.
Who Qualifies for a Baby Formula Lawsuit?
Families who had a premature infant diagnosed with NEC after being fed baby formula may be able to file a lawsuit. This may also apply to some full-term babies depending on a number of factors. You may be entitled to compensation.
The more information you have about the type of formula and frequency of delivery, the better your chances are of winning your case. There are multiple types of baby formula.
Find out if the hospital administered formula and what kind. Do your best to calculate how long your infant was receiving the formula before the NEC diagnosis. Your lawyer may be able to help you gather this information from the hospital.
You may have fed your baby Similac formula products or other potentially harmful baby formulas post-hospitalization. We encourage you to keep any receipts, proof of purchase, or packaging from the formula for evidence.
Your baby’s doctor will be called upon to provide written or oral testimony about the symptoms and diagnosis.
How Much Can I Get for My Baby Formula Lawsuit?
The amount you can receive for your baby formula NEC lawsuit depends on a number of factors.
Damages may include the following:
- Medical costs: Families may receive financial compensation for medical expenses associated with NEC caused by baby formula. These costs can be extensive and ongoing. If your infant survived NEC, it is important to take future costs into consideration.
- Lost wages: Caring for a sick baby often results in the inability to work. Forgone wages may be recoverable.
- Pain and suffering: The symptoms of NEC make it very clear that this condition is painful. It can also leave lasting effects.
- Wrongful death damages: Nearly one in three babies who develop NEC will not survive. When this happens, the family is entitled to compensation for their loss. These may include funeral expenses, the mental anguish of the family, and more.
Each case is different. The amount you receive for your Similac lawsuit will be unique to your family’s circumstances. An experienced attorney can help you make the most out of this difficult situation.
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Has Your Child Suffered From NEC?
If your preemie was diagnosed with NEC, talk with their medical providers about your child’s nutrition before symptoms began. If your child was fed a cow-milk-based formula, such as Similac or Enfamil, contact Gerling Law.
We’re experienced personal injury and mass tort lawyers. We’ve represented many individuals harmed by dangerous and defective consumer products. We want to hear your story and talk with you about whether you have a right to demand compensation.
Give us a call or use our online form to schedule a free case evaluation.