NEC Baby Formula Lawsuits: The Issues

What Are NEC Baby Formula Lawsuits and Where Does the FDA Stand? You may have heard of the NEC baby formula lawsuits but are not entirely sure what the issue is. As the parent of a newborn, you likely saw the cow’s milk-based formula brands Similac and Enfamil constantly. In fact, the hospital may have given you formula samples, and they were likely one of these brands. Unfortunately, cow’s milk-based infant formula may not be the best option for your baby, especially for premature babies. Studies have shown that premature babies are at a higher risk of developing necrotizing enterocolitis (NEC). Necrotizing enterocolitis is a very serious, even life-threatening intestinal infection. 

NEC inflames the gastrointestinal tissues, potentially resulting in a perforation in the baby’s intestine. Bacteria can then leak into the belly or bloodstream through this hole. Typically, NEC will develop within two to six weeks after birth and could be mild or very severe. Babies who have NEC are likely to be born before the 37th week of pregnancy and weigh less than 5 ½ pounds at birth. Some of the babies that develop NEC may have been fed through a tube in their stomachs. Symptoms of NEC in newborns include:

  • Abdominal pain
  • Swelling of the abdomen
  • Changes in body temperature
  • Changes in blood pressure or heart rate
  • Changes in breathing
  • Vomit that is green or yellow
  • Lethargy
  • Refusing to eat
  • Lack of weight gain
  • Diarrhea with bloody stool

Lawsuits have been filed against Mead Johnson and Abbott for failure to warn consumers about the risk of NEC in premature infants. The lawsuits that have been filed state that Mead Johnson and Abbott failed to warn parents about the potential risk of NEC when the formulas Enfamil and Similac are used—especially when used for premature babies. Almost 50 percent of all cases of NEC among premature infants will be fatal when deadly blood infections or serious illness results from bacteria from the intestine leaking into the abdomen or blood.  

There are many specific formula brands that are the target of NEC lawsuits including:

  • Similac Alimentum and Alimentum Expert Care, Similac NeoSure, Similac Human Milk Fortifier powder and concentrated liquid, Similac Special Care, Similac Liquid Protein Fortifier, Similac Special Care 20, Similac Special Care 24, Similac Special Care 24 High Protein, Similac Special Care 30, Similac Human Milk Fortifier Hydrolyzed Protein—Concentrated Liquid
  • Enfamil Human Milk Fortifier Acidified Liquid (and powder), Enfacare Powder, Enfamil Premature 20 Cal, Enfamil NeuroPro Enfacare, Enfamil Milk Fortifier Liquid Standard Protein, Enfamil Human Milk Fortifier Liquid High Protein, Enfamil Premature 24 Cal, Enfamil Premature 24 Cal HP, Enfamil Premature 30 Cal, Enfamil 24 DHA and AR Supplement

There are currently no NEC warnings by Mead Johnson or Abbott Laboratories regarding Enfamil and Similac products. As a result, parents are suing via Similac and Enfamil lawsuits for extensive emotional distress and financial losses related to their baby’s NEC injuries or death. Your baby may have been fed Similac or Enfamil while in the hospital, with or without your knowledge, or you may have fed your baby Similac or Enfamil after you and the baby were home from the hospital. It is beneficial to keep all receipts, proof of purchases, or even boxes or packaging as evidence in the event your baby becomes sick, and you file an NEC baby formula lawsuit.  

The FDA has not issued a recall of the cow’s milk-based formulas in association with NEC, however, in February 2022, Abbott Nutrition issued a baby formula recall for certain lots of Similac, Elecare, and Alimentum products that were manufactured at the Sturgis, Michigan facility. Four infants were infected with Cronobacter sakazakii, while one baby was infected with Salmonella Newport as a result of formula contamination. Two of those babies died from the contamination. In March 2022, following an inspection of the Sturgis facility, the FDA’s preliminary report stated that there was no system of process controls in place to prevent microorganisms from “adulterating” the infant formula. In the wake of the baby formula shortage, the Sturgis plant reopened in June 2022.  

What Are the Short and Long-Term Injuries to Premature Babies that NEC Baby Formula Can Cause? Necrotizing enterocolitis is both the most common intestinal disease among premature babies and potentially the most severe. NEC in infants results in the intestine no longer being able to hold waste, thus bacteria can pass into the bloodstream, triggering a potentially life-threatening infection. The injured portion of the intestine can die, requiring surgical removal. Causes of NEC include an underdeveloped intestine as seen in premature babies, formula feeding with cow’s milk-based formulas (breastfed babies are significantly less likely to develop NEC), injury to the lining of the intestine, and lack of oxygen or blood flow to the intestine (whether at the time of birth or later).

While babies born prior to 32 weeks gestation are the most likely to develop NEC symptoms, babies born between 32 and 37 weeks are the next group most likely to develop NEC. NEC in newborns is also seen in full-term babies with other health problems. Typically, babies who develop NEC will do so within the first four weeks of life. An NEC diagnosis can be confirmed by an X-ray with an abnormal gas pattern. A severe case of necrotizing enterocolitis might be confirmed when air shows up in the large veins of the liver or the abdominal cavity. A physician may insert a needle into the baby’s belly to withdraw fluid and determine whether there is a hole in the intestine.

Short-term symptoms of NEC in newborns include a swollen, red, or tender belly, lack of appetite, difficulty feeding, constipation or diarrhea, dark, bloody stools, lethargy or being less active, sleep apnea (pauses in the baby’s breathing), vomit that contains bile, a slowed heart rate, and low blood pressure. If NEC is suspected, the baby’s belly size will be checked regularly, since a hold in the intestine will make the belly swell. If the baby’s condition worsens, he or she may require surgery to remove dead or dying intestinal tissue, then repair the intestine.

Depending on the severity of the NEC, your baby could recover fully and have no further feeding problems or could have long-term issues related to the NEC.  One long-term NEC symptom is malabsorption, which occurs when the intestine is unable to absorb nutrients normally. This can cause lasting problems and is more common among babies who were required to have a part of their intestine removed. 

Babies with malabsorption are unable to get the nutrients they need from their food and may need to have nutrition delivered directly into a vein until the intestine is healed sufficiently to return to normal feeding. Other long-term effects of necrotizing enterocolitis include strictures and adhesions, short bowel syndrome, cholestasis, failure to thrive, and neurodevelopmental delays.  

How Can an NEC Baby Formula Lawsuit Lawyer Help? If your baby developed necrotizing enterocolitis symptoms, it can be extremely beneficial to speak to an NEC baby formula lawsuit lawyer to determine what you should do next. If your baby became ill or died as a result of one of the cow’s milk-based formulas listed above, you may consider filing a baby formula lawsuit against the manufacturer. The Illinois Judicial Panel for Multidistrict Litigation (MDL 3026) consolidated 97 NEC baby formula lawsuits in August 2022.

There is a separate class action MDL 3037 in Illinois specifically for Abbott’s recalled infant formulas as mentioned above. Litigation for the NEC MDL cases is in the initial stages, with the process of bellwether trial selection beginning in November 2022. The first trials are expected in early 2024.  If your baby developed necrotizing enterocolitis as a result of these baby formulas, having a highly experienced NEC baby formula lawsuit lawyer by your side can significantly improve your chances of a fair settlement.

Understandably, this is a very difficult time for you and your family. While no amount of money can change what happened to your baby, a monetary settlement accomplishes a number of different things. First, large corporations rarely change their behavior unless their financial bottom line is affected. When a large corporation is forced to pay out millions of dollars to those they harmed, they are more likely to both correct the current problems and to be more vigilant in ensuring safety standards are in place and are being properly met in the future.

A monetary settlement also allows you and your family to move forward in the best way possible. Your baby may require future medical interventions for months, years, or even longer as a result of Necrotizing Enterocolitis symptoms. These treatments can be expensive, even when the family is insured. To combat the long-term effects of short bowel syndrome, inadequate digestion, and poor growth, the following medical treatments may be required: IV antibiotics, prolonged hospitalization, respiratory support, extended bowel rest with total parenteral nutrition, placement of a peritoneal drain, or a laparotomy. Your knowledgeable, highly-skilled NEC baby formula lawsuit lawyer from Sullo & Sullo can answer all your questions, explaining the Similac and Enfamil lawsuits to you in a thorough, yet easy-to-understand manner.

DISCLAIMER: Statutes of Limitations limit the amount of time that an individual has to file a lawsuit, and not only vary from state to state, but also vary by cause of action. The information provided above and in the state-specific pages in this section is meant as a general guide, and is for informational purposes only. Each client’s case is unique, and the specific circumstances of any individual case can have significant bearing on the applicable statute of limitations. Any person who believes they may have a viable cause of action is strongly encouraged to consult with an attorney about the statute of limitations for his or her case. Attorney Andrew Sullo is licensed to practice law in Texas, and can prosecute cases that are part of a federal multi-district litigation. Andrew Sullo does not practice law in any other state, and is not certified by the Boards of Legal Specialization in any state. Not all states have board certifications. This information is not intended to solicit clients for matters outside of the State of Texas. Our firm is not accepting cases in any state where it would be impermissible for it to do so. Sullo & Sullo, LLP maintains its principal office in Houston, Texas.

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