NEC Baby Formula Lawsuits: The FDA
What Are the NEC Baby Formula Lawsuits? NEC baby formula lawsuits are finally getting the coverage they warrant. Parents of newborns are probably very familiar with formulas sold under the brand names Similac and Enfamil. Your baby may have been given one of these cow-based formulas or fortifiers at the hospital, especially if your baby was born prematurely.
In some cases, breast milk could be supplemented with these formulas, while in other cases, they might be used exclusively. These cow’s milk-based formulas might not be the best option for your baby, especially if he or she is a preemie. Premature babies have been shown to be at a much higher risk of developing necrotizing enterocolitis (NEC)—a serious, potentially life-threatening intestinal infection.
The gastrointestinal tissues of babies with NEC are often inflamed, potentially resulting in intestinal perforation. When this occurs, bacteria can leak through this intestinal hole into the bloodstream or the belly. NEC typically develops within two to six weeks after birth. Some babies will have only a mild case of NEC, while others may have much more severe symptoms, requiring surgery. Most babies diagnosed with NEC were born before the 37th week (often before the 32nd week) and weigh less than 5 and a half weeks.
Premature infants with other medical conditions are more likely to be diagnosed and adversely affected by necrotizing enterocolitis. Pre-term infants who otherwise appear to be getting healthier may develop NEC within 2-3 weeks following their birth. Many who study NEC believe that the bowel is prevented from producing mucus that protects the gastrointestinal tract. Others believe the cause of NEC is bacteria in the intestine. Infants who have received blood exchange transfusions and infants in a nursery where an outbreak of NEC has occurred are at a higher risk for NEC.
The symptoms of necrotizing enterocolitis may include the following:
Abdominal pain
Swelling of the abdomen
Rapid or unusual changes in body temperature
Changes in heart rate
Vomit that is green or yellow
Lethargy
Refusing to eat
Lack of weight gain
Diarrhea with bloody stool
Metabolic acidosis
Tender stomach
Jaundiced appearance
Low blood pressure
Abnormal breathing patterns
Lack of appetite
Sleep apnea
You may wonder where the FDA stands regarding cow’s milk-based formulas that may have caused NEC. The FDA has not issued a recall for these formulas, nor have they issued warnings to parents and hospitals regarding the potential risks of feeding a premature infant a formula that has a cow’s milk base.
What is the FDA’s Position on Cow’s Milk-Based Baby Formulas? The FDA did issue a recall of baby formula in February 2022, after four infants were affected with Cronobacter sakazakii, and another was infected with Salmonella Newport resulting from formula contamination. Upon inspection of the implicated Sturgis, Michigan facility, the FDA noted there was not a system of process controls in place that would prevent microorganisms from infiltrating the formula. The Sturgis plan reopened in June 2022 after a nationwide shortage of baby formula.
This issue, however, had nothing to do with the implicated cow’s milk-based formulas and fortifiers that appear to be causing NEC among premature babies. And this is an issue that the FDA has so far avoided taking a stance on. As the lawsuits against the manufacturers of the cow’s milk-based formula and fortifiers continue to mount, the FDA may have no choice but to weigh in and recall some of these formulas and fortifiers. At present, the following cow’s milk-based formulas and fortifiers have been implicated in infant NEC cases:
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
Since infant formula is considered food, the FDA uses the in-place laws and regulations that govern foods to also govern infant formula although there are additional statutory and regulatory requirements. These additional requirements are in place because infants are considered a vulnerable population. Infant formula is often used as the singular source of nutrition for infants during critical developmental and growth periods. As such, the FDA has certain nutritional requirements for infant formulas which specify a minimum amount for 29 separate nutrients and maximum levels for 9 nutrients.
Baby formulas that do not properly meet these minimum and maximum nutrient levels are “adulterated,” unless the formula is exempt. An exemption is possible among baby formulas that are specifically manufactured and marketed for low-birth-weight babies or those with metabolism issues. The FDA does not approve infant formulas prior to those formulas being marketed, only requiring that the manufacturer provide “elements and assurances required for a new or reformulated infant formula.” The FDA does have the authority to take action when there is a question regarding the safety of infant formula.
What Are the Risks of Developing NEC for Premature Babies? According to an NCBI article, as many as 12 percent of infants who weigh less than 3.3 pounds at the time of their birth will develop NEC and of that 12 percent, almost a third will not survive. The economic costs are also high—more than $5 billion per year, accounting for almost 20 percent of all neonatal expenses. An infant who is diagnosed with NEC will stay in the hospital at least 22 days longer than other premature infants if no surgical intervention is required. When surgery is required, those infants will stay an additional 60 days in the hospital. Cow’s milk-based formula has been proven to increase the likelihood of NEC among infants.
Those infants receiving both breast milk and formula are about three times more likely to develop NEC while infants receiving only formula are six to ten times more likely to develop NEC. Low birth weight babies and premature babies have an even higher risk of developing NEC when fed cow’s milk-based formula. Premature babies are much more susceptible to NEC because of something known as immature Paneth cells. The Paneth cells are the immune response cells in the intestines; studies showed that Paneth cell disruption and formula milk created these NEC injuries.
The manufacturers of baby formula almost exclusively use cow’s milk as a component in their formula recipes. Newborn ICUs typically feed preemies formulas like Enfamil Premature and Similac Special Care as a means of adding calorie-dense food to a premature baby’s diet. Unfortunately, the risks associated with NEC significantly outweigh the benefits of formula based on cow’s milk.
Why You Should Consider an NEC Baby Formula Lawsuit The FDA has not yet issued warnings regarding the use of cow’s milk-based baby formulas and the increased risk for premature babies to develop potentially deadly NEC. In the absence of FDA oversight on this issue, parents across the U.S. are filing Similac and Enfamil lawsuits against manufacturers Mead Johnson and Abbott Laboratories. These NEC baby formula lawsuits are considered a type of product liability lawsuit.
There are three types of defects that can lead to a product liability lawsuit. Design defects encompass inherently unsafe qualities or characteristics in the overall design of the product. In the case of baby formula, the fact that ingredients may be used in these cow’s milk-based formulas that are known to expose babies to an increased risk of NEC constitutes a design defect. A manufacturing defect means that the defect occurred during the creation and/or transportation of a specific product.
Regarding these cow’s milk-based formulas, a manufacturing defect would be something like a contamination error in a specific plant or incorrectly printed expiration dates on the formula. The third type of defect is a marketing defect. When a product is marketed or labeled incorrectly or information regarding the product is materially misrepresented, then a marketing defect has occurred. Since the manufacturers of the baby formulas in question have failed to warn consumers of the increased NEC risk when their formula is used for premature babies, this could be considered a marketing defect.
Should you choose to proceed with a baby formula lawsuit, remember the elements of such a suit. The product must have caused injury, the injuries must be the result of some type of defect that directly caused the injury, and you used the product in the way it was intended. These elements are easily proven in an NEC baby formula lawsuit. It is extremely beneficial to speak to an experienced NEC baby formula lawsuit attorney. Your attorney can answer any questions you may have regarding a necrotizing enterocolitis lawsuit and help you determine whether a baby formula lawsuit is right for you. A knowledgeable NEC baby formula lawyer from Sullo & Sullo can help you through this difficult time in the best way possible.
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.
