The American Academy of Pediatrics (AAP) recommends breast milk as the best nutrition for infants. But what's best isn't always possible. In some situations, health care providers recommend infant formulas and human milk fortifiers (nutritional boosters) for babies who are born prematurely (before 37 weeks) or with other health complications.
Most babies tolerate formula well. But some formula-fed babies, particularly premature babies who are fed cow's milk-based formulas, develop a life-threatening gastrointestinal disease called NEC. Starting in January 2020, hundreds of parents of premature infants have filed baby formula lawsuits against Mead Johnson (makers of Enfamil) and Abbott Laboratories (makers of Similac) for NEC-related harm caused by their popular formulas.
You might have a baby formula-related personal injury claim if all of the following are true:
Start here to understand the link between baby formulas and NEC and find out how much a baby formula lawsuit might be worth.
Necrotizing enterocolitis—or NEC (pronounced "neck")—is a life-threatening gastrointestinal disease in newborns. Premature infants are especially vulnerable to NEC because of their underdeveloped digestive and immune systems.
NEC develops when a baby's large intestine (colon) gets inflamed, causing parts of it to die. A hole (perforation) can form in the damaged intestine, allowing harmful bacteria to leak into the abdomen and bloodstream. Complications of NEC include:
Treatments for NEC include antibiotics, a nasogastric tube, and surgery.
Doctors aren't sure exactly what causes NEC. But scientific studies and peer-reviewed articles have shown that babies who are fed cow's milk-based formulas, like Enfamil and Similac, are significantly more likely to develop NEC than babies who are fed their own mother's breast milk, pasteurized donor breast milk, or formula and milk fortifiers (boosts of extra nutrition) derived from pasteurized breast milk.
In 2011, the U.S. Surgeon General acknowledged that, for premature infants, formula feeding is associated with higher rates of NEC.
Enfamil and Similac are the cow's milk-based formulas most commonly fed to premature babies in neonatal intensive care units (NICUs) all over the country.
As of 2023, the U.S. Food and Drug Administration (FDA) hasn't recalled Enfamil or Similac formulas over links to a baby's risk of developing NEC. But the manufacturers of Enfamil (Mead Johnson) and Similac (Abbott Laboratories) have initiated their own recalls over manufacturing defects in particular batches of their formulas.
For example, in February 2022, Abbott voluntarily recalled certain lots of Similac, Similac PM 60/40, Alimentum, and EleCare and halted production at one of its plants after the FDA cautioned parents and caregivers that the formulas may be linked to Cronobacter (a life-threatening infection or inflammation of the membranes that protect the brain and spine) and salmonella (a group of bacteria that can cause digestive illness and fever).
NEC-related product liability lawsuits aren't limited to specific batches of formulas. Instead, they claim that parents and health care providers aren't properly warned about the dangers of feeding cow's milk-based formulas to premature babies ("failure to warn") and the formulas are inherently dangerous for premature babies ("defectively designed").
Most baby formula lawsuits are brought by parents alleging one or both of these legal arguments:
Let's take a closer look at how medical care providers and manufacturers might be at fault for your baby developing NEC.
Some parents are filing medical malpractice lawsuits against health care providers and hospitals who authorized feeding their premature babies cow's milk-based formulas.
Medical malpractice and product liability are special types of personal injury cases. Parents of premature infants who develop NEC can file a product liability, a medical malpractice lawsuit, or both.
Your infant's NEC-related injury or death could be the result of medical negligence if:
Some parents (plaintiffs) are pursuing defective product claims against Mead Johnson and Abbott Laboratories (defendants). Specifically, many parents target the manufacturers' "failure to warn" by arguing:
Product liability plaintiffs can make more than one legal argument. In addition to alleging that Enfamil and Similac formulas were marketed and sold with inadequate warnings, some plaintiffs claim that the formulas are unreasonably dangerous (defectively designed) and that Mead Johnson and Abbott Laboratories falsely represent (in ads and marketing materials) that their formulas are safe and effective for premature babies (breach of warranty).
As of March 2024, around 400 NEC-related baby formula lawsuits were pending in federal court against Abbott Laboratories and Mead Johnson. The Judicial Panel for Multidistrict Litigation consolidated the lawsuits over NEC claims in Illinois MDL-3026. Consolidation is common in cases involving similar harms that affect large numbers of plaintiffs, like asbestos litigation and other mass torts. The goal of consolidation is to encourage settlement and save time and resources.
The first NEC-related jury trial was heard in early 2024. An Illinois jury returned a $60 million verdict against Mead Johnson over the death of a premature baby who was fed Enfamil and then developed NEC. The jury found that Mead Johnson was negligent and failed to adequately warn users of the risk of feeding cow's milk-based formulas to premature infants. In response to the verdict, Mead Johnson released a statement standing by the safety of its infant formula products.
Most NEC-related product liability lawsuits are still in the information-gathering phase called "discovery." The exact value of an individual NEC lawsuit is hard to predict. But here are the common types of compensation plaintiffs (injured children and their parents) are seeking in infant formula lawsuits.
Plaintiffs who win or settle their cases want compensation for any NEC-related medical care— past, ongoing, and future.
Plaintiffs also want compensation for "pain and suffering" (physical and mental) caused by NEC-related injuries and treatment. Mental pain and suffering include emotional distress, loss of enjoyment of life, fear, anger, anxiety, and other negative effects.
Plaintiffs want compensation for lost income and diminished earning capacity. For example, a child with a permanent NEC-related disability will ask for lost future earnings. Parents who took time off from work to care for their sick child will ask for compensation for that lost income.
In some states, parents can ask for "loss of consortium" damages, or compensation for the intangible benefits (care, nurturing, and affection) that the injured child provides the family. Historically, only a husband had a right to sue for interference with his relationship with his wife. But a growing number of states allow parents to recover loss of consortium damages when a child is seriously injured or disabled.
When a baby dies from NEC, wrongful death and survival laws allow survivors to receive compensation for losses, including:
Learn more about who can file a wrongful death lawsuit.
A "statute of limitations" is a law that puts a deadline on your right to file an infant formula lawsuit. Each state and the federal government sets its own deadlines for different types of cases. In some states, the deadline to file an infant formula lawsuit—typically two to three years—is the same as the one that applies to most personal injury cases.
Other states have separate statutes of limitation for product liability lawsuits and medical malpractice claims. To learn more, check out: Time Limits for Filing a Defective Product Liability Claim and State-by-State Medical Malpractice Laws and Deadline Requirements.
Figuring out when the statute of limitations clock starts and when it stops can be especially tricky when a child is injured or dies. In some situations, the statute of limitations might be paused ("tolled") until a child turns 18. Or, in California for example, parents might have until their child's eighth birthday to file a medical malpractice claim, instead of the typical three years. If you have questions, talk to a lawyer.
If you're thinking about filing an infant formula-related product liability or medical malpractice lawsuit (or both), having the right attorney can make a big difference in the outcome of your case.
You might be able to find an attorney who can handle both kinds of lawsuits, but it's more likely that you'll need one attorney who specializes in product liability and another who specializes in medical malpractice. Good sources for referrals include:
Be prepared for a lawyer to turn down the opportunity to represent you. Many lawyers don't take cases if they fall below a certain potential recovery amount, or if a key element of the case is less than clear. For example, suppose your premature son suffered a brain bleed at birth and battled NEC. His subsequent developmental delays could have been caused by either diagnosis.
If you can't find a lawyer right away, consider looking again as more infant formula lawsuits reach settlements and verdicts. You might need to be persistent in your search for a lawyer, as your baby's health and prognosis (and the legal landscape) change.
You might be emotionally and financially drained after your baby's premature birth and battle with NEC. You probably don't have the resources to pay a lawyer hundreds of dollars an hour to file a lawsuit.
If you decide to pursue a NEC-related lawsuit, you almost certainly won't have to pay lawyers' fees up-front. Lawyers who file product liability and medical malpractice lawsuits typically handle cases on a "contingency fee" basis.
In a contingency fee agreement, you pay your lawyer a percentage (often one-third) of your compensation if you win your case. If you lose, you don't have to pay your lawyer a fee. (But beware: Win or lose, you'll probably be on the hook for costs and expenses like court filing and expert witness fees.)
The serious illness or death of a child from NEC is a traumatic event that will have long-term effects—emotional and financial—on your family. Parents are often left wondering whether their infant's NEC could or should have been prevented. Start by asking yourself:
If you answered "yes" to all of these questions, you might want to talk to a lawyer about filing an infant formula lawsuit. Nothing can adequately compensate you for your child developing NEC, but you can seek damages for things like medical expenses, lost wages, and pain and suffering. You can also hold negligent manufacturers and medical providers responsible for the harm they've caused your family and try to prevent them from causing similar harm in the future.
Learn more about finding the right personal injury lawyer. When you're ready, you can also connect with a lawyer directly from this page for free.
Need a lawyer? Start here.