Studies have shown that premature babies who are fed cow's milk-based formulas are more likely than others to develop a serious disease called necrotizing enterocolitis (NEC). Cow's milk-based formulas are the most prevalent type of formula on the market. As of 2018, Mead Johnson (the maker of Enfamil) and Abbott Laboratories (the maker of Similac) each control about 40 percent of the baby formula market.
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, the potential liability of the manufacturers of formulas (and in some cases, health care providers and hospitals), and issues you'll need to consider when filing a baby formula lawsuit.
Necrotizing enterocolitis—or NEC (pronounced "neck")—is a life-threatening gastrointestinal disease in newborns. Premature infants (those born before 37 weeks of pregnancy) 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 studies 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 2022, 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 and have faced lawsuits, mostly over manufacturing defects in particular batches of their formulas.
For example, in 2010 Abbott Laboratories recalled millions of containers of Similac after beetles were found in the formula and in the factory where it was made. In 2008, nearly 50,000 cans of Enfamil were recalled after metal particles were found in the formula.
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").
Federal and state laws typically don't allow minors—in most states, that means a person under 18—to file lawsuits. But the parents (or legal guardians) of a premature baby who gets NEC can file a lawsuit on their child's behalf.
The mere fact that your premature baby was formula-fed in the hospital isn't enough to file a:
Cases like these require measurable harm, and that usually means a diagnosis of NEC after your baby drank a cow's milk-based formula, like Enfamil or Similac. A NEC diagnosis is the first step in understanding (and proving) the nature and extent of your damages (losses), which can include medical bills, the cost of future medical care, and pain and suffering.
Most baby formula lawsuits are brought by parents alleging one or both of these legal arguments:
Let's take a closer look at how manufacturers and medical care providers might be at fault for your baby developing NEC.
Some parents (called plaintiffs in court) are filing defective product claims against Mead Johnson and Abbott Laboratories (defendants). Specifically, plaintiffs target the manufacturers' "failure to warn" by alleging:
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).
Some parents (plaintiffs) are filing medical malpractice lawsuits against health care providers and hospitals who authorized feeding their premature babies cow's milk-based formulas.
Like product liability claims, medical malpractice claims are a special type of personal injury case. Parents of premature infants who develop NEC can file a product liability or medical malpractice lawsuit, or both.
Your infant's NEC-related injury or death could be the result of medical negligence if:
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. See below for tips on how to find the right attorney for your case.
As of late 2022, no one has brought a class action that claims that Enfamil and Similac caused premature babies to develop NEC. But a woman in Illinois has filed a class-action lawsuit against Abbott, alleging that the company is misleading consumers when it says that its Similac formulas are close to breast milk when they aren't.
The reason why no one has brought a NEC-related class action lies in understanding how class action lawsuits work: they're best suited to situations where plaintiffs' injuries are mostly financial and uniform across the class. Class action tends to be a better fit for consumer fraud cases than personal injury cases. Consumer fraud is when defendants use deceptive or unfair business practices to dupe plaintiffs, like Abbott misleading consumers about the health benefits of its formulas, for example, or car companies cheating on emissions tests.
Babies who develop formula-based NEC, however, don't experience the same harm. Each formula-fed baby who develops NEC suffers unique injuries and requires individualized medical care. It isn't possible (or appropriate) for courts to award the same damages to all plaintiffs in NEC cases.
The lack of NEC-related class action lawsuits doesn't mean, however, that parents can't sue. As of April 2022, NEC-related product liability lawsuits are pending in federal and state courts across the country. In April 2022, all NEC formula lawsuits filed in federal court were consolidated for discovery and other pretrial matters in the Northern District of Illinois. (In re: Abbott Laboratories, et al., Preterm Infant Nutrition Prod. Liab. Lit.– MDL No. 3026.) Consolidation like this (called "multi-district litigation or MDL") is common in cases involving similar harms that affect large numbers of plaintiffs, like asbestos litigation and other product liability lawsuits. The goal of consolidation is to encourage global settlement and save resources.
Learn more about how MDL works in product liability cases and why it's a better fit for NEC-related infant formula lawsuits than a class action.
As with all injury-related legal claims, the dollar value of a baby formula lawsuit (product liability or malpractice) depends on the individual plaintiff's unique experience and circumstances. Judges and juries consider:
If the unthinkable happens, and your formula-fed baby dies from NEC, you might be able to bring a special kind of lawsuit called a wrongful death claim. Compensation in a wrongful death lawsuit is similar to an injury-related lawsuit, but might also include:
Most civil lawsuits like these end up reaching an out-of-court settlement before trial. But it's not easy to predict how much a plaintiff might receive in a settlement. Some formula-fed preterm babies who develop NEC might require tube feedings or colostomy care for the rest of their lives, while others might experience significant developmental delays that affect their education and career opportunities.
Estimating a settlement is also complicated by your inability to know how other similar cases have settled. Settlement agreements are almost always confidential. Many defendants require plaintiffs to sign non-disclosure agreements (NDAs) in personal injury settlements, which require plaintiffs to keep the existence and terms of the settlement private.
As of April 2022, no settlement agreements or jury verdicts in NEC-related baby formula lawsuits are publicly available.
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.
For more tips on how to search for an experienced lawyer you can trust, check out: Finding an Attorney for Your Infant Formula Lawsuit.
When you interview a potential attorney for your baby formula-related lawsuit, you'll want to ask the right questions. Your questions will depend on whether you're filing a product liability claim against the makers of Enfamil and Similac, a medical malpractice case against the medical providers who fed it to your child, or both. Here are some sample questions:
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.
The good news is that 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.)
NEC is a life-threatening disease with potentially long-term complications. If you have questions about whether your baby's NEC could or should have been prevented and worry about who is going to pay for all the losses caused by your formula-fed baby's NEC, you should talk to a lawyer about your options.
Learn more about hiring a personal injury lawyer. You can also connect with an attorney directly from this page for free.