Enfamil and Similac Injury Lawsuits

If your premature baby developed NEC after formula feeding, the makers of the formula and others might be legally responsible for your baby’s harm.

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:

  • your baby was born premature or with other health problems (like a heart defect)
  • health care providers fed your baby Enfamil or Similac formula, and
  • your baby developed NEC.

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 an baby formula lawsuit.

What is NEC?

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:

  • severe infection (sepsis)
  • scarring and narrowing in the intestines (strictures)
  • reduced ability to absorb nutrients (growth failure)
  • developmental delays, and
  • death.

Treatments for NEC include antibiotics, a nasogastric tube, and surgery.

What Is the Link Between Baby Formula and NEC?

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.

Have Enfamil and Similac Formulas Been Recalled?

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 2021, 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.

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"). Read on for more details on these legal arguments.

Who Can File a Baby Formula Lawsuit?

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.

Who Would I Sue If My Premature Baby Had NEC?

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.

Product Liability

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:

  • cow's milk-based formulas increase a premature baby's risk of NEC
  • defendants knew (or should have known) their formulas increase the risk of NEC
  • defendants failed to warn parents and medical providers that their formulas increase the risk of NEC, and
  • as a result of the lack of instructions or warnings, premature babies were seriously injured or died.

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).

Medical Malpractice

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:

  • your premature baby was improperly fed Enfamil or Similac formula
  • your child's NEC was misdiagnosed or improperly treated, or
  • health care providers didn't tell you that the intended formula feeding increased your baby's risk of NEC.

What If It's Been Years Since My Baby Had NEC?

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 "tolled" (paused) 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.

Has Anyone Brought a Class Action Involving Infant Formulas Products?

As of 2021, no one has brought a class action that claims that Enfamil and Similac caused premature babies to develop NEC. The reason 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. For example, class action is a good fit for a lot of consumer fraud cases. (Consumer fraud is when defendants use deceptive or unfair business practices to dupe plaintiffs, like car companies that cheat on emissions testing or food companies that mislabel their products as organic). Babies who develop formula-based NEC, however, don't experience the same harms and future medical needs. 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 these cases.

The lack of class action lawsuits doesn't mean, however, that parents can't sue. As of September 2021, parent plaintiffs in Illinois filed a cluster of product liability lawsuits (including one case with seven different plaintiffs). (Mead Johnson and Abbott Laboratories manufacture their formulas in that state.) Other individual baby formula lawsuits are scattered across the country and in federal court.

If enough plaintiffs file product liability lawsuits against Mead Johnson and Abbott Laboratories in federal court, their cases could be consolidated into multi-district litigation (MDL), a process that centralizes pre-trial steps and encourages settlement. Learn more about how MDL works and why it might be a better fit for infant formula lawsuits than class action.

How Much Is a Baby Formula Case Worth?

As with all injury-related legal claims, the dollar value of an baby formula lawsuit (product liability or malpractice) depends on the individual plaintiff's unique experience and circumstances. Judges and juries consider:

  • the severity of your baby's NEC
  • your baby's prognosis for a full recovery
  • the possible need for future medical treatment
  • the financial impact on you and your baby (like the size of medical bills and lost income), and
  • "pain and suffering" (physical and mental) caused by your baby's NEC.

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:

  • funeral and burial costs
  • loss of the deceased person's expected income, and
  • loss of love, society, and companionship from the deceased.

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 in any case 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 September 2021, no settlement agreements or jury verdicts in NEC-related baby formula lawsuits are publicly available.

How Do I Find the Right Attorney for a Baby Formula Lawsuit?

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:

  • friends, family, and co-workers who have had a positive experience with a lawyer
  • lawyers you already know who can tap into their network and suggest someone whom they know and trust
  • city, county, and state bar associations, and
  • online resources like AllLaw.com and Nolo.com.

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.

What Should I Ask a Potential Baby Formula Lawyer?

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:

  • How long has the lawyer been practicing law? Older lawyers who have many years of experience aren't necessarily better than newer attorneys, but they bring different skill sets to the table.
  • How much of the lawyer's practice is devoted to product liability (specifically failure-to-warn claims) and medical malpractice lawsuits? Both types of lawsuits require legal and medical expertise and a willingness to litigate against high-powered defendants and their teams of lawyers.
  • Does the lawyer typically represent plaintiffs or defendants? You probably want someone with experience fighting for plaintiffs, not helping defendants avoid liability at all costs. (Although hiring a savvy lawyer with some defense experience can be a plus: The ability to see both sides of a case can help resolve lawsuits and sharpen a lawyer's trial skills.)
  • Would the lawyer personally handle your case or rely on less experienced lawyers or paralegals to do the bulk of the work?
  • Will the lawyer get paid by the hour or work under a contingency fee agreement? Most personal injury lawyers get paid on a contingency fee basis. We'll discuss fees more in the next section.

How Will My Baby Formula Lawyer Get Paid?

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.

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