The American Academy of Pediatrics (AAP) recommends breast milk as the best nutrition for infants. But what's best is not 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, dozens 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.
Read on for more about the link between infant formula and NEC, the growing number of infant formula lawsuits, and a breakdown of how much an infant formula lawsuit might be worth.
Necrotizing enterocolitis—or NEC (pronounced "neck")—is a life-threatening gastrointestinal disease in newborns. Any newborn can get NEC, but it's most common in very sick or premature babies.
NEC develops when a baby's large intestine is damaged by inflammation. Bacteria can leak out from the damaged intestine, causing infection, scarring, growth restriction, and death. Treatment for severe NEC might include a nasogastric tube, intravenous (IV) medication, and surgery to remove the damaged intestine.
Doctors don't know exactly what causes NEC, but scientific studies and peer-reviewed articles have identified a connection between cow's milk-based formulas and premature babies who develop NEC.
According to 2020 U.S. Census data, 3.22 million Americans used Enfamil formulas, and 3.18 million Americans used Similac formulas.
As of early 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. (Recalls are actions to remove an unsafe product from the market.) Most plaintiffs in infant formula lawsuits claim that Mead Johnson and Abbott Laboratories failed to warn doctors and parents of potential dangers associated with the products, not that the products are inherently dangerous and need to be removed from the market.
The first infant formula lawsuits were medical malpractice claims. These lawsuits typically alleged that parents weren't able to give informed consent to let health care providers feed their babies cow's milk-based formulas, because the providers didn't warn them of the increased risk of NEC. In response, many health care providers tried to shift the blame, arguing that formula manufacturers didn't inform them of the NEC risks.
Some parents and guardians (called "plaintiffs" in court) are still filing individual medical malpractice claims against medical professionals and hospitals. But a growing number of plaintiffs are shifting the blame to the manufacturers of the formulas. The targeted products include, but are not limited to the following:
As of April 2022, NEC-related product liability lawsuits are pending in federal and state courts across the country. In December 2021, plaintiffs' lawyers in Illinois, asserting claims on behalf of dozens of infants, asked the Illinois Supreme Court to consolidate the NEC lawsuits for discovery and other pretrial matters.
In January 2022, Abbott Laboratories asked the U.S. Judicial Panel on Multi-District Litigation (JPML) to consolidate the NEC-related federal cases currently pending against the company and send them to the District of Connecticut. Consolidation like this (sometimes 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.
In April 2022, the JPML consolidated the federal cases in MDL -3026 in the Northern District of Illinois, the plaintiffs' lawyers preferred jurisdiction.
Most NEC-related product liability lawsuits are still in the early stages. As of April 2022, no settlement agreements or jury verdicts are publicly available, so it's hard to put an exact dollar figure on these cases. But here are the common types of compensation (damages) plaintiffs are seeking in infant formula lawsuits.
Plaintiffs who win or settle their cases want compensation for any NEC-related medical care, whether it be past, ongoing, or future care.
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, parents who took time off from work in order to care for their child might ask for compensation for that lost income. A child with a permanent NEC-related disability will ask for lost future earnings.
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's services and physical and emotional affection and comfort. 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 damages, like funeral and burial costs, the deceased person's pre-death pain and suffering, medical treatment costs prior to death, and potentially a portion of the deceased person's expected income, among others.
If your premature baby was given Enfamil or Similac and then developed NEC, you probably have a lot of questions about whether your baby's NEC could or should have been prevented. Talk to a lawyer about your legal options right away. A lawyer can explain the link between baby formula and NEC and help you file the right kind of lawsuit within the statute of limitations deadline in your state.
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