On July 27, a jury ruled that the formula manufacturer Abbott Laboratories has to pay a family $495 million in damages after their baby developed a life-threatening bowel disease called necrotizing enterocolitis (NEC).[1]
In courts across the country, nearly 1,000 similar lawsuits have been filed against Abbott and another company called Reckitt Benckiser, which make Similac and Enfamil formulas, respectively. These lawsuits allege that the companies failed to warn doctors about the chance that preemies receiving these formulas might be at an increased risk of developing NEC, when compared to babies who are exclusively given breast milk. Both of these companies have denied the claims and say they will appeal the decision.
As a former NICU parent myself, whose daughter was born six weeks early and used a fortified formula, this news was worrisome, to say the least.
Babies are given fortified formulas, especially when born prematurely, because breast milk may not be sufficient for their growth and development. So if your baby ends up needing fortified formula, do you need to worry about the risk of NEC? We spoke to experts, and the short answer is no, that this isn’t something you need to stress about. Read on to learn more.
How did this case come about?
In this most recent case against Abbott, one mom in Illinois alleged that Abbott failed to adequately disclose that its fortified formula could increase the risk of a life-threatening disease called NEC in premature babies — something she says her daughter developed as a result of receiving their formula, which ultimately led to brain damage. Abbott says her daughter developed the issues as a result of birth trauma, rather than from NEC. "We stand by the vital role our preterm infant formula and human milk fortifiers serve in the hospital in nourishing premature babies. These products are safe and there is no scientific evidence showing Abbott’s preterm infant products cause or contribute to causing NEC," said Scott Stoffel, Vice President of External Communications at Abbott, when What to Expect reached out for a statement.*
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What is NEC?
Necrotizing enterocolitis is a condition that affects the intestines of babies, mostly preterm infants, pediatrician and president of the American Academy of Pediatrics Benjamin Hoffman, M.D., said in a statement earlier this week.
The condition affects 1 in 1,000 premature babies, so it's pretty rare.[2] That said, it is one of the leading causes of illness and death in preemies — especially those who weigh less than 2 pounds.[3] The good news is that, while NEC can be serious for some babies, eight in 10 babies with NEC survive, according to the Cleveland Clinic.
What does this mean for parents?
The outcome of this latest lawsuit means that companies are being held accountable so that they can be more transparent moving forward. That said, the AAP says this type of formula is still very important for many infants.[4]
"Special formulas designed for preterm infants provide an essential source of nutrition," Dr. Hoffman said in the same AAP statement earlier this week. “Using human breast milk to feed preterm infants may reduce the risk of NEC, but it does not eliminate this risk.”
Dr. Hoffman goes on to say that “Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families," and that the type of formula your baby has should be made collaboratively, depending on your baby's needs at the time. Also, because the exact cause of NEC is often unclear, it's hard to point a finger specifically at the formula.
"It is unfortunate whenever any child suffers, especially such a severe and terrible disease," says Micah Resnick, M.D., pediatrician and What to Expect Medical Review Board member. "However, it would be really hard to blame solely the formula since determining the cause of the disease is a very complex process."
Again, the experts we spoke with emphasize that the benefits of a preemie getting full, adequate nutrition definitely outweigh the risk of NEC. The biggest thing we need for a premature infant’s health is for them to grow, says Tina Feeley, M.D., pediatrician and What to Expect Medical Review Board member, "and the only way to do that is through adequate nutrition, which might include fortified formulas.”
That said, the spotlight on the health effects of these formulas is something to keep an eye on and definitely talk to your doctors about if you find your baby needs this type of nutrition. You can always ask questions about the known risks and benefits, says Dr. Resnick. "Like any decision about medically fragile babies, it should be made in a team setting, with the best interests of the child being primary," he says.
What if my baby had this formula already?
If your baby was in the NICU and had this formula, there's no need to worry. It's likely that you would know by now if your child developed NEC, as it typically occurs within the first two to six weeks of life.
How can I keep my formula-fed baby safe?
No matter what type of formula your baby is using, the lawsuit is a step in the right direction, holding companies accountable for disclosing when their products may have side effects.
"Given this is something seen mostly in the NICU, parents of formula-fed babies who are at home should still feel comfortable giving formula," says Dr. Feeley. And if your baby is getting fortified formula in the NICU, rest assured that the NICU will do everything they can to keep your baby safe and healthy, says Gina Posner, M.D., pediatrician and What To Expect Medical Review Board member. This might include slowing feeds to prevent any complications like NEC.
No matter what, you have the right to ask questions about your baby and the type of formula they're being given, so never feel afraid to speak up to your baby's provider. "If a child is in the NICU, the best thing is to keep close communication with the NICU team,” says Dr. Feeley.
To stay up to date on the latest formula research in general, you can always turn to the American Academy of Pediatrics, too.
*Full statement from Abbott's Scott Stoffel, Vice President of External Communications: "For decades, Abbott has researched, developed and produced specialized nutrition products that help doctors provide lifesaving nutrition to premature infants, and countless babies have benefited from these products. Abbott stands by the vital role its preterm infant formula and human milk fortifiers serve in the hospital in nourishing premature babies. These products are safe and there is no scientific evidence showing Abbott’s preterm infant products cause or contribute to causing NEC. Specialized formulas and fortifiers, like the one in this case, are part of the standard of care by the medical community and, along with mother’s milk and donor human milk, are the only available options to feed premature infants."
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