A court decision on July 27 stipulated that Abbott Laboratories, a leading manufacturer of baby formula, must pay a family $495 million in damages. This verdict came about after their child contracted a potentially fatal gut disorder known as necrotizing enterocolitis (NEC).
Similar lawsuits have been lodged across the country by close to 1,000 plaintiffs against Abbott Laboratories and Reckitt Benckiser. These companies are the manufacturers of the Similac and Enfamil infant formulas, respectively.
The lawsuits allege that the companies failed to warn doctors about the possible risk that premature babies fed with these formulas could face a heightened risk of NEC when compared to infants fed exclusively breast milk. Both Reckitt Benckiser and Abbott Laboratories deny these claims and are planning to appeal against the ruling.
Even as a parent of a former NICU patient who was born six weeks prematurely, and with a diet comprising mostly fortified formula, this news brings with it perturbing implications.
Fortified infant formulas are commonly given to babies born prematurely as breast milk may not provide sufficient nutrition for their growth and development. So, if your baby requires fortified formulas, should you be concerned about the risk of NEC? We consulted experts to gain insight into this issue. According to them, this isn't a stress factor that parents need to agonize over.
This particular case against Abbott began when a mother from Illinois accused Abbott of failing to adequately warn that its fortified formula could elevate the risk of the life-threatening NEC in premature babies. This, the mother claims, led to her daughter developing the disease as a result of receiving their formula and subsequently led to brain damage.
Abbott defended itself stating that the child's health issues were caused by birth trauma, not NEC. Scott Stoffel, Vice President of External Communications at Abbott, stated, "We stand by the crucial role our preterm infant formula and human milk fortifiers play in nourishing premature babies. There is no scientific evidence suggesting that Abbott's preterm infant products cause NEC."
NEC is a condition that affects the intestines, typically in preterm infants, according to pediatrician and president of the American Academy of Pediatrics Benjamin Hoffman, M.D. This condition affects 1 in 1,000 premature babies.
Despite being a rare condition, NEC is one of the leading causes of illness and deaths among premature babies, especially those below 2 lbs. The good news is that 80% of babies affected by NEC survive, notes the Cleveland Clinic.
The recent lawsuit ruling means companies are now being held more culpable and are expected to improve transparency with respect to the potential side effects of their products. Nevertheless, the AAP recognizes that this type of formula is vital for several infants.
'The decision regarding the choice of formula for your infant should be made collaboratively with your health advisors, tailored to your baby's health requirements. It is crucial to note that while NEC can be a serious condition for some infants, the benefits of providing full, adequate nutrition to a premature infant far outweigh the risk of NEC,' says Dr. Tina Feeley, pediatrician and member of the What to Expect Medical Review Board.
If your baby has already been fed this formula, there's no need to worry. If your child had contracted NEC, it would typically occur within the initial two to six weeks of life.
Parents can continue to feel confident about feeding formula to their babies at home. Dr. Feeley assures that if your baby requires fortified formula in the NICU, the NICU staff will make every effort to ensure the safety and well-being of your baby.
Always remember your right to ask questions about your baby and the type of formula they're being administered. Never hesitate to communicate with the NICU team, advises Dr. Feeley.
Parents can keep abreast of the latest formula research through resources such as the American Academy of Pediatrics.
Scott Stoffel, Vice President of External Communications at Abbott, defended his company by stating: '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. Our preterm infant formula and human milk fortifiers play a crucial role in nourishing premature babies. These products are safe and no scientific evidence shows that they cause or contribute to 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.'