These are difficult days for baby formula manufacturers and parents of infants.
Thousands of NEC baby formula lawsuits have been filed against Abbott Laboratories and Mead Johnson because of their formulas created and marketed for premature babies.
Some infants are becoming gravely ill with some dying, after contracting Necrotizing Enterocolitis (NEC) from certain formulas that are made with cow’s milk as a main ingredient. The lawsuits allege the manufacturers are selling the products without warning parents and doctors of the severe danger.
In addition to NEC baby formula cases making headlines, parents also are concerned about bacteria contamination in baby formula and the recall of some products.
However, the two issues concerning baby formulas are not related.
NEC Linked to Formula for Premature Infants
NEC causes severe inflammation in the intestines and leads to the destruction of bowel tissue. It is considered a severe gastrointestinal condition and for newborns who contract NEC, the fatality rate is between 15 to 40 percent. Preterm infants fed cow’s milk-based formula, especially those weighing three pounds or less, are more likely than other babies to develop NEC.
The specific formulas involved in the NEC lawsuits are made by Abbott Laboratories and Mead Johnson. They include Enfamil Human Milk Fortifier, Enfacare Powder, Enfamil NeuroPro EnfaCare Infant Formula, Similac Special Care, Similac Neosure, and Similac Human Milk Fortifier.
Many lawsuits have been consolidated in an Illinois federal court, with others pending in Illinois, Missouri, and Pennsylvania.
Plaintiffs in the NEC lawsuits allege that the baby formula products put premature infants at greater risk than a mother’s own breast milk or donor milk. They claim that the manufacturers were aware of the risks, but did not warn parents and medical providers.
Lawyers for the manufacturers disagree that their formulas were the reason the babies got sick, and claim instead that they are “life-saving nutrition products.”
Along with that, as ABC News reported, lawyers for the manufacturers stress that the formulas are made specifically for premature babies and distributed by doctors or hospital staff, and therefore, fall under what is “the learned intermediary doctrine.’’ They contend the products should be considered “in the same manner as prescription medications and medical devices which puts medical professionals in the best position to know the risks and benefits of a particular treatment and to communicate that to patients.”
NEC Baby Formula Trials
So far, one NEC baby formula lawsuit reached a conclusion ending in an award of $60 million for the plaintiff.
The trial was held in a state court in St. Clair County, Illinois. The plaintiff was a mother who delivered twin boys several weeks early. Because she could not produce the breast milk necessary to feed the two babies, the hospital staff supplemented her milk with an Enfamil formula by Mead Johnson with a label that described it as designed specifically for premature, low-birthweight infants.
After being fed the formula, one twin survived. However, the other became ill with NEC. After undergoing three surgeries in an attempt to save his life, he died. The trial lasted for three weeks, and on March 14 the jury announced its decision to award the plaintiff the $60 million for compensatory damages for loss and grief as well as for the pain and suffering of the baby. According to the jury, Mead Johnson did not adequately warn that the incidence of NEC is higher in formula-fed premature babies and therefore the company was negligent.
Another NEC baby formula trial, which is being held in a state court in St. Louis, Missouri, began on July 9. It is focusing on Abbott Laboratories’ Similac premature baby formulas.
In the case, the plaintiff is the mother of a baby girl who contracted NEC after being given Similac. Although the baby survived, it is alleged that after being fed the formula, she suffered serious, life-long injuries.
As in the trial against Mead Johnson, the plaintiff’s lawyers are saying that Abbott was aware of the risks of its product but failed to provide adequate warnings.
According to the lawsuit, Abbott made “no attempt to tell physicians and those inside the hospital in a clear or direct way” that its products could cause NEC in premature babies.
Lawyers also allege the manufacturer is aggressive in their marketing despite the knowledge of the risks and harm that can come to babies.
The defense lawyers, however, have argued that the baby had medical issues before she was given the formula and that her injuries were caused by birth trauma when she was deprived of oxygen.
Baby Formula Recalls
As of now, the Abbott and Mead Johnson formulas for premature babies involved in the NEC lawsuits are not being recalled.
However, other formulas that have been contaminated by bacteria are being recalled. The bacteria currently associated with recalled baby formula is known as Cronobacter sakazakii, and it is especially dangerous to infants.
In February 2022, after the bacteria was discovered at Abbott Laboratories’ baby formula plant in Sturgis, Michigan, company officials were forced to shutter the plant. Along with the closure, several Abbott products under the labels of Similac, Alimentum, and EleCare, were recalled after several infant deaths were reported.
Although the plant eventually reopened, the closure of the Sturgis facility exacerbated an infant formula shortage that caused problems for families across the country during the COVID-19 pandemic. The country had already been experiencing supply chain disruptions.
Since then, there have been several other recalls related to Cronobacter sakazakii, yet none are associated with the struggles surrounding NEC and premature babies.
To find current updates on baby formula recalls, visit the Food and Drug Administration’s website where recalls are announced in real time.
New parents want nothing more than to keep their baby healthy and thriving. If they are aware of the risks of NEC associated with cow’s milk-based formulas, they at least have the information to take the proper actions necessary to protect their child.
If your child suffered NEC after being fed formula, contact an experienced NEC baby formula lawyer who can hold the manufacturers responsible for not providing you with the information necessary to keep your baby safe and who can help you move through the next steps for you to see the outcome you deserve.
