Flood of lawsuits threatens supply of baby formula for premature babies

More than a thousand lawsuits stemming from sickness following the use of specialized formula for premature babies could lead to manufacturers dropping production, medical experts and lawmakers warn.

Two leading manufacturers of infant formula, Abbott and Mead Johnson, face the onslaught of litigation from the parents of premature babies claiming their infants were harmed or killed by necrotizing enterocolitis or NEC, after consuming Similac and Enfamil formulas developed specifically for babies born prematurely.

The costly suits have led manufacturers to consider ending production of the specialized formula, warned industry leaders and the American Academy of Pediatrics.

“The AAP is concerned that lawsuits against specialty formula makers threaten the availability of formulas that provide important nutrition for preterm infants,” the group said in an October statement.

A Republican House lawmaker, Rep. Diana Harshbarger of Tennessee, has introduced legislation that would temporarily shield manufacturers of preterm infant formula while the FDA reviews whether to add warning labels to the packaging. The measure has so far idled in the House Energy and Commerce Committee.

“As a pharmacist and a mother, I introduced this bill because no parent should ever be told that a safe, life-saving nutritional product for their preterm infant is no longer available because of a feeding frenzy of fear-driven litigation,” she said. “Doctors and families, not trial lawyers, should make medical decisions for these fragile infants. My bill ensures continued access to these formulas while allowing the FDA time to develop a long-term regulatory solution.”

Peter J. Pitts, a former Food and Drug Administration associate commissioner and president of the Center for Medicine in the Public Interest, said the FDA tightly controls the labeling on the formula and should take steps to ensure Abbott and Mead Johnson aren’t sued out of business for labeling they don’t fully control.

“I think it’s important for the FDA to hold a series of scientific meetings, to create a blue ribbon panel, to reach a conclusion as to whether or not the current labeling is appropriate, or if it’s not, how it should be changed,” Mr. Pitts said.

In a July call with investors, Abbott CEO Robert Ford said the company may no longer produce the specialty formulas in the wake of the mounting lawsuits. Their premature infant formula products make up about $9 million of Abbott’s $42 billion global portfolio of health care and nutrition products. Mead Johnson sells about $1 million in specialty formulas.

The lawsuits could cost the companies exponentially more.

In March of 2024, an Illinois jury awarded $60 million to the mother of a premature baby who died after consuming Mead Johnson’s Enfamil specialty formula. Three months later, in June 2024, Abbott was ordered to pay $495 million to the family of a baby girl born prematurely who lost part of her intestine and suffered brain damage after consuming Abbot’s Similac Special Care formula and developing NEC.

The disease causes bowel tissue to die.

Both companies deny that the formulas caused the infants’ illnesses and are appealing the verdicts, but the wins opened the floodgates to additional lawsuits that claim the formula companies did not adequately warn them that their cow’s milk-based formulas for premature babies could cause the infection.

Lawyers solicit prospective plaintiffs online.

“Our NEC Baby Formula Lawyers continue to lead the fight for justice on behalf of families affected by toxic infant formula products,” the Missouri law firm of TorHoerman advertises on its website. “If your child developed necrotizing enterocolitis (NEC) after being fed cow’s milk-based formula in the maternity ward or NICU of a hospital, you may be eligible to file an NEC Baby Formula Lawsuit.”

Lawyers for the plaintiffs in the different lawsuits scoff at threats by Abbott to pull their specialty formula from the market. They say formula companies have long been aware that cow’s milk-based formula “significantly increases the risk of NEC in premature babies.”

But that’s not the conclusion of the FDA, which said in an October statement that there is “no conclusive evidence that preterm infant formula causes NEC.”

The statement, issued jointly with the Centers for Disease Control and Prevention and the National Institutes of Health, cited “strong evidence” that human breast milk protects against NEC and said the absence of breastfeeding is more likely the cause of NEC in premature infants, rather than exposure to the specialty formulas.

Breast milk for premature babies is not always available, medical experts said.

“As collective work continues on this important topic, one point remains clear: while there is a preference for human milk, all infants should be fed as soon as is medically feasible through whatever appropriate nutritious food source is available,” the FDA concluded.