Parents of premature babies are contending with head-spinning legal drama over specialized formulas that U.S. agencies have endorsed as standard options but face hundreds of lawsuits and inconsistent outcomes in court.
The lawsuits say babies who get the specialized formulas risk getting a serious intestinal disease that can be fatal, prompting federal health officials in the fall to reassure Americans there is “no conclusive evidence” the products cause the condition.
A mountain of litigation has produced a mix of verdicts in the St. Louis area, however, and more cases are scheduled by summer, making it a point of concern for pediatricians and some Capitol Hill lawmakers who fear the formula could become unavailable if the companies retreat from the market because of their courtroom strife.
“Right now, there is solid science that shows that these products are safe, and all of the professional medical organizations that deal with these babies support using these products as needed,” said Peter J. Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner at the FDA. “Companies stop making products if they’re going to get litigated out of business. And that would be a disaster because it leaves parents with fewer options.”
Nearly 1,000 lawsuits have been filed against Abbott Laboratories, the maker of Similac formula, and a unit of Reckitt Benckiser, Mead Johnson, which makes Enfamil.
The lawsuits center on cow’s milk-based formula that is only available in doctor-supervised settings, as opposed to formulas from these companies that are sold in stores for the general population. The specialized formula is given to babies whose mothers cannot supply breast milk or rely on donor supplies from a breast milk bank, or in cases where a supplement to parental or donor milk is needed for the health of the infant.
Some parents say it is a vital option that worked for them.
“I think that like all other mothers, breast milk is the best milk, but only when it’s available. When it’s not available, and there isn’t enough breast milk to sustain the growth that these preterm babies need, we need to allow our medical professionals to access these innovative products that helped my son and have helped hundreds of other babies out there,” said Carrie Perry, director of the Preemie Advocacy Network whose 13-year-old son, Elliot, needed special formula to grow after preterm birth.
Yet plaintiffs’ lawyers around the country say too many families were not warned that babies who receive specialized formula could have a greater risk of developing necrotizing enterocolitis, or NEC, compared to those who receive breast milk or donor milk. One baby dies every day in the U.S. from NEC, and those that survive may face traumatic surgeries, neurodevelopment impairments or lifelong health issues, according to U.S. health agencies.
Law firms are advertising their services to families whose children have taken the specialized formulas and suffered or died from the intestinal condition.
Jake Plattenberger, a partner at TorHoerman Law in Chicago, said his law firm is handling hundreds of lawsuits that accuse the companies of design defects in their formulas and a failure to warn parents about the possibility of contracting NEC. His firm is focused on babies who are roughly younger than 35 weeks and weigh under 1,500 grams, which is a little over three pounds.
“They have underdeveloped guts. They can’t handle the preterm formula,” Mr. Plattenberger said.
He said the lawsuits target the formula makers, and not regulators or doctors, because companies are ultimately for the products that they sell.
“That’s the way it is and that’s the way it should be,” Mr. Plattenberger said. “If you’re a company and you’re putting a product into the market that you know carries with it certain risks, you absolutely have an obligation and we would say a legal duty to properly inform people of those risks. It’s no defense to say, well, [the Food and Drug Administration] hasn’t caught us yet or FDA hasn’t forced us yet.”
Lawsuits are going to trial in places like Missouri, which has seen mixed results. In July, a St. Louis jury awarded $495 million in damages to an Illinois plaintiff who sued Abbott.
The formula companies won a more recent verdict in Missouri but the judge ordered a new trial, saying lawyers for the defendant formula makers engaged in misconduct during the proceedings.
The FDA, National Institutes of Health and Centers for Disease Control and Prevention issued a joint statement in October saying there is no firm evidence that specialized formulas cause NEC.
“For infants where the supply of human milk is insufficient, these formulas are part of the standard of care for premature infants,” the statement said. “Available evidence supports the hypothesis that it is the absence of human milk — rather than the exposure to formula — that is associated with an increase in the risk of NEC.”
“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 agencies said.
Mr. Plattenberg said the statement did not change the landscape around the lawsuits.
“It’s just a restatement of things that have been in the literature and have been known for decades,” he said. “We’ve been very clear with juries, and clear with Abbott, the formula increases the risks for developing NEC.”
The American Academy of Pediatrics responded to the lawsuits last year by saying courtrooms are “not the best place to determine clinical recommendations for the care of infants.”
“Feeding decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences,” academy President Benjamin Hoffman said.
The court cases are unfolding alongside a renewed focus by Health and Human Services Secretary Robert F. Kennedy Jr. on infant formula safety and its availability after a shortage of the products during the Biden era sowed distrust in the industry.
Mr. Kennedy’s effort, dubbed Operation Stork Speed, increases testing for heavy metals and other contaminants in infant formula and encourages companies to work with the FDA to increase transparency around labeling.
The latter provision could address issues at play in the current litigation, since formula is an FDA-regulated product and companies need agency collaboration to change their labels, according to Mr. Pitts.
“I think that’s a great idea. Because done properly, that reinforces the trust in that baby formula,” he said.
For now, the situation is also causing whiplash for the companies. Their stock shares are rising and falling with the positive and adverse decisions.
Abbott pointed to the support of medical associations in defending its product.
“Abbott stands by the vital role its preterm infant formula and human milk fortifiers serve in hospitals,” the company said. “Lawsuits involving these products seek to advance a theory that is not based in science and is not supported by the medical community or the health regulators in the U.S.”
Abbott CEO Robert Ford addressed their ability to stay in the market during an earnings call in October, telling investors that “if the regulatory process is disregarded, if the science is disregarded, it’s going to be very difficult for any company to remain on the market with these products, taking on that indefinite liability here, at least in the United States.”
The Washington Times was unable to reach Mead Johnson for comment. Reacting to a positive verdict in October, the company said the decision was “consistent with the scientific consensus that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC, and that where human milk is unavailable or when supplementation is necessary, specialized preterm hospital nutrition products can provide essential, lifesaving nutrition.”
Mr. Perry, who lives in New Hampshire, said she was unable to breast-feed her son because it elevated her blood pressure, so doctors recommended the special formula after Elliot’s weight gain on donor milk wasn’t progressing as they’d like.
She takes a balanced view of the lawsuits.
“I think being able to hear both sides of it is really important,” she said. “If you’re hearing so strongly from people who lost children due to this and you’re not hearing as much from people who have a success story on the other side — that’s important, too. For me, I look at my son and I look at him and I think, he wouldn’t be here if I didn’t have access to these products.”
Some lawmakers on Capitol Hill are concerned about the lawsuits.
“The downstream effects of current product litigation are dire. Currently, only two companies make cow-based preterm infant formulas in the United States and they could decide to exit the market,” Rep. Diana Harshbarger, Tennessee Republican, wrote to federal health officials in a December letter co-signed by six other House Republicans. “Should that happen, we believe the absence of these products would put the health and safety of preterm infants at risk.”
Mr. Plattenberg said there is no reason to believe the companies will no longer make the product, and his law firm has not taken the position that it should be withdrawn as it pursues its cases.
“It’s an incredibly important product for [the companies]. I just don’t find it credible or necessary for them to threaten to remove this product from the market,” Mr. Plattenberger said. “The first and easiest thing for them to do is to put a proper warning on the product.”
