Nutrition companies, parents clash in court over cause of infant intestinal disease

Chance Dean was alive for just 25 days.

Yet his tragic story has reverberated in hospitals around the country, impacted the stock price of two multinational corporations, and ignited a high-stakes legal clash over a pernicious disease that kills hundreds of babies a year in the United States.

Born two months early and weighing less than four pounds, Chance spent all his days under close medical supervision in neonatal intensive care units (NICUs) near his family’s home in Southern Illinois.

His mother, Jasmine Watson, was unable to produce enough breast milk to fully nourish Chance and his fraternal twin brother, Chase. She initially opted to have her sons fed with a combination of her own milk and human breast milk from donor banks.

As Chance and his brother were being prepared for transfer to a hospital where donor milk was unavailable, doctors began transitioning them on Day 12 to a formula designed specifically for premature, low-birthweight infants, in addition to Watson’s breast milk, which was fortified to adequately support their nutrition.

On Day 22, Chance took a sudden turn for the worse.

“He just seemed like he just didn’t feel good,” Watson, 25, said in an interview. “It seemed like he was uncomfortable.”

Doctors diagnosed Chance with necrotizing enterocolitis (NEC, pronounced “neck”), a devastating illness of the intestines that primarily affects premature infants. The disease led to three urgent surgeries in an unsuccessful effort to save his life.

At 9:43 p.m. on March 28, 2020, Chance died in the arms of his mother.

“In that moment, I felt like the only thing that I could do for him was be there,” Watson said. “I held him the entire time until his heart stopped beating.”

Chance’s twin, who received the same formula at the same time, did not develop NEC.

Four years later, a photograph of Chance — in a tiny blue knit cap — was displayed for jurors as “Plaintiff’s Exhibit 887” at the St. Clair County Courthouse in Belleville, Illinois. Watson alleged in a civil lawsuit that Chance’s NEC developed because of the switch from donor breast milk to a cow’s milk-based formula made by Mead Johnson, a global pediatric nutrition company.

“The reason we’re here in this courtroom is because Chance Dean never made it out of the hospital,” Watson’s lawyer Sean Grimsley said in his opening statement. “He died because he was given formula manufactured and sold by defendant Mead Johnson.”

Phyllis Jones, a defense attorney for Mead Johnson, stepped up to tell jurors that Watson’s lawyers were unjustifiably pinning the blame for Chance’s death on the formula. “It’s an easy answer, but it’s not the right answer.” Jones said. “It’s not the answer that the evidence will ultimately support in this case.”

“Four different neonatologists at two different hospitals made the decision that preterm infant formula … was the right option for Chance Dean to keep him growing, to keep him developing,” Jones said.

After a three-week trial, the jury decided that the company was negligent and had failed to adequately warn Watson that the incidence of NEC is higher in formula-fed premature babies. The jury awarded Watson $60 million to compensate for her loss and for the suffering Chance endured.

“For good reason, we believe this is the largest compensatory damages award ever in St. Clair County and stands as one of the most substantial in Illinois state history,” Watson’s lawyers wrote in a press release following the verdict.

Mead Johnson , in a statement from its UK-based parent company Reckitt Benckiser, said it was “surprised and deeply disappointed with the verdict” and vowed to “pursue all options” to have it overturned.

“It is important to note that this is a single verdict in a single case and should not be extrapolated,” the statement said. “We continue to believe that the allegations from the plaintiff’s lawyers in this case were not supported by the science or experts in the medical community.”

The company told ABC News that the verdict “sets a dangerous precedent that interferes with the practice of medicine and the patient-doctor relationship.”

‘Warning moms’

The Watson case, which concluded in March, was the first of its kind to go to trial. Interest in the proceedings was so expansive that an overflow courtroom was opened to accommodate all the lawyers from around the country who came to observe.

That’s because there are more than a thousand similar lawsuits in the U.S., involving over 7,000 families whose premature babies died or suffered serious injuries from NEC — with the first NEC case against formula-maker Abbott, Mead Johnson’s chief rival, scheduled to go to trial Monday in St. Louis.

The lawsuits allege the cow’s milk-based preterm infant formulas made by Mead Johnson and Abbott cause or substantially increase the risk of premature infants contracting NEC, when compared to babies who are fed a diet of their mother’s own milk or donated breast milk.

“Our allegation is that these formula manufacturers should be, at minimum, warning moms, doctors, dietitians, nurses, and hospitals of the risk of this horrendous disease that comes with switching preterm infants from a human milk to a cow’s milk-based formula,” said Ben Whiting, a partner at Keller Postman, a national law firm that represents Watson and hundreds of other plaintiffs suing the companies.

Over the past three years, claims against one or both formula-makers have been filed in state courts from Connecticut to California. Hundreds more are pending in federal court. Plaintiffs argue that the companies have long been aware of the risks but have failed to provide adequate warnings to parents and their medical providers.

“We were never given any information about additional risk with formula,” said Brent Rheinecker, whose premature baby daughter Willa died from NEC four years ago. Brent and his wife Elizabeth filed suit against the formula makers in Madison County, Illinois. Their case has not yet been set for trial.

“We never want another family to go through what we did. We never want another child to go through what our baby did. Her life was so short,” Elizabeth Rheinecker said.

In their legal complaints, lawyers for the families suing Mead Johnson and Abbott cite several scientific studies spanning three decades that have reported a higher occurrence of NEC in formula-fed preemies. The magnitude of the risk, however, varies widely in the scientific literature — from no significant difference to as much as three to ten times greater. Still, no study to date has shown that formula causes NEC.

Recent research, published in January in the Journal of the American Medical Association, followed 483 extremely preterm infants and found that babies in a preterm formula group gained weight more rapidly than those fed only with nutrient-fortified human donor milk — but that over twice as many formula-fed babies (9.0% compared to 4.2%) developed NEC compared to those fed only with donor milk. Health care providers say this is not enough to show a conclusive cause, but enough for scientists to continue to study the association. At the same time, some premature babies who were never given formula went on to develop NEC, suggesting that human milk is not completely protective.

“What we’re trying to do is to make sure that moms and doctors have the complete information that they need in order to make the best decision possible that they can for their preterm babies,” Whiting said. “The pain and suffering that these babies go through with this NEC is absolutely enormous. The way that it tears families apart — even if you’re a strong mom like Jasmine Watson — is significant.”

The lawsuits targeting the preterm formulas do not allege that the products are contaminated. The litigation is unrelated to Abbott’s baby formula recalls in 2022, which led to nationwide shortages.

‘An essential part of the medical toolkit’

Mead Johnson and Abbott, direct competitors in business, have been largely aligned in defending their respective preterm formulas, which they describe as “essential, safe, life-saving nutrition products” that have been successfully administered in NICUs for decades, according to court filings. The companies contend the mass litigation is itself “causing fear among parents” and “endangering the relationships” between parents and their physicians.

“No published study has ever concluded that defendants’ products cause NEC,” attorneys for the companies wrote in a joint filing in federal court. “Despite plaintiffs’ recent campaign against these products, NICU medical teams — including in the world’s best hospitals — continue to administer them as an essential part of the medical toolkit for treating these most fragile of patients.”

Amy Gates, a pediatric nutrition specialist who serves as Mead Johnson’s medical director, said in an interview after the Watson verdict that plaintiffs’ attorneys are “taking advantage” of the emotional impact that comes with the loss of a child.

“My fear is that we lose sight of the science and we allow emotion to win. And if that happens, there will be thousands of preemies who will be at risk,” Gates said. “Not every baby can sustain himself on just breast milk. And loss of access to these life-saving products would be a tragedy.”

The two companies have also argued that because their preterm formulas are used almost exclusively under medical supervision in hospital settings, they should therefore be considered by courts in the same manner as prescription medications and medical devices, where a legal principle known as the “learned intermediary doctrine” often applies. The logic of the doctrine is that medical professionals — the learned intermediaries — are best positioned to know the risks and benefits of a particular treatment and to communicate that to patients.

Three courts, however, have rejected that argument, declining to apply the doctrine to preterm infant formula, because – as one judge wrote – “it is not a recognized prescription medication or medical device.”

Read more in ABC News.