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

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The companies say no published study's ever concluded their products cause NEC.

The companies say no published study's ever concluded their products cause NEC.Jasmine Watson sits with her partner, Cedric Dean, and their son Chase, 4. Pictured on the pillow is Chance Dean, who died from NEC in March, 2020.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.

Doctors diagnosed Chance with necrotizing enterocolitis , 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."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.

"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. 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.

"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.

"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.

"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." Mead Johnson contends that jury instruction severely undercut their defense. The company argued at trial that it had no legal obligation to warn Watson or other patients, because the doctors who administer preterm formula already know about the risks of NEC.

"Babies who are born preterm, particularly those that are born with a birth weight less than three pounds, or who are very low birthweight, are at risk of a number of complications related to prematurity. That doesn't just include NEC. It can also include their lungs and their brain," said Dr. Ravi Patel, a neonatologist at Children's Healthcare of Atlanta.

Though a definitive cause of NEC has not been determined, it has been shown that the use of breast milk can be protective. "Overall, pasteurized donor milk is nutritionally suboptimal to a mother's own milk," according to an AAP clinical report published in 2021. "And those nutrition decisions are made at the bedside between clinicians and families, taking in the context of the unique circumstances of each baby," he added.Attorneys for Mead Johnson argued during Watson's trial that the reason for differences in NEC rates is "not because formula is harmful. It's because formula doesn't protect in the same way that breast milk does. It doesn't include the same protective factors.

The trial's outcome also prompted a cautionary public statement from the NEC Society, a nonprofit patient-led advocacy group, urging against abrupt changes to neonatal care based on a single jury's findings.

 

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