ST. CLAIR COUNTY, Ill. — The first time Matt and Susan Leas heard the words “Necrotizing Enterocolitis” was when a doctor told them one of their premature twins, Sophia, was probably not going to survive it.
“We had no idea what it was,” said Matt Leas.
“I remember to the hospital saying, ‘Don't Google us because it's going to alarm you if you Google it,” Susan Leas said of the hospital staff at Inova Fairfax Hospital in Washington D.C.
They didn’t listen. And, they were shocked by what they found.
Study after study, like the ones the I-Team found, states babies fed with cow’s milk-based formulas – as almost every formula is – are more likely to get the deadly disease. The formula companies say those studies have limitations.
Some of the research goes back decades.
“This is not a new issue,” Matt Leas said. “It’s been going on for a very long time.”
The new parents wondered how it could happen, why they weren’t warned and why no one seemed to have definitive answers about the disease that essentially attacks a premature baby’s intestines.
Treatment involves stopping all feeds to a premature infant and IV antibiotics. Sometimes surgery is to drain infection. Sometimes surgery is to remove intestines. Sometimes, it’s too late and sepsis sets in, followed by death.
Now, the Leas are among thousands of parents across the country who are suing formula manufacturing giants Abbott and Mead Johnson – hoping to change the way premature infants are fed in NICUs.
The I-Team found more than 330 lawsuits filed nationally. One of them includes a Ferguson mother, whose twin sons contracted the disease 11 years ago. One died and the other is now profoundly disabled, according to court documents.
Most of the cases have been combined into a multi-district litigation suit, and the first trial is expected to begin Feb. 20 in St. Clair County.
“Feb. 20 is a day of reckoning in my opinion for Abbott and Mead Johnson,” said Stephen Reck, who filed the first lawsuit against the companies three years ago in Connecticut. "The science is going to be tested."
Abbott sent a statement, which read: “Abbott has spent decades researching, developing, testing and producing formulas and fortifiers for premature infants, and countless infants have benefitted tremendously from these products. These allegations are without merit, advancing a theory promoted by plaintiffs’ lawyers rather than the medical community, which considers these products part of the standard of care for premature infants.”
Mead Johnson did not respond to the I-Team’s request for comment.
In court filings responding to the lawsuits, Mead Johnson has written: “Mead Johnson denies that Enfamil products cause NEC or increase risks of NEC in infants.”
The company also wrote, “Mead Johnson expressly denies that the medical and scientific community has confirmed any link between NEC and any infant nutritional products containing cow’s milk, including but not limited to Enfamil Premature Nutrition Products.”
Signs of NEC in preemies
Susan Leas went into labor with her twins when she was just 25 weeks pregnant.
But she said Sophia and Patrick started to thrive in the NICU where they live in Washington D.C. as she kept up with their nutritional needs by pumping her own breast milk they received through feeding tubes.
Then, the couple says doctors told them Sophia wasn’t gaining weight fast enough and recommended she be given fortifier – which is essentially formula added to breast milk.
Matt and Susan Leas said they started noticing Sophia’s belly began to bulge and started turning a darker color shortly after the fortifier feedings began.
They said they felt like no one was taking their observations seriously, telling them the breathing apparatus can have that effect. Then, around midnight, they got a phone call from the hospital.
That’s when they heard the words "Necrotizing Entercolotis" for the first time.
“They said, ‘Sophia has something called Necrotizing Enterocolitis, and it's a very dangerous thing for babies to have, and at this time, we're putting her back on a ventilator and stopping all feeds," Susan Leas recalled. "We think that we caught it early enough, and she's going to be OK.’”
“And I just remember waking mad up because we didn't know what Necrotizing Enterocolitis meant. And so we were trying to really understand the information that was just told to us.”
Sophia pulled through. She was considered a case of medical NEC because she did not require surgery, and it resolved with medications alone.
The Leas were reluctant to allow her to receive formula again, but were told she had a less than 10% chance of contracting the disease a second time.
Three weeks later, it happened again.
“It was a lot more severe, and they had to do an emergency surgery, put a drain into her belly to relieve some of the pressure,” Susan Leas recalled, excusing herself to wipe away tears and apologizing for how difficult it is to relive the experience. “She had to go off of all of her feeds.
“She had to go back on the ventilator, but she did not need to have the surgery to remove any intestines. We didn't know what was going to happen. They told us at that point that she had a 70% chance she would not make it to her first birthday.”
Again, Sophia pulled through.
But her parent’s quest to learn more about how and why this happened to her continued.
Some of the research they found is now included in the lawsuits filed against the formula companies.
It includes:
- A 1990 study of 926 preemies found NEC was six to ten times more common in exclusively formula-fed babies than in those fed breast milk alone and three times more common than in those who received formula plus breast milk. The study found babies born at more than 30 weeks gestation confirmed that NEC was rare in those whose diet included breast milk, but it was 20 times more common in those fed formula only.
- A study titled, “An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis than a Death of Human Milk and Bovine Milk-Based Products,” published in 2009 in the Journal of Pediatrics found preemies fed an exclusively human milk-based diet were 90% less likely to develop surgical NEC as compared to a diet that included some bovine milk-based products
- In 2011, the U.S. Surgeon General published a report titled, “The Surgeon General's Call to Action to Support Breastfeeding. It stated, “Premature babies who are not breastfed are 138% more likely to develop NEC.”
- In 2012, The American Academy of Pediatrics wrote: "Preterm infants should only receive their own mother's milk or pasteurized human donor milk."
- IN 2017, a study in the American Society for Nutrition found milk products found bovine milk products provided consistent calories and were less expensive, but significantly increased the risk of NEC and death
How formula companies respond
In October 2023, the Food and Drug Administration sent a warning letter to Abbott stating the marketing materials for one of its formula products, “refer to your product as a probiotic,” and “you sell it for use in preterm infants.”
It continued: “Based on the statements on your website and your marketing materials, your product is an unapproved new drug and unlicensed biological product.”
It states, “The American Academy of Pediatrics does not endorse the routine use of living microorganisms in preterm infants, finding conflicting data on its safety and efficacy in this vulnerable population.”
The I-Team requested interviews with at least a dozen neonatologists across the country – including those from St. Louis Children’s Hospital and Mercy. All declined to comment, citing the pending litigation.
Inova Fairfax Hospital’s media relations staff did not return a phone call and an email from the I-Team seeking comment.
Some of the lawsuits also name hospitals as defendants – including St. Louis area hospitals.
At issue is whether formula companies – and in some cases, hospitals – adequately warn parents about the risk of NEC when bovine-based products are given to preemies.
Reck went from one client three years ago to more than 1,000 across the country.
“They were not happy,” Reck said. “Abbott filed a 300-page sanctions motion against me.
“They really wanted to stop us from pursuing this case as they tried everything in the beginning to basically put us out of business.”
Now, he’s formed a law firm that deals solely with NEC cases.
“I'm a small-town trial lawyer in a little town called North Stonington, Connecticut,” he said. “I never expected to have over a thousand NEC cases, but this is my cause in life now.
“I truly believe we're going to change the way preemies are fed.”
In court filings, Mead Johnson writes Reck’s accusations: “grossly oversimplifies complex anatomical structure and physiological processes.”
“The pathology of NEC is complex, as is the structure, composition and function of a premature infant’s gastrointestinal tract,” according to the filing. “Plaintiff’s summary grossly oversimplifies complex anatomical structure and physiological processes, the development of NEC, and its mortality risks, so as to be incomplete and inaccurate.”
The company also criticizes the research cited in the lawsuits, stating it has “material weaknesses and important limitations,” and accuses the plaintiff of omitting “important content and context” from the summary of the U.S. Surgeon General’s 2011 statements. Can we add some of this to the broadcast, too? It’s important that they question the research
Alternatives to formula made with cow's milk for preemies
Some hospitals offer formulas and fortifiers made with human milk only.
The most popular product is called Prolacta.
Reck says human milk formulas and fortifiers like Prolacta are much more expensive than formulas made with cow’s milk.
Atlanta-based Piedmont Healthcare uses human milk products with "stunning" results, according to the healthcare company's website.
"Units that provide exclusive breast milk combined with the fortifier derived from human milk have seen a 77 percent reduction in NEC," according to the website.
Piedmont's Dr. Scott Johnson calls NEC "a devastating disease with a 50% mortality rate."
The Leas say they didn’t know to ask for a human milk fortifier when doctors recommended Sophia boost her caloric intake.
Sophia and her twin Patrick are now 3 years old.
Patrick never contracted the disease – proof that not all preemies contract it.
“There are many factors related to why a child gets NEC, prematurity is obviously the biggest one because their guts really haven't been formed yet,” Reck said. “But in my opinion, after prematurity, the biggest factor to get NEC is to feed that child a cow’s milk-based product.”
The Leas agree.
They also allege their daughter’s developmental delays are the result of how long she was deprived of nutrition due to her battle against NEC.
She doesn’t often make eye contact with people around her. She often sings and talks mostly to herself. She also often walks on her tiptoes, and her bowel movements remain a much different consistency than her brother’s.
“It makes you wonder, ‘What could be the cause of that?’” Matt Leas said. “And you start pulling the thread back on that and you're looking at NEC.
“It's just a terrifying thing. And nobody should have to go through it.”
And, he says, nobody should have to wait until it happens to their child to hear about it for the first time.
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