The corporate battle over infant formula for preterm babies
In a Jan. 19, 2024, deposition, Abbott scientist Bridget Barrett-Reis testified about her reasons for undertaking the AL16 clinical trial. Deposition video clips are from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.
In 2013, a scientist at Abbott Laboratories saw study results with potentially big implications for the company’s profits and the lives of some of the world’s most fragile people: preterm infants.
The upshot, she wrote in an email: Babies fed rival Mead Johnson Nutrition’s acidified liquid human milk fortifier — a nutritional supplement used in neonatal intensive care units — developed certain complications at higher rates than those given an Abbott fortifier, a researcher at the University of Nebraska had found.
At least one of those complications can be deadly.
The Abbott scientist, Bridget Barrett-Reis, described the results in the email to colleagues, using two exclamation points. Then she proposed that Abbott test the Mead Johnson fortifier, acidified for sterilization, against another Abbott product.
The clinical trial among preterm infants that Abbott subsequently sponsored, known as AL16, is a case study of corporate warfare in the high-stakes business of infant nutrition, wherein preemies have been coveted like commodities; their anxious, vulnerable parents have been — whether they know it or not — targets of calculated commercial pursuit; and scientific research has been used as a marketing tool.
In hospitals around the country, dozens of babies born an average of 11 weeks early were fed Mead Johnson’s fortifier. Dozens of others were fed an Abbott fortifier that wasn’t acidified.
The clinical trial became a boon for Abbott, which publicized the results to wrest market share from Mead Johnson. But for some of the babies enrolled, it didn’t turn out so well, a KFF Health News investigation found.
Far more infants given Mead Johnson’s product developed a buildup of acid in the blood called metabolic acidosis than those fed Abbott’s product — 19 versus four, according to results published in the journal PharmacoEconomics.
Two outside doctors monitoring infants in the study became so alarmed that they refused to enroll any more babies, according to an April 2016 email one of them sent to Abbott.
In a related email to Abbott, neonatologist Robert White of Memorial Hospital in South Bend, Indiana, and Pediatrix Medical Group — an investigator in the study — explained his concerns.
“We had another SAE” — serious adverse event — “today in which a child developed profound metabolic acidosis while on the study fortifier,” White wrote. The severity was “unlike what we would see in most children with these issues.”
A manager at Abbott replied that the company was “taking your concerns very seriously.”
The study continued for almost a year.
At least some of the consent forms used to inform parents about risks did not mention metabolic acidosis or the often-fatal necrotizing enterocolitis, another condition identified in the 2013 email that led to the study.
In a November response to questions for this article, Abbott spokesperson Scott Stoffel said the clinical trial “was safe and ethical” and that the fortifiers it compared were “on the market and widely used.”
The study was “led by 20 non-Abbott investigators,” Stoffel said.
According to a federal website, Abbott’s Barrett-Reis chaired the study.
Stoffel added that the study was approved “by 14 independent safety review boards at hospitals” and “published in a leading peer-reviewed scientific journal.”
“It is reckless and not credible to suggest that these doctors and institutions conducted and then published the results of an unsafe or unethical study,” Stoffel said.
A spokesperson for Mead Johnson, Jennifer O’Neill, did not comment on Abbott’s clinical trial but said in a November statement to KFF Health News that existing studies “cannot responsibly support” any connection between the acidified fortifier and conditions such as necrotizing enterocolitis or metabolic acidosis.
Mead Johnson executive Cindy Hasseberg argued in a deposition that Abbott waged a “smear campaign” against the acidified fortifier that was “very hard to come back from.”
In 2024, Mead Johnson discontinued the product.
Winning the ‘Hospital War’
Behind their warm-and-fuzzy marketing, industry giants Abbott, maker of Similac products, and Mead Johnson, maker of the Enfamil line, have turned neonatal intensive care units into arenas of brutal competition.
This article quotes from and is based largely on records from three lawsuits against formula manufacturers that went to trial in 2024 and are now on appeal. The cases are Watson v. Mead Johnson, Gill v. Abbott Laboratories and Whitfield v. St. Louis Children’s Hospital. The records include emails, internal presentations and other company documents used as exhibits in litigation, as well as court transcripts and witness testimony from depositions.
The records provide an inside view of the business of infant formula and fortifier, a nutritional supplement added to a mother’s milk. For example, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”
Urging employees to win more sales from neonatal intensive care units, the document said: “It is time to open up a can of ‘Whoop Ass.’”
In internal documents and other material from litigation reviewed by KFF Health News, formula makers described hospitals as gateways to the much larger retail market because parents are likely to stick with the brand their babies started on. Products used in the NICU help win hospital contracts, and hospital contracts help establish brand loyalty, according to court records.
Manufacturers vie for contracts that can be “exclusive” or nearly so, according to records from the litigation, including company documents and testimony by people who have worked in management for the companies.
An undated Abbott presentation used in the Gill case, apparently referring to inroads with hospitals in its rivalry with Mead Johnson, boasted of “MJ Strongholds Broken!”
It saluted two employees who “Own 27K Babies Exclusively,” and said another “Stole 600 formula feeders from MJ.”
Still others were praised for “Playing in Mom’s mailbox” or “kicking … and ‘taking names.’”
In July 2024, Abbott CEO Robert Ford said in a conference call for investors that formula and fortifier for preterm infants generated total annual revenue of about $9 million — a small portion of Abbott’s total sales of $42 billion in 2024 and its $2.2 billion of sales in the United States from pediatric nutritional products.
Industry documents cited in litigation provide a different perspective.
“‘First Bottle Fed’ drives our business,” stated an Abbott training presentation from about a decade ago used in the Gill and Whitfield trials.
That described a baby’s first formula feeding in the hospital, the document said. Over 74% of the time, an infant fed formula in the hospital stays on that brand at home, the document said.
Abbott’s goal was that the first-bottle-fed strategy would help generate more than $1.5 billion in sales, the document showed. A staff training slide displayed during the Whitfield trial showed how that momentum could pay off in bonuses for Abbott sales representatives, leading to a “Happy Rep.”
Mead Johnson has espoused a similar strategy.
The company rolled out a “Flip & Win” incentive plan with cash rewards for flipping hospitals from Abbott, according to a 2019 document marked for internal use by Mead Johnson and its parent company, England-based Reckitt Benckiser Group, and admitted into evidence in the Watson case.
“Winning in the NICU is critical to contract gains and acquisition,” stated a company plan for 2022 that was cited in the Whitfield case.
One Abbott document shown in the Whitfield trial said more than half of first feedings happen at night, adding, “Nighttime is the right time to drive your business.”
A “Mead Johnson University” training document described a scenario in which a sales rep overhears patient information in a NICU and encouraged the rep to promote the company’s products. The document, titled “Advanced NICU Skills,” was admitted as evidence in the Watson case.
“[Y]ou are walking back into your most important NICU,” it said. “You overhear the HCP’s” — health care providers, apparently — “stating all of the notes,” it said. “There may be some information that may help you to position your products as a resource for this patient and to handle any objections that the HCP may present you with.”
To win parents’ business, companies have supplied formula to hospitals free or at a loss, court records show. That has resulted in such curiosities as a Mead Johnson “purchasing agreement” cited in the Watson case, listing the price for product after product as “no charge.”
In a 2017 strategy document prepared for Mead Johnson, a consulting firm laid out a plan “to win hospital war.”
Why focus on hospitals? “INFLECTION POINT FOR VULNERABLE MOMS,” it explained.
The document was displayed in the Whitfield case.
In the market for preterm nutrition, Abbott and Mead Johnson compete with each other, not against the use of human milk, the companies told KFF Health News.
“Thus, references in documents about wanting to ‘win’ or ‘own’ the NICU refer to out-performing Mead Johnson by offering the highest-quality products,” Abbott’s Stoffel said in February.
Asked specific questions about business strategies and internal documents, Mead Johnson’s O’Neill said the company was “concerned that you are presenting a misleading and incomplete picture.”
Mead Johnson’s products “are safe, effective, and recommended by neonatologists when clinically appropriate,” O’Neill added.
On the defensive
In courthouses around the country, Abbott and Mead Johnson are on the defensive — and have been for years.
In hundreds of lawsuits, parents of sickened or deceased preterm infants have alleged that formula designed for preemies has caused necrotizing enterocolitis, or NEC, a devastating condition in which immature intestinal tissue can become infected and die, spreading infection through the body.
Lawsuits also accuse the manufacturers of failing to warn parents of the risk.
One of the cases on which this article is based, Watson v. Mead Johnson, resulted in a $60 million judgment against Mead Johnson. Another, Gill v. Abbott Laboratories, et al., resulted in a $495 million judgment against Abbott. The third, Whitfield v. St. Louis Children’s Hospital, et al., resulted in a jury verdict in favor of Abbott and Mead Johnson, but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and granted the plaintiff a new trial.
The cases have involved children like Robynn Davis, who was born at 26 weeks, lost 75% to 80% of her intestine to NEC, suffered brain damage — and, at almost 3 years old, couldn’t walk, couldn’t really talk, and was eating through a tube, as Jacob Plattenberger, an attorney representing her, described in court in 2024.
An attorney for Abbott, James Hurst, said in court that Robynn suffered a catastrophic brain injury at birth, 10 days before she received any Abbott formula, and that her NEC resulted not from formula but from many health problems.
In at least three cases, a federal judge has granted summary judgment in favor of Abbott — ruling for the company before the lawsuits even reached trial.
The formula makers have repeatedly denied fault.
Addressing stock analysts in 2024, Abbott’s chief executive denounced as “without merit or scientific support” the theory that preterm infant formula or milk fortifier caused NEC.
In a joint statement issued in 2024, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health said there was “no conclusive evidence that preterm infant formula causes NEC.”
Mead Johnson’s O’Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.
Neonatologists use the products routinely, O’Neill said.
O’Neill cited a statement by the American Academy of Pediatrics saying the causes of NEC “are multifaceted and not completely understood.”
In a legal brief filed with an Illinois appeals court in the Watson case, the company said “the NEC-related risks” of a formula for preterm infants “are the subject of medical debate,” adding that trial evidence “demonstrated, at a minimum, uncertainty as to the magnitude of the risk, as well as the causal role of various feeding options in the development of NEC.”
Manufacturers say formula is needed when mother’s milk or human donor milk isn’t an option. Fortifier, a product tailored to preemies, is meant to augment mother’s milk when babies are born prematurely and a mother’s milk alone doesn’t deliver enough nutrition. The Mead Johnson fortifier used in the head-to-head clinical trial sponsored by Abbott was acidified to prevent bacterial contamination.
In March 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that his department, which encompasses the Food and Drug Administration, was undertaking a review of infant formula, dubbed “Operation Stork Speed.” It includes reassessing nutrient requirements and increasing testing for heavy metals and other contaminants, HHS said.
However, FDA oversight of infant formula is limited. The agency doesn’t approve the products or their labeling. Whether to report adverse events — illnesses or deaths potentially related to the products — to the FDA is largely at manufacturers’ discretion.
The business of infant formula further spotlights a central contradiction in the Trump administration’s health policies. When it comes to food and medical products, the administration has criticized industry-funded research as unworthy of trust. Yet under Kennedy, it has disrupted, defunded, or sought to cut government-funded research, which could leave industry-funded research with a larger and more influential role.
It “is entirely appropriate for the Department to scrutinize research design, conflicts of interest, and funding sources, particularly when research is used to inform public policy,” HHS spokesperson Andrew Nixon said.
‘At the table’
Company emails cited in litigation shed light on the industry’s approach to research.
In a 2015 email, when Mead Johnson was considering supplying some of its formula to a researcher for a study, a company neonatologist expressed concern that the results could be spun to make the preemie product look unsafe.
“However, we are more likely to have control over final language if we provide the small support and are ‘at the table’ with him,” Mead Johnson’s Timothy Cooper added in the email, which was cited in the Watson trial.
In 2017, Abbott exchanged a series of messages with researchers at the Johns Hopkins University about a study on how the composition of infant formula might affect NEC in mice. The email thread became an exhibit in the Whitfield case.
Abbott was both funding and collaborating on the work, a later publication in a scientific journal shows.
Forwarding a draft of the resulting paper to Abbott, David Hackam, chief of pediatric surgery at the Johns Hopkins University School of Medicine, said in one of the emails, “We hope you like it.” He also requested help from Abbott in filling in information.
“The manuscript looks great!” Abbott’s Tapas Das wrote in May 2017, after a back-and-forth.
But Abbott had some changes, the email thread shows.
“We (VM & DT) made some edits in the text especially to soften a bit with the statement ‘infant formula seems responsible for developing NEC,’” Das wrote.
“Instead, we thought if we could state as ‘infant formula is linked to severity of NEC’. So we made changes throughout the text emphasizing on severity of NEC by infant formula rather than development of NEC by infant formula,” Das wrote.
Das wrote that “other factors are involved for NEC development as described in the text.”
Hackam did not respond to questions KFF Health News sent by email.
Efforts to reach Das and Cooper — including by phoning numbers and sending letters to addresses that appeared to be associated with them — were unsuccessful.
When Mead Johnson provided support to scientific researchers, the company would want to make sure they reported the results “in an honest way,” Cooper said in a deposition played in the Watson trial.
The Abbott co-authors “proposed routine edits to the article for scientific accuracy and for the consideration of the other authors, some of the most well-respected NEC researchers in the world,” Abbott’s Stoffel said.
“Abbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,” Stoffel said.
“The research studies Mead Johnson supports are conducted independently and appropriately, with full transparency,” said O’Neill, the Mead Johnson spokesperson.
‘In the wrong direction’
Transparency can be subjective.
More than a decade ago, Mead Johnson sponsored a clinical trial testing what was then a new acidified liquid fortifier against a powdered fortifier already on the market.
In the study, which enrolled 150 babies, 5% of infants fed the acidified liquid developed NEC compared with 1% of infants fed the powder, according to deposition testimony and a record of the clinical trial used in the Watson case.
That information was not included in a 2012 medical journal article that reported the study results.
The article, in the journal Pediatrics, whose authors included two Mead Johnson employees, concluded it was safe to use the new liquid fortifier instead of the powdered one. The article also said that, comparing babies fed the liquid with those fed the powder, the study observed no difference in the incidence of NEC.
The unpublished finding of 5% to 1% represented so few babies that it was not statistically significant.
Nonetheless, retired neonatologist Victor Herson, who ran a NICU in Connecticut and has studied fortifiers, said in an interview he would have wanted to see those numbers.
“The trend was in the wrong direction,” Herson said, “and would have, I think, alerted the typical neonatologist that, well, maybe not to rush in and adopt” the new fortifier.
It’s common for study publications to include tables showing complications even if they aren’t statistically significant so that readers can draw their own conclusions, Herson said.
Neonatologist Fernando Moya, a co-author of the Pediatrics article, had a different perspective.
“You may not be very familiar with medical literature but when there are no ‘statistically significant’ differences, we do not comment on whether something was increased or decreased,” Moya said by email. He referred questions to Mead Johnson.
Mead Johnson’s O’Neill gave several reasons why “the data you cite was not included in the publication.” She said the study was designed to examine infant nutrition and growth, NEC was a “secondary outcome,” the NEC numbers weren’t statistically significant, and the size of the study, “while appropriate, was not powered to draw any conclusions with respect to any potential differences in NEC.”
In a deposition used in the Watson trial, Carol Lynn Berseth — a co-author of the paper and Mead Johnson’s director of medical affairs for North America when the study was completed — testified that the article was peer-reviewed and that no reviewer asked for additional data.
“Had they asked for it, we would have shown it,” Berseth testified.
Berseth did not respond to a phone message or to an email or letter sent to addresses apparently associated with her.
‘It should not be in a NICU’
The Abbott scientist who flagged research on Mead Johnson’s acidified fortifier in 2013, Bridget Barrett-Reis, was later listed as chair of AL16, the follow-up clinical trial Abbott sponsored, and as a co-author of resulting publications.
In a deposition, she was asked why she conducted the study.
“I conducted that study because I thought [the acidified fortifier] could be dangerous,” she said, “and I thought it would be a good idea to find out if it really was because nobody was doing anything about it.”
Elaborating on the thinking behind the study, she testified: “It should not be in a NICU in the United States. That product should not be anywhere for preterm infants.”
In her 2013 email recommending that Abbott conduct a study, Barrett-Reis cited findings by “an independent investigator,” Ann Anderson-Berry, that, compared with preterm infants fed an Abbott powder, those on Mead Johnson’s acidified liquid “had slower growth, higher incidence of metabolic acidosis and NEC!!”
Asked about the exclamation points, Barrett-Reis testified in a January 2024 deposition used in the Gill case that she wasn’t excited about the findings. “I am known to put exclamation points instead of question marks and everything anywhere, so I have no idea at the time what those meant,” she testified.
The corporate battle over infant formula for preterm babies
In a Jan. 19, 2024, deposition, Abbott scientist Bridget Barrett-Reis testified about her use of exclamation points in a 2013 email. Deposition videoclips are from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.
The research that caught her eye in 2013 reviewed patient records from the Nebraska Medical Center. The institution had switched to the acidified fortifier with high hopes but stopped using it after four months because it was concerned about patient outcomes, Anderson-Berry and Nebraska co-authors reported in January 2014.
In an interview, Anderson-Berry said she set out to analyze why, during those four months, babies’ growth “fell apart in our hands.”
Abbott was “very pleased” with Anderson-Berry’s findings and paid her to go around the country discussing them, she said.
Metabolic acidosis can be fatal, Anderson-Berry said. But typically it can be managed, she said, adding that she didn’t know of deaths from metabolic acidosis caused by the acidified fortifier.
Research has found that metabolic acidosis “is associated with poor developmental and neurologic outcomes in very low birth weight infants,” according to a paper Barrett-Reis co-authored. In addition, it is “a risk factor for neonatal necrotizing enterocolitis,” the paper said.
Barrett-Reis did not respond to inquiries for this article, including a message sent via LinkedIn and a letter sent to an address that appeared to be associated with her.
In court, Abbott representative Robyn Spilker testified that metabolic acidosis can be a very serious condition and that nobody should knowingly put kids at risk for getting NEC in an effort to make money.
Before infants were enrolled in the AL16 study, their parents or guardians had to sign consent forms disclosing, among other things, the risks that clinical trial subjects would face.
International ethical principles for medical research on humans, known as the Declaration of Helsinki, say each participant must be adequately informed of the “potential risks.”
Questioning Abbott’s Spilker in litigation, plaintiff’s attorney Timothy Cronin said, “Ma’am, despite the hypothesis going in, are you aware Abbott did not put metabolic acidosis on the informed consent form given to parents that signed their kids up for that study?” Spilker, who identified herself in court as a senior brand manager, said she didn’t know what was on the consent forms.
Through a request under a Kentucky open-records law, KFF Health News obtained an informed consent form for the AL16 study used at a public institution, the University of Louisville. The form mentioned risks such as diarrhea, constipation, gas, and fussiness. It did not mention metabolic acidosis or NEC.
KFF Health News also reviewed an informed consent form for the AL16 study used at Memorial Hospital of South Bend. It was largely identical to the one used in Louisville and did not mention metabolic acidosis or NEC.
Cronin, the plaintiff’s attorney, said in an interview that Abbott showed disregard for the health and safety of premature babies participating in the AL16 clinical trial.
“I think it’s unethical to do a study if you know you are subjecting participants in the study to an increased risk of a potentially deadly disease and you don’t at least tell them that,” Cronin said.
Anderson-Berry told KFF Health News that Abbott was “ethically well positioned” to conduct the AL16 clinical trial because her paper was not definitive.
Yet she said she was unwilling to enroll any of her patients in the Abbott clinical trial because she didn’t want to take the chance that they would be given the acidified liquid.
White, the neonatologist who stopped enrolling patients in the study, defended the decision to conduct it. In an interview, he said it was appropriate to conduct a large, properly controlled clinical trial to see whether concerns raised in earlier research were borne out. The two babies whose serious adverse events he reported to Abbott ended up doing fine, he said.
But White, who went on to be listed as a co-author of the study, told KFF Health News that parents should have been informed that the risks included metabolic acidosis and NEC.
“In retrospect, obviously, that is something that we, I think, should have informed parents of,” he said.
Abbott did not directly answer questions about the consent forms.
The results of AL16 were published in the Journal of Pediatrics in 2018. The conclusion: Infants fed the acidified product — in other words, the Mead Johnson fortifier — had higher rates of metabolic acidosis and poorer feeding tolerance. Plus, poorer “initial weight gain.”
The title of the article trumpeted “Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier” — in other words, the Abbott product.
Eight of the 78 infants receiving the Mead Johnson fortifier were treated for metabolic acidosis, compared with none of the 82 receiving the Abbott product, the article said. Four infants on Mead Johnson’s product experienced serious adverse events, compared with one on the Abbott product, the article reported.
One infant receiving the Mead Johnson product died — from sepsis, the article said. One had a case of NEC, and infants on Mead Johnson’s fortifier “had significantly more vomiting,” the article said.
However, in a pair of letters to the editor published in the Journal of Pediatrics, doctors criticized the article as hyped. Writers said the article emphasized findings that were subjective and susceptible to bias.
In its business battle with Mead Johnson, Abbott deployed the study. It produced an annotated copy for its sales force, which was shown in the Whitfield trial.
Abbott’s use of AL16 as a marketing tool worked.
In 2019, when Barrett-Reis applied for a promotion at Abbott, she wrote that the results of the study had been “leveraged to secure whole hospital contracts which have increased hospital share to > 70%.”
Her letter was displayed in a deposition video filed in the Gill litigation.
Internally, Mead Johnson conceded it had been beaten in the fight over fortifiers. In the slide deck for a 2020 national sales meeting, the company said, “Abbott won the narrative.”
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