In 2013, a scientist at Abbott Laboratories noticed examine outcomes with probably huge implications for the corporate’s earnings and the lives of among the world’s most fragile individuals: preterm infants.
The upshot, she wrote in an e-mail: Infants fed rival Mead Johnson Diet’s acidified liquid human milk fortifier — a dietary complement utilized in neonatal intensive care items — developed sure issues at greater charges than these given an Abbott fortifier, a researcher on the College of Nebraska had discovered.
At the least a kind of issues could be lethal.
The Abbott scientist, Bridget Barrett-Reis, described the ends in the e-mail to colleagues, utilizing two exclamation factors. Then she proposed that Abbott check the Mead Johnson fortifier, acidified for sterilization, towards one other Abbott product.
The medical trial amongst preterm infants that Abbott subsequently sponsored, often called AL16, is a case examine of company warfare within the high-stakes enterprise of toddler diet, whereby preemies have been coveted like commodities; their anxious, susceptible dad and mom have been — whether or not they comprehend it or not — targets of calculated business pursuit; and scientific analysis has been used as a advertising and marketing software.
In hospitals across the nation, dozens of infants born a mean of 11 weeks early had been fed Mead Johnson’s fortifier. Dozens of others had been fed an Abbott fortifier that wasn’t acidified.
The medical trial grew to become a boon for Abbott, which publicized the outcomes to wrest market share from Mead Johnson. However for among the infants enrolled, it didn’t prove so nicely, a KFF Well being Information investigation discovered.
Much more infants given Mead Johnson’s product developed a buildup of acid within the blood referred to as metabolic acidosis than these fed Abbott’s product — 19 versus 4, in accordance with outcomes revealed within the journal PharmacoEconomics.
Two outdoors docs monitoring infants within the examine grew to become so alarmed that they refused to enroll any extra infants, in accordance with an April 2016 e-mail one in all them despatched to Abbott.
In a associated e-mail to Abbott, neonatologist Robert White of Memorial Hospital in South Bend, Indiana, and Pediatrix Medical Group — an investigator within the examine — defined his issues.
“We had another SAE” — critical antagonistic occasion — “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 supervisor at Abbott replied that the corporate was “taking your concerns very seriously.”
The examine continued for nearly a yr.
At the least among the consent kinds used to tell dad and mom about dangers didn’t point out metabolic acidosis or the often-fatal necrotizing enterocolitis, one other situation recognized within the 2013 e-mail that led to the examine.
In a November response to questions for this text, Abbott spokesperson Scott Stoffel mentioned the medical trial “was safe and ethical” and that the fortifiers it in contrast had been “on the market and widely used.”
The examine was “led by 20 non-Abbott investigators,” Stoffel mentioned.
In response to a federal web site, Abbott’s Barrett-Reis chaired the examine.
Stoffel added that the examine was authorised “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 mentioned.
A spokesperson for Mead Johnson, Jennifer O’Neill, didn’t touch upon Abbott’s medical trial however mentioned in a November assertion to KFF Well being Information that current research “cannot responsibly support” any connection between the acidified fortifier and situations reminiscent of necrotizing enterocolitis or metabolic acidosis.
Mead Johnson government Cindy Hasseberg argued in a deposition that Abbott waged a “smear campaign” towards the acidified fortifier that was “very hard to come back from.”
In 2024, Mead Johnson discontinued the product.
Profitable the ‘Hospital War’
Behind their warm-and-fuzzy advertising and marketing, {industry} giants Abbott, maker of Similac merchandise, and Mead Johnson, maker of the Enfamil line, have turned neonatal intensive care items into arenas of brutal competitors.
This text quotes from and relies largely on data from three lawsuits towards system producers that went to trial in 2024 and are actually on attraction. The circumstances are Watson v. Mead Johnson, Gill v. Abbott Laboratories, and Whitfield v. St. Louis Youngsters’s Hospital. The data embody emails, inside displays, and different firm paperwork used as reveals in litigation, in addition to courtroom transcripts and witness testimony from depositions.
The data present an inside view of the enterprise of toddler system and fortifier, a dietary complement added to a mom’s milk. For instance, a Mead Johnson slide deck for a 2020 nationwide gross sales assembly — later used within the Whitfield trial — outlined a plan for “Branding NICU Babies.”
Urging workers to win extra gross sales from neonatal intensive care items, the doc mentioned: “It is time to open up a can of ‘Whoop Ass.’”
In inside paperwork and different materials from litigation reviewed by KFF Well being Information, system makers described hospitals as gateways to the a lot bigger retail market as a result of dad and mom are prone to stick to the model their infants began on. Merchandise used within the NICU assist win hospital contracts, and hospital contracts assist set up model loyalty, in accordance with courtroom data.
Producers vie for contracts that may be “exclusive” or practically so, in accordance with data from the litigation, together with firm paperwork and testimony by individuals who have labored in administration for the businesses.
An undated Abbott presentation used within the Gill case, apparently referring to inroads with hospitals in its rivalry with Mead Johnson, boasted of “MJ Strongholds Broken!”
It saluted two workers who “Own 27K Babies Exclusively,” and mentioned one other “Stole 600 formula feeders from MJ.”
Nonetheless others had been praised for “Playing in Mom’s mailbox” or “kicking … and ‘taking names.’”
In July 2024, Abbott CEO Robert Ford mentioned in a convention name for traders that system and fortifier for preterm infants generated complete annual income of about $9 million — a small portion of Abbott’s complete gross sales of $42 billion in 2024 and its $2.2 billion of gross sales in america from pediatric dietary merchandise.
Trade paperwork cited in litigation present a unique perspective.
“‘First Bottle Fed’ drives our business,” said an Abbott coaching presentation from a few decade in the past used within the Gill and Whitfield trials.
That described a child’s first system feeding within the hospital, the doc mentioned. Over 74% of the time, an toddler fed system within the hospital stays on that model at residence, the doc mentioned.
Abbott’s aim was that the first-bottle-fed technique would assist generate greater than $1.5 billion in gross sales, the doc confirmed. A employees coaching slide displayed in the course of the Whitfield trial confirmed how that momentum may repay in bonuses for Abbott gross sales representatives, resulting in a “Happy Rep.”
Mead Johnson has espoused the same technique.
The corporate rolled out a “Flip & Win” incentive plan with money rewards for flipping hospitals from Abbott, in accordance with a 2019 doc marked for inside use by Mead Johnson and its guardian firm, England-based Reckitt Benckiser Group, and admitted into proof within the Watson case.
“Winning in the NICU is critical to contract gains and acquisition,” said an organization plan for 2022 that was cited within the Whitfield case.
One Abbott doc proven within the Whitfield trial mentioned greater than half of first feedings occur at evening, including, “Nighttime is the right time to drive your business.”
A “Mead Johnson University” coaching doc described a state of affairs through which a gross sales rep overhears affected person info in a NICU and inspired the rep to advertise the corporate’s merchandise. The doc, titled “Advanced NICU Skills,” was admitted as proof within the Watson case.
“[Y]ou are walking back into your most important NICU,” it mentioned. “You overhear the HCP’s” — well being care suppliers, apparently — “stating all of the notes,” it mentioned. “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 dad and mom’ enterprise, firms have provided system to hospitals free or at a loss, courtroom data present. That has resulted in such curiosities as a Mead Johnson “purchasing agreement” cited within the Watson case, itemizing the worth for product after product as “no charge.”
In a 2017 technique doc ready for Mead Johnson, a consulting agency laid out a plan “to win hospital war.”
Why concentrate on hospitals? “INFLECTION POINT FOR VULNERABLE MOMS,” it defined.
The doc was displayed within the Whitfield case.
Out there for preterm diet, Abbott and Mead Johnson compete with one another, not towards the usage of human milk, the businesses informed KFF Well being Information.
“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 mentioned in February.
Requested particular questions on enterprise methods and inside paperwork, Mead Johnson’s O’Neill mentioned the corporate was “concerned that you are presenting a misleading and incomplete picture.”
Mead Johnson’s merchandise “are safe, effective, and recommended by neonatologists when clinically appropriate,” O’Neill added.
On the Defensive
In courthouses across the nation, Abbott and Mead Johnson are on the defensive — and have been for years.
In a whole lot of lawsuits, dad and mom of sickened or deceased preterm infants have alleged that system designed for preemies has brought on necrotizing enterocolitis, or NEC, a devastating situation through which immature intestinal tissue can change into contaminated and die, spreading an infection by the physique.
Lawsuits additionally accuse the producers of failing to warn dad and mom of the chance.
One of many circumstances on which this text relies, Watson v. Mead Johnson, resulted in a $60 million judgment towards Mead Johnson. One other, Gill v. Abbott Laboratories, et al., resulted in a $495 million judgment towards Abbott. The third, Whitfield v. St. Louis Youngsters’s Hospital, et al., resulted in a jury verdict in favor of Abbott and Mead Johnson, however the choose discovered errors and misconduct on the a part of protection counsel, faulted his personal efficiency, and granted the plaintiff a brand new trial.
The circumstances have concerned youngsters like Robynn Davis, who was born at 26 weeks, misplaced 75% to 80% of her gut to NEC, suffered mind harm — and, at nearly 3 years previous, couldn’t stroll, couldn’t actually discuss, and was consuming by a tube, as Jacob Plattenberger, an lawyer representing her, described in courtroom in 2024.
An lawyer for Abbott, James Hurst, mentioned in courtroom that Robynn suffered a catastrophic mind damage at delivery, 10 days earlier than she obtained any Abbott system, and that her NEC resulted not from system however from many well being issues.
In a minimum of three circumstances, a federal choose has granted abstract judgment in favor of Abbott — ruling for the corporate earlier than the lawsuits even reached trial.
The system makers have repeatedly denied fault.
Addressing inventory analysts in 2024, Abbott’s chief government denounced as “without merit or scientific support” the idea that preterm toddler system or milk fortifier brought on NEC.
In a joint assertion issued in 2024, the FDA, the Facilities for Illness Management and Prevention, and the Nationwide Institutes of Well being mentioned there was “no conclusive evidence that preterm infant formula causes NEC.”
Mead Johnson’s O’Neill mentioned the scientific consensus is that there isn’t a established causal hyperlink between the usage of specialised preterm hospital diet merchandise and NEC.
Neonatologists use the merchandise routinely, O’Neill mentioned.
O’Neill cited a press release by the American Academy of Pediatrics saying the causes of NEC “are multifaceted and not completely understood.”
In a authorized temporary filed with an Illinois appeals courtroom within the Watson case, the corporate mentioned “the NEC-related risks” of a system for preterm infants “are the subject of medical debate,” including that trial proof “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.”
Producers say system is required when mom’s milk or human donor milk isn’t an possibility. Fortifier, a product tailor-made to preemies, is supposed to enhance mom’s milk when infants are born prematurely and a mom’s milk alone doesn’t ship sufficient diet. The Mead Johnson fortifier used within the head-to-head medical trial sponsored by Abbott was acidified to stop bacterial contamination.
In March 2025, Well being and Human Companies Secretary Robert F. Kennedy Jr. introduced that his division, which encompasses the FDA, was enterprise a evaluation of toddler system, dubbed “Operation Stork Speed.” It contains reassessing nutrient necessities and growing testing for heavy metals and different contaminants, HHS mentioned.
Nevertheless, FDA oversight of toddler system is proscribed. The company doesn’t approve the merchandise or their labeling. Whether or not to report antagonistic occasions — sicknesses or deaths probably associated to the merchandise — to the FDA is essentially at producers’ discretion.
The enterprise of toddler system additional spotlights a central contradiction within the Trump administration’s well being insurance policies. In relation to meals and medical merchandise, the administration has criticized industry-funded analysis as unworthy of belief. But beneath Kennedy, it has disrupted, defunded, or sought to chop government-funded analysis, which may go away industry-funded analysis with a bigger and extra influential position.
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 mentioned.
‘At the Table’
Firm emails cited in litigation make clear the {industry}’s method to analysis.
In a 2015 e-mail, when Mead Johnson was contemplating supplying a few of its system to a researcher for a examine, an organization neonatologist expressed concern that the outcomes might 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 within the e-mail, which was cited within the Watson trial.
In 2017, Abbott exchanged a sequence of messages with researchers at Johns Hopkins College a few examine on how the composition of toddler system may have an effect on NEC in mice. The e-mail thread grew to become an exhibit within the Whitfield case.
Abbott was each funding and collaborating on the work, a later publication in a scientific journal reveals.
Forwarding a draft of the ensuing paper to Abbott, David Hackam, chief of pediatric surgical procedure on the Johns Hopkins College College of Medication, mentioned in one of many emails, “We hope you like it.” He additionally requested assist from Abbott in filling in info.
“The manuscript looks great!” Abbott’s Tapas Das wrote in Could 2017, after a back-and-forth.
However Abbott had some modifications, the e-mail thread reveals.
“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 didn’t reply to questions KFF Well being Information despatched by e-mail.
Efforts to achieve Das and Cooper — together with by phoning numbers and sending letters to addresses that seemed to be related to them — had been unsuccessful.
When Mead Johnson supplied assist to scientific researchers, the corporate would wish to be sure they reported the outcomes “in an honest way,” Cooper mentioned in a deposition performed within 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 mentioned.
“Abbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,” Stoffel mentioned.
“The research studies Mead Johnson supports are conducted independently and appropriately, with full transparency,” mentioned O’Neill, the Mead Johnson spokesperson.
‘In the Wrong Direction’
Transparency could be subjective.
Greater than a decade in the past, Mead Johnson sponsored a medical trial testing what was then a brand new acidified liquid fortifier towards a powdered fortifier already available on the market.
Within the examine, which enrolled 150 infants, 5% of infants fed the acidified liquid developed NEC in contrast with 1% of infants fed the powder, in accordance with deposition testimony and a document of the medical trial used within the Watson case.
That info was not included in a 2012 medical journal article that reported the examine outcomes.
The article, within the journal Pediatrics, whose authors included two Mead Johnson workers, concluded it was secure to make use of the brand new liquid fortifier as a substitute of the powdered one. The article additionally mentioned that, evaluating infants fed the liquid with these fed the powder, the examine noticed no distinction within the incidence of NEC.
The unpublished discovering of 5% to 1% represented so few infants that it was not statistically important.
Nonetheless, retired neonatologist Victor Herson, who ran a NICU in Connecticut and has studied fortifiers, mentioned in an interview he would have wished to see these numbers.
“The trend was in the wrong direction,” Herson mentioned, “and would have, I think, alerted the typical neonatologist that, well, maybe not to rush in and adopt” the brand new fortifier.
It’s widespread for examine publications to incorporate tables exhibiting issues even when they aren’t statistically important in order that readers can draw their very own conclusions, Herson mentioned.
Neonatologist Fernando Moya, a co-author of the Pediatrics article, had a unique 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 mentioned by e-mail. He referred inquiries to Mead Johnson.
Mead Johnson’s O’Neill gave a number of the reason why “the data you cite was not included in the publication.” She mentioned the examine was designed to look at toddler diet and progress, NEC was a “secondary outcome,” the NEC numbers weren’t statistically important, and the dimensions of the examine, “while appropriate, was not powered to draw any conclusions with respect to any potential differences in NEC.”
In a deposition used within 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 examine was accomplished — testified that the article was peer-reviewed and that no reviewer requested for added knowledge.
“Had they asked for it, we would have shown it,” Berseth testified.
Berseth didn’t reply to a telephone message or to an e-mail or letter despatched to addresses apparently related along with her.
‘It Should Not Be in a NICU’
The Abbott scientist who flagged analysis on Mead Johnson’s acidified fortifier in 2013, Bridget Barrett-Reis, was later listed as chair of AL16, the follow-up medical trial Abbott sponsored, and as a co-author of ensuing publications.
In a deposition, she was requested why she performed the examine.
“I conducted that study because I thought [the acidified fortifier] could be dangerous,” she mentioned, “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 pondering behind the examine, 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 e-mail recommending that Abbott conduct a examine, Barrett-Reis cited findings by “an independent investigator,” Ann Anderson-Berry, that confirmed, in contrast with preterm infants fed an Abbott powder, these on Mead Johnson’s acidified liquid “had slower growth, higher incidence of metabolic acidosis and NEC!!”
Requested concerning the exclamation factors, Barrett-Reis testified in a January 2024 deposition used within the Gill case that she wasn’t excited concerning 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 analysis that caught her eye in 2013 reviewed affected person data from the Nebraska Medical Middle. The establishment had switched to the acidified fortifier with excessive hopes however stopped utilizing it after 4 months as a result of it was involved about affected person outcomes, Anderson-Berry and Nebraska co-authors reported in January 2014.
In an interview, Anderson-Berry mentioned she got down to analyze why, throughout these 4 months, infants’ progress “fell apart in our hands.”
Abbott was “very pleased” with Anderson-Berry’s findings and paid her to go across the nation discussing them, she mentioned.
Metabolic acidosis could be deadly, Anderson-Berry mentioned. However sometimes it may be managed, she mentioned, including that she didn’t know of deaths from metabolic acidosis attributable to the acidified fortifier.
Analysis has discovered that metabolic acidosis “is associated with poor developmental and neurologic outcomes in very low birth weight infants,” in accordance with a paper Barrett-Reis co-authored. As well as, it’s “a risk factor for neonatal necrotizing enterocolitis,” the paper mentioned.
Barrett-Reis didn’t reply to inquiries for this text, together with a message despatched through LinkedIn and a letter despatched to an handle that seemed to be related along with her.
In courtroom, Abbott consultant Robyn Spilker testified that metabolic acidosis is usually a very critical situation and that no one ought to knowingly put youngsters in danger for getting NEC in an effort to earn a living.
Earlier than infants had been enrolled within the AL16 examine, their dad and mom or guardians needed to signal consent kinds disclosing, amongst different issues, the dangers that medical trial topics would face.
Worldwide moral ideas for medical analysis on people, often called the Declaration of Helsinki, say every participant should be adequately knowledgeable of the “potential risks.”
Questioning Abbott’s Spilker in litigation, plaintiff’s lawyer Timothy Cronin mentioned, “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 recognized herself in courtroom as a senior model supervisor, mentioned she didn’t know what was on the consent kinds.
By means of a request beneath a Kentucky open-records legislation, KFF Well being Information obtained an knowledgeable consent type for the AL16 examine used at a public establishment, the College of Louisville. The shape talked about dangers reminiscent of diarrhea, constipation, gasoline, and fussiness. It didn’t point out metabolic acidosis or NEC.
KFF Well being Information additionally reviewed an knowledgeable consent type for the AL16 examine used at Memorial Hospital of South Bend. It was largely equivalent to the one utilized in Louisville and didn’t point out metabolic acidosis or NEC.
Cronin, the plaintiff’s lawyer, mentioned in an interview that Abbott confirmed disregard for the well being and security of untimely infants taking part within the AL16 medical 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 mentioned.
Anderson-Berry informed KFF Well being Information that Abbott was “ethically well positioned” to conduct the AL16 medical trial as a result of her paper was not definitive.
But she mentioned she was unwilling to enroll any of her sufferers within the Abbott medical trial as a result of she didn’t wish to take the possibility that they’d be given the acidified liquid.
White, the neonatologist who stopped enrolling sufferers within the examine, defended the choice to conduct it. In an interview, he mentioned it was acceptable to conduct a big, correctly managed medical trial to see whether or not issues raised in earlier analysis had been borne out. The 2 infants whose critical antagonistic occasions he reported to Abbott ended up doing effective, he mentioned.
However White, who went on to be listed as a co-author of the examine, informed KFF Well being Information that oldsters ought to have been knowledgeable that the dangers included metabolic acidosis and NEC.
“In retrospect, obviously, that is something that we, I think, should have informed parents of,” he mentioned.
Abbott didn’t instantly reply questions concerning the consent kinds.
The outcomes of AL16 had been revealed within the Journal of Pediatrics in 2018. The conclusion: Infants fed the acidified product — in different phrases, the Mead Johnson fortifier — had greater charges 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 different phrases, the Abbott product.
Eight of the 78 infants receiving the Mead Johnson fortifier had been handled for metabolic acidosis, in contrast with not one of the 82 receiving the Abbott product, the article mentioned. 4 infants on Mead Johnson’s product skilled critical antagonistic occasions, in contrast with one on the Abbott product, the article reported.
One toddler receiving the Mead Johnson product died — from sepsis, the article mentioned. One had a case of NEC, and infants on Mead Johnson’s fortifier “had significantly more vomiting,” the article mentioned.
Nevertheless, in a pair of letters to the editor revealed within the Journal of Pediatrics, docs criticized the article as hyped. Writers mentioned the article emphasised findings that had been subjective and vulnerable to bias.
In its enterprise battle with Mead Johnson, Abbott deployed the examine. It produced an annotated copy for its gross sales pressure, which was proven within the Whitfield trial.
Abbott’s use of AL16 as a advertising and marketing software labored.
In 2019, when Barrett-Reis utilized for a promotion at Abbott, she wrote that the outcomes of the examine had been “leveraged to secure whole hospital contracts which have increased hospital share to > 70%.”
Her letter was displayed in a deposition video filed within the Gill litigation.
Internally, Mead Johnson conceded it had been crushed within the battle over fortifiers. Within the slide deck for a 2020 nationwide gross sales assembly, the corporate mentioned, “Abbott won the narrative.”
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