In 2013, a scientist at Abbott Laboratories saw study results with potentially big implications for the company\u2019s profits and the lives of some of the world\u2019s most fragile people: preterm infants.<\/p>\n
The upshot, she wrote in an email<\/a>: Babies fed rival Mead Johnson Nutrition\u2019s acidified liquid human milk fortifier \u2014 a nutritional supplement used in neonatal intensive care units \u2014 developed certain complications at higher rates than those given an Abbott fortifier, a researcher at the University of Nebraska had found.<\/p>\n At least one of those complications can be deadly<\/a>.<\/p>\n 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.<\/p>\n The clinical trial among preterm infants that Abbott subsequently sponsored, known as AL16<\/a>, 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 \u2014 whether they know it or not \u2014 targets of calculated commercial pursuit; and scientific research has been used as a marketing tool.<\/p>\n In hospitals around the country, dozens of babies born an average of 11 weeks early were fed Mead Johnson\u2019s fortifier. Dozens of others were fed an Abbott fortifier that wasn\u2019t acidified.<\/p>\n The clinical trial became a boon for Abbott, which publicized the results<\/a> to wrest market share from Mead Johnson. But for some of the babies enrolled, it didn\u2019t turn out so well, a KFF Health News investigation found.<\/p>\n Far more infants given Mead Johnson\u2019s product developed a buildup of acid in the blood called metabolic acidosis than those fed Abbott\u2019s product \u2014 19 versus four, according to results published in the journal PharmacoEconomics<\/a>.<\/p>\n 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.<\/p>\n In a related email to Abbott, neonatologist Robert White of Memorial Hospital in South Bend, Indiana, and Pediatrix Medical Group \u2014 an investigator in the study \u2014 explained his concerns<\/a>.<\/p>\n \u201cWe had another SAE\u201d \u2014 serious adverse event \u2014 \u201ctoday in which a child developed profound metabolic acidosis while on the study fortifier,\u201d White wrote. The severity was \u201cunlike what we would see in most children with these issues.\u201d<\/p>\n A manager at Abbott replied that the company was \u201ctaking your concerns very seriously.\u201d<\/p>\n The study continued for almost a year.<\/p>\n 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.<\/p>\n In a November response to questions for this article, Abbott spokesperson Scott Stoffel said the clinical trial \u201cwas safe and ethical\u201d and that the fortifiers it compared were \u201con the market and widely used.\u201d<\/p>\n The study was \u201cled by 20 non-Abbott investigators,\u201d Stoffel said.<\/p>\n According to a federal website, Abbott\u2019s Barrett-Reis<\/a> chaired the study.<\/p>\n Stoffel added that the study was approved \u201cby 14 independent safety review boards at hospitals\u201d and \u201cpublished in a leading peer-reviewed scientific journal.\u201d<\/p>\n \u201cIt is reckless and not credible to suggest that these doctors and institutions conducted and then published the results of an unsafe or unethical study,\u201d Stoffel said.<\/p>\n A spokesperson for Mead Johnson, Jennifer O\u2019Neill, did not comment on Abbott\u2019s clinical trial but said in a November statement to KFF Health News that existing studies \u201ccannot responsibly support\u201d any connection between the acidified fortifier and conditions such as necrotizing enterocolitis or metabolic acidosis.<\/p>\n Mead Johnson executive Cindy Hasseberg argued in a deposition that Abbott waged a \u201csmear campaign\u201d against the acidified fortifier that was \u201cvery hard to come back from.\u201d<\/p>\n In 2024, Mead Johnson discontinued the product.<\/p>\n Winning the \u2018Hospital War\u2019<\/strong><\/p>\n 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.<\/p>\n 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<\/em><\/a>, <\/em>Gill v. Abbott Laboratories<\/em><\/a>, and Whitfield v. St. Louis Children\u2019s Hospital<\/em>.<\/a> 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.<\/p>\n The records provide an inside view of the business of infant formula and fortifier, a nutritional supplement added to a mother\u2019s milk. For example, a Mead Johnson slide deck for a 2020 national sales meeting \u2014 later used in the Whitfield<\/em> trial \u2014 outlined a plan for \u201cBranding NICU Babies.\u201d<\/p>\n Urging employees to win more sales from neonatal intensive care units, the document said: \u201cIt is time to open up a can of \u2018Whoop Ass<\/a>.<\/a>\u2019\u201d<\/p>\n 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.<\/p>\n \t\t\t\t\t \t\t\t\t\t Manufacturers vie for contracts that can be \u201cexclusive\u201d or nearly so, according to records from the litigation, including company documents and testimony by people who have worked in management for the companies.<\/p>\n An undated Abbott presentation used in the Gill<\/em> case, apparently referring to inroads with hospitals in its rivalry with Mead Johnson, boasted of \u201cMJ Strongholds Broken!\u201d<\/p>\n It saluted two employees who \u201cOwn 27K Babies Exclusively,\u201d and said another \u201cStole 600 formula feeders from MJ.\u201d<\/p>\n Still others were praised for \u201cPlaying in Mom\u2019s mailbox\u201d or \u201ckicking \u2026 and \u2018taking names.\u2019\u201d<\/p>\n 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 \u2014 a small portion of Abbott\u2019s total sales of $42 billion in 2024 and its $2.2 billion of sales in the United States from pediatric nutritional products.<\/p>\n Industry documents cited in litigation provide a different perspective.<\/p>\n \u201c\u2018First Bottle Fed\u2019 drives our business<\/a>,\u201d stated an Abbott training presentation from about a decade ago used in the Gill<\/em> and Whitfield<\/em> trials.<\/p>\n That described a baby\u2019s 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.<\/p>\n Abbott\u2019s goal was that the first-bottle-fed strategy would help generate more than $1.5 billion in sales<\/a>, the document showed. A staff training slide displayed during the Whitfield<\/em> trial showed how that momentum could pay off in bonuses for Abbott sales representatives, leading to a \u201cHappy Rep.\u201d<\/p>\n Mead Johnson has espoused a similar strategy.<\/p>\n The company rolled out a \u201cFlip & Win\u201d incentive plan<\/a> 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<\/em> case.<\/p>\n \u201cWinning in the NICU<\/a> is critical to contract gains and acquisition,\u201d stated a company plan for 2022 that was cited in the Whitfield<\/em> case.<\/p>\n One Abbott document shown in the Whitfield<\/em> trial said more than half of first feedings happen at night, adding, \u201cNighttime is the right time to drive your business<\/a>.\u201d<\/p>\n A \u201cMead Johnson University\u201d training document described a scenario in which a sales rep overhears patient information in a NICU and encouraged the rep to promote the company\u2019s products. The document, titled \u201cAdvanced NICU Skills<\/a>,\u201d was admitted as evidence in the Watson<\/em> case.<\/p>\n \u201c[Y]ou are walking back into your most important NICU,\u201d it said. \u201cYou overhear the HCP\u2019s\u201d \u2014 health care providers, apparently \u2014 \u201cstating all of the notes,\u201d it said. \u201cThere 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.\u201d<\/p>\n To win parents\u2019 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 \u201cpurchasing agreement\u201d cited in the Watson<\/em> case, listing the price for product after product as \u201cno charge.\u201d<\/p>\n In a 2017 strategy document prepared for Mead Johnson, a consulting firm laid out a plan \u201cto win hospital war.\u201d<\/p>\n Why focus on hospitals? \u201cINFLECTION POINT FOR VULNERABLE MOMS<\/a>,\u201d it explained.<\/p>\n The document was displayed in the Whitfield<\/em> case.<\/p>\n 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.<\/p>\n \u201cThus, references in documents about wanting to \u2018win\u2019 or \u2018own\u2019 the NICU refer to out-performing Mead Johnson by offering the highest-quality products,\u201d Abbott\u2019s Stoffel said in February.<\/p>\n Asked specific questions about business strategies and internal documents, Mead Johnson\u2019s O\u2019Neill said the company was \u201cconcerned that you are presenting a misleading and incomplete picture.\u201d<\/p>\n Mead Johnson\u2019s products \u201care safe, effective, and recommended by neonatologists when clinically appropriate,\u201d O\u2019Neill added.<\/p>\n On the Defensive<\/strong><\/p>\n In courthouses around the country, Abbott and Mead Johnson are on the defensive \u2014 and have been for years.<\/p>\n 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.<\/p>\n Lawsuits also accuse the manufacturers of failing to warn parents of the risk.<\/p>\n One of the cases on which this article is based, Watson v. Mead Johnson<\/a><\/em>, resulted in a $60 million judgment<\/a> against Mead Johnson. Another<\/a>, Gill v. Abbott Laboratories, et al.<\/em>, resulted in a $495 million judgment<\/a> against Abbott. The third<\/a>, Whitfield v. St. Louis Children\u2019s Hospital<\/em>, et al.<\/em>, resulted in a jury verdict in favor of Abbott and Mead Johnson<\/a>, but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and granted the plaintiff a new trial<\/a>.<\/p>\n 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 \u2014 and, at almost 3 years old, couldn\u2019t walk, couldn\u2019t really talk, and was eating through a tube, as Jacob Plattenberger, an attorney representing her, described in court<\/a> in 2024.<\/p>\n An attorney for Abbott, James Hurst, said in court<\/a> 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.<\/p>\n In at least three cases, a federal judge has granted<\/a> summary<\/a> judgment<\/a> in favor of Abbott \u2014 ruling for the company before the lawsuits even reached trial.<\/p>\n The formula makers have repeatedly denied fault.<\/p>\n Addressing stock analysts in 2024, Abbott\u2019s chief executive denounced<\/a> as \u201cwithout merit or scientific support\u201d the theory that preterm infant formula or milk fortifier caused NEC.<\/p>\n In a joint statement<\/a> issued in 2024, the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health said there was \u201cno conclusive evidence that preterm infant formula causes NEC.\u201d<\/p>\n Mead Johnson\u2019s O\u2019Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.<\/p>\n Neonatologists use the products routinely, O\u2019Neill said.<\/p>\n O\u2019Neill cited a statement by the American Academy of Pediatrics<\/a> saying the causes of NEC \u201care multifaceted and not completely understood.\u201d<\/p>\n In a legal brief filed with an Illinois appeals court in the Watson<\/em> case, the company said \u201cthe NEC-related risks\u201d of a formula for preterm infants \u201care the subject of medical debate,\u201d adding that trial evidence \u201cdemonstrated, 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.\u201d<\/p>\n Manufacturers say formula is needed when mother\u2019s milk or human donor milk isn\u2019t an option. Fortifier, a product tailored to preemies, is meant to augment mother\u2019s milk when babies are born prematurely and a mother\u2019s milk alone doesn\u2019t deliver enough nutrition. The Mead Johnson fortifier used in the head-to-head clinical trial sponsored by Abbott was acidified to prevent bacterial contamination.<\/p>\n In March 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that his department, which encompasses the FDA, was undertaking a review of infant formula, dubbed \u201cOperation Stork Speed.\u201d It includes reassessing nutrient requirements<\/a> and increasing testing for heavy metals and other contaminants, HHS said.<\/p>\n However, FDA oversight of infant formula<\/a> is limited. The agency doesn\u2019t approve the products or their labeling. Whether to report adverse events \u2014 illnesses or deaths potentially related to the products \u2014 to the FDA is largely at manufacturers\u2019 discretion.<\/p>\n The business of infant formula further spotlights a central contradiction<\/a> in the Trump administration\u2019s 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.<\/p>\n It \u201cis entirely appropriate for the Department to scrutinize research design, conflicts of interest, and funding sources, particularly when research is used to inform public policy,\u201d HHS spokesperson Andrew Nixon said.<\/p>\n \u2018At the Table\u2019<\/strong><\/p>\n Company emails cited in litigation shed light on the industry\u2019s approach to research.<\/p>\n 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.<\/p>\n \u201cHowever, we are more likely to have control over final language if we provide the small support and are \u2018at the table\u2019 with him,\u201d Mead Johnson\u2019s Timothy Cooper added in the email, which was cited in the Watson<\/em> trial.<\/p>\n In 2017, Abbott exchanged a series of messages<\/a> with researchers at 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<\/em> case.<\/p>\n Abbott was both funding and collaborating on the work, a later publication in a scientific journal<\/a> shows.<\/p>\n 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, \u201cWe hope you like it.\u201d He also requested help from Abbott in filling in information.<\/p>\n \u201cThe manuscript looks great!\u201d Abbott\u2019s Tapas Das wrote in May 2017<\/a>, after a back-and-forth.<\/p>\n But Abbott had some changes, the email thread shows.<\/p>\n \u201cWe (VM & DT) made some edits in the text especially to soften a bit with the statement \u2018infant formula seems responsible for developing NEC,\u2019\u201d Das wrote.<\/p>\n \u201cInstead, we thought if we could state as \u2018infant formula is linked to severity of NEC\u2019. So we made changes throughout the text emphasizing on severity of NEC by infant formula rather than development of NEC by infant formula,\u201d Das wrote.<\/p>\n Das wrote that \u201cother factors are involved for NEC development as described in the text.\u201d<\/p>\n Hackam did not respond to questions KFF Health News sent by email.<\/p>\n Efforts to reach Das and Cooper \u2014 including by phoning numbers and sending letters to addresses that appeared to be associated with them \u2014 were unsuccessful.<\/p>\n When Mead Johnson provided support to scientific researchers, the company would want to make sure they reported the results \u201cin an honest way,\u201d Cooper said in a deposition played in the Watson<\/em> trial.<\/p>\n The Abbott co-authors \u201cproposed 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,\u201d Abbott\u2019s Stoffel said.<\/p>\n \u201cAbbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,\u201d Stoffel said.<\/p>\n \u201cThe research studies Mead Johnson supports are conducted independently and appropriately, with full transparency,\u201d said O\u2019Neill, the Mead Johnson spokesperson.<\/p>\n \u2018In the Wrong Direction\u2019<\/strong><\/p>\n Transparency can be subjective.<\/p>\n 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.<\/p>\n 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<\/em> case.<\/p>\n That information was not included in a 2012 medical journal article<\/a> that reported the study results.<\/p>\n 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.<\/p>\n The unpublished finding of 5% to 1% represented so few babies that it was not statistically significant.<\/p>\n 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.<\/p>\n \u201cThe trend was in the wrong direction,\u201d Herson said, \u201cand would have, I think, alerted the typical neonatologist that, well, maybe not to rush in and adopt\u201d the new fortifier.<\/p>\n It\u2019s common for study publications to include tables showing complications even if they aren\u2019t statistically significant so that readers can draw their own conclusions, Herson said.<\/p>\n Neonatologist Fernando Moya, a co-author of the Pediatrics article, had a different perspective.<\/p>\n \u201cYou may not be very familiar with medical literature but when there are no \u2018statistically significant\u2019 differences, we do not comment on whether something was increased or decreased,\u201d Moya said by email. He referred questions to Mead Johnson.<\/p>\n Mead Johnson\u2019s O\u2019Neill gave several reasons why \u201cthe data you cite was not included in the publication.\u201d She said the study was designed to examine infant nutrition and growth, NEC was a \u201csecondary outcome,\u201d the NEC numbers weren\u2019t statistically significant, and the size of the study, \u201cwhile appropriate, was not powered to draw any conclusions with respect to any potential differences in NEC.\u201d<\/p>\n In a deposition used in the Watson<\/em> trial, Carol Lynn Berseth \u2014 a co-author of the paper and Mead Johnson\u2019s director of medical affairs for North America when the study was completed \u2014 testified that the article was peer-reviewed and that no reviewer asked for additional data.<\/p>\n \u201cHad they asked for it, we would have shown it,\u201d Berseth testified.<\/p>\n Berseth did not respond to a phone message or to an email or letter sent to addresses apparently associated with her.<\/p>\n \u2018It Should Not Be in a NICU\u2019<\/strong><\/p>\n The Abbott scientist who flagged research on Mead Johnson\u2019s acidified fortifier in 2013, Bridget Barrett-Reis, was later listed as chair<\/a> of AL16, the follow-up clinical trial Abbott sponsored, and as a co-author<\/a> of resulting publications<\/a>.<\/p>\n In a deposition, she was asked why she conducted the study.<\/p>\n \u201cI conducted that study because I thought [the acidified fortifier] could be dangerous,\u201d she said, \u201cand I thought it would be a good idea to find out if it really was because nobody was doing anything about it.\u201d<\/p>\n Elaborating on the thinking behind the study, she testified: \u201cIt should not be in a NICU in the United States. That product should not be anywhere for preterm infants.\u201d<\/p>\n In her 2013 email recommending that Abbott conduct a study, Barrett-Reis cited findings by \u201can independent investigator,\u201d Ann Anderson-Berry, that showed, compared with preterm infants fed an Abbott powder, those on Mead Johnson\u2019s acidified liquid \u201chad slower growth, higher incidence of metabolic acidosis and NEC!!\u201d<\/p>\n Asked about the exclamation points, Barrett-Reis testified in a January 2024 deposition used in the Gill<\/em> case that she wasn\u2019t excited about the findings. \u201cI am known to put exclamation points instead of question marks and everything anywhere, so I have no idea at the time what those meant,\u201d she testified.<\/p>\n 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<\/a>.<\/p>\n In an interview, Anderson-Berry said she set out to analyze why, during those four months, babies\u2019 growth \u201cfell apart in our hands.\u201d<\/p>\n Abbott was \u201cvery pleased\u201d with Anderson-Berry\u2019s findings and paid her to go around the country discussing them, she said.<\/p>\n Metabolic acidosis can be fatal, Anderson-Berry said. But typically it can be managed, she said, adding that she didn\u2019t know of deaths from metabolic acidosis caused by the acidified fortifier.<\/p>\n Research has found that metabolic acidosis \u201cis associated with poor developmental and neurologic outcomes in very low birth weight infants,\u201d according to a paper Barrett-Reis co-authored<\/a>. In addition, it is \u201ca risk factor for neonatal necrotizing enterocolitis,\u201d the paper said.<\/p>\n 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.<\/p>\n In court, Abbott representative Robyn Spilker testified that metabolic acidosis can be a very serious condition<\/a> and that nobody should knowingly put kids at risk for getting NEC in an effort to make money.<\/p>\n 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.<\/p>\n International ethical principles for medical research on humans, known as the Declaration of Helsinki<\/a>, say each participant must be adequately informed of the \u201cpotential risks.\u201d<\/p>\n Questioning Abbott\u2019s Spilker in litigation, plaintiff\u2019s attorney Timothy Cronin said, \u201cMa\u2019am, despite the hypothesis going in, are you aware Abbott did not put metabolic acidosis<\/a> on the informed consent form given to parents that signed their kids up for that study?\u201d Spilker, who identified herself in court as a senior brand manager, said she didn\u2019t know what was on the consent forms.<\/p>\n 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.<\/p>\n 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.<\/p>\n Cronin, the plaintiff\u2019s attorney, said in an interview that Abbott showed disregard for the health and safety of premature babies participating in the AL16 clinical trial.<\/p>\n \u201cI think it\u2019s 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\u2019t at least tell them that,\u201d Cronin said.<\/p>\n Anderson-Berry told KFF Health News that Abbott was \u201cethically well positioned\u201d to conduct the AL16 clinical trial because her paper was not definitive.<\/p>\n Yet she said she was unwilling to enroll any of her patients in the Abbott clinical trial because she didn\u2019t want to take the chance that they would be given the acidified liquid.<\/p>\n 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.<\/p>\n 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.<\/p>\n \u201cIn retrospect, obviously, that is something that we, I think, should have informed parents of,\u201d he said.<\/p>\n Abbott did not directly answer questions about the consent forms.<\/p>\n The results of AL16 were published in the Journal of Pediatrics<\/a> in 2018. The conclusion: Infants fed the acidified product \u2014 in other words, the Mead Johnson fortifier \u2014 had higher rates of metabolic acidosis and poorer feeding tolerance. Plus, poorer \u201cinitial weight gain.\u201d<\/p>\n The title of the article trumpeted \u201cImproved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier\u201d \u2014 in other words, the Abbott product.<\/p>\n 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\u2019s product experienced serious adverse events, compared with one on the Abbott product, the article reported.<\/p>\n One infant receiving the Mead Johnson product died \u2014 from sepsis, the article said. One had a case of NEC, and infants on Mead Johnson\u2019s fortifier \u201chad significantly more vomiting,\u201d the article said.<\/p>\n However, in a pair of letters to the editor published in the Journal of Pediatrics, doctors criticized<\/a> the article as hyped. Writers said the article emphasized findings that were subjective and susceptible to bias<\/a>.<\/p>\n 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<\/em> trial.<\/p>\n Abbott\u2019s use of AL16 as a marketing tool worked.<\/p>\n In 2019, when Barrett-Reis applied for a promotion at Abbott, she wrote that the results of the study had been \u201cleveraged to secure whole hospital contracts which have increased hospital share to > 70%.\u201d<\/p>\n Her letter was displayed in a deposition video filed in the Gill<\/em> litigation.<\/p>\n 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, \u201cAbbott won the narrative.\u201d<\/p>\n Share your story with us:<\/em><\/strong> Do you have experience with infant formula or any insights about it that you\u2019d like to share? We\u2019d like to hear from you. Click here<\/a> to contact our reporting team.<\/em><\/p>\n\n KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/p>\n
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