In a , the small Department of Health and Human Services agency known as AHRQ told researchers it was halting , many aimed at improving patient safety. Although Congress appropriated $345 million for AHRQ for this fiscal year, the agency has spent less than $15 million on grants and hasn’t issued a new one in over a year, according to a review of federal records. About 75% of agency staffers have been fired or quit since President Donald Trump took office last year, according to HHS.

Trump and HHS Secretary Robert F. Kennedy Jr. have sought to slash the federal government’s investment in biomedical research, terminating grants and forcing scientists out of agencies across the health department. The gutting of AHRQ strikes some of the administration’s critics as particularly shortsighted, though, because of the agency’s noncontroversial focus on patient safety and its overall alignment with Trump and Kennedy’s “Make American Healthy Again” campaign against chronic illness.

“When you think about everything Americans hate about our healthcare system — that it costs too much, that you can’t get in to see a physician, that the treatment isn’t right, that the records contain wrong information — all that is what AHRQ studies,” said Aaron Carroll, chief executive of AcademyHealth, a health services research group that supports AHRQ’s work.

The Trump and Kennedy changes to AHRQ appear intended to be permanent. All of AHRQ’s grant managers have been fired, so there would be no way for AHRQ to directly oversee future grants, said Brent Sandmeyer, a former AHRQ program officer. “You wonder about this administration’s commitment to fighting fraud,” he said.

HHS spokesperson Emily Hilliard said AHRQ intended to establish a new “framework” for grants. She did not reply to requests for further details.

Researchers who received the letter from AHRQ Director Roger Klein expressed bewilderment because much of their work has the same objectives that Klein highlighted as the agency’s current priorities.

“AHRQ is the only federal agency that’s focused on safety and quality,” said Hardeep Singh, director of the Houston Methodist Safety, Quality and Well-Being Institute. His research, funded until recently by AHRQ, has aimed to reduce medical errors introduced by inadequate software design.

Klein stated that AHRQ’s research interests include patient safety, preventing antibiotic resistance, countering overmedication of children, promotion of digital health tools, and research “focused on scientifically valid, measurable health outcomes and solution-oriented approaches in health disparities research.”

³Ô¹Ï²»´òìÈ examined about 20 of the canceled grants and found that nearly all had objectives that overlapped with the priorities Klein outlined.

“If there’s an ideology, lay it out clearly. But there’s no clarity whatsoever,” said Goutham Rao, chairman of the Department of Family Medicine and Community Health at Case Western Reserve University in Cleveland. AHRQ has funded Rao’s work for 16 years and ended three of his department’s current grants.

As an AHRQ-funded researcher since 2010, Rao has produced work that led to new approaches for common problems seen in doctors’ offices, such as how to respond to weight loss in aged and frail patients. His work has helped reduce diagnostic tests in the elderly and improve hypertension screening of children.

“The priorities they lay out in that letter make me think they didn’t even look at what we were doing,” said Andrea Shields, a University of Connecticut OB-GYN whose AHRQ grant was also eliminated.

Shields developed and implemented training of nonspecialist doctors, nurses, and emergency medical technicians to deal with high-risk pregnancies. Women in rural areas are two to three times as likely to die during pregnancy as those elsewhere in the U.S.

A Long Legacy

AHRQ-funded research has been key to improving patient safety, structuring medical information technology, and introducing the concept of patient-centered care into the health system.

The agency is perhaps best known for its work on curbing hospital infections. Practices introduced because of AHRQ-funded studies prevented an estimated 20,500 deaths and saved $7.7 billion in healthcare costs from 2014 to 2017 alone, according to an analysis the agency conducted.

Teams at Harvard, Yale, and Rand in Santa Monica, California, developed a national standardized patient survey that HHS and healthcare systems use to refine healthcare practices with patient perspectives in mind, said Susan Edgman-Levitan, who has worked on that project since 1995 but recently lost her funding. She and her colleagues developed a definition of patient- and family-centered care that became a pillar of healthcare evaluation. The Centers for Medicare & Medicaid Services bases some of its payments on hospital surveys her group designed.

AHRQ researchers working on five-year grants typically get letters confirming their award in the summer or fall each year. Last year, Edgman-Levitan said, they got no word and no money. They wrote a letter to Klein but heard “not a peep” in response. Then, around 5 p.m. on July 15, an emailed termination notice arrived. The $1 million annual grant was for developing hospital surveys regarding childbirth and behavioral health services.

“My salary is gone. The salaries of all my research assistants, survey scientists, all lost. It’s terrible,” she said. “But I’m near the end of my career. The salary piece is not as devastating as the loss of what I view as really critical work and support for improving childbirth care and patient care in general.”

Klein, a molecular pathologist and Federalist Society-affiliated lawyer who took over the agency last July, has told staff that artificial intelligence can replace much of the evidence review and analytics done by AHRQ scientists, according to one current and one recently departed AHRQ official, whom ³Ô¹Ï²»´òìÈ agreed not to name to protect their jobs.

Such comments align with a report issued July 22 by White House science adviser Michael Kratsios, which said the government should “refocus support on individual scientists rather than legacy institutions, diversify funding mechanisms beyond slow consensus peer review,” and build the future with AI.

Klein did not respond to requests for comment. HHS spokesperson Hilliard also did not respond to specific questions about AHRQ’s plans or objectives.

Of the July 15 letter, Hilliard said: “Under statute, the AHRQ director must determine whether continuation funding is in the best interest of the federal government. AHRQ determined that certain non-competing continuation grants and jointly funded grants would not receive continuation awards.”

Hilliard said the grants were not terminated but rather were “not awarded continued funding.” This subtlety may have legal relevance for grantees planning to sue the administration, said Lauren Adams, a spokesperson for AcademyHealth.

‘None of It Makes Any Sense’

The Society for General Internal Medicine sued Klein and health secretary Kennedy last August over AHRQ’s failure to issue new grants. The lawsuit, , argues that failure to use most of AHRQ’s $369 million fiscal 2025 appropriation is illegal under a 1974 law intended to protect Congress’ power of the purse.

“None of it makes any sense,” said Nora Becker, a pediatrician at Michigan Medicine who lost the last two years of a five-year training and research grant on the relationship between financial difficulty and health outcomes. “The MAHA agenda could fit nicely with AHRQ priorities — we focus on chronic conditions, the quality of care, deprescribing, identifying harms of overmedication.”

She added: “To be honest, it doesn’t feel like any of this is being done in good faith. Part of me just wonders whether the goal was to destroy AHRQ. But I don’t know why AHRQ was such a target.”

Hilliard said that “the Trump Administration remains committed to the responsible stewardship of taxpayer dollars.”

In March 2025, Kennedy announced plans to fold AHRQ and parts of other HHS agencies into a new Office of Strategy. But Congress has shown no interest in the reorganization plan.

Klein hasn’t publicly commented about AHRQ’s overall objectives or plans since attacking previous AHRQ activities in a Newsweek opinion piece he co-wrote with an assistant that was published in January.

The article argued that under previous administrations, “scientific neutrality” had given way to “moral signaling” on diversity and equity. But now, Klein wrote, the Trump administration had righted AHRQ’s focus to “generate evidence that improves how health care is delivered.”

Klein has held no agency-wide meetings, has declined to meet with AHRQ supporters and grantees, and never announced a blueprint for the agency, according to current and former AHRQ employees. They said he is infrequently seen at the agency’s Rockville, Maryland, offices.

Staff members currently number 74, Hilliard said, down from about 300 in early 2025. The agency has halted about $100 million in this year’s commitments to grantees, a substantial chunk of its congressionally approved budget, according to a tabulation by AcademyHealth.

“These claims about Dr. Klein are pointedly false,” Hilliard said. “AHRQ is strengthening its grants process, reviewing agency work for quality, aligning with its statutory mission, and focusing on research to improve patient outcomes.”

She did not respond to a request for specific information on grant funding.

AHRQ continues to conduct some data collection and has kept up its , which measures how Americans use and pay for medical care, insurance, and out-of-pocket costs. However, publication has slowed to a trickle because Klein reviews every piece of data or report issued by the agency, said Elisabeth Kato, who worked at AHRQ for 16 years before resigning from a senior position in April.

AHRQ also runs the U.S. Preventive Services Task Force, a panel whose assessments on the value of drugs and procedures determine whether insurers are required to cover them.

The task force hasn’t met since March 2025. Trump fired two of the group’s senior leaders and currently has only six of the 16 members it had when he took office. “The longer they don’t meet, the longer we’re losing connection between evidence and coverage,” said Sandmeyer, one of the former AHRQ officials.

A meeting of the task force is set for the end of August, Hilliard said.

Pediatrician Courtney Mangus lost her grant in the middle of a five-year project aimed at reducing cancers by using a software tool to help reduce the number of CT scans done on children who come to emergency rooms with abdominal pain. In rural and community emergency rooms, children are much more likely to be scanned for appendicitis than they are in better-equipped children’s pediatric hospitals. Each scan contributes to cancer risk.

Mangus wonders how AHRQ’s disappearance as a funding source will affect her career. “I need some funding to finish what I’ve started,” she said, “so then I could apply for bigger awards that can move the needle on this issue.”

She has applied to smaller foundations and may seek support from the National Institutes of Health, but her work was “really best suited for AHRQ.”

As the NIH, AHRQ, and other federal funders have cut grants over the past two years, new applications have flooded private biomedical foundations.

“It’s baffling to me why AHRQ refuses to fund research that has legally been appropriated by Congress and signed by the president,” Carroll said. “I don’t understand why everyone else in government isn’t going out of their mind about this.”

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

“REMOVE ME FROM YOUR LIST!!!! DO NOT EMAIL OR MAIL ME ANY MORE!

“It is because of your animal based pre-term artificial baby food crap that you peddle to hospital NICU’s that my son is dead from NEC.”

The mother was referring to neonatal intensive care units and necrotizing enterocolitis, an often fatal condition in which intestinal tissue can die and allow infection to spread through the body of an infant born prematurely.

In an internal memo, Mead Johnson cited its “extensive quality and safety checks” and concluded there was “not a reasonable possibility” that the formula caused the baby’s death. “No further investigation is needed. This file can be closed,” the memo said.

And with that decision, the company narrowed the chance that the mother’s anguish could draw attention to any danger the formula might pose to other infants.

The mother’s email and the company’s memo assessing it were used as evidence in the court cases and .

When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry.

Mead Johnson’s handling of the mother’s email showed how that can play out.

Under , if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate.

But it doesn’t always have to inform the government agency that oversees the safety of infant formula.

A company must complete an investigation and notify the Food and Drug Administration within only if it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.”

If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.

‘Never Reported’

Under the Freedom of Information Act, ³Ô¹Ï²»´òìÈ asked the FDA for all notifications that manufacturers of infant formula sent the agency per the regulatory requirement since Jan. 1, 2020. The agency’s Human Foods Program “did not receive any,” Kimberly Jones, a government information specialist at the FDA, responded in March.

³Ô¹Ï²»´òìÈ then asked the FDA to go back decades further — to Jan. 1, 2000. “After a diligent search of our files, we did not locate any responsive records,” Jones wrote on May 5.

The FDA’s search results were consistent with court testimony.

John Wallingford, a paid expert witness for Abbott, testified in a Missouri court in October 2024 that Abbott had under any regulation for preterm infant formula.

that he was not referring to adverse events in clinical trials, which are studies used for research and development and are subject to different procedures. Abbott informed the FDA about adverse events that occurred during a clinical trial, .

Christina Valentine testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her seven years as Mead Johnson’s medical director for North America. In the deposition, used in the Whitfield case, she said she never concluded there was a reasonable possibility that an infant’s death from NEC might have been related to a Mead Johnson product.

As medical director for North America, she was responsible for signing off on those determinations, she testified in the Watson trial.

In the deposition, Valentine said she wasn’t sure whether anyone else at the company sent a death report to the FDA.

In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added to the picture.

“Where there is a physician report that includes an opinion that one of our products caused NEC in a preterm infant, we have treated that as a ‘reasonable possibility of a causal relationship,’ and we submitted an adverse event report to the FDA,” she wrote.

“These physician reports were generally made by plaintiffs’ paid experts, with which we disagree,” she wrote.

O’Neill left unclear whether events Mead Johnson reported to the FDA were raised in lawsuits and, if so, whether the company reported them to the FDA before they surfaced in litigation.

Asked repeatedly when Mead Johnson filed the reports, O’Neill didn’t say.

It’s unclear why the FDA found no record of them.

Nor would O’Neill say whether the company submitted one related to the distraught mother’s September 2016 complaint.

That mother’s name wasn’t publicly disclosed in the court record containing her complaint.

“[P]rior to the current litigation, we received very few reports relating to our products and NEC and even fewer for which our investigation uncovered any evidence supporting a reasonable possibility of a causal relationship,” O’Neill wrote.

Industry personnel have reacted to some complaints with circular reasoning, as shown by court records from the Watson, Whitfield, and cases. Company personnel didn’t think their products caused harm, and they didn’t view new cases as evidence of harm, records show.

‘Reprehensible’ Conduct

About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost , according to a ³Ô¹Ï²»´òìÈ analysis of a for those years. The database doesn’t attempt to explain what caused those babies to develop NEC, and it doesn’t count babies who survived NEC.

A wave of lawsuits has alleged that infant formula made by Abbott or Mead Johnson harmed or killed preterm babies by causing or contributing to cases of NEC. As of late January, 1,760 NEC lawsuits were pending against Abbott, company spokesperson Scott Stoffel said, clarifying a disclosure in a .

This article is based largely on transcripts, deposition videos, and exhibits from three court cases that went to trial in 2024. The lawsuits were filed by parents of babies who suffered or died from NEC.

Abbott and Mead Johnson have denied fault. They, along with various medical authorities including and the , have said that, when nutritional needs can’t be met with human milk, formula is vital.

One of the cases, , led to a against Mead Johnson. , Gill v. Abbott, led to a against Abbott. , Whitfield v. St. Louis Children’s Hospital, et al., led to 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 .

The judge’s ruling in the Whitfield case is on appeal.

On May 5, a Missouri appeals court against Abbott, saying “we find Abbott’s conduct significantly reprehensible.”

“Throughout the trial, the jury heard evidence that Abbott knew its formula posed significant risks to preterm infants weighing under 1500g yet made little effort to mitigate that risk,” the court wrote.

On June 12, an Illinois appeals court against Mead Johnson and sent the case back for a new trial. The trial court risked prejudicing the jury by improperly admitting evidence about Mead Johnson’s finances, including its revenues, profits, and executive compensation, the appeals court said.

In addition, the trial judge gave the jury erroneous instructions, the appeals court ruled. Any negligence on Mead Johnson’s part hinged on a failure to warn, and the company’s duty was not to warn the mother in that case of any danger, as she had claimed, but rather to warn doctors, the appeals court ruled.

In April, after another trial, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is contesting that verdict and the Missouri appeals court’s decision.

In at least four cases, judges have in favor of Abbott — ruling for the company before the lawsuits reached trial.

‘Branding NICU Babies’

Abbott makes Similac products, and Mead Johnson makes the Enfamil line.

The two companies have vied to place their products in neonatal intensive care units, which serve as entry points to hospital contracts and the retail market, ³Ô¹Ï²»´òìÈ reported in a March article based largely on records from court cases.

For instance, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”

The litigation opened a wider window into the business and regulation of infant formula, including adverse event reports.

“Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints,” Stoffel said in November. “FDA routinely conducts audits that include Abbott’s adverse event investigations and reporting as part of its active regulation of infant nutrition.”

Mead Johnson’s O’Neill echoed that.

“Our adverse event reporting complies with all applicable regulatory requirements,” O’Neill said in a November statement to ³Ô¹Ï²»´òìÈ. “The FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.”

The reports the company filed with the FDA were submitted through the agency’s regional office in Detroit, she said.

It’s unclear whether the FDA looked in Detroit.

FDA rules require manufacturers to send written confirmations in the Washington area that oversees infant formula and other foods.

Asked if the company sent them to that office, O’Neill did not answer.

³Ô¹Ï²»´òìÈ requested an interview with Mead Johnson to clarify its statements about how it handled adverse event reports. The company did not grant one.

Plaintiffs have used internal documents from the companies to allege that, in house, people have long recognized a correlation between NEC and the use of preterm formulas made from cow’s milk.

For example, in a 2010 research proposal shown in a deposition used in the Gill case, Abbott scientists wrote that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”

A Mead Johnson document used in the Whitfield lawsuit cited “80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.”

Abbott that correlation does not equal causation.

“Numerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; it’s the absence of human milk that increases NEC risk rather than anything harmful in formula,” Abbott spokesperson Stoffel said.

The FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health weighed in with a in October 2024, saying, “There is no conclusive evidence that preterm infant formula causes NEC” and “there is strong evidence that human milk is protective against 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.

O’Neill cited a statement by the 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.”

Managing Potential Warnings

Court records from lawsuits shed light on how the manufacturers have managed potential warnings from the field.

Fabrizis Suarez, who was director of medical safety and surveillance at Abbott from 2006 to 2023, said in a January 2024 deposition used in the Gill and Whitfield cases that he knew of no instance in which Abbott notified the FDA that a baby had died of NEC that could have been caused by Abbott’s formula for preterm infants.

There were numerous cases in which healthcare providers told Abbott they believed the formula caused the NEC, but Abbott disagreed every time, Suarez testified.

Abbott tracks and reviews every NEC report it receives and looks for patterns, Suarez testified.

Courtney Colombo, who identified herself in a March 2024 deposition used in the Gill and Whitfield cases as director of postmarketing medical safety and surveillance at Abbott, likewise testified that she knew of no instance in which Abbott reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a death caused by NEC.

Abbott from the FDA, according to testimony from Wallingford, a paid expert witness on regulatory matters who spent 10 years at the FDA. The complaints were in company files FDA inspectors reviewed during annual inspections, he said in the Whitfield case.

Wallingford also testified that inspections are for reporting infant deaths.

Questioning Wallingford in court, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché about the .

Wallingford declined to comment for this article. Valentine and Colombo did not respond to messages sent via LinkedIn. Valentine and Suarez did not respond to letters mailed to addresses that appeared to be associated with them. A letter to Colombo with signature required, sent to an address apparently associated with her, was returned unopened.

Not Publicly Reported

Adverse event reports can prompt the FDA to take action to protect the public.

For example, in 2011, the parents, caregivers, and healthcare providers not to feed SimplyThick, a thickening gel, to premature infants fitting a particular profile. The product, used to manage swallowing difficulties, might cause NEC, the FDA said.

The FDA first learned about possible problems with SimplyThick from physicians, according to an FDA document that an attorney for Abbott, Sierra Elizabeth, read from during the Whitfield trial.

The stakes for companies and consumers are high.

A finding under the “reasonable possibility” standard could trigger a product recall, said Martin Hahn, a regulatory attorney for Mead Johnson.

The FDA’s handling of adverse event reports for infant formulas — and fortifiers, which are used to nutritionally supplement a mother’s milk when babies are born prematurely — contrasts with its handling of reports about drugs and medical devices.

The FDA posts manufacturers’ adverse event reports on and online in databases available to the public.

But the notifications manufacturers are required to submit about formulas and fortifiers are not publicly reported, said Emily Hilliard, a spokesperson for the Department of Health and Human Services, which includes the FDA.

In addition, the FDA’s reporting requirements for drugs and medical devices are, in key ways, more demanding than those for infant formula.

Device makers not just deaths but also “serious injuries” that the product “may have caused or contributed to.”

Drugmakers are required to report any “” adverse event, “.” That fatal or life-threatening events.

The FDA also maintains a about dietary supplements, foods, and infant formulas, among other products, that includes from consumers and healthcare practitioners.

³Ô¹Ï²»´òìÈ searched that database and found one death report that mentioned NEC and a formula made for premature or low-birth-weight babies.

The search turned up seven other reports of infant deaths that mentioned NEC and fortifiers designed for premature or low-birth-weight babies. One of those reports, obtained by ³Ô¹Ï²»´òìÈ through the Freedom of Information Act, said three preterm babies at the same hospital had NEC and died within a month of one another in 2024.

The FDA cautions that reports are not verified and do not prove causation.

A former attorney for Abbott now leads the FDA.

Before becoming the FDA’s last year and being named acting head of the agency in May, Kyle Diamantas in the and lawsuits, court records show.

Diamantas “complies with all applicable ethics laws and regulations,” said Hilliard, the HHS spokesperson. “That included a specific recusal related to Abbott Laboratories, which concluded in January 2026.”

“During that period, Mr. Diamantas voluntarily recused himself from all matters involving infant formula to avoid any appearance of partiality,” Hilliard said.

‘No Health Hazard’

³Ô¹Ï²»´òìÈ asked the FDA a series of questions for this article. The agency left many unanswered.

“Infant formula safety is a top priority of the FDA given the vulnerability of the intended population,” Hilliard said.

³Ô¹Ï²»´òìÈ asked Abbott and Mead Johnson for data on all infant death reports the companies received and those they forwarded to the FDA. Neither company provided that information.

Court records provide fragmentary data.

Abbott lawyer Elizabeth said in court that, before Wallingford took the stand as an expert witness, the company gave him from 2005 through 2022 that contained the search term “NEC.”

When Wallingford went through the files, he found that mentioned death and NEC, he testified.

If Similac Special Care products for preterm infants were a problem, and if only 1% of adverse events led to a report, “you would expect to see of complaints,” Wallingford testified.

In 2010, a registered dietitian at a Cincinnati hospital notified Abbott that three babies had died of NEC shortly after starting on an Abbott formula. The dietitian thought there might be a correlation, according to an internal Abbott summary of the complaint shown during Colombo’s deposition. The babies, who were about 17 days old, had no complications other than prematurity, the summary said.

After reviewing the complaint, Abbott’s Colombo wrote, as shown in a deposition video, that she found “NO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE.”

“PREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD,” she concluded.

As for Mead Johnson, Valentine “testified that NEC was not one of the top adverse event complaints for Enfamil premature formulas of the 68 received between 2015-2019,” O’Neill, the company spokesperson, told ³Ô¹Ï²»´òìÈ.

Valentine — who was Mead Johnson Nutrition’s medical director for North America from 2014 to 2021 and parent company Reckitt’s chief medical officer from 2022 to 2023, according to a LinkedIn profile — signed off on the decision to close the 2016 file on the distraught mother’s complaint, according to an exhibit and her deposition testimony played in the Whitfield trial.

When she signed off, Mead Johnson didn’t know which of its products the complaint involved, Valentine said in the deposition.

Asked about it during the Watson trial in February 2024, Valentine testified that, in light of the mother’s request never to contact her again, it wouldn’t have been appropriate to call her back for more information.

Valentine “testified that she believes that the Mead Johnson complaint team appropriately investigated reports of death from NEC based on the information provided,” Mead Johnson’s O’Neill said.

Valentine also testified that the FDA encourages infant formula companies to send in all adverse event reports and that nothing prevented Mead Johnson from doing so.

As reflected in an email thread used in the Watson case, Valentine reacted skeptically in 2019 when a colleague told her a particular hospital wanted to exit its contract with Mead Johnson.

“They had 3 cases of NEC since they started using our formulas. They had 0 cases when they were with Abbott,” the colleague reported.

Valentine agreed to follow up but added: “Sad but please reassure them we are not seeing this with our formula … so no science basis for sure.”

Share your story with us: Do you have experience with necrotizing enterocolitis (NEC) or infant formula that you’d like to share? We’d like to hear from you. Click here to contact the ³Ô¹Ï²»´òìÈ reporting team.

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

LISTEN: After a guilty verdict for negligent homicide, a former nurse has found receptive audiences on the speaking circuit. She says she hopes her story can help shed light on problems in the healthcare industry.

When RaDonda Vaught got her first speaking request, it had been a year since that day in a Nashville courtroom, when she listened as a jury read her guilty verdict for negligent homicide and neglect of an impaired adult.

That was in 2022. Vaught was sentenced to three years of probation for administering the wrong medication and killing a patient at Vanderbilt University Medical Center in 2017.

She also lost her nursing license. So Vaught became a full-time farmer. She and her husband live on a in Bethpage, Tennessee, tucked in the rolling hills north of Nashville. They sell eggs at farmers markets on Saturdays and supply meat to local butchers and restaurants.

The controversial trial had been national news, and now the healthcare industry wanted to hear from her. So Vaught started giving speeches across the country about what happened that day in the hospital. She says her hope is that others in an industry increasingly turning toward automation and artificial intelligence can understand the multiple factors that contributed to the deadly medication mix-up.

She says she’s painfully aware that it could appear she is profiting from a tragedy of her making.

“It wasn’t something that I wanted to happen. It wasn’t even something that was on my radar to think about,” Vaught said of the speaking requests. “The opportunities just kept presenting themselves.”

The speaking engagements provide her with an income that replaces what she made as a nurse, a career she can never return to. Last year, she told her story more than 20 times, and she is paid $5,000 to $10,000 per event.

But her speaking engagements also provoke criticism. After she told her story at length on Nashville Public Radio’s in March, a retired nurse, Gary Wood, fired off an email to the station. Such medical mistakes could never be justified, he wrote: “It put a stain on a proud and dedicated profession.” Yet, Vaught often finds a receptive audience, eager to hear her perspective.

“I’ve seen her a few times now in person, and I’ve never seen RaDonda tell the story and not be upset,” said Charlene Verga, who invited Vaught to be the closing speaker at the ’s clinical nursing conference last year.

“RaDonda speaking the way she is, she literally is transforming her mistake into a teaching moment,” Verga said.

Vaught expected the speaking gigs would be short-lived. But the reviews were good. And she realized she was comfortable in front of a crowd.

“It was emotionally overwhelming and a little cathartic, but I’m going to tell you, you could have heard a pin drop,” Vaught said of her first talk in 2023 to hundreds of industrial professionals at a meeting organized by , a Knoxville, Tennessee-based company that specializes in root cause analysis.

Vaught has turned her story into a cautionary tale that she hopes will make hospitals safer. She says that humans are going to make mistakes and that systems in healthcare need to be designed so people can fail without killing someone.

“This whole mockery of our healthcare system — people feeling afraid to talk about mistakes and come forward when they happen — it doesn’t save people. It kills them,” she said in a presentation to the .

Onstage, Vaught confronts the painful and embarrassing details directly, often choking back tears when talking about the patient who died — Charlene Murphey.

It wasn’t just one mistake that led to the death.

A doctor had ordered a sedative called Versed to settle Murphey’s claustrophobia before an imaging procedure. Vaught typed “VE” into the search function to retrieve Versed from the electronic medicine cabinet. When it did not dispense, she overrode the system.

In Vaught’s trial, fellow nurses testified that during a time when the hospital was upgrading some of its technology, they could use overrides to bypass delays.

When Vaught took that step, one of the drug options available was vecuronium, a powerful paralytic. Vaught overlooked multiple warnings about the danger of vecuronium, including on the bottle’s cap, which said “Warning: Paralyzing Agent,” according to court records.

Vaught administered the vecuronium and also left the patient alone.

While not disputing most of the facts, Vaught pleaded not guilty to all charges, claiming there were other factors, such as a new electronic health record system that was causing widespread problems in the hospital. A lead investigator for the prosecution testified in the criminal case that Vanderbilt also shared some responsibility.

As previously reported by ³Ô¹Ï²»´òìÈ, Vanderbilt did not initially report the error to regulators as required and told the medical examiner that the patient died of natural causes. The medical center fired Vaught and negotiated a settlement with the Murpheys that keeps the family from talking publicly about her death.

Once the case became a criminal matter, though, the details entered the public record. Vaught is not bound by the hospital’s settlement, allowing her to share whatever she feels comfortable sharing with whomever she wants.

Vanderbilt spokesperson Craig Boerner declined to comment about Vaught’s public speaking or what the medical center learned from the incident.

The two largest companies that make drug-dispensing cabinets, Omnicell and BD, have updated their machines with recommendations from the . One update requires the user to type in more than the first two letters of a medication to pull up a list of options.

Many hospitals also tweaked their drug administration protocols, such as by requiring wristband barcode checks anywhere a patient gets medication in a hospital.

Reacting to Vaught’s case, the state legislature in Kentucky that became law in 2024 providing immunity for on-the-job healthcare mistakes. Support wasn’t just bipartisan. It was unanimous.

Nursing consultant went to nursing school with Vaught and has worked directly with her as a nurse. Vaught’s criminal case inspired him to go to law school, he said. He now plans to help other nurses defend themselves in similar cases, even though he sees the need for accountability.

If it had been up to him, he also would have fired Vaught, Garvey said. He also thinks that the Tennessee Board of Nursing should have taken action immediately. Only after the patient’s death escalated to a criminal matter did the board revisit the case and revoke Vaught’s license.

But the defendants’ side of the story is rarely ever told, Garvey said, because they are advised by their lawyers not to talk.

Now that she has a platform, Garvey said, it’s therapeutic for Vaught. Her talks resonate with anxious nurses across the nation, he said, and promote a much-needed discussion about collective responsibility.

“We can’t change what happened. We can only change what we do moving forward,” Garvey said. “Having the individual who can tell you the play-by-play — that was there when it actually happened — is incredibly valuable.”

This article is from a partnership that includes ,Ìý, and ³Ô¹Ï²»´òìÈ.

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

She was in “reasonably good health,” and the risks of the procedure — bleeding, reaction to anesthesia, perforation of her colon — were fairly low. But she was 85. And she would need to briefly discontinue the blood thinners she took because of the cardiac stents keeping her arteries open; doing so could increase the risks.

Had Itzkowitz and his patient faced this decision five years ago, he might have scheduled the screening “without even thinking about it,” he said. But recent research has shown again that the benefits of a repeat colonoscopy .

Now, he said, “I’m saying to myself, ‘What are we accomplishing here?’”

He’s not the only doctor — or patient — having second thoughts. The risks and benefits of common screenings, procedures, and drugs add up differently at advanced ages, and research continues to point out fresh examples of some that may become unnecessary.

Recently, investigators have taken on questions about common skin lesions that probably don’t need to be removed, a widely used thyroid medication that many older patients can safely discontinue, and colonoscopies that reduce colon cancer mortality so slightly that the risks may outweigh the benefits.

Ugly but Probably Harmless

The reddened or rough patches on the skin are called, in doctor-speak, actinic keratoses. Because they result from long-term sun exposure, they usually appear on faces, scalps, forearms, and the backs of hands.

Such lesions appear most commonly on older patients. One large study of traditional Medicare beneficiaries found that over a five-year period, with an actinic keratosis. Then what?

“The vast majority of the time, they’re removed,” said Allison Billi, a dermatologist at the University of Michigan and an author of on the topic in JAMA Internal Medicine. That typically involves cryosurgery (freezing with liquid nitrogen), topical creams, or laser therapy.

The rationale: The patches could become cancerous. But “for the average patient with no history of skin cancer, there is less than a 1-in-1,000 chance of it progressing to skin cancer,” Billi said, citing . The lesions are far more likely to disappear on their own.

“The treatment may be more burdensome than the condition itself,” she added. Removal “is actually extremely painful, both during and after.” It can cause swelling, irritation, and lasting discoloration.

Besides, an actinic keratosis , or new ones will emerge. “This is a chronic condition,” Billi said.

She has proposed active surveillance, instead: Primary care doctors could observe the lesions annually for warning signs like bleeding, pain, or rapid growth, which might warrant removal. But “in many cases, it’s not necessary,” she said. “We don’t always need to do everything we can do.”

She does recommend using sunscreen, however.

Questionable Treatment

Patients take levothyroxine, one of the world’s most frequently prescribed drugs, when their thyroid glands can’t produce sufficient thyroid hormone.

With this condition, called hypothyroidism, “people gain weight. They have less energy. Their hair and skin are dry,” explained Jacobijn Gussekloo, a primary care doctor and researcher at Leiden University Medical Center in the Netherlands. “Everything slows down.”

Doctors also increasingly prescribe it for a borderline condition called subclinical hypothyroidism, which usually causes no symptoms but can progress to hypothyroidism.

Most patients take the drug for life — but do they have to? Gussekloo’s team has found that in many older adults with subclinical hypothyroidism, on their own.

The researchers have also reported that among older people with the condition, and “no apparent benefit.”

Like any drug, it can also cause harm. It may interact with other medications that older patients typically take. Moreover, “it requires frequent lab tests and follow-ups, more visits and expense,” said Maria Papaleontiou, an endocrinologist at the University of Michigan and an author of in JAMA accompanying the latest Dutch study.

“In high doses, it can cause hyperthyroidism, which can lead to cardiac arrhythmias and bone loss,” she added. Patients taking it also have to adjust their diets and meal schedules.

To determine whether some patients could stop taking levothyroxine, the Dutch researchers devised a protocol that gradually reduced doses over 30 weeks, with ongoing lab testing and consultations with doctors.

After a year, a quarter of the 370 participants, all over 60, while maintaining healthy thyroid function. Most had been on lower doses to begin with.

Patients shouldn’t stop levothyroxine on their own, Papaleontiou cautioned. Discontinuation requires tapering off gradually, with testing and monitoring. Some patients will always need the drug.

But it appears that “a select group of adults over 60 may not require this treatment lifelong,” Papaleontiou said.

A Screening With Risks

The question of when older patients can safely stop screening for colon cancer has prompted years of debate. The influential U.S. Preventive Services Task Force gives the screening a lukewarm , calling the benefit “small.”

Yet almost 60% of older patients who have had previous colonoscopies and face limited life expectancies (less than five years) are advised to undergo another screening, found.

As a gastroenterologist at the University of California-San Diego, Samir Gupta regularly encounters this issue with older patients. “I know they really have a low risk of colon cancer, and I’m putting them through more risk,” he said.

The risk of complications following a colonoscopy rise with age. One study found that nearly 7% of patients over 75 had within a month of the procedure.

Is it worth it? Gupta is the lead author of of almost 92,000 Veterans Affairs patients over 75 who had previous colonoscopies. In about 28%, the procedure had found an adenoma, a type of polyp that can become cancerous. Though only a small fraction do, gastroenterologists generally remove them.

The researchers found that after 10 years, veterans with a previous adenoma were more likely to develop colon cancer than those without one, though the rate was extremely low in both groups.

But just 0.5% — yes, one-half of 1% — of those with a previous adenoma died of colon cancer, compared with 0.4% of those without one. “A tiny difference,” Gupta said.

Both groups were dwarfed by the number of veterans — almost half — who died within the decade of other causes.

“Even if the procedure goes well, you’ll either find nothing or you’ll find something that’s not going to have real impact on your longevity,” said Itzkowitz, an author of published alongside the study.

Yet he has found that many patients who have had polyps removed want to continue colonoscopies.

It is hard to shift established medical norms. can meet with opposition from both patients and health care professionals.

Many older women past the point of documented benefit, and older men often beyond the recommended age.

Colonoscopies are less pleasant, so perhaps older patients will be glad to forgo them. “Even with polyps, the chance of dying from colon cancer is so low compared to everything else that can get you,” Itzkowitz said.

So he told his 85-year-old patient that she could skip another colonoscopy. She seemed pleased.

The New Old Age is produced through a partnership with .

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

The upshot, : 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 .

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, , 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 to wrest market share from Mead Johnson. But for some of the babies enrolled, it didn’t turn out so well, a ³Ô¹Ï²»´òìÈ 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 .

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 — .

“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, 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 ³Ô¹Ï²»´òìÈ 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 , , and 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: “’”

In internal documents and other material from litigation reviewed by ³Ô¹Ï²»´òìÈ, 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.

“‘,” 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 , 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 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.

“ 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, “.”

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 “,” 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? “,” 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 ³Ô¹Ï²»´òìÈ.

“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, , resulted in a against Mead Johnson. , Gill v. Abbott Laboratories, et al., resulted in a against Abbott. , Whitfield v. St. Louis Children’s Hospital, et al., resulted in a , but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and .

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, in 2024.

An attorney for Abbott, James Hurst, 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 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, as “without merit or scientific support” the theory that preterm infant formula or milk fortifier caused NEC.

In a issued in 2024, the FDA, 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 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 FDA, was undertaking a review of infant formula, dubbed “Operation Stork Speed.” It includes and increasing testing for heavy metals and other contaminants, HHS said.

However, 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 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 case.

Abbott was both funding and collaborating on the work, 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 , 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 ³Ô¹Ï²»´òìÈ 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 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 of AL16, the follow-up clinical trial Abbott sponsored, and of .

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 showed, 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 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 .

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 . 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 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 , 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 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, ³Ô¹Ï²»´òìÈ 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.

³Ô¹Ï²»´òìÈ 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 ³Ô¹Ï²»´òìÈ 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 ³Ô¹Ï²»´òìÈ 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 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, the article as hyped. Writers said the article emphasized findings that were .

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.”

Share your story with us: Do you have experience with infant formula or any insights about it that you’d like to share? We’d like to hear from you. Click here to contact our reporting team.

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

Raven’s case reveals a little-known gap in the U.S. donation system: There is no clear, nationally binding way to opt out — or to ensure a later “no” overrides an earlier “yes” in a different state.

This gap, along with a range of other issues related to the organ procurement system, has become a point of bipartisan congressional concern. Late last year, the House Ways and Means subcommittee on oversight examining what members described as shortcomings, including alleged consent failures.

The panel’s scrutiny of organ procurement organizations, or OPOs, and their consent practices is a first step toward a more meaningful accountability plan that could help maintain trust across the system, according to some committee staff members.

The trust in our organ procurement and transplant system “has been eroded,” said Rep. Terri Sewell of Alabama, the panel’s senior Democrat, calling for stronger transparency and oversight to rebuild public confidence.

“Respect for autonomy — our ability to make our own decisions (self-determination) — allows for both ‘yes’ and ‘no’ decisions and for changing one’s mind,” Margaret McLean, a bioethicist at Santa Clara University, said in an email.

“Medical decision-making is not well served in a context of ambiguity,” she said.

And if a donor revokes consent, she added, “revocation by that person should carry the same ethical and procedural weight as the initial authorization, perhaps more.”

Raven Kinser Changed Her Mind

Raven was 25 when she died. Her parents, Jeff and Jaime Kinser, were at home in Michigan when they received the phone call that shattered their world. They drove through the night to the Newport News hospital, where they learned Raven’s disposition had been referred to LifeNet Health, the region’s federally designated OPO. LifeNet a failing OPO by the Centers for Medicare & Medicaid Services, meaning it doesn’t meet the government’s standards for how well it finds donors and recovers usable organs for transplant compared with other organizations.

Under federal law, hospitals are required to refer deaths and imminent deaths to OPOs, which take responsibility for donation-related decisions and discussions.

OPOs occupy a hybrid position in the health care system, as private nonprofit entities that hold exclusive, federally authorized contracts to recover organs within defined regions. They are regulated by CMS and overseen by the Health Resources and Services Administration, but that oversight occurs primarily through certification standards, performance metrics, and periodic audits rather than routine public disclosure requirements. With donor registries largely managed at the state level and no unified federal reporting requirement for removals, comprehensive national data on revocations is elusive.

OPOs are meant to separate bedside care from organ procurement decisions — to help prevent conflicts of interest and preserve the trust that decisions about life-sustaining treatment are made solely in the dying patient’s interest. But the , leaving families unsure who is in control if and when conflicts arise.

The Kinsers, for instance, felt their daughter would not have wanted to go through the donation process, but, at the time, had no evidence. Jaime remembers telling her husband that Raven would have been mad at them for letting it happen. In an effort to stop it, Jaime inquired about whether she would be asked to sign a consent form. But a LifeNet staff member told her that wasn’t an option because donation was Raven’s “living will,” Jaime said. Meanwhile, Raven’s parents said, her personal effects, including her Virginia driver’s license, which bore no donor designation, had not yet been turned over to the family, leaving them no meaningful way to challenge LifeNet’s determination in real time.

Jaime struggled with this outcome, even mentioning in Raven’s obituary that she was an organ donor. “How would you try to make peace with something that you felt was so wrong but had no proof?” Jaime said.

Two months passed before the Kinsers gained possession of the license, which, as they had expected, showed that Raven had not opted to be an organ donor.

According to the Kinsers, LifeNet staff told them that Raven’s status as a registered donor was established by her designation on her older Michigan license.

An emailed statement attributed to Douglas Wilson, LifeNet executive vice president, said the OPO follows federal law on organ donation, the , and queries applicable state donor registries, relying on time stamps and governing law to determine the , legally valid expression of intent. Under that framework, a prior donor authorization remains enforceable unless a valid revocation is recorded in the regional OPO’s donor registry.

Because of privacy laws, Wilson said, LifeNet could not comment on the specifics of any individual case.

Raven Kinser’s choice not to be a donor when she applied for a Virginia license in July 2024 was not reflected in the registry LifeNet consulted, according to her parents, who said that is what the organization told them. According to Lara Malbon, executive director of Donate Life Virginia, which manages the state’s organ donor registry, if someone changes their donor status while completing a Virginia driver’s license or ID transaction, “that information is sent to our registry, and the registry is updated daily to reflect those changes.” Malbon also said Virginia’s registry includes only people who have “affirmatively said ‘yes’ to becoming an organ, eye, and tissue donor, and it retains records solely for those who have made that decision.”

The Kinsers said they were never told why Raven’s Virginia DMV record was insufficient, or how an older yes from Michigan could outweigh a newer no in Virginia.

In December, the Kinsers filed a complaint with the Health Resources and Services Administration, urging federal regulators to investigate LifeNet’s actions and require OPOs to provide families with documented proof of the donor’s current status at the time of referral. They also called for OPOs, which operate as federally designated regional monopolies but are structured as private nonprofits, to be made subject to public records laws.

When Opting Out Doesn’t Stick

Such confusion is not unique to the Kinser family. It is a consequence of the organ donation consent process in the United States.

“I have also wondered that: why there’s not just one” registry for organ donation, Jaime said. If you go to get a firearm, you have one federal registry, she said.

Here’s how the system works: Americans typically register their organ donation intentions when they apply for driver’s licenses through state DMVs, and that decision remains governed largely by state law. That has led to 50 different sets of rules and very little federal regulation of what has become an in the U.S.

In some states, a donor checkbox is a binding legal document. In other states, the same choice may have different rules about when it takes effect, what it covers, and how it can be revoked.

Those differences can be big. State rules determine whether a person’s “gift” is limited to transplantation or also includes research and education. They determine whether the donation authorization includes tissue. And they can determine what counts as a valid revocation and when it is legally recognized.

Because of the system’s fragmentation, though, signals can cross when someone changes their mind, like Raven; it’s not always reflected from one state system to another.

Under state versions of the Uniform Anatomical Gift Act, a donor’s most recent legally valid expression of intent is meant to control.

“Personal autonomy is paramount to everything,” said Adam Schiavi, a neurointensivist who studies end-of-life decision-making. “If I say I want to be a donor, or if I say I don’t want to be a donor, that has to take precedence over everything else.”

But states differ in how revocation must be recorded and which registry is considered authoritative if someone has lived in more than one state. Those inconsistencies can create uncertainty when records conflict across jurisdictions.

“It has to be the most recent expression, not the most recent yes,” Schiavi said.

In Michigan, a change to someone’s donor status is reflected immediately in the secretary of state’s system, but only affirmative “yes” registrations appear in the registry. Removal information remains in internal motor vehicle records. In Virginia, the state registry includes only those who have affirmatively said “yes,” retaining records solely of donors, creating potential gaps if someone believes a DMV change alone is sufficient.

Elsewhere, processes and volumes differ sharply. New Mexico updates driver records in real time but does not transmit status changes to its donor registry. Instead, donor services receive restricted search access. The state logged nearly 15,000 removals in late 2021 and almost 30,000 in 2022. Florida, which maintains formal removal records through weekly DMV data files, reported 356,161 removals in 2020, more than 1.5 million in 2023, and over 1.2 million in 2025. Kentucky processed 847,371 donor registrations from 2020 to 2025, but only 16,043 icon removals, with registry withdrawal handled separately. In 2025, more than 570,000 Texans opted into the registry, while over 31,000 individuals requested removal.

According to a federal official who asked not to be identified for fear of professional repercussions, OPOs have been highly effective at lobbying states to broaden the definition of consent and authorization — shaping how those terms are applied, whether those statuses must be renewed, and how easy or difficult it is for someone to opt out.

In subsequent correspondence with federal officials, the Kinsers have urged reforms to prevent OPOs from relying on older registry entries when a more recent state DMV record exists, and they have called for criminal penalties in cases in which consent is knowingly misrepresented. Federal regulators have not indicated whether such proposals are under consideration.

Congress Takes a Closer Look

Ethicists have long cautioned that consent must be more than a checkbox and must remain grounded in respect for the donor-patient. In an October on organ transplantation, the American College of Physicians emphasized that clinicians’ primary duty is to the patient in their care, and that maintaining trust requires transparency and safeguards to prevent conflicts of interest from blurring that “bright line.”

Advocates say those steps leave unresolved the core problem raised by the Kinser family: the lack of a clear, legally binding way for people to say “no” and for that decision to follow them across state lines.

The said it “supports strengthening donor registries and enhancing registry interoperability to ensure that an individual’s documented donation decision is honored.” But OPOs have also argued that current policies protect donation as a legally enforceable gift and prevent families from overriding a loved one’s “yes” in the midst of grief. They argue that stronger, more durable consent helps reduce missed donations and saves lives.

Congress and federal regulators are considering changes to the nation’s organ donation system, including how consent is recorded and what should happen when a donor changes their mind.

Sen. Ron Wyden (D-Ore.) last year to create new federal standards for patient safety, transparency, and oversight of organ transplants, including a formal authorization for hospital or OPO staff to pause harvesting if there is any “clinical sign of life.”

HHS press secretary Emily Hilliard said the agency is “committed to holding organ procurement organizations accountable” and to “restoring integrity and transparency” to organ donation policy, calling reforms essential to informed consent and protecting donor rights. CMS issued related March 11, but it does not address the problems highlighted by the Kinsers’ case.

Critics of the organ transplant system say it is difficult for families to obtain documentation or independently verify how consent determinations were made in disputed cases.

HRSA has launched a sweeping modernization of the Organ Procurement and Transplantation Network, the national system that oversees organ allocation and transplant policy. Federal officials have described the overhaul as the most significant restructuring of the transplant system in decades, aimed at breaking up a long-standing contractor monopoly, strengthening patient safety oversight, and replacing aging technology infrastructure.

Central to that effort is modernizing the OPTN’s data systems: improving interoperability, audit trails, and transparency in how decisions are documented and reviewed. A more modern federal data architecture could make it easier to trace which registry was queried, what time stamp controlled, and how a consent determination was reached in disputed donations that span multiple states. But the modernization effort would not change the underlying state-by-state legal framework for donor authorization and what counts as a valid “no.”

Meanwhile, Donate Life America, a national nonprofit that supports state donor registries, also runs the , a central database that allows people to sign up as organ donors directly. Unlike many DMV systems, the national registry lets people log in at any time to view, update, or remove their registration and print proof of their decision. The group is also starting a project to let participating states send registrations directly into the national system, creating one place to track donor sign-ups and removals across state lines.

Each of the proposals comes with trade-offs, and both advocates and OPOs have raised concerns about how they would work in practice.

“Just doing a dump truck dump of information is not going to do much unless you really apply it through checking and auditing,” said Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine. “It could be like the IRS. They don’t have to audit everybody. Just do a spot audit once in a while.”

The Kinsers aren’t opposed to organ donation itself. They celebrated Raven’s donation in her obituary, and in their complaint to federal regulators, they wrote, “We are NOT anti-organ donation, and we will never take away the gift of life our oldest daughter gave to others. However, that was not LifeNet’s choice to make.”

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

Engineered quartz countertops have surged in popularity in the home renovation market, with industry analysts estimating the global engineered stone market at . It’s continuing to expand as quartz surfaces replace natural stone in kitchens in the United States and worldwide.

When González was working, the dust that rose from his saw didn’t look extraordinary. It settled on his clothes, in his hair, across the shop floor. In a small countertop fabrication shop, he cut marble and granite before shifting to engineered stone after the 2008-09 recession, when demand for cheaper quartz countertops surged.

But the crystalline silica released while the engineered stone was cut and polished also settled into his lungs, scarring them beyond repair. What began as breathlessness hardened into silicosis, an irreversible disease that stiffens the lungs until even ordinary movement becomes effort.

A lung transplant was his path forward. The procedure can extend survival, but it redraws the boundaries of a life: anti-rejection drugs every day, constant monitoring, vulnerability to infection, the knowledge that breathing depends on the fragile acceptance of another person’s donated organ.

González, who was diagnosed with silicosis in 2023, is not alone in dealing with a disease that once was associated with miners at the end of long careers. It’s now prevalent among the much younger, often Hispanic men who work in this industry, physicians and public health officials say.

In the United States, cases are appearing in countertop fabrication shops from California to Texas, Florida, and the Northeast. Because silicosis is not a nationally reportable disease and surveillance varies by state, no comprehensive national count exists. But clinicians who treat occupational lung disease say the number of workers — often men in their 30s and 40s — diagnosed after cutting engineered stone has risen sharply over the past decade.

As of , California had identified 519 confirmed cases of engineered-stone-associated silicosis and 29 deaths since 2019. The median age at diagnosis is 46; at death, 49.

Doctors don’t debate whether working with engineered stone can scar lungs.

Manufacturers argue, though, that proper ventilation, wet cutting, and respirators can make fabrication safe. Workers, physicians, and plaintiffs’ attorneys counter that a material composed almost entirely of crystalline silica may be impossible to handle safely at scale.

“This is comparable to the tobacco industry saying cigarettes are safe,” said epidemiologist David Michaels, an assistant labor secretary under President Barack Obama who led the Occupational Safety and Health Administration.

More than 370 lawsuits have been filed by workers who say engineered stone manufacturers failed to warn employees about the risks or sold a product that cannot be fabricated safely. At the same time, members of Congress are that would largely shield manufacturers from liability in those cases, turning a workplace health crisis into a national debate over regulation, responsibility, and the limits of civil litigation.

Gustavo Reyes, 36, is part of that debate. Like González, he spent the early years of his career cutting marble and granite before shifting to engineered stone, a quartz-based material that can contain up to 95% silica and generates far more hazardous dust when cut.

In the shop, he said, cutting was done with water to control the dust. But finishing work — sanding and shaping — generated heavy dust. He said he wore disposable respirator masks or a reusable elastomeric respirator with filters. A door was kept open. Fans ran overhead.

When he was diagnosed in 2021, he did not know what silicosis meant. The doctor told him that there was no medication and that he had three to five years to live. He received a lung transplant in 2023.

Asked who he believes is responsible, Reyes answered: “The industries who created the artificial stone, the product.” Manufacturers dispute that characterization. Major companies say engineered stone can be fabricated safely when employers follow OSHA dust controls, including wet cutting, ventilation, and respirator use.

An Old Disease, Reengineered

Silicosis is not new. It was synonymous with mining disasters and sandblasting, most notoriously in the , when hundreds of workers drilling through silica-rich rock in West Virginia in the early 1930s developed acute silicosis after months of unprotected exposure to dust. In 1938, advised that the disease could be prevented if dust controls were conscientiously applied.

What is new is the industry in which it has resurfaced.

Engineered stone, often marketed as “quartz,” is typically composed of crushed quartz bound with resins and pigments. Unlike marble, which contains little crystalline silica, engineered slabs contain very high levels of the substance.

Cutting changes the material.

“When you grind it, when you cut it, you’re pulverizing it,” said Robert Blink, an occupational and environmental medicine specialist who treats patients with advanced silicosis in Chicago and is a member of the Western Occupational and Environmental Medical Association. “You’re weaponizing the silica.”

Power tools fracture the surface into respirable particles small enough to lodge deep in the lungs. Repeated exposure triggers inflammation and fibrosis. Once scarring begins, it doesn’t reverse.

What Happens When You Look for It

In California, physicians say the pattern emerged gradually.

Robert Harrison, an occupational medicine physician at the University of California-San Francisco, helped identify the of engineered stone silicosis cases in California in 2019 after several workers from the same countertop fabrication shop died or were diagnosed with the disease. He described the crisis as “the largest outbreak of silicosis in decades.” What initially appeared as isolated cases of unexplained lung scarring in young men resolved into a recognizable occupational epidemic once work histories were examined.

Jane Fazio, a pulmonologist at UCLA, recalls seeing advanced fibrosis in otherwise healthy workers. “They have families. They were working full-time,” she said. Some experienced respiratory failure within a few years.

When doctors compared work histories, the pattern became unmistakable: Many of the men had worked in small shops cutting and polishing engineered stone countertops.

Sheiphali Gandhi, an occupational and environmental pulmonologist at UCSF, warned that the true burden remains uncertain. “We’re missing cases,” she said. “There’s no national surveillance system for this.”

California designated silicosis a reportable disease . Since 2019, statewide surveillance has identified hundreds of cases linked to engineered stone. The numbers probably underestimate the toll, though makes the illness visible.

Outside California, there is no comparable tracking.

Early Warnings

California was not the first place this happened.

The earliest modern alarm came from Israel. Caesarstone, a company founded on a kibbutz in the late 1980s, helped popularize quartz countertops globally.

Israeli physicians began in young countertop workers as early as 1997.

“We had never seen this before,” said Mordechai Kramer, a retired pulmonologist who previously worked at Rabin Medical Center in Israel. “In classic silicosis, you expect long exposure, decades. Here, it was much shorter.”

Several patients required lung transplantation.

Despite the warning signs, the market continued to expand.

Australia confronted the same pattern in the late 2010s.

Rather than wait for sporadic diagnoses, Australian regulators launched systematic CT-based screening of artificial-stone workers. Disease prevalence was far higher than anticipated.

Ryan Hoy, a respiratory physician and occupational health researcher at Australia’s Monash University, described severe disease in workers with relatively short exposures.

Authorities examined whether wet cutting, ventilation, and respirators could reduce exposure sufficiently. They ultimately concluded that even with controls, fabrication of high-silica engineered stone posed unacceptable risk.

In 2024, Australia prohibited the manufacture, supply, and installation of engineered stone containing high levels of crystalline silica. Manufacturers pivoted toward lower- and zero-silica formulations.

In the United States: Who’s To Blame?

Fabrication in the U.S. continues under OSHA’s silica standard, which relies on exposure limits, wet cutting, ventilation, and respiratory protection. Manufacturers argue that compliance works and that the problem lies with shops that fail to follow the rules.

OSHA first adopted silica limits based on research from mining, quarrying, and foundry work. Although the agency updated the rule , it regulates crystalline silica broadly and does not distinguish between natural stone and high-silica engineered quartz.

The regulatory debate has now spilled into Congress. , introduced in September by Rep. Tom McClintock (R-Calif.), would largely shield manufacturers and distributors of engineered stone from civil lawsuits arising from the manufacture or sale of their products. McClintock’s office did not respond to a request for comment.

The bill was the subject of a January .

Supporters of the measure argue that manufacturers should not be held liable for injuries caused by employers who fail to follow OSHA standards. Opponents warn that removing litigation pressure would eliminate one of the few mechanisms capable of driving product reform if the material itself cannot be safely handled.

Michaels, the former OSHA official, sees the stakes as historical. “Litigation drives change,” he said, pointing to past battles over asbestos and tobacco.

Plaintiffs’ attorneys argue that compliance with the OSHA silica standard does not eliminate risk.

“It’s not a few bad actors,” said Raphael Metzger, a product liability attorney who has filed roughly 200 silicosis-related injury cases and a class action seeking medical monitoring. He said the issue is the product’s composition, not isolated regulatory noncompliance.

James Nevin, a tort attorney representing workers in silicosis cases, framed the congressional debate as a fight over accountability. “When it comes to causation, there’s no question,” he said, arguing that the wave of cases explains why manufacturers are now seeking what he calls “a manufacturer bailout.”

In mid-2025, Caesarstone US introduced its first products containing less than 1% silica. In response to questions, Irene Williams, a spokesperson for Caesarstone, said, “The company is not responding as these are matters of pending litigation.”

The U.S. engineered stone market is dominated by a handful of large brands — including Caesarstone, Spain-based Cosentino, and U.S.-based Cambria — while the volume of slabs imported from Asian manufacturers is growing.

Cosentino, too, is moving to low-silica products: “One third of the portfolio, including most new collections, contain less than 10% of crystalline silica,” said Kamela Kettles, a Cosentino spokesperson. “Cosentino will not be providing additional commentary at this time,” she said.

Commenting on behalf of Cambria, Mark Duffy, a communications consultant for the company, wrote, “Reckless employers are criminally violating the law, exposing workers to deadly working conditions.” He added that engineering and administrative controls, when properly used, are effective in reducing exposures below OSHA limits and said Cambria maintains exposures below the OSHA Action Level in its own facilities.

While Caesarstone and Cosentino are headquartered overseas, Cambria is based in Minnesota. Its chief executive, Marty Davis, has been a major Republican political donor, to President Donald Trump’s election campaigns as well as to other Republican candidates and political action committees, according to federal campaign finance records. Davis has also contributed to the campaign of Rep. Brad Finstad (R-Minn.), a co-sponsor of the legislation. Finstad’s office did not respond to a request for comment.

Nevin, the attorney, said the bill would give manufacturers “free rein” from civil liability.

He also questions whether regulatory enforcement alone can address the problem. Even before the Trump administration’s funding and staffing cuts, “you had a better chance of being struck by lightning than being visited by OSHA,” he said, arguing that inspections are too infrequent to prevent disease in an industry composed largely of small shops.

Breathing on Borrowed Time

For González, the debate arrives after the fact. The dust he inhaled has already reshaped his life.

And Reyes’ transplanted lungs may last years, but not decades. The median survival time for transplanted lungs is about eight years, UCSF’s Gandhi said.

Reyes said he hopes people shopping for countertops understand that buying artificial stone “will harm the worker. The one who cuts it, the one who manufactures it.”

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

Bostic learned of a federal program designed to help people who suffer rare vaccine reactions.

The Vaccine Injury Compensation Program was created in 1986 after a flood of vaccine injury lawsuits drove drugmakers from the market. Congress aimed to offer a faster and more generous path to compensation for people injured by vaccines, while shielding manufacturers from liability. The VICP, commonly known as vaccine court, is taxpayer-funded. The government pays any award to claimants as well as attorneys fees.

Bostic filed a claim in 2022 for compensation to cover her son’s spiraling medical bills. She then contacted the Carlson Law Firm, which referred her to Arizona-based attorney Andrew Downing — who now serves as a senior adviser to Health and Human Services Secretary Robert F. Kennedy Jr.

Downing declined to comment and HHS did not respond to requests for comment for this article.

Downing, who has represented hundreds of plaintiffs in vaccine court in Washington, D.C., signed on to take their case, according to reviewed by ³Ô¹Ï²»´òìÈ. They agreed Downing would pursue the claim before the VICP.

Bostic shared documents and medical records as he requested them. Months passed as she waited for news on her son’s case.

After several months of making court filings, Downing told her it was time to opt out of the vaccine program and sue the drugmaker. When she refused to opt out, he withdrew from the case.

The government paid Downing $445 an hour for representing Bostic, for program attorneys with his experience, according to court records.

Three years later, Bostic said, she hasn’t received a dime for her son’s injury. Thomas, now 18, endures debilitating pain that doctors say may never go away.

Rather than help them work through the program, Bostic feels that Downing steered them away from it and toward a lawsuit against the manufacturer. The VICP ultimately dismissed her case.

Bostic was furious that the court paid Downing anything.

“Y’all could’ve gave that to me for my son,” she said. “How dare y’all.”

In Business With Washington

In June, Kennedy’s HHS also awarded Downing’s law firm, Brueckner Spitler Shelts, a to consult on an overhaul of the VICP. The contract has grown to $410,000. Downing is the only attorney listed on the firm’s website who has practiced in vaccine court.

Kennedy has routinely questioned vaccine safety and saying it shields drug companies from some liability “.” As a personal injury lawyer, Kennedy previously spearheaded civil litigation against vaccine maker Merck.

Downing and about a dozen other lawyers have transferred hundreds of clients from the vaccine program to civil suits, where the financial rewards — for patients and their lawyers — could run far higher, according to a ³Ô¹Ï²»´òìÈ analysis of court records and program data. They’ve collected millions of taxpayer dollars in attorneys fees from vaccine court while launching precisely what it was designed to avoid: lawsuits against vaccine manufacturers.

This shift in legal strategy has fueled Kennedy’s crusade against Merck, and it could end up hurting some vaccine-injured clients, several experts said.

University of California Law-San Francisco professor Dorit Reiss has studied vaccine court for over a decade and has tracked the rise of anti-vaccine forces in American politics. She said VICP attorneys who are also suing vaccine makers have “incentives to direct more people” to lawsuits, “when it might not be in their best interest.”

A Delicate Balance

Kennedy has criticized the VICP as a barrier to accountability. But for Bostic, vaccine court offered an opportunity to hold the government to its promise of caring for casualties of widespread immunization.

Like any medication, vaccines can have side effects. Serious reactions to routine shots are rare, but for the unlucky few who bear this burden, the government promises recourse through its administrative program.

Vaccine court aims to strike a balance between protecting public health and helping individuals who may pay its price. The no-fault program allows claimants with vaccine-related injuries to get help without showing that the vaccine maker did anything wrong, even when the evidence doesn’t meet courtroom standards.

The program has made more than 12,500 awards, totaling roughly $5 billion in compensation. Historically, nearly half of claims have been resolved with some kind of award.

If patients aren’t satisfied with the outcome or don’t get a ruling within 240 days, they may leave the administrative program and sue the vaccine maker in civil court. Plaintiffs could potentially win larger awards. Lawyers could obtain higher fees, which they can’t in vaccine court.

But winning a civil suit is far more difficult, in part because plaintiffs have a greater burden of showing the vaccine caused their injury and that the maker was at fault. Since the VICP was created, no vaccine injury lawsuit has won a judgment in regular court, records show.

That hasn’t stopped some lawyers from trying. After the requisite 240 days, they have transferred hundreds of VICP claims into civil litigation against HPV vaccine manufacturer Merck, the ³Ô¹Ï²»´òìÈ analysis found.

The lawyers who represented those claims include Downing and other VICP attorneys with ties to Kennedy, court records show. Those include Kennedy advisers and people who work in the law office of his longtime personal lawyer Aaron Siri or with Children’s Health Defense, the anti-vaccine outfit Kennedy founded, as well as a former Kennedy co-counsel in suits against Merck over its HPV vaccine, Gardasil.

Downing, whose describes him as “one of the preeminent litigation attorneys in the Court of Federal Claims,” has not won an HPV vaccine injury claim in the past five years, records show. Vaccine court did compensate dozens of HPV vaccine claims in that time, but most — including nearly all of Downing’s — were withdrawn upon reaching the opt-out period.

VICP data and court records show that over the past five years, Downing and other lawyers withdrew roughly 400 Gardasil claims from vaccine court before a ruling was issued. The plaintiffs received nothing from the program. Hundreds of these cases joined the litigation against Merck, according to court records.

Once the opt-out period arrived in Bostic’s case, Downing informed her that he was preparing to withdraw her son’s claim and move the case back to the original law firm for a lawsuit against Merck.

“That,” he wrote in an email, “was the plan all along.”

Fighting for Compensation

Thomas, who hopes to enroll in community college and become a computer programmer, has intermittent numbness in his fingers and stabbing sensations in his arm nearly every day. The pain often radiates across his back or up his neck, and he’s developed migraines. Once an active kid who dreamed of playing basketball professionally, he now spends his time playing video games and trying to sleep during lulls in his pain.

Bostic’s claim on behalf of her son made him one of about 1,000 people who have filed with vaccine court for HPV vaccine injuries. More than 200 have received compensation — just over one for every million shots given. Court records show program awards were typically $50,000 to $100,000, with some also covering past medical bills or future health care expenses.

Richard Hughes IV, a health care attorney and former pharmaceutical executive who teaches vaccine law at George Washington University Law School, reviewed Thomas’ records and said cases like his were exactly what the vaccine program was designed to address.

“That just seems straightforward,” Hughes said of Thomas’ claim. “That should have gotten compensated.”

Bostic wanted the federal agencies that had approved and recommended Gardasil to answer for her son’s injuries. The single mother hoped compensation from the program would allow Thomas to see specialists including neurologists, afford natural treatments, and enroll in physical therapy.

“He would have had the best of the best health care,” she said.

When Downing took their case, Bostic said, he told her during a phone call that vaccine court’s $250,000 limit on pain and suffering was too low for her son’s injury. Bostic said Downing advised she could get more money by suing Merck, though that could take longer.

“I said, ‘No, that will take years. My son needs help now,’” Bostic recalled.

Bostic said she told Downing she wanted a fund set up for Thomas’ health care as soon as possible.

In the following weeks, Bostic sent paperwork to Downing’s office but had difficulty getting in touch with him, email and text messages show. Downing’s show a gap in his work on the case from late September until mid-November.

In November 2022, Downing emailed Bostic, “The opt out date for K.T.’s case is set for April 23, 2023. At that point, we will be in a position to opt K.T.’s case out of the Vaccine Program and move the case back over to the Carlson Law Firm for handling in the Merck litigation.”

Bostic said she was confused at the time by that language. But she remembers being emphatic in a follow-up phone call with Downing, repeatedly telling him she would not opt out.

After that, Bostic said, she didn’t hear from Downing for months despite calling his office and leaving messages with secretaries.

Downing’s billing records show that he and his paralegals spent fewer than nine hours on Bostic’s case in that stretch. This included time spent requesting, reviewing, and filing medical records, as well as drafting and filing extension requests. The billing records did not include any communication with Bostic during that time.

The court granted each of Downing’s extension requests, pushing back the deadline a month at a time.

In April 2023, Downing sent Bostic an email noting that 240 days had passed, so he could drop their government claim and they could sue Merck.

“Gardasil cases do not receive very fair treatment in the Vaccine Program,” Downing wrote, adding that he would withdraw as her attorney if Bostic stayed in the program.

Bostic chose to stick with vaccine court, later telling the vaccine court judge by email that she’d advised her attorney “I was not trying to become a millionaire.”

That exchange of emails in April is when Bostic said she learned Downing was already representing plaintiffs in lawsuits over Gardasil. The litigation encompassed hundreds of other patients who — most of them under Downing’s counsel — had filed VICP claims in recent years.

Running out the 240-day clock, critics say, is allowed but subverts the program’s intent.

Some legal experts criticize the way Downing handled Bostic’s case.

“They trusted him to file the VICP case,” Reiss said. “It’s his job to zealously advocate for his clients. In this case, his clients want to go through VICP. It’s his job to fight for them in VICP, not to wait for 240 days.”

When Downing joined HHS as a senior adviser to Kennedy, court records show, he handed off his remaining vaccine court cases to other attorneys in firms involved in the litigation against Merck.

A New Approach

The vaccine program has long faced criticism for giving claimants too little, too late. Even VICP advocates see the need for reform, with eight officials deciding a growing , driving up wait times. The cap on pain and suffering payments has not changed since 1986. But the court can award further compensation like a fund for lifetime medical care that can reach millions.

Most vaccine-injured individuals are better off in the administrative program than in civil litigation, legal experts said.

Renée Gentry, director of GWU’s Vaccine Injury Litigation Clinic and a founding member of the Vaccine Injured Petitioners Bar Association, has represented hundreds of families alleging vaccine injuries. Most of them, she said, aren’t focused on big payouts; rather, they “want their kid taken care of or they want to be taken care of.”

For claims that often fail in vaccine court, however, Gentry said a lawsuit may be the best option. According to Gentry, HPV vaccine claims like Thomas’ are particularly challenging to win in the VICP.

“If you’re not going to win, then you want those clients to have at least an opportunity at something,” she said.

For Mark Sadaka, a prominent vaccine court lawyer representing some claims in Merck litigation, sending clients to regular court is a last resort.

Sadaka said certain Gardasil injury claimants, such as those alleging mental rather than physical harm, might be better off in litigation. But by sticking it out in the VICP, Sadaka has won HPV vaccine injury claims that were the first of their kind, including for narcolepsy, alopecia, and even a deadly arrhythmia.

“He’s going to get taken care of for the rest of his life,” Sadaka said of his client who won compensation for narcolepsy in 2023. “And he doesn’t have to pay me anything.”

Sadaka, like all program lawyers, gets an hourly rate from the VICP. He said that he could make much more money representing the same claims in traditional litigation, since he could get a cut of any awards.

“It’s a better thing for me to file in regular court and get a higher fee, but for the client, sometimes it makes sense, sometimes it doesn’t,” Sadaka said. “My role is to explain both sides in gross detail for them and give them as much information as possible so they can make an informed decision.”

According to Sadaka, some lawyers in the VICP automatically advise their clients to leave vaccine court and file a lawsuit.

“If they can extract settlements, they’re going to be very happy to put that money in their pockets,” Hughes noted.

Winning a lawsuit or reaching a major settlement could also spell trouble for nationwide vaccine access, replaying the events that gave rise to vaccine court in the 1980s.

Some vaccine lawyers and policymakers believe Kennedy and his colleagues might welcome a return to those days.

“If they can bring down the system, that’s a feather in their cap,” Hughes said.

Lawyers cannot win contingency fees in vaccine court. They get paid for time spent on reasonable claims whether they win or lose. Downing made more than $1 million representing clients before the VICP in recent years, according to court records.

A shows that since fiscal year 2020, the program has paid scores of attorneys about $280 million — including over $43 million for cases they did not win.

In each of the last two fiscal years, lawyers got roughly $9 million for VICP claims in which their clients got nothing. That was more than the program had ever previously paid to attorneys for unsuccessful claims, according to vaccine court data.

‘Learning How To Cope’

After discovering her attorney would not pursue VICP compensation for her son, Bostic decided to advocate for Thomas herself.

“Please help me,” she wrote in a letter to the court.

VICP staff gave Bostic extra time to find a new lawyer and gather records.

The following months proved difficult for the family. Bostic was hospitalized with a life-threatening condition. Her mother’s health declined. She was laid off and lost her family’s health insurance.

By the time Bostic could take Thomas to a pediatric neurologist to get medical records for his VICP case, she said, the doctor had moved hours away to Orlando.

Bostic repeatedly missed deadlines and failed to communicate with program staff as required, court records show. Emails, docket entries, and letters suggest she may have misunderstood some court orders and not received others.

When Thomas’ medical records remained incomplete for another year, the presiding official dismissed Bostic’s claim, writing that while he had sympathy for what she and her son had endured, “the case cannot be allowed to remain pending indefinitely.”

Thomas said he can no longer play basketball with friends. He can’t even help his mother carry groceries into the house.

“I got to live with this, and there’s pain,” he said.

Bostic now works from home as a bank fraud analyst. With an income just above the cutoff for government assistance, she puts in overtime in hopes of affording health insurance for Thomas and her six other children.

“People are asking, ‘How’s your son doing?’” Bostic said. “I normally say, ‘Still the same. We just learning how to cope with it.’”

Methodology

The ³Ô¹Ï²»´òìÈ analysis began with court records for cases in the U.S. Court of Federal Claims, which includes vaccine court. We first identified all cases since 2006 (when the HPV vaccine was introduced) in which the “nature of suit” field explicitly mentioned human papillomavirus, or in which “nature of suit” was categorized as “other” vaccine injury/death and the case text included the word “papillomavirus.” The latter made up about 10% of identified cases, mostly claims filed before the HPV vaccine was added to the program or claims involving multiple vaccines. We cross-referenced the number of cases with data from VICP reports to verify completeness.

After identifying the relevant vaccine court cases, we pulled these claims’ filing and closing dates and took the difference to find the number of days that each case spent in vaccine court. To estimate total attorneys fees awarded for these claims, we added the fee amounts recorded in dozens of the VICP rulings and derived a minimum estimate based on the number of such cases.

We then searched federal court records for litigation over Merck’s HPV vaccine, Gardasil, and pulled the names of the plaintiffs and attorneys involved. To gauge the scale of claims diverted from the VICP to litigation, we searched for each attorney in the Gardasil-related vaccine court cases and searched for the last name of each plaintiff in the titles of those cases.

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .

Genesis HealthCare, once the nation’s largest nursing home chain, filed for Chapter 11 reorganization bankruptcy in July with a proposal to protect its controlling investor, Joel Landau, from legal liability. In court papers, Genesis had originally estimated all its settled and pending cases — which it said numbered nearly a thousand — would cost $259 million to resolve.

³Ô¹Ï²»´òìÈ reported this month that in the years before filing for bankruptcy, Genesis had settled at least 155 patient injury and death lawsuits with provisions that allowed it to delay paying, sometimes for more than a year. As a result, when Genesis filed for bankruptcy in July, it still owed $41 million out of the $58 million promised in those settlements with families of current or former residents, according to the bankruptcy and case records ³Ô¹Ï²»´òìÈ reviewed.

In hearings Wednesday and last week in U.S. Bankruptcy Court in Dallas, Judge Stacey G.C. Jernigan said she would not approve a sale of the company’s assets that included legal releases from liability for Landau and a private equity associate, David Gefner. Landau, who was seeking to purchase the assets through another company he controlled, did not attend the bankruptcy hearings or respond to a subpoena, lawyers said in court.

“I’m very encouraged that someone is watching and paying attention to this,” said Erin Pearson, whose father, James Sanderson, died in 2018 after spending less than a month in a Genesis facility in Albuquerque. “And the guy who owns the most shares, not only did he not show up but doesn’t just get to move things around and rebuy” the nursing homes.

According to Pearson’s lawsuit, filed in 2019, Sanderson developed a bowel obstruction and sepsis while at the facility but was not sent to the hospital for more than a week.

Genesis did not pay Pearson the $500,000 it agreed to in a settlement, according to Pearson’s claim filed in bankruptcy court. “I don’t know if I’ll ever see that settlement, but I would like to be hopeful,” Pearson said in an interview Dec. 17.

Genesis, Landau, Gefner, and their attorneys did not immediately respond to requests for comment. In a public statement last week, David Harrington, the executive chairman of Genesis’ board of directors, praised Landau and his company’s investment in Genesis for helping it avoid bankruptcy in 2021. That “lifeline,” he said, enabled Genesis to transform into a “nimble, market-based model dedicated to prioritizing resident and patient care.”

Ian Norris, who represents 19 clients with lawsuits against Genesis — including four who have not been paid their settlements — said the judge’s ruling was “a huge win for all those who were confronting the possibility that they would not be able to recover the settlements that were promised to them by Genesis prior to the bankruptcy.”

According to Genesis’ bankruptcy filings, the company owes more than $1.6 billion in unpaid claims that are not secured by liens, including claims not only from former residents and their families but also from a pension fund; contractors that provided health services and equipment; and Pennsylvania, New Mexico, and West Virginia, which are owed provider taxes. Daniel Simon, a lawyer representing Genesis’ owners, said in court on Dec. 17 that $155 million would be available from the proceeds of the sale for these creditors under a bid for the nursing home assets from a new company controlled by Landau and Gefner.

Genesis last month held an auction for its assets and announced that Landau’s bid was the best, but the U.S. Trustee’s Office and creditors objected, saying Genesis had unfairly excluded one group from bidding and downplayed the value of another group’s bid that would have provided more money to creditors. Jernigan said there were too many irregularities in the auction for her to approve it and ordered it be redone under the watch of the U.S. Trustee’s Office.

“I am aware that there is huge concern about Mr. Landau, and he is not here,” Jernigan said last week. “There is no way I can approve these releases without him on the witness stand and me being convinced of his good faith.”

Sen. Elizabeth Warren (D-Mass.), who along with two Senate colleagues filed an amicus brief questioning the fairness of the auction, said in a media statement: “A private equity company tried to abuse the bankruptcy system to slither out of paying what they owe to neglected seniors in its nursing homes. This is a textbook case of why we need to get private equity out of health care altogether, and this decision is a good step forward in the fight to deliver relief for the victims of Genesis.”

In the Dec. 17 hearing, representatives of the company controlled by Landau and Gefner said they would bid again for the remains of Genesis without the promise of liability releases. The auction is expected to occur in January. Simon, the lawyer for Genesis, said at the hearing that the judge’s ruling “has humbled us.”

Lawyers for former and current Genesis residents said they hope to sue Landau and other parties that controlled the company and led it into bankruptcy. John Anthony, a Tampa attorney who represents 341 claimants, said, “The victims believe that Mr. Landau richly deserves his day in court, so he can explain to a jury of his peers how he has apparently gotten so rich running all these supposedly insolvent facilities into the ground.”

This article first appeared on ³Ô¹Ï²»´òìÈ and is republished here under a .