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 Ñî¹óåú´«Ã½Ò•îl Health News investigation found.

Far more infants given Mead Johnson’s product developed a buildup of acid in the blood called metabolic acidosis than those fed Abbott’s product — 19 versus four, according to results published in the journal .

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 Ñî¹óåú´«Ã½Ò•îl Health News that existing studies “cannot responsibly support” any connection between the acidified fortifier and conditions such as necrotizing enterocolitis or metabolic acidosis.

Mead Johnson executive Cindy Hasseberg argued in a deposition that Abbott waged a “smear campaign” against the acidified fortifier that was “very hard to come back from.”

In 2024, Mead Johnson discontinued the product.

Winning the ‘Hospital War’

Behind their warm-and-fuzzy marketing, industry giants Abbott, maker of Similac products, and Mead Johnson, maker of the Enfamil line, have turned neonatal intensive care units into arenas of brutal competition.

This article quotes from and is based largely on records from three lawsuits against formula manufacturers that went to trial in 2024 and are now on appeal. The cases are , , 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 Ñî¹óåú´«Ã½Ò•îl Health News, formula makers described hospitals as gateways to the much larger retail market because parents are likely to stick with the brand their babies started on. Products used in the NICU help win hospital contracts, and hospital contracts help establish brand loyalty, according to court records.

Manufacturers vie for contracts that can be “exclusive” or nearly so, according to records from the litigation, including company documents and testimony by people who have worked in management for the companies.

An undated Abbott presentation used in the Gill case, apparently referring to inroads with hospitals in its rivalry with Mead Johnson, boasted of “MJ Strongholds Broken!”

It saluted two employees who “Own 27K Babies Exclusively,” and said another “Stole 600 formula feeders from MJ.”

Still others were praised for “Playing in Mom’s mailbox” or “kicking … and ‘taking names.’”

In July 2024, Abbott CEO Robert Ford said in a conference call for investors that formula and fortifier for preterm infants generated total annual revenue of about $9 million — a small portion of Abbott’s total sales of $42 billion in 2024 and its $2.2 billion of sales in the United States from pediatric nutritional products.

Industry documents cited in litigation provide a different perspective.

“‘,” 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 Ñî¹óåú´«Ã½Ò•îl Health News.

“Thus, references in documents about wanting to ‘win’ or ‘own’ the NICU refer to out-performing Mead Johnson by offering the highest-quality products,” Abbott’s Stoffel said in February.

Asked specific questions about business strategies and internal documents, Mead Johnson’s O’Neill said the company was “concerned that you are presenting a misleading and incomplete picture.”

Mead Johnson’s products “are safe, effective, and recommended by neonatologists when clinically appropriate,” O’Neill added.

On the Defensive

In courthouses around the country, Abbott and Mead Johnson are on the defensive — and have been for years.

In hundreds of lawsuits, parents of sickened or deceased preterm infants have alleged that formula designed for preemies has caused necrotizing enterocolitis, or NEC, a devastating condition in which immature intestinal tissue can become infected and die, spreading infection through the body.

Lawsuits also accuse the manufacturers of failing to warn parents of the risk.

One of the cases on which this article is based, , 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 Ñî¹óåú´«Ã½Ò•îl Health News sent by email.

Efforts to reach Das and Cooper — including by phoning numbers and sending letters to addresses that appeared to be associated with them — were unsuccessful.

When Mead Johnson provided support to scientific researchers, the company would want to make sure they reported the results “in an honest way,” Cooper said in a deposition played in the Watson trial.

The Abbott co-authors “proposed routine edits to the article for scientific accuracy and for the consideration of the other authors, some of the most well-respected NEC researchers in the world,” Abbott’s Stoffel said.

“Abbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,” Stoffel said.

“The research studies Mead Johnson supports are conducted independently and appropriately, with full transparency,” said O’Neill, the Mead Johnson spokesperson.

‘In the Wrong Direction’

Transparency can be subjective.

More than a decade ago, Mead Johnson sponsored a clinical trial testing what was then a new acidified liquid fortifier against a powdered fortifier already on the market.

In the study, which enrolled 150 babies, 5% of infants fed the acidified liquid developed NEC compared with 1% of infants fed the powder, according to deposition testimony and a record of the clinical trial used in the Watson case.

That information was not included in a 2012 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, Ñî¹óåú´«Ã½Ò•îl Health News obtained an informed consent form for the AL16 study used at a public institution, the University of Louisville. The form mentioned risks such as diarrhea, constipation, gas, and fussiness. It did not mention metabolic acidosis or NEC.

Ñî¹óåú´«Ã½Ò•îl Health News also reviewed an informed consent form for the AL16 study used at Memorial Hospital of South Bend. It was largely identical to the one used in Louisville and did not mention metabolic acidosis or NEC.

Cronin, the plaintiff’s attorney, said in an interview that Abbott showed disregard for the health and safety of premature babies participating in the AL16 clinical trial.

“I think it’s unethical to do a study if you know you are subjecting participants in the study to an increased risk of a potentially deadly disease and you don’t at least tell them that,” Cronin said.

Anderson-Berry told Ñî¹óåú´«Ã½Ò•îl Health News that Abbott was “ethically well positioned” to conduct the AL16 clinical trial because her paper was not definitive.

Yet she said she was unwilling to enroll any of her patients in the Abbott clinical trial because she didn’t want to take the chance that they would be given the acidified liquid.

White, the neonatologist who stopped enrolling patients in the study, defended the decision to conduct it. In an interview, he said it was appropriate to conduct a large, properly controlled clinical trial to see whether concerns raised in earlier research were borne out. The two babies whose serious adverse events he reported to Abbott ended up doing fine, he said.

But White, who went on to be listed as a co-author of the study, told Ñî¹óåú´«Ã½Ò•îl Health News that parents should have been informed that the risks included metabolic acidosis and NEC.

“In retrospect, obviously, that is something that we, I think, should have informed parents of,” he said.

Abbott did not directly answer questions about the consent forms.

The results of AL16 were 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.”

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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.”

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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.”

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Ballad Health announced in January that it would spend about $44 million to rebuild the 10-bed Unicoi County Hospital in a field behind a Walmart in Unicoi, Tennessee, about 7 miles from the shuttered hospital that was the site of catastrophic flooding and a daring helicopter rescue on Sept. 27, 2024.

But the new location also faces significant flood risk, according to a Ñî¹óåú´«Ã½Ò•îl Health News review of information from and , two climate data companies whose flood modeling is considered more sophisticated than outdated flood maps published by the Federal Emergency Management Agency. Both Fathom and First Street estimate that a 100-year flood — a weather event more common and less intense than Helene — could cover much of the hospital site with more than 2 feet of water.

“The proposed site is so obviously a flood plain geomorphologically,” said Oliver Wing, chief scientific officer at Fathom. “You don’t need a model to see that.”

Wing said the new hospital site was actually more likely to flood than the old site and “very risky” for development due to a nearby creek and potential storm runoff from mountains to the west. But the flooding would be less powerful than at the old site, Wing said, and its impact could be lessened by elevating the hospital or building earthen embankments.

Ballad Health confirmed the new hospital location but did not respond to questions about flood risk or defenses planned for the site. In a brief written statement, spokesperson Molly Luton said Ballad was working with geotechnical professionals, Zurich Insurance Group, and a high-profile architecture firm in Nashville, Earl Swensson Associates, to “plan and build a safe hospital for the Unicoi County community.” Luton said Ballad is also working with FEMA, which is providing about .

FEMA has served as the nation’s de facto authority for estimating flood risk for half a century, and its flood maps generally determine which buildings must be designed to withstand a flood. But those maps are often incomplete and do not account for the impacts of climate change. FEMA’s flood maps of Unicoi, last updated in 2008, do not identify the new hospital site as a flood hazard zone.

Nationwide, FEMA maps don’t capture much of the flood risk identified by Fathom and First Street, which use sophisticated computer models and detailed terrain data to create flood simulations that are relied on by major developers, insurance companies, and government agencies. First Street publishes much of its modeling online, while Fathom shared data with Ñî¹óåú´«Ã½Ò•îl Health News through a data-use agreement.

Chad Berginnis, executive director of the Association of State Floodplain Managers, said that while the hilly terrain of northeastern Tennessee may limit Ballad’s options to rebuild, it should not ignore the data from Fathom and First Street or rely purely on FEMA’s maps, which suggest the hospital could be built with minimal flood protections.

If Ballad builds behind the Walmart, Berginnis said, it should follow the from the American Society of Civil Engineers, which recommend elevating hospitals enough to withstand a 1,000-year flood — like the one caused by Helene.

According to those standards and Google Earth elevation data, that could require earthwork to raise the ground of the Unicoi site by at least 8 feet and as much as 18 feet before construction.

“It’s going to require some elevation, and there is going to be some cost,” Berginnis said. “But, my God, you just lost your dang hospital.”

The destruction of Unicoi County Hospital in 2024 prompted a Ñî¹óåú´«Ã½Ò•îl Health News investigation into hospital flood risk, which used Fathom data to identify more than 170 hospitals across the nation that face the greatest risk of significant or dangerous flooding. Of those hospitals, at least 39 faced circumstances similar to Unicoi’s: Nearby rivers or creeks were predicted to swell beyond their banks and engulf the facility.

Ballad Health, which owns Unicoi and 19 other hospitals in Tennessee and Virginia, is the nation’s largest state-sanctioned hospital monopoly and the only option for hospital care for most residents in a 29-county region of Appalachia.

In a news release announcing the Unicoi reconstruction, Ballad said it was finalizing a land purchase for the new hospital site and expected construction to begin in the spring and last two years. Ballad Health Chief Operating Officer Eric Deaton said the reconstruction announcement was “a long-awaited step toward healing.”

“Rebuilding Unicoi County Hospital is about more than bricks and mortar,” Deaton said in the release. “It’s about keeping care close to home for people who have been through so much.”

Tennessee state Rep. Renea Jones, a Republican whose district includes both the old and new Unicoi hospital sites, praised the reconstruction plan in Ballad’s news release. The release did not mention that Ballad would buy about 15 acres of land for the new hospital from Jones’ family, which was first reported by and later confirmed by Tennessee public records.

Jones did not agree to be interviewed about the sale of the property or its flood risk.

The destroyed Unicoi County Hospital, which cost $30 million, was built along a bend of the Nolichucky River even though FEMA had labeled that area a flood zone for decades. Mountain States Health Alliance began construction in 2017, then later became Ballad Health, which opened the hospital in 2018.

Alan Levine, who was the CEO of Mountain States and now leads Ballad, told Ñî¹óåú´«Ã½Ò•îl Health News in a 2024 interview that Mountain States was aware of the flood risk when Unicoi was built but believed levees could protect the facility.

“I feel like everything we did when we built it was done the right way,” Levine said.

Helene proved too much to handle. As the hurricane carved a deadly path across Southern states and into Appalachia, heavy rainfall caused the Nolichucky to overspill its banks and engulf the hospital in as much as 12 feet of water.

Floodwater pushed inside the hospital and cut the power, forcing patients and staff to evacuate to the roof in hopes of rescue. Ultimately, helicopters plucked 70 people from the roof and the rushing water, narrowly avoiding fatalities.

Angel Mitchell, a Unicoi survivor who was airlifted to safety with her ailing mother, said she was appalled that the hospital would be rebuilt in an area vulnerable to another flood.

But the worst part, Mitchell said, was that locals would have little choice but to tolerate the risk because of Ballad’s monopoly.

“It’s ridiculous,” Mitchell said. “We want to go somewhere to heal, not somewhere to worry.”

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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 Ñî¹óåú´«Ã½Ò•îl Health News. 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 Ñî¹óåú´«Ã½Ò•îl Health News 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 Ñî¹óåú´«Ã½Ò•îl Health News 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 Ñî¹óåú´«Ã½Ò•îl Health News 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.

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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.

Ñî¹óåú´«Ã½Ò•îl Health News 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 Ñî¹óåú´«Ã½Ò•îl Health News 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.”

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The chains sell an array of body-reshaping operations, such as “” and liposuction, targeting customers willing to pay up to $20,000 out-of-pocket for a new figure.

A joint investigation by Ñî¹óåú´«Ã½Ò•îl Health News and NBC News found that cosmetic surgery chains have been the target of scores of medical malpractice and negligence lawsuits alleging disfiguring injuries — including 12 wrongful death cases filed over the past seven years.

Injured patients have accused the chains of hiring doctors with minimal cosmetic surgery training, of failing to recognize and treat life-threatening infections and other dangerous surgical complications, and of using high-pressure sales tactics that minimized safety risks, court records show. The companies have denied the allegations in court.

“These people promise to turn you into the fairest person in the land, and the risks aren’t often worth the reality,” said Sean Domnick, a Florida attorney who heads the American Association for Justice, a trial lawyers’ group.

Robert Centeno, a medical director for Sono Bello, the largest of the chains, disagrees. He said the company’s mission is to “help each and every one of our patients live their best lives now.” Sono Bello offers “life-changing transformations” that enhance a person’s “appearance as well as their quality of life,” said Centeno, a surgeon at the company’s Troy, Michigan, office. boasts it is “America’s top cosmetic surgery specialist.”

But many established plastic surgeons worry that chain surgery groups may be inclined to spend more effort on marketing and sales than on making sure their doctors are properly credentialed and capable of handling any complications that arise.

Medical practices owned by private equity or investment firms have more money to spend drawing in patients and “the ability to operate and provide quality patient care is now less important,” said Mark Domanski, a plastic surgeon in Northern Virginia.

Erin Schaeffer, 37, spent a week in a Florida hospital battling a severe infection after having a type of tummy tuck and liposuction at the Jacksonville branch of Sono Bello.

More than a year later, scars remain on her lower body. And in a lawsuit, she is accusing Sono Bello of using an obstetrician-gynecologist who was inadequately trained to remove her excess skin and fat, a procedure she says caused excruciating pain. Sono Bello and the doctor denied the allegations in a joint court filing.

“I literally felt like I was skinned alive,” Schaeffer said.

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Schaeffer went on to spend a week in a Florida hospital battling a severe infection after a type of tummy tuck and liposuction at the Jacksonville branch of Sono Bello, a national cosmetic surgery chain.

More than a year later, scars remain on her lower body — and in a lawsuit she is accusing Sono Bello of using an obstetrician-gynecologist who was inadequately trained to remove her excess skin and fat, a procedure she says caused excruciating pain.

“I literally felt like I was skinned alive,” said the 37-year-old, who works as a training manager for United Parcel Service.

Schaeffer and her husband, Jonathan, are suing Sono Bello and Manuel Herrera in Duval County Circuit Court. The suit accuses Herrera, a board-certified OB-GYN, of “performing procedures that he was not trained or qualified to perform.”

Sono Bello and Herrera denied the allegations in a joint court filing. And in an interview with Ñî¹óåú´«Ã½Ò•îl Health News and NBC News, Robert Centeno, Sono Bello’s medical director for the East region, said its surgeons undergo “very rigorous training.”

Backed by private-equity financing, Sono Bello is the largest of a breed of cosmetic surgery chains vying for a slice of the growing body-contouring market in the U.S. One research firm estimated that the market, which includes procedures ranging from wrinkle removal to liposuction, in 2024.

The chains sell an array of body-reshaping operations, such as “” and liposuction, targeting customers willing to pay up to $20,000 out-of-pocket for a new figure, often on credit with steep interest rates from companies specializing in credit for elective medical procedures. boasts it is “America’s top cosmetic surgery specialist.”

But a joint investigation by Ñî¹óåú´«Ã½Ò•îl Health News and NBC News found that Sono Bello and other cosmetic surgery chains have been the target of scores of medical malpractice and negligence lawsuits alleging disfiguring injuries — including 12 wrongful death cases filed over the past seven years.

Injured patients have accused the chains of hiring doctors with minimal cosmetic surgery training, of failing to recognize and treat life-threatening infections and other dangerous surgical complications, and of high-pressure sales tactics that minimized safety risks, court records show. Sono Bello and the other companies in court.

“These people promise to turn you into the fairest person in the land, and the risks aren’t often worth the reality,” said Sean Domnick, a Florida attorney who heads the American Association for Justice, a trial lawyers’ group.

Sono Bello’s Centeno disagrees. He said the company’s mission is to “help each and every one of our patients live their best lives now.” Sono Bello offers “life-changing transformations” that enhance a person’s “appearance as well as their quality of life,” said Centeno, a surgeon himself at the company’s Troy, Michigan, office.

The doctors who perform such surgeries, court records show, are sometimes paid more for taking on patients with a high body mass, as obesity raises the risk of .

And as the chains grow, there’s little regulatory oversight. While the FDA maintains a database of complaints about drugs or medical devices, there’s nothing similar for cosmetic surgeries.

Schaeffer had liposuction at Sono Bello in January 2024 and was satisfied with the results. On the morning of March 29, 2024, she went in for more liposuction and a mini-tummy tuck that . The medical staff gave her Xanax, a tranquilizer, and the painkiller oxycodone in pill form, according to medical records Sono Bello turned over to Schaeffer’s attorney. During the procedure, she received an infusion of lidocaine to numb the area but remained awake. Sono Bello says the local anesthesia is safer and promotes faster healing with “,” so patients may return to work or other normal activities within a week.

That didn’t happen for Schaeffer, who said she felt so much pain during the operation that she began to cry and “begged” the doctor to stop near the end.

“I said, ‘I don’t care what I look like,’” she said in an interview. “‘I can’t handle the pain.’”

Two days later, she spiked a fever, and a day after that her pubic area swelled up “severely,” she said. Sono Bello medical staff told her that was normal and that she was fine, she said. Two days later, however, blood and fluid spilled out of her stomach when she got up.

On one visit to the office, Herrera told her she required surgery at a hospital to treat her wounds. But, Schaeffer recounted, Herrera said he couldn’t arrange that because he was an obstetrician, not a plastic surgeon, and didn’t have hospital privileges locally. Herrera has hospital privileges in the Orlando area, about 140 miles southwest of Jacksonville.

“I was just in utter shock,” Schaeffer said.

Sono Bello spokesperson Mark Firmani said the company does not require its doctors to have local hospital privileges, though many do have them.

Centeno said Schaeffer’s painful experience is not common.

“The reality is that over 90% of our patients who have our procedures completed are extremely comfortable during the procedure and they do quite well,” he said. Patients of Sono Bello and some other clinics also have complained to the of unexpectedly painful procedures.

Centeno said that Herrera still works for the company, but the doctor’s name does not appear on the company’s . Herrera runs an practice, which includes skin care treatments, in Winter Garden, Florida, near Orlando, and is board-certified by the .

Sono Bello has considered him a rising star; Herrera’s work in 2023 won Sono Bello’s annual “,” given to a company doctor who exhibits “exceptional technical skills, productivity, and off-the-charts brand loyalty.”

a Sono Bello that teaches a “suite of aesthetic procedures” in a six- to eight-week course under the direction of a company surgeon. The company says the fellowship offers “patient-focused training in awake total body contouring and skin excision procedures.” Sono Bello allows physicians who have completed formal residencies in more than half a dozen types of surgery to apply for its fellowship.

In a , Herrera said that before taking the fellowship course, he “had been a skilled surgeon for over 13 years with extensive experience in other areas but limited knowledge on body sculpting.” Herrera did not respond to calls and emails requesting comment and directed Sono Bello to respond on his behalf. Company spokesperson Firmani said Herrera is still a member of the Sono Bello team.

Many established plastic surgeons who spoke with Ñî¹óåú´«Ã½Ò•îl Health News and NBC News worry that chain surgery groups may be inclined to spend more effort on marketing and sales than on making sure their doctors are properly credentialed and capable of handling any complications that arise.

Medical practices owned by private equity or investment firms have more money to spend drawing in patients and “the ability to operate and provide quality patient care is now less important,” said Mark Domanski, a plastic surgeon in Northern Virginia.

Doctor Entrepreneurs

Formed in 2008 by entrepreneurial physician Tom Garrison, Sono Bello now runs more than 100 centers nationwide. Private equity investors have pumped $816 million into the company, most of it since 2023, , which tracks the industry. Sono Bello advertises widely on television and online, aimed at what one major investor termed the “.” It having “150+ board-certified surgeons who have performed over 300,000 laser lipo & body contouring procedures.”

Sono Bello limits its offerings to services such as liposuction and its version of tummy tucks, which it believes its surgeons have mastered. It does not perform Brazilian butt lifts, or fat transfers, though many other cosmetic surgery chains do.

While Sono Bello boasts that the vast majority of its patients are satisfied, court records show that allegations of substandard medical care have trailed its rapid growth.

Sono Bello and its corporate affiliates and surgeons have defended more than 60 medical malpractice cases, including four suits involving patient deaths, since April 2013, court records show. Sono Bello has settled three of four wrongful death cases filed since May 2018, while one is pending, court records show.

Schaeffer’s suit in Jacksonville is among at least 19 filed since the start of March 2023. Many are pending in the courts, and the company has denied the allegations.

Other physicians who have extended their brands to multiple cities and relied heavily on social media and splashy websites to bring in patients have also faced lawsuits.

Mia Aesthetics, formed in 2017 by Texas surgeon Sergio Alvarez, runs a dozen cosmetic surgery clinics from Miami to Las Vegas. Mia Aesthetics provides “the highest quality plastic surgery at affordable prices proving that being beautiful and saving money are two realities that can exist simultaneously,” . Alvarez is a board-certified plastic surgeon.

Patients filed at least 30 medical negligence cases against Mia Aesthetics and its affiliates from November 2020 through March of this year, court records show. A dozen suits target its Miami surgery center. The company has sought, and often won, dismissal of malpractice suits because patients signed contracts agreeing to arbitration of any disputes, court dockets show. Alvarez did not respond to requests for comment.

Owned by New York physician Sergey Voskin since 2016, Goals Aesthetics and Plastic Surgery has branched out from a small cosmetic surgery office in the Brooklyn borough of New York City to a it manages in eight states.

Goals clinics and affiliated surgeons have been named as defendants in at least 40 malpractice suits filed from October 2018 through March, court records show. The Atlanta branch accounted for more than 20 such cases in Georgia courts from September 2022 through June 2024. Most are pending. Goals defended two lawsuits brought by the families of New York patients who died shortly after having liposuction procedures, court records show. Goals denied the allegations and won dismissal of some cases by invoking arbitration agreements, according to court dockets. The company says these agreements are commonly used throughout the medical industry.

Voskin declined to be interviewed. In a statement, Goals lawyer Joshua Lurie said the medical offices it manages have performed more than 10,000 procedures and have “one of, if not the highest track records of safety among similar types of medical practices.”

Lurie said the “vast majority” of malpractice claims are “meritless.” These “bad faith filings create an implication of risk when none exist and when, again, there is a very negligible negative outcome from surgery compared to the total procedures performed,” he wrote.

No Guarantees

Malpractice suits by themselves are not proof of wrongdoing. Nobody tracks the outcome of these lawsuits, which often are settled under confidential terms that keep key details out of public view and prohibit patients from discussing their experiences. Surgeons often argue that complications are a risk of surgery and that a poor outcome doesn’t mean the doctor was negligent. To prove negligence, injured patients generally must show their care fell below what a would have done.

That can be a challenge. Typically, the surgery chains fight back by arguing that complications are a risk of any surgical procedure and that they never guarantee results.

Before their procedures, patients must sign consent forms acknowledging that their expectations must be “realistic” and that complications or dissatisfaction with the result does not necessarily mean the surgeon botched the job. The American Society of Plastic Surgeons against its members, but not allegations of competence or malpractice.

Some pre-surgery contracts allow for low-cost “revisions” for disgruntled patients. Sono Bello has offered a “satisfaction commitment,” which states: “If your surgeon’s evaluation determines your results to be deficient, we will touch up the area at no cost to you.”

Other contracts contain disclaimers, such as reminding patients that dramatic “before and after” photos widely shown in online advertisements and other solicitations may not reflect typical results.

I don’t care what I look like. I can’t handle the pain.

Erin Schaeffer

Demonstrating the influence of social media in driving sales, Goals once required patients to sign a non-disparagement clause. The contract stated that patients who bad-mouth the company on social media without first giving the company “an opportunity to remedy any alleged issues” agree to pay damages of .

In a civil investigation of Goals’ marketing tactics, Georgia Attorney General Chris Carr alleged that policy, and others, violated state consumer protection laws. In September 2022, Goals agreed to stop using the non-disparagement clause and to pay the state $119,480 to , without admitting any wrongdoing.

Both Goals and Mia Aesthetics have clauses in their service contracts that in lieu of court action, a process many consumer advocates believe favors the industry. These agreements are becoming more common among plastic surgeons. The arbitration clauses have prevented some aggrieved patients from getting their day in a courtroom.

That happened in a wrongful death case filed by the family of Angela Mendez, 57, who was found dead in her apartment a day after liposuction at a Goals office in New York City in March 2021. She died from a pulmonary thromboembolism, a blood clot in her lung, as a complication of cosmetic surgery, according to an autopsy report.

Her family sued the company alleging negligence. But, in June 2024, a judge ruled that Mendez had signed a form requiring the case to be heard in arbitration and the lawsuit was dismissed.

Attorney Gary Zucker, who represents the family, is appealing. “It’s been a one-two punch for the family,” Zucker said.

Goals attorney Lurie called arbitration “a common practice throughout the industry and many industries” that is “intended to speed the process to come to resolutions in a more expedited fashion.” In a 2023 deposition, Lurie said patients can opt out of the arbitration agreement, which “has happened multiple times.”

‘A Hard Sell’

When Erin Schaeffer first visited Sono Bello, a sales agent told her she was a “perfect candidate” for a tummy tuck procedure, she said in an interview with Ñî¹óåú´«Ã½Ò•îl Health News and NBC News.

Though she wanted to think about it and talk it over with her family, she said, the salesperson persuaded her to go ahead. Because cosmetic surgery is elective, insurance doesn’t cover it. Schaeffer made a down payment and signed up for a credit plan through outside companies to repay most of the $19,838 bill over a five-year period, according to her medical records. She said she’s now paying $420 a month.

“I definitely felt like it was a hard sell,” Schaeffer said. “She didn’t want me to leave out of there without putting money down on it.”

Schaeffer said she didn’t meet the doctor until about a week before the procedure, and only briefly. Some patients suing other companies have argued in court filings that they didn’t meet the surgeon until the day of their operations, a practice that draws sharp criticism from more traditional surgeons.

Scott Hollenbeck, president of the American Society of Plastic Surgeons, said patients need time with their doctor to fully understand the pros and cons of surgery and shouldn’t be pressured into quick decisions.

“It is not possible to do that when you see the doctor an hour before surgery for the first time,” he said. “You should have time to process what they told you, think about it, and make a decision.”

“That is best done with a surgeon, not a marketer,” Hollenbeck said.

Good Candidates

Many plastic surgeons discourage people with obesity from undergoing liposuction and other cosmetic procedures because of an of infections and other serious medical complications. Candidates are considered obese at a of 30 or above. Sono Bello patients have an average BMI of 31, according to Centeno. At the time of her surgery, Schaeffer had a BMI of 36.

But there’s no consensus over who should be turned away because of their size — and policies vary.

Sono Bello says its can be done safely with a body mass index as high as 42, well beyond the body mass limits for a done using general anesthesia. The AbEX removes loose and sagging skin around the stomach “to achieve a more toned and sculpted look,” according to the company.

Centeno said that high BMI “does confer additional risk, which can be managed.” But he said it would be “discriminatory, unethical, and inappropriate for Sono Bello or any other medical practice to deny care to a patient based solely on their BMI.”

Yet high BMI patients have alleged they suffered devastating complications, according to Ñî¹óåú´«Ã½Ò•îl Health News’ review of the court cases filed against Sono Bello and other companies.

One patient is Marissa Edwards, then 45, a California medical receptionist with three children. At 5 feet 3 inches tall, she weighed 237 pounds, with a body mass index of 41.

She had AbEX and liposuction at a Sono Bello clinic in San Diego on Oct. 11, 2022, according to court filings. During an office visit eight days later, she complained of swelling and pain in her abdomen, but a nurse “dismissed her complaints,” according to the suit. On Nov. 4, Edwards noticed the incision was opening, while a rash formed around her belly button. In a text to Sono Bello, she attached a photo of her wound which, the suit alleges, should have alerted the staff that it needed “immediate evaluation by a qualified medical professional.”

On Nov. 5, she woke up “feeling extremely hot,” and “nearly fainted,” according to her complaint. Her husband drove her to an urgent care center, which diagnosed her with sepsis and rushed her to a hospital by ambulance.

When she awoke the next morning, her bedsheets were soaked with body fluid. As she stood up, “fluid began to pour out of her stomach and hit the floor,” according to the complaint. She spent six days in the hospital.

Edwards alleges in her lawsuit that Sono Bello’s medical staff failed to recognize and respond to early signs of trouble.

“I have sepsis and could have died,” she texted to Sono Bello’s office line, according to court documents. “I am very upset.”

In one text that was included in her lawsuit, she wrote: “So I would appreciate some type of empathy from you!! If you only knew what I have been through and you went through this I’m sure you wouldn’t be giving me this snotty attitude.”

Sono Bello denies any negligence. In a court filing, the company noted that infections are a risk of surgery, and that Edwards had signed a consent form that stated in part: “The practice of medicine and surgery is not an exact science and results are not guaranteed.” Sono Bello filed a motion for summary judgment that argued her care was not negligent and “not a substantial factor” in causing her alleged injuries. The case was settled earlier this month under confidential terms.

Value Units

While patients with high BMI are riskier, they also are more lucrative for Sono Bello surgeons, court records show.

The company pays its surgeons for procedures based in part on the patient’s BMI, using a formula it calls a “surgical value unit.”

The compensation plan surfaced in a lawsuit filed in December 2023 by Shirley Webb, then a 79-year-old Nevada woman. Hoping to slim down for a dream cruise, she paid $14,703 for an AbEX tummy tuck and liposuction of her stomach at the Sono Bello branch in Las Vegas.

Eighteen days after her operation, she was “oozing and bleeding” from her surgical wounds, and her son rushed her to a hospital, where doctors diagnosed “severe sepsis with shock,” according to the complaint. She spent several months in hospitals and rehabilitation care, running up medical bills of more than $2.6 million, her lawyer stated during a deposition.

Lloyd Krieger, a California plastic surgeon who served as a medical expert for Webb’s legal team, said the operations never should have happened because she was at “very high risk for multiple procedures given her advanced age and high BMI,” according to the suit.

In a court deposition, Sono Bello surgeon Charles Kim testified that operating on Webb earned him “surgical value units” that boosted his pay to about $2,000 for the procedure.

Sono Bello and Kim denied Webb’s negligence claims and the parties settled the case in early 2025 under confidential terms, court records show.

Centeno said Sono Bello surgeons are paid more for higher BMI patients because they “require additional work and additional complexity in terms of decision-making.” He added that “our high BMI patients routinely undergo our procedures safely with an extremely high patient satisfaction rate.”

Schaeffer said people hoping to reshape their bodies need to do a lot of research before plunging ahead with plastic surgery. She said she was hoping to get rid of excess skin and fat after dropping 100 pounds.

Instead, she missed seven weeks of work recovering from her tummy tuck in Jacksonville. “I went into this procedure to try to make myself feel better after losing the weight, and I came out with something even worse,” she said.

“I trusted. I believed in what they told me, which I think most people do,” Schaeffer said.

“Not anymore.”

Have you had liposuction, a “Mommy Makeover,” a tummy tuck, a Brazilian butt lift, or another type of cosmetic surgery? We’d like to hear about your experience. Click here to contact our reporting team.

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The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.

The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a Ñî¹óåú´«Ã½Ò•îl Health News investigation late last year.

“Why doesn’t the public know?” said , a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. “And their patients are suffering adverse events,” he said.

The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 devices.

Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.

“To date, the number of deaths reported appears consistent with the ,” Hils said in an email.

According to the FDA’s recall notice, the devices can cause buildup of “biological material” that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient’s chest.

Doctors were advised to watch out for “low-flow alarms” on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump. “Rates of outflow obstruction are low,” Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally “have no reason for concern.”

A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a Ñî¹óåú´«Ã½Ò•îl Health News review of the database.

Monday’s alert is the second Class 1 recall of a HeartMate device this year.

In January, Abbott issued an urgent “” to hospitals about in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status. The FDA in March.

In February, Abbott issued to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device’s monitor that may indicate an obstruction. The company said in the letter that it is working on “a design solution” to prevent the blockages.

A in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.

The only other Class 1 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.

The FDA recall notice issued Monday includes to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.

At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.

If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said , a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option — no pump ever is — but this is as good as it’s ever been.”

It’s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than and more than .

The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of , a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.

Only device manufacturers, device importers, and hospitals are to report device-related injuries, deaths, and significant malfunctions to the FDA.

“If this is something physicians were aware of, but they weren’t mandated to report to the FDA,” Kinard said, “at what point does that communication between those two groups need to happen?”

Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.

“We’re going to expect to have some data saying, ‘Hey we created this fix, and this fix works, and it doesn’t cause a new problem.’ That’s what I want to know,” he said. “There’s just a ton more that I feel in the dark about, to be honest, and I’m sure that patients and their families do as well.”

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

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Steve Galella, the inventor of the Anterior Growth Guidance Appliance, or “AGGA,” has said in court depositions that his device had been used on about 10,000 patients, and that he trained many dentists to use the AGGA in classes around the U.S. and overseas.

At least 23 patients, some of whom described being desperate for relief from sleep apnea or temporomandibular joint disorder (TMJ), have sued Galella in recent years claiming that the AGGA damaged their mouths and, in some cases, caused tooth loss. Galella denied wrongdoing in those lawsuits and has settled almost all of them within the past few months.

Galella was deposed before he settled the largest of those lawsuits. According to a recently obtained by Ñî¹óåú´«Ã½Ò•îl Health News and CBS News, Galella said under oath that he had not represented that the AGGA could treat or cure TMJ or sleep apnea.

Video footage tells a different story.

Galella repeatedly references treating TMJ and sleep apnea patients with the AGGA, sometimes in conjunction with other devices, in footage from a training session he led with Australian dentists in 2017, which was produced in discovery in an AGGA lawsuit.

At one point in the footage, Galella can be seen displaying two versions of the AGGA to the dentists, pointing to one he says is preferred by “TMJ and sleep patients” — and then saying, “And I give it to them.”

“Can you cure TMJ? Yes,” Galella , according to the footage. “Can you cure mild to moderate sleep apnea? Yes.”

The AGGA, which Galella recently rebranded as the Osseo-Restoration Appliance, resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. This year, after a joint investigation by Ñî¹óåú´«Ã½Ò•îl Health News and CBS News reported allegations of patients harmed by the AGGA, the FDA and the Department of Justice opened investigations into the device.

Dentists across the country have promoted the AGGA on their websites, often claiming it can “grow,” “remodel,” or “expand” an adult’s jaw without surgery, sometimes saying it has the potential to make patients more attractive and to treat common ailments like TMJ and sleep apnea, which afflict millions of Americans. Galella has said in depositions and video footage that the AGGA causes the bones in an adult’s jaw to “remodel” forward, reshaping their face.

The 2017 video footage contains other examples of Galella teaching dentists to treat TMJ and sleep apnea patients with the AGGA, which he sometimes calls a “growth appliance.” In one segment, he describes using a growth appliance on “nine out of 10” of his TMJ patients. In another instance, Galella presents photos of what he says is a TMJ patient, then proceeds to describe how he treated them with an AGGA while showing photos of the patient’s device and saying: “It’s easy with this appliance.” The footage also shows Galella calling a growth appliance “the cure” for sleep apnea, and he later says in reference to sleep apnea that “with a growth appliance, yeah, you can fix it.”

When Galella was confronted with this video footage during his recent deposition, he said his statements had been taken “out of context,” according to the deposition transcript.

The AGGA plaintiffs alleged in their lawsuits not that Galella treated them directly but instead that he or his company consulted with their dentists and prepared AGGA “treatment plans” for each patient.

Galella said during his deposition he had reviewed more than 12,000 treatment plans but said he’d never seen one that used the AGGA to treat TMJ or sleep apnea, according to the transcript. In the AGGA lawsuits, about a , and some of those plans list the patient’s “chief complaint” as TMJ or sleep apnea.

Galella’s attorneys did not respond to multiple recent requests for comment, and Galella declined to be interviewed when approached in person in February. One of Galella’s attorneys, Alan Fumuso, said in a written statement in February that the AGGA “is safe and can achieve beneficial results” when used properly.

The Ñî¹óåú´«Ã½Ò•îl Health News-CBS News investigation of the AGGA was based on interviews with 11 people who said they were hurt by the device and dental specialists who said they’d witnessed severe complications in AGGA patients. The investigation found no record of the AGGA being registered with the FDA and no peer-reviewed evidence showing the device “expands” or “remodels” the jaw as Galella and other dentists have claimed.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon and sleep apnea specialist who has . “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”

In the wake of the Ñî¹óåú´«Ã½Ò•îl Health News-CBS News investigation, the FDA announced it was “” about the AGGA and a similar device, the Anterior Remodeling Appliance. The agency said the devices had been used to treat TMJ and sleep apnea even though they were not cleared by the FDA and their safety and effectiveness had not been established.

Weeks later, the criminal investigation into the AGGA was disclosed in court filings by Galella and device manufacturer Johns Dental Laboratories, who said the U.S. attorney’s office in Memphis, Tennessee, was “potentially bringing criminal charges” against them. In another court filing, Johns Dental provided a copy of a grand jury subpoena seeking a wide variety of AGGA documents, including “any complaints received from any source whatsoever regarding the AGGA.”

Since then, Galella has resolved lawsuits from at least 19 AGGA plaintiffs through out-of-court settlements without any public admission of fault. Additional AGGA lawsuits were filed in Indiana, Pennsylvania, and Washington, with all plaintiffs alleging they were harmed while being treated for TMJ or sleep apnea.

Alice Runion, a 30-year-old IT consultant living outside Indianapolis, alleged in one of those lawsuits that wearing an AGGA as part of her TMJ treatment resulted in “permanent impairment and disfigurement” and “caused severe damage to the roots of [her] teeth.”

In an interview, Runion added that the AGGA caused lingering migraines that have left her unable to work on a computer for long stretches, forcing her out of her job. Runion said that even after corrective jaw surgery that cost tens of thousands of dollars, some of her teeth may still be at risk.

“My surgeon and my health care providers have told me that it is possible that I could lose teeth in the future still because of the treatment I received,” Runion said.

The AGGA is also being studied by orthodontists Neal Kravitz and Jeffrey Miller, who said they intend to publish a research paper next year on how the device hurts patients. Miller, who has been a paid consultant for some AGGA plaintiffs, said he has examined dental scans from at least 30 patients who were “damaged” by the AGGA.

“It’s not difficult to see the pattern,” Miller said. “The patients lose bone that supports the housing of their teeth.”

Miller and Kravitz said that they bought an AGGA in May for their research and that the Department of Justice sent an official to photograph the unboxing of the device for the criminal investigation.

Miller and Kravitz added that Johns Dental was willing to sell them the AGGA only if they did not refer to the device by name while purchasing it. They provided Ñî¹óåú´«Ã½Ò•îl Health News and CBS News with a copy of an email in which a Johns Dental employee writes: “To order the growth appliances from here on out, you’ll need to avoid using the names of those appliances or Dr. Galella’s name.”

A Johns Dental facility was inspected by the FDA in July, according to online inspection records. Those records show the company was pertaining to medical devices, but do not specifically mention the AGGA or any specific device. One citation was for an unspecified device whose “design history file does not demonstrate that the design was developed following the requirements” of federal law. Johns Dental declined to comment through its attorney, Jeffrey Oberlies.

Ten days after that FDA inspection, Johns Dental owner Jerry Neuenschwander was deposed in an AGGA lawsuit, court records show. He pleaded the Fifth in response to every question, according to a obtained by Ñî¹óåú´«Ã½Ò•îl Health News and CBS News.

Spokespeople for the Justice Department and the FDA declined to comment on the AGGA. Attorneys for Neuenschwander did not respond to requests for comment.

CBS News producer Nicole Keller contributed to this report.

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

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This story can be republished for free (details).