Brett Kelman, Author at ĢӰԺ Health News Wed, 29 May 2024 20:42:44 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 /wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Brett Kelman, Author at ĢӰԺ Health News 32 32 161476233 Tennessee Gives This Hospital Monopoly an A Grade — Even When It Reports Failure /news/article/tennessee-a-grade-ballad-health-hospital-monopoly/ Wed, 29 May 2024 09:00:00 +0000 /?post_type=article&p=1856409 A Tennessee agency that is supposed to hold accountable and grade the nation’s largest state-sanctioned hospital monopoly awards full credit on dozens of quality-of-care measurements as long as it reports any value — regardless of how its hospitals actually perform.

Ballad Health, a 20-hospital system in northeast Tennessee and southwest Virginia, has received A grades and an annual stamp of approval from the Tennessee Department of Health. This has occurred as Ballad hospitals consistently fall short of performance targets established by the state, according to health department documents.

Because the state’s scoring rubric largely ignores the hospitals’ performance, only 5% of Ballad’s final score is based on actual quality of care, and Ballad has suffered no penalty for failing to meet the state’s goals in about 50 areas — including surgery complications, emergency room speed, and patient satisfaction.

“It doesn’t make any sense,” said Ron Allgood, 75, of Kingsport, Tennessee, who said he had a heart attack in a Ballad ER in 2022 after waiting for three hours with chest pains. “It seems that nobody listens to the patients.”

Ballad Health was created six years ago after Tennessee and Virginia lawmakers waived federal anti-monopoly laws so two competing hospital companies could merge. The monopoly agreement established two quality measures to compare Ballad’s care against the state’s baseline expectations: about 17 “target” measures, on which hospitals are expected to improve and their performance factors into their grade; and more than 50 “monitoring” measures, which Ballad must report, but how the hospitals perform on them is not factored into Ballad’s grade.

Ballad has failed to meet the baseline values on 75% or more of all quality measures in recent years — and some are not even close — according to reports the company has submitted to the health department.

Since the merger, Ballad has become the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina. Critics are vocal. Protesters rallied outside a Ballad hospital for months. For years, longtime residents like Allgood have alleged Ballad’s leadership has diminished the hospitals they’ve relied on their entire lives.

“It’s a shadow of the hospital we used to have,” Allgood said.

And yet, every year since the merger, the Tennessee health department has reported that the benefits of the hospital merger outweigh the risks of a monopoly, and that Ballad “continues to provide a Public Advantage.” Tennessee has also given Ballad an A grade in every year but two, when the scoring system was suspended due to the covid-19 pandemic and no grade issued.

The department’s , released this month, awarded Ballad 93.6 of 100 possible points, including 15 points just for reporting the monitoring measures. If Tennessee rescored Ballad based on its performance, its score would drop from 93.6 to about 79.7, based on the scoring rubric described in health department documents. Tennessee considers scores of 85 or higher to be “satisfactory,” the documents state.

Larry Fitzgerald, who monitored Ballad for the Tennessee government before retiring this year, said it was obvious the state’s scoring rubric should be changed.

Fitzgerald likened Ballad to a student getting 15 free points on a test for writing any answer.

“Do I think Ballad should be required to show improvement on those measures? Yes, absolutely,” Fitzgerald said. “I think any human being you spoke with would give the same answer.”

Ballad Health declined to comment. Tennessee Department of Health spokesperson Dean Flener declined an interview request and directed all questions about Ballad to the Tennessee Attorney General’s Office, which also has a role in regulating the monopoly. Amy Wilhite, a spokesperson for the AG’s office, directed those questions back to the health department and provided documents showing for how Ballad is scored.

The Virginia Department of Health, which is also supposed to perform “” of Ballad as part of the monopoly agreement, has fallen several years behind schedule. Its most recent assessment of the company was for fiscal year 2020, when it found that the benefits of the monopoly “.” Erik Bodin, a Virginia official who oversees the agreement, said more recent reports are not yet ready to be released.

Ballad Health was formed in 2018 after state officials approved the nation’s biggest so-called Certificate of Public Advantage, or COPA, agreement, allowing a merger of the Tri-Cities region’s only two hospital systems — Mountain States Health Alliance and Wellmont Health System. Nationwide, COPAs have been used in about 10 hospital mergers over the past three decades, but none has involved as many hospitals as Ballad’s.

The that hospital monopolies lead to increased prices and decreased quality of care. To offset the perils of Ballad’s monopoly, officials required the new company to agree to more robust regulation by state health officials and a long list of special conditions, including the state’s quality-of-care measurements.

Ballad failed to meet the baseline on about 80% of those quality measures from July 2021 to June 2022, according to a report the company submitted to the health department. The following year, Ballad fell short on about 75% of the quality measures, and some got dramatically worse, another company report shows.

For example, the median time Ballad patients spend in the ER before being admitted to the hospital has risen each year and is now nearly 11 hours, according to the latest Ballad report. That’s more than three times what it was when the monopoly began, and more than 2.5 times the state baseline.

And yet Ballad’s grade is not lowered by the lack of speed in its ERs.

Fitzgerald, Tennessee’s former Ballad monitor, who previously served as an executive in the University of Virginia Health System, said a hospital company with competitors would have more reason than Ballad to improve its ER speeds.

“When I was at UVA, we monitored this stuff passionately because — and I think this is the key point here — we had competition,” Fitzgerald said. “And if we didn’t score well, the competition took advantage.”

Midwest correspondent Samantha Liss contributed to this report.

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Medics at UCLA Protest Say Police Weapons Drew Blood and Cracked Bones /news/article/ucla-protest-gaza-israel-rubber-bullets-injuries-volunteer-medics/ Thu, 16 May 2024 09:00:00 +0000 /?post_type=article&p=1852778 Inside the protesters’ encampment at UCLA, beneath the glow of hanging flashlights and a deafening backdrop of exploding flash-bangs, OB-GYN resident Elaine Chan suddenly felt like a battlefield medic.

related coverage from 2020

Less-Lethal Weapons Blind, Maim and Kill. Victims Say Enough Is Enough.

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Police were pushing into the camp after an hours-long standoff. Chan, 31, a medical tent volunteer, said protesters limped in with severe puncture wounds, but there was little hope of getting them to a hospital through the chaos outside. Chan suspects the injuries were caused by rubber bullets or other “less lethal” projectiles, which police have confirmed were fired at protesters.

“It would pierce through skin and gouge deep into people’s bodies,” she said. “All of them were profusely bleeding. In OB-GYN we don’t treat rubber bullets. … I couldn’t believe that this was allowed to be [done to] civilians — students — without protective gear.”

The UCLA protest, which gathered thousands in opposition to Israel’s ongoing bombing of Gaza, began in April and grew to a dangerous crescendo this month when counterprotesters and police clashed with the activists and their supporters.

In interviews with ĢӰԺ Health News, Chan and three other volunteer medics described treating protesters with bleeding wounds, head injuries, and suspected broken bones in a makeshift clinic cobbled together in tents with no electricity or running water. The medical tents were staffed day and night by a rotating team of doctors, nurses, medical students, EMTs, and volunteers with no formal medical training.

At times, the escalating violence outside the tent isolated injured protesters from access to ambulances, the medics said, so the wounded walked to a nearby hospital or were carried beyond the borders of the protest so they could be driven to the emergency room.

“I’ve never been in a setting where we’re blocked from getting higher level of care,” Chan said. “That was terrifying to me.”

Three of the medics interviewed by ĢӰԺ Health News said they were present when police swept the encampment May 2 and described multiple injuries that appeared to have been caused by “less lethal” projectiles.

Less lethal projectiles — including beanbags filled with metal pellets, sponge-tipped rounds, and projectiles commonly known as rubber bullets — are used by police to subdue suspects or disperse crowds or protests. Police drew widespread condemnation for using the weapons against Black Lives Matter demonstrations that swept the country after the killing of George Floyd in 2020. Although the name of these weapons downplays their danger, less lethal projectiles can travel upward of 200 mph and have a documented potential to injure, maim, or kill.

The medics’ interviews directly contradict an account from the Los Angeles Police Department. After police cleared the encampment, LAPD Chief Dominic Choi on the social platform X that there were “no serious injuries to officers or protestors” as police moved in and made more than 200 arrests.

In response to questions from ĢӰԺ Health News, both the LAPD and California Highway Patrol said in emailed statements that they would investigate how their officers responded to the protest. The LAPD statement said the agency was conducting a review of how it responded, which would lead to a “detailed report.”

The Highway Patrol statement said officers warned the encampment that “non-lethal rounds” may be used if protesters did not disperse, and after some became an “immediate threat” by “launching objects and weapons,” some officers used “kinetic specialty rounds to protect themselves, other officers, and members of the public.” One officer received minor injuries, according to the statement.

Video footage that circulated online after the protest appeared to show a Highway Patrol officer firing less lethal projectiles at protesters with a shotgun.

“The use of force and any incident involving the use of a weapon by CHP personnel is a serious matter, and the CHP will conduct a fair and impartial investigation to ensure that actions were consistent with policy and the law,” the Highway Patrol said in its statement.

The UCLA Police Department, which was also involved with the protest response, did not respond to requests for comment.

Jack Fukushima, 28, a UCLA medical student and volunteer medic, said he witnessed a police officer shoot at least two protesters with less lethal projectiles, including a man who collapsed after being hit “square in the chest.” Fukushima said he and other medics escorted the stunned man to the medical tent then returned to the front lines to look for more injured.

“It did really feel like a war,” Fukushima said. “To be met with such police brutality was so disheartening.”

Back on the front line, police had breached the borders of the encampment and begun to scrum with protesters, Fukushima said. He said he saw the same officer who had fired earlier shoot another protester in the neck.

The protester dropped to the ground. Fukushima assumed the worst and rushed to his side.

“I find him, and I’m like, ‘Hey, are you OK?’” Fukushima said. “To the point of courage of these undergrads, he’s like, ‘Yeah, it’s not my first time.’ And then just jumps right back in.”

Sonia Raghuram, 27, another medical student stationed in the tent, said that during the police sweep she tended to a protester with an open puncture wound on their back, another with a quarter-sized contusion in the center of their chest, and a third with a “gushing” cut over their right eye and possible broken rib. Raghuram said patients told her the wounds were caused by police projectiles, which she said matched the severity of their injuries.

The patients made it clear the police officers were closing in on the medical tent, Raghuram said, but she stayed put.

“We will never leave a patient,” she said, describing the mantra in the medical tent. “I don’t care if we get arrested. If I’m taking care of a patient, that’s the thing that comes first.”

The UCLA protest is one of many that have been held on college campuses across the country as students opposed to Israel’s ongoing war in Gaza demand universities support a ceasefire or divest from companies tied to Israel. Police have used force to remove protesters at Columbia University, Emory University, and the universities of Arizona, Utah, and South Florida, among others.

At UCLA, student protesters set up a tent encampment on April 25 in a grassy plaza outside the campus’s Royce Hall theater, , according to the Los Angeles Times. Days later, a “violent mob” of counterprotesters “attacked the camp,” the Times reported, attempting to tear down barricades along its borders and throwing fireworks at the tents inside.

The following night, police issued an unlawful assembly order, then swept the encampment in the early hours of May 2, clearing tents and arresting hundreds by dawn.

Police have been widely criticized for not intervening as the clash between protesters and counterprotesters dragged on for hours. The University of California system announced it has to investigate the violence and “resolve unanswered questions about UCLA’s planning and protocols, as well as the mutual aid response.”

Charlotte Austin, 34, a surgery resident, said that as counterprotesters were attacking she also saw about 10 private campus security officers stand by, “hands in their pockets,” as students were bashed and bloodied.

Austin said she treated patients with cuts to the face and possible skull fractures. The medical tent sent at least 20 people to the hospital that evening, she said.

“Any medical professional would describe these as serious injuries,” Austin said. “There were people who required hospitalization — not just a visit to the emergency room — but actual hospitalization.”

Police Tactics ‘Lawful but Awful’

UCLA protesters are far from the first to be injured by less lethal projectiles.

In recent years, police across the U.S. have repeatedly fired these weapons at protesters, with virtually no overarching standards governing their use or safety. Cities have spent millions to settle lawsuits from the injured. Some of the wounded have never been the same.

During the nationwide protests following the police killing of George Floyd in 2020, at least 60 protesters sustained serious injuries — including blinding and a broken jaw — from being shot with these projectiles, sometimes in apparent violations of police department policies, according to a by ĢӰԺ Health News and USA Today.

In 2004, in Boston, a college student celebrating a Red Sox victory was killed by a projectile filled with pepper-based irritant when it tore through her eye and into her brain.

“They’re called less lethal for a reason,” said Jim Bueermann, a former police chief of Redlands, California, who now leads the Future Policing Institute. “They can kill you.”

Bueermann, who reviewed video footage of the police response at UCLA at the request of ĢӰԺ Health News, said the footage shows California Highway Patrol officers firing beanbag rounds from a shotgun. Bueermann said the footage did not provide enough context to determine if the projectiles were being used “reasonably,” which is a standard established by federal courts, or being fired “indiscriminately,” which was outlawed by a California law in 2021.

“There is a saying in policing — ‘lawful but awful’ — meaning that it was reasonable under the legal standards but it looks terrible,” Bueermann said. “And I think a cop racking multiple rounds into a shotgun, firing into protesters, doesn’t look very good.”

This article was produced by ĢӰԺ Health News, which publishes , an editorially independent service of the .

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

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Médicos que atendieron a manifestantes en la protesta estudiantil en la UCLA dicen que la policía dejó huesos rotos y hemorragias /news/article/medicos-que-atendieron-a-manifestantes-en-la-protesta-estudiantil-en-la-ucla-dicen-que-la-policia-dejo-huesos-rotos-y-hemorragias/ Thu, 16 May 2024 08:59:00 +0000 /?post_type=article&p=1854446 En el campamento que habían montado los estudiantes dentro del campus de la Universidad de California en Los Ángeles (UCLA), de repente la ginecóloga y obstetra residente Elaine Chan se sintió como una médica en un campo de batalla.

La policía avanzó hacia el campamento luego de horas de enfrentamiento y tensión.

Chan, de 31 años, voluntaria en el puesto de atención médica, dijo que los manifestantes llegaban con dificultades para caminar y con graves heridas punzantes. Pero, por el caos que reinaba afuera, había pocas posibilidades de trasladarlos a un hospital donde se les pudiera brindar otro tipo de cuidados.

Chan expresó su sospecha de que esas lesiones habían sido causadas por balas de goma u otros proyectiles “menos letales”. Después del desalojo del campamento, la policía confirmó que había usado estos dispositivos.

“Los proyectiles atravesaron la piel y se clavaron profundamente en el cuerpo de las personas”, explicó Chan. “Todos sangraban profusamente. Los médicos que nos especializamos en obstetricia y ginecología no hemos sido capacitados para atender heridos por balas de goma… No podía creer que se permitiera atacar de ese modo a civiles, a estudiantes, que tenían ningún equipo de protección”.

La protesta de la UCLA, que reunió a miles de personas que se oponen a los continuos bombardeos de Israel sobre la Franja de Gaza, comenzó en abril y alcanzó un peligroso crescendo en mayo, cuando manifestantes pro Israel y la policía se enfrentaron a los activistas y a los que los apoyaban.

En entrevistas con ĢӰԺ Health News, Chan y otros tres médicos voluntarios describieron cómo debieron atender a manifestantes con heridas sangrantes, lesiones en la cabeza y huesos presuntamente fracturados en una clínica improvisada en tiendas de campaña, sin electricidad ni agua corriente.

En los puestos sanitarios del campamento hubo día y noche médicos, enfermeras, estudiantes de medicina, paramédicos y voluntarios sin formación médica formal.

En muchos momentos, la escalada de la violencia fuera de la carpa sanitaria fue de tal magnitud que impedía que los manifestantes heridos llegaran hasta las ambulancias, explicaron los médicos. Esto obligó a que los heridos fueran caminando por sus propios medios hasta algún hospital cercano. A otros los llevaron más allá de los límites de la protesta para trasladarlos a una sala de emergencias.

“Nunca había estado en una situación en la que se nos impidiera ofrecer una atención de mayor nivel”, dijo Chan. “Y eso me aterrorizó”.

Tres de los médicos entrevistados por ĢӰԺ Health News dijeron que estaban presentes el 2 de mayo, cuando la policía arrasó el campamento, y describieron que debieron ocuparse de múltiples lesiones que parecían haber sido causadas por proyectiles “menos letales”.

Estos proyectiles “menos letales” incluyen balas llenas de perdigones de metales pesados o plomo; y municiones comúnmente conocidas como balas de goma. Los utiliza la policía para controlar a sospechosos o para dispersar multitudes y protestas.

La policía recibió una condena generalizada por haber utilizado estas armas contra las manifestaciones del movimiento Black Lives Matter, que se extendieron por todo el país tras el asesinato de George Floyd en 2020.

Aunque el nombre de estas armas parece minimizar su peligrosidad, los proyectiles menos letales pueden viajar a más de 200 mph y está comprobada su capacidad de herir, mutilar o matar.

Las entrevistas a los médicos que atendieron en la posta sanitaria contradicen directamente la versión del Departamento de Policía de Los Ángeles (LAPD). Después que los agentes desalojaran el campamento, el jefe de Policía, Dominic Choi, afirmó en una que “no hubo heridos graves entre los agentes ni entre los manifestantes” durante el operativo en el hubo más de 200 arrestos.

En las respuestas enviadas por correo electrónico a las preguntas de ĢӰԺ Health News, tanto el Departamento de Policía de Los Ángeles como la Patrulla de Carreteras de California afirmaron que investigarían cómo habían actuado sus agentes durante la protesta en la UCLA. Esas indagaciones, dijeron, darán lugar a un “informe detallado”.

La declaración de la Patrulla de Carreteras asegura que los oficiales advirtieron previamente a los manifestantes que si no se dispersaban podrían utilizar “municiones no letales”.

Después que algunos manifestantes se convirtieran en una “amenaza inmediata” porque “lanzaban objetos y armas”, algunos oficiales utilizaron “balas cinéticas especiales para protegerse a sí mismos, a otros oficiales y a los miembros del público”. Un agente resultó con heridas leves, según el comunicado.

Las imágenes de un video que circuló por Internet después del desalojo del campamento parecían mostrar a un oficial de la Patrulla de Carreteras disparando con una escopeta estos proyectiles de menor letalidad contra los manifestantes.

“El uso de la fuerza y cualquier incidente que implique el uso de un arma por parte del personal de la CHP es un asunto serio, y la CHP llevará a cabo una investigación justa e imparcial para garantizar que las acciones fueron coherentes con la política y la ley”, respondió la Patrulla de Carreteras en su declaración.

El Departamento de Policía de la UCLA, que también participó en el operativo vinculado a la protesta, no respondió al pedido de testimonio de ĢӰԺ Health News.

Jack Fukushima, de 28 años, estudiante de medicina de la UCLA y socorrista voluntario, contó que presenció cómo un agente de policía les disparó a por lo menos dos manifestantes con proyectiles de menor letalidad.

Entre ellos, a un hombre que se desplomó tras recibir un impacto “justo en el pecho”. Fukushima explicó que, junto con otros médicos, acompañaron al hombre, aturdido, a la carpa sanitaria. Luego volvieron a la zona de los enfrentamientos para buscar más heridos.

“Realmente lo sentí como una guerra”, aseguró Fukushima. “Encontrarse con semejante brutalidad policial fue muy descorazonador”.

Cuando los médicos estuvieron de regreso en la primera línea, la Policía ya había traspasado los límites del campamento y se encontraba forcejeando directamente con los manifestantes, recordó Fukushima.

En esa situación, el socorrista vio como el mismo policía que antes le había disparado al herido que habían llevado al puesto sanitario ahora le disparaba a otro manifestante en el cuello. El muchacho cayó al suelo. Fukushima supuso lo peor y corrió a su lado.

“Cuando logré acercarme le pregunté: ‘Oye, ¿estás bien?’”, contó Fukushima. “Y él, con una valentía impresionante, me respondió: ‘Sí, no es mi primera vez’. Y volvió de inmediato a la acción”.

Sonia Raghuram, de 27 años, otra estudiante de medicina que colaboró en la carpa sanitaria dijo que durante el operativo policial atendió a un manifestante que tenía una herida punzante abierta en la espalda, a otro con un moretón del tamaño de una moneda en el centro del pecho y a un tercero con un corte que sangraba “a borbotones” sobre el ojo derecho y que probablemente tenía una costilla rota.

Raghuram contó que los pacientes le dijeron que las heridas habían sido causadas por los proyectiles policiales, lo que, según ella, coincidía con la gravedad de sus lesiones.

Los pacientes les advirtieron claramente que los agentes de policía se estaban acercando a la posta sanitaria, dijo Raghuram, pero ella no se movió.

“Nunca abandonaremos a un paciente”, aseguró, aludiendo al mantra de la carpa médica. “No me importa que nos detengan. Si estoy atendiendo a un paciente, eso es lo prioritario”, concluyó.

La protesta de la UCLA es una de las muchas que se han organizado en campus universitarios de todo el país. Los estudiantes que se oponen a la guerra que Israel mantiene en Gaza exigen que la universidad apoye un alto el fuego y que se retiren las inversiones que pueda tener en empresas vinculadas a Israel.

La Policía utilizó la fuerza para desalojar a los manifestantes de campamentos en la Universidad de Columbia, la Universidad de Emory y las universidades de Arizona, Utah y el sur de Florida, entre otras.

En el campus de la UCLA, el 25 de abril los estudiantes que protestaban instalaron tiendas de campaña en una plaza cubierta de césped frente al teatro Royce Hall.

El asentamiento , según Los Angeles Times. Días más tarde, una “violenta turba” de manifestantes de signo contrario “atacó el campamento”, informó el Times, e intentó derribar las barricadas que protegían sus límites, arrojando fuegos artificiales contra las carpas que había en su interior.

La noche siguiente, la Policía declaró ilegal la demostración y luego desalojó el campamento en las primeras horas del 2 de mayo. Hubo cientos de arrestos.

La Policía ha sido muy criticada por no haber intervenido durante el enfrentamiento entre los manifestantes que acampaban y los que fueron a atacarlos, una confrontación que se prolongó durante horas.

La red de Universidades de California anunció que en materia policial para que investigara los actos de violencia y para “resolver las preguntas sin respuesta sobre la planificación y los protocolos de la UCLA, así como sobre el trabajo de colaboración interinstitucional”.

Charlotte Austin, de 34 años, residente de cirugía, dijo que cuando los manifestantes opositores atacaron el campamento de protesta, vio a unos 10 agentes de seguridad privada del campus de pie, “con las manos en los bolsillos”, mientras los estudiantes eran golpeados y ensangrentados.

Austin asegura que atendió a pacientes con cortes en la cara y posibles fracturas de cráneo. La posta médica envió al menos a 20 personas al hospital esa noche, agregó.

“Cualquier profesional de la medicina calificaría esas lesiones de graves”, dijo Austin. “Hubo personas que debieron ser internadas, no se limitó solo a una visita a la sala de emergencias, sino que necesitaron una hospitalización real”.

Tácticas policiales: “lícitas pero horribles”

Los manifestantes de la UCLA no son los primeros heridos por proyectiles de menor letalidad, ni mucho menos.

En los últimos años, la policía de todo Estados Unidos ha disparado cientos de veces estas armas contra manifestantes, sin que prácticamente exista una normativa general que regule su uso o su seguridad. Algunos de los heridos nunca han vuelto a ser los mismos y las ciudades han gastado millones para responder a las demandas de los damnificados.

Durante las protestas que se produjeron en todo el país tras la muerte de George Floyd a manos de la policía en 2020, al menos 60 manifestantes sufrieron lesiones graves incluso ceguera y fractura de mandíbula— por disparos de estos proyectiles, a veces en aparente violación de las políticas de los departamentos de policía, según una de ĢӰԺ Health News y USA Today.

En 2004, en Boston, una estudiante universitaria que celebraba la victoria de los Red Sox murió por el impacto de un proyectil lleno de gas pimienta, que le atravesó el ojo y le llegó al cerebro.

“Se llaman ‘menos letales’ por una razón”, sentenció Jim Bueermann, ex jefe de policía de Redlands, en California, que ahora lidera el Future Policing Institute. “Pueden matarte”.

Bueermann, que a petición de ĢӰԺ Health News revisó las imágenes de video de la intervención de la policía en la UCLA, dijo que muestran a agentes de la Patrulla de Carreteras de California disparando balas de salva con una escopeta.

Bueermann opinó que las imágenes no proporcionaban suficiente contexto como para determinar si los proyectiles se estaban utilizando “razonablemente”, según indica la norma establecida por los tribunales federales, o se estaban disparando “indiscriminadamente”, lo que fue prohibido por una ley de California en 2021.

“Hay un dicho en la Policía — “legal pero horrible”— lo que significa que es razonable bajo los estándares legales, pero se ve terrible”, explicó Bueermann. “Y creo que un policía cargando múltiples balas en una escopeta y disparando contra los manifestantes, no es algo que se vea muy bien”.

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

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FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device /news/article/fda-inspection-johns-dental-agga-device/ Mon, 13 May 2024 11:30:00 +0000 /?post_type=article&p=1838624 The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.

According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by ĢӰԺ Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.

The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.

Two former FDA officials said the AGGA was likely able to stay on the market — and off the FDA’s radar — for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded , which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

“That’s a red flag for me. If I don’t see a single report to the FDA, I typically think there is something going on,” Kinard said. “When they don’t report, what you have is devices that stay on the market much longer than they should. And patients get harmed.”

Johns Dental Laboratories declined to comment when reached by phone and its lawyers did not respond to requests for an interview. The family-owned company, which has operated since 1939 in the western Indiana city of Terre Haute, to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.

Twelve of Johns Dental’s products are registered with the FDA as medical devices, meaning they carry at least a moderate risk, and some have been featured on the company website for at least two decades, according to preserved by the Internet Archive.

The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental’s other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella’s exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental’s total sales revenue.

In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella’s company a “royalty” of $50 to $65 for every sale.

“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella’s specifications,” she said, according to a deposition transcript.

The FDA’s lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time, it was not required to inspect Johns Dental until 2018 when the company registered as a “contract manufacturer” of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a “dental laboratory,” which normally do not manufacture their own products and only modify devices made by other companies to fit dentists’ specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.

Kinard said that based on her experience at the FDA she believes the agency prioritizes medical devices over dental devices, which may have contributed to the lack of inspections at Johns Dental.

“There hasn’t been much attention to dental devices in the past,” Kinard said. “Hopefully that’s going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.”

The AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application. Last year, the ĢӰԺ Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone — and some said they’d lost teeth. Multiple dental specialists said in interviews that they had examined AGGA patients whose teeth had been shoved out of position by the device, sometimes causing tens of thousands of dollars in damage.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who that appeared on a National Institutes of Health website. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.

Johns Dental and Galella have negotiated out-of-court settlements with the original 20 AGGA plaintiffs without publicly admitting fault. At least 13 more AGGA patients have filed similar lawsuits since the ĢӰԺ Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.

Galella declined to be interviewed in 2023 and neither he nor his attorneys responded to recent requests for comment. One of his attorneys, Alan Fumuso, said in a 2023 statement that the AGGA “is safe and can achieve beneficial results” when used properly.

In the wake of the ĢӰԺ Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.

Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA’s website shows that Johns Dental was , but the substance of the agency’s findings was not known until the inspection report was obtained this year.

FDA investigator David Gasparovich wrote in that report that he arrived unannounced at Johns Dental last July and was met by five attorneys who instructed employees not to answer any questions about the AGGA or the company’s complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.

“He asked if he could photograph my credentials,” Gasparovich wrote in his report. “This was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.”

The FDA requires device companies to investigate product complaints and submit a “medical device report” to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich’s inspection report states that Johns Dental had “not adequately investigated customer complaints,” and its complaint policies were “not adequately established,” allowing employees to not investigate if the product was not first returned to the company.

Johns Dental received four complaints about the AGGA after the ĢӰԺ Health News-CBS News report, including one that came after the about the device, according to the inspection report.

“Zero (0) out of the four (4) complaints were investigated,” Gasparovich wrote in the report. “Each complaint was closed on the same day it was received.”

In the months after Gasparovich’s inspection, Johns Dental sent letters to the FDA saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address other FDA concerns, according to the documents obtained through FOIA.

Former FDA analyst M. Jason Brooke, now an attorney who advises medical device companies, said the FDA uses an internal risk-based algorithm to determine when to inspect manufacturers and he advises his clients to expect inspections every three to five years.

Brooke said the AGGA is an example of how the FDA’s oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don’t report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.

When a company “doesn’t follow the law,” Brooke said, “the FDA is in the dark.”

“If there aren’t complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there’s just a dearth of information for the FDA to consume to trigger an inspection,” Brooke said.

CBS News producer Nicole Keller contributed to this article.

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The NIH Hopes To Make TMJ ‘Bearable.’ It Has a Long Way To Go. /news/article/health-202-tmj-disorders-jaw-pain-nih-funding-research/ Wed, 10 Apr 2024 13:39:20 +0000 /?p=1838539&post_type=article&preview_id=1838539 The National Institutes of Health is spending more money than ever to solve the mysteries of TMJ disorders — little-understood ailments that afflict as many as 33 million Americans.

Temporomandibular joint disorders, known as TMJ or TMD, cause pain in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Despite its prevalence, TMJ remains under-researched and ineffectively treated, an investigation by ĢӰԺ Health News and CBS News found.

The NIH recently doubled annual funding for TMJ research, to $34 million, and in 2023 funded a new collaborative to better understand and treat the disorders.

Rena D’Souza, director of the National Institute of Dental and Craniofacial Research, said she’s “hopeful” the lives of future TMJ patients will be made “bearable.” But the millions of Americans suffering from the disorder must tread carefully when seeking care, she warned.

“I would say that the treatments overall have not been effective, and I can understand why,” D’Souza said. “We don’t understand the disease.”

The increased NIH funding is a direct response to a comprehensive 2020 study of TMJ by the National Academies of Sciences, Engineering and Medicine.

The study found that most health-care professionals, including dentists, have received “” on TMJ disorders and common treatments are not backed by compelling scientific evidence or consistent results. Because of the lack of proven treatments, TMJ patients are “often harmed” by “overly aggressive” care, the national academies found.

The NIH echoes these findings on its website, warning that some common from any treatment that permanently changes their teeth, bite or jaw — including surgery.

Some TMJ patients have the same advice, learned the hard way.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

One reason treatment options for TMJ aren’t better, multiple experts said, is because the disorders predominantly affect women. Their complaints were historically dismissed as neither serious nor complex, and therefore TMJ was not a priority for research.

“That has been a bias that is really long-standing,” D’Souza said. “And it’s certainly affected the progress of research.”

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The Horrors of TMJ: Chronic Pain, Metal Jaws, and Futile Treatments /news/article/investigation-tmj-chronic-pain-metal-jaws-futile-treatments/ Thu, 04 Apr 2024 12:15:00 +0000 /?post_type=article&p=1834173 A TMJ patient in Maine had six surgeries to replace part or all of the joints of her jaw.

Another woman in California, desperate for relief, used a screwdriver to lengthen her jawbone daily, turning screws that protruded from her neck.

A third in New York had bone from her rib and fat from her belly grafted into her jaw joint, and twice a prosthetic eyeball was surgically inserted into the joint as a placeholder in the months it took to make metal hinges to implant into her jaw.

“I feel like Mr. Potato Head,” said Jenny Feldman, 50, of New York City, whose medical records show she’s had at least 24 TMJ-related surgeries since she was a teenager. “They’re moving ribs into my face, and eyeballs, and I feel like a toy … put together [by] somebody just tinkering around.”

These are some of the horrors of temporomandibular joint disorders, known as TMJ or TMD, which afflict up to 33 million Americans, according to the National Institutes of Health. Dentists have attempted to heal TMJ patients for close to a century, and yet the disorders remain misunderstood, under-researched, and ineffectively treated, according to an investigation by ĢӰԺ Health News and CBS News.

Dental care for TMJ can do patients more harm than good, and a few fall into a spiral of futile surgeries that may culminate in their jaw joints being replaced with metal hinges, according to medical and dental experts, patients, and their advocates speaking in interviews and video testimony submitted to the FDA.

TMJ disorders cause pain and stiffness in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Dentists have commonly treated the disorder with splints and orthodontics. And yet these treatments are based on “strongly held beliefs” and “inadequate research” — not compelling scientific evidence nor consistent results — according to the National Academies of Sciences, Engineering, and Medicine, which reviewed decades of research on the topic. The NIH echoes this message, warning that there is “” that splints reduce pain and recommends “staying away” from any treatment that permanently changes the teeth, bite, or jaw.

“I would say that the treatments overall have not been effective, and I can understand why,” said Rena D’Souza, director of the NIH’s National Institute of Dental and Craniofacial Research. “We don’t understand the disease.”

For this investigation, journalists with ĢӰԺ Health News and CBS News interviewed 10 TMJ patients with severe symptoms who said they felt trapped by an escalating series of treatments that began with splints or dental work and grew into multiple surgeries with diminishing returns and dwindling hope.

In every interview, the patients said the TMJ pain worsened throughout their treatment and they regretted some, if not all, of the care they received.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

TMJ has become an umbrella term for about 30 disorders that afflict roughly 5% to 10% of Americans. Minor symptoms may not require treatment at all, and many cases resolve by themselves over time. Severe symptoms include chronic pain and may limit the ability to eat, sleep, or talk.

In a by the national academies, including input from more than 110 patients, experts found that most health care professionals, including dentists, have received “” on TMJ disorders and patients are “often harmed” by “overly aggressive” care and the lack of proven treatments.

Almost 100 years this has been in dentistry, and look at what we have… A whole ton of people pretending they know everything, and we don’t know anything.

Terrie Cowley, TMJ patient

The , which represents about 160,000 dentists nationwide and establishes guidelines for the profession, declined an interview request. In a written statement, ADA President Linda Edgar said that TMJ disorders are “often managed rather than cured” and that it sees “great potential” in new efforts to research more treatment options.

Terrie Cowley, a longtime TMJ patient who leads the TMJ Association, an advocacy group that has spoken with tens of thousands of patients, said she was so disillusioned with dental care for TMJ that she advises many patients to avoid treatment entirely, potentially for years.

“Almost 100 years this has been in dentistry, and look at what we have,” Cowley said. “A whole ton of people pretending they know everything, and we don’t know anything.”

‘Not Taken Seriously’

Scientific studies have found that TMJ disorders arise , particularly those in their 20s and 30s, leading to theories that the cause may be linked to reproductive hormones. But a true understanding of TMJ disorders remains elusive.

Kyriacos Athanasiou, a biomedical engineering professor at the University of California-Irvine, said it was because TMJ disorders are more prevalent among women that they were historically dismissed as neither serious nor complex, slowing research into the cause and treatment.

The resulting dearth of knowledge, which is glaring when compared with other joints, has been “a huge disservice” to patients, Athanasiou said. In a 2021 study he co-authored, researchers found that the knee, despite being a much simpler joint, was the subject of about six times as many research papers and grants in a single year than the jaw joint.

D’Souza agreed that TMJ disorders were “not taken seriously” for decades, along with other conditions that predominantly affect women.

“That has been a bias that is really long-standing,” she said. “And it’s certainly affected the progress of research.”

Patients have felt the effect too. In interviews, female patients said they felt patronized or trivialized by male health care providers at some point in their TMJ treatment, if not throughout. Some said they felt blamed for their own pain because they were viewed as too stressed and clenching their jaw too much.

“We desperately need research to find the reasons why more women get TMJ disease,” wrote Lisa Schmidt, a TMJ Association board member, in . “And surgeons need to stop blaming this condition on women.”

Every time you have a surgery, your pain gets worse… If I could go back in time and go talk to younger Lisa, I would say ‘Run!’

Lisa Schmidt, TMJ patient

Schmidt, 52, of Poway, California, said she was diagnosed with TMJ disorder in 2000 due to headaches, and an orthodontist immediately recommended her for a splint, braces, and surgery.

After wearing the splint for only three days, Schmidt said, she was in “excruciating pain” and could no longer open her mouth far enough to eat solid food. Schmidt said she spent the next 17 years stuck on a “surgery carousel” with no escape, and eventually was in so much pain she abandoned her career as an aerospace scientist who worked alongside NASA astronauts.

Schmidt said her low point came in 2016. In an attempt to restore bone that had been cut away in prior surgeries, a surgeon implanted long screws into Schmidt’s jaw that protruded downward out of her neck. Schmidt said she was instructed to tighten those screws with a screwdriver daily for about 20 days, lengthening the corners of her jaw to restore the bone that had been lost. It didn’t work, Schmidt said, and she was left in more pain than ever.

“Every time you have a surgery, your pain gets worse,” Schmidt said. “If I could go back in time and go talk to younger Lisa, I would say ‘Run!’”

Lack of Sufficient Evidence

Many of the shortcomings of TMJ care were laid bare in the published by the national academies in March 2020 that received limited public attention amid the coronavirus pandemic. The report’s 18 authors include medical and dental experts from Harvard, Duke, Clemson, Michigan State, and Johns Hopkins universities.

Sean Mackey, a Stanford professor who co-led the team, said it found that patients were often steered toward costly treatments and “pathways of futility” instead of being taught to manage their pain through strategies and therapies with “good evidence.”

“We learned it’s a quagmire,” Mackey said. “There is a perverse incentive in our society that pays more for things we do to people than [for] talking and listening to people. … Some of those procedures, some of those surgeries, clearly are not helping people.”

Among its many findings, the national academies said it has been widely assumed in the field of dentistry that TMJ disorders are caused by a misaligned bite, so treatments have focused on patients’ teeth and bite for more than 50 years. But there is a “” that a misaligned bite is a cause of TMJ disorders, and the belief traces back to “inadequate research” in the 1960s that has been repeated in “poorly-designed studies” ever since, the report states.

Therefore, TMJ treatment that makes permanent changes to the bite — like installing braces or crowns or grinding teeth down — has “no supporting evidence,” according to the national academies report. The that these TMJ treatments “don’t work and may make the problem worse.”

Dental splints, the most common TMJ treatment, also known as night guards or mouth guards, are removable dental appliances that are molded to fit over the teeth and can cost hundreds or even thousands of dollars out-of-pocket, according to the TMJ Association. Like most medical devices, splints generally go through the FDA’s 510(k) clearance process, which does not require each splint to be proven effective before it can be sold, according to the agency.

The national academies’ report states that splints produce “mixed results” for TMJ patients, and even when splints succeed at reducing jaw pain it is not understood why they work. Hundreds of splint designs exist, the report states, and some dentists reject research that challenges the use of splints unless it focuses on the specific design they prefer.

“Because of the hundreds of variations in [splint] design, it is unlikely that any study could ever be conducted that will be considered sufficient to a particular dentist with a pre-existing belief about the effectiveness of one appliance,” the report states.

Other treatments fare no better. The FDA has not labeled any drugs specifically for TMJ disorders, and to be a long-term solution, according to the TMJ Association. Botox injections may ease pain but have during animal testing. The NIH warns that minor surgeries that flush the jaw with liquid bring only temporary pain relief and that more complex surgeries should be reserved for severe cases because they have yet to be proved safe or effective in the long term.

To improve care, the national academies called for better education about TMJ disorders across medicine and dentistry and more research funding from the NIH, which has a “ripple effect” on research and training across the nation.

Since the 2020 report, the NIH has launched a and increased annual research funding from about $15 million to about $34 million, D’Souza said. TMJ care was added to must teach to be accredited in 2022. The national academies launched an last year.

But TMJ funding still pales in comparison to other ailments. The NIH spends billions each year to research deadly diseases, like cancer and heart disease, that also afflict large numbers of Americans. It spends millions more on research of non-life-threatening conditions like arthritis, back pain, eczema, and headaches.

Mackey noted that much of the NIH’s spending is allocated by Congress.

“If Congress comes in and says, ‘We want to devote X amount of money to [TMJ],’ all of the sudden you will see an increase in money,” Mackey said. “So that’s my message to people out there: Raise your voices. Write your legislator.”

Total Jaw Replacements

Plagued by TMJ symptoms, and after failed treatments, some patients turn to a last resort: replacing their jaw joint with synthetic implants. Surgeons might replace the cartilage disk at the core of the joint or use “total joint replacement surgery” to fasten a metal hinge to the bones of the skull.

But the implants have a harrowing history: Several disk implants were recalled or discontinued in the ’90s due to dangerous failures. The FDA now classifies TMJ implants among its because the products on the market today can cause “adverse health consequences” if the devices fail, according to the agency’s website.

Two companies, Zimmer Biomet and Stryker, make the only total jaw replacement implants currently sold in the U.S.

Zimmer Biomet, which has made its implant for more than two decades, described it in email statements as “a safe and efficacious solution” for patients who need their jaw joint replaced, either due to TMJ disorders, failed surgeries, injuries, or other ailments. An FDA-mandated study completed in 2017 found about 14% of patients who get the Zimmer Biomet implant require additional surgery or removal within 10 years, said agency spokesperson Carly Pflaum.

Stryker, which in 2021 bought a company that made a total jaw replacement implant and now makes the implant itself, declined to comment. Although the NIH has advised TMJ patients to avoid surgery since at least 2022, Stryker launched a “” for the implant last year and is recruiting surgeons to be added to a “surgeon locator” feature on the site, according to posts on Facebook and .

A study of the Stryker implant’s success rate was mandated by the FDA and completed in 2020, but the agency has yet to make the results public.

D’Souza, the NIH official, said that based on her professional experience, she estimates that most total jaw replacement surgeries are ultimately ineffective.

“The success rate is low,” D’Souza said. “It is not very encouraging.”

Multiple patients provided ĢӰԺ Health News and CBS News with medical records showing their total jaw replacement implants had to be removed due to malfunction, infection, or previously unknown metal allergies. Several patients said that since their implants were removed months or years ago, they have lived with no hinge in their jaw at all.

Kalinowski, the TMJ patient in Maine, has had portions of her jaw joint replaced six times, including receiving four implants. Her medical records show that the cartilage disk on her right side was replaced in 1986 with an implant that was later recalled and again in 1987 with another that was later discontinued. Her left and right disks were replaced in 1992 with a muscle flap and rib graft, respectively, and her entire right joint was replaced with yet another implant that was later discontinued in 1998. Both joints were replaced again in 2015, her records show.

Since then, Kalinowski said, her artificial jaw has functioned properly, although she remains in pain and cannot move her jaw from side to side. Her mouth hangs open when her face is at rest, and she drinks protein shakes for lunch because it’s easier than struggling with solid food.

But the “worst part,” Kalinowski said, is that her surgeries caused nerve damage on her lower face, and so she has not felt her husband’s kisses since the ’90s.

“If there was one moment in my life I could take back and do over again, it would be that first surgery. Because it set me on a trajectory,” Kalinowski said. “And it never goes away.”

CBS News producer Nicole Keller contributed to this article.

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

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A State-Sanctioned Hospital Monopoly Raises Concerns /news/article/health-202-ballad-health-hospital-monopoly-emergency-room-wait-times/ Thu, 28 Mar 2024 13:04:24 +0000 /?p=1833175&post_type=article&preview_id=1833175 TheFederal Trade Commissionhas long argued that competition makes the economy better. But some states have stopped the agency from blocking hospital mergers that create local or regional monopolies, and the results have been messy.

Two dozen states have at some point passed controversial legislation waiving anti-monopoly laws, allowing rival hospitals to merge and replacing competition with prolonged state oversight.

Six years ago, Tennessee and Virginia ushered in the largest state-sanctioned hospital monopoly in the nation with the creation ofBallad Health. For most of the1.1 millionresidents in the Tri-Cities region of northeast Tennessee and southwest Virginia, the merged system became the only option for hospital care.

The argument for Ballad was that two hospital companies couldn’t survive in the region, and a merger would prevent them from closing or being bought up. But critics say fears a monopoly would jeopardize access to and quality of care have been realized.For example, since the merger, patientsspend three times as long in Ballad emergency roomsbefore admission to hospitals, according to reports released by the Tennessee health department.

“I do not want to further risk my life and die at a Ballad hospital,” saidNeal Osborne, a city council member in Bristol, Va. In an interview, Osborne said he spent 30 hours in a Ballad ER this year as he suffered diabetic crisis. “The wait times just to get in and see a doctor in the ER have grown exponentially.”

The legislation that created Ballad is known as a certificate of public advantage, or COPA. The FTC has repeatedly warned states to be wary of COPAs, which “only exist to protect a merger that would otherwise be illegal under antitrust law,”Rahul Rao, a deputy director of theBureau of Competitionat the agency, told ĢӰԺ Health News in an interview last year.

There have been about10 hospital mergersin the past three decades that depended on COPAs, and afterward, the feds saw rising prices, decreases in quality, reductions in access and a decrease in wages, Rao said.

Since Ballad’s COPA, the merged system hasnot met most quality-of-care goalsset by the states in recent years. It has fallen short of charity care promises made to Tennessee by about$191 millionover a five-year span.

Ballad has attributed its quality struggles to the coronavirus pandemic, its charity shortfalls to Medicaid changes and its longer ER stays to staffing and discharge challenges it says are beyond its control.

Ballad said ER times for admitted patients have dropped to about7.5 hourssince its latest annual report.

“On those issues Ballad Health can directly control, our performance has rebounded from 2022,” said a Ballad spokesperson,Molly Luton.

The FTC announced in 2019 that it would study the Ballad merger but has yet to issue a report.

Legislation was introduced this year to limit COPAs in Tennessee. But on Tuesday, a state legislative subcommitteewithout debate, refusing to hear testimony from Tri-Cities residents who drove five hours to Nashville for a chance to speak against Ballad.

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After Appalachian Hospitals Merged Into a Monopoly, Their ERs Slowed to a Crawl /news/article/ballad-health-er-wait-times-copa-monopoly-appalachia-hospitals/ Mon, 25 Mar 2024 09:00:00 +0000 /?post_type=article&p=1831404 In the small Appalachian city of Bristol, Virginia, City Council member Neal Osborne left a meeting on the morning of Jan. 3 and rushed himself to the hospital.

Osborne, 36, has Type 1 diabetes. His insulin pump had malfunctioned, and without a steady supply of this essential hormone, Osborne’s blood sugar skyrocketed and his body was shutting down.

Osborne went to the nearest hospital, Bristol Regional Medical Center. He said he settled into a wheelchair in the emergency room waiting area, where over the next few hours he drifted in and out of consciousness and retched up vomit, then bile, then blood. After 12 hours in the waiting room, Osborne said, he was moved to an ER bed, where he stayed until he was sent to the intensive care unit the next day. In total, the council member was in the ER for about 30 hours, he said.

Osborne said his ordeal echoes stories he’s heard from constituents for years. In his next crisis, Osborne said, he plans to leave Bristol for an ER about two hours away.

“I want to go to Knoxville or I want to go to Roanoke, because I do not want to further risk my life and die at a Ballad hospital,” he said. “The wait times just to get in and see a doctor in the ER have grown exponentially.”

Ballad Health, a 20-hospital system in the Tri-Cities region of Tennessee and Virginia, benefits from the largest state-sanctioned hospital monopoly in the United States. In the six years since lawmakers in both states waived anti-monopoly laws and Ballad was formed, ER visits for patients sick enough to be hospitalized grew more than three times as long and now far exceed the criteria set by state officials, according to released by the Tennessee Department of Health.

Tennessee and Virginia have so far announced no steps to reduce time spent in Ballad ERs. The Tennessee health department, which has a more direct role in regulating Ballad, has each year issued a report saying the agreement that gave Ballad a monopoly “continues to provide a Public Advantage.” Department officials have twice declined to comment to ĢӰԺ Health News on Ballad’s performance.

According to , which was released this month and spans from July 2022 to June 2023, the median time that patients spend in Ballad ERs before being admitted to the hospital is nearly 11 hours. This statistic includes both time spent waiting and time being treated in the ER and excludes patients who weren’t admitted or left the ER without receiving care.

The federal government once tracked ER speed the same way. When compared against the latest from 2019, which includes more than 4,000 hospitals but predates the covid-19 pandemic, Ballad ranks among the 100 hospitals with the slowest ERs. More current federal data is not available because the Centers for Medicare & Medicaid Services retired this statistic in 2020 in favor of other measurements.

Newer data tells a similar story. The Joint Commission, a nonprofit that accredits health care organizations, collected this same measurement for 2022 from about 250 hospitals that volunteered the data, finding a median ER speed of five hours and 41 minutes — or about five hours faster than Ballad’s latest annual report.

Ballad Health spokesperson Molly Luton said in an email statement that, by holding patients in the ER, where they are observed while waiting for a bed, Ballad avoids “overwhelming” its staff. Luton said ER delays are also caused by two nationwide crises: a nursing shortage and fewer admissions at nursing homes and similar facilities, which can create a backlog of patients awaiting discharge from the hospital.

Luton added that Ballad’s ER time for admitted patients has dropped to about 7½ hours in the months since the company’s latest annual report.

“On those issues Ballad Health can directly control, our performance has rebounded from 2022, and is now among the best in the nation,” Luton said.

Luton also noted that Ballad performs better than or close to the national average on several other measurements of ER performance, including having fewer patients who leave without being treated. CMS data shows the national average is about 3%. Ballad reported 1.4% in its latest annual report.

Osborne, the Bristol council member, attributed this statistic to Ballad’s monopoly.

“Just because they aren’t leaving the ER doesn’t mean they are happy where they are,” he said. “It just means they don’t have anywhere else they could be.”

Ballad’s Big Monopoly

Ballad Health was formed in 2018 after state officials approved the nation’s biggest hospital merger based on a so-called Certificate of Public Advantage, or COPA, agreement. COPAs have been used in about 10 hospital mergers over the past three decades, but none has involved as many hospitals as Ballad’s.

State lawmakers in Tennessee and Virginia waived federal anti-monopoly laws so rival hospital systems — Mountain States Health Alliance and Wellmont Health System — could merge into a single company with no competition. Ballad is now the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina.

The Federal Trade Commission warns that hospital monopolies lead to increased prices and decreased quality of care. To offset the perils of Ballad’s monopoly, officials required the new company to commit to a long list of special conditions, including dozens of quality-care metrics spelled out with specific benchmarks.

In its latest annual report, Ballad improved on many quality-of-care metrics over the prior year, including several that the company prioritized, but still fell short on 56 of 75 benchmarks.

ER time for admitted patients is one of those. The benchmark was set at three hours and 47 minutes in the original COPA agreement. Ballad met or nearly met this goal for three years, according to its annual reports. Then the ERs slowed.

In , Ballad reported a median ER time for admitted patients of about six hours.

In , it reported the same statistic at seven hours and 40 minutes.

In , ER time for admitted patients had reached 10 hours and 45 minutes.

CMS, which grades thousands of hospitals nationwide, that timely ER care is “essential for good patient outcomes,” and that more time spent in the ER has been linked to higher complication rates and delays in patients getting pain medication and antibiotics.

Ben Harder, chief of health analysis for U.S. News & World Report, said extensive ER times can be a symptom of slowdowns throughout a hospital, including in the operating room.

“A long delay in getting patients admitted is both a risk in itself, in that a test may not get conducted as promptly,” Harder said. “But it’s also an indication that the hospital is backed up, and that there are problems getting patients moved from one unit to another.”

Bill Christian, a spokesperson for the Tennessee Department of Health, said Ballad’s rising ER times had been “noted” but did not say if the agency had taken or was considering any action. Christian directed questions about Ballad’s latest stats to the company itself.

‘A Nightmare for Community Members’

Ballad has also fallen short — by about $191 million over the past five years — of its obligation to Tennessee to provide charity care, which is free or discounted care for low-income patients, according to health department documents and Ballad’s latest report. The health department in each of the past four fiscal years. Ballad has said it would ask for another this year.

In a two-hour interview last year, Ballad CEO Alan Levine defended his company and said that because the Tri-Cities region could not support two competing hospital companies, the COPA merger had likely prevented at least three hospital closures. Levine attributed Ballad’s failure to meet quality benchmarks to the pressure of the covid pandemic and said charity care shortfalls were partly caused by Medicaid changes beyond Ballad’s control.

“Our critics say, ‘No Ballad. We don’t want Ballad.’ Well, then what?” Levine said. “Because the hospitals were on their way to being closed.”

Some residents see Ballad as a savior. John King, who runs a physical therapy clinic in the core of Ballad’s region, said at a that in multiple visits to Ballad ERs, including one for a stroke, he found their care to be quick and compassionate.

“If it weren’t for Ballad Health, I literally would not be here today,” King said, according to a hearing transcript.

Ballad’s failures to live up to the terms of the COPA agreement were detailed in a ĢӰԺ Health News investigation last September, and the company faced a new wave of criticism in the months that followed.

Local leaders in Carter County, Tennessee, in October debated but did not pass a resolution calling for Ballad to be better regulated or broken up. Tennessee Attorney General Jonathan Skrmetti, a Republican, said in an published in November that Ballad must be constantly monitored in light of community complaints. Earlier this month, Tennessee state Rep. David Hawk (R-Greeneville), who represents a region within Ballad’s monopoly, called for Levine’s resignation, according to wjhl.com.

In response, Ballad Health said in a statement it has “strong relationships with the majority of elected officials” in Carter County and welcomed scrutiny from the Tennessee attorney general. Ballad said Hawk’s “opinion certainly does not reflect our broader relationships” within the area. Tennessee lawmakers are also considering legislation to in the state, which Ballad said “risks putting more hospitals at risk for closure.”

The bill was introduced by state Sen. Heidi Campbell (D-Nashville) and state Rep. Gloria Johnson (D-Knoxville), who is running for the U.S. Senate. Johnson said the bill would end Ballad’s protection from antitrust laws.

“It’s just been a nightmare for community members out there,” Johnson said. “And they have no other option.”

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

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‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea /news/article/agga-inventor-testifies-dental-device-not-designed-for-tmj-or-sleep-apnea/ Fri, 22 Dec 2023 10:00:00 +0000 /?post_type=article&p=1785341 A Tennessee dentist who has been sued by multiple TMJ and sleep apnea patients over an unproven dental device he invented has said under oath that he never taught dentists to use the device for those ailments — contradicting video footage of him telling dentists how to use it.

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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 ĢӰԺ 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 ĢӰԺ 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 ĢӰԺ 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 ĢӰԺ 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 ĢӰԺ 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 ĢӰԺ 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.

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

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Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half. /news/article/profemur-artificial-hips-malfunction/ Tue, 05 Dec 2023 12:30:00 +0000 /?post_type=article&p=1780675 Bradley Little, a physical education teacher in Arizona, was leading his class through a school hallway in 2017 when he collapsed. Little feared he was having a stroke. Or, in a sign of the times, that he’d been shot. He tried to stand, but his leg wouldn’t move.

A student ran for help. Firefighters arrived and hoisted Little onto a gurney. At the hospital, an X-ray revealed that the artificial hip implant in Little’s right leg had “suddenly and catastrophically structurally failed,” according to a lawsuit Little would later file in federal court. The implant severed at its “neck” — a 2-inch-long titanium part linking Little’s thigh to his torso.

“It looked like a laser went through it,” Little said in an interview. “It was like someone just went in there and cut it right in the middle.”

Profemur artificial hips were once considered innovative for a feature known as a “dual modular neck,” intended to modernize total hip replacement surgery. Hundreds of thousands of Americans undergo hip implant surgery each year and devices are expected to last at least 20 years, according to the American College of Rheumatology. The Profemur necks, available in an array of lengths and angles, made it easier to customize the hip implants for patients.

But the neck also proved to be a weak point. Over the past two decades, more than 750 Profemur hips like Little’s have fractured at the neck, an attorney for the manufacturer once said in court while defending the device as not defective. In interviews, patients said they were left unable to walk and in need of emergency surgery. Reports submitted to the FDA describe Profemur patients stranded in the midst of routine life, while hiking, golfing, bowling, mowing the lawn, lifting a potted plant, getting out of a chair, putting on pants, and leaning over to pick up a key.

After each break, patients endure an hours-long repair surgery that can be traumatic because the broken implant is embedded in their bone and difficult to remove, according to three orthopedic surgeons who’ve performed such a procedure. The repair surgery, which can cost tens of thousands of dollars and may not be fully reimbursed by insurance, often requires a patient’s femur to be cracked open to extract a metal stem that was inserted down its length. Lawsuits have likened removing the bone around the stem to peeling a banana.

“It’s gruesome,” said Lee E. Rubin, an orthopedic surgeon and expert on prosthetic hips at Yale School of Medicine. “There’s no way around the fact that there’s a failed or broken implant in that patient’s thigh. We have to remove it.”

Many Profemur fractures in patients’ bodies could have been avoided if the manufacturer or the FDA responded to early signs of failure with more urgency, according to a months-long investigation by ĢӰԺ Health News and CBS News. An FDA database shows reports of Profemur’s titanium modular necks breaking inside U.S. patients since at least 2005, but the corresponding parts were not recalled until 15 years later, if at all. Ten sizes of the titanium neck eventually were recalled in 2020 after being identified in more than 650 reports of fractures submitted to the FDA. Six other sizes of titanium necks, identified in about 75 additional fracture reports, have not been permanently recalled.

Aidin Eslam Pour, another Yale orthopedic surgeon , said the manufacturer “waited too long.”

“This implant should have been pulled out of the market earlier,” he said.

Profemur’s original manufacturer, Wright Medical Technology, in 2009 switched the metal of the modular neck from titanium to a stronger cobalt-chromium alloy, FDA documents show. Then, after some of those necks also began to break, the company recalled one size but left 11 others on the market despite reports of corrosion causing the implants to fail, FDA documents show.

In total, at least 28 sizes of the Profemur artificial hips with a dual modular neck have allegedly fractured or corroded, but just 11 sizes have been permanently recalled, according to FDA data and records.

Wright Medical, a Tennessee company founded in 1950, has made implantable medical devices since at least the 1970s, according to . Wright sold its hip and knee implant division, including the Profemur, to Chinese company MicroPort for $285 million in 2013, according to the . Stryker Corp., one of the nation’s largest device companies, paid about $4 billion for the rest of Wright in 2020.

Wright Medical declined to comment in an email from Stryker spokesperson Jon Zimmer. MicroPort did not respond to more than a dozen requests for comment sent to its attorneys, public relations firm, and U.S. offices. MicroPort still on its website, where the devices are listed as “not marketed/registered in United States.”

The FDA declined to provide an official for an interview and did not answer written questions about why some Profemur sizes were not permanently recalled. In an email, FDA spokesperson Audra Harrison said medical device manufacturers are largely responsible for deciding which products to recall and when to do so, while the agency “monitors” this process and requests recalls only in “urgent situations.” In the case of the Profemur modular necks, all recalls were initiated by MicroPort, and the FDA “took action accordingly,” the agency said.

For this investigation, journalists with ĢӰԺ Health News and CBS News analyzed thousands of reports of Profemur complications submitted over the past two decades to the , which catalogs reports of medical device problems and malfunctions. MAUDE is unverified, incomplete, and imperfect — for example, not all device problems are properly submitted to the database, and a single issue may be reported more than once. However, the database still offers the best available perspective on medical device complications in the United States. The FDA has used MAUDE to identify device problems since the early ’90s.

ĢӰԺ Health News and CBS News also reviewed about 180 lawsuits filed in federal court in the past decade alleging Profemur modular necks broke or corroded. Plaintiffs have alleged severe pain, swelling, a “debilitating lack of mobility,” and, in at least a few cases, nerve damage and neurological issues from cobalt and chromium ions leaking into their bloodstream.

Most of the lawsuits have been resolved through out-of-court settlements without Wright Medical or MicroPort publicly admitting fault, according to court filings. The remainder of the lawsuits are ongoing.

Wright Medical has denied liability in some lawsuits before settling them and has defended Profemur implants in court in the years before some of the implants were recalled for fracturing.

“A device fracture does not mean it is defective,” Wright Medical attorney Tiffany Carpenter said in federal court in 2018, according to . “Devices fracture all the time.”

Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7½ years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years, the lawsuits allege.

Some plaintiffs say they got Profemur implants in both legs — then they both ended up breaking.

Mark Feld, 75, of New Hampshire, who was an avid runner, said he was implanted with Profemur artificial hips in his right and left legs in 2005 and 2008, then the right hip fractured within 10 years, according to a lawsuit he filed. Wright Medical denied liability in court filings and settled out of court for an undisclosed amount.

Feld said that because he surrendered all claims against Wright in the settlement, he could not sue again when his left implant broke in 2020 as he was walking across a bridge near his apartment.

He crawled home to call 911, he said, and was rushed to the hospital.

“I couldn’t walk across that bridge for a year,” Feld said. He now has new hip implants made by another company, but his fear lingers. “To this day, I still feel like a ticking time bomb. … Nobody could confirm for me that it can’t happen again.”

Little, the Arizona teacher, also suffered a second Profemur break, four years after his first, according to his lawsuit, in which Wright Medical denied liability and settled out of court. Little said in an interview that this time he was teaching class on a tennis court when he felt a sensation in his left leg that reminded him of crushing an aluminum can. He said he narrowly avoided tumbling onto his students.

After his two broken hip implants and replacement surgeries, Little said, he had to stop coaching basketball and will retire from teaching at the end of this school year — four years earlier than planned. He still feels unsteady and is afraid to climb a stepladder to change a lightbulb, he said.

“I’ve been robbed of some things,” Little said. “There should be accountability for it.”

It is not publicly known how many Profemur hips have failed. According to , Carpenter, the attorney for Wright Medical, said in court in 2018 that the company was aware of 768 fractures among about 353,000 Profemur necks sold. That’s a fracture rate of about 0.2%.

Other sources report a much higher rate. The Profemur devices that were permanently recalled in 2020 had a U.S. fracture rate of 2.2% — 11 times what was described in court — according to FDA documents. Peer-reviewed studies estimate fracture rates as and as for some Profemur models.

Even the lowest estimates are “unacceptable,” said Samo Fokter, an orthopedic surgeon and Profemur expert at University Medical Center Maribor in Slovenia.

Fokter has co-authored more than 10 peer-reviewed studies on the Profemur, , and said he implanted about 50 of them before they were known to fracture.

“This should not happen,” Fokter said. “If you put too much force on any implant, it can fracture, of course, but this is very, very rare. Not approaching 1%. It should be less than one in 100,000, let’s say.”

Like a Black Hole Developed Under Their Foot’

The Profemur’s problems originate from its “neck,” which is a metal connector between the upper components in the hip socket to a lower “stem” that is inserted into a patient’s thigh bone, according to peer-reviewed studies, court records, and expert interviews.

Historically, an artificial hip’s stem and neck were a single piece of metal. The Profemur line added a junction at the top of the stem so the neck was separate. Because these dual modular necks detached on both ends, the size and angle could be changed to better fit a patient.

But the Profemur’s additional junction was also its downfall. Rubin, one of the Yale experts, who also maintains at the university, said in some patients tiny cracks formed on the portion of the neck that slotted into the socket of the stem. Patients had no idea their implant was cracking until the neck snapped, he said.

“From a patient’s perspective, they’re walking around on what otherwise would seem like a successful hip implant,” Rubin said. “And all of a sudden, as they took a step, they could not bear weight … like a black hole had developed under their foot.”

The dual modular neck was developed by a European company, Cremascoli Ortho Group, in the ’80s, then purchased by Wright Medical in 1999 to be introduced as the Profemur in the United States. The Profemur was cleared for sale by the FDA in 2000 through the , which permits new medical devices to be sold without extensive testing if they are deemed to have “substantial equivalence” to other devices already on the market. Through this process, new medical devices can piggyback on a single approval for decades.

Wright Medical told the FDA that the Profemur was substantially equivalent to five existing artificial hip systems, and the agency agreed, according to FDA documents obtained through a Freedom of Information Act request. However, of those five hip systems, at least three had significantly different necks than the Profemur, Rubin said. And one was later recalled because of its high failure rate, according to the FDA.

The FDA documents state that although the Profemur is different from the older hip implants that its approval was based on, those differences were “not expected to affect the device’s safety and effectiveness.” Spokesperson Harrison said in an email that the FDA “followed the statutory framework” when the Profemur was reviewed and cleared.

Once it was cleared by the FDA, Wright touted the Profemur’s dual modular neck as a feature.

In a 2004 promotional document obtained by ĢӰԺ Health News and CBS News, Wright guaranteed the “structural reliability” and “absence of fretting corrosion” at the junction of the stem and neck. Then Wright marketed the Profemur to people with an “active lifestyle,” saying the product was for patients who wanted to return to activities like golf, tennis, karate, and wrestling after their hip replacements, according to at least two dozen lawsuits filed against the company.

Wright also hired Jimmy Connors, who was the world’s top-ranked tennis player in the ‘70s, as a spokesperson.

“This hip has given me back my quality of life. It’s allowed me to do anything I did before,” Connors said on JimmysNEWHip.com, a website launched by Wright in 2006, according to preserved by the Internet Archive.

When the website launched, Wright Medical knew of at least some reports of modular neck fractures. Multiple lawsuits allege the company was aware as of 2000 that some Cremascoli hips had fractured at the modular neck, and then became aware of more fractures in 2003 and 2004. The FDA database shows Wright was also aware of two Profemur implants that allegedly fractured at the neck and were returned to Wright in spring 2005.

In 2006, FDA data showed six reports of Profemur fractures that identified the neck as the part that allegedly broke. By 2007, there were 11 such reports. By 2008, there were 30.

Connors, reached on his cellphone, said Wright Medical did not inform him of Profemur fractures at the time of his endorsement or since. Connors said his own hip implant did not fracture but had to be replaced in 2012 because of other complications.

If he had been told about a fracture risk, Connors said, he might have chosen another implant.

“If I was going through it now, I’d know a lot more to ask than I did back in the first time,” Connors said.

Perry Parks, 79, who played football for the Los Angeles Rams in the ’60s, said Connors’ endorsement persuaded him to get a Profemur hip in 2007. His implant snapped six years later during a bike ride, according to his lawsuit. Wright Medical denied liability and settled out of court.

In an interview, Parks said he was lucky to be biking at the beach at the time of the break, where he tumbled into sand, instead of in traffic.

“The thing that incenses me more is that they knew this,” Parks said. “There was some intentionality here to put … profits over the health of people.”

New Metal, New Complications

In 2009, Wright Medical introduced a new version of the Profemur modular neck that once again was cleared for sale by the FDA. Agency documents show that the neck material was switched from titanium to a cobalt-chromium alloy, a stronger metal.

“That was a big mistake,” Fokter said.

While the cobalt-chromium necks were less susceptible to fracture, they created a new problem at the same junction between the neck and stem, said Fokter and the two Yale experts. Once implanted, the cobalt-chromium neck could rub against the stem’s titanium socket, leading to a form of bimetallic corrosion that can cause pain and swelling and leak small amounts of metal ions into a patient’s bloodstream, potentially causing a long list of complications, the three experts said.

Robert Rembisz, 75, a retiree in Vero Beach, Florida, alleged in an ongoing lawsuit that Profemur corrosion in his right leg caused elevated metal levels in his blood and “neurologic symptoms” including nerve damage, tinnitus, and balance and coordination problems. Wright Medical has not yet responded to the allegations in Rembisz’s lawsuit.

Rembisz added in an interview that he believes the implant hindered his memory and cognition, leading him to question whether he was suffering early signs of dementia. He provided to ĢӰԺ Health News and CBS News lab reports showing the metals in his blood rising over years, with cobalt levels peaking at nearly 12 times the normal range. Rembisz said most of the symptoms faded after his implant was removed in 2021.

“The problems I developed weren’t even close to my hip,” Rembisz said. “This problem could be occurring in [other people’s] bodies as well. And they don’t even know it.”

Six years after Profemur switched metals, MicroPort recalled one size of the cobalt-chromium neck affecting about 10,500 implants, citing an “,” according to FDA records. But it is unknown how many could not be returned because they’d already been implanted.

Kristin Biorn had one.

Biorn, 74, of Pasadena, California, alleged in a lawsuit that this particular size of Profemur neck was implanted in her left leg in 2013 and broke within two years — four months before the recall. Wright Medical and MicroPort denied liability in her lawsuit, then settled out of court.

In an interview, Biorn said the break occurred as she was working at her burgeoning home-staging business. While putting final touches on a client’s home with her teenage son, she fell to the floor, unable to stand or crawl, she said.

“Honestly, it gives me nightmares about what could have happened had my son not been there,” Biorn said. “My phone was downstairs and there was no way I could have gotten down the stairs alone. No one was scheduled to come in for four days.”

Biorn said in her interview that it took three surgeries to fix her hip after the Profemur fracture and she was ultimately forced to close her business and retire.

She now walks with a cane.

Although MicroPort recalled one cobalt-chromium size in 2015, the company did not recall 11 other sizes made of the same metal with the same design, and some lawsuits have faulted the company for leaving “interchangeable” products on the market. MicroPort also did not at that time recall any of the titanium necks, which as of 2015 were identified in more than 500 fracture reports in FDA’s database. MicroPort recalled 10 titanium sizes in 2020.

Finally, also in 2020, MicroPort issued a sweeping recall for all available Profemur modular necks, regardless of whether they were made of titanium or cobalt-chromium, according to FDA records.

The recall was temporary so MicroPort could included in the packaging of Profemur implants. The revised documents added a “general precaution” that doctors should consider a patient’s activity level and weight before implanting them with a Profemur, and said that patients should not have “unrealistic” expectations that include “substantial walking, running, lifting, or muscle strain.”

Afterward, the recall was lifted, and the FDA once again allowed the implants to be put up for sale.

ĢӰԺ Health News data editor Holly K. Hacker and CBS News producer Nicole Keller contributed to this report.

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

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