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Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

Less than one in five women physicians are practicing in the top five high-paying specialties. Women compose only 6% of orthopedic surgeons, 8% of interventional cardiologists, 10% of urologists, 17% of plastic surgeons, and 18% of otolaryngologists, according to the 2020 Association of American Medical Colleges Physician Specialty Data Report.

Plastic surgeons earn an average of $526,000 annually, which is the highest-paying specialty. Otolaryngologists earn an average of $417,000 annually, and urologists earn $427,000, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Yet, far more women are practicing in specialties that pay less. Women are the majority in pediatrics (64%), ob.gyn. (59%), internal medicine (53%), and endocrinology (51%), the AAMC data show. The exception is dermatology, which pays well and in which 51% are women. The annual average pay is $394,000.

Why are so many women avoiding the top-paying specialties?

Several physician researchers and leaders in the top-paying specialties point to four main factors: Women are attracted to specialties that have more women in faculty and leadership positions, women prioritize work-life balance over pay, women residents may be deterred from the high-paying specialties because of gender discrimination and sexual harassment, and the longer training periods for surgical specialties may be a deterrent for women who want to have children.
 

Lack of women leaders

The specialties with the most women tend to have the highest proportion of women in leadership positions. For example, obstetrics and gynecology had the highest proportion of women department chairs (24.1%) and vice chairs (38.8). Pediatrics had the highest proportion of women division directors (31.5%) and residency program directors (64.6%), a study shows.

Surgical specialties, on the other hand, may have a harder time attracting female residents, possibly because of a lack of women in leadership positions. A recent study that examined gender differences in attitudes toward surgery training found that women would be more likely to go into surgery if there were more surgical faculty and residents of their same gender.

An analysis of orthopedic residency programs shows that more trainees were drawn to programs that had more female faculty members, including associate professors and women in leadership positions.

Terri Malcolm, MD, a board-certified ob.gyn. and CEO/founder of Master Physician Leaders, said women need to consider whether they want to be a trailblazer in a specialty that has fewer women. “What support systems are in place to accommodate your goals, whether it’s career advancement, having a family, or mentorship? Where can you show up as your whole self and be supported in that?”

Being the only woman in a residency program can be a challenge, said Dr. Malcolm. If the residents and attendings are predominantly men, for example, they may not think about creating a call schedule that takes into account maternity leave or the fact that women tend to be caretakers for their children and parents.

The study of gender differences toward surgery training shows that 75% of women, in comparison with 46% of men, would be more willing to enter surgery if maternity leave and childcare were made available to female residents and attending physicians.
 

Women want work-life balance

Although both men and women want families, women still shoulder more family and childcare responsibilities. That may explain why women physicians ranked work-life balance first and compensation second in the Medscape Women Physicians 2020 Report: The Issues They Care About.

“My physician colleagues have been and are supportive of intellectual abilities, but I feel they don’t fully understand the uneven distribution of childcare issues on women,” a woman dermatologist commented.

Women may want to work fewer hours or have a more flexible schedule to take care of children. “I can count on one hand the number of women who have a part-time job in orthopedics. It’s very rare, and working part time absolutely is a barrier for someone who wants to be a surgeon,” said Julie Samora, MD, PhD, a researcher and pediatric hand surgeon at Nationwide Children’s Hospital, in Columbus, Ohio. She is also a spokesperson for the American Association of Orthopedic Surgeons.

Preeti Malani, MD, a professor of medicine who specializes in infectious diseases at the University of Michigan, chose to work full-time in academia while raising two children with her husband. In a decade, she rose through the ranks to full professor. “I took the advice of a woman who wanted to recruit me to have a full-time position with maximum flexibility rather than work part time, often for more hours and less pay. I also have tried to build my career so I was not doing all clinical work.”

Her husband is a surgeon at the University of Michigan. His schedule was not flexible, and he was unable to take on family responsibilities, said Dr. Malani. “I knew someone had to be able to grab the kids from daycare or pick them up at school if they were sick.” She also took work home and worked weekends.

Young women physicians in particular are thinking about combining parenting with work – in the Medscape report, that issue ranked third among the issues women care about. Seeing other women doctors navigate that in their particular specialty can have a positive impact.

“When I chose adolescent medicine, I remember working with a doctor in this field who talked about how much she enjoyed raising her kids even as teenagers and how much she was enjoying them as young adults. She seemed so balanced and happy in her family, and it gave me a nice feeling about the field,” said Nancy Dodson, MD, MPH, a pediatrician specializing in adolescent medicine at Pediatrics on Hudson in New York.

Rachel Zhuk, MD, a reproductive psychiatrist in New York, took a break after medical school to spend time with her newborn son. She met a woman who was also a young parent and a psychiatrist. “We were both figuring out parenting together – it was like looking into my future.” That friendship and her desire to have more time with patients influenced her decision to pursue psychiatry instead of internal medicine.
 

Discrimination and harassment influence specialty choice

Women doctors in the top-paying surgical and other specialties have reported experiencing more discrimination and harassment than men.

Of 927 orthopedic surgeons who responded to an AAOS survey, 66% said they experienced gender discrimination, bullying, sexual harassment, or harassment in the health care workplace. More than twice as many women (81%) experienced these behaviors as men (35%).

“This study shows that women in orthopedic surgery disproportionately experience these negative behaviors, and only a handful of institutions in the United States provide any type of training to prevent them,” said Dr. Samora, the lead author of the AAOS report.

Radiology is another male-dominated field – women represent 26% of all radiologists, the 2020 AAMC specialty report shows. A systematic review shows that 40% of women radiologists experienced gender discrimination at work, compared with 1% of men, and that 47% of women experienced sexual harassment.

Female trainees in surgery have also reported disproportionate rates of discrimination and harassment. Female general surgical residents have experienced more gender discrimination than male residents (65.1% vs. 10.0%) and more sexual harassment than male residents (19.9% vs. 3.9), a national survey indicates.

When medical students are exposed to these behaviors through personal experience, witnessing, or hearing about them, it can affect which specialty they choose. A survey of fourth-year medical students shows that far more women than men reported that exposure to gender discrimination and sexual harassment influenced their specialty choices (45.3% vs. 16.4%) and residency rankings (25.3% vs. 10.9%). Women who chose general surgery were the most likely to experience gender discrimination and sexual harassment during residency selection; women who chose psychiatry were the least likely to experience such behaviors, the report shows.

“If young trainees witness such behaviors in a specific field, they would naturally migrate toward a different specialty,” said Dr. Samora.

Trainees can also be put off by residency directors asking them inappropriate questions. Of nearly 500 female orthopedic surgeons surveyed, 62% reported that they were asked inappropriate questions during their residency interviews. “Inappropriate questions and comments directed toward women during residency interviews are clearly not conducive to women entering the field,” the authors stated. They found that little changed during the study period from 1971 to 2015.

The most frequent inappropriate questions concerned whether the prospective residents would be getting pregnant or raising children during residency and their marital status. One female orthopedic surgeon reported: “I was asked if I have children and was told that it would be too difficult to complete an orthopedic residency with children.”

The interviewers also made frequent comments about the inferiority of women to men. For example, “I was told by one program interviewer that ‘I don’t have a bias about women in medicine, I have a bias about women in orthopedic surgery,’ ” another female orthopedic surgeon commented.
 

Longer training

Residency training for the top-paying surgical specialties, including orthopedic surgery, plastic surgery, and otolaryngology, lasts 5-6 years. This compares with 3-4 years for the lower-paying specialties, such as pediatrics, internal medicine, and ob.gyn., according to data from the American Medical Association.

Women doctors are in their prime childbearing years during residency. Women who want to start a family will consider whether they want to get pregnant during residency or wait until they finish their training, said Dr. Malcolm.

The vast majority (84%) of 190 female orthopedic surgery trainees who responded to a survey indicated that they did not have children or were pregnant during residency. Nearly half (48%) reported that they had postponed having children because they were in training.

“The longer training is definitely a concerning issue for women of childbearing age. Many professional women are waiting to have children, for multiple reasons, but one major fear is the stigma due to taking time off from work obligations. There is a risk of irritating your peers because they may have to take on more work and cover more calls for you during your absence,” said Dr. Samora.

That fear is not unfounded. At least half of the 190 female orthopedic residents reported that they encountered bias against becoming pregnant during training from both coresidents (60%) and attendings (50%), according to the study.

Another recent survey suggests that pregnant surgical residents face several barriers during their training, including a lack of salary for extended family leave, resentment from fellow residents who need to cover for them during maternity leave, and a lack of formal lactation policies.

A few policy changes by national board organizations, including those in the surgical specialties, may make life a little easier for female trainees to have children, suggested Dr. Samora.

Residents and fellows are now allowed a minimum of 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

In addition, the American Board of Orthopaedic Surgery and the American Board of Surgery have enacted policies that allow lactating women to take a break to pump during their board exams.

A version of this article first appeared on Medscape.com.

Less than one in five women physicians are practicing in the top five high-paying specialties. Women compose only 6% of orthopedic surgeons, 8% of interventional cardiologists, 10% of urologists, 17% of plastic surgeons, and 18% of otolaryngologists, according to the 2020 Association of American Medical Colleges Physician Specialty Data Report.

Plastic surgeons earn an average of $526,000 annually, which is the highest-paying specialty. Otolaryngologists earn an average of $417,000 annually, and urologists earn $427,000, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Yet, far more women are practicing in specialties that pay less. Women are the majority in pediatrics (64%), ob.gyn. (59%), internal medicine (53%), and endocrinology (51%), the AAMC data show. The exception is dermatology, which pays well and in which 51% are women. The annual average pay is $394,000.

Why are so many women avoiding the top-paying specialties?

Several physician researchers and leaders in the top-paying specialties point to four main factors: Women are attracted to specialties that have more women in faculty and leadership positions, women prioritize work-life balance over pay, women residents may be deterred from the high-paying specialties because of gender discrimination and sexual harassment, and the longer training periods for surgical specialties may be a deterrent for women who want to have children.
 

Lack of women leaders

The specialties with the most women tend to have the highest proportion of women in leadership positions. For example, obstetrics and gynecology had the highest proportion of women department chairs (24.1%) and vice chairs (38.8). Pediatrics had the highest proportion of women division directors (31.5%) and residency program directors (64.6%), a study shows.

Surgical specialties, on the other hand, may have a harder time attracting female residents, possibly because of a lack of women in leadership positions. A recent study that examined gender differences in attitudes toward surgery training found that women would be more likely to go into surgery if there were more surgical faculty and residents of their same gender.

An analysis of orthopedic residency programs shows that more trainees were drawn to programs that had more female faculty members, including associate professors and women in leadership positions.

Terri Malcolm, MD, a board-certified ob.gyn. and CEO/founder of Master Physician Leaders, said women need to consider whether they want to be a trailblazer in a specialty that has fewer women. “What support systems are in place to accommodate your goals, whether it’s career advancement, having a family, or mentorship? Where can you show up as your whole self and be supported in that?”

Being the only woman in a residency program can be a challenge, said Dr. Malcolm. If the residents and attendings are predominantly men, for example, they may not think about creating a call schedule that takes into account maternity leave or the fact that women tend to be caretakers for their children and parents.

The study of gender differences toward surgery training shows that 75% of women, in comparison with 46% of men, would be more willing to enter surgery if maternity leave and childcare were made available to female residents and attending physicians.
 

Women want work-life balance

Although both men and women want families, women still shoulder more family and childcare responsibilities. That may explain why women physicians ranked work-life balance first and compensation second in the Medscape Women Physicians 2020 Report: The Issues They Care About.

“My physician colleagues have been and are supportive of intellectual abilities, but I feel they don’t fully understand the uneven distribution of childcare issues on women,” a woman dermatologist commented.

Women may want to work fewer hours or have a more flexible schedule to take care of children. “I can count on one hand the number of women who have a part-time job in orthopedics. It’s very rare, and working part time absolutely is a barrier for someone who wants to be a surgeon,” said Julie Samora, MD, PhD, a researcher and pediatric hand surgeon at Nationwide Children’s Hospital, in Columbus, Ohio. She is also a spokesperson for the American Association of Orthopedic Surgeons.

Preeti Malani, MD, a professor of medicine who specializes in infectious diseases at the University of Michigan, chose to work full-time in academia while raising two children with her husband. In a decade, she rose through the ranks to full professor. “I took the advice of a woman who wanted to recruit me to have a full-time position with maximum flexibility rather than work part time, often for more hours and less pay. I also have tried to build my career so I was not doing all clinical work.”

Her husband is a surgeon at the University of Michigan. His schedule was not flexible, and he was unable to take on family responsibilities, said Dr. Malani. “I knew someone had to be able to grab the kids from daycare or pick them up at school if they were sick.” She also took work home and worked weekends.

Young women physicians in particular are thinking about combining parenting with work – in the Medscape report, that issue ranked third among the issues women care about. Seeing other women doctors navigate that in their particular specialty can have a positive impact.

“When I chose adolescent medicine, I remember working with a doctor in this field who talked about how much she enjoyed raising her kids even as teenagers and how much she was enjoying them as young adults. She seemed so balanced and happy in her family, and it gave me a nice feeling about the field,” said Nancy Dodson, MD, MPH, a pediatrician specializing in adolescent medicine at Pediatrics on Hudson in New York.

Rachel Zhuk, MD, a reproductive psychiatrist in New York, took a break after medical school to spend time with her newborn son. She met a woman who was also a young parent and a psychiatrist. “We were both figuring out parenting together – it was like looking into my future.” That friendship and her desire to have more time with patients influenced her decision to pursue psychiatry instead of internal medicine.
 

Discrimination and harassment influence specialty choice

Women doctors in the top-paying surgical and other specialties have reported experiencing more discrimination and harassment than men.

Of 927 orthopedic surgeons who responded to an AAOS survey, 66% said they experienced gender discrimination, bullying, sexual harassment, or harassment in the health care workplace. More than twice as many women (81%) experienced these behaviors as men (35%).

“This study shows that women in orthopedic surgery disproportionately experience these negative behaviors, and only a handful of institutions in the United States provide any type of training to prevent them,” said Dr. Samora, the lead author of the AAOS report.

Radiology is another male-dominated field – women represent 26% of all radiologists, the 2020 AAMC specialty report shows. A systematic review shows that 40% of women radiologists experienced gender discrimination at work, compared with 1% of men, and that 47% of women experienced sexual harassment.

Female trainees in surgery have also reported disproportionate rates of discrimination and harassment. Female general surgical residents have experienced more gender discrimination than male residents (65.1% vs. 10.0%) and more sexual harassment than male residents (19.9% vs. 3.9), a national survey indicates.

When medical students are exposed to these behaviors through personal experience, witnessing, or hearing about them, it can affect which specialty they choose. A survey of fourth-year medical students shows that far more women than men reported that exposure to gender discrimination and sexual harassment influenced their specialty choices (45.3% vs. 16.4%) and residency rankings (25.3% vs. 10.9%). Women who chose general surgery were the most likely to experience gender discrimination and sexual harassment during residency selection; women who chose psychiatry were the least likely to experience such behaviors, the report shows.

“If young trainees witness such behaviors in a specific field, they would naturally migrate toward a different specialty,” said Dr. Samora.

Trainees can also be put off by residency directors asking them inappropriate questions. Of nearly 500 female orthopedic surgeons surveyed, 62% reported that they were asked inappropriate questions during their residency interviews. “Inappropriate questions and comments directed toward women during residency interviews are clearly not conducive to women entering the field,” the authors stated. They found that little changed during the study period from 1971 to 2015.

The most frequent inappropriate questions concerned whether the prospective residents would be getting pregnant or raising children during residency and their marital status. One female orthopedic surgeon reported: “I was asked if I have children and was told that it would be too difficult to complete an orthopedic residency with children.”

The interviewers also made frequent comments about the inferiority of women to men. For example, “I was told by one program interviewer that ‘I don’t have a bias about women in medicine, I have a bias about women in orthopedic surgery,’ ” another female orthopedic surgeon commented.
 

Longer training

Residency training for the top-paying surgical specialties, including orthopedic surgery, plastic surgery, and otolaryngology, lasts 5-6 years. This compares with 3-4 years for the lower-paying specialties, such as pediatrics, internal medicine, and ob.gyn., according to data from the American Medical Association.

Women doctors are in their prime childbearing years during residency. Women who want to start a family will consider whether they want to get pregnant during residency or wait until they finish their training, said Dr. Malcolm.

The vast majority (84%) of 190 female orthopedic surgery trainees who responded to a survey indicated that they did not have children or were pregnant during residency. Nearly half (48%) reported that they had postponed having children because they were in training.

“The longer training is definitely a concerning issue for women of childbearing age. Many professional women are waiting to have children, for multiple reasons, but one major fear is the stigma due to taking time off from work obligations. There is a risk of irritating your peers because they may have to take on more work and cover more calls for you during your absence,” said Dr. Samora.

That fear is not unfounded. At least half of the 190 female orthopedic residents reported that they encountered bias against becoming pregnant during training from both coresidents (60%) and attendings (50%), according to the study.

Another recent survey suggests that pregnant surgical residents face several barriers during their training, including a lack of salary for extended family leave, resentment from fellow residents who need to cover for them during maternity leave, and a lack of formal lactation policies.

A few policy changes by national board organizations, including those in the surgical specialties, may make life a little easier for female trainees to have children, suggested Dr. Samora.

Residents and fellows are now allowed a minimum of 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

In addition, the American Board of Orthopaedic Surgery and the American Board of Surgery have enacted policies that allow lactating women to take a break to pump during their board exams.

A version of this article first appeared on Medscape.com.

Less than one in five women physicians are practicing in the top five high-paying specialties. Women compose only 6% of orthopedic surgeons, 8% of interventional cardiologists, 10% of urologists, 17% of plastic surgeons, and 18% of otolaryngologists, according to the 2020 Association of American Medical Colleges Physician Specialty Data Report.

Plastic surgeons earn an average of $526,000 annually, which is the highest-paying specialty. Otolaryngologists earn an average of $417,000 annually, and urologists earn $427,000, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Yet, far more women are practicing in specialties that pay less. Women are the majority in pediatrics (64%), ob.gyn. (59%), internal medicine (53%), and endocrinology (51%), the AAMC data show. The exception is dermatology, which pays well and in which 51% are women. The annual average pay is $394,000.

Why are so many women avoiding the top-paying specialties?

Several physician researchers and leaders in the top-paying specialties point to four main factors: Women are attracted to specialties that have more women in faculty and leadership positions, women prioritize work-life balance over pay, women residents may be deterred from the high-paying specialties because of gender discrimination and sexual harassment, and the longer training periods for surgical specialties may be a deterrent for women who want to have children.
 

Lack of women leaders

The specialties with the most women tend to have the highest proportion of women in leadership positions. For example, obstetrics and gynecology had the highest proportion of women department chairs (24.1%) and vice chairs (38.8). Pediatrics had the highest proportion of women division directors (31.5%) and residency program directors (64.6%), a study shows.

Surgical specialties, on the other hand, may have a harder time attracting female residents, possibly because of a lack of women in leadership positions. A recent study that examined gender differences in attitudes toward surgery training found that women would be more likely to go into surgery if there were more surgical faculty and residents of their same gender.

An analysis of orthopedic residency programs shows that more trainees were drawn to programs that had more female faculty members, including associate professors and women in leadership positions.

Terri Malcolm, MD, a board-certified ob.gyn. and CEO/founder of Master Physician Leaders, said women need to consider whether they want to be a trailblazer in a specialty that has fewer women. “What support systems are in place to accommodate your goals, whether it’s career advancement, having a family, or mentorship? Where can you show up as your whole self and be supported in that?”

Being the only woman in a residency program can be a challenge, said Dr. Malcolm. If the residents and attendings are predominantly men, for example, they may not think about creating a call schedule that takes into account maternity leave or the fact that women tend to be caretakers for their children and parents.

The study of gender differences toward surgery training shows that 75% of women, in comparison with 46% of men, would be more willing to enter surgery if maternity leave and childcare were made available to female residents and attending physicians.
 

Women want work-life balance

Although both men and women want families, women still shoulder more family and childcare responsibilities. That may explain why women physicians ranked work-life balance first and compensation second in the Medscape Women Physicians 2020 Report: The Issues They Care About.

“My physician colleagues have been and are supportive of intellectual abilities, but I feel they don’t fully understand the uneven distribution of childcare issues on women,” a woman dermatologist commented.

Women may want to work fewer hours or have a more flexible schedule to take care of children. “I can count on one hand the number of women who have a part-time job in orthopedics. It’s very rare, and working part time absolutely is a barrier for someone who wants to be a surgeon,” said Julie Samora, MD, PhD, a researcher and pediatric hand surgeon at Nationwide Children’s Hospital, in Columbus, Ohio. She is also a spokesperson for the American Association of Orthopedic Surgeons.

Preeti Malani, MD, a professor of medicine who specializes in infectious diseases at the University of Michigan, chose to work full-time in academia while raising two children with her husband. In a decade, she rose through the ranks to full professor. “I took the advice of a woman who wanted to recruit me to have a full-time position with maximum flexibility rather than work part time, often for more hours and less pay. I also have tried to build my career so I was not doing all clinical work.”

Her husband is a surgeon at the University of Michigan. His schedule was not flexible, and he was unable to take on family responsibilities, said Dr. Malani. “I knew someone had to be able to grab the kids from daycare or pick them up at school if they were sick.” She also took work home and worked weekends.

Young women physicians in particular are thinking about combining parenting with work – in the Medscape report, that issue ranked third among the issues women care about. Seeing other women doctors navigate that in their particular specialty can have a positive impact.

“When I chose adolescent medicine, I remember working with a doctor in this field who talked about how much she enjoyed raising her kids even as teenagers and how much she was enjoying them as young adults. She seemed so balanced and happy in her family, and it gave me a nice feeling about the field,” said Nancy Dodson, MD, MPH, a pediatrician specializing in adolescent medicine at Pediatrics on Hudson in New York.

Rachel Zhuk, MD, a reproductive psychiatrist in New York, took a break after medical school to spend time with her newborn son. She met a woman who was also a young parent and a psychiatrist. “We were both figuring out parenting together – it was like looking into my future.” That friendship and her desire to have more time with patients influenced her decision to pursue psychiatry instead of internal medicine.
 

Discrimination and harassment influence specialty choice

Women doctors in the top-paying surgical and other specialties have reported experiencing more discrimination and harassment than men.

Of 927 orthopedic surgeons who responded to an AAOS survey, 66% said they experienced gender discrimination, bullying, sexual harassment, or harassment in the health care workplace. More than twice as many women (81%) experienced these behaviors as men (35%).

“This study shows that women in orthopedic surgery disproportionately experience these negative behaviors, and only a handful of institutions in the United States provide any type of training to prevent them,” said Dr. Samora, the lead author of the AAOS report.

Radiology is another male-dominated field – women represent 26% of all radiologists, the 2020 AAMC specialty report shows. A systematic review shows that 40% of women radiologists experienced gender discrimination at work, compared with 1% of men, and that 47% of women experienced sexual harassment.

Female trainees in surgery have also reported disproportionate rates of discrimination and harassment. Female general surgical residents have experienced more gender discrimination than male residents (65.1% vs. 10.0%) and more sexual harassment than male residents (19.9% vs. 3.9), a national survey indicates.

When medical students are exposed to these behaviors through personal experience, witnessing, or hearing about them, it can affect which specialty they choose. A survey of fourth-year medical students shows that far more women than men reported that exposure to gender discrimination and sexual harassment influenced their specialty choices (45.3% vs. 16.4%) and residency rankings (25.3% vs. 10.9%). Women who chose general surgery were the most likely to experience gender discrimination and sexual harassment during residency selection; women who chose psychiatry were the least likely to experience such behaviors, the report shows.

“If young trainees witness such behaviors in a specific field, they would naturally migrate toward a different specialty,” said Dr. Samora.

Trainees can also be put off by residency directors asking them inappropriate questions. Of nearly 500 female orthopedic surgeons surveyed, 62% reported that they were asked inappropriate questions during their residency interviews. “Inappropriate questions and comments directed toward women during residency interviews are clearly not conducive to women entering the field,” the authors stated. They found that little changed during the study period from 1971 to 2015.

The most frequent inappropriate questions concerned whether the prospective residents would be getting pregnant or raising children during residency and their marital status. One female orthopedic surgeon reported: “I was asked if I have children and was told that it would be too difficult to complete an orthopedic residency with children.”

The interviewers also made frequent comments about the inferiority of women to men. For example, “I was told by one program interviewer that ‘I don’t have a bias about women in medicine, I have a bias about women in orthopedic surgery,’ ” another female orthopedic surgeon commented.
 

Longer training

Residency training for the top-paying surgical specialties, including orthopedic surgery, plastic surgery, and otolaryngology, lasts 5-6 years. This compares with 3-4 years for the lower-paying specialties, such as pediatrics, internal medicine, and ob.gyn., according to data from the American Medical Association.

Women doctors are in their prime childbearing years during residency. Women who want to start a family will consider whether they want to get pregnant during residency or wait until they finish their training, said Dr. Malcolm.

The vast majority (84%) of 190 female orthopedic surgery trainees who responded to a survey indicated that they did not have children or were pregnant during residency. Nearly half (48%) reported that they had postponed having children because they were in training.

“The longer training is definitely a concerning issue for women of childbearing age. Many professional women are waiting to have children, for multiple reasons, but one major fear is the stigma due to taking time off from work obligations. There is a risk of irritating your peers because they may have to take on more work and cover more calls for you during your absence,” said Dr. Samora.

That fear is not unfounded. At least half of the 190 female orthopedic residents reported that they encountered bias against becoming pregnant during training from both coresidents (60%) and attendings (50%), according to the study.

Another recent survey suggests that pregnant surgical residents face several barriers during their training, including a lack of salary for extended family leave, resentment from fellow residents who need to cover for them during maternity leave, and a lack of formal lactation policies.

A few policy changes by national board organizations, including those in the surgical specialties, may make life a little easier for female trainees to have children, suggested Dr. Samora.

Residents and fellows are now allowed a minimum of 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

In addition, the American Board of Orthopaedic Surgery and the American Board of Surgery have enacted policies that allow lactating women to take a break to pump during their board exams.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.

When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”

But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.

As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.

The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.

For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.

Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.

That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.

In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”

The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”

The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.

Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
 

Warning signs

In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.

A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.

The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.

The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.

The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.

For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.

But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.

Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.

Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.

For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.

The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.

Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”

The 15-day deadline passed, and the FDA never penalized the company.

The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.

But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.

Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.

Again, the inspection report said the company “promised to correct” the issues.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.

One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
 

“A no-brainer”

When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.

For a while, she felt invulnerable with the HVAD on her heart.

Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.

Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.

Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.

“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”

Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.

Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.

But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.

She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.

Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.

Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.

As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.

Nothing changed, and panic crept into the voice on the phone.

An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.

Still nothing.

Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.

Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.

She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.

She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.

Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
 

Company-led oversight

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.

Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.

Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.

Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.

Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.

In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.

But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.

In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.

In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.

The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.

In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”

The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”

Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”

HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.

A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.

Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.

A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
 

Rewards, not penalties

As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.

With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.

In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.

HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.

Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.

According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.

Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”

Leadership proceeded with human testing anyway, the suit alleges.

Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.

HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.

None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.

In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.

“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”

Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.

Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.

“Slipped Through The Cracks”

After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.

It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.

“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”

Her doctor later told her she must have “slipped through the cracks,” she said.

The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”

She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.

Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.

Winkler and an attorney for the other family said they could not comment on their settlements.

Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.

“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
 

“Run its course”

Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.

She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.

They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.

Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.

Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.

But her new pump had problems soon after the surgery.

The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.

Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.

Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.

Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”

This article first appeared on Propublica.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.

When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”

But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.

As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.

The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.

For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.

Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.

That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.

In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”

The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”

The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.

Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
 

Warning signs

In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.

A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.

The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.

The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.

The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.

For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.

But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.

Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.

Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.

For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.

The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.

Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”

The 15-day deadline passed, and the FDA never penalized the company.

The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.

But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.

Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.

Again, the inspection report said the company “promised to correct” the issues.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.

One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
 

“A no-brainer”

When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.

For a while, she felt invulnerable with the HVAD on her heart.

Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.

Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.

Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.

“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”

Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.

Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.

But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.

She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.

Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.

Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.

As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.

Nothing changed, and panic crept into the voice on the phone.

An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.

Still nothing.

Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.

Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.

She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.

She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.

Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
 

Company-led oversight

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.

Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.

Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.

Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.

Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.

In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.

But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.

In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.

In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.

The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.

In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”

The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”

Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”

HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.

A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.

Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.

A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
 

Rewards, not penalties

As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.

With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.

In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.

HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.

Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.

According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.

Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”

Leadership proceeded with human testing anyway, the suit alleges.

Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.

HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.

None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.

In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.

“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”

Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.

Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.

“Slipped Through The Cracks”

After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.

It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.

“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”

Her doctor later told her she must have “slipped through the cracks,” she said.

The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”

She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.

Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.

Winkler and an attorney for the other family said they could not comment on their settlements.

Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.

“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
 

“Run its course”

Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.

She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.

They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.

Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.

Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.

But her new pump had problems soon after the surgery.

The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.

Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.

Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.

Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”

This article first appeared on Propublica.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.

When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”

But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.

As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.

The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.

For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.

Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.

That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.

In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”

The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”

The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.

Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
 

Warning signs

In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.

A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.

The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.

The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.

The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.

For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.

But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.

Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.

Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.

For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.

The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.

Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”

The 15-day deadline passed, and the FDA never penalized the company.

The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.

But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.

Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.

Again, the inspection report said the company “promised to correct” the issues.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.

One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
 

“A no-brainer”

When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.

For a while, she felt invulnerable with the HVAD on her heart.

Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.

Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.

Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.

“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”

Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.

Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.

But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.

She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.

Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.

Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.

As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.

Nothing changed, and panic crept into the voice on the phone.

An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.

Still nothing.

Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.

Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.

She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.

She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.

Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
 

Company-led oversight

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.

Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.

Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.

Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.

Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.

In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.

But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.

In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.

In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.

The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.

In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”

The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”

Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”

HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.

A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.

Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.

A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
 

Rewards, not penalties

As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.

With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.

In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.

HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.

Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.

According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.

Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”

Leadership proceeded with human testing anyway, the suit alleges.

Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.

HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.

None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.

In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.

“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”

Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.

Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.

“Slipped Through The Cracks”

After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.

It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.

“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”

Her doctor later told her she must have “slipped through the cracks,” she said.

The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”

She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.

Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.

Winkler and an attorney for the other family said they could not comment on their settlements.

Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.

“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
 

“Run its course”

Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.

She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.

They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.

Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.

Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.

But her new pump had problems soon after the surgery.

The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.

Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.

Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.

Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”

This article first appeared on Propublica.

Bother me, I’m working 

Although some of us have been comfortably functioning in a virtual work environment, others are now trickling back into the office. And you know what that means? People come to your desk to show you pictures of their cat or tell you about their kid’s birthday party. You may sneer at the interruption, but a study shows you actually like it.

Rawpixel/Thinkstock

A team of researchers at the University of Cincinnati surveyed 111 full-time employees twice a day for 3 weeks about their work experience. They asked about mental exhaustion, workplace interruptions, sense of belonging, and overall job satisfaction. They found that employees had a higher sense of belonging and job satisfaction when interrupted with a social versus work interruption.

“Interruptions can actually benefit individuals from an interpersonal perspective – people feel like they belong when others come and talk to them or ask them questions, even while being distracted from their tasks,” said Heather C. Vough, senior investigator and a former university faculty member.

Chitchatting at work is often seen as a distraction, but this study suggests that it’s not like heating up fish in the breakroom microwave.

So the next time someone hits you with the “Hey, do you have a sec?,” do yourself a favor and enjoy the interruption.
 

A smorgasbord of science

It’s probably difficult to recruit patients for some medical trials. Try this new drug and potentially get all sorts of interesting and unpleasant side effects. Pass. We suggest the approach a group of researchers from the University of Kansas took for a recent study into weight gain: Invite a bunch of 20-something adults to an all-you-can-eat buffet. They’ll be beating down your door in no time.

pxfuel

Their study, published in Appetite, focused on hyperpalatable food – the sort of food you can keep eating – and compared it with high-energy-dense food and ultra processed food. The test patients had their body composition measured, were let loose on the buffet, and were measured again a year later.

The patients who favored salty/carbohydrate-filled hyperpalatable food (such as pretzels or popcorn) were much more likely to gain weight, compared with those who focused on salty/fat-filled food of any variety. As a matter of fact, those who stuck to fatty food during the buffet had no change in weight over the 1-year study period. The researchers noted that those who ate the carb-filled food tended more toward hedonic eating, or the act of eating simply for pleasure.

The study is no doubt helpful in the long battle against obesity and overeating, but it’s also a very helpful guide to getting the most bang for your buck at the buffet. Stay away from the cheap salty snack food. Go for the steak and seafood. Get your money’s worth. In the long run you won’t even gain any weight. No promises about tomorrow though.
 

There’s a cheat code for that

For a large percentage of kids and young adults, and maybe even older adults (we don’t judge), a storm warning means a cozy night in playing video games. Staying inside is probably the safest bet when there’s a storm, and the weatherman never says to avoid playing video games when there’s lightning.

xresch/Pixabay

Maybe he should, though, since a man from Tennessee reportedly got struck by lightning through his game controller. Emergency crews determined that lightning either hit the man’s house or struck near it and went through the controller. The type of console was not revealed, even though some people may want to know the specifics before playing during the next storm.

Luckily, the man was not seriously hurt and did not need to go to the hospital. This is apparently not unheard of, as a professional gamer was shocked through a wired controller last year, causing burns on her hands and a broken controller.

This might be our cue to do less electrical types of activities during thunderstorms, like knitting or reading by candlelight.
 

Freeze, squeeze, and enjoy … cramping

As you were ingesting last week’s installment of the never-ending buffet that is LOTME, you probably wondered: What’s going on? Where’s the latest bodily insult being perpetuated by the gang over at TikTok?

Daria-Yakovleva/Pixabay

Have no fear, good readers. We would never make you go 2 straight weeks without serving up some hyperpalatable TikTok tidbits.

Our bodily insult du jour is frozen honey, and it’s exploding all over TikTok … and a few other places. “The hashtag ‘#FrozenHoney’ has been viewed nearly 600 million times, and the hashtag ‘#FrozenHoneyChallenge’ has been viewed more than 80 million times,” NBC News recently reported.

After a few hours in the freezer, honey can be squeezed out of a plastic bottle as a semisolid, toothpastelike goo – it’s stiff enough to rise out of a container that’s pointed straight up – and bitten off in large chunks. And therein lies the problem.

Some people are overdoing it. “Honey is great, but having it in small amounts to sweeten is really a healthy relationship with food, and using it to get a lot of followers and a lot of attention and having it in excess amounts is crazy,” Kristin Kirkpatrick, a registered dietitian at the Cleveland Clinic, told NBC.

Besides the possible weight gain from eating massive amounts of sugar, experts warned that “gobbling up bottles of frozen honey” could lead to stomach cramping, bloating, and diarrhea. Some TikTokers, NBC noted, said that they “were running for the bathroom.”

As we said, it’s a trend that is exploding.

Be sure to tune in next week, when we learn how TikTokers use ground meat as a skin moisturizer.
 

Bother me, I’m working 

Although some of us have been comfortably functioning in a virtual work environment, others are now trickling back into the office. And you know what that means? People come to your desk to show you pictures of their cat or tell you about their kid’s birthday party. You may sneer at the interruption, but a study shows you actually like it.

Rawpixel/Thinkstock

A team of researchers at the University of Cincinnati surveyed 111 full-time employees twice a day for 3 weeks about their work experience. They asked about mental exhaustion, workplace interruptions, sense of belonging, and overall job satisfaction. They found that employees had a higher sense of belonging and job satisfaction when interrupted with a social versus work interruption.

“Interruptions can actually benefit individuals from an interpersonal perspective – people feel like they belong when others come and talk to them or ask them questions, even while being distracted from their tasks,” said Heather C. Vough, senior investigator and a former university faculty member.

Chitchatting at work is often seen as a distraction, but this study suggests that it’s not like heating up fish in the breakroom microwave.

So the next time someone hits you with the “Hey, do you have a sec?,” do yourself a favor and enjoy the interruption.
 

A smorgasbord of science

It’s probably difficult to recruit patients for some medical trials. Try this new drug and potentially get all sorts of interesting and unpleasant side effects. Pass. We suggest the approach a group of researchers from the University of Kansas took for a recent study into weight gain: Invite a bunch of 20-something adults to an all-you-can-eat buffet. They’ll be beating down your door in no time.

pxfuel

Their study, published in Appetite, focused on hyperpalatable food – the sort of food you can keep eating – and compared it with high-energy-dense food and ultra processed food. The test patients had their body composition measured, were let loose on the buffet, and were measured again a year later.

The patients who favored salty/carbohydrate-filled hyperpalatable food (such as pretzels or popcorn) were much more likely to gain weight, compared with those who focused on salty/fat-filled food of any variety. As a matter of fact, those who stuck to fatty food during the buffet had no change in weight over the 1-year study period. The researchers noted that those who ate the carb-filled food tended more toward hedonic eating, or the act of eating simply for pleasure.

The study is no doubt helpful in the long battle against obesity and overeating, but it’s also a very helpful guide to getting the most bang for your buck at the buffet. Stay away from the cheap salty snack food. Go for the steak and seafood. Get your money’s worth. In the long run you won’t even gain any weight. No promises about tomorrow though.
 

There’s a cheat code for that

For a large percentage of kids and young adults, and maybe even older adults (we don’t judge), a storm warning means a cozy night in playing video games. Staying inside is probably the safest bet when there’s a storm, and the weatherman never says to avoid playing video games when there’s lightning.

xresch/Pixabay

Maybe he should, though, since a man from Tennessee reportedly got struck by lightning through his game controller. Emergency crews determined that lightning either hit the man’s house or struck near it and went through the controller. The type of console was not revealed, even though some people may want to know the specifics before playing during the next storm.

Luckily, the man was not seriously hurt and did not need to go to the hospital. This is apparently not unheard of, as a professional gamer was shocked through a wired controller last year, causing burns on her hands and a broken controller.

This might be our cue to do less electrical types of activities during thunderstorms, like knitting or reading by candlelight.
 

Freeze, squeeze, and enjoy … cramping

As you were ingesting last week’s installment of the never-ending buffet that is LOTME, you probably wondered: What’s going on? Where’s the latest bodily insult being perpetuated by the gang over at TikTok?

Daria-Yakovleva/Pixabay

Have no fear, good readers. We would never make you go 2 straight weeks without serving up some hyperpalatable TikTok tidbits.

Our bodily insult du jour is frozen honey, and it’s exploding all over TikTok … and a few other places. “The hashtag ‘#FrozenHoney’ has been viewed nearly 600 million times, and the hashtag ‘#FrozenHoneyChallenge’ has been viewed more than 80 million times,” NBC News recently reported.

After a few hours in the freezer, honey can be squeezed out of a plastic bottle as a semisolid, toothpastelike goo – it’s stiff enough to rise out of a container that’s pointed straight up – and bitten off in large chunks. And therein lies the problem.

Some people are overdoing it. “Honey is great, but having it in small amounts to sweeten is really a healthy relationship with food, and using it to get a lot of followers and a lot of attention and having it in excess amounts is crazy,” Kristin Kirkpatrick, a registered dietitian at the Cleveland Clinic, told NBC.

Besides the possible weight gain from eating massive amounts of sugar, experts warned that “gobbling up bottles of frozen honey” could lead to stomach cramping, bloating, and diarrhea. Some TikTokers, NBC noted, said that they “were running for the bathroom.”

As we said, it’s a trend that is exploding.

Be sure to tune in next week, when we learn how TikTokers use ground meat as a skin moisturizer.
 

Bother me, I’m working 

Although some of us have been comfortably functioning in a virtual work environment, others are now trickling back into the office. And you know what that means? People come to your desk to show you pictures of their cat or tell you about their kid’s birthday party. You may sneer at the interruption, but a study shows you actually like it.

Rawpixel/Thinkstock

A team of researchers at the University of Cincinnati surveyed 111 full-time employees twice a day for 3 weeks about their work experience. They asked about mental exhaustion, workplace interruptions, sense of belonging, and overall job satisfaction. They found that employees had a higher sense of belonging and job satisfaction when interrupted with a social versus work interruption.

“Interruptions can actually benefit individuals from an interpersonal perspective – people feel like they belong when others come and talk to them or ask them questions, even while being distracted from their tasks,” said Heather C. Vough, senior investigator and a former university faculty member.

Chitchatting at work is often seen as a distraction, but this study suggests that it’s not like heating up fish in the breakroom microwave.

So the next time someone hits you with the “Hey, do you have a sec?,” do yourself a favor and enjoy the interruption.
 

A smorgasbord of science

It’s probably difficult to recruit patients for some medical trials. Try this new drug and potentially get all sorts of interesting and unpleasant side effects. Pass. We suggest the approach a group of researchers from the University of Kansas took for a recent study into weight gain: Invite a bunch of 20-something adults to an all-you-can-eat buffet. They’ll be beating down your door in no time.

pxfuel

Their study, published in Appetite, focused on hyperpalatable food – the sort of food you can keep eating – and compared it with high-energy-dense food and ultra processed food. The test patients had their body composition measured, were let loose on the buffet, and were measured again a year later.

The patients who favored salty/carbohydrate-filled hyperpalatable food (such as pretzels or popcorn) were much more likely to gain weight, compared with those who focused on salty/fat-filled food of any variety. As a matter of fact, those who stuck to fatty food during the buffet had no change in weight over the 1-year study period. The researchers noted that those who ate the carb-filled food tended more toward hedonic eating, or the act of eating simply for pleasure.

The study is no doubt helpful in the long battle against obesity and overeating, but it’s also a very helpful guide to getting the most bang for your buck at the buffet. Stay away from the cheap salty snack food. Go for the steak and seafood. Get your money’s worth. In the long run you won’t even gain any weight. No promises about tomorrow though.
 

There’s a cheat code for that

For a large percentage of kids and young adults, and maybe even older adults (we don’t judge), a storm warning means a cozy night in playing video games. Staying inside is probably the safest bet when there’s a storm, and the weatherman never says to avoid playing video games when there’s lightning.

xresch/Pixabay

Maybe he should, though, since a man from Tennessee reportedly got struck by lightning through his game controller. Emergency crews determined that lightning either hit the man’s house or struck near it and went through the controller. The type of console was not revealed, even though some people may want to know the specifics before playing during the next storm.

Luckily, the man was not seriously hurt and did not need to go to the hospital. This is apparently not unheard of, as a professional gamer was shocked through a wired controller last year, causing burns on her hands and a broken controller.

This might be our cue to do less electrical types of activities during thunderstorms, like knitting or reading by candlelight.
 

Freeze, squeeze, and enjoy … cramping

As you were ingesting last week’s installment of the never-ending buffet that is LOTME, you probably wondered: What’s going on? Where’s the latest bodily insult being perpetuated by the gang over at TikTok?

Daria-Yakovleva/Pixabay

Have no fear, good readers. We would never make you go 2 straight weeks without serving up some hyperpalatable TikTok tidbits.

Our bodily insult du jour is frozen honey, and it’s exploding all over TikTok … and a few other places. “The hashtag ‘#FrozenHoney’ has been viewed nearly 600 million times, and the hashtag ‘#FrozenHoneyChallenge’ has been viewed more than 80 million times,” NBC News recently reported.

After a few hours in the freezer, honey can be squeezed out of a plastic bottle as a semisolid, toothpastelike goo – it’s stiff enough to rise out of a container that’s pointed straight up – and bitten off in large chunks. And therein lies the problem.

Some people are overdoing it. “Honey is great, but having it in small amounts to sweeten is really a healthy relationship with food, and using it to get a lot of followers and a lot of attention and having it in excess amounts is crazy,” Kristin Kirkpatrick, a registered dietitian at the Cleveland Clinic, told NBC.

Besides the possible weight gain from eating massive amounts of sugar, experts warned that “gobbling up bottles of frozen honey” could lead to stomach cramping, bloating, and diarrhea. Some TikTokers, NBC noted, said that they “were running for the bathroom.”

As we said, it’s a trend that is exploding.

Be sure to tune in next week, when we learn how TikTokers use ground meat as a skin moisturizer.
 

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

A version of this article first appeared on Medscape.com.

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

A version of this article first appeared on Medscape.com.

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

A version of this article first appeared on Medscape.com.

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

A version of this article first appeared on Medscape.com.

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

A version of this article first appeared on Medscape.com.

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

A version of this article first appeared on Medscape.com.

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

A version of this article first appeared on Medscape.com.

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

A version of this article first appeared on Medscape.com.