An Arm and a Leg: ‘An Arm and a Leg’: When Hospitals Sue Patients (Part 2)

Some hospitals sue patients who can’t afford to pay their medical bills. Such lawsuits don’t tend to bring in much money for the hospital but can really harm patients already experiencing financial hardships.

In this episode of “An Arm and a Leg,” Dan Weissmann goes toe-to-toe with Scott Purcell, CEO of ACA International, a trade association for the collection industry, on the effects these lawsuits have on patients.

With help from The Baltimore Banner and Scripps News, Weissmann pulls back the curtain on hospital bill lawsuits in three states — Maryland, Wisconsin, and New York — and discovers some good news for a change.

Dan Weissmann @danweissmann Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting.

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Emily Pisacreta Producer Adam Raymonda Audio wizard Ellen Weiss Editor Click to open the Transcript Transcript: ‘An Arm and a Leg’: When Hospitals Sue Patients (Part 2)

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Dan: Hey there – So, this is part two of a two-part story. If you missed part one, or just want a refresher, here’s three quick things: 

First: Some hospitals – definitely not all – sue a LOT of patients over unpaid bills. Hundreds or even thousands every year. 

Second: There’s very little money in it for these hospitals. When reporters and researchers add up the total amounts they’re suing for, it looks tiny compared to, say, their annual surplus. Or what they pay executives. Tiny.

Third: There’s data showing a LOT of the people being sued are … pretty hard up already. 

That a lot of them would qualify for charity care under the hospitals’ own financial-assistance policies.

In fact, as we reported last time, a guy named Nick McLaughlin, who spent a decade working for a medical-bill collections agency… now runs a business telling hospitals they’d be better off – financially – writing these bills off through charity care or financial assistance programs. 

And I should point out: Nick’s not a do-good crusader. He has started a business, to help hospitals do this. And he’s staked his family’s financial future on it.

Nick: I had a good but challenging conversation with my wife. And she said, hey, so is the reason we’re not doing this full time because we’re scared the money’s not gonna come in? And I said, well as the sole provider of a family of five that’s kind of a big deal. She said, yeah, I think we should do it.

Dan: And at the end of our last episode, I asked Nick: So, why would some hospitals make the decision to sue people, if there’s no money in it? What’s behind that decision:

Nick: It’s really, I would say, philosophically based.

Dan: So, in this episode, we’ll do two things: One, we’ll try to get a peek at that philosophy – inside the heads of the people who might hold it.

And TWO: We’re gonna share some hard data about what’s going on with these lawsuits in three states. We partnered with two awesome news organizations to get this data. 

And I’m gonna tell you: we found what really looks like some good news.

And the whole inquiry really drove home ways we can help ourselves, and each other. 

Here we go.

With Scripps News and the Baltimore Banner, this is An Arm and a Leg – a show about why health care costs so freaking much, and what we can may be do about it. 

I’m Dan Weissmann. I’m a reporter, and I like a challenge. So our job on this show is to take one of the most enraging, terrifying, depressing parts of American life and bring you something entertaining, empowering, and useful.

So, let’s talk about that philosophy. You could call it a form of… not thinking too hard. Let’s start with a witness. 

These days, Ruth Lande works for a nonprofit you may have heard of – RIP Medical Debt – to get hospital bills forgiven.

But WE talked with her because she spent more than 25 years working in hospital billing, most of it at Memorial Sloan-Kettering Cancer Center. And by the way, she loved it.

Ruth Landé: In general, I think it’s good if a job has three things. It’s for a good mission. Two, it should be hard. It should be complicated so it engages your brain every day. And third, it should be with really good colleagues. And I got to tell you, working revenue cycle satisfied all three of those for me. 

Dan: And of course, during her quarter-century in the business, the question of whether or not to file lawsuits over hospital bills did come up. 

When she got a promotion. 

In her earlier role, she’d run one part of the billing department, where they never sued. Now she was taking over another part of the billing department, a bigger one, where sometimes they did. 

She says her new colleagues were aware that in her earlier position, she’d taken a no-lawsuits approach.

Ruth Landé: There was an assumption, oh yeah, Ruth won’t allow that. 

Dan: But, she told me, she didn’t want to be in conflict with her new colleagues from Day One. 

Ruth Landé: And so I said, well, I’m not going to just ban it, but you know, bring me cases. If you believe that we should be suing a person, then just bring me the case so I can review it. And they never brought a case to me ever. 

Dan: Never ever. She thinks those colleagues maybe hadn’t stopped to look at who they were suing.

Ruth Landé: When you really examine closely you see the harm. I They would have probably imagined that they’re only suing some really rich people sitting up in a mansion somewhere, not bothering to pay their bills.

You might imagine: It would be interesting to talk with someone who thinks this way – really talk with them, push them on their point of view.

And that did happen. Kind of. 

It was honestly one of the most confusing conversations I’ve ever had. It was with this guy. 

Scott Purcell: My name is Scott Purcell. I’m the CEO of ACA International.

Dan: That’s the industry association for folks in the bill-collection business. Scott was super-accommodating – got on Zoom with me within a day of my first email to him. So quickly that it wasn’t till we got on that I realized we hadn’t set a length. 

Dan: How long do I actually have you for?

Scott Purcell: How long do you need us for?

Dan: Uh, I like to talk to people for a long time, but we start with a half an hour and maybe…

Scott Purcell: um, bum bum bum. I just need to change one meeting. 

Dan: We talked for more than an hour. 

The first half-hour was one kind of frustrating. 

I’d describe our findings and findings from other people’s reports — for instance, how little money hospitals seem to gain from these lawsuits — and ask if he had data to help understand what we’re seeing, and he kept saying, effectively: 

Hey, let’s not jump to policy conclusions. How would a new policy on debt collection affect a medical office with just three doctors? 

Scott Purcell: And I would say that three person doctor office is different from one of the top 10 nonprofit health care system. Their economics are completely different. And yet we’re talking about policy positions. that impact both

Dan: And then, in retrospect I’ve figured out a spot where we really, really lost each other. I was talking about one observer’s take on why these lawsuits don’t bring in much money:

Dan: A lot of the people that end up as your defendants are effectively indigent. Um, you know, they don’t have a lot of income. They may not have W2 employment that you could garnish. They don’t have other assets you can take. So, the amount that you get is not, not what you might expect from looking at the number of cases and the number of judgments. So that was another…

Scott Purcell: If I could stop you there, I’d love to see that data. Do you know that it takes a lot of money to file a lawsuit? I can’t think. And so my lived experience, I cannot think of one instance where either the hospital or the collection agency or the attorney would choose to sue an indigent person because if they are going to have a low probability of being able to repay that that over time, why would you invest? 

Dan: What I didn’t realize then, was: when I said some people were “effectively indigent,” Scott Purcell had latched onto the word “indigent” and had a very specific image in his mind, of absolute destitution. From that point forward, anything I would say about people being sued who were hard up, who qualified for charity care, who really couldn’t pay – was gonna run through this filter. 

And: Any example I’d bring up of someone being sued who got put in an extremely tough position… was just gonna sound to him like a novel anecdote.

A half-hour in, I got pretty direct with Scott, so I asked:

Dan: How did this happen? How did it happen that we, like, got to the point where so many people are being sued over debts they can’t pay? What do you know about that?

And this is where things got really confusing to me. Because here’s how Scott responded:

Scott Purcell: Well, if you just sued somebody who can’t pay, they’re not going to pay you. So, they’re not out any money. So you made a bad business decision, but truly Dan, what is the harm they’re experiencing? The fact that they got sued and they can’t pay?

Dan: I didn’t see that coming – the idea that being sued could be “harmless”?. Here’s what I said:

My gosh. Well, I can tell you that, you know, people, by the time they’ve been sued, they’ve been getting tons of collections calls, their credit may have suffered, and they have a judgment against them that says like any money that shows up in their bank account can be seized or that, you know, the next time they get a job, their wages can be garnished. That’s pretty significant harm. 

I described to Scott the story of Liz Jurado, a woman on Long Island who says she found out, years after the fact, that she had been sued over a bill relating to the birth of one of her kids. A bill she says she thought insurance had paid. Her husband was the main breadwinner, until he got laid off. Liz took a job working for DoorDash to support the family – her first W2 paycheck – and she says that’s how she found out about the lawsuit. Because once she starts the job, she starts getting letters, saying her wages are going to be garnished. And she’s like:

Liz Jurado: What is this? Where did it come from? How could they not tell me about it until now?  I get a job and three months later, you’re coming after me. I mean, this is my family’s bread and butter.  This is horrible.

Dan: I said to Scott: That seems bad, right?

Dan: So I’m, I’m, I’m trying to give you the opportunity to respond to that point that lots of people make that. If you get sued over a debt you can’t pay, there’s harm. That’s, that’s a lot of people’s positions, and I find it fairly persuasive. How do you respond to that? 

Scott Purcell: You and I were using a hypothetical. You said somebody got sued who’s indigent. Has no money.

Dan: Do you think that doesn’t happen?

Scott Purcell: I don’t understand the business case as to why that would. 

Dan: But, like, do you think it doesn’t happen because, like, do you think the reports that show that it happens a lot are wrong? I mean, I talked to a couple, a couple months ago who got sued over a debt. I mean, their story was like, they got hit with a bunch of medical problems.

I described to him the story of Casey and Ron Gasior, who we met in our last episode. The bills for those medical adventures threw their finances completely out of whack.

Casey: We would dig little bit out of our hole, and then we’d go right back down. 

Dan: … until they were in danger of losing their house. They filed for chapter 13 bankruptcy – wrapping everything they owed into a five year payment plan. They’d just about made it through, when they got a letter from a law firm earlier this year: They were being sued over a medical bill, that had arrived just after their bankruptcy started. I was getting a little worked up. 

Dan: So, these are not hypothetical, and these are not, like, you know, these stories are just entirely consistent with the data that, that gets collected. So, when you ask me, like, what’s the harm? I want to give you this opportunity to say, like, you sure that’s your position?

Scott Purcell: So, first of all, that was on a different, that was a different question. I made an assumption of that story that they were indigent now and would be indigent – I was saying, I don’t know why that decision got made if indeed that person, um, is indigent, why a particular, um, provider has whatever parameters they’ve set for their lawsuit program. I can’t speak to the business decisions they’re making. I can speak to, societally, what do we expect people to pay and not pay? 

Dan: With the case of the couple in Wisconsin, if they couldn’t pay ever, if their chapter 13 hadn’t worked out, and they’d lost their house, and they’d lost their jobs, and they couldn’t pay ever, are you saying they wouldn’t be harmed?

Scott Purcell: I’m saying the answer lies in taking those stories to the table. And let’s take a look at what are the other policy changes that should be made in order to get better outcomes. So, in the situation you did outline, I am sure that individual actually went through emotional stress. But there’re safeguards throughout. 

Dan: So you’re saying you view this as a kind of exceptional case and that generally there are, from what you know, guidelines and guardrails, as you say, to prevent this sort of thing from happening.

Scott Purcell: It’s the thing I don’t have data to answer it. 

Dan: Yeah, it’s — I mean, I just need to say: It’s striking, um, that you asked — you’re, yeah, like: Where’s, where’s the harm?

Scott Purcell: I made an assumption of that story that they were indigent now and would be indigent–

Dan: Well, I guess I just don’t understand, I, I don’t really quite understand the difference. Can you explain the distinction between someone being indigent right now, being indigent forever, I don’t really get the distinction at all. And I don’t know in which case, in which case there is harm, in which case there isn’t in your view.

Scott Purcell: So, um, I wasn’t being flippant. I was taking a very extreme… um, I’m in D.C. I see homeless people now. So when I heard you say indigent, I’m thinking somebody who’s living under a bridge. They deserve to be treated with dignity and respect. I was thinking that level of indigency. You’re talking about, I think, the, the working class, and people beyond that. And up to the higher end scale is your question. And for that, my question or my answer is back to there are safeguards that should be occurring. And if those safeguards don’t occur, harm does happen. And we collectively need to look at why there are gaps in those safeguards.

Dan: So in retrospect – knowing how Scott Purcell took that word indigent – I’m a little less mystified. But the conversation still seems really… striking to me.

For one thing, there’s the idea — even if it’s not a conscious philosophy  — that some people are beyond hope, so they’re beyond harm. So morally, it wouldn’t matter if, say, you sued them.

But the other thing that strikes me is the difficulty Scott Purcell had understanding – believing – that people being really harmed is something that happens at scale. That last thing he said: “There are safeguards that should be occurring, and IF those safeguards don’t occur, harm does happen.”

That word “IF” seems to be doing a lot of work there. 

Beyond the mountains of data that folks have compiled – showing that people get sued who qualify for charity care, and that people who get sued over medical bills tend to live in neighborhoods where poverty is high – there’s the finding that’s practically a cliche: 

About four out of ten Americans don’t have enough money on hand to cover a 400 hundred dollar emergency expense. Maybe I should have explained that to Scott Purcell. 

But I just didn’t think I’d need to. He’s sitting atop a whole industry that NEEDS to know, basically, how much money people have. Since we talked, I’ve seen a report for folks in his industry – third-party collections – that goes into a lot of detail on that topic. 

Of course, third-party collections agencies are for-profit businesses. And at least for some of them, lawsuits like these are part of the business. 

So, I guess I’m starting to understand – maybe belatedly – how hard it is to get some people to reconsider business as usual. Is business as usual a philosophy?

But sometimes business as usual does change. In fact, I’m about to share some much more cheerful news with you. It’s what our partners found when we went looking for details on these hospital bill lawsuits in three states. 

Because the big surprise was in what we DIDN’T find.

That’s coming right up. 

This episode is produced in partnership with KFF Health News. That’s a nonprofit newsroom covering health care in America. Their incredible journalists win all kinds of awards every year. I’m so glad to get to work with them. 

This investigation builds directly on reporting by KFF reporters like Jay Hancock, Noam Levey and Jordan Rau. Respect. 

OK, so this whole inquiry — into why some hospitals sue so many patients who could just get charity care — started a couple of years ago. 

That’s when I spotted what looked like a clue – in a big report done by National Nurses United. It looked at 145 thousand hospital lawsuits against patients in Maryland over a ten-year period.

And in addition to documenting how little money hospitals were getting from these suits — compared to the million-dollar salaries they paid a lot of executives — 

This report also noted– just kind of by-the-way, on page 18 of a 68-page report – that a relatively small number of attorneys were filing most of these lawsuits.

Just five attorneys filed almost two-thirds of the cases.

And just one attorney filed more than 40,000 cases. 

I was like, huh! Maybe that’s a clue. 

It seems like hospitals don’t get a lot of benefit from these lawsuits. But maybe we’re looking at someone who does. We should find out more. 

Starting with the names of those lawyers, which weren’t in the report.

And I was gonna want a big update on Maryland.

That report was part of a big advocacy campaign – which really worked. 

In 2021, Maryland enacted a new law saying hospitals couldn’t sue anybody without checking to see if they qualified for free care.

Which in retrospect, may seem like an obvious requirement. Here’s Malcolm Heflin, one of the organizers who worked on the campaign.

Malcolm Heflin: It’s like reading the postscript in a Dickens novel almost. It’d be like, “Oh yeah. Hey, look, now we can’t chain children to factory machines.” Like what? Wait, what? That was legal before? 

Dan: Anyway, if that report was the “before” picture, what would “after” look like? I was gonna need help. And I got some.

Ryan Little: my name is Ryan Little and I am the data editor at the Baltimore Banner.

Dan: The Banner is a new nonprofit daily newspaper – without the paper. Data reporting is a big specialty, and Ryan is the big specialist. Pulling a LOT of Maryland courts data was already on his to-do list.

Ryan Little: And so I said, maybe there’s a way that we can make a partnership happen. And then many months later, you’ve probably regretted that, but we’ve had a good time doing it. Anyways…

Dan: No way. Are you kidding me?

Ryan’s amazing. I am so lucky to get to work with him. 

But I wanted to know about more than just Maryland. And I got lucky there too. 

Maryland’s not the only state where advocates compiled a bunch of court data to push for change. You might remember Elisabeth Benjamin in New York from our last episode. 

She’s the one who pointed out how little money is involved in these suits – for hospitals she has looked at.

Elisabeth Benjamin: They’re suing people for pennies. right. The average law suits maybe 1900 bucks. So they’re suing them for chump change, but that $1,900 is like life ruining for the patient.

Dan: She knew that because she had pulled more than 50 thousand hospital-bill lawsuits from across the state. She used that data in a series of reports that got new laws passed – like one banning wage garnishment to pay medical debts. 

And she shared a giant spreadsheet with me, which included the names of attorneys in 40 thousand cases.

And guess what? Just three law firms handled the majority of those cases. So now we knew: This wasn’t just a Maryland thing.

But we were gonna want to look somewhere else too. Someplace where no new laws had been passed. Someplace that was still a “before” picture. Someplace like Wisconsin.

I’d been getting reports from a public-interest lawyer there named Bobby Peterson. He’d been publishing some data about lawsuits, but hadn’t gotten laws passed. And he also wasn’t able to share data. I was gonna need MORE help. 

Rosie Cima: My name is Rosie Cima and I manage a data reporting team at Scripps News. I also report for them. 

Dan: YES! More data help. Scripps News came aboard as a partner, and Rosie started looking for the data we’d need in Wisconsin.

And at this point, it may be getting clearer why it has taken us more than a year to bring this story to you. Let’s just recap for a second all the moving parts we’ve got in play here:

We’ve got Ryan, pulling cases in Maryland, Rosie doing the same in Wisconsin, and me with some New York cases.

We’re looking to see what the “after” picture looks like in Maryland and New York, and we’re looking at the role of a few lawyers.

And this is where I admit: that initial hypothesis? That the lawyers were driving these lawsuits, sweet-talking hospitals to drum up business?

It didn’t really pan out. As far as I can tell, after talking with a bunch of people and looking at a bunch of reports, it doesn’t seem to work that way. 

A lot of the time, anyway, it seems like the lawyers are often freelancers. They get hired by the collection agencies.

Who get their marching orders from the hospital revenue office.

But I’m so glad we went looking, because of what we did find. 

Or, you could say, what we didn’t.

In Maryland, Ryan spent months and months and months collecting hundreds of thousands of cases, then weeks and weeks crunching the numbers. And then… 

Ryan Little: On Wednesday, September 6th, I sent this email. I find this hard to believe. But it may be that there were zero medical debt lawsuits filed by hospitals against individuals in 2022 and 2023. 

Dan: He found it hard to believe – like, it must be wrong – so he went back to try to find his mistake. That took almost a week.

Ryan Little: On Monday, September 11th, I emailed, Hey Dan, news that hospital debt collection lawsuits had ended in Maryland was wrong. It looks like the Maryland Judiciary is somehow suppressing them in case search. Either intentionally or not, I’m rewriting the code to account for this.

Dan: He thought the Maryland court system was HIDING these cases. Not only did he rewrite the code, he went to the courthouse to go hunt for whatever was missing. 

It took him another week. And then I got one more email.

Ryan Little: So on September 18th, I said, Maryland hospitals are dot, dot, dot. Basically not suing anyone for medical debt anymore. 

Dan: Basically not suing anyone for medical debt this year. WOW. I mean, we had expected a significant drop– if only because Maryland had passed that 2021 law, which required hospitals to see if people were eligible for charity care before suing them. 

But zero was a much bigger drop than we’d expected. 

Next stop, New York. A few months ago, we looked at those three law firms – the ones that handled the majority of hospital-bill cases there. 

And as far as we could tell, two of them were just not doing any work for hospitals at all anymore.

But OK, again: We’d expected an “after” picture in both these states. What about Wisconsin?

Well, for one thing, it turned out to be TOUGH. 

Rosie Cima: When we took this on the first time, it definitely seemed like it’d be a lot easier than it ended up being. 

Dan: You can pull some case data from the web, but there’s a problem: Once a case has been dismissed, it gets taken off that website after a few years. 

Rosie Cima: So all the data that we had from before 2020 was missing some unknown number of cases

We can laugh about it now, but that sucked. We did find some guys who had data on older cases socked away. From them, we got the full caseloads for two lawyers we’d heard did a lot of medical-bill lawsuits.

Rosie Cima: We found more than 8000 cases in one year, um, for two lawyers, 

Dan: That was 2019. Pre-pandemic. 

Rosie Cima: And in 2022, There were fewer than 1400 for both of them.

Dan: In other words, these two lawyers were doing less than a quarter as much medical-bill business as they’d been doing three years earlier.

And Rosie pulled numbers year by year, client by client, which was super-revealing. 

Because for both of them, many of their biggest clients – hospitals and medical practices for whom they had been filing hundreds of cases a year – weren’t filing any cases.

Which wasn’t totally conclusive. We knew these lawyers were getting less work…

Rosie Cima: The thing that we didn’t know was, like, whether, Hospital A had stopped suing, or whether they just stopped hiring this lawyer.

Dan: Right. So Rosie went back to the public data website to see whether those hospitals A, B, C and so on were suing. And for the most part, they weren’t — at least not like they used to. 

Rosie Cima: Yeah, we now know that those cases weren’t going to a different lawyer. Right? They’re just not, they’re just not being filed.

Dan: Just not. Being filed. And it wasn’t just the hospitals that had been using these two lawyers that had fallen away. Other hospitals that had been suing tons of patients had cut way back. 

From more than a thousand in 2019 to a few dozen, or less than a dozen. Or one. Or zero. 

One hospital system sued more than 47 hundred people in 2019. In 2023 so far, they’ve sued one.

And remember, because older cases get wiped from the web, there’s some unknown number of cases from 2019 we aren’t seeing. The decline is probably bigger than what we see.

So, one thing to say is: We don’t know WHY this is happening. In any of these states. Our colleagues at the Baltimore Banner called every hospital in Maryland to ask about these changes, and got a bunch of no-comment. We emailed dozens of hospitals in Wisconsin and basically got the same answer.

So we’re left with some guessing – and here are some of our best guesses: 

Those new laws in New York and Maryland didn’t outlaw lawsuits… but the Maryland law made them more difficult, and the New York laws made it harder to collect. 

And the campaigns that led to those laws brought a LOT of negative attention to hospitals that filed a lot of lawsuits. So one way or another, it seems like a lot of hospitals decided it wasn’t worth it.

And in Wisconsin? Laws didn’t change, but the reports that the lawyer Bobby Peterson put out there did get some attention locally. 

We know in Wisconsin, lawsuits halted altogether for a while when the pandemic started. Maybe hospitals noticed that they weren’t exactly losing a ton of money when that happened?

Here’s one last data point from Rosie. She looked closely at the cases she had for those two lawyers from 2019. The ones where the hospital was awarded a judgment.

Rosie Cima: We found that the majority of those awards were never fulfilled, like, I, I feel like that’s important, a judge said, yes, you defendant owe this case. company, the plaintiff, this much money and in a lot of cases, the plaintiff hasn’t paid out. And it’s been years.

Dan: Which I don’t think is evidence that “Wow, these folks were really good at dodging payment!” No, because in a lot of these old cases, the judge gave an OK to garnish these folks’ wages: To take money directly from their paycheck.

So if these debts haven’t been paid, years later – and remember, these are often amounts of a thousand dollars or less – it seems like these folks may be earning so little that garnishing their wages for years doesn’t get you much. 

So, to start wrapping up: There’s a TON we don’t know. For one thing, there’s 47 other states we haven’t looked at. And we don’t know if hospitals in these three states will start suing again, when they think nobody’s looking.

But here’s something I do know: A surprising number of those other states have been passing new laws and regulations in the last couple years, to prevent hospitals from filing so many lawsuits against folks who qualify for charity care: 

Illinois, Arizona, Colorado, Minnesota, Washington, Oregon. I’m probably missing some. 

But here’s the single biggest thing I’m taking away from this whole adventure: A LOT more people qualify for charity care– free or discounted care from the hospital– than we think.

And we can help ourselves and each other, just by spreading the word.

I called Casey Gasior in Wisconsin a couple weeks ago. It wasn’t a great day for her.

Casey: Everybody in my house is sick and I just tested positive for covid. And now we’re going to lose work time.

Dan: Right.

Casey: I tell you, it never ends.

Dan: I was calling because I knew: Casey and her husband Ron have had more medical adventures this year. More knee trouble for him, emergency surgery for her, time away from work and lost income for both of them. And thousands of dollars of new medical bills. 

I said to her: It seems like maybe you and Ron might qualify to have some of those bills forgiven through charity care.

Casey: I think my, my husband makes too much. 

And I was like, well, maybe. But as we learned from Nick McLaughlin in our last episode, almost 60 percent of Americans qualify for charity care at a bunch of hospitals. 

And the nonprofit Dollar For has created a database of the charity care policies of almost every hospital in the country – and they’ve built it into their website. 

So you can type in a few details – where you were treated, how much you make – and it’ll tell you whether you’re likely to qualify for help.

Dan: So, I’m looking at their website right now.

And would it be okay with you to just kind of walk through kind of what they’re asking you, what they, um…

Casey: Yeah, sure.

Dan: Questions included: Where’d you get seen, and when?

Casey: Um, my surgery was July 24th.

Dan: Casey and I went line by line, filling out the form. I had her hunting for tax returns, and other documents

Casey: Hey, Ron. Can you send me a, um, a pay stub? Can you send me a picture of it? Like, now?

Dan: Okay. Alright, I’m going to add those up. There we go.

And yeah, so Dollar For thinks that you would qualify, 

Casey: Wow. That surprises me. 

Dan: This is good.

Casey: This is really…

Dan: Yeah. I’m really glad that we took this step.

Casey: Yeah, me too, because I was kind of, I didn’t know where to go and like, it, it seems so weird asking for charity.

Dan: But Casey was ready to take the next step.

Casey: Now this application that I’m filling out now do I have to do one for myself and one for Ron. 

Dan: Yes. Yeah. 

Casey: Okay, I’m going to work on this

Dan: Okay. Fantastic.

And this is a thing that we can do for ourselves, and each other. Spread the word: The majority of people qualify for at least some charity care – at least partially wiping out your bill – at a LOT of hospitals. 

The Dollar For website is set up to tell you if you’re likely to qualify, and to help you apply. They’ve also got actual human beings on staff to help if you get stuck.

Their website is Dollar For – that’s Dollar F-O-R dot org. Dollar F-O-R dot org. 

And that is our story. We never got all the way to the bottom of the question of WHY these bulk lawsuits happened – or why they seem to have stopped in some places – but we did get a peek into the process. 

And we learned some things that are heartening – a lot fewer lawsuits in these three states!

I’ve learned a lot more, along the way – there’ll be follow-ups. 

This has been a HUGE project for our little outfit. We got a ton of help from our partners, and we put a TON of resources into it: Travel to Wisconsin and Michigan, MONTHS of phone calls, 1600 bucks to get court records. 

We’ve been able to do that because you’ve been supporting us– giving us the resources to do the job. And this is the absolute best time to pitch in: 

Every dollar you give is matched. A few generous Arm and a Leg listeners have put up more than 10 thousand dollars in matching funds ON TOP of what the Institute for Nonprofit News does through their NewsMatch program – and I want to max it out. 

The place to go is Arm and a Leg Show, dot org, slash support. And there’s a link in the show notes – pretty much anywhere you’re listening to this. 

We’ll be back next week with a quick little coda to this story.

Meanwhile, thank you so much for helping us make this show. I’m gonna give that address one more time: Arm and a Leg show dot com, slash support. 

I’ll catch you next week.

Till then, take care of yourself.

This episode of An Arm and a Leg was produced by me, Dan Weissmann, with Emily Pisacreta and Bella Czakowski. 

In partnership with Scripps News, thanks to Rosie Chima, Amber Strong, Claire Malloy, Jacqueline Baylon and Zach Toombs and the Baltimore Banner, thanks to Ryan Little, Meredith Cohn, Brenna Smith and Kimi Yoshino and the McGraw Center for Business Journalism at the Craig Newmark Graduate School of Journalism at the City University of New York, with thanks to Jane Sasseen.

Our work on this story is supported by the Fund for Investigative Journalism, and edited by Ellen Weiss. 

Big thanks also to Jared Walker, Bobby Peterson, Luke Messac, Jeff Bloom, Emily Stuart, Berneta Hayes, Matt Szaflarski, Amanda Dunkler, and Marceline White! Plus Barry and Jo from Court Data Techologies, in Wisconsin.

Gabrielle Healy is An Arm and a Leg’s managing editor for audience – she edits the First Aid Kit newsletter.

Sarah Ballema is our Operations Manager. Bea Bosco is our Consulting Director of Operations.

An Arm and a Leg is produced in partnership with KFF Health News. 

That’s a national newsroom producing in-depth journalism about health care in America, and a core program at KFF — an independent source of health policy research, polling, and journalism. 

You can learn more about KFF Health News at arm and a leg show dot com, slash KFF. 

Zach Dyer is senior audio producer at KFF Health News. He is an editorial liaison to this show. 

Thanks to the INSTITUTE FOR NONPROFIT NEWS for serving as our fiscal sponsor, allowing us to accept tax-exempt donations. You can learn more about INN at I-N-N dot org. 

And thanks to everybody who supports this show financially. 

If you haven’t yet, we’d love for you to pitch in to join us. Again, the place for that is arm and a leg show dot com, slash support.

And now, time for one of my favorite parts: Shouting out some of the folks who have made donations since our last episode. Thanks this time to…

[DAN READS NAMES]

Thank you so much!

“An Arm and a Leg” is a co-production of KFF Health News and Public Road Productions.

This episode was produced in partnership with Scripps News, The Baltimore Banner, and the McGraw Center for Business Journalism at the Craig Newmark Graduate School of Journalism at the City University of New York.

Work by “An Arm and a Leg” on this article is supported by the Fund for Investigative Journalism.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and X, formerly known as Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

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And subscribe to “An Arm and a Leg” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

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

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RFK Jr.’s Campaign of Conspiracy Theories Is PolitiFact’s 2023 Lie of the Year

As pundits and politicos spar over whether Robert F. Kennedy Jr.’s presidential campaign will factor into the outcome of the 2024 election, one thing is clear: Kennedy’s political following is built on a movement that seeks to legitimize conspiracy theories.

His claims decrying vaccines have roiled scientists and medical experts and stoked anger over whether his work harms children. He has made suggestions about the cause of covid-19 that he acknowledges sound racist and antisemitic.

Bolstered by his famous name and family’s legacy, his campaign of conspiracy theories has gained an electoral and financial foothold. He is running as an independent — having abandoned his pursuit of the Democratic Party nomination — and raised more than $15 million. A political action committee pledged to spend between $10 million and $15 million to get his name on the ballot in 10 states.

Even though he spent the past two decades as a prominent leader of the anti-vaccine movement, Kennedy rejects a blanket “anti-vax” label that he told Fox News in July makes him “look crazy, like a conspiracy theorist.”

But Kennedy draws bogus conclusions from scientific work. He employs “circumstantial evidence” as if it is proof. In TV, podcast, and political appearances for his campaign in 2023, Kennedy steadfastly maintained:

  • Vaccines cause autism.
  • No childhood vaccines “have ever been tested in a safety study pre-licensing.”
  • There is “tremendous circumstantial evidence” that psychiatric drugs cause mass shootings, and the National Institutes of Health refuses to research the link out of deference to pharmaceutical companies.
  • Ivermectin and hydroxychloroquine were discredited as covid-19 treatments so covid vaccines could be granted emergency use authorization, a win for Big Pharma.
  • Exposure to the pesticide atrazine contributes to gender dysphoria in children.
  • Covid-19 is “targeted to attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese.”

For Kennedy, the conspiracies aren’t limited to public health. He claims “members of the CIA” were involved in the assassination of his uncle, John F. Kennedy. He doesn’t “believe that (Sirhan) Sirhan’s bullets ever hit my father,” former Attorney General Robert F. Kennedy. He insists the 2004 presidential election was stolen from Democratic candidate John Kerry.

News organizations, including PolitiFact, have documented why those claims, and many others, are false, speculative, or conspiracy-minded.

Kennedy has sat for numerous interviews and dismissed the critics, not with the grievance and bluster of former President Donald Trump, but with a calm demeanor. He amplifies the alleged plot and repeats dubious scientific evidence and historical detail.

Will his approach translate to votes? In polls since November of a three-way matchup between President Joe Biden, Trump, and Kennedy, Kennedy pulled 16% to 22% of respondents.

Kennedy’s movement exemplifies the resonance of conspiratorial views. Misinformers with organized efforts are rewarded with money and loyalty. But that doesn’t make the claims true.

Robert F. Kennedy Jr.’s campaign based on false theories is PolitiFact’s 2023 Lie of the Year.

How an Environmental Fighter Took Up Vaccines

Kennedy, the third of 11 children, was 9 when he was picked up on Nov. 22, 1963, from Sidwell Friends School in Washington, D.C., because Lee Harvey Oswald had shot and killed Uncle Jack. He was 14 when he learned that his father had been shot by Sirhan Sirhan following a victory speech after the California Democratic presidential primary.

RFK Jr., who turns 70 in January, wouldn’t begin to publicly doubt the government’s findings about the assassinations until later in his adulthood.

As a teenager, he used drugs. He was expelled from two boarding schools and arrested at 16 for marijuana possession. None of that slowed an elite path through higher education, including Harvard University for his bachelor’s degree and the University of Virginia for his law degree.

He was hired as an assistant district attorney in Manhattan in 1982 but failed the bar exam and resigned the next year. Two months later, he was arrested for heroin possession after falling ill on a flight. His guilty plea involved a drug treatment program, a year of probation, and volunteer work with a local anglers’ association that patrolled the Hudson River for evidence of pollution that could lead to lawsuits.

Kennedy’s involvement with Hudson Riverkeeper and the Natural Resources Defense Council ushered in a long chapter of environmental litigation and advocacy.

An outdoorsman and falconer, Kennedy sued companies and government agencies over pollution in the Hudson River and its watershed. (He joined the New York bar in 1985.) He earned a master’s degree in environmental law at Pace University, where he started a law clinic to primarily assist Riverkeeper’s legal work. He helped negotiate a 1997 agreement that protected upstate New York reservoirs supplying New York City’s drinking water.

In 1999, Kennedy founded the Waterkeeper Alliance, an international group of local river and bay-keeper organizations that act as their “community’s coast guard,” he told Vanity Fair in 2016. He stayed with the group until 2020, when he left “to devote himself, full-time, to other issues.”

On Joe Rogan’s podcast in June, Kennedy said that virtually all of his litigation involved “some scientific controversy. And so, I’m comfortable with reading science and I know how to read it critically.”

PolitiFact did not receive a response from Kennedy’s campaign for this story.

He became concerned about mercury pollution from coal-burning power plants; methylmercury can build up in fish, posing a risk to humans and wildlife. As he traveled around the country, he said, women started appearing in the front rows of his mercury lectures.

“They would say to me in kind of a respectful but vaguely scolding way, ‘If you’re really interested in mercury contamination exposure to children, you need to look at the vaccines,’” Kennedy told Rogan, whose show averages 11 million listeners an episode.

Kennedy said the women sounded “rational” as they explained a link between their children’s autism and vaccines. “They weren’t excitable,” he said. “And they had done their research, and I was like, ‘I should be listening to these people, even if they’re wrong.’”

He did more than listen. In June 2005, Rolling Stone and Salon co-published Kennedy’s article “Deadly Immunity.” Kennedy told an alarming story about a study that revealed a mercury-based additive once used in vaccines, thimerosal, “may have caused autism in thousands of kids.” Kennedy alleged that preeminent health agencies — the Centers for Disease Control and Prevention, the Food and Drug Administration, the World Health Organization — had colluded with vaccine manufacturers “to conceal the data.”

Kennedy’s premise was decried as inaccurate and missing context. He left out the ultimate conclusion of the 2003 study, by Thomas Verstraeten, which said “no consistent significant associations were found between [thimerosal-containing vaccines] and neurodevelopmental outcomes.”

Kennedy didn’t clearly state that, as a precaution, thimerosal was not being used in childhood vaccines when his article was published. He also misrepresented the comments of health agency leaders at a June 2000 meeting, pulling certain portions of a 286-page transcript that appeared to support Kennedy’s collusion narrative.

Scientists who have studied thimerosal have found no evidence that the additive, used to prevent germ growth, causes harm, according to a CDC FAQ about thimerosal. Unlike the mercury in some fish, the CDC says, thimerosal “doesn’t stay in the body, and is unlikely to make us sick.” Continued research has not established a link between thimerosal and autism.

By the end of July 2005, Kennedy’s Salon article had been appended with five correction notes. In 2011, Salon retracted the article. It disappeared from Rolling Stone.

Salon’s retraction was part of a broader conspiracy of caving “under pressure from the pharmaceutical industry,” Kennedy told Rogan. The then-Salon editor rejected this, saying they “caved to pressure from the incontrovertible truth and our journalistic consciences.”

Kennedy has not wavered in his belief: “Well, I do believe that autism does come from vaccines,” he told Fox News’ Jesse Watters in July.

David Remnick, editor of The New Yorker, interviewed Kennedy for a July story. Noting that Kennedy was focusing more on vaccine testing rather than outright opposition, Remnick asked him whether he was having second thoughts.

“I’ve read the science on autism and I can tell you, if you want to know,” Kennedy said. “David, you’ve got to answer this question: If it didn’t come from the vaccines, then where is it coming from?”

How Covid-19 Helped RFK Jr.’s Vaccine-Skeptical Crusade

In 2016, Kennedy launched the World Mercury Project to address mercury in fish, medicines, and vaccines. In 2018, he created Children’s Health Defense, a legal advocacy group that works “aggressively to eliminate harmful exposures,” its website says.

Since at least 2019, Children’s Health Defense has supported and filed lawsuits challenging vaccination requirements, mask mandates, and social media companies’ misinformation policies (including a related lawsuit against Facebook and The Poynter Institute, which owns PolitiFact).

From the beginning, the group has solicited stories about children “injured” by environmental toxins or vaccines. This year, it launched a national bus tour to collect testimonials. The organization also produces documentary-style films and books, including Kennedy’s “The Wuhan Cover-Up and the Terrifying Bioweapons Arms Race” and “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health.”

In 2020, Children’s Health Defense and the anti-vaccine movement turned attention to the emerging public health crisis.

Kolina Koltai, a senior researcher at Bellingcat, an investigative journalism group, had seen anti-vaccine groups try to seize on Zika and Ebola outbreaks, with little success. But the covid-19 pandemic provided “the exact scenario” needed to create mass dissent: widespread fear and an information vacuum.

Children’s Health Defense published articles in March and April 2020 claiming the “viral terror” was an attempt to enact the “global immunization agenda” and a “dream come true” for dictators. The group echoed these points in ads and social media posts and grew its audience, including in Europe.

On X, then known as Twitter, Children’s Health Defense outperformed news outlets that met NewsGuard’s criteria for trustworthiness from the third quarter of 2020 to the fourth quarter of 2021, according to a report by the German Marshall Fund think tank, even as Children’s Health Defense published debunked information about covid-19 and vaccines.

In 2019, Children’s Health Defense reported it had $2.94 million in revenue, and paid Kennedy a $255,000 salary. Its revenue grew 440% through 2021, according to IRS filings, hitting $15.99 million. Kennedy’s salary increased to $497,013. (Its 2022 form 990 for tax disclosure is not yet public. Kennedy has been on leave from the organization since he entered the presidential race in April.)

On social media, the message had limits. Meta removed Kennedy’s personal Instagram account in February 2021 for spreading false claims about covid-19 and vaccines, the company said, but left his Facebook account active. A year and a half later, Meta banned Children’s Health Defense’s main Facebook and Instagram accounts for “repeatedly” violating its medical misinformation policies. Several state chapters still have accounts.

As the group’s face, Kennedy became a leader of a movement opposed to masks and stay-at-home orders, said David H. Gorski, managing editor of Science-Based Medicine and a professor of surgery and oncology at the Wayne State University School of Medicine.

“The pandemic produced a new generation of anti-vaxxers who had either not been prominent before or who were not really anti-vax before,” Gorski said. “But none of them had the same cultural cachet that comes with being a Kennedy that RFK Jr. has.”

Rallying a crowd before the Lincoln Memorial on Jan. 23, 2022, Kennedy protested covid-19 countermeasures alongside commentator Lara Logan and anti-vaccine activist Robert Malone. The crowd held signs reading “Nuremberg Trials 2.0” and “free choice, no masks, no tests, no vax.” When Kennedy took the stage, mention of his role with Children’s Health Defense prompted an exuberant cheer.

In his speech, Kennedy invoked the Holocaust to denounce the “turnkey totalitarianism” of a society that requires vaccinations to travel, uses digital currency and 5G, and is monitored by Microsoft Corp. co-founder Bill Gates’ satellites: “Even in Hitler’s Germany, you could cross the Alps into Switzerland. You could hide in an attic like Anne Frank did.”

Days later, facing criticism from his wife, the actor Cheryl Hines, Jewish advocacy groups, and Holocaust memorial organizations, Kennedy issued a rare apology for his comments.

Asked about his wife’s comment on Dec. 15 on CNN, he said his remarks were taken out of context but that he had to apologize because of his family.

Recycle. Repeat. Repeat.

When he’s asked about his views, Kennedy calmly searches his rhetorical laboratory for recycled talking points, selective research findings, the impression of voluminous valid studies, speculation, and inarguable authority from his experience. He refers to institutions, researchers, and reports, by name, in quick succession, shifting points before interviewers can note what was misleading or cherry-picked.

There is power in repetition. Take his persistent claim that vaccines are not safety-tested.

  • In July, he told “Fox & Friends,” “Vaccines are the only medical product that is not safety-tested prior to licensure.”
  • On Nov. 7 on PBS NewsHour, Kennedy said vaccines are “the only medical product or medical device that is allowed to get a license without engaging in safety tests.”
  • On Dec. 15, he told CNN’s Kasie Hunt that no childhood vaccines have “ever been tested in a safety study pre-licensing.”

This is false. Vaccines, including the covid-19 vaccines, are tested for safety and effectiveness before they are licensed. Researchers gather initial safety data and information about side effects during phase 1 clinical trials on groups of 20 to 100 people. If no safety concerns are identified, subsequent phases rely on studies of larger numbers of volunteers to evaluate a vaccine’s effectiveness and monitor side effects.

Kennedy sometimes says that some vaccines weren’t tested against inactive injections or placebos. That has an element of truth: If using a placebo would disadvantage or potentially endanger a patient, researchers might test new vaccines against older versions with known side effects.

But vaccines are among “the most tested and vetted” pharmaceutical products given to children, said Patricia Stinchfield, a pediatric nurse practitioner and the president of the National Foundation for Infectious Diseases.

Kennedy encourages parents to research questions on their own, saying doctors and other experts are invariably compromised.

“They are taking as gospel what the CDC tells them,” Kennedy said on Bari Weiss’ “Honestly” podcast in June.

Public health agencies have been “serving the mercantile interests of the pharmaceutical companies, and you cannot believe anything that they say,” Kennedy said.

Experts fret that the Kennedy name carries weight.

“When he steps forward and he says the government’s lying to you, the FDA is lying to you, the CDC is lying to you, he has credence, because he’s seen as someone who is a product of the government,” said Paul Offit, a pediatrics professor in the Children’s Hospital of Philadelphia’s infectious diseases division and the director of the hospital’s Vaccine Education Center. “He’s like a whistleblower in that sense. He’s been behind the scenes, so he knows what it looks like, and he’s telling you that you’re being lied to.”

Kennedy name-drops studies that don’t support his commentary. When speaking with Rogan, Kennedy encouraged the podcaster’s staff to show a particular 2010 study that found that exposure to the herbicide atrazine caused some male frogs to develop female sex organs and become infertile.

Kennedy has repeatedly invoked that frog study to support his position that “we should all be looking at” atrazine and its impact on human beings. The researcher behind the study told PolitiFact in June that Kennedy’s atrazine claims were “speculation” given the vast differences between humans and amphibians. No scientific studies in humans link atrazine exposure to gender dysphoria.

In July, Kennedy floated the idea that covid-19 could have been “ethnically targeted” to “attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese.” The claim was ridiculously wrong, but Kennedy insisted that it was backed by a July 2020 study by Chinese researchers. That study didn’t find that Chinese people were less affected by the virus. It said one of the virus’s receptors seemed to be absent in the Amish and in Ashkenazi Jews and theorized that genetic factors might increase covid-19 severity.

Five months later, Kennedy invoked the study and insisted he was right: “I can understand why people were disturbed by those remarks. They certainly weren’t antisemitic. … I was talking about a true study, an NIH-funded study.”

“I wish I hadn’t said them, but, you know, what I said was true.”

Kennedy answered using scientific terms (“furin cleave,” “ACE2 receptor”), but he ignored explanations found in the study. He didn’t account for how the original virus has evolved since 2020, or how the study emphasized these potential mutations were rare and would have little to no public health impact.

Public health experts say that racial disparities in covid-19 infection and mortality — in the U.S., Black and Hispanic people often faced more severe covid-19 outcomes — resulted from social and economic inequities, not genetics.

Kennedy says “circumstantial evidence” is enough.

Antidepressants are linked to school shootings, he told listeners on a livestream hosted by Elon Musk. The government should have begun studying the issue years ago, he said, because “there’s tremendous circumstantial evidence that those, like SSRIs and benzos and other drugs, are doing this.”

Experts in psychiatry have told PolitiFact and other fact-checkers that there is no causal relationship between antidepressants and shootings. With 13% of the adult population using antidepressants, experts say that if the link were true they would expect higher rates of violence. Also, the available data on U.S. school shootings shows most shooters were not using psychiatric medicines, which have an anti-violence effect.

Conspiracy Theories, Consequences, and a Presidential Campaign

The anti-censorship candidate frames his first bid for public office as a response to “18 years” of being shunned for his views — partly by the government, but also by private companies.

“You’re protected so much from censorship if you’re running for president,” Kennedy told conservative Canadian podcaster and psychologist Jordan Peterson in June.

In June, Kennedy’s Instagram account was reinstated — with a verified badge noting he is a public figure. Meta’s rules on misinformation do not apply to active political candidates. (PolitiFact is a partner of Meta’s Third Party Fact-Checking Program, which seeks to reduce false content on the platform.)

In July, he was invited to testify before the Republican-led House Select Subcommittee on the Weaponization of the Federal Government. He repeated that he had “never been anti-vax,” and railed against the Biden White House for asking Twitter to remove his January 2021 tweet that said Baseball Hall of Famer Hank Aaron’s death was “part of a wave of suspicious deaths among elderly,” weeks after Aaron, 86, received a covid-19 vaccine. The medical examiner’s office said Aaron died from unrelated natural causes.

Throughout 2023, alternative media has embraced Kennedy. He has regularly appeared on podcasts such as Peterson’s, and has also participated in profiles by mainstream TVonline, and print sources.

“You’re like, ‘But you’re talking right now. I’m listening to you. I hear your words. You’re not being censored,’” said Whitney Phillips, an assistant professor in the School of Journalism and Communication at the University of Oregon who researches how news media covers conspiracy theories and their proponents. “But a person can believe they’re being censored because they’ve internalized that they’re going to be,” or they know making the claim will land with their audience.

Time will tell whether his message resonates with voters.

Kyle Kondik, managing editor of Sabato’s Crystal Ball at the University of Virginia Center for Politics, said Kennedy may be a “placeholder” for voters who are dissatisfied with Trump and Biden and will take a third option when offered by pollsters.

The only 2024 candidate whose favorability ratings are more positive than negative? It’s Kennedy, according to FiveThirtyEight. However, a much higher percentage of voters are unfamiliar with him than they are with Trump or Biden — about a quarter — and Kennedy’s favorability edge has decreased as his campaign has gone on.

Nevertheless, third-party candidates historically finish with a fraction of their polling, Kondik said, and voters will likely have more names and parties on their fall ballots, including philosopher Cornel West, physician Jill Stein, and a potential slate from the No Labels movement.

Kennedy was popular with conservative commentators before he became an independent, and he has avoided pointedly criticizing Trump, except on covid-19 lockdowns. When NBC News asked Kennedy in August what he thought of Trump’s 2020 election lies, Kennedy said he believed Trump lost, but that, in general, people who believe elections were stolen “should be listened to.” Kennedy is one of them. He still says that the 2004 presidential election was “stolen” from Kerry in favor of Republican George W. Bush, though it wasn’t.

American Values 2024 will spend up to $15 million to get Kennedy’s name on the ballot in 10 states including Arizona, California, Indiana, New York, and Texas. Those are five of the toughest states for ballot access, said Richard Winger, co-editor of Ballot Access News.

Four of Kennedy’s siblings called Kennedy’s decision to run as an independent “dangerous” and “perilous” to the nation. “Bobby might share the same name as our father, but he does not share the same values, vision or judgment,” the group wrote in a joint statement.

Kennedy brushes it off when asked, saying he has a large family and some members support him.

On her podcast, Weiss asked whether Kennedy worried his position on autism and vaccines would cloud his other positions and cost him votes. His answer ignored his history.

“Show me where I got it wrong,” he said, “and I’ll change.”

In a campaign constructed by lies, that might be the biggest one.

PolitiFact researcher Caryn Baird contributed to this report.​

PolitiFact’s source list can be found here.

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

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In Year 6, KFF Health News-NPR’s ‘Bill of the Month’ Helps Patients in a Changing System

In 2023, our nationwide reporting team has been hard at work on a holiday gift to you: a packet of advice for navigating the labyrinthine American medical system.

In the sixth year of KFF Health News-NPR’s “Bill of the Month” series, readers shared more than 750 tales of medical billing problems, contributing to our ongoing effort to investigate the financial consequences of becoming sick or injured in the United States — and empower patients to advocate for themselves.

Reporters analyzed more than $730,000 in charges, including more than $215,000 owed by 12 patients and their families.

The investigations were cited by decision-makers on Capitol Hill and at the White House. Last summer, the Biden administration announced plans to lower health costs, such as by targeting a loophole that has allowed health providers to evade the federal surprise-billing law — a loophole identified by “Bill of the Month.”

More changes are on Washington’s agenda next year; federal regulators are expected to develop a Biden administration plan to bar medical debt from affecting credit scores. But as this important project has shown since its start in 2018, patients are often their own best advocates.

“If I’m able to push back a little bit against this massive system, well, hey, maybe other people can, too,” said Jered Gebel of Alaska, who fought back against disparities and outright errors in charges for his wife’s chemotherapy. “And who knows, maybe eventually health care prices can come down.”

Check out this year’s stories below to learn more about how you can protect yourself and your loved ones from a big, unexpected, or downright wrong bill.

From all of us at “Bill of the Month,” happy holidays — and, when in doubt, don’t pay the bill.

A Baby Spent 36 Days in an In-Network NICU. Why Did the Hospital Next Door Send a Bill?

By Harris Meyer, 

January 30, 2023

A baby spent more than a month in a Chicago NICU. A big bill revealed she was treated by out-of-network doctors from the children’s hospital next door. Her parents were charged despite a state law protecting patients from such out-of-network billing — and sent to collections when they didn’t pay up.

Surprise-Billing Law Loophole: When ‘Out of Network’ Doesn’t Quite Mean Out of Network

By Harris Meyer, 

February 28, 2023

Billing experts and lawmakers are playing catch-up as providers find ways to get around new surprise-billing laws, leaving patients like Danielle Laskey of Washington state with big bills for emergency care.

ER’s Error Lands a 4-Year-Old in Collections (For Care He Didn’t Receive)

By Daniel Chang, 

March 29, 2023

A Florida woman tried to dispute an emergency room bill, but the hospital and collection agency refused to talk to her — because it was her child’s name on the bill, not hers.

Expectant Mom Needed $15,000 Overnight to Save Her Twins

By Renuka Rayasam, 

April 27, 2023

Doctors rushed a pregnant woman to a surgeon who charged thousands upfront just to see her. The case reveals a gap in medical billing protections for those with rare, specialized conditions.

He Returned to the US for His Daughter’s Wedding. He Left With a $42,000 Hospital Bill.

By Sarah Jane Tribble, 

May 23, 2023

After emergency surgery, an American expatriate with Swiss insurance now carries the baggage of a five-figure bill. Costs for medical care in the U.S. can be two to three times the rates in other developed countries, so foreigners and expats with good insurance in their home countries need travel insurance to protect themselves from “crazy prices.”

The Hospital Bills Didn’t Find Her, but a Lawsuit Did — Plus Interest

By Bram Sable-Smith, 

June 27, 2023

Recovering from emergency gallbladder surgery, a Tennessee woman said she spent months without a permanent mailing address and never got a bill. She was sued by the health system two years later.

His Anesthesia Provider Billed Medicare Late. He Got Sent to Collections for the $3,000 Tab.

By Phil Galewitz, 

July 28, 2023

Medicare was supposed to cover the entire cost of his procedure. But after the anesthesia provider failed to file its claims in a timely manner, it billed the patient instead.

She Paid Her Husband’s Hospital Bill. A Year After His Death, They Wanted More Money.

By Samantha Liss, 

August 29, 2023

A widow encountered a perplexing reality in medical billing: Providers can come after patients to collect well after a bill has been paid.

She Received Chemo in Two States. Why Did It Cost So Much More in Alaska?

By Arielle Zionts, 

September 29, 2023

A breast cancer patient who received similar treatments in two states saw significant differences in cost, illuminating how care in remote areas can come with a stiffer price tag.

When That Supposedly Free Annual Physical Generates a Bill

By Julie Appleby, 

October 30, 2023

Completing a routine depression screening questionnaire during an annual checkup is cost-free under federal law. But, as one woman discovered, answering a doctor’s follow-up questions might not be.

Out for Blood? For Routine Lab Work, the Hospital Billed Her $2,400

By Rachana Pradhan, 

November 21, 2023

Convenient as it may be, beware of getting your blood drawn at a hospital. The cost could be much higher than at an independent lab, and your insurance might not cover it all.

When a Quick Telehealth Visit Yields Multiple Surprises Beyond a Big Bill

By Darius Tahir, 

December 19, 2023

For the patient, it was a quick and inexpensive virtual appointment. Why it cost 10 times what she expected became a mystery.

Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

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

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Cancer Patients Face Frightening Delays in Treatment Approvals

Marine Corps veteran Ron Winters clearly recalls his doctor’s sobering assessment of his bladder cancer diagnosis in August 2022.

“This is bad,” the 66-year-old Durant, Oklahoma, resident remembered his urologist saying. Winters braced for the fight of his life.

Little did he anticipate, however, that he wouldn’t be waging war only against cancer. He also was up against the Department of Veterans Affairs, which Winters blames for dragging its feet and setting up obstacles that have delayed his treatments.

Winters didn’t undergo cancer treatment at a VA facility. Instead, he sought care from a specialist through the Veterans Health Administration’s Community Care Program, established in 2018 to enhance veterans’ choices and reduce their wait times. But he said the prior authorization process was a prolonged nightmare.

“For them to take weeks — up to months — to provide an authorization is ridiculous,” Winters said. “It doesn’t matter if it’s cancer or not.”

After his initial diagnosis, Winters said, he waited four weeks for the VA to approve the procedure that allowed his urologic oncologist at the University of Texas Southwestern Medical Center in Dallas to remove some of the cancer. Then, when he finished chemotherapy in March, he was forced to wait another month while the VA considered approving surgery to remove his bladder. Even routine imaging scans that Winters needs every 90 days to track progress require preapproval.

In a written response, VA press secretary Terrence Hayes acknowledged that a “delay in care is never acceptable.” After KFF Health News inquired about Winters’ case, the VA began working with him to get his ongoing care authorized.

“We will also urgently review this matter and take steps to ensure that it does not happen again,” Hayes told KFF Health News.

Prior authorization isn’t unique to the VA. Most private and federal health insurance programs require patients to secure preapprovals for certain treatments, tests, or prescription medications. The process is intended to reduce spending and avoid unnecessary, ineffective, or duplicative care, although the degree to which companies and agencies set these rules varies.

Insurers argue prior authorization makes the U.S. health care system more efficient by cutting waste — theoretically a win for patients who may be harmed by excessive or futile treatment. But critics say prior authorization has become a tool that insurers use to restrict or delay expensive care. It’s an especially alarming issue for people diagnosed with cancer, for whom prompt treatment can mean the difference between life and death.

“I’m interested in value and affordability,” said Fumiko Chino, a member of the Affordability Working Group for the Memorial Sloan Kettering Cancer Center. But the way prior authorization is used now allows insurers to implement “denial by delay,” she said.

Cancer is one of the most expensive categories of disease to treat in the U.S., according to the Centers for Disease Control and Prevention. And, in 2019, patients spent more than $16 billion out-of-pocket on their cancer treatment, a report by the National Cancer Institute found.

To make matters worse, many cancer patients have had oncology care delayed because of prior authorization hurdles, with some facing delays of more than two weeks, according to research Chino and colleagues published in JAMA in October. Another recent study found that major insurers issued “unnecessary” initial denials in response to imaging requests, most often in endocrine and gastrointestinal cancer cases.

The federal government is weighing new rules designed to improve prior authorization for millions of people covered by Medicare, Medicaid, and federal marketplace plans. The reforms, if implemented, would shorten the period insurers are permitted to consider prior authorization requests and would also require companies to provide more information when they issue a denial.

In the meantime, patients — many of whom are facing the worst diagnosis of their lives — must navigate a system marked by roadblocks, red tape, and appeals.

“This is cruel and unusual,” said Chino, a radiation oncologist. A two-week delay could be deadly, and that it continues to happen is “unconscionable,” she said.

Chino’s research has also shown that prior authorization is directly related to increased anxiety among cancer patients, eroding their trust in the health care system and wasting both the provider’s and the patient’s time.

Leslie Fisk, 62, of New Smyrna Beach, Florida, was diagnosed in 2021 with lung and brain cancer. After seven rounds of chemotherapy last year, her insurance company denied radiation treatment recommended by her doctors, deeming it medically unnecessary.

“I remember losing my mind. I need this radiation for my lungs,” Fisk said. After fighting Florida Health Care Plans’ denial “tooth and nail,” Fisk said, the insurance company relented. The insurer did not respond to requests for comment.

Fisk called the whole process “horribly traumatic.”

“You have to navigate the most complicated system on the planet,” she said. “If you’re just sitting there waiting for them to take care of you, they won’t.”

A new KFF report found that patients who are covered by Medicaid appear to be particularly impacted by prior authorization, regardless of their health concerns. About 1 in 5 adults on Medicaid reported that their insurer had denied or delayed prior approval for a treatment, service, visit, or drug — double the rate of adults with Medicare.

“Consumers with prior authorization problems tend to face other insurance problems,” such as trouble finding an in-network provider or reaching the limit on covered services, the report noted. They are also “far more likely to experience serious health and financial consequences compared to people whose problems did not involve prior authorization.”

In some cases, patients are pushing back.

In November, USA Today reported that Cigna admitted to making an error when it denied coverage to a 47-year-old Tennessee woman as she prepared to undergo a double-lung transplant to treat lung cancer. In Michigan, a former health insurance executive told ProPublica that the company had “crossed the line” in denying treatment for a man with lymphoma. And Blue Cross and Blue Shield of Louisiana “met its match” when the company denied a Texas trial lawyer’s cancer treatment, ProPublica reported in November.

Countless others have turned to social media to shame their health insurance companies into approving prior authorization requests. Legislation has been introduced in at least 30 states — from California to North Carolina — to address the problem.

Back in Oklahoma, Ron Winters is still fighting. According to his wife, Teresa, the surgeon said if Ron could have undergone his operation sooner, they might have avoided removing his bladder.

In many ways, his story echoes the national VA scandal from nearly a decade ago, in which veterans across the country were languishing — some even dying — as they waited for care.

In 2014, for example, CNN reported on veteran Thomas Breen, who was kept waiting for months to be seen by a doctor at the VA in Phoenix. He died of stage 4 bladder cancer before the appointment was scheduled.

Winters’ cancer has spread to his lungs. His diagnosis has advanced to stage 4.

“Really, nothing has changed,” Teresa Winters said. “The VA’s processes are still broken.”

Do you have an experience with prior authorization you’d like to share? Click here to tell your story.

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

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Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

  • Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.
  • Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.
  • Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.
  • And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

3,000

Approximate number of low- to moderate-risk devices cleared every year through 510(k). 

30

Approximate number of devices receiving original approval from the FDA each year through stricter premarketing requirements. 

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.

According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit.

In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

10%

Approximate number of reports in which more than a year or two elapsed from when a death or serious injury occurred to when the FDA received the reports 

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.” For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

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The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

Legal Barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

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

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