The Bleeding Edge Filmmakers: ‘Many of These Devices Are Hurting and Killing People’


This Episode's Guests
Kirby Dick, American Film Director

Kirby Dick

Academy Award Nominated Documentary Film Director
Amy Herdy, Film Producer and Author

Amy Herdy

Documentary Film Producer and Investigative Journalist

Filmmakers Kirby Dick and Amy Herdy join me on this episode of Drugwatch Podcast. Dick and Herdy are two of the creative forces behind Netflix’s original documentary The Bleeding Edge.

The film does a deep dive into the powerful medical device industry. It highlights the lack of regulation and testing of medical devices.

“The thing that was most shocking to us is that the overwhelming majority of medium-risk and high-risk devices are never tested in humans,” Dick, the film’s director, told Drugwatch.

The worst thing about it is they get away with it, and they’ve been doing it for years, Dick and Herdy said.

The idea for the film came from Herdy. After being treated for breast cancer, she spoke with a health care advocate. What she found out shocked her.

“Several hundred thousand Americans die every year due to medical mistakes. I remember thinking, ‘No, this can’t be.’… it’s the equivalent of two 747s crashing and killing everyone on board every day,” Herdy, one of the film’s producers, said.

She brought the story to Dick and fellow producer Amy Ziering. Herdy, Dick and Ziering crafted their film around the stories of people injured by devices such as Essure, transvaginal mesh and metal-on-metal hip implants.

Part of the problem is that industry funds the U.S. Food and Drug Administration, Herdy said.

“I hope more people will ask questions about medical devices before they have them implanted … because their life could depend on it,” Herdy said.

The Bleeding Edge premieres on Netflix on July 27.

Transcript -

You're listening to the Drugwatch podcast, with your host Michelle Llamas. The Drugwatch podcast provides useful medical information directly from the experts to you. It also features the stories of consumers just like you, who are affected by dangerous drugs and medical devices. Drugwatch podcast is not a substitute for professional legal or medical advice. The views and opinions expressed by the host and guests do not necessarily reflect those of Drugwatch.

Michelle Llamas

Hi there, welcome to another episode of the Drugwatch podcast. I'm your host, Michelle Llamas. On today's episode we've got some special guests. We always have doctors or patients on the show, but I'm really excited to have filmmakers on our show today, and the reason for this is because of The Bleeding Edge documentary, which is going to premiere on Netflix on July 27 — hopefully — it's a tentative date. Very excited about it because it talks about the medical device industry and a lot of things that consumers really need to know. So, on the show today, I've got Kirby Dick. He's the director of the film. And I've got Amy Herdy. She did a lot of the research and is one of the film’s producers. So, thank you both for being on the show.

Kirby Dick

Thank you very much, and I just want to let you know that July 27 is the definite date that it's going to premiere on Netflix.

Michelle Llamas

OK, perfect. OK, good. So that is for sure. People can expect to watch it on July 27 there. The cool thing is, I know a lot of people are having some screenings also prior to this, so if anybody is in a city that is having one of the screenings, they can actually check the film out there. But let's go ahead and start talking about it. So the birth of The Bleeding Edge — I was really fortunate to be able to see it when it premiered at Tribeca in April, and I was really struck by the professionalism of the piece, the emotion of it and the investigative journalism behind it. So, I think previously you talked about how it started and Amy actually came up with the kernel of the idea first. So, I want to ask Amy how did that idea come to you and what made you bring it to Kirby Dick and Amy Ziering?

Amy Herdy

I'm a breast cancer survivor, and I actually just finished treatment a month before I heard the idea for this film, and so sitting on that paper covered table in the gaping gown and feeling vulnerable was still really raw. I met an amazing patient safety advocate named Kathleen Bartholomew and over lunch she dropped this bombshell that several hundred thousand Americans die every year due to medical mistakes. I remember thinking, "No, this can't be." And she said, "Yes, it is. It's the equivalent of two 747s crashing and killing everyone on board every day. It's the third leading cause of death after heart disease and cancer." In other words, what you don't know can kill you. So I said, "Well, we've got to look into this." So I started researching it, and then I brought it to Kirby and Amy.

Michelle Llamas

Now, you had worked with them previously. Is that kind of how you knew each other?

Amy Herdy

Yeah, so they interviewed me for The Invisible War, which was about sexual assault in the military, and then I started helping them with research on that film. And so when they made their next film, The Hunting Ground, they asked me if I would work with them, and I said absolutely because I knew their process and I trusted it, and I trusted their expertise and their vision. They're amazing. I mean they're extraordinary filmmakers, and I knew in their hands that this would get the attention it deserved.

Michelle Llamas

Those are award-winning films — you know? So it's one of those things with also the emotional impact of those films, which kind of carries over to this one. So that sort of leads into my next question. This is for Kirby. We talked before about how you thought The Bleeding Edge was similar as well as different to The Hunting Ground and The Invisible War, which you know, again, we talked about are about sexual assault. When Amy brought this idea to you, what was your first reaction, and what made you want to make the film?

Kirby Dick

Well, when I heard that there were hundreds of thousands of people that had died in the medical system every year from preventable medical error, I initially didn't believe it. I mean it just seemed astonishing. I started doing research and that is the case, and what happens, and as Amy and I started doing more research on this, we heard a woman, Diana Zuckerman, who's the real expert in this. She's the CEO of the National Center for Health Research in Washington, D.C., and she talked about one aspect of this issue, which is how many people are harmed by medical devices. And the thing that was most shocking to us is the overwhelming majority of medium-risk and high-risk devices are never tested in humans.
So these devices are implanted in people, are never tested in people first. And so anybody receiving many of these devices is actually becoming a guinea pig. And what we learned that was even more astonishing as we made the film was that most doctors who are implanting these devices don't know that most of the devices they're implanting have not been tested in humans.

Michelle Llamas

Yeah, real quick let me stop you there. I think everybody talks about the FDA, and they're supposed to be the agency that watches out for all of this stuff, right? And most Americans, like you mentioned, they expect once it's being sold that it's been tested and that everything's OK and that it's actually safe. You know, that's the thing there. So I guess you were just as shocked as everyone else, and like Amy said, a couple 747s.

Kirby Dick

Right.

Michelle Llamas

That's a lot of people. So yeah, continue.

Kirby Dick

Exactly. We decided to focus on the medical device industry because obviously people know about all the issues with Big Pharma, I mean, just the many great books, documentaries, you know, newspaper pieces on it, but you know, very few people know that there's a sister industry, which is the medical technology, medical device industry, that is nearly as large, is much less regulated, and well the same kind of problems, in many ways, worse. And so what we wanted to do, is — this is what we do with all our films — is we like to take on an area that people don't know about, and really bring it to the public, and then hopefully when patients, legislators, people within the medical industry see it, they will want to do something about it and improve the situation to protect patient safety.
So we've had great luck with our previous films. I mean they've lead to legislative change, policy change on a national basis, and we certainly hope that the same thing will happen here is that once people become aware of the problem, they'll move to solve it.

Michelle Llamas

Amy, you mentioned that you came to this film almost from the patient side at first, right? Because you were in the health care industry there, you were having treatment, and then you're doing now research for this film. How did that affect you? Was that a personal thing when you started finding out all these egregious fact?

Amy Herdy

Absolutely, because having gone through treatment where you're in it for your life, you realize just how vulnerable people are when they're facing any kind of medical procedure or facing the idea of using any kind of medical device, and I became increasingly horrified that people just weren't having these important facts brought to their attention, that these devices weren't being tested and people put their trust in the medical system and in their physicians, and sometimes that trust is misplaced.

Michelle Llamas

So then it became kind of like a "Hey, we really need to let people know about this." Almost like a driving advocacy behind it. Because like Kirby mentioned, you like to show people things and hopefully change comes out of it. So clearly this film has a lot of hard hitting facts and research in there that's kind of intertwined with a lot of the emotional stories that we see in it. On that research front Amy, what were some of your biggest challenges pulling the facts together?

Amy Herdy

Well once we narrowed our purpose to medical devices, the finding of the subject was really a challenge because they needed to have compelling stories and documentation and be willing to be followed by a camera, which can be very daunting. And then also whittling down all the information that we felt was the most important to present to audiences — that was really tough. Kirby had to keep reminding me that the film would only be about 90 minutes, not four hours.

Michelle Llamas

Yes, you could do a complete series on this honestly, right? If you wanted to.

Amy Herdy

Exactly. Easily.

Michelle Llamas

So when you were doing the research — one of the challenges I wondered — did you reach out to the actual medical device companies for input into this?

Amy Herdy

Absolutely.

Michelle Llamas

And I guess that's probably one of the challenges, too. Did they just ignore you? Like what did they do?

Amy Herdy

They very politely declined.

Michelle Llamas

Yeah, very politely, no, OK, we won't be involved in that.
You know, you almost wish they had something to say about it that would counteract all the other things that are being talked about in there. I was hoping that they would say something, but clearly they decided to stay out of it. So-

Kirby Dick

Yeah, I mean I think they're really afraid to actually be — have the tough questions thrown at them because they know there's a long history of people being harmed, a long history by their devices. A long history of people being harmed by devices that they knew in many cases were harmful before they even sold them to people, and I think if you started putting CEOs of medical device companies and had them really be forced to answer these questions, I think it would be very eye-opening. I think Congress should probably take some of these CEOs and have them at a hearing and ask these questions for the public to get the answers that nobody has that they're unwilling to answer at this point.

Michelle Llamas

Now one thing without really spoiling too much about the film for people because I really want people to see it. But you do have some insiders, right? Talking about things in the film, which I think is actually pretty amazing that obviously they're kind of hidden, right? They don't really want to come out and say their names. But when you hear them talk about the kind of things that they do, it's pretty appalling because like you said, they've got a long history and they've been doing that for years. So it's great that you all put this out there because, again, no one knows this is happening.

Kirby Dick

Yeah, no, you're absolutely right. I mean when we talked to people who work for medical device companies and seeing this on the ground the kind of things that were happening, it was really shocking. What we found though is that these people, even after they left the industry, were really afraid to talk. You know, we've made a lot of films where we take on very powerful institutions, but we've never encountered the kind of fear that we found around the medical device industry. People were very afraid of this industry because it’s very, very powerful. So the people that did speak were very courageous.

Michelle Llamas

Oh yeah.

Kirby Dick

And not only the people that spoke, but also the patients themselves. I mean that takes a lot of courage as well because people are afraid that the companies will come after them.

Michelle Llamas

Oh yeah, no, some of the ladies in the film that I've spoken to before that we'll see we sometimes make jokes that after they talk to me about something or reveal something, they're gonna have some black SUVs show up outside their house or something. It's kind of a funny joke, but obviously it's serious, and things like that happen, but that's the kind of fear like you mentioned that people have. So … we talked about the humanity and the people that are in the movie. It's extremely moving to watch these people share their stories. And there's a lot of science and facts, right? That you need them there as well.
So as the director Kirby, how did you go about achieving the balance between this like humanity and the facts?

Kirby Dick

Well I think it sort of begins in a lot of ways with the interviews that we did and Amy Ziering, who is the other producer on the film, is a phenomenal interviewer. She's able to really get to the core of the story and develop a really close bond with the people that she's interviewing during the interview time. And so you really get to know these people in a way that I've really never seen on film before. So that was the first step. And then of course the science of this is really complicated, right? We're dealing with medical technology. It's one of the most complicated fields there is, and you know, that was a tribute to Amy Herdy who was just day in and day out going out there, researching, getting the facts, getting experts to come forward, getting people who had worked in the industry willing to speak. I mean you know, Amy Herdy comes out of journalism, and it's really been a real pleasure and opportunity to be able to work with her because she's sort of like a secret weapon for us. She's able to get these stories that no one else can get and get these facts that no one else can get, and that's what in the end, really makes this film so solid and so powerful is because you know, she's able to get that information.

Michelle Llamas

Yeah, and when I was watching it, I definitely, you know, people talk about it as a documentary and things like that, but to me it was on par with like some of the investigative stuff that you find on like, you know, Frontline, Dateline, 60 Minutes. You know, that kind of stuff, but like made very accessible to people, and that humanity I thought was very important because you understand, you know, the human cost, that we say comes out of all this stuff.

Kirby Dick

That's important because you know, hundreds of thousands of people each year are hurt and killed by medical devices. I mean, there's I think 70 million medical devices implanted in Americans, and a huge percentage of them are harming and killing people. I mean, this is, I mean people talk about big tobacco and all the people that are harmed by that. This is almost The Insiders, you know, that was a fiction film on how big tobacco was blown open and how they had harmed so many people. This is sort of the equivalent of that. It's a documentary about the medical device industry.

Michelle Llamas

And the U.S. is actually the biggest market. It's you know, it’s by far where everybody spends all the money for research and development and all this stuff, and most of these devices are sold here. So you know, that's another thing. When you dug up all the facts, all the things that you learned, what was probably for both of you, the most shocking thing that you learned? Small fact, large fact, anything that probably still sticks with you to this day that you learned on the film?

Amy Herdy

Kirby, do you want to go first?

Kirby Dick

I mean, for me I think it was that we're all, that American patients and worldwide patients are guinea pigs when it comes to medical devices. That most of the devices that have been implanted in people have not been tested in humans first, and it just, you know, that's not true with drugs.

Michelle Llamas

Oh yeah.

Kirby Dick

With drugs, drugs are tested first.

Michelle Llamas

Very rigorously actually.

Kirby Dick

Yes. For some reason medical devices, which are actually much more consequential because a drug you can stop taking, a medical device once it's in you, you have to do a whole procedure, operation to get it out, that can be very dangerous in itself.

Michelle Llamas

Yeah, or in some cases it stays in you because it's too dangerous to remove it, which-

Kirby Dick

Exactly.

Michelle Llamas

I think some people say that you could die if we take this out. So you have side effects forever.

Kirby Dick

Exactly.

Michelle Llamas

What about you Amy?

Amy Herdy

Well I think two operant words that Americans really need to understand are approve and clear. There's a huge difference.

Michelle Llamas

Yes.

Amy Herdy

So the FDA does not approve most moderate- to severe-risk medical devices. It simply clears them, which means the FDA is essentially saying to the manufacturer, OK, we're giving you the green light to go ahead and put your device on the market, and it's more than likely that device has never had a single human, clinical trial. So as Kirby said, the patients become the guinea pigs. So people need to be aware of that. It's not FDA approved, it's more than likely just simply cleared. And they need to ask their physician or their surgeon. Has this device been cleared or approved? What category is this device? What is the safety numbers on this device?

Michelle Llamas

So that for you was the crazy thing that you learned — which 90 percent are cleared. So that's the interesting part.

Kirby Dick

Yeah, 98 percent I think.

Michelle Llamas

Yeah, there you go.

Amy Herdy

Yeah, more than 90 percent.

Michelle Llamas

They're cleared. You know, tongue depressors, weird things like that that people don't usually think of those as devices. But the implants now, most of the hips, knees, you know, the mesh for hernias or I guess when you’re talking about prolapse or incontinence or those type of things, those are all just cleared as you mentioned Amy. So, oh, and let's talk about the fact that those are cleared based on devices that were on the market before, even if they've been recalled. So I think that's something that we've got to explain to people that they sort of clear them based on pre-existing devices, but they don't care if those pre-existing devices were dangerous or not. I think that's an interesting thing as well.

Amy Herdy

It's appalling.

Michelle Llamas

It's super appalling. And you think about this happening, you go, "Ah, this is the United States, we don't do stuff like that here." You know, apparently yes, yes we do.

Kirby Dick

Well I think that people think — they think the FDA is doing a great job, and it is doing a good job in some places, in food safety. I mean obviously there's been a lot of failures. In drugs there's a lot of problems … it is really failing in medical devices.

Michelle Llamas

Yeah.

Kirby Dick

And people think, like you said, they hear the word FDA cleared and they think "Oh, everything's fine." Not at all

Michelle Llamas

Oh, you mentioned that they do a great job in other places.

Kirby Dick

Well I wouldn't say a great job. I just say they do an OK job.

Michelle Llamas

Yeah, there we go, OK ,OK, yeah, definitely not great. But a patient called me one time and she said, "You know, if we had the same people that are working in like the pet food recalls ..." because you know, they're recalling things like crazy there.

Kirby Dick

Exactly.

Michelle Llamas

If they find anything wrong with pet food, hey, it's off the market. However, medical devices? Not so much, you know?
So is there anything that didn't make it in the film that you both wish you were able to put in if you had more time?

Kirby Dick

There are so many devices for us to look into. There are so many devices that were hurting and killing people, and we looked into dozens of them, and as you said, there could've been a series. So I mean you know, there's a lot of them in our film, but there's a lot more that we weren't able to cover. But you know what, what we were able to cover is we were able to cover some very heroic stories of people who have been harmed and who were getting together and fighting back against the medical companies and the medical device companies and the FDA, and you know, I think it's sort of the future of the patient movement is we document it in our film that this group of incredible women that's now I think over 36,000 women and some men who gathered together. They have really been taking on these companies, the medical device companies, and the FDA, and it's a very thrilling story that we capture in the film.

Michelle Llamas

I think it's a great public service that you guys did. So I want to personally thank you for that because it's an educational piece that everyone really needs to see. You know, we're all touched by this stuff. You know someone that's had an implant maybe, or that's looking into them. So again, super important. Did you want to say anything on that Amy as far as what you think you wish you might wanted to put in the film but didn't make it?

Amy Herdy

That the FDA is funded for the most part by industry. We had to choose which facts we were going to put in and we couldn't go down that road because then that's another whole segment … that would've added another two hours to the film right there. But yes, the FDA is funded by the very industry that they are supposed to regulate. There's a huge conflict of interest.

Michelle Llamas

The fees that they pay go up every year because Congress approves that they pay a bigger and bigger chunk every year, and tax payers are less and less a part of that. So it's interesting that they're supposed to be working for tax payers you know, and making us safe, but then now they're run by industry, like you said. So now you know, the film is about to come out here on Netflix soon — that'll be amazing. What do both of you hope this film will accomplish?

Kirby Dick

Well I think first and foremost, I hope that it informs people to not to just assume that when their doctor says you need this medical device, you should get it implanted, that they should just go ahead and do that. I think, sadly, even if they have a really good doctor, their doctor may not know all of the information that they need to know. So first off, of course, get a second opinion. I mean that would be the first thing. But I also would say do your research because many of these devices are hurting and killing people, and you know, we have so many stories of people who should never have gotten these devices and they were trying in most cases, deal with a simple health problem, and then it became a very serious health problem, and in some cases, a life and death issue. So you know, just don't assume that a medical device is what you need. And also don't assume that because it's a new medical device it's better. The newest medical devices haven't been around and people don't even know whether they're harming people. At least the ones that have been around 10 or 20 years, at least you can find out by doing some research if they're harming people.

Michelle Llamas

New is not always better. A lot of times the industry puts innovations before safety, right? Or so-called innovation. They just want a new patent to money on. But your turn here, what do you hope this film will accomplish?

Amy Herdy

Greater awareness. I hope everyone watches the film who has medical device, who uses a medical device, who knows someone who uses a medical device, and that's just about everyone, right?

Michelle Llamas

It is.

Amy Herdy

It includes contact lens and tongue depressors and CT scanners, and you know, hip devices, I mean it goes on and on and on. So as Kirby said, I hope that people will ask more questions about any medical device before they use it or have it implanted. I hope they ask questions of their physicians. I hope they check into the safety record of that particular medical device. All of those things, because you know, their life could depend on it.

Kirby Dick

And you know, we're moving into a time where medical devices — the future of medicine is medical devices, and there's going to be more and more and more implanted in more and more people. And so you know, nothing so far has changed in terms of how they're regulated. So the risk is just increasing.

Michelle Llamas

Any parting thoughts for anyone that is listening to the show today that you might want to say to anybody?

Kirby Dick

Well I would just encourage people to see the show. I mean one of the things you know, when we show it to audiences, they are so grateful for having seen the film. Not only do they find it extremely informational — we see people texting relatives about what they're learning in the film as the film is going on —it's also actually a film about women getting together and fighting for change. So it's actually a very thrilling film to watch in a lot of ways. But, you know, the film can not only change your life, it could actually potentially save your life or save the life of someone you know.

Michelle Llamas

Anything to say Amy?

Amy Herdy

It's very inspirational. It's a testament to the power of advocacy and patients banding together to demand change.

Michelle Llamas

I keep saying how amazing this is and I'm gonna thank you guys again. So thanks for the film, and thank you for being on the podcast.

Kirby Dick

Thank you so much.

Michelle Llamas

Thank you for listening to this episode of the Drugwatch podcast. For more information on this episode, or if you would like to be a guest on the show, visit Drugwatch.com, or email Michelle Llamas. Drugwatch podcast is not a substitute for professional legal or medical advice. The views and opinions expressed by the hosts and guests do not necessarily reflect those of Drugwatch.

Please seek the advice of a medical professional before making health care decisions.

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