Deadly Malfunctions, FDA Inaction and Vulnerable Patients
ProPublica reporter Neil Bedi published a disturbing story recently about a heart pump called the HeartWare Ventricular Assist Device, or HVAD. HeartWare is for patients who are suffering from heart failure. Surgeons implant it on patients’ hearts, and it helps pump blood, often until a patient can receive a transplant. But there’s a problem: The device itself comes with serious risks. Risks that the Food and Drug Administration was aware of but most patients did not know about.
Here are Neil’s findings:
- FDA inspectors found manufacturing and device quality problems at HeartWare over and over since 2014, but they never penalized the company.
- Thousands of patients were implanted with the HVAD while the FDA knew the company had serious manufacturing problems.
- The FDA trusts medical device companies to investigate cases where their devices may have hurt patients or led to deaths, despite the clear conflict of interest.
- Patients told ProPublica they were unaware of major FDA citations against the company and even some serious device recalls.
In response to these findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
Medtronic declined to make senior executives available for comment, but in an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients. … Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
Something that always disturbs me about ProPublica stories like this one is how ill-equipped most of us are to grapple with life-or-death medical decisions, especially on the fly. Those kinds of decisions tend to find everybody eventually. So I spoke to Neil about what it means to make those choices, for yourself or for your family, and the support systems that don’t exist. Our conversation has been edited for length and clarity.
Karim Doumar: While you were reporting, you talked to a lot of people who either themselves or their loved ones ended up with what appeared to be faulty equipment attached to their hearts. What are the main emotions you heard from them? Do they regret getting the devices? Are they angry?
Neil Bedi: For a lot of them, when we first started talking, they were grateful for the device and accepted that there could be problems. Some of them I had talked to before the company decided to shut down the device, and that was a clear trigger for some people to say, if the device got shut down, why were you implanting it in me? When I started telling them a bit more about the problems the FDA found in inspection reports (the fact that the FDA had determined that the company wasn’t meeting federal standards as far back as 2014), they started to really feel upset that they were never told about this before, that the FDA and the overall system was set up so that they could get these devices implanted into their hearts. The surgery actually cores out a hole from your heart to put the device in.
Doumar: Most of us really depend on our doctors’ expertise, and doctors should obviously be on top of FDA warnings and company recalls, but it’s really clear in your story that they often weren’t and were recommending the device to patients. What are the hurdles that stand between doctors and good up-to-date date information?
Bedi: I think they’re in a tricky situation right now because it’s coming out that this device had problems, and they don’t want to say they didn’t know about the problems (because who wants to hear that their doctor didn’t know about problems?) and they also don’t want to say that they did know about problems and decided to implant the devices anyway.
It is really interesting, though, that some of these FDA findings don’t necessarily go straight to health care providers. The FDA even told me they found problems, knew companies weren’t resolving the problems and started meeting with the company more often. Their solution was to meet with the company a lot to try to help them resolve the problems, but at some point, when you’re talking about six, seven years of unresolved problems, that’s not working.
Doumar: Do you mean that they’re not even releasing information publicly or telling doctors at all? They’re just trying to resolve it quietly with the company?
Bedi: It’s not clear what doctors do and don’t know, and that’s been one tough part about this. Warning letters, which are the FDA’s big citations, are posted online. Specific inspection reports aren’t posted online. They can be obtained through the Freedom of Information Act, and sometimes news organizations or industry publications obtain them and publish them online, but they aren’t as readily available. Maybe what we’re getting at is patients, especially patients with this device, don’t know. And when they are in the position where they need this device, they don’t really have time, energy or anything to research. They’re in a position where their doctors are telling them you need this device or you can go into hospice.
Doumar: You can get some of this information through freedom of information requests, but I know in the story it says there are big backlogs. Why isn’t this information more publicly available and easily accessible?
Bedi: It’s not clear. Some critics say that the overall system is built to be pretty industry friendly. I’m planning to report on that next, and figure out how the system was built this way, and why it sometimes doesn’t help patients.
[Note: If you or a loved one have a heart pump, pacemaker or some other life-sustaining medical device, or if you’re a medical professional who works with these devices, you can help Neil continue his reporting by filling out this form.]
Doumar: I can’t stop thinking about this quote from the story where Latoya Johnson Keelen, whose pump failed, said: “I kept seeing Medtronic on record saying they notified patients. Who did they contact? No one told me.” That’s in reference to a recall effort. How do recalls work and why do they break down in terms of communicating with people.
Bedi: Recalls in this case are really interesting because you’re talking about a device that is inside of you. The pieces that are on your heart, you can’t really touch or fix. So each recall for these kinds of devices is a little different. Sometimes the recall can tell health care providers to contact their patients and replace certain external components of their device. Sometimes when the problems are internal or the problems are with a certain way of handling the device that could cause issues, they’ll send out warnings and say “don’t do this; we’ve seen that cause problems; be careful the way you handle your device.”
Doumar: As part of your reporting you obtained some X-rays, and I think it’s really jarring to see electronic devices inside of people’s bodies. Can you talk through how you got patients or their families to send you these things, what you learned from them and how you use that kind of really personal information to shed light on systemic issues?
Bedi: I knew I needed to understand what it was like to live with these devices because I had no idea. I don’t know what it’s like to rely on one or have a disease serious enough. So I started reaching out to as many patients that were willing to talk to me. For the ones specifically in the story, I went out and met with them. I asked to see whatever documents, whatever information they had. One of the patients let me put my ear against her back to hear what the device sounded like. My best comparison is like a laptop fan, humming. And it’s just constantly happening because it’s constantly spinning. Patients told me they don’t necessarily hear it during the day, but when they lie down, they can definitely hear it. They also told me if you lean over in a certain way, even though the pump itself is very light, you can feel it press against your ribcage, and you’re just always aware that it’s there. Johnson Keelen, she found comfort in that. She knew that the one piece of her body that had broken down was now powered by a machine, and that felt empowering. So the devices, when they work, can really help patients. What happened with her later is she found out there were these problems that were well known to the FDA, well known to the company, but not well known to her, and it put a totally different framing on her experience with the device.
Doumar: This is personal so you can be vague if you’d like, but how does reporting a story like this impact how you think about your own health care?
Bedi: There are two takeaways. Maybe one isn’t really much of a takeaway. It’s just that I’m thinking about it way more often. When I see health care systems mess up for patients, that let down patients, I’m always thinking about my own medical care a bit more keenly. I’m curious if I’m going to a doctor, are there any records of problems with the doctor, or if I’m going to a hospital, what do the hospital’s inspection reports look like? So I am always thinking about that.
But on a positive note, whenever I do one of these investigations into patients who have been hurt, I’m just always really impressed seeing how strong they are in the face of those events and seeing them persevere. That always gives me hope. They’re always stronger than I ever expect myself to be. And hopefully that means I find some strength from that too.