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Part I: Consumer Reports Official Advocates for Warranties on Medical Devices

Lisa McGiffert of Consumer Reports

Welcome to a special two-part podcast featuring Lisa McGiffert, director of Consumers Union’s Safe Patient Project, the policy arm of Consumer Reports, a publication trusted for its integrity and dedication to the best interests of the American consumer.

On this episode, McGiffert phoned in from Safe Patient’s offices in Austin, Texas to talk about their mission and a new revolutionary campaign to get manufacturers of hip and knee implants to warranty their products.

After all, if cars and other products are warrantied, why shouldn’t companies provide warranties for medical devices implanted in humans?

Some of the most troublesome devices are metal-on-metal hip implants. These devices have the highest premature failure rates, and more than 750,000 Americans received these implants over the last decade.

Hip implant manufacturers now face a deluge of lawsuits filed by people who suffered complications from failed devices. Injuries range from infections and dislocations to bone and tissue damage that requires multiple revision surgeries to correct.

Safe Patient proposes that a warranty will hold manufacturers accountable, make products safer and help patients handle the costs of replacing the device.

‘End Secrecy, Save Lives’

The Safe Patient Project has spent the last decade enacting key legislation that protects patients and makes information more accessible to the public, allowing them to make better decisions about their health.

Its mission: End secrecy, save lives.

McGiffert says Safe Patient advocates for patients and endeavors to prevent medical harm by educating the public.

The campaign sets itself apart by working hand-in-hand with people who suffered medical harm from dangerous medical devices, hospital negligence and other causes. Through its dedicated national network of activists, Safe Patient crusades to make health care safer for everyone.

They also work closely with the health ratings system of Consumer Reports, publishing information about infection rates in hospitals, how patients fare after treatment in hospitals and error rates of surgeons and other physicians.

In September, the advocates at Safe Patient rolled out their latest campaign focused on warranties for hip and knee implants to improve the safety of these devices and educate the public.

“Patients have a right to know how long medical device manufacturers are willing to stand by their products,” said McGiffert. “While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty.”

Why Should Hip and Knee Implants Carry Warranties?

Doctors perform nearly a million hip and knee and hip replacement surgeries a year, and the surgery is becoming more common as the aging population grows.

The majority of hip and knee implants, especially newer models, have an improved design that makes them safer and more durable than older models. However, when these implants fail, they cause problems that affect a patient’s physical, emotional and financial health.

Currently, the patient and their insurance company have to deal with the cost when the implants fail.

“These implants are being used in younger and younger patients. If you are 40 years old when you get your first implant, and it only lasts 10 years, you may have to have four or five revisions. Each revision is going to get more and more difficult,” McGiffert said. “These are things that people need to consider when they are thinking about getting an implant.”

Even people who don’t have these implants suffer consequences.

American taxpayers contribute to Medicare and foot the bill for these faulty devices to be replaced in patients over age 65. According to Safe Patient, the average cost of hip replacement surgery is $19,000. Revision surgery, a more complex procedure, can cost thousands more.

Here is another little known fact: Most of these devices are not tested for safety before being implanted in patients.

The Food and Drug Administration’s 510(k) approval process only requires manufacturers to say their device is “substantially similar” to another device previously on the market before they are allowed to sell it.

“This is the way the market works,” McGiffert said. “So there are a lot of unknowns going in. A lot of the patients we’ve talked to don’t even know what specific device they have.”

Making matters worse, there is no standardized system for notifying patients and doctors during a recall because the devices are not tracked.

What Should a Warranty Include?

The Safe Patient website details points of an ideal warranty program:

  • Cover the implant for at least 20 years.
  • Cover the full replacement costs of a flawed device, including the device, surgeon, and hospital costs, as well as the related patient out-of-pocket costs.
  • Give the consumer the option to replace the failed device with another manufacturer’s product if the implant has been recalled by the FDA or the company, is subject to FDA warnings, is under investigation by the FDA, or if the product is no longer being sold by the company.
  • Establish a clear communications system for patients to use, including a toll-free number and a registration number to track the claims process. Physicians will charge the device company, not the patient.
  • Not require the patient pay out-of-pocket expenses. For example, the patient should not have to pay the device maker or surgeon first, and get reimbursed later.
  • Provide the patient with full information concerning a warranty claim denial and a process to allow the patient to appeal the decision.
  • Not limit or eliminate a patient’s right to sue if they use the warranty.
  • Not disqualify patients across the board if they have specific diseases or illnesses not related to the failure of a device.
  • Not disqualify patients for normal activities, including falls.
  • Not disqualify patients due to information that is not routinely available to them, such as information that is on the device packaging or placed into their medical records.

Join the Conversation

Have an opinion on whether hip and knee implants should be warrantied or have questions about a problematic implant? Drugwatch wants to hear from you. You can email us at [email protected] or tweet us @DrugwatchRadio. You can also comment on our Facebook page.

Join us on the next episode of Drugwatch Radio for Part 2 of this series.

Podcast Transcript

Michelle Llamas: Hi there, and welcome to another episode of drug watch radio. On this special two-part series, we talk about hip and knee implants. When a product fails, many times we can count on a warranty to replace or repair it. This is not the case with hip and knee implants. My guest today is working to change that. Lisa McGiffert directs Consumer’s Union’s Safe Patient Project. Consumer’s Union is the advocacy arm of Consumer Reports. The campaign works on state and national levels, to make information available to consumers about medical harm, focusing on healthcare-acquired infections, medical device safety, medical errors and physician accountability. Lisa joined us via telephone to talk about their mission and to talk about their new campaign to get manufacturers to warranty these important medical devices. The following is the recorded telephone interview.

Michelle: Welcome to the show, Lisa, glad to have you with us.

Lisa McGifferet: Thanks, it’s nice to be here.

Michelle: Lisa is calling in to our show from Austin, Texas, today and so we are very fortunate to have her. Tell us a little about Safe Patient Project, its mission and how it’s connected to Consumer Reports.

Lisa: Our mission statement is end secrecy, save lives. So a lot of our work to advocate for consumers and patients in the arena of the health care system trying to prevent medical harm is focused on getting information to consumers so they can see which health care providers have the worst record. For example: on medical harm and also to be just more informed consumers. So much of our work is around that mission. And Consumers Union is the policy arm and advocacy arm of Consumer Reports. And one of the things that we do with Consumer Reports is work very closely with the health rating center that was created about five years ago and is publishing ratings of hospitals using information about infections and other outcome measures about how patients fare in hospitals, and they also do a little bit on physician groups like surgeons. And, hopefully, in the future that rating center will become more and more robust, as more information is available to us on errors that occur in the health care system.

Michelle: I see, so you’re trying to do a lot more of that rating system which is kind of helpful to people and I think there is one that is similar right now like US News and World Report that, you know, they kind of do the rating system for, I believe, hospitals every year and stuff like that, is that kind of what you are trying to get more into?

Lisa: Well, they have a different system. We are taking the traditional Consumer Reports blobs, we call them, the circles, the red and black and half-red circles that we use with other products and that people are familiar with to give a quick, at-a-glance reference to people on how well their hospitals are doing and behind those blobs will be real data, if they want to look further into this. So we have our own system, we have our – Consumer Reports has a long history of being trusted and accurate and reliable and we use really careful processes to figure out how to rate hospitals and so I think it’s a, it’s different than the US News and World Report, but there are a number of other rating systems out there in America that are taking some of this information that’s now available, and translating it. And generally, we think that’s, you know, that is a really important part of getting this data. You can’t just throw a bunch of numbers out to the public. There needs to be translations to the public. And we pride ourselves on being able to translate information to consumers while other translators might be focusing on health care providers like hospitals or doctors and, and they would translate the information a little bit differently. So it’s going to take a lot of different translators to really make this, the data that’s available about outcomes and harm, make it more usable to various stakeholders in the public.

Michelle: Now, I was going to say that’s one thing that I think that I find extremely useful about the way that you present this information as opposed to other people who, you know, they might just list a bunch of information and while it’s there and you can see it, I like how you unpack each of those statistics and you kind of  go in there with reports like I was reading on the hip and knee replacements which we will be talking about today and how you actually go in to each company and you provide the background on the research, you know, that is related to it, and it makes it very easy to understand for someone that, you know, is looking at these statistics and saying, “Well, hey, what does this really mean?” So, you know, and that’s fantastic.

Lisa: Thank you.

Michelle: But now how long has the Safe Patient project been around?

Lisa: Well, we’ve – this is our 10th anniversary year. We started in 2003.

Michelle: Congratulations! Yes.

Lisa: Yeah, and, over the 10 years we have, we’ve been working on various issues that we’ll talk about later. But during the process, one of the things that’ve been consistent, is we ask people to share their stories with us. And we engage consumers to become activists. And in our project, we have been able, and it’s been a distinct privilege to meet so many people who have experienced harm, survived it, or, perhaps lost a loved one and they are extremely dedicated to try and make sure nobody else has to experience what they have experienced. So we’ve developed this whole network of consumer advocates from around the country who extend our reach, because we’re rather small in, in our staffing, but we have all these people around the country and they do work locally, nationally and state-wide, in their respective states. For example, in September, nine of them are attending a national meeting that the US Health and Human Services Agency is putting on for their national strategy meeting on eliminating hospital-acquired infections.

Michelle: Yes, yes.

Lisa: And we work, we work to bring more accountability to patients from state and medical boards that regulate doctors, as well as, we work to improve the safety of medical devices like hip and knee implants.

Michelle: You’ve launched a new campaign that is trying to get the hip and knee implant makers to warranty their products, and you know, people already have warranties on their cars, warranties on all kinds of other products, so you know, to me it makes sense. But how did the medical device warranty campaign for the hip and knee implants come about?

Lisa: Well, I think I’d have to say it percolated up from the activists that we work with. We, last year, we worked on, on some congressional legislation to strengthen the laws in regulating medical implants and we did some visits with activists that we work with and the issue of, “Why aren’t these products warrantied?” kept coming up in their presentations to congressional members. And we started thinking about it and thinking, “Well this is a pretty good idea.” And, and so it seemed to be a natural for Consumers Union and Consumer Reports and it seems to be a no-brainer because people expect these kind of guarantees when they buy all kinds of products.

Michelle: Oh yeah, I mean, food, cereal, you know, every – everything. So, yeah.

Lisa: Absolutely, and, and it’s interesting because a lot of people think that these products already have a warranty. But, they, you know, they really don’t. And it’s, it’s, it’s very important for these implants to have a warranty because they’re, you know, in people’s bodies. It’s even more imperative to have a warranty on something that is so invasive and we think that patients should, should have a clear understanding of how long this device is expected to last. And a very clear process to follow if their device should fail prematurely.

Michelle: Yeah, because right now, basically, they are taking the word of the manufacturers who say, “Okay, these things are going last about 15 to 20 years.” And that’s just sort of based on the marketing and then, the only way they know what to do, if anything at all is if there is a recall letter. You know? And some of these things like, I believe, recently which has gotten a lot of media attention because of the lawsuits attached to it the DePuy hip, which is the ASR. It was a staggering failure rate of 40-percent failure rate. You know, within five years, which is nowhere near to the 15 to 20 year range that the manufacturers claim, so that was another thing. And there were 93,000 of those sold. And like you said, it seems like something that makes a lot of sense but yet has sort of not been tossed out until actually – until you all. You know, until Safe Patient decided to, to pick up this cause, but now, let’s talk about the reasons why the product should be warrantied. They’ve been on the market several years and people have sort of not even thought about it, so why bring up the whole warranty aspect now?

Lisa: Well, a lot of what you’ve already said – companies make claims in their ads all the time that allude to how long they will last. They use – the one phrase that we see a lot is, “25 years of clinical heritage,”  or “30 years of heritage” to show that the company has been around a long time. And they also show in their ads long-distance bicyclists and mountain climbers. They have names like “Triathlon Knee” and, and so we think that it’s really important if you’re promoting the, your products in this way that you stand behind them. And you actually give a finite number. We are asking for a 20-year warranty. We’ve heard from many consumers and they’ve been told, you know, anywhere from – most of them between 10 and 25 years. And they’re typically told by their doctors, and it’s, it’s more of a casual conversation, than a piece of paper that says, “Here’s how long it’s guaranteed, and if it fails, call this number.” Which is what we want. The other things that are important for why we think a warranty is important right now is that more and more of these devices are going into younger patients and we have a growing Baby Boomer population that is more active and will live longer than those before them. Most of them aren’t just sitting on the couch. We have many active 70-, 80-, 90-year olds in this country. And so there are some limits to the number of the, of revisions that are possible. So if you’re 40 years old when you get the first, your first implant, if it only lasts ten years, you may have to have four or five revisions. And at some point, each revision is going to be more and more difficult due to, you know, the, the tissue and the bone that you have left. So these are things that people need to consider when they’re trying to make informed choices about whether or not they’re ready for an implant. The other issue is that, there are several, there are several other issues! But the vast majority of these implants have never been tested for safety by the FDA. They’ve been approved or cleared – they don’t even call it approved on a fast-track process where they just have to prove that they’re substantially similar to a device that was already on the market.

Michelle: Yes, and, and this is the 510(k) process.

Lisa: The 510(k) process. Yes, and this has happened for decades. And each one is an iteration of the one before. And when you go back far enough, you get to the ones that were grandfathered in and never had any safety testing. This is the way the market works. So there’s a lot of unknowns going in. And then on the back end, after you get these devices implanted, there’s no national system for post-market surveillance or tracking what happens to these devices after we put them in patients. And then when there are recalls, which are done by the companies almost always – volunteer recalls – we don’t have a system to notify patients or even doctors who have put these in all their patients. And the companies often can’t find the patients and so often difficult to identify and locate those people who have a particular device. We found, from a lot of people we’ve talked to that a lot of them don’t even know what specific device they have.

Michelle: Yeah, no, you’re right!

Lisa: So if there is a recall, they might not know that’s the one that was in them. So these are all issues that I think that we want to get at. We think not just a warranty. I mean we are doing other education – for consumers to ask more questions, find out what type there is being put on, into your body. Ask for the box, ask for the inserts, have that information in your hands, so that you know you have it all with you, if something should go wrong. And most implants don’t fail. But sometimes they do.

Michelle: Yeah, and, and when they do, you’re, you know, you’ve got to have a, a clear understanding of, of what to do next. . . . If you are just joining us, we are here speaking with Lisa of Safe Patient Project and we are talking about the very important issue of warranting knees and hips. Now, we were talking about why they should be warrantied and we talked about these implants in general. Are there specific designs of implants that you’ve seen probably could use a warranty more than others.

Lisa: Well, we’re not discriminating on designs, we’re asking for all the hips and knees to be warrantied.

Michelle: I got you. So across the board.

Lisa: Yeah, across the board. And, and we have targeted the six top sellers of hips and knees, because they make up the most, the majority of the market. And so we’re asking them to warranty their products. And we feel that if they do it, others will follow. And that will, that will cover most of them. Certainly there are some failures that have been particularly spectacular, like the metal-on-metal hip.

Michelle: I like how you say that: “particularly spectacular”!

Lisa: Yeah, in . . . in a bad way.

Michelle: In a bad way, yes. Now, so we’ve got the issue of the warranties now, we kind of know the problem, we’ve talked about people with these implants. Some other people, you know, that don’t have them, they probably wonder why they should support this. Is this something that, you know, is important to them as well?

Lisa: Yeah, we get that question a lot, and when you think about young, young people, this is not something that’s on their radar.

Michelle: Yeah, yeah.

Lisa: But, but they or someone they love is probably going to need an implant at some point in their lives. The number of implants are increasing every year. It’s a, it’s a really booming business I guess I would say – quite a significant increase year to year. Additionally, these add an extraordinary amount of cost to the health care systems – billions of dollars. And all of that goes in to, you know, the insurance premiums we pay, Medicare costs which is supported in part by taxpayers and, and generally the cost to the health care system. So if you have devices that fail that, that will trigger more cost to the system. And if the patient – we don’t want the patients or Medicare or insurance companies to have to pay for something that was really the fault of the, of the manufacturer.

Michelle: I see so yeah, there you go. You –

Lisa: We want the responsibility to go with them. Because that’s good business practice.

Michelle: Yes, yes, it is.

Lisa: And that’s the bottom line.

Michelle: Yeah, and if you are guaranteeing these products, or making claims, you know that they last “X” number of years, it should be no problem right? To warranty them at that point if they’ve, you know, passed your own in-house company standards. So now –

Lisa: That’s right, and many of them say that they’re, you know, they, they say they are very proud of their products and that’s a good thing. And they say that they have very few failures and we would say to that then, “What’s the problem? Surely you would be able to guarantee these, these few that fail.” So that people when they’re down, you know, when they’re hurting, when they’re really in bad trouble – they need a, they need a clear system and they need to know that they’re not going to have to worry about going bankrupt to get this taken care of.

Michelle: Yeah, because, I think you had some numbers and figures that I think are actually lower than I thought about each revision surgery costing roughly $25,000, right, each time this happens.

Lisa: We’ve had a lot, we’ve had a lot of comments about the cost estimate that we used in some of our background papers and, and we were conservative. The fact of the matter is we don’t really know how much it costs. Because often, these, when these companies sell their products to, say, hospitals or orthopedics clinics, they do it in a large bundle of products.

Michelle: Got to, yeah.

Lisa: And, and, and they have a negotiated price and very frequently, as part of that negotiation, the provider, the surgeons group or the hospital has to agree to not disclose how much they paid for the devices.

Michelle: I see, now that’s very interesting. See, now, I didn’t know that. Okay, yeah.

Lisa: And even Medicare doesn’t always know how much they’re going to cost because these devices keep changing over time very quickly, they tweak it a little bit, change it, put a new name on it and then Medicare has to go through their system again to figure out how much will they pay on that product. So it’s a, it’s a process and of course, replacing the device will be at significantly less cost to the device maker because – I would guess that most of these devices don’t cost more than three or four hundred dollars to make.

Michelle: No, and they make thousands on each. So yeah.

Lisa: But they sell for tens of thousands.

Michelle: Yeah, so there shouldn’t be a, you know, question there of “Well, we haven’t got enough money set aside to guarantee these products.” So, I mean, just based on what you would make on the first sale, you would think, anyway, that they could cover anything that would come out of that for each patient. But also you mentioned there, you know, that each patient shouldn’t have to deal with this because, yeah, there’s, I mean, there’s a lot that goes into something when, when a hip fails, a hip or knee or any of these devices, and you know there’s care givers also involved the family’s involved, there’s lost work, there’s, I mean there’s a lot of stuff that, that goes into this, beyond the medical bills themselves. Now we talked a little bit about the history of implant failure that Consumer Reports has done. Now, is this a bigger problem than, than most people suspect? We said earlier that, you know, most implants don’t fail, and that’s true, but do people take for granted the fact that maybe they’re more reliable than statistics would actually show?

Lisa: I think that there’s, there are some unknowns to that. I think that most people think that someone is minding the store up front. That before these are implanted into thousands and thousands, tens of thousands – hundreds of thousands – of patients that there is someone that has tested it, declared that it was safe based on the evidence before it moves out. And that simply does not happen. In fact, much of what we’re part of is a big, a big test.

Michelle: With these devices especially.

Lisa: Once these go on the market, they, they – that’s the test. How, they don’t really know, how long these are going to last and whether they’re going to fail or what the impact of them are and so we, we have to look at history. And so what we did was, we looked at the recalls of these top six companies to see, you know, well, how, how often have they had recalls and in the last ten years just these six alone we found more than 1200 recalls. And some of the recalls, are you know, are for parts or, most of the recalls that – the FDA typically doesn’t recall devices, but they do have a requirement that when a company recalls something, they report that to the FDA. And the FDA classifies those recalls as to serious, you know, how serious they are. And they, they also have a database online, where people can look up to see whether a product has been recalled.

Michelle: Welcome back to Drug Watch Radio. I’m your hose, Michelle Llamas. . . . You mentioned that FDA database. Now I have been on it myself, for, you know, various things and it is not at all patient-friendly. It’s not.

Lisa: It is not.

Michelle: It is difficult to navigate that. So, even if someone knew it existed, like, finding these products is very tough.

Lisa: It is very tough. We, we thought we could do a quick scan to figure out how many of these products did each of these companies –

Michelle: Oh, and you said quick scan!

Lisa: And, we couldn’t come up with it. You know, we, we couldn’t come up with a definitive list. And, but it was hundreds and hundreds and hundreds of parts. And it was very difficult, because they had different names or different parts, and, and we discovered that there’s another, another sort of category of recalls that we had not thought about before and those were what we were calling sort of tools that the device maker offers to the, the doctors to help them.

Michelle: Yeah, like kits, or, or something, right?

Lisa: They’re kits, they’re – they’re software, sometimes. They’re guides to show where to cut the bone. And when those are off, that can cause failure also to a patient. And a number of those were recalled also. It’s sort of like, our understanding is that all the parts are sealed so that they’ll be sterile in, you know, in the operating room, you open up the parts and you find out that maybe they’re mislabeled or they might be longer than they should be or, all of this –

Michelle: Yeah, and this isn’t like you are putting together a desk from Ikea.

Lisa: That’s right. That’s right.

Michelle: You know, it’s a person’s limb! So, yeah.

Lisa: Yeah, it’s a lot more serious. And these things do happen and that requires some scrambling while the patient is sitting there, anesthetized, and, the longer the procedure, the more risk of things like infection, which aren’t typically connected with the flaw in the device, but that can happen if the procedure is delayed.

Michelle: I for one, as a consumer, appreciate the research that you all have done to put this together in something that’s more coherent.

Lisa: One of the things that the companies all say is that it’s really difficult to tell what caused the problem. And we know that there are infections, there are errors on the part of the physicians, there are infections due to some conditions in the hospital, there are things that happen, there are horrible falls or something that a patient might do that causes the failure. We’re not asking the companies to guarantee that. We’re asking them to warranty the failure – their particular product against failure. And to have that process like any other product in America . . . When you call in and say, “I want to – you know, I’m equipped with a warranty and I want you to honor that warranty.” They’re going to ask you questions: “Did you throw that radio in the bathtub?” “Did you abuse it?” “Did you plug it into the wrong kind of socket?” “Did you . . .” You know, what are the things that happened? That’s the process that we want them to go through. And we’ve been told that it’s pretty, you know, it’s not that difficult to figure out if it was a flaw in the product or some other thing that caused the failure.

Michelle: Thank you for joining us on this episode of Drugwatch Radio. We hope you’ve enjoyed this podcast. If you have any questions about anything you heard on today’s show, you can email me at [email protected]. You can also tweet us @Drug_watch. Please join us on the next episode for Part II of this special podcast with Lisa McGiffert. I’m your host Michelle Llamas and on behalf of the team at Drugwatch, thanks for listening.

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