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131 - Tom Wilson - The Philips CPAP Recall

Tom Wilson

[00:00:00] 

Emma Cooksey: Tom, thank

Tom Wilson: You're welcome.

Emma Cooksey: just to give everybody else listening and watching the background, we first met because ASAP, the Alliance of, I want to say, sleep apnea partners, and did a webinar about the Phillips Recall, and we were both on that webinar, and I thought to myself, I've got to have him on the podcast, because I haven't actually done an episode about the Phillips Recall.

I've talked to lots of people affected, but this is the first time we're really talking about it. So, some of it. is going to seem pretty basic to you but I want to just make sure everybody has all of the information. So why don't you start off with just telling people, you come at this from a patient perspective but then also an interest in consumer rights

So did you want to just start by explaining to people a little bit about your professional background and then we'll get into more of your Personal journey with sleep

Tom Wilson: Yeah, my background [00:01:00] is I am a business person. I have been in pretty much consumer products my entire career. I'm retired now, but I worked for Colgate, Pomalov in New York, and then I worked for Kimberly Clark, a total of about 30 years. I've also started up three businesses on my own. And so in the consumer products marketing space, you know, we're talking about brands like Colgate and Palmolive liquid and Huggies diapers and Kleenex and pull ups and Kotex

 but also along the way, starting in the, Mid seventies actually I ran into a situation where a store was not living up to what they said. In other words, we bought a, we bought a video game and my wife asked if it could be returned if her brother got one for Christmas or he didn't like it.

And he said, sure, as long as it's not open and you have a receipt. So after Christmas brought it back and he wouldn't [00:02:00] do it. So that really made me angry and I started keeping a file on different situations like that and over literally over a 30 year period, figuring out ways to, for consumers to get what they deserve when something goes wrong, dealing with an organization, whether it is a company whether it is a a nonprofit doesn't matter.

So ultimately we wrote a book on it and it's called Negotiate Anything. And so I am a consumer advocate. It's just a passion of mine. You know, like most authors made zero dollars off, off the book, but it was something that we just had to do. And so along the way, I was diagnosed with sleep apnea and I got myself a machine and happened to be a Phillips.

Emma Cooksey: So, so normally I interview a lot of people about their journey to diagnosis and for some of us that, that story and that journey takes about 45 [00:03:00] minutes to go through,we say, you know, when did you first notice the symptoms? And they say, well, you know, and like for me, I went undiagnosed for 10 years.

So there, there's a whole arc of like misdiagnosis and over here and doing all these things. But for you, I suspect, I suspect your diagnosis story can be done and dusted in like 30 seconds, so can you tell everybody,did you notice that you were having symptoms? how did it come about that you

Tom Wilson: Mine was totally typical. You know, my wife was always complaining that I kept her up at night snoring. And of course, Typical male. I said, no, I don't snore. And finally I relented and I went and had a sleep study. Which, anyone that's had one of those, that's an interesting situation in and of itself.

When you're,

Emma Cooksey: So you were in an in lab sleep study where you had to

Tom Wilson: no, you know, they hook you up with a thousand wires and you can see the cameras where they're looking at you while you're sleeping. [00:04:00] Anyway, so I was diagnosed with sleep apnea, but a very mild case. For example, they just measure how many times you wake up during the night. And I was waking up about 13 to 15, which is called mild.

I think yours is more, was more like, was it 60?

Emma Cooksey: No, so mine's severe, so now it's about 40 in the, like, sort of 41,

Tom Wilson: Okay.

Emma Cooksey: depending on which study, So what did they say about treatment

Tom Wilson: The only option was we're going to sign you up with a machine. And

Emma Cooksey: So they said

Tom Wilson: yes, now the way the insurance works here in the US is insurance companies, you have to have a certain severity. And with Medicare, and I was just like three months out from getting Medicare, their threshold was actually higher, okay, than typical insurance.

So I wouldn't qualify for Medicare to cover the device. And so I went online and I ordered a machine off of [00:05:00] Amazon. And this was a Philips DreamStation, the one that had been recalled.

Emma Cooksey: So you needed a prescription,

Tom Wilson: a prescription

Emma Cooksey: doctor, your doctor was able to do the prescription, just the insurance company

Tom Wilson: that, that's, that's right. So if you look now, you'll see that Amazon does not sell devices. I don't know why they had this listed at the time, but it was my DME, their price was, I think about 12 or 1300. I bought it for, I'm thinking in the 300 range, brand new. So anyway, I got it and happily used it for about two or three years.

And I also bought a device to clean it called SoClean, which uses ozone to clean the equipment. I thoroughly researched it. I looked at all their quote unquote clinical studies and paid 300. And so every morning, [00:06:00] I would drop my little face mask into the bucket and turn it on. And that was that. And then one day I called up one of the largest online purveyors of CPAP equipment called CPAP.

com and I had a question for them. So I had up on my computer screen, I had the website and I was talking to somebody about a certain mask when I noticed a little blurb on the screen that talked about a recall. And I said, well, what's with this recall? And so she explained it to me, she didn't know too much not that she wasn't intelligent, it's just that,

Emma Cooksey: I don't think anyone knew that much to begin with for sure.

Tom Wilson: So what immediately went through my mind was, this isn't good, they're saying it could be up to a year, which for me is code that it's going to be at least a year you're breathing in these specks and particles and nobody knows I had immediately called my pulmonologist. [00:07:00] They didn't have a clue.

They had heard about it, but they didn't know to say keep using, don't keep using

Emma Cooksey: Yes, that was one of the most interesting things that came out of, I was doing some research before the ASAP webinar and one of the interesting things from that, I think I just like heard from a lot more doctors, I just assumed as a patient, I call my doctor's office too and I don't even have You know, the machine that's affected, but it's just like, I don't know anything about the recall, so I was calling them and they were saying they didn't really know much else apart from what Phillips had put out in the initial recall statement, and I thought to myself, like, they must know all, you know, did the company not have to contact them and give them directions to go to patients, but now it seems like not.

I think the doctors just really were blindsided

Tom Wilson: I had also immediately, like, I guess a lot of people had done a Google search and I came across a quote from a, you know, really a [00:08:00] specialist at Mayo Clinic in Rochester. And he was, the gist of his quote was that, they're leaving us here with no information in how to what to recommend to patients.

Okay. And he felt like he was in a very vulnerable position. So I'm thinking, well, it's going to probably be at least a year. Nobody knows. You got these little specks and particles and you might be breathing in VOCs, volatile organic compounds. So, I thought, the other thing I knew was that the supply chain was all messed up and it was wrapped around chips and these things have chips in them, so I immediately ordered from CPAP.

com a competitive machine, a ResMed 10. Which of course they were selling at full price because the supply, I mean, this thing had just started. I was at the very front end, the tip of the spear so I paid about a thousand dollars for that, that device. And I [00:09:00] immediately quit using both the SoClean as well as the the Philips Dream Station.

Emma Cooksey: Of course Philips was already pointing fingers at SoClean that it's, well, it's really their fault. so just to explain, if people are listening and they haven't heard anything about it, I mean, I would have thought they would have heard about the recall, but they don't really understand what you're talking about. So the Soclean is a unit that uses ozone to clean the CPAP machine. So, Lots of, we've talked about them a bunch on the podcast before, especially like ResMed have a specific clause where, their warranty has an exclusion if you've used that machine because, you know, they're like, it hasn't been FDA approved to be used with their CPAP machine.

Philips. in that initial statement when they did the recall, there was some talk of like breakdown of foam and you were beginning to hear from people, perhaps these ozone cleaning [00:10:00] machines could have been part of that problem. So yeah,

Tom Wilson: that's good. That,

Emma Cooksey: to people that that

Tom Wilson: that is, that is correct. Philips also said that they specifically did not recommend you should not use the SoClean and that they've stated that. Well, I, I still had both of my manuals. When you buy these devices, you get two manuals, one for the quote unquote professional to set it up and one for the consumer.

So, I read every single word, all the nitty gritty. There was no mention of do not use. ozone cleaning devices. Now my, that was probably printed three to five years prior, but at that time there, there was no problem with it. And also at that time when I purchased it they were advertising they, meaning so clean, was on television frequently being advertised.

Emma Cooksey: The FDA also had a statement that essentially said that ozone is not effective, okay[00:11:00] and you shouldn't use it. For it to be effective, it would have to be at dangerous levels but at the levels that it the amount of ozone it puts out on its own, it would, it would be non effective. So, that, you know, that concerned me.

Tom Wilson: So, you know, I quit using ozone too and I put that away. As long as we're talking about SoClean and Ozone, I then wrote a very detailed letter to the CEO of SoClean telling him all the, all the problems and that the companies don't recommend it. And here's the FDA statement and requesting a full refund and they pushed back, but ultimately I got one.

They didn't want the machine back or the device.

Emma Cooksey: Yeah, because you wrote a book about how to do that, so I'm sure you got a refund.

Tom Wilson: yeah, it took, you know, it took three months.

Emma Cooksey: As I say in the book, you need obsessive brute persistence and facts. They also did not ask me to sign any kind of you know, waiver that said I wouldn't confidentiality agreement. [00:12:00] So now that battle still goes on. I believe that the FDA is in con is, is in conversations with.

Tom Wilson: Soclean, and probably the others there's lawsuits. Soclean has sued Philips, and Philips has a lawsuit against Soclean. So, those, those folks are battling that out.

Emma Cooksey: This is the part I need you for, because I almost, like, can't keep up with, like, the lawsuits going back and

I, you know, I believe, I'm no, I'm not a lawyer but I've been involved in enough of these kind of activities to have a sense. And I think that Philips is probably using this lawsuit to some degree to try to deflect the responsibility onto Soclean. Right. the thing that was odd to me was I'm not sure if it was maybe the ProPublica article or maybe their little video they did they were talking about a lot of the ventilators that were recalled for similar reasons [00:13:00] Those, are not supposed to be used, like, you know, SoClean was never suggested as a way to use, to clean those, it seems like that's not the only thing going on here, right? So, as far as you were personally concerned, you saw that there was a recall when you were on CPAP. com and you immediately got a replacement machine because you bought one. So then, take us through So, each night you were doing just fine because you were on this new machine, but as far as the actual recall, what were the steps you had to go through as a patient with one of these affected machines to return it to, Philips or get them to remediate

Tom Wilson: Well, just a little backstory. As I was sitting there after a few days or something, it dawned on me that going back a year or two, I had had some weird medical things going on. Three times randomly, [00:14:00] separated by months, I woke up at, let's say, 2. 30 in the morning and threw up. Well, it turns out that one of the symptoms of breathing in the VOCs and or the particulate is vomiting.

Okay? And so I had gone to my GP who had, you know, he did what he could do. Then he sent me to a pulmonologist for further study. I went to a gastroenterologist. Because the first time I threw up, I thought, well, you know, I had some bad sardines or something

Emma Cooksey: Right. Yeah. But more times than that

Tom Wilson: And the second time it's like, well, that's strange.

And the third time I'm like, okay, that's not normal. So, I went through a series of tests and, you know, it never happened again after I discontinued it. Now, I'm not going to say, you know, that's the, the, the causal effect,

Emma Cooksey: I bundle up all [00:15:00] that medical information, all the appointments, the CPT codes, and I sent it all to Phillips and I sent it to the FDA and I sent it to the, the lawyers that I'm using for the Class Action lawsuit.

but you know, at this point, I don't have anything that's been diagnosed. So that's that. I quickly realized as soon as I read this, this report about the recall on CPAP. com that this is a big deal. This is involving, you know, 5 million plus people, it's global, and it could seriously affect people's lives.

Tom Wilson: I, I noticed that there was a Facebook group and I befriended the guy that started it. And he had started it, but he was really busy. And I said, well, why don't you make me a you know, like a moderator, co lead, which he did. And so I really got the group going and I'll tell you what the, what my [00:16:00] objectives were.

I also noticed there were two other groups that had started up. And so over time I joined forces so that the three of us together were working together representing over 13, 000 Philips CPAP users. Our objectives are number one is to provide. the members in our group, factual, timely information, and to answer questions.

Yes. Yes.

Emma Cooksey: that was sorely missing through this whole process. Like, I can't tell you the number of people that I felt so much for because they just couldn't get any information and, you know, it was pretty much like, go to the Philips website and you had, that one page and they're but I have questions, it really was, was challenging and really stressful and

Tom Wilson: It is. I mean, if you think like somebody who's a truck driver, for example, this is, they can't drive or fly a plane. You have [00:17:00] to have your equipment and you're sitting there and nobody can tell you. Is it safe or should I discontinue it? I can't get another device because guess what? There's been a run on them.

There's no chips and for you know, one to at least two year period, they were sold out at any price.

Emma Cooksey: Yeah. Absolutely.

Tom Wilson: okay, so number one is help people get factual and timely information, answer their questions, try to get major media coverage. We've been successful with New York Times, LA Times, Washington Post, Wall Street Journal I'd like to say ProPublica, but that, You know, and that's, that was the best coverage out there.

So that's number two. Number three was putting pressure on the company by leveraging their security analysts that follow the company, sending them questions to ask during quarterly calls. And the fourth is I've been dealing direct,

Emma Cooksey: Smart

Tom Wilson: with the largest stockholder in the company. It's a [00:18:00] French family suggesting what, what they might do to help alleviate.

And last but not least is we made connection with high levels at the FDA to if nothing else, cause the FDA can't share any. Private information with us, but to, to send them literally quotes from what we're hearing from our members, which they in turn have forwarded to Phillips.

 I guess, because my Google is so used to seeing nothing but sleep apnea for me, it seems like for months and months, all I saw was like, have you been affected by this Philips CPAP recall? Because there's going to be a class action lawsuit.

Emma Cooksey: And so, Can you tell us, like, I have a degree in law from a Scottish university, so I am not up on, like, class action lawsuits here in the United States, so can you maybe explain a little bit about the legal action and, and how that started and, [00:19:00] and how that went

Tom Wilson: Again, I'm, I'm not a lawyer.

Emma Cooksey: I'm not going to call them ambulance chasers. I guess I just did, but you know, they, they, the, the law firms around the country, they keep their, their their ear to the rail, so to speak, that if something pops up, whether it's you know, the J& J talcum powder. The, the abdominal mesh and so this one popped up and they could see it's a big deal.

Tom Wilson: And it's also tied to a big company, big global company. And so within, within a year, there was I think 100, 125 law firms that, you know, had filed suits. And so nobody could manage that. So the way that works in the U. S. at least is you consolidate them all into one lawsuit. There's a board of lawyers that, that picks out somebody one of the judges to head that up.

Emma Cooksey: And in this case, it's called Judge Joy Conti in Pittsburgh, the Western District. So they consolidate all these lawsuits into one and they divide them [00:20:00] up and they say, okay. XYZ law firm, you're in charge of building a database to put all the names in. Of all the plaintiffs, so all the people who've been affected are gonna

Tom Wilson: So different, different law firms have different responsibilities, which are designated by the Joy Judge Conte. She said she wanted to move this fast and she defined fast as three years. So we're about two years, nah, about a year and a half into it, I guess, something like that. There's three parts to the lawsuit.

Number one is financial compensation for those people like myself that had, that went out and had to buy a replacement machine. We're, we're going to get our money back. I think there's going to be some compensation for people that turned in a device that was one year old and they in return got one back that was four years old.

Emma Cooksey: Yeah, some people said they came back dirty, you know, they were dirty. Philips did the bare minimum because with these devices, you have the device, you have a power [00:21:00] cord, you have a humidifier. They just threw it in a bag and it was just the one part. You didn't even get a power, power cord. So if you didn't save your power cord from the other device, you had to get a power cord.

Tom Wilson: So they really did do the bare minimum.

Emma Cooksey: Okay, there's three parts to the

there's the cash compensation, which should, should, disbursements I believe should be made this year, later this year. That's number one. Number two is medical monitoring. So, if you've been exposed to this particular VOC's. They'll set up something, I don't know what it will be, it could be some kind of labs every now and then, a scan, that's to be determined.

Tom Wilson: And then number three is for those that perhaps have died. Or have serious medical conditions, some recognition of compensation for them. That's the most difficult part because Philips will tell you that their products are safe and [00:22:00] effective, and the other side, the plaintiff's side, will say that no, your device actually caused this.

Emma Cooksey: It's pretty hard to have a, let's face it. They could never 100 percent say that cigarette smoking caused cancer and the tobacco folks fought it for years, so it's the same kind of thing here and you, you get the experts on both sides, And I think one of the things that, I've kind of heard probably more from the Phillip side is that, you know, like so many different things can cause, like, we don't know what causes some of these cancers, but I think when you start to see them coming up again and again in this population of people who have.

Tom Wilson: have been using these particular machines, so maybe we won't ever know well, and, and the folks listening may have heard this, it's because it's been on the news for, gosh, I don't know, maybe 10 years now. the beautiful Johnson [00:23:00] Johnson company and their baby powder. Well, guess what? You know, a lot of people claim that they died from inhalation of that powder because it has asbestos in it.

J& J, even though they've lost billions of dollars of lawsuits already, And it's not done yet claims that their, the telcom powder did not. So, this comes down to either a judge or a jury making a call. I'm quite sure that Phillips doesn't want to have a jury trial because juries, let's face it, they tend to lean in the favor of the plaintiffs.

So we'll have to see where this leads, but phase one, the financial portion recognition of buying a machine and getting refunded should happen this year.

Emma Cooksey: so then, people will just kind of watch the space of what they have to do in order to get refunded money if they were in a

Tom Wilson: There, there's a website that was set up and there's a big gnarly form to fill out and it's [00:24:00] confusing and the website, at least early on, didn't work right. I called and. The person that answered could have cared less. It's, it's just not pretty, but you know, it is, it is,

Emma Cooksey: Imagine being a podcaster trying to get someone from Philips to come on my podcast.

Tom Wilson: I have written,

Emma Cooksey: at least six senior executives from the CEO down. And I've, besides getting a little happy talk from a, you know, one of their media people, I, I've heard nothing. So,

I bet.

Tom Wilson: you know, the, the, the lawsuit is, is proceeding. The other big wild card and one thing I want to mention is

Emma Cooksey: right after the recall was announced, Phillips stock declined 75%.

Tom Wilson: So three quarters of the value of the entire company, and they make, they make MRIs. MRI scanners and all kinds of medical equipment, three quarters of the company just went up in smoke. [00:25:00] It, and then I think right now it's, it's down around two thirds. Okay. And the big dark cloud besides this lawsuit is what's called a the justice department has a consent decree, which just, they're going to provide some rules that, and fines that Phillips is going to have to adhere to.

Those have been under negotiation or discussion now for at least a year and a half, and those can go really bad for a company and, and no one knows, no one knows which way that's going to go. So,

Emma Cooksey: Do we know a time frame for that?

Tom Wilson: is, only that it's ongoing discussions. That's what Phillip says is we're having ongoing discussions.

Obviously we can't, you know, we can't discuss it. And so as an investor, you know, it's like you, you've got this big wild card that you don't know what's going to happen. So people are, [00:26:00] investors are reluctant to invest in Philips. And so what's happening because these products are branded Philips, it's affecting, you know, it's affecting across all their lines of products, whether it's toothbrushes, MRI scanners, or all the products they make.

Emma Cooksey: One of the thingsI wanted to ask you about was just the FDA's response to this. Like, I think from my point of view, I thought it was a bit frustrating that they weren't You know, more involved, more quickly and you just are way more in the middle of it than I am, so, so what do you see in the FDA, and, like, do they need I More funding to be more effective.

Do we need to give them more power so that they can hold companies to account? What do you think?

Tom Wilson: There's there's three divisions within the FDA to regulate different products. This one happens to fall under devices. Guy named Dr. Jeff Shuren. He's been in his role for a long time. I think, and I'm not an expert, but I, I think that as a [00:27:00] governmental body, their, their hands are pretty tied. I'm quite sure just because I've had some, a couple of discussions, that they are mad at Philips and not happy.

I think they could have been stronger early on because theThis would be very poor, okay in terms of the, the response and, and how it was managed.

Emma Cooksey: But they claim that the products are, and I, there's a word that they used and this is not the one, but the products are generally safe and effective.

Tom Wilson: Okay. There's a little bit of a qualifier, not because nothing is a hundred percent. And so if something is generally safe and effective, that means that some of the time, maybe it's not FDA made a statement that they didn't know if they agreed with all the findings that Philips came up. So they had requested some further, further data and that's being developed now.

But the whole recall [00:28:00] worldwide,you talk to, I think about five different groups. You have the consumer, you have the medical community, the pulmonologist, the sleep people you have the DMEs, durable medical equipment dealers who sell it, or the online people like cpap.

com. Then you have the insurance companies, and on the other side you have the government, Medicare, Medicaid, Veterans Affairs,

Emma Cooksey: Yes.

Tom Wilson: And it became so gnarly and no one, there's no one that I've spoken to, or I've heard others spoken with that say, Oh yes, we feel like they kept us in the loop and we were fully informed.

Emma Cooksey: the other thing that happened was, especially in those early days where doctors and DME companies really weren't given any information to go off of, aside from what Phillips put out to everybody, patients would be saying that they were going to their doctor and the doctor was saying, well, we just prescribed [00:29:00] the machine,

And then they would, send them to the DME company and the DME company would be like, we don't know any more than your doctor does, and they'd all just kind of send them back to Philips, which was just this annoying, one page, website I think for so many people, Especially in the United States, they're coming to the end of this process where they've already completed the form online and all of that, but some of the people who have been left behind by this process are people, elderly people with no access to you know, I just heard recently a story about An elderly gentleman who had a recalled machine hadn't been to his sleep specialist in a long time, didn't know about the recall, didn't have access to the internet to, to do all of those steps.

So, so for anybody who might be supporting someone in that situation, the first step if somebody has a recall device and hasn't yet [00:30:00] taken action, they need to go find that Philips website and enter their details. That's the first step, right?

Tom Wilson: now the recall site, like in my case, I had a, I had a device. That I paid for cash and I'm seeking compensation. That was put together, I believe, by the courts, I think. Maybe Phillips put it together, but I think under the direction of the courts.

Emma Cooksey: Okay, so if people are actually in a position where they bought a different device because they figured out that theirs had been recalled, there is also something else they can fill out to get the compensation. So we can put links, once you give them to me, I can put links in the show notes. So that people can easily find them.

And then as far as support goes, do you want to tell people about where they can find your Facebook group in case they, want to connect with

Tom Wilson: It's Philips CPAP Recall Support Group.

Emma Cooksey: Awesome. So, I'll have, I'll put that in the show notes as well, and then people [00:31:00] can link straight to it. Was there anything else that we didn't cover? I feel like we've kind of covered a

Tom Wilson: those are the key, the key points. I would say if you owned one of these devices, you know, get involved follow it. Go to those links. Join the class action lawsuit if you can. That's what you can do as an individual.

Emma Cooksey: And tell everyone again

Tom Wilson: Ah, yes Negotiate Anything, Tom Wilson. It's got a pink cover.

Emma Cooksey: Okay. We can link to that as well. Well, listen, Tom, thank you so much for your time. I really appreciate

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