Via America’s Lawyer: Millions of Americans suffer from sleep apnea and rely on CPAP machines to get them through the night. But Philips’s DreamStation devices have been shown to break apart, releasing cancer-causing chemicals into people’s airways. From the Mass Torts Made Perfect conference in Las Vegas, RT’s Brent Jabbour fills in for Mike Papantonio, to sit down with attorney Troy Bouk to discuss the widespread dangers of these devices which could be slowly killing users in their sleep. Plus, Beovu is a popular injection used to treat age-related macular degeneration. But the medicine has been shown to actually cause permanent vision loss and blindness. Attorney Joshua Harris talks about Novartis’s aggressive marketing campaign that pushed such a dangerous drug through the FDA’s approval process.
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Mike Papantonio: Millions of Americans who suffer from sleep apnea depend on CPAP machines to get them through the night. But it turns out these devices are releasing cancer causing materials, slowly killing users in their sleep. At a meeting in Las Vegas, RT’s Brent Jabbour sat down with attorney Troy Bouk to discuss the dangers of these devices.
Brent Jabbour: Troy, tell us exactly about the safety concerns of these CPAP machines.
Troy Bouk: Okay. Well, basically the CPAPs, the BiPAPs and the ventilators all use the same type of foam that is used for sound abatement, and that’s called PE-PUR foam. And that foam basically breaks down over time into little pieces and those pieces get inhaled into a person’s lung, and they can also be digested into a person’s system like that. And so you can get anything from kidney cancer, liver cancer, you know, nasal cancers we’ve been seeing, and you can also get sort of inflammation of the lungs and it can cause significant inflammation of the lungs. And I recently signed up a guy who has sarcoidosis, and I think that’s going to be one of the injuries in this case.
Brent Jabbour: And, you know, the company is behind these CPAP machines and BiPAP machines and so on, you know, they have to tout the quietness of these machines because if you’ve ever been around a loved one or had to sleep in the same room as someone with a CPAP machine and these type of ventilators, they can be very loud. They can be quite a noise nuisance, correct?
Troy Bouk: Yeah, you’re exactly right. And in fact, you know, for the DreamStation line, which is a very significant product line that Phillips advertises, their, their key advertisement was that it was 64% quieter than the competition. And so this foam was their competitive edge.
Brent Jabbour: And do we know if a company like Phillips knew of the dangers of using this type of foam to actually dampen the sound?
Troy Bouk: Well, I think there’s indicia there that they absolutely knew and I think when all the evidence comes out, we’re going to see that they knew, there was no question about it, right. And, you know, really, even in the way this recall was set up, we saw that on April 13th of this year, 2021, you know, Phillips announced a new product line, the DreamStation 2. And it was supposed to be, hey, this, this great new product line, you know, and, but it uses a different type of foam. And then you see just two weeks later on April 26th, they announced in Phillip’s quarterly report, hey, we’re going to have to take a reserve because those, that old line that we’ve been selling is dangerously defective. And then two weeks after that, they issue of recall of the DreamStation. So they basically announced their new product line and then they, you know, recalled their old product line.
Brent Jabbour: So, it is essentially that they knew there was a problem, but they said, wait, wait, wait, before we do something, let’s make sure we have the, the next product in line set up so that we don’t have these issues. So we don’t lose any profit.
Troy Bouk: Brent, you’re exactly right. That’s exactly how it looks.
Brent Jabbour: And where is the litigation with this right now?
Troy Bouk: So right now, the JPML panel, which is the federal panel of judges, just decided this past week that they’re going to situate this MDL. They actually agreed to form the MDL and they’ve issued it to judge Conti in the Western district of Pennsylvania, which is Pittsburg, basically.
Brent Jabbour: And how many people are we talking about being involved? I mean, I know we say that millions of Americans, these are very common devices. I mean, I think we all know somebody who uses a CPAP machine for sleep apnea, because if you don’t know about sleep apnea, I mean, you could wake up because of the way it closes your throat and the way the air is actually transmitted through your body. It actually can wake you up hundreds of times, or up to 100 times that is to say, an hour while you’re trying to get a good night’s rest. So this is something that affects people and can really be detrimental if you have to struggle with it and this looks, and the way we’re looking at this right now.
Troy Bouk: Yeah, you’re exactly right. Sleep apnea is a serious condition. If you don’t, or are not able to use your CPAP machine, like in this case, due to the recall, you could potentially die because it keeps your airways open. And that’s the problem. If your airways happened to close up and your, you know, your system, your internal system, didn’t wake yourself up to take that extra breath of air you could potentially pass away.
Brent Jabbour: And then you brought up an interesting point there because you talked about the FDA and regulators here. I mean, these devices have to be approved and it’s the same thing we see with medication. They have to be approved by regulators in the United States and in any country, generally, that they’re selling these in. So when that’s the case, why did regulators miss this?
Troy Bouk: You know, that’s a good question and it’s really because they’re not the ones doing the actual testing. Usually they’re having to rely on the company to self report. Hey, you know, these are the claims that we’re seeing in people contacting us and if the company simply doesn’t transmit them onto the FDA, the FDA may never know. Right. And it’s the same with all drugs. The FDA is not the ones doing the testing. They’re looking at all the data that the companies produce while doing their testing.
Brent Jabbour: And what is Phillips actually saying in response to, as these, because there’s obviously they’ve done the recall, but what were they saying as far as when we start to see litigation coming forward?
Troy Bouk: Well, they actually came out and they said, you know, as part of this recall, unless you absolutely have to use these devices, don’t use them, except for the ventilators. Ventilators are sort of a life support device and so they’ve told people do not stop using them until you have an alternative device to go to. But for the CPAPs and BiPAPs, they basically said you need to contact your doctor and determine if your doctor weighs the risks versus the reward of using the machine. And that’s a lot to put on a doctor and I’ve talked to lots of pulmonologists now, and they’re quite upset about this because it is basically having a doctor make a medical decision based on information they’re not aware of because, you know, the pulmonologists that I spoke to said, hey, you know, I don’t know how dangerous these machines are. I haven’t done any studies. I haven’t seen any results. There’s no epi studies in there. So how, how can I make that reasonable decision and tell my patients, oh yeah, continue to use it? You know, Phillips needs to be coming forward and bringing this information to us. How dangerous are your machines? You’re saying you’re recalling them all. You’re saying that could be carcinogenic. But what are we talking here? What’s the probabilities? What’s the chances?
Brent Jabbour: Troy Bouk, thank you so much.
Troy Bouk: Yeah. You’re welcome, Brent.
Mike Papantonio: Beovu is a popular injection used to treat macular degeneration, but the medicine has been shown to actually cause permanent vision loss and blindness. Brent Jabbour also interviewed attorney Joshua Harris at the aggressive marketing campaign that’s being ignored and he’s ignoring the risk of this new product.
Brent Jabbour: Tell us about this issue with Beovu.
Joshua Harris: Well, Beovu is a eye injection for macular degeneration produced by Novartis. It received FDA approval in October of 2019 and since then there were about an estimated 60,000 vials of this that were prescribed. Now, what Novartis did was they had a heavy marketing campaign for this and they were going against their competitors, Eylea and Lucentis, which require numerous injections throughout the year to treat AMD age-related macular degeneration. What Novartis did was they claimed that their drug was just as effective with half the number of injections, which was appealing to doctors and patients because the less times they had to get jabbed in the eye with a needle, that seemed more effective. But what we learned was that they lied on their clinical data to the FDA, the FDA didn’t catch it and now they were forced to have a label change in June of 2020.
Brent Jabbour: So you’re telling me they tried to cut corners. That they tried to say, well, while you need multiple injections, we only need one. And that didn’t quite work out that way.
Joshua Harris: No, and in fact, they were seeing such high adverse event rates compared to the safer alternatives and the other two drugs that were already proven effective on the market. So what happened was, Novartis then had to do a label change because the American society of retinal specialists went back and did a safety review on Novartis’ clinical trial data. And what they learned there was that Novartis severely underestimated and severely underreported the number of adverse events to try to make their drug more effective and safe so they could get a good label from the FDA. And the issue is the FDA doesn’t test these drugs, they get, they get it from the drug company. So if they underreport or misreport then the FDA just goes with what they’ve got.
Brent Jabbour: And, I mean, and the fact that they lied on the data, maybe I’m saying lied is the wrong word, but misrepresented their data to the FDA. I mean, that seems like, you know, that doesn’t even need attorneys. The FDA should be taking care of that directly, right?
Joshua Harris: Well, you, you would think so and they’re, they’re forcing them to change the label, but that’s not enough. In fact, the problems have persisted so much that in May of this year, 2021, almost two full years after the drugs on the market, Novartis has completely stopped phase three clinical trials because it’s so damaging that they don’t even feel comfortable testing it on people for these clinical trials. So unfortunately the FDA has not done enough to do anything about this. So, you know, our law firm stepped in and we’re representing folks who have suffered and, you know, people are going blind in the worst cases and losing vision and having inflammation and all sorts of other injuries and eye problems.
Brent Jabbour: And how many people are we seeing being effected by this?
Joshua Harris: You know, the drug was only on the market for a short period, but because of the aggressive marketing campaign, like I said earlier, there’s an estimated 60,000 bottles of these that have been sent out and an estimated about 40,000 people that have probably received Beovu injections. So, usually these adverse events that we’re seeing happen fairly quickly after there’s injections. So I don’t know the full extent, but I’m sure there’s gotta be tens of thousands of people who’ve been effected by this out there.
Brent Jabbour: And you would have to imagine, I mean, a lot of this basically comes down to negligence from Novartis, right?
Joshua Harris: Absolutely. I mean, if they took the time to do what they wanted to do and make a safe effective drug, they could have done that. They could have reported this to the FDA and been honest and open. But instead they cut the corners so they could get this drug on the market and sell it. And in the first quarter alone it was on the market, it made $68 million. So their, their lies and their marketing campaign were effective for them. They, they made money off this.
Brent Jabbour: And how, I mean, this may not be a question you have an answer to, but I’d love to hear your opinion on this. This, the fact is, is that, you know, like we’ve said, we, we hear about this over and over again, that the FDA essentially puts the ball in the court of the drug maker to do the research and give us the trial data and that’s how they make their decision. Is that the best way to do this when we see so many problems with drugs as we go through this?
Joshua Harris: No, and, and the FDA is severely overworked, overextended and under supported, and the problem is that they’re hoping and praying that these companies that want to make money, do the right thing to make that money. But I’m sure you’ve seen it before, the corporate greed, it’s too easy to worry about the bottom line and not worry about the end user.
Brent Jabbour: Well, right. And when you have to answer to shareholders, not to your patients, that seems like a huge problem there.
Joshua Harris: Well, the Wall Street and the tickers always tell the truth, you know.
Brent Jabbour: Absolutely. Now where is litigation with this right now?
Joshua Harris: So, litigation has commenced, at least our firm has filed a few cases in the district of Nebraska that have survived motion to dismiss phase. So we’re getting ready to start serving discovery and start getting documents from Novartis and we’re confident that when we see those, it’s going to show the true extent of what they knew when they underreported these issues to the FDA. And then we’re, we’re pushing for an aggressive trial date.
Brent Jabbour: And you mentioned this earlier that this all forced a label change. What does that label change mean?
Joshua Harris: So a label change, the two specific injuries are retinal vasculitis and retinal vascular occlusion and blindness. The label originally in October, 2019, when Novartis said, hey, FDA our drug’s safe, our drug’s okay. Here’s the few issues you may have. It may burn, redness a few days afterwards. Didn’t say anything about the severe issues that we’ve seen pop up in people. So label change now requires Novartis to say, oh, well, in addition to these other things, you may go blind, which a lot of patients and a lot of doctors would say, well, it’s not worth it. And they would have bypassed it, which means that Novartis would have sold less and made less money.
Brent Jabbour: It’s one of those things where it seems like the side effect is much worse than the disease it was meant to be treating.
Joshua Harris: Absolutely.
Brent Jabbour: Joshua Harris, thank you so much.
Joshua Harris: Thank you.
Mike Papantonio: That’s all for tonight. Find us on Twitter and Facebook @facebook.com/rtamericaslawyer and stream us live on YouTube. Be sure to check out RT’s new portable app, where you can watch all your favorite shows. I’m Mike Papantonio and this is America’s Lawyer where every week we tell you the stories that corporate media is ordered not to tell because their advertisers won’t let them. Have a great night.