2022 CPAP Litigation Updates

By Susan Barfield
March 28, 2022

Susan Barfield (00:06):
Hello everyone. Thank you for joining Case Works. We’re talking today about CPAP. And so we certainly appreciate everyone joining and learning about the updates and what’s new about the tort. We’re joined today by Shanon Carson, John Albanese, and Dena Young from Berger Montague. I’m Susan Barfield, founder and CEO of Case Works. And we’ve got Dan Comunale who is VP of sales and marketing here at Case Works. And we just certainly appreciate you taking time out of your day to listen and to talk about CPAP.

Dan Comunale (00:38):
All right. Thank you so much, Susan. Appreciate it. Before we jump into, obviously introducing our gracious hosts here, I just wanted to give a quick shout and a thanks to our past panelists, Danielle Mason from Milberg Coleman, and Rick Meadow from The Lanier Law Firm. If any of our viewers haven’t seen that, go watch it. It’s a very informative, very information-driven livestream that I strongly encourage you to go check out. So first I’d like to introduce Shanon Carson. His one of the managing shareholders of Berger Montague he’s on numerous leadership positions. I would do a disservice listing them all, so during your intro, I’ll let you, but he’s, as I mentioned, a co-chair of the employment unpaid wages, consumer protection, mass tort, defective drugs, all things mass torts. So Shanon, I’ll let you further introduce yourself and tell us a little bit about yourself and how you got into this practice.

Shanon Carson (01:35):
Sure. Thanks Dan. Thanks Susan. Thanks for having us today and thanks for putting this together. We really appreciate it. I’m Shanon Carson. I’m one of the managing shareholders of Berger Montague PC. We’re a firm with about 65 lawyers. Our main office is in Philadelphia, Pennsylvania. We also have offices in Minneapolis, Minnesota, in San Diego, California, Washington DC. We have a very mixed practice. Our firm concentrates very heavily in complex litigation, class action litigation and mass tort litigation. And our firm’s been around doing this since 1970. So going on just about 52 years now. We got into this litigation, right at the beginning. On June 14th, 2021 Philips announced in conjunction with the FDA this recall, this massive recall of CPAP machines, BiPAP machines and ventilators that were sold globally right around the world. And U.S. was its biggest market.

Shanon Carson (02:55):
So I’ve seen numbers ranging from four to 10 million recalled machines in the United States. So this is an issue that’s affecting literally millions of Americans. The recall was announced on, I think I said on June 14th, 2021, and soon thereafter cases began to be filed regarding these defective products. The recalled devices contain a polyester, a polyurethane based sound abatement foam known in shorthand as PE-PUR foam that does two things. One, it degrades over time. And so the foam that is in the machine degrades as the result of ordinary use by consumers, into small particles that people are breathing in, and those and those particles contain toxic components. They also off-gas. So an independent issue, they also off-gas volatile organic compounds that people are breathing in.

Shanon Carson (04:04):
And so again, these are machines that people are using primarily to help them with their sleep apnea. And so, many people are familiar with these machines. They sit on the night side table next to your bed, they have the breathing apparatus with the home and a tube and a mask that one puts over their mouth and nose while they’re sleeping to help them breathe while they’re sleeping and help relieve their sleep apnea symptoms. And so they’re literally breathing in the air through the machine all night, every night, day after day, week after week, month after month. And as the particles in the machine degrade and off-gas, people are potentially affected by the severe health consequences that can result.

Dan Comunale (04:48):
Excellent. Thank you so much. Before we jump into any more of the meat of the litigation, I just want to also introduce the two other guests on. John Albanese, who’s also a shareholder in the Minneapolis office. John, if you could just give a little bit of a quick bio and we can just jump into everything, and then we won’t forget Dena as well after. So thank you.

John Albanese (05:07):
Sure. And just to echo what Shanon said, thanks for having us. Really happy to be here. I am a shareholder in the Minneapolis office. I’ve been working at Berger Montague since 2016. I helped open the Minneapolis office back then. My practice is in all aspects of consumer and product liability law, and a lot of mass torts now as well.

Dan Comunale (05:34):
Excellent. Thanks so much. And last, but certainly not least, Dena. I know we’ve known each other for a little bit here, so it’s definitely a pleasure to have you, looking forward to catching up next time we can, but Dena please by all means, give a little bit of a intro and bio.

Dena Young (05:48):
Thanks, Dan. It’s good to see you. I joined Berger Montague in June of 2021, so it hasn’t been a full year yet, but it feels like it. I came over to help with their mass tort department and consumer cases. So I’m happy to be there.

Shanon Carson (06:08):
If I could just mention, I think Dena may have joined our firm the week before this recall…

Susan Barfield (06:14):

Shanon Carson (06:15):
… this recall was originally announced. And so talk about being thrown into something from day one. So we’re so glad to have Dena at our firm and on our team, she has massive mass tort experience, and that was the reason that we hired Dena.

Dena Young (06:32):
Thanks, Shanon.

Susan Barfield (06:33):
That was great timing that you came on board.

Dena Young (06:36):
Yes, it was.

Susan Barfield (06:38):
Shanon, you gave a great overview and high level of CPAP and the issues and about the products. Tell us about the machines involved in the case.

Shanon Carson (06:50):
Sure. So the recall actually affects a number of different models of CPAP, BiPAP and ventilator, including the main flagship model of CPAP machine manufactured by Philips for the U.S. market, which is called the DreamStation 1. And all of the DreamStation 1 machines to my knowledge in the U.S. are subject to the recall. The flagship ventilator product for Philips is the Trilogy Series. And the Trilogy Series is also subject to the recall. And there are websites that have been set up where consumers can register their device and find out if they have a recalled machine by putting their serial number, which is located physically on the machine, into the website and figuring out whether or not they have a recalled machine that way. And of course they can also contact us at Berger Montague and we can help them as well.

Shanon Carson (08:11):
We’ve been contacted by thousands of American consumers and have really done a lot here to assemble a large team. Everyone has seen John and Dena and myself, behind us as just an incredible staff of paralegals and project analysts and case intake analysts who are working with literally thousands of consumers who have contacted us. And we’re doing everything we can to try to answer their questions.

Dan Comunale (08:51):
Actually, that makes… That’s fantastic to hear. And John, if you can just touch in, Shanon touched upon this a little bit, what is the actual problem with this product that’s causing all of the defect? If you could just dive in a little bit deeper there, that’d be fantastic.

John Albanese (09:06):
Yeah, sure. Yeah, happy to. The problem with the product is the way it’s designed, that the air passage goes through the foam. And so when the foam off-gases, as Shanon said, or when it degrades in particles, they go straight into the air passage and people are breathing it in and out all night for eight hours or however long they’re sleeping. And that foam was… it’s not fit for human consumption. You’re not supposed to be breathing in particles from this foam because they’re carcinogenic. And likewise, the off-gassing that the foam is doing is carcinogenic too. Simply the design of the machines leads to the breakdown of this foam, which gets in the air passageways that people are breathing in every night. And the whole point of the CPAP and BiPAP machine is to help you breathe at night. So it’s just not fit for the purpose of which it was sold for.

Dan Comunale (10:18):
That makes total sense. And I’m just going to open this one up to the floor. What is the, and by all means anyone, but what is the estimated impact of these defective products? How many people in the U.S. suffer from sleep apnea and what would be the potential scope, just so we can give those who aren’t familiar, the full scope of what this litigation could become?

Shanon Carson (10:41):
So, like, as I said, the scope of the recall by the number of consumers who purchased recalled products is in the millions. And there are many thousands of injuries that have been reported across the country to law firms across the country as people are finding out about the recall. A subsidiary issue in this case has been whether the recall itself by Philips has been sufficient. Just last week, the FDA issued something very out of the ordinary called out a 518 notification letter that took issue with Philips notification of consumers in the United States regarding the recall, finding that perhaps as little as half of the affected consumers even know about the recall at this point, and while Philips probably has a different version of that story, that’s the story that the FDA is telling in this 518 notification letter, and thus has ordered further steps by Philips to renotify, or notify in the first instance, U.S. consumers, doctors, suppliers, durable medical equipment manufacturers who distribute the product, et cetera, so that they get the word out regarding the potential harms.

Shanon Carson (12:09):
Philips itself announced that this foam, and I’m reading, may break down and be inhaled or ingested and may emit volatile organic compounds that can be inhaled, ingested, adversely affect organs, and are carcinogenic. And the specific injuries that have been potentially tied to these machines, in answer to your question, Dan, about the harm, include different forms of cancer, including lung cancer, kidney cancer, liver cancer, other cancers associated with the respiratory systems such as esophagal cancer and throat cancer and nose cancer, things like that, sarcoidosis, COPD, acute respiratory failure, other serious respiratory injuries and infections, carbon dioxide poisoning, esophageal irritation and inflammation, chest tightness, and chronic sinusitis. And the list goes on.

Shanon Carson (13:12):
And we’ve been contacted by so many people that we’ve really seen a large swath and cross section of all of these types of injuries that I’m alleging in the form of real people contacting our office and saying, “I was really in good health before I began to use this machine. I used this machine for a number of years, and I don’t have a history of cancer in my family, and now I’ve just been diagnosed with esophageal cancer. I never smoked, I don’t know what’s going on, but I want you to look into this for me, Berger Montague.” And so those are the types of cases that we and others you’re seeing here. And those are the types of cases that are being filed in the multidistrict litigation.

Susan Barfield (14:00):
Shanon, I was just going to ask you, or Dena, John, whoever wants to respond to this question, oftentimes during the product recall, the manufacturers usually replace at no cost, the equipment to the users. And so considering this is a product that people use every night, has Philips stepped in and offered to replace these devices?

Dena Young (14:27):
So I’ll take that one. Philips is replacing some of the devices and then repairing some of them, or they’ll provide a replacement pack with instructions on how to go about removing the foam and replace it with another product, but they’re not doing it in a timely matter. Some of our clients have been without use of a CPAP since June and haven’t received a replacement and can’t afford to purchase a replacement, so… Some of these machines can cost over a $1,000. If Philips isn’t providing them the replacement and they can’t afford a replacement on their own, they’re just without a machine, which in itself causes its own risks-

Susan Barfield (15:18):

Dena Young (15:18):
… for the user. They need it for health reasons. So if they’re not using it and they don’t have a replacement, they’re in bad shape.

Susan Barfield (15:28):

Dena Young (15:29):
It’s a problem.

Shanon Carson (15:31):
It’s really one of the largest sources of frustration in this whole thing that we’ve seen is the way in which the recall has been conducted, the lack of information and transparency regarding the repair and replacement process and the remedies that consumers are being given, the lack of information around the process, the lack of information around the recall, the lack of communication about the recall, the lack of communication with consumers. And so, we’re just trying to fill that void a little bit. Understandably we only can do it to a certain extent in our role as lawyers and as a large plaintiff’s law firm. But that’s what we’re trying to do. We’re trying to help people. We’re trying to get the information out there that’s available.

Dena Young (16:28):
Right. And it’s just recently, Philips came up with a process to alert users of where they are in line in getting their replacement machine. But it’s been eight or nine months since the recall started, and just now they can find out where they are in line. And so up until this point, people had no idea where they fell and when they were going to get a machine, if at all. It’s really unfortunate. People are very upset.

Dan Comunale (17:03):
Yeah, you mentioned obviously eight or nine months that this goes back, but as far as existing plaintiffs go, how far back does this, the timeline reach for law firms looking to establish case criteria, how far back are we talking about for this litigation?

Shanon Carson (17:21):
Sure. I’m happy to handle that. And that every state, as you know, has something called statutes of limitation. So you kind of start the analysis with that. And it’s a different analysis depend on which state the plaintiff lives in. And then every state has law around its application of statutes of limitation, including something called the discovery rule, which says that the statute of limitation doesn’t start to run until somebody discovers their injury. And so the statute of limitations for people who have suffered physical injuries is something that they should discuss with a lawyer, for sure.

Shanon Carson (18:06):
With respect to economic injuries and injuries that arise out of the recall itself, the recall was initially announced on June 14th, and so you would go back in each state’s statute of limitation. Most states, the majority of states have at least a three year statute of limitation to go back before then, some states have longer. And so that’s the type of analysis that we undertake, but ultimately for claims for economic harms and claims for medical monitoring, we hope that those claims will be addressed through the class action device in the multidistrict litigation. Following the recall, there were probably over 150 class actions filed. All of those cases have now been consolidated in one federal court before Judge Joy Flowers Conti in the United States District Court for the Western District of Pennsylvania, which is the federal court in Pittsburgh.

Shanon Carson (19:07):
And the first order of business, now that the case has been organized, and now that the case has been… all of the cases in federal court have been consolidated in one court, will be for the plaintiffs to file a consolidated class action complaint or complaints. And that process is already underway. We expect that the economic harm class action complaint will be filed approximately within the next several months, within the next three months. And then that will be the operative class action complaint for the economic harms on which the motions to dismiss practice and the case will thereafter proceed.

Dan Comunale (19:52):
Excellent. Nice. And John, real quick, Shanon mentioned medical monitoring. Are you at all familiar with the types of potential future injuries that sort of, that we’re monitoring, that, sorry, they’re monitoring throughout this litigation?

John Albanese (20:06):
Sure. It’s the same injuries Shanon mentioned. There are costs of… The point of having a medical monitoring remedy is that going to the doctor and getting tested and getting specific tests necessary to try to test for these diseases that are potentially caused by the foam and the off-gassing is expensive. So the medical monitoring remedy is normally set up a panel of expert doctors to discuss an appropriate medical monitoring program and how people make sure that people have access to testing and that it’s paid for so that if they are developing a disease related to the CPAP machine, that it’s caught early and hopefully can be treated appropriately. So it’s the same list of answers and other types of injuries Shanon was mentioning.

Shanon Carson (21:01):
I’d also like to sort of draw a bright line here, Dan, because on the one side you have the us action cases, and on the other side of that line, you have the cases that are individual cases for physical personal injuries up to and including death. And there are wrongful death cases that are part of this litigation. And so that court, the federal court I mentioned in Pittsburgh that’s overseeing all the federal litigation, is overseeing both the class action side of the case, as well as the personal injury side of the case. And we do expect that there will be ultimately thousands of individual personal injury cases that are filed that are part of the MDL litigation as well. And those are just getting underway as well.

Dan Comunale (21:48):
Excellent. And Shanon, if you don’t mind, if you’re at this point allowed to say your involvement in leadership, sort of what your role is in leadership, if you could kind of speak to that a little bit, to the extent you can, would be appreciated.

Shanon Carson (22:03):
Sure. Happy to. So the case, as I mentioned, the case has been organized. Leadership has been appointed by Judge Conti several weeks ago. And there was a leadership structure that was put in place by the court. My firm, Berger Montague was appointed to a role on the Plaintiffs’ Steering Committee, so we’re involved on the Plaintiffs’ Steering Committee. And I was also subsequently asked to be a co-chair of the law and briefing committee, which is a subcommittee of the Plaintiffs’ Steering Committee that will focus on all of the law and briefing issues in the case, motion practice in the case, legal research issues in the case, class certification, legal issues in the case, and other legal issues as they arise in the litigation.

Shanon Carson (23:02):
And so we’re working with a number of firms on the Plaintiffs’ Steering Committee and the co-chairs of the litigation that have been appointed by the court. And we are… it’s a great team. It’s got just an absolute wealth of resources and experience. It’s diverse. It’s got everything that you would ask for in a dream team. And it’s working very cooperatively now to get the case under underway.

Susan Barfield (23:35):
Dena, how far ahead of the official filing was CPAP on the firm’s radar as a case to pursue?

Dena Young (23:42):
I think we learned of… We learned of the recall the same time as the rest of the country, on June 14th. And then, we quickly started working on a complaint because the issue seemed really serious and the amount of people it affected seemed crazy. And so we had to do something. So we started working on it quickly and interviewing clients. And I mean, people are really scared and worried about their health, and rightfully so. We were glad to do what we could to help them.

Susan Barfield (24:17):
Yeah. Has there been any recent updates?

Dena Young (24:24):
We could talk about the tolling agreement, which is a pretty big step forward for us. The parties met and conferred and talked about a tolling agreement so that firms and their clients could toll their key cases, which is a way we could stop the statute of limitations from running while we work on the case. And it protects the claims so that you don’t have to file it in court, but you’re tolling their… you’re basically putting a flag on their case and saying, hold this, so that their statute doesn’t continue to run. It’s a really great… It’s great that we’ve come to this agreement and that the judge has entered an order putting the tolling agreement into place. It’s available for any firm that needs to toll clients. It’s on the court’s website.

Dena Young (25:28):
You can also reach out to any of us and we’ll provide it with the exhibit that you have to attach, including all of your client’s information. It’s really simple. And then there’s a, the defense attorney has an email address and you just send the tolling agreement with your exhibit of clients to that email address, and then your clients are considered told. So it’s really helpful. And we’re happy to help anybody who needs to put their clients on there so that you don’t have to file your cases, but you’re protecting their claims.

Dan Comunale (26:01):
Absolutely. And so just a large amount of our viewers, subscribers and people on our email are, a lot of firms that dabble in mass torts, if you will, what would be the best way if they just want to refer to your firm and just send you guys some cases, what is the best way for them to get in touch with you guys?

Shanon Carson (26:20):
So the best way for them to get in touch with us is just to give us a call or to email us so we can set up a meeting with them. We’ve heard from so many firms with that are exactly like what you just described that may have been approached or been retained by two or five or 10 people or something like that. They’re looking for a law firm partner that can help them co-counsel those cases. And we’re certainly available to have those discussions. They can call us directly. They can call me. They can email us. I think all of our information is on the Berger Montague website, bergermontague.com. And they are certainly encouraged to get in touch with us. And we’d be delighted to talk to them.

Dena Young (27:08):
We also have, Dan, we also have an email address that goes to the three of us. So if any firm wants to just reach out to all three of us at once, they can, the email address is phillipsrecalllawyers@bm, like burgermontague, .net.

Dan Comunale (27:29):
Okay. And we’ll also provide that in the notes and the comments of this as well, and put it in the email as well. So that’s…

Dena Young (27:35):
And we’re also, if they don’t want to refer cases, like I said before, we’re also happy to direct them and how to get on that tolling agreement. If they don’t want to refer the cases, they can do it themselves. And we’re glad to help direct anybody.

Shanon Carson (27:50):
Yeah, that’s exactly right. We just want to be a resource for folks.

Dan Comunale (27:54):
That’s great. That’s great. And Dena, I know you’re involved in the Allergan breast implants, what is the similarities, or what do you see that sort of in terms of… what do you like about large scale litigation that… where do you see the blend of the two litigations?

Dena Young (28:13):
The blend of these litigations is that they’re these people, women for the Allergan implants, and then all sorts of people for this case, but that long term exposure can cause serious injury, if not death. And it’s enraging to me, and it’s upsetting. And it’s upsetting to the clients that companies put out a product that’s not fit for use and not fit for life. And they expect to get away with it. So to me, it’s doing good work to represent people who are at risk for disease from a manufacturer that just wants to get rich. And so that’s the similarities, that these people, all users of Allergan implants that are textured, and all users of Philips CPAP that had this foam are at risk for serious bodily injury, and they deserve compensation.

Susan Barfield (29:15):
Yeah. John, what would a successful resolution for the CPAP case look like for the firm?

John Albanese (29:26):
That’s a great question. I think whenever we take a case, we’re a very client focused firm and we want to always do the best we can by our clients. So a successful resolution is for those people who are out money because they may have bought a replacement CPAP machine rather than wait on Philips to provide one, or if they just aren’t comfortable using a Philips machine anymore, they should be entitled for that money back that they paid for the replacement machine. For the people that were seriously injured, and we can show that their injuries were caused by the use of the Philips machine and the foam, then they should be compensated for their injuries. That’s where are our firm really focuses on, what our clients want and what they are entitled to. So a successful result is when we can get compensation for our client and represent them the best that we can against the multi-billion dollar international corporation.

Dena Young (30:28):
Yeah. There are people, going back to Allergan as well, the users, the people who’ve been affected by these products feel really violated. It’s a real feeling to have a… to be injured by a company and learn through discovery that these companies knew for a long time that their products were dangerous and didn’t do anything about it. It’s really upsetting. So, a lot of this for the clients, even if they don’t want money per se, is to get justice and to show that they’re angry and upset. And how could you do this?

Susan Barfield (31:09):

Dena Young (31:11):
So it’s like cathartic for them.

Shanon Carson (31:15):
Yeah. And if can I add one thing, too, for those that are watching, because this is not a fact that’s true in every case, the judge in this case is very focused, even at this early stage, on trying to encourage the parties to reach resolution. So part of the leadership committee that’s been appointed includes element committee. And as recently as the last hearing with the court, the court reiterated her commitment to doing whatever the court can do to help push this case towards a resolution sooner rather than later, which is really what people need, to Dena’s point.

Susan Barfield (32:03):
Yeah. Well, Dena, Shanon, John, we greatly appreciate the three of you taking time to connect. Not only is your knowledge, but certainly, especially Dena, I can hear your passion come through about these cases. And so, as Dan mentioned, a lot of our viewers and a lot of the firms that we assessed are going to need to find homes for these cases. And so we would love to be able to partner with you guys and appreciate you giving your information so that they have a resource that they can reach out to, whether they’re referring cases now or maybe they need to in the future.

Dena Young (32:35):

Susan Barfield (32:35):
But we just are so thankful for you taking time to talk all things CPAP today. And we just thank you for that. Dan, any last…

Dan Comunale (32:45):
No, again, just to reiterate, thank you so much, obviously for attending. I know Susan mentioned passion and our why, that is a big reason of, we want to get involved in the CPAP litigation for exactly that. We want to help as many people as possible. So we are looking to work with leadership in every facet, be a part of the MDL and be able to help in any way, shape or form, because this is going to be a very large scale litigation. And that’s exactly what we do. We scale up and we provide that resource. So we are very passionate about getting involved. So I thank you all for joining. Very much looking forward to meet you in person real soon. And thank you again for coming today.

Dena Young (33:27):
Thank you. Thank you for inviting us.

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