Amid Recall Crisis, Philips Agrees To Stop Selling Sleep Apnea Machines In the United States (propublica.org) 61
An anonymous reader quotes a report from ProPublica: Reeling from one of the most catastrophic recalls in decades, Philips Respironics said it will stop selling sleep apnea machines and other respiratory devices in the United States under a settlement with the federal government that will all but end the company's reign as one of the top makers of breathing machines in the country. The agreement, announced by Philips early Monday, comes more than two years after the company pulled millions of its popular breathing devices off the shelves after admitting that an industrial foam fitted in the machines to reduce noise could break apart and release potentially toxic particles and fumes into the masks worn by patients.
It could be years before Philips can resume sales of the devices, made in two factories outside Pittsburgh. The company said all the conditions of the multiyear consent decree -- negotiated in the wake of the recall with the Department of Justice on behalf of the Food and Drug Administration -- must be met first. The move by a company that aggressively promoted its machines in ad campaigns and health conferences -- in one case with the help of an Elvis impersonator -- follows relentless criticism about the safety of the machines. A ProPublica and Pittsburgh Post-Gazette investigation found the company held back thousands of complaints about the crumbling foam for more than a decade before warning customers about the dangers. Those using the machines included some of the most fragile people in the country, including infants, the elderly, veterans and patients with chronic conditions.
"It's about time," said Richard Callender, a former mayor in Pennsylvania who spent years using one of the recalled machines. "How many people have to suffer and get sick and die?" Philips said the agreement includes other requirements the company must meet before it can start selling the machines again, including the marquee DreamStation 2, a continuous positive airway pressure, or CPAP, device heralded by Philips when it was unveiled in 2021 for the treatment of sleep apnea. The settlement, which is still being finalized, has to be approved by a court and has not yet been released by the government. It remains unclear how the halt in sales will impact patients and doctors. The company's U.S. market share for sleep apnea devices in 2020 was about 37% -- behind only one competitor, medical device maker ResMed, according to an analysis by iData Research. Philips has dominated the market in ventilator sales, the data shows.
It could be years before Philips can resume sales of the devices, made in two factories outside Pittsburgh. The company said all the conditions of the multiyear consent decree -- negotiated in the wake of the recall with the Department of Justice on behalf of the Food and Drug Administration -- must be met first. The move by a company that aggressively promoted its machines in ad campaigns and health conferences -- in one case with the help of an Elvis impersonator -- follows relentless criticism about the safety of the machines. A ProPublica and Pittsburgh Post-Gazette investigation found the company held back thousands of complaints about the crumbling foam for more than a decade before warning customers about the dangers. Those using the machines included some of the most fragile people in the country, including infants, the elderly, veterans and patients with chronic conditions.
"It's about time," said Richard Callender, a former mayor in Pennsylvania who spent years using one of the recalled machines. "How many people have to suffer and get sick and die?" Philips said the agreement includes other requirements the company must meet before it can start selling the machines again, including the marquee DreamStation 2, a continuous positive airway pressure, or CPAP, device heralded by Philips when it was unveiled in 2021 for the treatment of sleep apnea. The settlement, which is still being finalized, has to be approved by a court and has not yet been released by the government. It remains unclear how the halt in sales will impact patients and doctors. The company's U.S. market share for sleep apnea devices in 2020 was about 37% -- behind only one competitor, medical device maker ResMed, according to an analysis by iData Research. Philips has dominated the market in ventilator sales, the data shows.
A damn shame (Score:2)
Re: A damn shame (Score:3)
ResMedâ(TM)s range is also excellent, and doesnâ(TM)t⦠you know⦠poison you.
Re: A damn shame (Score:4, Funny)
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Any phone you damn well choose works just fine. The only people looking stupid are Slashdot's coders who are stuck in some weird pre-unicode world, and the guy who's so excited about his choice of phone that he has to post on the internet about how everyone else is wrong.
Re: (Score:3)
Any phone you damn well choose works just fine. The only people looking stupid are Slashdot's coders who are stuck in some weird pre-unicode world, and the guy who's so excited about his choice of phone that he has to post on the internet about how everyone else is wrong.
I dunno, man. It's an apostrophe. Kind of a solved problem. I mean... it's in the bottom 128 ANSI characters, so it's been available since we were using 7-bit character sets.
But no. Apple's got to be special.
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You're right, it's a solved problem. Perhaps the Slashdot coders should use that solution to actually support UTF-8, which has been in existence five years more than Slashdot itself has been. Or if it's crucial for some reason to restrict posts to 7-bit ASCII, recognize the well-known byte sequences for common UTF-8 characters to translate to the nearest ASCII equivalents. All it takes is a single regex. And maybe clean up uncommon or untranslatable Unicode characters as well so we don't have to see absolut
Re:A damn shame (Score:5, Informative)
I've had my Respironics model for many years and it continues to provide a good night's sleep. I would appreciate a smaller unit that would be easier to take with me when traveling and that could perhaps run off a common power bank when the power goes out, but those would be bonus features.
The thing that took me the longest to get correct was the mask type. There are three main categories of masks -- nasal pillow, nasal mask, and full-face mask -- with multiple brands and styles in each category. I found the Swift 2 nasal pillow from ResMed works best for me. It is small, doesn't need a large amount of elastic pressure to stay on my face, swivels while I sleep so I can sleep on either side, and is very good for people that are claustrophobic.
If you are a CPAP user and haven't looked at some of the new masks available, it might be worth a review and possible test of a new mask type.CPAP mask types [google.com]
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The ResMed AirFit F30 is an excellent, small full face mask. It works great for a side sleeper like myself.
https://www.1800cpap.com/airfi... [1800cpap.com]
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There are three main categories of masks
Five, I would say. There's also the smooth under-nose style of the airfit n30 and the adhesive patches used by the bleep dreamport. Everything else is a variant on those.
Re: A damn shame (Score:2)
Well, there's also the Oracle oral "mask", but ugh, no.
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Yeah we don't talk about that one.
The thing I never understood, and none of my friends with one could explain either, is why CPAP masks all seem to be built backwards to conventional wisdom about "sprung" vs "unsprung". You'd think the better design would be to have the straps and stuff as close to the contact point as possible and then allow the rest of the mask to move much more freely.
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Perhaps Phillps could have used materials that were biocompatible? Or just redesigned the thing.
BTW, their market dominance has quashed innovative startups in this space.
I've only owned Philips CPAP machines (Score:2)
I'm on my fifth, including my current one that was replaced as part of the recall. I've never used a different make, and I'm pretty concerned about switching when the time comes.
Re:I've only owned Philips CPAP machines (Score:4, Informative)
I got a resmed, first new one in quite a while (was limping along old Intellipap machines), and it's great. Philips is not the only decent machine.
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I currently have a Phillips machine that was recalled and replaced as well.
It replaced a ResMed unit that I still have as a backup.
That one replaced a unit I got when I was first diagnosed with OSA in 1996.
I understand your concerns, but there are several good suppliers to choose from.
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My ResMed Airsense 11 is pretty great, but I've only ever used ResMed devices. Dead silent and I have less than 1 event per hour with a basic nasal mask. I wouldn't be overly concerned about it.
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Re: I've only owned Philips CPAP machines (Score:2)
Yeah, no. Have a big neck. I inherited it. It's a principal factor.
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Another version of the trolley problem? (Score:3)
A. Philips made a decent machine except the foam problem
B. Foam problem may have sickened and killed X people
C. Untreated sleep apnea would have sickened and killed X * N people
Um...keep selling the machine and service recalls as fast as you can? Somebody's gonna die, but OTOH, we all are.
Re:Another version of the trolley problem? (Score:5, Insightful)
I would have agreed with you, somewhat, however this bit was worrying:
A ProPublica and Pittsburgh Post-Gazette investigation found the company held back thousands of complaints about the crumbling foam for more than a decade before warning customers about the dangers.
Re: Another version of the trolley problem? (Score:2)
Well yeah, an ethical solution requires an ethical actor.
Re:Another version of the trolley problem? (Score:5, Insightful)
That sounds like criminal conspiracy. Until people involved in actions like this aren't able to successfully hide behind the corporation anymore, this sort of thing will happen again and again.
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Except other companies also make a decent machine but without the foam problem, so not the trolly problem. There was a switch position that wouldn't kill anyone.
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Oh. Oops.
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C wouldn't occur because there are other sleep apnea machines at the same level of accessibility. You're also forgetting Option D which is fix the foam problem.
Even less competition... (Score:3)
Even less competition...in an industry where very simple machines already sell for at least $600. Terrible idea.
Re: Even less competition... (Score:3)
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Eh, that makes no sense whatsoever.
Those who still need a CPAP machine face less competition and higher prices. How would reducing the size of a market have any positive impact on prices and innovation, especially after removing a big chunk of the competition??
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Exactly what part of reducing demand significantly as it relates to supply, do you not grasp here? Hell with the sheer amount of greed involved, I question if even half of CPAP users, actually need the hardware.
Perhaps validating this entire market, is long overdue.
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You sound like some CPAP company sales executive. Less competition is not good, no matter what someone like you would have us believe.
CPAP machines are already massively overpriced due to heavy medical device regulation. Their prices are not strongly linked to demand or supply.
Supply isn't gonna fall for long at all, since the other CPAP companies will just increase production of their own very high margin machines. These devices are very simple and have been around a very long time. Making them is easy
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Which words are you confused by?
Recall replacement was a downgrade. (Score:2)
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Actually, it's $150: $100 as part of the settlement and $50 that was offered before the settlement. That probably does not change our opinion on the compensation, however.
I've had one of these recalled CPAP machines for 10 years (I just never bothered to replace it since it worked perfectly fine) but it doesn't have the problems described by the recall, probably because I live in California and the two factors that cause the foam to deteriorate—heat and humidity—do not usually exist where I li
Boeing, pay close attention! (Score:1)
Good! Screw em (Score:3)
They lied/hid issues with the foam, the recall / replacement was a total disaster -- was more than 1 YEAR to get mine replaced by them. I'd get these emails full of legalese explaining how much they cared, but it was going to take a while because of x y and z.
What actually happened was my pcp got me a different make/model since he knew the recall was so slow and cumbersome. I did eventually get my replacement from Philips, something like 15 months after the recall, but by that time I've been using the one the doc got for me for over a year.
Fuck them... and the horse they rode in on.
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Same, except I didn't have a PCP give me jack shit. I never returned my 13 year old original one either. I still have class action shit sitting on my desk I haven't opened.
They did eventually send a new machine but I had to use the recalled one for years past their notice because they never sent shit. By the time the 'new' one got here I was able to get a different one from a sleep doctor.
My doctors keep quitting and moving so getting a replacement was basically impossible for a very long time.
On the Bright Side (Score:3)
This is terrible news for CPAP owners.
On the other hand, I have 4 Iron Lungs for sale...
--
Better three hours too soon than a minute too late. - William Shakespeare
See pappy? (Score:1)
"How many people have to suffer and get sick and die?"
Probably more now, without cpap machines. Thanks, lawyers.
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"How many people have to suffer and get sick and die?"
Probably more now, without cpap machines. Thanks, lawyers.
Yeah, or this is when we find out just how corrupt Greed is in the medical industry, pushing CPAP solutions to address an apparent “epidemic” that seemingly came out of nowhere in the last decade. Much like Adderal, you rarely find a “modern” household now that doesn’t have a CPAP patient. Start asking why.
Re:See pappy? (Score:5, Informative)
"How many people have to suffer and get sick and die?"
Probably more now, without cpap machines. Thanks, lawyers.
Yeah, or this is when we find out just how corrupt Greed is in the medical industry, pushing CPAP solutions to address an apparent “epidemic” that seemingly came out of nowhere in the last decade. Much like Adderal, you rarely find a “modern” household now that doesn’t have a CPAP patient. Start asking why.
Hrrm. Maybe because a} they're no longer massive devices and b} they're no longer stupid expensive devices?
I can only speak to the anecdote that the person in my household who uses one absolutely was doing the whole completely-stopping-breathing thing every night and shuddering back into gasping distress. She sleeps much better with it. As do I.
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Hrrm. Maybe because a} they're no longer massive devices and b} they're no longer stupid expensive devices?
”Stupid” is a matter of perspective when the average household would struggle paying a sudden $400 expense. If they were stupid cheap we probably wouldn’t be here talking about something anyone could afford to easily buy, replace and maintain with no insurance pimp.
I can only speak to the anecdote that the person in my household who uses one absolutely was doing the whole completely-stopping-breathing thing every night and shuddering back into gasping distress. She sleeps much better with it. As do I.
I have a loved one that relies on one as well; my own father. I was more speaking of addressing root cause, since I have no desire or intention to inherit that condition, nor do I wish to pass it on, unlike the Medical Industri
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How many people will die because the only thing they were prescribed was the sponsored for-profit solution that’s now banned from sale instead of making lifestyle changes to avoid it altogether? No one asks that question. Obesity is a major cause of OSA, which consumes 90% of all apnea types. It’s not a mystery as to how this has problem has grown, or how it can be reduced.
You're spot-on here. You know it and I know. And my wife knows it. And the people who recommended the machine knew it and told her.
But... if weight-loss were an easy decision, it wouldn't be a problem. I absolutely won't make excuses, but I recognize that food addiction is unique in that you can't actually give it up. Alcoholic? Zero-tolerance rule. Gambling addict? Don't go to a casino ever. Coke fiend? Don't ever, ever buy any. But food... you have to moderate and that's massively harder, app
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From the study Obstructive Sleep Apnea and Cardiac Arrhythmias [nih.gov]:
Sleep apnea is a highly prevalent disorder among patients with all forms of cardiovascular disease. Decades of data from several large prospective patient registries have revealed that sleep apnea—in particular, obstructive sleep apnea (OSA)—is practically endemic in cardiology clinics and cardiac inpatient wards across the globe [1,2]. OSA has been closely associated with prevalent and incident hypertension [3], ischemic heart disease [4,5], heart failure [6], stroke [7], and all forms of cardiac rhythm disturbance [8]. Additionally, central sleep apnea (CSA) or combined OSA and CSA often affects patients with heart failure and stroke [9]. Sleep apnea and cardiovascular disease are so intertwined with respect to their epidemiology and shared pathophysiology that one can think of them as being two components of a global, multi-system metabolic syndrome driven largely by obesity.
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Patient: I have sleep apnea.
Doctor: You could probably adjust your diet and lose some weight and it will go away.
Patient: Impossible. Do you have a pill I could take instead?
Doctor: No, but I can sell you this machine.
The medical industry is only responding to consumers who are seemingly allergic to personal responsibility. There isn't any kind of vast conspiracy by government, corporations, or some shadowy organization to push this on people. We as a society chose this for ou
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I had Sleep Apnea long before I was significantly overweight. I'd say the sleep issues drove weight gain rather than weigh gain driving sleep issues. Things aren't as simple as you think they are.
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Now we can all breathe easier... (Score:2)
Now to wait and see if they get one of those lovely "fines" from the government. The company will sure learn once you cost them a couple cups of high priced coffee, let me tell you!
Maybe they'll even get the whole "we're not admitting fault here. We didn't do anything, we're just paying money because reasons. Stop asking questions now. " routine. That'll show em!
What a fucking joke.
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Um, if they're efffectively out of the US market, they have seriously pain, like hundreds of millions or billions of dollars they don't get.
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Did you even read the summary?
How can I file a claim? (Score:1)
What about Canada? (Score:2)