6 ms·

Philips hid CPAP machine problems from FDA and patients for years

94 points by dtagames 3y ago

theshrike79 3y ago
> The company acknowledged that the foam it had chosen could crumble in heat and humidity and send potentially “toxic and carcinogenic” material into the noses, mouths, throats and lungs of users. > Philips withheld more than 3,700 complaints over 11 years from the FDA > the company did not launch a formal investigation of the problem until 2019 — nine years after the first wave of complaints and three years after the first known tests for the company found that the foam was degrading This is not some minor "problem", people actually got _cancer_ from the degrading devices.
- inamberclad 3y ago
  It's linked to a whole lot of deaths, it seems. How on earth can a company betray trust like this and continue to function? There needs to be a corporate equivalent of a life sentence, or a permanent ban from a certain industry for leadership involved in a business unit that conducts such malfeasance.
  - darth_avocado 3y ago
    > How on earth can a company betray trust like this and continue to function? Uhhh, like welcome to America? It’s literally the history of every industry in this country. No or understaffed regulatory body. Industry allowed to self report. Eventually people die and there is a public outrage. Eventually (hopefully) industry is regulated, often when the harm reaches children. Industry find something else that is questionable. Rinse and repeat.
  - emacsen 3y ago
    Why punish the company, punish the executives! Putting a foam they knew to be dangerous into a medical product? Choices not to disclose? Prosecute executives in jail for manslaughter. A few executives in prison for a decade or two, having to return all their assets gained, and we'll see less of this type of criminal activity. Corporate veils are important for some types of activity, but when it comes to the loss of life, and choices made, executives who make 1.5m USD a year (as the Philips CEO does) should be held to a very high standard.
    - sofixa 3y ago
      > Putting a foam they knew to be dangerous into a medical product I doubt it's the executives deciding on the materials to use. Like in Boeing's case, it probably wasn't executives that decided not to use redundancy on a critical input. Both executives (command principle) and the actual engineers/designers and everyone else who received the reports or somehow knew about it deserves prison time.
      - olliej 3y ago
        Literally the entire argument for board and executive compensation being grossly inflated vs the people who actually do real work for companies is the responsibility they have. If an executive approves a design that kills people, they should be responsible. If an executive approves a design that they can't understand kills people, why are they being paid more than the people who do ostensibly know what they're doing? Either the executives and board understand what they're doing and deserve both the up and downsides of their choices, be those financial or criminal, or they don't. The idea that the substantially lower paid employee who thinks "this looks like a reasonable choice" is more responsible than the ostensibly more competent, and again certainly compensated as such, that approves of the approach (and also determines compensation and bonuses on the basis of cost saving to those lower paid employees) is not is patently absurd. The entire compensation story for executives and the board is based on them being responsible for the actions of the company. If they are unwilling to stop illegal actions by the company, they should quit.
        sofixa 3y ago
        > If an executive approves a design that kills people, they should be responsible. Do you really think it's executives approving design specifics such as materials used? > The idea that the substantially lower paid employee who thinks "this looks like a reasonable choice" is more responsible than the ostensibly more competent, and again certainly compensated as such, that approves of the approach Unfortunately competency in the actual field is never a requirement for management and executives. There are whole diplomas and schools founded upon the principle that management is management and business is business, regardless of the field and what is actually being managed. So thinking executives have any competencies outside of maybe managing people and business is misguided hope. Yes, executives should be held responsible for big failures at their companies (and not getting tens of millions of dollars in a golden parachute and retiring with yachts). But that doesn't mean that the people who actually designed, QAed, approved the design should get off free.
theshackleford 3y ago
I used one of these for years up until the recall. Ironically over that same time I have developed an odd cough. Actually just recently given a referral to a respitory specialist. Hopefully its just asthma or something. What in the fuck is with my odds, why does this keep happening to me. It feels like the universe is literally trying to kill me.
- M95D 3y ago
  I'm sorry it happend to you and I hope it's not cancer. But the universe IS trying to kill you. It's trying to kill us all, and eventually, it will. We call it the 2nd law of thermodynamics. https://en.wikipedia.org/wiki/Heat_death_of_the_universe https://en.wikipedia.org/wiki/Heat_death_of_the_universe
- catchnear4321 3y ago
  > It feels like the universe is literally trying to kill me. it is, but is it doing so on purpose? that would be quite the signal. either way, the important thing is whether or not it succeeds. as it stands, you’re undefeated.
schmorptron 3y ago
Yeah, no. Everyone who knew of this needs to be hold personally accountable and serve jail time. And not just some low fall guy, but the managers, higher-ups who could've known of the report. In cases like this, the fines for the company need to also be so incredibly high that it cannot survive.
- duke_sam 3y ago
  In an ideal world the state would prosecute the company and the evidence from that would be usable in a class action suit with huge punitive damages.
  - sofixa 3y ago
    That would still be the company paying, but the individuals responsible avoiding punishment.
- deleted 3y ago
  [deleted]
arp242 3y ago
FDA says 561 deaths tied to recalled Philips sleep apnea machines - https://news.ycombinator.com/item?id=39223982 https://news.ycombinator.com/item?id=39223982 - Feb 2024 (71 comments)
jader201 3y ago
Could something like this cause IPF? My father passed away a few years ago, after being diagnosed with IPF only about 1-1.5 years before passing. He had no past of being exposed to anything hazardous. His pulmonologist couldn’t ever figure out what could’ve caused it. He was diagnosed with sleep apnea probably 15 or so years before passing, and used a CPAP nightly. He eventually developed a nasty cough that never went away, and was finally diagnosed with IPF. I’m not looking for any sort of retribution, more just possible answers or even just clues, since it’s not clear whether it was related to anything hereditary (I have 3 siblings). And to be clear, I’m not even sure what brand/model he used (though my mom would likely know). So there’s a decent chance it’s unrelated.
- bagels 3y ago
  One of the lawsuits claims that it can be a cause of Pulmonary Fibrosis. https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-lawsuit/#:~:text=Pulmonary%20fibrosis%20is%20a%20severe,for%20permanent%20injuries%20and%20disabilities https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-l....
  - jader201 3y ago
    Thank you for sharing, that’s a helpful article.
herbst 3y ago
Does this apply to machines sold in Europe?
moogly 3y ago
Philips Respironics is signing a consent decree with the FDA to basically pull out of the US[1]. Imagine if a murderer could also sign a consent decree to just promise not to murder anyone else (in that country, mind you), and get away scot free. But no news out of Europe... I sure hope they will not be permitted to sell any machines there ever again too. Luckily for me, I use ResMed machines. [1]: https://www.medtechdive.com/news/philips-stops-selling-devices-fda-consent-decree/705822/ https://www.medtechdive.com/news/philips-stops-selling-devic...
- ametrau 3y ago
  Historically the consequences for these decisions make it basically risk free.
- catchnear4321 3y ago
  this is the complexity of scale. the consequence decreases the competition faced by resmed. this is not to suggest that resmed the corporate animal will now take advantage. it also isn’t to suggest that it won’t.

94 points by dtagames 3y ago

> The company acknowledged that the foam it had chosen could crumble in heat and humidity and send potentially “toxic and carcinogenic” material into the noses, mouths, throats and lungs of users. > Philips withheld more than 3,700 complaints over 11 years from the FDA > the company did not launch a formal investigation of the problem until 2019 — nine years after the first wave of complaints and three years after the first known tests for the company found that the foam was degrading This is not some minor "problem", people actually got _cancer_ from the degrading devices.

inamberclad 3y ago
It's linked to a whole lot of deaths, it seems. How on earth can a company betray trust like this and continue to function? There needs to be a corporate equivalent of a life sentence, or a permanent ban from a certain industry for leadership involved in a business unit that conducts such malfeasance.
- darth_avocado 3y ago
  > How on earth can a company betray trust like this and continue to function? Uhhh, like welcome to America? It’s literally the history of every industry in this country. No or understaffed regulatory body. Industry allowed to self report. Eventually people die and there is a public outrage. Eventually (hopefully) industry is regulated, often when the harm reaches children. Industry find something else that is questionable. Rinse and repeat.
- emacsen 3y ago
  Why punish the company, punish the executives! Putting a foam they knew to be dangerous into a medical product? Choices not to disclose? Prosecute executives in jail for manslaughter. A few executives in prison for a decade or two, having to return all their assets gained, and we'll see less of this type of criminal activity. Corporate veils are important for some types of activity, but when it comes to the loss of life, and choices made, executives who make 1.5m USD a year (as the Philips CEO does) should be held to a very high standard.
  - sofixa 3y ago
    > Putting a foam they knew to be dangerous into a medical product I doubt it's the executives deciding on the materials to use. Like in Boeing's case, it probably wasn't executives that decided not to use redundancy on a critical input. Both executives (command principle) and the actual engineers/designers and everyone else who received the reports or somehow knew about it deserves prison time.
    - olliej 3y ago
      Literally the entire argument for board and executive compensation being grossly inflated vs the people who actually do real work for companies is the responsibility they have. If an executive approves a design that kills people, they should be responsible. If an executive approves a design that they can't understand kills people, why are they being paid more than the people who do ostensibly know what they're doing? Either the executives and board understand what they're doing and deserve both the up and downsides of their choices, be those financial or criminal, or they don't. The idea that the substantially lower paid employee who thinks "this looks like a reasonable choice" is more responsible than the ostensibly more competent, and again certainly compensated as such, that approves of the approach (and also determines compensation and bonuses on the basis of cost saving to those lower paid employees) is not is patently absurd. The entire compensation story for executives and the board is based on them being responsible for the actions of the company. If they are unwilling to stop illegal actions by the company, they should quit.
      - sofixa 3y ago
        > If an executive approves a design that kills people, they should be responsible. Do you really think it's executives approving design specifics such as materials used? > The idea that the substantially lower paid employee who thinks "this looks like a reasonable choice" is more responsible than the ostensibly more competent, and again certainly compensated as such, that approves of the approach Unfortunately competency in the actual field is never a requirement for management and executives. There are whole diplomas and schools founded upon the principle that management is management and business is business, regardless of the field and what is actually being managed. So thinking executives have any competencies outside of maybe managing people and business is misguided hope. Yes, executives should be held responsible for big failures at their companies (and not getting tens of millions of dollars in a golden parachute and retiring with yachts). But that doesn't mean that the people who actually designed, QAed, approved the design should get off free.

theshackleford 3y ago

I used one of these for years up until the recall. Ironically over that same time I have developed an odd cough. Actually just recently given a referral to a respitory specialist. Hopefully its just asthma or something. What in the fuck is with my odds, why does this keep happening to me. It feels like the universe is literally trying to kill me.

M95D 3y ago
I'm sorry it happend to you and I hope it's not cancer. But the universe IS trying to kill you. It's trying to kill us all, and eventually, it will. We call it the 2nd law of thermodynamics. https://en.wikipedia.org/wiki/Heat_death_of_the_universe https://en.wikipedia.org/wiki/Heat_death_of_the_universe
catchnear4321 3y ago
> It feels like the universe is literally trying to kill me. it is, but is it doing so on purpose? that would be quite the signal. either way, the important thing is whether or not it succeeds. as it stands, you’re undefeated.

schmorptron 3y ago

Yeah, no. Everyone who knew of this needs to be hold personally accountable and serve jail time. And not just some low fall guy, but the managers, higher-ups who could've known of the report. In cases like this, the fines for the company need to also be so incredibly high that it cannot survive.

duke_sam 3y ago
In an ideal world the state would prosecute the company and the evidence from that would be usable in a class action suit with huge punitive damages.
- sofixa 3y ago
  That would still be the company paying, but the individuals responsible avoiding punishment.
deleted 3y ago
[deleted]

arp242 3y ago

FDA says 561 deaths tied to recalled Philips sleep apnea machines - https://news.ycombinator.com/item?id=39223982 https://news.ycombinator.com/item?id=39223982 - Feb 2024 (71 comments)

jader201 3y ago

Could something like this cause IPF? My father passed away a few years ago, after being diagnosed with IPF only about 1-1.5 years before passing. He had no past of being exposed to anything hazardous. His pulmonologist couldn’t ever figure out what could’ve caused it. He was diagnosed with sleep apnea probably 15 or so years before passing, and used a CPAP nightly. He eventually developed a nasty cough that never went away, and was finally diagnosed with IPF. I’m not looking for any sort of retribution, more just possible answers or even just clues, since it’s not clear whether it was related to anything hereditary (I have 3 siblings). And to be clear, I’m not even sure what brand/model he used (though my mom would likely know). So there’s a decent chance it’s unrelated.

bagels 3y ago
One of the lawsuits claims that it can be a cause of Pulmonary Fibrosis. https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-lawsuit/#:~:text=Pulmonary%20fibrosis%20is%20a%20severe,for%20permanent%20injuries%20and%20disabilities https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-l....
- jader201 3y ago
  Thank you for sharing, that’s a helpful article.

herbst 3y ago

Does this apply to machines sold in Europe?

moogly 3y ago

Philips Respironics is signing a consent decree with the FDA to basically pull out of the US[1]. Imagine if a murderer could also sign a consent decree to just promise not to murder anyone else (in that country, mind you), and get away scot free. But no news out of Europe... I sure hope they will not be permitted to sell any machines there ever again too. Luckily for me, I use ResMed machines. [1]: https://www.medtechdive.com/news/philips-stops-selling-devices-fda-consent-decree/705822/ https://www.medtechdive.com/news/philips-stops-selling-devic...

ametrau 3y ago
Historically the consequences for these decisions make it basically risk free.
catchnear4321 3y ago
this is the complexity of scale. the consequence decreases the competition faced by resmed. this is not to suggest that resmed the corporate animal will now take advantage. it also isn’t to suggest that it won’t.