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Philips hid CPAP machine problems from FDA and patients for years (propublica.org)
94 points by dtagames on Feb 2, 2024 | hide | past | favorite | 34 comments


> 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.


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.


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.


There is a benefit for pushing the company. It impacts share holders too.

This would cause a society shift in what companies we invest in, and what are the hard questions we ask.

It would force the companies to not just put short term profits ahead.


Then why not both? Shouldn’t all parties here suffer the consequences?


I agree with you, I wasn’t clear that I didn’t mean _only_ the company.


> 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.


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.


> 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.


> Do you really think it's executives approving design specifics such as materials used?

The executives approve and oversee the compensation structure that allows for stuff like this.

They also foster a culture where whistleblowing about cancerous materials or reports about people suffering when using their devices isn't encouraged or protected.

Yes, they should be held responsible. That's why they get paid millions and get huge option packages, because of the massive responsibility. (not really, they get paid $$$ because they know the right people and went to private school with them)


All that you said is true, but that doesn't absolve the actual people who actually made the dangerous decisions of their responsibility.

Regardless of your work environment, if you make a decision that you know is dangerous and kills people, it's your fault too, and you should be criminally charged alongside those above you that didn't catch it, or enabled it through shitty culture, or enforced it due to time/money pressure.


I didn't say that no one other than executives are responsible.

I'm saying that the executives making the decisions, and being compensated for the risk/responsibility (again, this is their own justification for exorbitant compensation), are at minimum just as criminally responsible as the much lower paid person that may make the original choice.

But it's also not a given that that the lower ranked (and paid) individual is the one who has liability - they may reasonably believe the material or product design is safe, because they don't have all the information the company as a whole has, and again, it's the job of the executives to ensure that all the information the company has is correctly considered and routed to the right people, and if that doesn't happen, then the responsibility is on the executives who failed to ensure that happened.

If the executives of a company have demonstrated that they will penalize people for raising safety concerns, they're definitionally taking full responsibility for any consequences of that, including a failure to do full safety analysis in the first place. Similarly if the executives approve employment contracts that include penalties for reporting safety concerns externally they're responsible (non-executive employees aren't likely being paid enough to afford a lawyer to determine whether or not such contract terms are legal, let alone being able to afford being laid off if they're wrong).

Finally, in this case, it's very clear Philips was aware of the problems with this device and intentionally hid that information, and I really don't think that was the decision of some random low level employee. Again, before you go and blame the low level employee, if they're just being told "this is not a real issue and is being overblown" how are they expected to know differently? The lower ranked/paid someone is the higher the perceived risk of asking "are you sure that's accurate?" or similarly rocking the boat. Obviously this is on a scale (don't explicitly put this in our safety notes vs destroy all the documents we have on this issue, the latter should trigger at least a "I'll confirm with legal the exact documents to destroy and CC you" from anyone). But again, if a company is in that position, or employees believe asking about safety issues can result in penalization or termination, that's due to the actions of the executives, and so again, they are liable for the outcome.

The model you're advocating is the mob model of 'I didn't explicitly say "poison someone", one of my associates misunderstood me and went too far, but I didn't break the law'


You keep moving the goalposts.

I don't see why the executives should be liable as long as they didn't personally choose the foam or hid the complaints.

In a big company it's impossible for a single person to know everything that's happening at every level.


Here, as an exec, i'll offer a reason:

They are paid to be liable, and usually have the explicit authority to bind the company with their decisions (IE signing/etc authority). Part of the job is to be accountable for the decisions your organization makes, whether you made them personally or not. The buck stops here, so to speak.

This is intentional - in large companies actual responsibility for failure can be so diffuse that nobody would otherwise ever held accountable.

If you break down what happened here into pieces:

1. Root cause of problem

2. Responsibility for the problem

3. Accountability for the problem

4. What accountability looks like

This amounts to:

1 is "someone chose to use the wrong foam" for $reasons.

2 is whoever did that, probably not an exec. In large companies, or complex problems, responsibility can also be very spread out.

3 is what we are discussing - I would argue strongly that executives should be held civilly accountable for the decisions made by their organizations and criminally accountable for decisions made by their organization that they had direct knowledge of.

In general, execs usually are indemnified by the company for reasonable business decisions they make, so holding them civilly liable will not result in personal liabilty for them except to the degree they lied/hid/committed fraud, which is basically what you want.

4 i honestly have no idea what to do here.


The argument that the execs must be the one to choose the foam to be liable is a bit silly. While in some white collar crimes, you will find individual actions by execs, such as in banking and tobacco, that's rarely the case.

Here there's evidence of a coverup- of deaths reported and Phillips choosing to not disclose or recall until forced to.

An argument could be made that until that point, there's no action by the executive that is wrong- though again, it's a medical device so it should be held up to high standards. Once the company had reason to believe that their device could be dangerous, it had a duty to act. Executives were surely notified when there was a liability concern, and the decision not to act on them is the trigger event.

Was it the CEO? Maybe not? Phillips is a huge corporation, but I'd venture a guess that even in a company that size, there's a bit of "pass the buck" and higher up executives knew something of the situation, and if someone knew of deaths, they had a responsibility to look into it.


"The argument that the execs must be the one to choose the foam to be liable is a bit silly. While in some white collar crimes, you will find individual actions by execs, such as in banking and tobacco, that's rarely the case."

Sure. Generally criminal liability (in the US) requires a "guilty mind". That is, you have to have the intention/knowledge of wrongdoing for it to be criminal, regardless of the acts.

This isn't always true (there are strict liability crimes, etc), but it's mostly true.

What you are suggesting would not really be in line with that, at least in the US.

Now, we could as a society decide we have a big enough problem that we want more strict liablity crimes for execs. I don' feel like i have a good enough understanding of the practical tradeoffs/data to have a strong opinion there yet.


No, the company should be civilly liable, the individuals have criminal liabilities.

Alternatively, who is going to jail if a company is found guilty of a crime that requires jail time, if not the executives and board of directors? Again by the specific claims used to justify executive compensation, they're responsible.

The result of companies being criminally liable, and individuals being civilly liable, is that no one is criminally liable, the executives running the company just have to pay fines, that the company will then cover, either directly due to contractual indemnification, or by golden parachutes and similar.

If a company's executives are running the company properly (1) should be caught before production starts, failing to do so is the result of executive decisions: if an executive chooses to not adequately fund safety and QA tests, that isn't the fault of the designers and engineers. If issues start coming in after the product is on the market, it is the decision of the company executives to halt production, to re-do the safety analysis, or - as in this case - withhold any information and pretend there's no problem.


> I don't see why the executives should be liable as long as they didn't personally choose the foam or hid the complaints.

Because that's what your job is as a higher up. You direct stuff, which comes with the responsibility of the results of that directing. In exchange you have a lot of power and get paid handsomely.

It wasn't Dennis Muilenburg personally who coded the shitty unredudant software that made Boeing 737 Maxes crash themselves into the ground, but he was forced to resign nonetheless (even though he got a golden parachute so it was more of a reward than a punishment). It wasn't Vincent Van Quickenborne who personally didn't process the necessary paperwork that left a terrorist free in Belgium and allowed the later to murder people, but he took accountability and resigned.

There's a whole legal doctrine in international law when it comes to war crimes, called the command responsibility, where commanders are responsible for crimes committed by their subordinates (unless they're American, then they all get medals).


> In a big company it's impossible for a single person to know everything that's happening at every level.

you do not need to know everything about a thing to be responsible for it.

do you own a pet? if yes, are you a veterinarian? if no, how do you care for your pet if you can’t run a blood screen?


> 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.


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.


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.


That would still be the company paying, but the individuals responsible avoiding punishment.


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-devic...


Historically the consequences for these decisions make it basically risk free.


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.


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


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.


One of the lawsuits claims that it can be a cause of Pulmonary Fibrosis.

https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-l....


Thank you for sharing, that’s a helpful article.


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.


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


> 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.


Does this apply to machines sold in Europe?




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