[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[WakeUpTime]

Start fining philips on a daily basis for every illegal device left on the market and see how quickly units get replaced. As it stands, they have no motivation to resolve the recalled devices. In fact just the opposite is true - the longer they drag their feet the more likely effected patients will replace their cpap on their own, or just die waiting. 

That does seems to be the true state of affairs, one year later.  Perhaps the FDA feared that, due to the massive size of the Recall, they wanted to be gentle on Philips from the start.  There was never a risk of over-pushing Philips for quicker better results.  Phillips is a very large multinational, and Philips has a very large source of future medical systems revenues at stake in the U.S. and elsewhere.  

It's not too late for the FDA to motivate Philips now strongly, through penalties, to provide better faster results - and across the board to ALL affected devices, regardless of their model or age.  If someone still owns a faulty product, Philips is obligated to replace it.  Philips does not seem to be having the same severity of 'supply chain issues' from its many other product divisions.  Philips has been allowed to prioritize part allocations to their profitable divisions.  It's regretable that they felt they had that option. 

Philips has now indicated that many customers will be waiting until 2023, 2 years after their announcement to replace a tiny piece of foam.  Unacceptable and negligent, in addition to all the issues that lead up to the Recall.  No one, especially Philips, should be surprised at any sudden strong actions by the FDA.  It’s past due.  After all, we're not talking about a recalled lawn mower.  We're talking about a necessary nightly breathing device.  Waiting two years for a fix/replacement is appalling.  

In hindsight, the FDA should have given Philips 12 months to fix/replace faulty products.  Failing that, Philips would be liable to reimbursement remaining unfixed/unreplaced Recalled device owners for their original purchase price, or the price of an equivalent replacement device.  I have absolutely no doubt that Philips would have met that objective.

[PauloMaia]

Unfortunately I am a Phillips customer in Canada.  I registered in September 2021.  In January 2022, as I had not heard anything, I contacted the 1-877-907-7508 number.  I was told them that the first batch of replacements had been completed and I would be included in the next one and should be contacted soon.  Today, Jul/11/2022, I decided that I had waited long enough and contacted the 1-877 number again.  I was asked for the confirmation number, my name, address and phone number.  After they confirmed all the information I was told that my DME would contact me.  I then asked for the information they had on my DME so I could contact them to follow up; I was then told that they did not have this information to give to me.  Back in January I was at my DME here in Canada and they flatly told me that they were not involved in the process, I had to deal with Phillips directly.

So my situation is simple: my DME in Canada tells me that they are not involved, I should contact Phillips directly.  Phillips tells me that my DME will contact me but they do not have the information of who this DME is (I asked to talk to a supervisor, lady put me on hold and after a few minutes came back and said supervisor confirmed all the info she had given me).

Phillips has given the finger to users in Canada.  I am not buying another product from Phillips.

[WakeUpTime]

<< above >>

Philips has been allowed to choose who gets fixes/replacements and the timing - and it's not necessarily in order of Recall registration.  As you've found, there isn't any oversight agency that's holding Philips accountable, and looking out for the best interests of affected device owners.  Instead, Philips is using metrics that look out for Philips' own best interests.

Many countries have a leading lawfirm representing Recalled Philips device owners.  It couldn't hurt to pass your details on to them.  For Canada, I believe it's:  https://www.thomsonrogers.com/philips-cp...ss-action/

As in the U.S., Canada also seems to have interesting legal events related to the Philips Recall.  They have an interesting Philips Recall Lawsuit Conference video that may interest everyone:  https://youtu.be/I61mlkLAK8c.  

There's also a medical doctor, University medical school instructor, and Recalled device owner (Dr. Sheldon Nathanson) that's privately suing Philips regarding his own Recalled device.  I wonder what would happen if every Recalled device owner privately sued Philips for all expenses (initial equipment costs, immediate replacement costs, medical costs possibly related to Philips' faulty foam and legal costs) as a result of Philips' faulty foam.  It would be nice if country class actions encompass everyone's relevant expenses.

[PauloMaia]

Thank you very much, I will contact them.

[TimaaaaaaaahRocks]

Philips-Respironics is still trying to 'prove' and/or 'argue' that the foam particles being pumped deep into patients' lungs are not toxic. Anything except clean air is toxic to the human respiratory system - duh!  

“Ultimately, this science will be very important,” van Houten said.

Truly hideous. Let us all hope that the DOJ's response to this nonsense is not as incompetent as the FDA's. 

[StratCat48]

I'm still wondering how someone that may have impaired lungs or other respiratory problems could prove 100% that it was caused by foam particulates or off gassing of VOC's from a Philips CPAP. There are simply just a plethora of other factors, both in the environment and work related that could cause the same health issues. I suspect the burden of proof and cost would be on the claimant(?)

[DaveCar]

Phillips has given the finger to users in Canada.  I am not buying another product from Phillips.

Im in the same province as you, and my DME handled everything. They registered my unit for the recall and,  Im just going by memory so I could be off on the time but,  after 8 months my replacement (DS2) arrived.  It truly sucked (howling sound with every breath), so the DME took it back to attempt a replacement unit.  I dont imagine that part is going to go smooth nowadays.  

But the main point is replacement units are indeed flowing into Canada,  your DME should be doing a better job (maybe you should consider another DME after this is done ?).   Mine has my back so well, after I was able to prove foam shedding under my blower housing of the DS,  they got me a temporary non-Philips loaner.  Im a customer for life now.

[pholynyk]

>>>I'm still wondering how someone that may have impaired lungs or other respiratory problems could prove 100% that it was caused by foam particulates or off gassing of VOC's from a Philips CPAP.

This won't be a criminal trial, StratCat48. It's not necessary to prove beyond a reasonable doubt, only to convince a jury (of laypeople) of the balance of probabilities. The foam is a known possibility and there are no other known factors in evidence. That's all it takes in a civil trial for damages.

[Crimson Nape]

The only way I can see this happening would be after the fact. It would require an autopsy and the family initiates a wrongful death lawsuit. Not a happy thought.

[TimaaaaaaaahRocks]

This won't be a criminal trial, StratCat48. It's not necessary to prove beyond a reasonable doubt, only to convince a jury (of laypeople) of the balance of probabilities. The foam is a known possibility and there are no other known factors in evidence. That's all it takes in a civil trial for damages.

Yep. Quantifying the degree of damage is extremely difficult in this problem. But most likely irrelevant.

Exhibit A: A prescription medical device intended to treat the human body that was NOT properly designed, tested, labelled, marketed, sold, and supported as per the provisions and regulatory requirements detailed in the Federal Food Drug & Cosmetic Act (FD&C Act) United States Code, Title 21.

*crickets*

'the Plaintiff rests' 

Expect the civil cases to be settled out of court. The civil claims are indefensible slam dunks for the Plaintiff. Just call the FDA as the first witness, then that dude who sent the foamgate email; stick a fork in it, done. The first case philips takes to trial and loses will just result in a more expensive litigation future. Wall Street will demand results.

The only sound choice is to write a few big checks, spend a few extra bucks on some damage control pr, a few extra rounds of golf with dmes, and fuggedaboutit. Let us all hope that somehow during this process CPAP users find efficacious solutions to treat their sleep apnea.