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

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Response from Dr. Jeff Shuren, FDA

We have checked regarding what information we can provide about the replacement foam. We are limited in what we can provide as it is considered confidential commercial information. However, it is a silicone-based foam for which we have seen some testing data and have requested additional information. We are looking for ways to make relevant information available to the public.

[WakeUpTime]

Response from Dr. Jeff Shuren, FDA

It's incredible that you've got that dialog going.  It's likely that no one else, and no where else, would have that happening.  Incredible.

I wonder if silicone-based implies "100% silicone" or does it mean contains some silicone along with other components.  If it's the latter, then I suppose Philips could justify that the additional other foam components are "safe" and therefore there's no need to disclose them either to the FDA or to the general public.  But as we've learned, components that initially are seen as safe might still break down and be inhaled/ingested in the long term.  Also, what if something now deemed "safe" later becomes "unsafe"?   Since Philips isn't required to disclose those "safe" components, we will never know that they are potentially carcenogentic later.

I'm guessing that silicon-based means that it's the majority ingredient, just like latex in latex paint (where there are many additives).

Confidential Commercial Information - I suppose that means that they don't have to provide the details pubicly but that they will provide the details to the FDA - but maybe not even that.  Maybe they don't have disclose to the FDA what's already been previousy deemed "safe".  Nothing like public censorship to potentially protect bad things becoming known.  It's better to have 8 billion investigators than one.  There are vast numbers of things that were initially proven "safe" that later were shown to be extremely "unsafe".  If Philips doesn't have to disclose all of those components to the FDA, one would think that the FDA would strongly state that, given the extreme nature of this foam recall, we're requiring Philips to disclose all those components, regardless of their safety levels.

For example, teflon, formaldehyde and aluminum are all deemed "safe".  But if any of them were to be used in Philips' foam with the possibility of it breaking down over time and being ingested, then I think we should know about that.  (Note: I'm not suggesting that any of these components are contained in Philips' foam, but we can't say for certain that they aren't.)

I'm really greatful to the FDA but I can't help but find this wording to be rather disturbing.  Who's in charge here?  The impression is that it's Philips in charge and the FDA only comes in once the company self-discloses a problem (or with significant consumer complaints).  The danger there is that investigations are pushed far down the road and significant delays occur - with those delays making a negative impact on the health of the general public.  That opens the door, as we've now learned, for companies to hide or minimize complaints, further delaying disclosure by years.

There is one benefit in dealing with a large multinational company.  Philips can absorb a $2-$4B expense, spread out over a few years.  With many other companies, they would have closed by now, or at least closed their division, which often is a separate company.  If there indeed is a later problem with Philips' new foam, we'll revisit the process.

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I'm guessing that silicon-based means that it's the majority ingredient, just like latex in latex paint (where there are many additives).

In an e-mail on the 23rd, the Dr. said this:

There will be information about the polyester-based polyurethane foam and testing made available in the next few days.
This is the definition: Polyurethanes based on polyester polyols, in general, exhibit higher tensile and tear properties, abrasion resistance, thermal stability, chemical resistance, and weathering performance compared to polyether-based polyurethanes. They are preferred in the most demanding environments and applications.

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RE >above post<



Polyether-based polyurethanes foam vs Polyurethanes based on polyester polyols foam. You got to read this over a few times before you see that the foam Philips may be using is not the best between the two. 

We definitely need more info before we get too far into this.

[WakeUpTime]

Looking back, I’m amazed at how Philips was able to significantly delay the process of repairing and replacing four million faulty devices.  Most government agencies worldwide have accepted Philips plan to wait 1.5 years (June 2021 to December 2022) for 90% of users to have solutions.  

Accepting that allows Philips to continue to claim that the large numbers of those still awaiting a solution (those with older devices, those who don’t have current DME and xPAP pressure data in the Philips cloud, etc.) must be in the remaining 10% - when in fact that number could be significantly greater than 10%, going into 2023.  It’s my guess that the reality will be that 20-30% of applicable devices (likely those that Philips considered > 5 years old and considered by Philips to be ‘shelved’) will remain faulty.

It's incredible how that sizable group will have to ultimately wait up to 2 years for a solution, and that was found to be acceptable amongst the many health and consumer protection agencies around the world, Australia notwithstanding.  Agencies should have strong-armed Philips from the beginning to say, “Provide a fix within 6 months or provide refunds and other monetary incentives for the value of those devices.  Those who purchased within 5 years would receive 100% return value, even if it’s the reduced amount paid by the Philips dealer."  Even more, governments that are truly supportive of their citizens could have told Philips, "For owners you can't fix within 6 months, reimburse them for the cost of an equivalent device by any other manufacturer."

ResMed scales back the earnings it expects from Philips recall
https://www.massdevice.com/resmed-scales...ps-recall/

ResMed deserved better but faced supply-chain shortages and the allowance by government agencies to accept Recalled device owners continue to use their carcinogenic-foam devices.  ResMed’s CEO was correct when he said that supply chains favored cell phones, TVs, etc., when it came to chip shortages.  They even favor larger corporations like Philips, although they’re complaining too.  Investigative reporters should investigate Philips to see if Philips is allocating new chips more often for its profit-making devices rather than its Recalled (free replacement) devices.

Philips Subpoenaed by DOJ Over Sleep-Apnea Device Recall             (*may have been posted earlier)
Healthcare giant says recall now likely to affect 5.5 million machines
https://www.wsj.com/articles/philips-sub...1650887950
or https://axlepoll.com/philips-subpoenaed-...ce-recall/

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Those who purchased within 5 years would receive 100% return value, even if it’s the reduced amount paid by the Philips dealer."  Even more, governments that are truly supportive of their citizens could have told Philips, "For owners you can't fix within 6 months, reimburse them for the cost of an equivalent device by any other manufacturer."

First I need to say that I am not a member of the current Class Action Lawsuit. 

I do know a few things about it;

1. The out of pocket cost to purchase an equivalent device is covered 
   
2. They have inserted the discovery rule into the suit. Under this exception, the statute of limitations may be suspended for the period during which an injured person cannot reasonably be expected to discover the injury upon which a malpractice claim may be based.
   

This only has any meaning if you are part of the suit.

[WakeUpTime]

This only has any meaning if you are part of the suit.

I certainly hope that there are general awards to all Recalled device past purchasers.  I always thought that was the core nature of class-actions, in that most extended to all product owners.  If they don’t, the lawyers are missing out on a much greater opportunity and doing a disservice to the greater community. 

After all, most Recalled device owners didn’t/won’t wait for a Philips fix/replacement and purchased another system.  Those might be important stats that the FDA, and perhaps a judge, should investigate.  Since Philips has the e-mail addresses, they should provide them to the FDA, judge, and the lawyers in the class-action, so that simple surveys can be taken.  A logical time for that survey would either be at one year after the announcement, or one year from the start of the Sept-2021 Philips fix/replacement shipments, or at the 2022 year-end (at the latest).

The effectiveness of the Philips Recall campaign needs to be measured and audited outside of Philips.

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The effectiveness of the Philips Recall campaign needs to be measured and audited outside of Philips.

Like always you have offered a logical and thoughtful observation of the right way individuals like most of us should have been treated by the Government and Philips. Unfortunately, in large cases like this, that does not usually happen. Unless we become part of a larger group, (Class Action), we have been left to more or less fend for ourselves.

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MEDTECHDIVE

Earnings week 2: Supply chain shortages slowed ResMed, other medtechs from meeting demand
Philips and ResMed were among several medtechs that listed supply chain shortages as a challenge in earnings calls last week.

Several companies also reported not being able to meet all of the demand for products because of shortages of critical supplies or hospital staffing. 

One of them was ResMed, which has been grappling with shortages of semiconductor chips for the last year as its competitor, Philips, undergoes a months-long recall of its Respironics ventilators and sleep apnea devices.

ResMed CEO Mick Farrell said a semiconductor supplier “had a very significant, double-digit de-commit.” 

“The patients are there. And I think it’s awful that somebody might have to wait four weeks or eight weeks. I don’t want them to wait more than four to eight hours. But right at the moment, we’re in this situation; [it] will be that way for a period of time given these unprecedented circumstances.”
 
Earnings week 2: Supply chain shortages slowed ResMed, other medtechs from meeting demand | MedTech Dive

[TimaaaaaaaahRocks]

I certainly hope that there are general awards to all Recalled device past purchasers.  I always thought that was the core nature of class-actions, in that most extended to all product owners.  If they don’t, the lawyers are missing out on a much greater opportunity and doing a disservice to the greater community. 

I know a few folks who are pursuing 'reimbursement' for out of pocket expenses via small claims court. Pretty simple concept, they got ripped off and the want to be made whole. If PR doesn't show up or fails to file a Notice of Intention to Defend they judge will most likely rule for the Plaintiff. All one has to prove is that they had to pay to correct a problem that was caused by respironics.