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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(03-18-2022, 03:32 PM)Crimson Nape Wrote: I've been expecting Philips to declare that division insolvent and close it down.  It is far cheaper than all the pending litigation from every country in the world.   Within a few months, you will see a new brand of CPAP on the market under some catchy name.

The Johnson & Johnson way out. Knowingly break the law and harm customers for years? Bundle it all in a nice neat bankruptcy package and set it on fire when you get caught.

Hard to imaging how PR could stay above water when they can't generate any revenue for more than a year, maybe two years at their current replacement rate. We're talking about a business unit that used to generate some serious profits. They could have avoided a billion plus dollar loss by simply playing by the FDA rules and spending an extra $0.05 per machine for a foam material that meets biocompatability standards as per ISO 10993. I expect the lawsuits will cost them an additional billion plus dollars.

Replace recalled units............a billion dollars.
Lost revenue.........................a billion dollars.
Settle lawsuits.......................a billion dollars.
Burning billions of dollars cause you used the wrong material to save a few pennies, priceless.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(03-18-2022, 03:12 PM)SuperSleeper Wrote: If the FDA attempts to disqualify Philips from entering into the CPAP marketplace, that would eliminate a major incentive they have to replace affected machines during this recall.  They could simply say, "If you're kicking us out of the market altogether, we'll simply quit distributing replacements and have our Respironics division declare bankruptcy and call it a day.".

It's their hope for future profits that keeps them engaged in this recall effort.

Exactly why The Food, Drug, and Cosmetic Act is a joke to moralless corporations.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(03-18-2022, 04:33 PM)TimaaaaaaaahRocks Wrote: They could have avoided a billion plus dollar loss by simply playing by the FDA rules and spending an extra $0.05 per machine for a foam material that meets biocompatability standards as per ISO 10993.

Do you have documentation that the foam they used for decades didn't meet the required standards at the time?


Specifically what requirement of the standard at the time failed.

And how was that affected by grandfathering allowed by the FDA (Whee materials previously approved are allowed in a new device)

If you've been making something for 20 years you don't normally retest it to new standards just because there are new standards.

There are thousands of approved drugs from decades ago that weren't tested to modern requirements and they never will be retested.

When something changes that does require such testing it's usually removed instead of retesting.
Look at OTC bronchial dilators when CFCs were banned. The old efficacy data wasn't accepted and the product is gone because it's not profitable enough to retest and get approval using a new propellant.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
How do you join a class acton lawsuit on the matter? I'm in Australia but I bought the Dreamstation through an online retailer in the US and had it delivered to my son's address in California. The retailer has been keeping me updated on what Philips is (rather, is not) doing but I don't think they will show me how to join a class action lawsuit.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
For what little I've been involved in a class action lawsuit, be aware that if you join one, a monetary settlement is usually divided equally between plaintiffs (after the lawyers draw their fees of about 20-30%) and once settled you may have forfeited/waived any further right to sue if you feel you were shortchanged in the outcome. 
A few years ago I signed onto a class action lawsuit for which I suffered no known damages, but had used the product thus could be included. The settlement was upwards of $350 million. The lawyers took $72 million (lawyers like class action lawsuits) . As a participant plaintiff I was rewarded with a check for less than $100, which to my knowledge was the same as others received regardless of damages they may have actually incurred. I don't know how many were signed onto the suit, but suspect the numbers were very high for the resulting payout. This is my own experience with a class action lawsuit and perhaps others may have a different experience.

For those that may sign onto a class action lawsuit against Philips, what is your expectation of what you might receive as compensation, either as an immediate financial settlement or possibly protection against any future health issues which would need to proven to be related to Philips CPAP use.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(03-20-2022, 01:45 PM)BobbieM Wrote: How do you join a class acton lawsuit on the matter? I'm in Australia….

In Australia Carbone Lawyers are gathering participants for a class action lawsuit.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Thanks.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
More recalls from Philips


Newswires


Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm

Reason for Recall

Philips Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts that were put together using an expired adhesive. If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.

If ventilation stops and sounds an alarm, patients could be without ventilation support for the duration required for an alternate ventilator to be connected. If the ventilator does not sound an alarm when the ventilation stops, the patient could be deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.

There have been no reports of injuries, adverse health consequences, or death associated with the use of these devices.

Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm - EIN Presswire (einnews.com)

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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(03-20-2022, 01:15 PM)ST Dog Wrote: Do you have documentation that the foam they used for decades didn't meet the required standards at the time?

Apparently respironics does NOT have any documentation showing that the foam met bio-compatibility requirements. Not the first time PR has misused the whole 510k "Substantial Equivalence" clause when the products are clearly not. Why does the FDA bother with a 510k process when they make no attempt to verify the claims?

(reminds one of boeing filing one set of design criteria with the faa and shipping something altogether different, with fatal consequences) 

The material safety data sheet (MSDS) for polyester-based polyurethane foam says it is toxic, do not inhale the dust. Even if the particles were insert, if it disintegrates into inhalable particles it is NOT bio-compatible. PR failed to complete the bio-compatibility analysis as required by the FDA. The foam is in the air circuit that comes in contact with a patients respiratory system. Kinda of a no brainer to analyse the material. 

Selecting a cheap but toxic material was the first mistake. An incomplete or inaccurate bio-compatibility analysis was a mistake. Executive management, QA, and design engineering burying their heads in the sand when the problem was first reported was a mistake. No CAPA was a mistake. 

After receiving formal complaints about foam dust in the air circuit: (from the FDA)

No formal CAPA was initiated or implemented, when appropriate. Specifically, email correspondence between your firm and your raw foam supplier beginning 10/30/2015 and forward, document that your firm was made aware of polyester polyurethane foam degradation issues in/ around October 2015, which was later confirmed by your foam supplier on 08/05/2016, via email. Alternatively, no CAPA was initiated or implemented. CEO makes public disclosure April 2021. 

If you want to know more about the different toxic material PR device users were huffing:

https://www.expertinstitute.com/litigati...-toxicity/

A medical device labelled and sold as a breathing therapy, that instead pumps toxic particles into a patient's lungs -  oh the irony. Ignoring the problem - criminal.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Crowell

Recall Litigation Report: Philips Faces Supplier Class Action Following CPAP/BiPAP Recall

Now, Philips faces off against a different kind of class action plaintiff—medical device suppliers. Earlier this month, Baird Respiratory Therapy, Inc., filed a putative class action lawsuit against Philips in the U.S. District Court for the Eastern District of Pennsylvania, seeking to represent a nationwide class of durable medical equipment suppliers who purchased Philips’ recalled breathing machines.

In Baird Respiratory Therapy, Inc. v. Philips, 2:22-cv-00886 (E.D. Pa.) (filed March 9, 2022), Baird alleges that Philips breached its express warranty and misrepresented the risks inherent in the polyester-based polyurethane (PE-PUR) foam found in the machines, which can potentially cause cancer and other injuries.

According to the complaint (1) Philips “unreasonably delayed its recall” by waiting to notify Baird and other suppliers of reports indicating that the PE-PUR foam could breakdown and put users in harm’s way; (2) it knowingly allowed its packaging, labels, advertisements, promotional materials, and websites to intentionally mislead Baird and other suppliers about the recalled products; and (3) as a result, Baird and other suppliers lost money when they were unable to resell the recalled CPAP and BiPAP machines.

Recall Litigation Report: Philips Faces Supplier Class Action Following CPAP/BiPAP Recall | Retail & Consumer Products Law Observer (retailconsumerproductslaw.com)
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