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

[Phaleronic]

I received this on the 11th:

I am pleased to inform you that we are working on your new remediated device to replace your current recalled device, serial J16659834D3DC, which was recalled on June 14, 2021. Because a CPAP is classified as medical device, it cannot be sold or delivered without a valid prescription. Additionally, delivering devices without a valid prescription could lead to ineffective therapy or injury. Therefore, Philips Respironics will need to obtain your current prescription. We also need you to verify your legal name (including the spelling), date of birth and confirm your shipping address (No PO Box) so that we can ship your replacement device to you.

Required Actions:
1. Option 1: For faster remediation of your recalled device, please download the DreamMapper Application following the below instructions. Philips Respironics can then facilitate a secure transfer of your device prescription settings through the Philips Respironics DreamMapper app.

Please complete the steps below to provide Philips Respironics with your device settings:
• Download DreamMapper App from your mobile app store (if you don’t already have it)
• Register for DreamMapper with the same email address used to receive this message.
• Pair DreamMapper with your therapy device and perform a data upload that will transfer your therapy settings. Please click here to find instructions www.philips.com/dm22
• Once you have registered, successfully paired your device, and uploaded your therapy data, your device prescription settings will automatically be captured.
• For more information on privacy and security of the DreamMapper app, please see the Philips Respironics privacy policy.
• Provide your Legal name, Date of Birth and Shipping Address to Phillips Respironics by calling us directly at  888-511-2797.


2. Option 2: If you are unable to register for DreamMapper, please provide all the following information by calling us directly at 888-511-2797.
• Physician Name
*This is the physician who would have your sleep therapy device settings.
• Physician Phone Number
• Legal name (Please check spelling)
 
• Date of Birth
• Shipping Address (We are unable to ship to PO Boxes)
• Recalled device serial (referenced above)
• Registration confirmation (referenced above)

Once this information is received, our team will contact your doctor to obtain your current prescription settings.

[Labromaniac]

Today I called the number listed in the 2 options email. The woman was quit helpful. With option one, they will send you a FedEx QR code that you can take to a designated FedEx store and that store will pack and mail your machine back to Phillips at no cost, but she did warn that not all FedEx Locations would be available for drop off.

As for the new machine option she stated that you will receive a comparable current model machine but it may be new or refurbished and what you get is up to chance. She stated that the company hoped to complete the replacement by the end of this year.

I have a question. After receiving a replacement machine, will that be saleable privately on the board or elsewhere?

Also people have talked about the class action suits. Any info on how to navigate those or is that all too early?

[WakeUpTime]

Also people have talked about the class action suits. Any info on how to navigate those or is that all too early?

You've brought up an interesting dilemma.  The Judge in the Philips Class Action (the main one) authorized the creation of a registry of those users who wish to keep their device as evidence.  Yet those with older Recalled Philips devices received letters from Philips that provided them with $25 or $50 as compensation for not getting a replacement device.  They still must turn in their device to get their $25 or $50 from Philips.  

How can Philips demand return of the Recalled system prior to receiving the small compensation, or a replacement device, if Philips has been told that owners are legally allowed to NOT return them to Philips?  One would think that non-DreamStation owners should still be able to receive either their small compensation or a replacement device without first returning their older device to Philips.  It would seem that older device owners are not receiving the same replacement strategy (replacement first, return later) as earlier DreamStation replacement receivers.

(*Note: In order to be authorized by Philips to NOT return their faulty device, they must first put their name in the registry.  And for DreamStation owners, I've not yet heard of anyone being repeatedlly asked by Philips to return their old device following their receiving a replacement system.)

Regarding how to get in touch with class action law firms, there are several large firms that are taking the lead, and many smaller firms who are tied to the class action.  It may be that any law firm can add their name to the list of firms and be included.  Many firms are actively involved.  Here's a site that might provide some ideas:  https://www.drugwatch.com/philips-cpap/lawsuits/.  You can also get interesting updates merely by searching for latest updates related to Judge Joy Flowers Conti.  By searching her name along with "Philips", you'll get some good information.  (Note: I initially was going to provide some names of the largest active law firms, but I was concerned it may suggest an endorsement or violate rules of postings.)

You should also know that there are ways of being part of any possible class action without actually making significant contact with one of the law firms, beyond just adding your name to any of their lengthy lists of Recalled device owners.  There are also many separate registries related to the class action, including the keeping-my-device-as-possible-evidence registry.

[WakeUpTime]

My advice to everyone would be, if during the use of your faulty Recalled Philips system you developed one of the illnesses or conditions related to the faulty foam, or already had one of those conditioned that worsened with the use of the faulty Recalled Philips system, contact a lawyer that has significant familiarity with the class action.  

For others, it’s my belief that every Philips Recalled device owner deserves compensation for (1) out of pocket additional expenses because of the Recall and (2) the possibility of future illnesses developing related to the faulty foam.  Regarding (1), many were unwilling to wait 6-24 months for Philips to provide them with a replacement device, so they acquired through any available means a replacement system (temporarily, or permanently).  In the beginning, Philips instructed everyone to stop using their Recalled devices, unless their medical doctor told them otherwise.  Philips will insist this isn't necessary since they eventually (6-24 months later) provided a replacement, however many can not accept the ongoing use of a potentially damaging device for an extended period of time.  Regarding (2), a reserve fund should be setup for any future illnesses related to the consequences of using the carcinogenic foam, should they be diagnosed within the next 5 years following the conclusion of the class action.

[WakeUpTime]

"Philips Respironics Recalls 1 Million More Sleep Masks"
October 19, 2022

Today, the FDA has classified a recent Philips CPAP recall as a Class I, the most serious type of recall. The new classification comes after the US Food and Drug Administration (FDA) in September announced a Philips Respironics recall of certain BiPAP and CPAP masks due to a serious safety concern related to magnetic headgear clips that may cause harm to people who have implanted medical devices.

As of September 9, 2022, there have been 43 complaints, 14 of those were serious injuries, associated with this issue. The FDA reported that it is not aware of any associated deaths. Approximately 18.6 million devices, distributed between January 1, 2015, and September 9, 2022, are affected by the recall.

The FDA warns that people who use the recalled masks and people near a person using the masks, including healthcare personnel can be affected.

Masks that are part of the recall include:
 Amara View Full Face Mask
 DreamWisp Nasal Mask
 DreamWear Full Face Mask
 Wisp and Wisp Youth Nasal Mask
 Therapy Mask 3100 NC/SP

https://www.fda.gov/medical-devices/medi...may-affect
https://sleepreviewmag.com/sleep-treatme...s-level-i/
https://www.beckershospitalreview.com/su...masks.html

[WakeUpTime]

October 18, 2022
"SoClean Lawsuit Against Philips Amended Over Impact of Misleading Statements About CPAP Ozone Cleaners"

The SoClean lawsuit indicates Philips knew ozone was not the problem with its recalled CPAP devices years before the recall was announced.  In an amended complaint (PDF) filed on October 10, SoClean Inc. added a wealth of information that has been uncovered since the initial lawsuit was filed against Philips, highlighting the damages caused by Philips’ attempts to deceive owners of their CPAP machines and deflect blame for a dangerous design onto the SoClean ozone cleaners.  

All SoClean lawsuits were centralized earlier this year before U.S. District Judge Joy Flowers Conti, in the Western District of Pennsylvania, who was already presiding over all Philips CPAP lawsuits consolidated as part of a separate federal MDL.  Judge Conti is scheduled to meet with parties this week, for a status conference on October 19.

In the separate Philips CPAP MDL, which is expected to include tens of thousands of individual injury claims filed by former users diagnosed with cancer or other injuries after breathing the toxic foam particles that flowed into the air pathways, tubing and face mask, Judge Conti established a streamlined process for filing new lawsuits against Philips last week, allowing plaintiffs to bring new claims through an abbreviated Short Form Complaint, which adopts certain allocations outlined in a Master Long Form Complaint that will be filed by October 24, 2022.

As part of the coordinated pretrial proceedings before Judge Conti, it is expected that the Court will schedule a series of early “bellwether” trials to help the parties gauge how juries will respond to certain evidence and testimony that will be repeated throughout the claims. While the outcome of these early trial dates will not have any binding impact on other claims, they are expected to influence the amounts of Philips CPAP settlements if the company wants to avoid the need for thousands of individual cases to go before juries in the coming years.

https://www.aboutlawsuits.com/soclean-la...s-amended/


ALSO...

October 17, 2022
Philips Faces Fallout from Recall, Supply Issues"

News of supply chain issues and depreciating value of Philips' troubled sleep apnea business sent the company's stock plunging to its lowest levels since June 2012. The Amsterdam, Netherlands-based company warned that supply chain issues are hurting sales, and that the company will have to write down $1.26 billion of the value of its troubled sleep apnea business.

https://www.mddionline.com/regulatory-qu...s-and-more


October 15, 2022
"New Philips CEO Takes Over From Frans van Houten"


October 12, 2022
"Philips Warns of Fresh Hit from Respirator Recall"

Dutch health technology firm Philips warned on Wednesday that it would take a further 1.3-billion-euro ($1.26-billion) hit from a huge recall of faulty sleep respirators.

“Philips expects to record a 1.3 billion euro non-cash charge in the third quarter for the impairment of goodwill of its sleep and respiratory care business,” Philips said in a statement.  The Amsterdam-based firm has already set aside nearly 900 million euros for replacing and repairing the devices.  It recalled the respirators in June last year after announcing that users were at risk of inhaling or swallowing pieces of degraded sound-dampening foam.  

https://www.expatica.com/nl/general/phil...ll-351502/

[A KLERK]

The final blow to Philips?
A large dutch Newspaper published the following article:
https://www.nrc.nl/nieuws/2022/10/19/phi...n-a4145694

A flat-text translation is attached.

[A KLERK]

Really shocking is what happened during the French Hearing. In the article is a link to the 4.5 hour session. Look and hear for yourself what happens:
https://www.youtube.com/watch?v=ctvL0TcmWO8

Go to 2:15:00 and listen to what happens...

[EddyDee]

Hello, can you hear us?
Hello?

No, Philips doesn't want to hear you...
Yikes

[WakeUpTime]

A large dutch Newspaper published the following article:
"Philips had known for years that there was better foam..."  < English Translation (Google)  >

Really shocking is what happened during the French Hearing.  Go to 2:15:00 and listen to what happens...
[YouTube]: Public hearings - Philips ventilators and CPAP devices (European Health Agencies)  

Abbreviated Time Index to Video
00:30   Respiratory Insufficient Patients
00:46   Home Health Providers
01:08   Materiovigilance data
01:26   Philips Respironics
02:15   <<Philips Reaction Noted >>
02:27   Pneumology Society
02:54   Society for Sleep Research and Medicine
03:24   National Respiratory Apparatus Union
03:36   Food and Drug Administration
04:09   Obstructive Sleep Apnea and Incident Cancer
04:28   Health risks related to polyurethan foam degradationin CPAP devices used for sleep apnoea treatment

This very credible news content needs to be syndicated so that it doesn't go unnoticed.  It's one of the best Philips interviews - actually it's the only one in its class, that didn't merely consist of Philips Marketing or Philips Public Relations.

Just sent the details to the Wall Street Journal.  Others may also wish to forward the story to additional publications.