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

[btreger]

IN THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF PENNSYLVANIA

IN RE: PHILIPS RECALLED CPAP,
BI-LEVEL PAP, AND MECHANICAL
VENTILATOR PRODUCTS 
LITIGATION

MDL No. 3014

If you paid for a Philips Respironics CPAP, BiPAP, or
Ventilator that was recalled, you may be eligible for
a cash award from a proposed class action settlement.

● A proposed Settlement has been reached in a U.S. class action lawsuit alleging Economic Loss Claims
related to the purchase, lease, or rental of certain CPAPs, BiPAPs, and ventilators that Philips
Respironics recalled beginning in June 2021. These devices were sold in the U.S. between 2008 and
2021.

● The Settlement does not affect or release any claims for personal injuries or medical monitoring
relief.

● Eligible Users are entitled to:
a Device Payment Award for each Recalled Device they purchased, leased, or rented;

a Device Return Award of $100 for each Recalled Device they purchased, leased, rented, or were
prescribed that they have already returned or that they return to Philips Respironics by August 9,
2024; or

a Device Replacement Award if they spent their own money to purchase a comparable CPAP,
BiPAP, or ventilator on or after June 14, 2021, and before September 7, 2023, to replace a Recalled
Device.

● Users who return their Recalled Device to Philips Respironics by August 9, 2024 (as part of a
Recall Program or by Enrolling in the Settlement) will be entitled to a $100 Device Return Award
and a Device Payment Award without the need to submit a claim form.

https://www.pawd.uscourts.gov/sites/pawd...r_2390.pdf

Note: This is a long document to read:

[btreger]

RE > (above) <


I just received a copy of this document in the mail from the;

Settlement Administrator
Attn: Dept #3881

I am going to assume, that most Philips users that have registered, will receive the same letter.

[Homerec130]

SuperSleeper,

It is so bad, I am still trying to get replacement parts (battery and pads) for a Phillips AED. Phillips say we don't have, don't know when we will get any either. Even the major battery companies can't field replacements or alternatives. The one I usually use says 4 months, IF we can get them.

On a side note, Phillips sent me a set of replacement pads as part of a recall and the darn things are expired. Go figure.

Homer

[SarcasticDave94]

Up next?

Lightbulbs, toothbrush, and screwdrivers that are recalled.

[WakeUpTime]

PROPUBLICA
“Unacceptable”: Senators Call on GAO to Probe FDA’s Oversight of Medical Devices, Citing Series on Philips CPAP Recall
Senators Ask GAO to Probe FDA Medical Device Oversight — ProPublica

Your news update brought tears to my eyes to see some in leadership positions stand up and shout: No, it's not over yet; we have the unfinished business of the FDA's failure to oversee this sector of the medical industry, and the principal player involved.

UNITED STATES SENATE

The letter signed by the two lawmakers on Wednesday follows a yearlong investigation by ProPublica and the Pittsburgh Post-Gazette that detailed breakdowns by device maker Philips Respironics as well as the FDA in the years leading up to one of the largest and most disruptive recalls of its kind.

According to FDA, this issue could cause headaches, vomiting, allergic reactions, and “toxic or cancer-causing effects.” However, recent reporting indicated Philips Respironics—and FDA—knew about this issue for several years before the recall was initiated.

According to the Pittsburgh Post-Gazette and ProPublica, Philips Respironics received an adverse event report about this issue in 2010. Rather than reporting the adverse event report to FDA or initiating a recall, it waited and withheld thousands of additional adverse event reports for more than a decade.

Even when Philips Respironics conducted an internal health hazard evaluation, which confirmed that inhaling the chemicals from the sound abatement foam could cause “permanent impairment,” it did nothing, while patients suffered. That is unacceptable.

https://www.documentcloud.org/documents/...alls-final

[btreger]

Your news update brought tears to my eyes to see some in leadership positions stand up and shout: No, it's not over yet; we have the unfinished business of the FDA's failure to oversee this sector of the medical industry, and the principal player involved.

According to the Pittsburgh Post-Gazette and ProPublica, Philips Respironics received an adverse event report about this issue in 2010. Rather than reporting the adverse event report to FDA or initiating a recall, it waited and withheld thousands of additional adverse event reports for more than a decade.

Even when Philips Respironics conducted an internal health hazard evaluation, which confirmed that inhaling the chemicals from the sound abatement foam could cause “permanent impairment,” it did nothing, while patients suffered. That is unacceptable.

Unfortunately, I think there is even a bigger story yet to be told:

The Missing Link that connects the FDA, Philips, and Covid.

Remember, as you read this, the first Vaccine for Covid was not realized until December 14, 2020.

This is the article I posted here:

[b]On March 25, 2020, "The FDA Recommends CPAP As A Considered Alternative Combatant For Coronavirus Due To Ventilator Shortage"

[/b]
COVID-19, known informally as Coronavirus, is taking the world by storm and hitting the United States hard with over 9,000,000 cases as of November 2ND, 2020, according to the Johns Hopkins Coronavirus Resource Center.

The virus is inflicting tremendous strain on U.S. hospitals and the healthcare system at large resulting in a shortage of medical supplies including ventilators.

A ventilator is a medical device that helps patients who cannot properly breathe on their own by pumping air into their lungs. It is a lifesaver when combating COVID-19.  

Unfortunately, the U.S. is in short supply of ventilators with a total estimated supply of approximately 170,000 according to Johns Hopkins researchers.  

To put it in perspective, New York City alone is estimating a need for 35,000 ventilators to treat its Coronavirus patients and currently only has around 3,500, a tenth of what is estimated will be needed.  

As a result of this shortage, the U.S. Food & Drug Administration (FDA) recommends “that healthcare providers and facilities consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support” including Continuous Positive Airway Pressure (CPAP), auto-CPAP (APAP), and bilevel positive airway pressure (BiPAP or BiLevel) machines that are typically used for the treatment of sleep apnea.

The two largest CPAP manufacturers are ResMed and Philips Respironics. 

There are many issues this information raises. I do not have the answers, all I can do is ask these questions:

• Would lives have been saved if COVID-19 patients had not been put on any Philips Ventilators or CPAP Machines?
  
• Medical professionals did not know the potential dangers, Philips machines poised
  
• Did the FDA know about the Foam problem or only the complaints, (MDLs) concerning the DS 1?
  
• What would have happened if the Recall had been done at this time, instead of waiting over a year to do it? 
  

I did e-mail this information to a staff writer at ProPublica in the hopes they would do a more in-depth article on all this.

[TimaaaaaaaahRocks]

There are many issues this information raises. I do not have the answers, all I can do is ask these questions:

• What would have happened if the Recall had been done at this time, instead of waiting over a year to do it? 
  

I did e-mail this information to a staff writer at ProPublica in the hopes they would do a more in-depth article on all this.

 
Let us hope the GAO is not as incompetent as FDA. Based on public information the FDA should have been jumping up and down on respironics as far back as 2010; 11 years before the recall, long before da-Rona. Pretty clear now that FDA and respironics are both criminal organizations. Respironics has proven they are a sociopath corporation that put the all mighty dollar above human health and welfare. Company directors with stock compensation profited handsomely over those 11 years. DOJ should sentence the criminal actors to 11 years of using a non-conforming CPAP machine, but that would be cruel and unusual punishment.

[Old Steve]

I purchased and paid for a replacement CPAP during this time, so what exactly does this mean?  

"Device Replacement Awards If you spent your own money to purchase a comparable Replacement CPAP, BiPAP or ventilator to replace a Recalled Device on or after June 14, 2021 and before September 7, 2023, you may be eligible for a Device Replacement Award in addition to a Device Payment Award. • Complete a Device Replacement Claim Form and provide all required documentation. • The claim form is available at: http://www.RespironicsCPAP-ELSettlement.com or by calling 1-855-912-3432 • All submissions must be made by August 9, 2024"

The claim form does not specify what the Device Replacement Award is in this case. They never come right out and say that they will reimburse you for all the money you spent to buy a different CPAP.  They do say to qualify that you must return the DreamStation2 they sent you as a replacement for the recalled DS1. Any ideas?

[KSMatthew]

I purchased and paid for a replacement CPAP during this time, so what exactly does this mean?  

"Device Replacement Awards If you spent your own money to purchase a comparable Replacement CPAP, BiPAP or ventilator to replace a Recalled Device on or after June 14, 2021 and before September 7, 2023, you may be eligible for a Device Replacement Award in addition to a Device Payment Award. • Complete a Device Replacement Claim Form and provide all required documentation. • The claim form is available at: http://www.RespironicsCPAP-ELSettlement.com or by calling 1-855-912-3432 • All submissions must be made by August 9, 2024"

The claim form does not specify what the Device Replacement Award is in this case. They never come right out and say that they will reimburse you for all the money you spent to buy a different CPAP.  They do say to qualify that you must return the DreamStation2 they sent you as a replacement for the recalled DS1. Any ideas?

Page 11 of the letter I got has a table of reimbursement levels.

Edit: sorry for the confusion. That table is the “Device Payment Award” to reimburse you, partially, for the original purchase of the recalled device.

I haven’t found anything yet on amounts for the “Device Replacement Award”.

The claim form says:
>>>
You return to Philip Respironics any Remanufactured Device you received from Philips Respironics, if you received one (a pre-paid return label is available on the Settlement website).
<<<

But I didn’t receive a “Remanufactured Device” from Philips. I received a brand new DreamStation 2. When I stopped using the DS1 I bought a Resmed AirSense. So I don’t have a remanufactured device to send back.


Edit/Edit:

I looked at some of the legal documents online and found this:

"Remanufactured Devices shall mean repaired, refurbished, remanufactured, and/or new replacement...devices...provided to Users..."

So, yes, to be eligible for a reimbursement you do have to send the replacement back.

The best I've been able to find, as far as reimbursement figures, is there will be a designated pool of money allocated. When the reimbursement claims come in and they know how many customers are trying to get reimbursed, they'll pay out of that pool. But I still haven't seen just how much of a reimbursement allowance there will be.

Maybe they're holding off on that dollar amount announcement? In my case, I have a brand new DS2 that has only an hour or two on it from when I configured it to make sure it actually works. I wonder how much I can make by reselling it vs sending it back?

[Old Steve]

KSMatthew,

My DS2 was brand new too, unfortunately, I had to use it for about six weeks while the new ResMed AirSense 10 I purchased was in for repair.  I will not be sending my DS2 back until I know what the reimbursement amount is.  If it is like other class action suits I have been involved in the lawyers make a ton of money and the affected folks get next to nothing.  You may be right, we may get more of our money back by selling the DS2's.   I see that on their Device Replacement Award Claim Form they have a number to call for more information regarding the settlement.  I have doubts that I will get any answers, but I'll call and see what they say.