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

[btreger]

MEDTECHDIVE

FDA labels Philips 2018 field correction for ventilators a Class I recall

Dive Brief:

The FDA has labeled a 2018 corrective action from Philips affecting certain ventilators a Class I recall after the company failed to report the action to the agency despite dozens of complaints.

In 2018, Philips updated maintenance protocols for certain Trilogy ventilators, requiring the replacement at "specific intervals" of the foam used to dampen sound in the machines. A Philips spokesperson said in an emailed statement: "Based on the knowledge and insights at that time, this was not considered a correction and consequently was not reported to the FDA." According to Philips, the FDA discovered the correction during a facility inspection from August to November 2021, and the agency has now been labeled the correction a Class I recall, affecting about 230,000 units.

FDA labels Philips 2018 field correction for ventilators a Class I recall | MedTech Dive

[TimaaaaaaaahRocks]

A Philips spokesperson said in an emailed statement: "Based on the knowledge and insights at that time, this was not considered a correction and consequently was not reported to the FDA." According to Philips, the FDA discovered the correction during a facility inspection from August to November 2021, and the agency has now been labeled the correction a Class I recall, affecting about 230,000 units.

correction [ kuh-rek-shuhn ] noun
1. something that is substituted or proposed for what is wrong or inaccurate; emendation.
2. the act of correcting.

In the FDA's facility inspection form, called a Form 483, the agency wrote that the company did not notify the agency despite having reports of foam breaking down in Trilogy and other machines as early as 2014. The field correction was initiated in response to several complaints and at least one failure from a Trilogy machine caused by foam degradation, and the foam was later found to be "mutagenic, cytotoxic, carcinogenic, and non-biocompatible.

Correction? What correction? "Tis but a scratch"

[btreger]

Correction? What correction? "Tis but a scratch"

Are you referring to Monty Python or Shakespeare, or both?

[TimaaaaaaaahRocks]

Are you referring to Monty Python or Shakespeare, or both?

Monty Python, Shakespeare, and Frans van Houten!  

[chasmm]

I saw this on FB today. It's an Aussie law firm's statement on a potential class action in Australia. 

Take from it what you may...

From Slater and Gordon (Australia) regarding the Philips class action:


Outcome of the investigation:
Unfortunately, our investigation has led us to the conclusion that a potential class action against Philips is unlikely to be viable at this time, and it is therefore not a matter we can recommend pursuing at this stage.

There has clearly been significant inconvenience and distress associated with the recall of Philips Machines, in particular around the delay and uncertainty around timing of when machines will be repaired or replaced.

Findings of our investigation:
It is our view that, despite the distress and inconvenience arising from the recall, any compensation relating to financial loss would be relatively confined given our understanding that the manufacturer has undertaken to repair, replace or refund the models which are the subject of the recall. We understand the recall by Philips and the Therapeutic Goods Administration, albeit progressing slowly, is progressing and purchasers of the machine are able to be remediated for their recalled machines. This means that any claim for compensation would likely only relate to the distress and inconvenience suffered as a result of the delay, rather than the cost of the machine itself.

While we appreciate that for many people the distress and the inconvenience has been very significant, unfortunately at law that type of claim attracts very little, if any, compensation. Given the legal costs for undertaking class action litigation are very significant, it would be difficult to justify running a proceeding directed towards obtaining compensation for the inconvenience and or distress where the legal costs of the litigation would be expected to absorb the majority, if not all, of any compensation which could at law be recovered on behalf of the group and as such provide little or no net financial return to those affected.

In relation to any potential personal injury claims arising from injuries suffered from the risks which led to the recall of machines, the position is very unclear at this stage. While naturally manufacturers are unlikely to embark upon a costly recall without a proper basis, at this stage we have seen no scientific or medical evidence to warrant the commencement of a class action proceeding directed towards recovering compensation for physical injuries caused by the recalled products.

In litigation such as this, the scientific and medical expert evidence that would be required to succeed in bringing a claim is likely to be very complex and almost certainly would be strongly contested by the manufacturer. At the moment that evidence does not, on our investigations, appear to exist.

We would need to have sufficient evidence to form the view that a proceeding would be likely to succeed before being able to commence a class action, in particular it is not permissible at law to commence a claim and hope that the evidence later becomes available to succeed in the claim.

Time Limits:
We will continue to monitor the situation and if further evidence does come to light we will reconsider the prospects of bringing a claim. However, there are strict time limits within which a person must bring a claim, otherwise their right to do so will be extinguished at law. In very broad terms the relevant time limits are three years to bring a personal injury claim based in negligence and 6 years for a claim based in consumer protection legislation.

The deadline created by these limitation periods is generally strictly applied. Although it can be possible to apply for an extension of time to commence proceedings after this deadline has lapsed in some circumstances and jurisdictions, the availability of this option will depend on a number of different factors and doing so requires seeking permission from the court as a first step. Success in such an application is not guaranteed. A key factor that would be considered by a court in deciding whether to grant an extension is the explanation available for any delay, and relatedly, whether the claimant had previously obtained legal advice about their rights to pursue a claim before their time limit expired. Accordingly, we encourage you to seek any legal advice you require regarding an individual claim for compensation as promptly as possible in order to avoid any risks related to the applicable limitations period.

Final Steps
We are writing to you at this stage to advise that we currently see no realistic prospects of bringing a claim either in respect of the inconvenience claim or any personal injuries which may be attributable to the recalled models.

Other legal firms may take a different view as to the prospects of bringing such a proceeding and we are aware that at least one firm has made some public statements about pursuing a class action and may indeed have already commenced a class action. Accordingly, you may wish to make your own inquiries with any other firms that have advertised an interest in pursuing such litigation.

We regret that our investigations have led us to conclude that a class action concerning Philips recall appears unlikely to be viable at this time, and that we will therefore be unable to take any further action on your behalf in relation to this matter.

We will continue to monitor any new developments in relation to the recall and how you and other consumers of the machines are impacted by this issue, and if our assessment changes concerning the ability to pursue this matter as a class action, we will advise you accordingly.

We wish you all the best.

Yours faithfully,
Slater and Gordon Lawyers

[Aero Man]

My brand new DS1 unit was in-service for less than 1 year when the recall was announced.  I registered the DS1 on 6/16/21 and today - 3/23/22 - a replacement DS1 blower unit with a User Manual and instructions, 1 extra-fine pollen filter, return label and packaging tape strip were delivered to my porch.   Not included: a modem, humidifier, power supply, power cord, and tubing.  The shipment was double-boxed with instructions to return the original blower.

I get that these components were not affected by the recall so was not surprised that only the blower was provided.  On the bottom of the refurbished unit is a prominent label: "Recertified Device".

Originally, a brand new device with an expected life of 5 years was provided to me from my DME, yet this recall replacement is refurbished, not new. For the refurb, I have no idea what the remaining usable life of the motor actually is. The limited warranty for the refurbished unit is stated to be two years, so will it start whining in 2 years plus 1 day?  And, with their demonstrated capability in managing this recall, who knows how long it would take Philips to provide a serviced or replacement unit under their "warranty"...weeks, months, years?

One of the included docs titled "Basic Setup & Return Instructions" had the following statement "...Failure to return your original device to Philips could result in your being billed for payment of that device, as you now have two devices, but only paid for one." - yeah right.  The FDA has determined that the first device manufactured by Philips was defective and unsafe to use so I possess one, not two usable devices.

After receiving the refurbished blower, I was intending to return the original so another victim could get a refurbished unit, but now I have even less trust in Philips who cheapened this process further with their invoicing threat. The "fine print" on this doc advises that "...your affected device may be destroyed or refurbished" - Philip's own words in the footnotes. Sounds like "destroy the evidence" to me.

I expect that a real lawyer could put a monetary figure on the extended apprehension I felt by not knowing when I was to receive a replacement unit to resume my CPAP treatment.  Eventually, out of desperation and for lack of meaningful status reporting from Philips (until recently forced to do so by the FDA), I eventually purchased an out-of-pocket replacement machine so my health would not be at further risk. I suspect that the figure would be much more than the salvage cost or invoiced amount for the unreturned original machine.

So that summarizes my experience with the Philips recall.

-Aero Man

[TimaaaaaaaahRocks]

One of the included docs titled "Basic Setup & Return Instructions" had the following statement "...Failure to return your original device to Philips could result in your being billed for payment of that device, as you now have two devices, but only paid for one." - yeah right.  The FDA has determined that the first device manufactured by Philips was defective and unsafe to use so I possess one, not two usable devices.

They are going to send you a bill for payment?  Oh heck no, and hold on to the bill just in case there is a toilet paper shortage. 

I recommend you send the shipping box back with nothing but YOUR invoice for YOUR labor time reimbursement. Invoice them for the time you had to spend fixing THEIR problems. Fair is fair. Use the same hourly labor rate as CEO Frans van Houten - around $2250 an hour. 

You had to spend two hours of your time fixing Mr van Houten problems? They owe you $4500 plus a few grand for being a victim of breach of express warranty, fraudulent misrepresentation, fraud by omission, and unjust enrichment. If they don't pay up haul them into small claims court for failure to make you whole. 

[Aero Man]

Thanks. To be fair, Philip's instructions stated that they "may" bill me if I don't return the original defective unit; they didn't state outright that they would bill me (the threat). I haven't decided what to do yet as there are people like me who needed to buy an out-of-pocket replacement to restart CPAP therapy due to the uncertainty caused by Philip's lack of meaningful communication...so ultimately my therapy incurred expenses for two units. And for people after me who still need a Philips recall replacement to restart their own CPAP therapy; even if I elect to return the original defective unit to help other CPAP users, it's interesting that their explanations in the footnotes of their enclosed paperwork indicated that the returned unit would be destroyed or refurbished and that "destroyed" was sequenced ahead of "refurbished" - their words. Sounds like their lawyers missed this or they believe that their user base are actually that stupid. Sigh.

- Aero Man

[Dafod]

Received my replacement machine from Philips the other day - unlike Aero Man I got a slightly different mix of items:
1. DS1 blower - Manufactured 2021 Nov. (so, apparently not a reconditioned unit) with zero hours on it.
2. Power supply and cord
3. Basic (non-heated) tubing
4. Carry case w/(1 pollen filter & 1 fine filter)

I also got a QR code that allowed me to print out a form for the local post office for return shipping. I was instructed that I could keep all my original stuff other than the CPAP.

I then performed surgery on the new unit by removing the fan casing that included the "new and improved" foam and replaced it with the foamless casing I had been using (Amazon). I then re-inserted the hacked up original casing back in my older unit and shipped that back. I checked the new unit had the latest firmware, which it did - and now I am good.
Whilst I agree with others regarding the poor customer care etc. of Philips I am not going to worry anymore. In truth, when I originall pulled apart my three cpap machines I found the problematic foam to always be in perfect condition (like new) and really little dust etc in the units which provided some relief (ignoring the gassing). I have only ever soap cleaned cpap items (daily pillow and humidifier) , and honestly have never cleaned my cpap tubing (other than air).

[Moriarty]

In Australia Carbone Lawyers are gathering participants for a class action lawsuit.

...although Slater and Gordon have been reported as telling a prospective client that they have looked into the case and decided that, under Australian Law, the prospect of winning is not good enough for them to run the case as a Settlement Funded action.