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

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FDA U.S. FOOD & DRUG ADMINISTRATION

Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions

UPDATE: On May 2, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices manufactured after November 2015. Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more).

This proposal is in addition to the FDA’s previous action under section 518(a) to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices. We will continue to update the public about the status of this recall and share more information when it becomes available.

Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions | FDA



“CDRH is proposing an important step in its continuing efforts to address the impact of the recall on patients. We will take appropriate actions and use the tools available to us to help assure patients receive the relief they need.” — Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

[JJJ]

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. 

I can only speak as to small claims cases in the US, although I believe other countries whose legal systems descended from Britain have similar options. I must also mention that small claims cases are in local courts (state or provincial), not federal courts. Small claims requirements are designed to be inexpensive where litigants plead their complaints and answers themselves without attorneys, where a maximum low monetary amount is allowed. Awards of attorney's fees are usually not allowed (but see below).

The problem is that the plaintiff must serve the complaint on the defendant, and not all jurisdictions allow service by mail. And if the defendant is a corporation the service must be on the 'registered agent' of the corporation. As a rule, to do business in a state/province the corporation must file articles of incorporation with the appropriate provincial/state agency, and the filing must include the name and address of a registered agent. The duties of the registered agent are just to turn over any legal notices to the correct corporate officers. You can't just serve the corporation at their corporate headquarters, service must be on the registered agent at the agent's address as listed in the government filing. Failure of proper service means the plaintiff loses the case. In most states/provinces such public filings are available nowadays to the public online.

There will be a hearing (trial) where the plaintiff must appear, although the good news is that the hearing will usually be held in the court that is closest to the plaintiff's address. Unfortunately, when corporate officers receive the complaint their immediate action is to forward it to the legal department, and the legal department's first action will be to file a motion to move the case to a higher court where they can get attorney's fees if they win, plus they will ask for a change of venue to a distant location. Or they may decide it's not worth bothering with, and not even file an answer. If the latter, all the plaintiff needs to do is appear at the hearing and the judge will give the plaintiff judgment against the defendant.

The plaintiff generally is thrilled at having won judgment, but now comes the matter of collection. If you know a bank where the defendant has an account, you're good. All you have to do is serve the bank with an order of execution or garnishment, and the bank will deduct the amount from the plaintiff's account and send the money to the plaintiff. The plaintiff has to get the order from the court, which will add another fee, although it may be possible to add the fee to the judgment. If you don't know the plaintiff's bank things can become more difficult. You can even have vehicles towed if they're owned by the plaintiff, but locating the plaintiff's assets can be difficult. And if the plaintiff is in another country, things get even more convoluted and expensive.

Filing a small claims action against Philips Respironics may be time consuming and difficult, but you'll learn a lot about how your local legal system functions. And even if you don't end up collecting your damages, you'll p*** them off, which will at least make you feel better. I say, do it.

[WakeUpTime]

FDA U.S. FOOD & DRUG ADMINISTRATION

UPDATE: On May 2, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices manufactured after November 2015. 

So nice to see the suggestion of an 'order' arise finally.  On the other hand, it's bizarre that this suggestion comes out 10 months after the Recall announcement, and 8 months after the start of replacement shipments.  Philips will continue to push its strength in marketing marketing and public relations over creating consumer results.

Examples include:

We’ve now begun the Recall - suggesting that they’ve solved the issue.

Philips knew that they could stretch that out indefinitely. There was never an audit in place to show the ongoing % of owners each month, by machine type and region, that received fixes/replacements.  Merely publishing national, or international, shipment numbers doesn’t accomplish that.  

We’ll have 90% of the fixes/replacements completed by year-end 2022 - suggesting that a tiny number of remaining owners is insignificant.

No audit has been put in place to determine if the remaining number of ALL Recall registrants at that time will indeed by less than 10%.  There also isn’t a punishment in place for any failure to meet that objective.

Not all Recall registrants are going to get fixes/replacements, as a result of many Recalled devices considered ‘shelved’, ‘obsolete’ or ‘too old’.

Currently, the door has been left open for Philips to choose, at its own discretion, the effectiveness of the Recall for the entire database of registrants.  Quite simply, they'll announce completion when a significant number of Recalled devices remain unfixed.  Philips will argue that all the devices that they intended to fix, and were worthy of a 'fix', have been resolved.

There are supply-chain issues.

Philips has continuously referenced issues that are getting in the way of it achieving its stated targets.  Supply-chain issues, trade issues, labor shortages, etc., will provide Philips with ample excuses for not meeting its targets.

Refunds.

Finally discussed.  Philips will likely argue that it has no way of determining true original owners, original purchase prices and current system values as a result of the complex nature of its authorized distribution channel.  However, we know that Australia was successfully able to design a procedure for refunds.

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MEDTECHDIVE

Biden should send a ‘clear’ message to the semiconductor industry on prioritizing Medtech

With the chip shortage affecting all industries, medical device companies are competing with large consumer electronic companies, automakers, and other businesses for limited stocks. AdvaMed wants the U.S. government to step in to help Medtech given the impact of the industry’s devices.

Specifically, the organization said it’s pushing for the prioritization of Medtech, “full transparency for future allocations” to the industry, and actions to ensure the continuity of patient care in the U.S.


Biden should send 'clear' message to semiconductor industry on prioritizing medtech, AdvaMed says | MedTech Dive

[WakeUpTime]

"Philips shareholders vote against executive compensation plan"
Reuters May 10, 2022
https://www.reuters.com/business/philips...022-04-25/

Philips shareholders voted against the company's executive compensation plan at the annual shareholders' meeting on Tuesday, ANP reported, in a protest over the company's recent poor results and product recalls.

"Woman with terminal cancer joins lawsuit against CPAP maker"
Attorney says roughly 800 claimants are suing Philips for potential health risks caused by recalled products.
NBC15 May 5, 2022
https://www.nbc15.com/2022/05/06/sauk-co...pap-maker/

Roughly a year before the recall, in July 2020, Miller was diagnosed with cholangiocarcinoma, or bile duct cancer. She is going through chemotherapy with the disease now in stage four.  Miller said she was also diagnosed with asthma after breathing problems began in August 2016.

She is joining a multi-district litigation with Texas-based law firm Houssiere Durant & Houssiere.  “We have, I think, about 75 people that are dying of cancer or have died of cancer that have used this machine,” Charles Houssiere, a trial lawyer in the case, said.

Roughly 800 claimants have signed on to the litigation created in November, Houssiere said. They’re suing Philips for potential health risks caused by the recalled products.  “We’re investigating that to see how serious of a problem these people are having. We have a lot of people with cancer of various types in the respiratory system, and they’re very concerned,” Houssiere said.

With plans to file hundreds of suits in Pennsylvania, Houssiere also plans to appear before the court in the next two months to explain how the recalled devices work and what the problem with it is.

[Vice]

I'm wondering how many people are going to end up with cancer etc from Phillips total criminal negligence. How again did they approve this foam without doing testing on it etc

[TimaaaaaaaahRocks]

Following the DOJ subpoena and the involvement and orders from the FDA, Philips Respironics has committed another $177 million to recall costs. It’s important to note that the total costs (they’ve set aside – an estimated $954 million) don’t include potential legal fees or fines from federal regulators. With over 100 class action lawsuits, 185 personal injury lawsuits, a security class action case, a lawsuit by SoClean, and other international cases, Philips is facing legal fees and settlements that could amount to additional hundreds of millions of dollars.

At what point does it make sense for Frans van Houten to punt Philips Respironics into bankruptcy, after losing a billion, two billion, five billion?
Heck with Philips shareholders voting against the executive compensation plan this is getting personal for Frans. 

It is time for the board of directors to go. If they didn't know about the complete incompetence at Philips Respironics they need to go. If they knew about the complete incompetence at Philips Respironics they need to go - with criminal charges in hand.

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Philips

It has been close to a year since we had the recall and we all complied with the online registration. We then received a confirmation number to confirm our completed registration.

Done deal right, now we are all sitting back and waiting on Philips.

Wrong, apparently unlike all other companies, Philips does not keep very good records by S/N of the locations it has been shipping its equipment to.

Today I received this e-mail from them:

"For device remediation managed by Philips Respironics, it is essential to ensure that affected devices are registered by the patient and also matched to their durable medical equipment (DME) provider. This is because your DME has the information needed to transfer your existing therapy settings to your replacement unit so that the device you receive is ready to use.  Please log in to the Patient Portal to see if you have been matched to your DME. If you have not, please contact your DME directly and ask them to register the serial number, so we can match the affected device and continue the process.

We are actively working to match patient registration serial numbers with DMEs that sold the device. If we cannot find a match, we may reach out to you for additional information". 

I did not have a match, so I contacted my DME and calmly asked what the F**k is going on. Their response was they would contact Philips and get my unit tied to their company, and that I might be getting a new confirmation number.

Just another normal day of having to deal with Philips.

[StratCat48]

btreger....

From what my DME told me of the process, when I registered my machine for the recall, Philips subsequently reached out to my DME to confirm that I was and am still the registered owner of the recalled machine and to request the settings. I'm also a registered user of DreamMapper which is updated daily to show use (not sure this played into confirmation of ownership). Once confirmed, Philips began the process of the replacement which I got about 3-4 months after I registered. Part of the reason for the  confirmation is to ensure that the person requesting a replacement CPAP actually still owns and uses the device and has not sold it or discarded of it and not trying to game the system with a valid serial number simply to get a new CPAP for free. I believe if I tried long enough I could enter a serial number in the recall registration that might come up as valid.

My DME (fairly large brick & mortar establishment) was on the ball when Philips requested confirmation for my unit. For the massive size of the recall I could see many smaller DME's that lack staffing (perhaps internet only sales) that could fail to respond to Philip's confirmation request or simply ignore it until the patient calls like you did. Not Philips fault if the DME fails. There are a lot of people that have not received their replacement still after many months and I wonder how much of this goes back to a failure of their DME to do what they were supposed to do? Also if the recalled CPAP was bought used in a private sale the DME would have no information other than the registered original purchaser.

CPAP's are designated a class II  medical device and as such (in the US) are strictly mandated to be able to be tracked per Federal law. Perhaps in your various quests you might also pursue an audit of Philip's tracking of medical devices to ensure they are in compliance   .

PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
https://www.ecfr.gov/current/title-21/ch...H/part-821

[btreger]

CPAP's are designated a class II  medical device and as such (in the US) are strictly mandated to be able to be tracked per Federal law. Perhaps in your various quests you might also pursue an audit of Philip's tracking of medical devices to ensure they are in compliance   .

PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
https://www.ecfr.gov/current/title-21/ch...H/part-821

Thanks for the info. I intend to pass this on to the FDA. This might help them better understand at least some of the ongoing delays they have been seeing in the overall Philips response.