Philips CPAP & BiPAP Machines Cause Cancer & Death; Most Re-Called; Lawsuit Settlement

Nov 06, 2023 19:47

Philips Respironics agrees to $479 million CPAP settlement
BY KHRISTOPHER J. BROOKS
UPDATED ON: SEPTEMBER 8, 2023 / 8:00 PM EDT / MONEYWATCH

One of the nation's largest makers of machines for sleep apnea sufferers has agreed to pay at least $479 million to compensate customers who bought the devices.

Philips Respironics and Koninklijke Philips N.V., its Netherlands-based parent company, will also set aside $15 million for customers seeking to replace their continuous positive airway pressure (CPAP) machines, court documents posted Thursday show. The settlement comes more than two years after Philips recalled millions of its CPAP devices due to reports from users saying foam unexpectedly spewed from the devices and into their mouths.

The company admitted no wrongdoing in a recent blog post, adding that it already set aside $615 million earlier this year anticipating a settlement. "The final cost of the settlement may vary based on, among other things, how many patients participate in the settlement and what the court awards for the professional fees relating to the resolutions," the company said in its post.

Philips recalled its CPAP machines in 2021 and, since then, the U.S. Food and Drug Administration said it has received 105,000 complaints, including 385 reported deaths, reportedly linked to the leaking foam. The foam is purposely placed in Philips CPAP machines to help reduce noise.

In a statement to CBS MoneyWatch, Philips said it has fixed roughly 4.6 million of its devices globally since the recall, including 2.5 million in the U.S. "Patient safety and quality are our top priorities, and we want patients to feel confident when using their Philips Respironics devices," the company said. "We have structured this settlement to quickly deliver value to eligible patients in the U.S. and provide an additional measure of confidence in the safety and quality of Philips Respironics products."

Some of the complaints to the FDA included reports linking the devices to cancer, respiratory problems, pneumonia, chest pain, dizziness and infections. FDA officials warned Americans about using Philips CPAP machines earlier this year, saying the products "may cause serious injuries or death." Inhaling the foam can cause "serious injury which can be life-threatening," Philips wrote in its recall.

Philips tried to fix some of the machines, but the repaired ones were also recalled, the FDA said. The 2021 recall was for 20 different Philips devices, including its A-Series BiPAP ventilators and the DreamStation CPAP machines.

Dozens of sleep apnea patients have filed lawsuits in recent years against Philips related to the CPAP machines, but those lawsuits were consolidated in October 2022 as one class-action case in Pennsylvania. In many of those lawsuits, Philips customers accused the company of knowing the CPAP machines were defective but selling them anyway.

Lawyers representing the CPAP users said Thursday the settlement covers only the economic losses that customers faced and they will seek damages for people with personal injury claims.

About 30 million people in the U.S. suffer from sleep apnea, a disorder in which someone's airways become blocked during rest and interrupts breathing, according to 2022 data from the American Medical Association.

Although it's not possible yet to make a claim, eligible Philips customers seeking compensation from the settlement will eventually be able to do so here. In the meantime, consumers can sign up for emails to get alerts about updates.

Anyone with questions about the settlement can email Info@RespironicsCPAP-ELSettlement.com.

Philips said it expects to start paying the settlement funds in the first quarter of 2024 at the earliest.

https://www.cbsnews.com/news/philips-settlement-cpap-recall-lawsuit-fda/

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NOVEMBER 2, 2023
Philips CPAP Lawsuit Settlement Amount Projections
by Ronald V. Miller, Jr.
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Our law firm handles Philips CPAP machine lawsuits for injuries from the recalled Philips CPAP machine.

The Philips recall covered an estimated 3.5 million sleep apnea devices. There is a CPAP class action lawsuit with thousands of plaintiffs consolidated into a Multi-District-Litigation (MDL-1230). So every CPAP lawsuit in federal court - filed in New York, California, Texas, or wherever - is consolidated in federal court in Pennsylvania.

In this post, we will look closer at the recall, the MDL class action, and the side effects of these CPAP machines. Victims also want to know what our lawyers think CPAP lawsuit settlement amounts might look like and when the CPAP lawsuit might be settled. So we provide below educated speculation of what settlement payouts could be for a CPAP lawsuit and talk about the path to a Philips CPAP lawsuit payout for victims.

Our Philips CPAP lawyers also provide news and updates on the CPAP class action lawsuit. So come back regularly for updates. This page was last updated on November 1, 2023.

Latest CPAP Lawsuit Updates
Let’s start first with the latest CPAP lawsuit updates. We do not need more evidence of the pain the CPAP recall has brought to American families. But we still get more evidence of why thousands have filed a CPAP lawsuit or claim.

November 3, 2023 - Special Master Recommends Denial of Philips Motion

A Special Master submitted a Report and Recommendation to the CPAP recall MDL judge advising the court to reject virtually all of the arguments set forth by Philips in its prior motion to dismiss. Last week, Philips filed objections to the Report and Recommendation, in which it sought to reassert its arguments. The judge will almost certainly follow the Special Master’s recommendation and dismiss the motion.

October 23, 2023 - Philips Announced Further Recalls

Another Philips recall? Incredible. Philips Respironics has announced a recall of its V60 and V60 Plus Ventilators. The reason? The Power Management Printed Circuit Board Assemblies in these ventilators don’t meet the required standards, says the FDA.

The recall concerns nine ventilators: eight in the U.S. and one in the Philippines. These PCBAs were supplied by an external warehouse. Philips stock is down 4% this morning.

October 17, 2023 - CPAP MDL Adds 70 New Cases

Only 70 new cases were added to the Philips CPAP recall MDL over the last month. That brings the total number of pending cases in the class action up to 784 and marks a slight decrease in the level of new cases we had been seeing recently.

October 12, 2023 -CPAP Class Action Settlement (Consumer Claims) Update

Under the terms of the CPAP consumer class action settlement, the Philips companies have agreed to pay a minimum of $479 million. This compensation will go to individuals who paid for the affected breathing machines out of their own pockets and to insurance companies that reimbursed users for these machines.

Consumers impacted by the recall may receive compensation ranging from $56 to $1,552, with an additional $100 offered to those who return their recalled devices. The settlement is currently awaiting final approval, which is scheduled for April 11, 2024. Plaintiffs’ lawyers are, of course, seeking attorneys’ fees and litigation costs to the tune of $95 million.

Remember, this settlement has nothing to do with the personal injury and wrongful death lawsuits our firm is pursuing. Those CPAP machine lawsuits are still pushing forward.

October 7, 2023 - Phillips CPAP Recall Going Poorly… Still Two Years Later

The FDA is still unhappy with the progress of the Philips CPAP recall two years later.

What is the problem? The concern is the testing data submitted does sufficiently address the concerns related to the degradation of sound-dampening foam - the core issue in the recall and every CPAP lawsuit that has been filed. Philips says the foam particle exposure is likely to be harmless. That would be more reassuring if Phillps had any credibility on this issue.

October 6, 2023 - Joint Motion Seeks to Revise Plaintiff Fact Sheets

With the CPAP recall MDL starting to grow at a faster pace, both the plaintiffs and defense lawyers recently filed a joint motion for some amendments to the mandatory Plaintiff Facts Sheets. The revisions to the PFS are aimed at streamlining the process of identifying key facts for incoming personal injury plaintiffs in the litigation.

September 23, 2023 - Lawyers Withdrawing from Filed Cases

In every mass tort claim, attorneys and clients have differences. In two cases in the MDL, a CPAP lawyer had sought to be excused from representing a client who had filed a CPAP lawsuit, citing “irreconcilable differences.”

Judge Flowers ordered the withdrawing lawyer to provide the client with the request to withdraw and inform the client that they have 21 days to raise any objections to this request upon receiving it. Furthermore, the attorney must document in the case records that they have delivered the request to the client and communicated the 21-day objection period to the client.

Clients tend to get frustrated by two things: (1) lack of communication and, (2) the lack of advancement in their case. In this case, the first complaint is valid; the second is just the nature of the beast.

September 18, 2023 - MDL Passes 700 Cases

For the fifth straight month in a row, the Philips CPAP recall class action MDL has posted an increase in the monthly volume of new cases. There are now 716 total cases pending in the MDL, an increase of over 200 since the start of this summer.

September 7, 2023 - Philips CPAP Settlement

Koninklijke Philips has agreed to pay a minimum of $479 million to settle part of the ongoing litigation related to the 2021 recall of sleep apnea machines.

The CPAP lawsuit our law firm is focused on - the injury and wrongful death cases - is unaffected by this settlement. Still, it is progress; this had to get done first. Philips CEO said that these economic loss cases would get solved this year and the injury and death claims would get solved next year. So we are on pace for that.

Analysts estimate that Philips might face settlements of up to $4.5 billion for personal injury lawsuits associated with the recalled devices.

September 1, 2023 - Few Plaintiff Seek Remand Out of MDL

Yesterday was the deadline for any plaintiffs in the CPAP class action MDL in federal court to file motions to remand their cases back to state court and out of the MDL. In the last two weeks of August, only three motions to remand were filed. This is a good indication that the CPAP plaintiffs feel confident that their scientific evidence will be deemed admissible by the MDL judge. If there were doubts or concerns, we probably would have seen a lot more remand motions from plaintiffs seeking to bail out.

August 18, 2023 - New CPAP Lawsuit

A new CPAP lawsuit - Haffner v. Philips North America LLC - was filed last week in Illinois.

The plaintiff acquired a Philips Respironics REMstar SE Auto REMstar CPAP device and consistently used it every day for seven years, until late 2021. On September 1, 2021, the plaintiff became aware of Philips’ recall of numerous CPAP devices after being informed by his doctor.

His CPAP suit alleges that his CPAP caused his kidney cancer diagnosis, resulting in the need for the removal of his right kidney and adrenal gland in 2022.

He and his wife seek compensation for the pain and suffering and other damages they have incurred. The case was filed in federal court in Illinois but will be transferred to the CPAP MDL in Pittsburgh.

August 17, 2023 - 25 More Cases Added to MDL

Only 25 new cases were added to the Phillips CPAP class action MDL over the last 30 days, leaving the total number of pending cases in the MDL at 698. The previous month we saw a record high of 125 new CPAP cases added to the MDL. The recent down tick could just be a summer slowdown. It will be very interesting to see if the volume picks back up next month.

August 15, 2023 - More Problems with Philips

Philips is facing challenges in ensuring product safety. That is a gentile as I can say it. The FDA is elevating its concerns over the potential serious health risks associated with over 70,000 Philips Trilogy Evo Ventilators. These ventilators have been recalled because of issues that could lead debris in the breathing tubes, posing life-threatening risks to patients. Yesterday, the FDA upgraded this recall to Class I because it is now associated with at least one death and two severe injuries.

This is a Class I recall which is a big deal. Class I signifies the FDA’s belief that the recalled Philips Trilogy Evo ventilators could severely harm or result in the death of patients. Philips was at one point a really good company. It is time for the board of directions at Philips to take a long look at what they are doing here. Because this company is not only endangering patients, it is endangering something maybe more dear to them: their profits.

August 2, 2023 - Long Time Frame for MDL

Based on the most recent Case Management Order, it looks like the Philips CPAP class action MDL is moving forward in the litigation slow lane. The recently updated deadlines go all the way out to February 2025, which is when the court anticipates that it will hold a Daubert hearing. That means that the first test trial would not be until June or July 2025 at the earliest.

July 18, 2023 - 125 New CPAP Cases Added to MDL

125 new CPAP recall injury lawsuits were transferred into the MDL over the last 30 days. That is the highest monthly new case volume since the MDL was created over two years ago. There are now 673 active cases pending in the class action.

July 12, 2023 - CPAP Medical Monitoring Cases

Our Philips CPAP attorneys are focusing on injury and wrongful death claims, as opposed to representing victims seeking future medical monitoring for potential complications. The multidistrict litigation involving the CPAP lawsuits also has a medical monitoring component. Philips challenged these claims in a federal court over the last two days, arguing that CPAP lawsuits failed to provide adequate evidence of the plaintiffs’ exposure to the insulating foam’s toxins or the subsequent injuries warranting long-term monitoring.

The gist of it is that the lawyers representing Philips argue that the “medical monitoring” complaint is overly speculative. The complaint failed to present a specific plan essential for monitoring those who were potentially exposed to the degraded sound-insulating foam in the CPAP and BiPAP machines and ventilators, for the early detection of possible future illnesses.

As a part of a more extensive MDL class action centralized in Pittsburgh, the lawsuits are divided into different categories. These categories include claims for economic losses, personal injuries, and those demanding long-term medical monitoring in anticipation of potential diseases.

Our lawyers are with the medical monitoring plaintiffs. Sort of. A decrease in their settlement compensation might indirectly increase the settlement payouts for wrongful death and injury plaintiffs.

Koninklijke Philips NV has set aside $633.17 million as a provision, expecting to settle the economic class action lawsuit in the U.S. linked to the company’s recalled sleep apnea devices and respirators. So their goal here is to claw back some of that money they have set aside.

July 1, 2023 - 30 New Cases Added to CPAP Recall MDL

Over the last monthly period, 30 new lawsuits were transferred into the Philips CPAP recall MDL class action. 200 new CPAP cases have been added to the MDL since the start of the year, bringing the current total up to 548.

So we are seeing an unsurprising increase in new CPAP lawsuits. But this docket was generally slow-moving in June. We expect things to heat up more after the summer.

June 1, 2023 - Some CPAP Claimants May Face Filing Deadline in 2 Weeks

Two weeks will mark the two-year anniversary of the massive Philips CPAP recall. The recall prompted a large number of CPAP device users to pursue legal claims against Philips, alleging that they were harmed by inhaling toxic particles from the machines. As that date approaches, many prospective CPAP claimants could potentially be barred if they do not file suit or register their claim with Philips. Philips will likely argue that the recall announcement put claimants on notice and started the clock ticking on the applicable statute of limitations. This means that for those claimants in states with a 2-year statute of limitations period, Philips could assert that their claims will be time-barred after June 14th. There are exceptions to the statute of limitations… but you do not want to assume one applies if you can avoid it.

The statute of limitations passing for some CPAP claims makes it easier for Philips to offer settlement payouts. Why? The announcement of a global settlement draws in more plaintiffs. If the filing deadline has passed, Philips will not have to deal with more litigation. A Philips CPAP settlement is not imminent. But we explain this to underscore one reason why mass torts take as long to settle as they do.

May 12, 2023 - 13 New CPAP Cases Added to the MDL

A month ago we saw a significant spike in the volume of new CPAP recall lawsuits filed in the MDL. We assumed this might be the start of a new phase in which we started to see 100-200 new CPAP cases added each month. But the most recent monthly case totals suggest otherwise. After last month’s record high of 64 new CPAP cases, the number of new cases dropped to 13. There are now 518 pending cases in the Philips CPAP class action.

May 12, 2023 - Philips Reaches Settlement With SEC

Philips, already facing scrutiny for its handling of CPAP safety issues, has again come under the spotlight. The company has been hit with a $62 million settlement by the SEC over alleged violations of the Foreign Corrupt Practices Act in relation to its sales of medical equipment in China. Philips has attributed the settlement to “irregularities in the medical device industry” from 2014 to 2019 in China.

May 10, 2023 - Example CPAP Lawsuit

An example of a recently filed Philips CPAP lawsuit is the case of Deidra Jackson Holmes v. Koninklijke Philips N.V., et al., (2:21-mc-1230). Jackson filed her lawsuit in the MDL using the Short Form Complaint based on using a recalled Philips DreamStation CPAP device for sleep apnea. According to Jackson’s Complaint, her use of the CPAP machine caused several injuries, including cancer (multiple myeloma) and pulmonary inflammation. She also claims that she developed severe sinus infections requiring corrective surgery.

May 1, 2023 - Money Set Aside for a Philips CPAP Settlement

On its most recent financial statements, Philips has earmarked $630 million in future costs for the settlement of consumer class action lawsuits alleging economic damages resulting from the CPAP recall.

Our firm is handling CPAP injury and wrongful death claims. This set aside is for people who only suffered economic loss. The company has previously stated that it hopes to resolve all economic loss lawsuits by the end of the year.

Philips will still have to deal with the growing number of CPAP lawsuits alleging that the recalled devices caused severe personal injuries like cancer. Philips claims it wants to resolve the injury claims next year (if not this year, its CEO tells us). Saying the price tag for settlement payouts for these cases will be significantly higher would be an understatement.

April 14, 2023 - FDA and Philips Continue to Disagree on the Color of the Sky

The FDA and Philips really disagree about where the company is in dealing with the recall.

April 1, 2023 - The Broken Record of CPAP Injuries

The FDA recently published updated data on CPAP-related health incidents reported to the agency in the last two months of 2022. During those 60 days, over 8,000 new adverse health events connected to recalled CPAP devices were reported to the FDA, and the number of CPAP-related death reports increased by 30%. Over 98,000 adverse health events and 346 deaths related to CPAP devices have been reported to the FDA.

March 13, 2023 - Plaintiffs’ Response to Philips Motion to Dismiss

Several weeks ago, Philips filed a strange Motion to Dismiss a group of CPAP cases because the MDL Short Form Complaint (SFC) used in the cases is deficient and fails to meet the minimum requirements for a lawsuit. The plaintiffs filed a response in opposition to this motion last week. The opposition points out the obvious fact that Philips reviewed the SFC and expressly consented to its use in the MDL last year without making any objection to the deficiencies alleged in the motion to dismiss. In fact, Philips and its lawyers participated in drafting the SFC. Judge Conti also had an opportunity to review the SFC before she approved its use last year, so it seems highly unlikely she will grant the motion.

February 20, 2023 - Lawsuits Filed Update

Over the last month, 62 new Philips CPAP machine lawsuits were added to the MDL. There are now 420 cases pending against Philips in the CPAP recall class action. This is the most significant single volume of new cases since the start of the CPAP litigation. It is probably the result of the claims registration program ending recently, and we anticipate that this trend will continue throughout 2023.

February 14, 2023 -Latest Adverse Event Data

The FDA released updated data on the Medical Device Reports concerning the Philips CPAP and BiPAP devices recalled in June 2021. The news is not good.

As of the recent report in November 2022, there have been 98,000 serious adverse health incidents and 350 deaths allegedly linked to the recalled devices. In the three months since the last report, the FDA has received reports of an additional 9,000 adverse health incidents and, sadly, 90 deaths related to these devices.

January 30, 2023 - Philips Continues to Feel Pain from Recall

To cut costs, Philips announced that it will cut over 6,000 jobs. Philips has been hurting financially since the CPAP recall was launched in June 2001.

January 26, 2023 - CPAP Lawsuit Update

We summarize where we are now in the CPAP class action lawsuit.

January 25, 2023 - Conflicting Proposed Trial Dates

Both sides in the CPAP MDL submitted case management proposals to Jude Conti today. The plan endorsed by the plaintiffs would give us a bellwether trial in the summer of 2024. Under the defense proposal, however, we wouldn’t get a bellwether trial until late 2025 or even early 2026.

January 18, 2023 - Three New CPAP Lawsuits But…

The Philips CPAP MDL has 358 pending cases, an increase of just three since last month.

Is this small litigation? Of course not. Thousands of CPAP recall claims have been sitting on the claim registry. It does not make sense to file a CPAP lawsuit in the MDL if you can just park your case and toll the statute of limitations, and see if a reasonable settlement offer comes your way when the litigation advances to that stage.

January 9, 2023 - New CPAP Nasal Cavity Cancer Lawsuit

Plaintiffs continue to file new CPAP lawsuits. In one newly filed suit, Kirsh v. Koninklijke Phillips, N.V. (2:22-cv-01884), the plaintiff alleges that his defective CPAP caused nasal cavity cancer. The man’s wife also filed a loss of consortium claim. Nasal cavity cancer is rare, particularly for a non-smoker.

January 4, 2023 - New CPAP Lawsuit Involving Tongue and Mouth Cancer

A Long Island man filed the Philips CPAP recall lawsuit alleging that inhalation of toxic foam particles led to oral cancer. The plaintiff’s CPAP lawsuit asserts that he had sleep apnea and used Philips CPAP devices nightly for years before he began to suffer from recurring mouth and tongue cancer. His lawsuit contends that his cancer was caused by chronic exposure to the carcinogenic chemicals he inhaled from his CPAP machine at night.

Our lawyers think the tongue and mouth cancer lawsuits against Philips will be particularly strong.

January 2, 2023 - CPAP MDL Webpage Is Finally Up

As we usher in a new year that will likely be make or break for the CPAP lawsuits, the Western District of Pennsylvania has finally published a webpage for the MDL. The new Philips CPAP MDL page features an extensive index of documents, including all court orders and a schedule for monthly status conferences. This page has taken a while. But better late than never.

December 21, 2022 - CPAP Brain Cancer Lawsuit Filed

Now that the claim registration process with Philips is over, we will see more CPAP injury lawsuits get filed in the MDL. Last week, we saw the first CPAP brain cancer case get filed. Plaintiff Salvatore DiGrazia filed a 60-page Complaint that alleges that he used one of the recalled Philips CPAP machines, cleaned it with the SoClean ozone device for many years, and was later diagnosed with brain cancer. The Complaint names both Philips and SoClean as defendants. This is the first lawsuit our attorneys have seen asserting that toxic foam particles in a recalled CPAP device caused brain cancer. We expected we would see more brain cancer cases than we have.

December 15, 2022 - Consumer Class Action Lawsuit

Philips asks the court to dismiss the consumer class action case pending for economic damages related to recalled CPAP devices. Philips claims that the named plaintiffs (and the class they seek to represent) have no standing to sue because they cannot show that the recall harmed them. Philips claims there was no harm because it offered to repair or replace recalled machines for free. In response, the plaintiffs assert that they would never have bought the CPAP devices in the first place had they known about the risk.

November 24, 2022 - Updated CPAP Death Numbers

In a new report on Tuesday, the FDA reports that it has received more than 90,000 Medical Device Reports (MDRs). There were 260 reports of death from Philips ventilators, BiPAP, and CPAP machines.

November 23, 2022 - Is Philips CPAP Settlement with Justice Department Imminent?

The DOJ is close to finalizing a consent decree with Philips that will force the company to accept blame for the CPAP recall and take steps to avoid future problems. The fact that a consent decree is being negotiated is a clear sign of how bad things have gotten for Philips in the wake of the CPAP recall. The recall has already cost Philips a CEO and billions in valuation, not to mention the growing tide of CPAP recall injury lawsuits.

How does this impact the CPAP cancer and respiratory injury lawsuits? It takes the steam off the “we did nothing wrong” pushback when you publicly admit that you did something very wrong. Yes, Philips’ lawyers will continue to fight and argue that the CPAP did not cause specific injuries.

But if this Justice Department settlement happens, it will take some of the wind out of their sails of these defenses in the CPAP class action lawsuit.

November 22, 2022 - More Pain for CPAP Recall Victims

The FDA issued another public safety warning regarding a Philips CPAP and ventilator device last week. The Philips Trilogy ventilators were part of the massive CPAP recall due to problems with the toxic PE-PUR sound abatement foam. Philips sought to remedy the problem by replacing the ventilator’s PE-PUR foam with a new silicone foam insert.

Now, these new silicone inserts are causing their own problems. Seriously? How is this possible? This feels like a Saturday Night Live sketch, right? According to the FDA warning, the inserts frequently become detached and block the air pathways.

This is just the most recent in a long string of bad news for Philips over the last two years. Is this related to the litigation? I think it is. Philips is more likely to offer reasonable settlement amounts to settle these cases because it is becoming a larger daily embarrassment. Philips will want to put this disaster behind them.

October 28, 2022 - More Philips Disaster News

Philips can’t seem to get much right these days. After recalling millions of CPAP devices last year, in September, Philips was forced to recall millions of magnetic facemasks used with its CPAP machines (both new and old). This recall was prompted by complaints that the magnets in the masks were causing nearby medical devices (such as pacemakers) to stop working. This week, the FDA designated this as a Class I recall meaning it poses the risk of severe injury or death.

October 24, 2022: Philips’ Economic Health

Royal Philips NV announced it cut 4,000 jobs. A new CEO is looking to fix this mess. Bankruptcy is not out of the question, and it might now be the worst thing for victims in this case. The company might be worth more in pieces than it is put together right now.

October 23, 2022: SoClean Lawsuit Against Philips

SoClean Inc. recently filed a newly amended complaint in its separate action accusing Philips of wrongfully attempting to blame the CPAP recall on the ozone-cleaning device manufactured by SoClean.

According to SoClean, Philips attempted to deflect blame for the CPAP recall by perpetuating a false belief that SoClean’s ozone disinfection device was somehow to blame for the foam degradation in the CPAP machines. In the newly revised complaint, SoClean cites evidence that has arisen during the MDL, including internal documents showing that Philips knew about the real reason for the degrading foam as early as 2015.

October 20, 2022: CPAP Lawsuit Status Conference Dates Scheduled

The court scheduled a monthly status conference in the class action in Pittsburgh through March 2022.

October 15, 2022: Short Form Complaint When Filing a CPAP Lawsuit

The Philips CPAP Recall MDL judge now requires all new plaintiffs to use the court-approved Short Form Complaint when filing new CPAP lawsuits in the MDL class action.

This is par for the course. Short-form complaints are widespread in consolidated mass tort class action lawsuits. They help to streamline the process for new - case filings. Victims’ lawyers can initiate a claim - and protect the statute of limitations - with just a simple form rather than a formal pleading. Adopting the Short Form Complaint in the CPAP MDL comes as thousands of prospective claimants are expected to start filing their cases over the next few months.

October 1, 2022: Hits Keep Coming for Philips

More bad news for CPAP manufacturer Philips. The Department of Justice that the embattled CPAP maker recently agreed to pay over $24 million to the U.S. Government. Why? The government alleged it engaged in an illegal kickback scheme. The company allegedly paid illegal kickbacks to incentivize medical equipment suppliers to submit insurance claims for Philips CPAP and other breathing devices. These types of kickback schemes are unlawful. They defraud the federal Medicare and Medicaid programs.

What did this have to do with the CPAP lawsuit? Nothing and everything. CPAP lawyers alleged that Philips consistently goes off-grid in search of profits. This story is consistent with that thesis.

September 18, 2022: Investor Group Says Philips Will Pay Billions

Dutch investor association VEB says Koninklijke Philips NA is liable for billions of euros for misinforming investors about issues with sleep apnea devices. The interesting statistic was that Philips lost $27 billion in stock market value.

Everyone agrees that Philips will pay billions in settlement compensation and jury payouts in these suits.

September 15, 2022: Philips Adverse Event Reports

The FDA issued an update notice on the Philips CPAP recall. The FDA disclosed that it received over 48,000 adverse event reports associated with the breakdown of the sound foam in the recalled Philips CPAP and BiPAP devices between May 1 and July 31.

Forty-four of these side effects reports have involved fatalities, and 168 CPAP-related deaths have been reported since April 2021. In the Philips CPAP MDL, there were 323 pending cases as of August 15, 2022. But that is just the tip of the iceberg. Thousands of additional cases remain unfiled because the plaintiffs have entered into tolling agreements with Philips.

August 11, 2022: Science Day in CPAP Class Action Lawsuit

We talked about Science Day in the Philips CPAP machine lawsuit class action coming up in a few weeks on September 1, 2022, in the CPAP class action lawsuit in the Western District of Pennsylvania. The CPAP MDL Judge (Hon. Joy Flowers Conti) has invited a state court judge handling CPAP cases in Massachusetts to attend the event, at which both judges will be educated on scientific issues through presentations from both sides.

After the science day, Judge Conti is expected to set the schedule for the first round of bellwether test trials. As we have said before, trial dates are crucial to getting to meaningful Philips CPAP settlement negotiations because defendants need pressure before offering reasonable settlement compensation payouts to resolve lawsuits.

August 4, 2022: Science Day Coming

A “science day” has been scheduled for September 1 in the Philips CPAP Recall MDL. This is a good sign of progress - the judge is ready to start digging into the science, and most CPAP lawyers are bullish on the scientific evidence that links a large number of side effects to the CPAP recall.

In class action MDLs, a science day is intended to allow attorneys for both sides to make presentations to the MDL judge to educate the Court about complex scientific issues. The CPAP MDL Judge ordered the science day in response to a joint motion by the parties and gave them until August 18, 2022, to submit proposals for how the science day should be handled. Science days are common in MDLs involving product liability claims.

July 7, 2022: CPAP Lawsuit Moving Forward

Judge Conti just put out an order that gets the CPAP class action lawsuit moving. Attorneys can begin pretrial discovery. This is all work that needs to be done to get the CPAP lawsuit in a settlement posture for both sides. We are never going to get a CPAP settlement without a trial date to scare Philips with, and we will not get a trial date until discovery is completed.

June 27, 2022: New Court Order

The Philips CPAP MDL Judge recently issued a discovery management order imposing certain deadlines for the parties to submit joint proposals on pretrial discovery matters. Proposed plaintiff fact sheets and implementation rules are due by July 8, a protocol for depositions of fact and expert witnesses is due by August 15, and a proposal for written discovery including deadlines and limitations is due by September 9. What does this mean? It means the CPAP lawsuit is progressing.

June 14, 2022: Pre-Trial Discovery Going Poorly for Philips

Discovery in some of the CPAP recall lawsuits has yielded internal documents showing Philips knew about the issues with the sound abatement foam in their CPAP devices for 3 years before announcing a recall.

Back in April 2018, a product engineer from Philips contacted the foam supplier about customer reports of the foam shedding and getting into the airways of the CPAP devices. Philips knew of the problem and did nothing.

The email and the customer reports are powerful evidence that Philips knew about the health hazards of their CPAP machines for years before doing anything. This will help plaintiffs build the case against Philips in the CPAP lawsuit and hopefully speed up the path to a Philips CPAP settlement.

June 6, 2022: New Order from Judge False Flag for a CPAP Settlement

The judge presiding over the Philips CPAP recall class action lawsuit MDL recently issued Pretrial Order #16. This order appoints a retired Magistrate Judge (Diane M. Welsh) to serve as a settlement mediator in the litigation.

This is probably a false flag for a CPAP settlement. I do not think Philips is ready to offer reasonable settlement amounts until we get to the two-year statute of limitations point for older claims.

So, frustratingly for victims, this appointment does not suggest a CPAP settlement is imminent. Rule 16.1 of the Local Rules for the Western District of Pennsylvania requires participation in Court-sponsored ADR.

The appointment of Judge Welsh, an experienced jurist, as a settlement mediator was done to comply with this requirement. But Judge Welsh could take a large role in a CPAP settlement down the road.

May 25, 2022: Adverse Event Reports Post Recall

It has been a year since Philips first initiated the massive safety recall of over 15 million CPAP and BiPAP machines used for sleep apnea. During that time, regulators at the FDA have been deeply involved in - and concerned about - the CPAP recall investigation process and have kept the public well informed.

The FDA has published data on adverse health event reports it received between April 2021 and April 2020 in connection with recalled Philips CPAP devices. According to these reports, the FDA received over 21,000 reports of adverse health events connected to the CPAP machines.

Problems reported have included cancer, pneumonia, and respiratory problems. Depressingly, there have been 124 deaths related to CPAP were reported. There is no conclusive evidence that all 124 deaths were solely due to the recalled CPAP machines. But it is an accumulation of evidence.

You also have to remember that adverse events are woefully underreported to the FDA. These reports to the FDA offer a glimpse into what we can expect to see in the developing CPAP recall lawsuits.

May 10, 2022: New CPAP Lawsuit

CPAP defects will likely cause many deaths. Victims are just beginning to link the deaths of their loved ones with CPAP. One recently filed wrongful death CPAP lawsuit is a case in point. The plaintiff, Doug Shiffler of Oregon, lost his wife to cancer and filed a product liability lawsuit against both Philips and a Maryland company that manufactured the toxic sound abatement foam in the recalled CPAP machines (Wm. T. Burnett & Co). The CPAP lawsuit filed by Shiffler asserts that his wife used one of the recalled Philips DreamStation CPAP machines every night for about 20 months. She was diagnosed with advanced lung cancer. Joleen eventually died from her lung cancer and Doug filed a wrongful death lawsuit claiming that her lung cancer and death were caused by toxic particles in the foam of her DreamStation device.

May 6, 2022: CPAP Refund

The FDA is contemplating requiring Phillips to offer a full refund for people who want their money back for their defective CPAP. This seemingly logical decision is a bigger deal than you might think. It is a rare remedy that underscores how angry the FDA is with how Philips has botched the CPAP recall.

May 3, 2022: Criminal Implications for Philips in CPAP Recall?

I have been writing about how Philips completely botched the CPAP recall and against all reasons kept a product on the market it should have been recalled. But I always wonder who out there is dismissing my diatribes as a CPAP lawyer who just wants to make money off CPAP lawsuits. So today’s update underscores that I’m not using hyperbole. The Wall Street Journal reports that the medical device company recently received a subpoena from the Department of Justice seeking information and documents related to the CPAP recall. The subpoena suggests the DOJ has launched a formal investigation which could lead to penalties and actions beyond the growing number of civil lawsuits.

April 16, 2022: CPAP Lawsuit Update

There are now 274 active CPAP lawsuits in the MDL class action. This is a small fraction of the number of CPAP recall lawsuits. So where are these CPAP suits? Thousands of lawsuits will be registered with the MDL Court with a mechanism that allows victims to hold back filing a lawsuit but tolls the statute of limitations to preserve their claims.

The good news is these suits are now pushing forward. We have seen a surge of activity from the court of late. This is a good sign that the pretrial work should begin to flow.

March 23, 2022: Philips Ham-Handed Recall

The hits keep coming for Philips when it comes to their breathing machines. Philips is bungling everything. Nine months ago, the company had to recall 15 million CPAP and BiPAP breathing devices that were causing users to inhale small particles of cancer-causing foam during their sleep. Now Philips is announcing that they are recalling hundreds of ventilator machines used in hospitals across the country because defective adhesives can cause the machines to suddenly stop working. How does this relate to the CPAP recall lawsuit? It underscores that Philips is not a company that has its act together.

March 19, 2022: FDA Frustrated with Philips Recall

The FDA has now formally intervened in the Philips CPAP recall process. There is no question the FDA is frustrated with Philips. Earlier this month, the FDA sent Philips a letter advising the company that its efforts to notify consumers about the health risks posed by its recalled CPAP and BiPAP machines have been deficient. The FDA is now requiring Philips to “improve its communication about the recall and the serious risk posed by the foam used in the recalled products.” You do not typically see the FDA giving such a public lashing. The new notification efforts by Philips will take place under the close supervision of the FDA.

March 16, 2022: CPAP Lawsuit Update

There are now 262 filed CPAP recall lawsuits in the MDL class action.

March 10, 2022: CPAP Lawyers in Place

The next status conference on March 22, 2022, will be a different dynamic with the new CPAP lawyers Steering Committee in place. There were a lot of skeptics of the CPAP lawsuits’ viability in the early stages. But it is increasingly clear that many of these CPAP side effects lawsuits will be viable.

January 29, 2022: Preserving Evidence of Defective CPAP Machines

The Philips CPAP MDL judge recently issued an order laying out options for evidence preservation of recalled CPAP and BiPAP devices. Plaintiffs can return their recalled device to Philips to have it repaired for free, in which case Philips will be required to take pictures and document the condition of the device as evidence. Plaintiffs can also elect to send their device to Philips and have it held in evidence preservation and not repaired.

January 22, 2022: CPAP Repair Program Goes Awry

After issuing a recall of around 15 million CPAP and BiPAP machines last year, Philips got the FDA’s preliminary blessing on a repair program that would have replaced the toxic PE-PUR foam in the recalled devices with an alternative silicone-based foam. Soon after this new repair program was announced, however, concerns arose as to whether the new silicone foam presented potential health risks. Earlier this week, the FDA ordered Philips to submit independent testing of the new silicone replacement foam.

January 19, 2022: CPAP Lawsuit Update

There are now 221 CPAP lawsuits in the MDL class action lawsuit.

Recall of Philips CPAP and BiPAP Sleep Apnea Devices
Philips is one of the world’s leading manufacturers of night-time breathing assistance machines that are widely used for the treatment of sleep apnea. It was a company on the rise until this CPAP recall debacle.

Philips makes both Continuous Positive Airway Pressure (CPAP) devices and Bilevel Positive Airway Pressure (BiPAP). CPAP is a continuous airway stream that keeps those airways open to prevent sleep apnea and even snoring.

Philips announced in June 2021, a nationwide safety recall of almost all of its existing CPAP and BiPAP devices. The recall was prompted by potential dangers related to a polyurethane foam called PE-PUR that all the Philips devices used for “sound abatement” to make them run quietly. Philips disclosed that this PE-PUR foam may degrade into small particles or “off-gas” into chemicals that get inhaled by machine users as they sleep.

Polyurethane Foam
Polyurethane foam is a type of synthetic material that is widely used in a variety of applications due to its unique properties. It is made by reacting polyols and diisocyanates in the presence of other chemicals and additives, which causes the mixture to expand and form a foam.

DreamStation-CPAP-Auto-CPAP-BIPAP

There are several different types of polyurethane foam, including flexible foam, rigid foam, and spray foam. Flexible foam is used in furniture cushions, bedding, and automotive interiors, while rigid foam is used in insulation, packaging, and construction materials. Spray foam is often used for insulation and sealing in construction applications. The type of polyurethane foam used in CPAP masks and headgear is typically a flexible foam

Polyurethane foam is used as a cushioning material in Phillips CPAP masks and headgear. CPAP masks and headgear are designed to create a seal around the nose and mouth or the nose only, allowing air to be delivered from a machine through a hose to keep the airway open during sleep. To ensure a comfortable fit and reduce pressure points, many CPAP masks and headgear are designed with soft, flexible cushions made from polyurethane foam.

According to the recall announcement from Philips, inhalation of this PE-PUR foam “can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” Lab analysis of the degraded PE-PUR foam particles identified several very harmful chemicals including Toluene Diamine (“TDA”), which is a known human carcinogen.

Which Sleep Apnea Machines Were Recalled?
Philips is one of the largest manufacturers of sleep apnea devices. The safety recall applied to an estimated 3.5 million existing CPAP and BiPAP devices. Below is a list of recalled devices:

LIST OF RECALLED PHILIPS SLEEP DEVICES
DreamStation BiPAP . . . .

How serious is the CPAP recall?
The recall of all Philips CPAP and BiPAP devices is considered very serious. The machines were recalled because they could be causing users to inhale chemicals that are known to be toxic and potentially cause cancer. The recalled devices pose a legitimate health hazard to users.

Lawsuits Following the Philips CPAP Recall
The CPAP and BiPAP safety quickly generated 18 CPAP lawsuits against Philips in federal courts across the country. The early lawsuits were not actual product liability tort claims or personal injuries. So far, all of these cases are what we would call “consumer class-actions.” The plaintiffs in these cases are NOT alleging that they suffered serious bodily injury or developed cancer from using one of the recalled CPAP devices. Instead, the plaintiffs are claiming that they were victims of consumer fraud because they wasted money on CPAP devices that are now basically worthless. These CPAP lawsuits spawned a petition with the Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate these cases into a new class-action MDL. This motion was granted

These types of “consumer fraud” class actions often follow in the wake of major product recalls. They often get confused with traditional product liability tort lawsuits, but they are much different. The individual plaintiffs in these consumer fraud cases are only seeking limited economic damages, basically reimbursement for time and money wasted on defective machines.

By contrast, plaintiffs in the MDL CPAP class action lawsuit seek large amounts of financial compensation for serious physical injuries resulting from these defective devices.

CPAP Recall Product Liability Lawsuit Evidence
The Philips CPAP recall has led to thousands of plaintiffs in the MDL CPAP class action in Pennsylvania. Every CPAP lawsuit is complex and needs to be supported by expert medical and scientific evidence. But plaintiffs’ experts have done a great job of finding the evidence that links CPAP to cancer and a host of other problems. These scientific studies establish a concrete link between the inhalation of PE-PUR foam particles and any type of cancer or other physical injury or condition.

What Are Expected CPAP Settlement Amounts?
I wrote out some projected settlement compensation payouts for CPAP recall victims. I don’t mind speculating about settlement amounts. But you have to understand that with so many different types of injuries from the Dreamstation and other CPAP machines, settlement compensation projections are difficult. That said, I will give you my current speculation as of October 2023.

CPAP Cancer Settlement Amounts
I think the average settlement value of a CPAP cancer lawsuit that can make it to the jury - a big if - is between $100,000 and $500,000. I don’t see proving Philips is at fault as a huge obstacle. The key will be marshaling the science to link the defects in PE-PUR foam to cancer.

CPAP Respiratory Settlement Amounts
Last year, I thought the respiratory cases that are successful will be worth less than cancer cases. I was predicting between $100,000 and $150,000 for serious respiratory injuries that can make it past any Daubert scientific challenges. But my thinking has evolved on this. The science on many of these respiratory cases is really strong. So I think these claims will have a higher value.

Expected CPAP Jury Payouts
The trial value of these cases is much higher. Punitive damages will absolutely be in play in most jurisdictions. I don’t think jurors will be happy with Philips if it ever comes to a jury trial.

Nuisance Claims
There will also be less serious side effects in CPAP lawsuits where the claims fall as low as $5,000 or $10,000, dragging the average down.

CPAP Settlement Compensation Payout Predictions Are Fluid
Every CPAP lawyer seems to have a different opinion about the projected settlement amounts in the CPAP claims. Some attorneys believe it will be hard to prove respiratory claims and easier to prove cancer cases. And I have heard the exact opposite, too. My settlement compensation amount predictions are fluid. But these are my thoughts as of today.

Projecting settlement amounts in a mass tort lawsuit is hard. I cannot think of a piece of litigation that is more difficult to project in 2023 than the ultimate settlement amounts in the CPAP recall lawsuits (and - importantly - how many cases will survive summary judgment). So please do not put a ton of stock in these settlement projections and check back, and I will modify them as appropriate.

Settlement and verdicts in cases involving a CPAP

https://www.lawsuit-information-center.com/cpap-sleep-apnea-mdl.html

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