Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More | JD Supra (2024)

What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021.

After all, these patients relied on these machines to treat their sleep apnea and help prevent the serious medical complications the condition can cause. It’s no surprise that these patients were alarmed when they found out that the machines they used every night to help them breathe safely while sleeping were actually putting them at risk of developing cancer or other serious injuries.

Here are the latest developments in the Philips CPAP machine recalls and lawsuits.

Why Are Philips CPAP Machines Being Recalled?

As a quick refresher, the voluntary recall of Philips CPAP machines resulted from problems involving the polyester polyurethane foam used in the machine. This polyester-based polyurethane (PE-PUR) foam helps the machine run more quietly and reduces the vibrations produced by the machine.

Unfortunately, this foam can degrade over time—posing a potentially dangerous situation. As this foam degrades, it can produce small particles that the user may ingest. This danger can exist even if there isn’t visible damage to the foam, and ingesting it may increase the risk of developing cancer or other health problems, particularly those pertaining to lung issues and injuries.

This sound abatement foam may also pose another risk: volatile organic compound emission. Volatile organic compounds are chemicals that may be emitted from this foam through off-gassing. In particular, Philips CPAP foam off-gassing has been found to emit two compounds of concern in amounts that exceed safety thresholds, according to Philips:

  • Dimethyl Diazine
  • Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1methylpropyl)

Attorneys, however, have also raised concerns about the off-gassing of other chemicals, like the following, from the foam used in the recalled CPAP machines:

  • Benzene
  • Formaldehyde
  • Methylene chloride (dichloromethane)
  • Perfluorooctanesulfonate (PFOS)
  • Flame retardants
  • Solvents

Between these two potential dangers of particle ingestion and chemical off-gassing, the foam that is used in the recalled Philips CPAP machines has the potential to pose serious health risks.

Philips CPAP Lawsuit Attorneys Are Now Accepting New Cases Involving Additional Types of Injuries

When lawyers first began pursuing lawsuits against Philips CPAP manufacturer Philips Respironics, many attorneys were originally considering only cases that involved a cancer diagnosis. This is because the first reports of the health risks associated with the problem of polyester-based polyurethane foam degradation in recalled CPAP machines focused on cancer.

As more information has emerged in the Philips CPAP machine recall and the resulting lawsuits, some evidence has pointed to other health risks besides an increased likelihood of developing cancer. Today, attorneys are moving forward with Philips CPAP lawsuits on behalf of medical device users who have suffered health issues like the following:

  • Asthma
  • Pulmonary edema
  • Pulmonary fibrosis
  • Other lung diseases or conditions
  • Kidney disease or damage
  • Liver disease or damage
  • Heart damage
  • Hyper- or hypothyroid disease
  • Immune disorders

This change is important for the sleep apnea sufferers who have used the recalled Philips CPAP machines because it expands the scope of who can seek compensation—not to mention accountability on the part of the device manufacturer—for the very real harms they have suffered. Dealing with these serious and, in some instances, life-threatening health conditions is a huge burden that can take a physical, emotional, and financial toll on the patient and their family. Now, more of the people harmed by foam degradation in recalled CPAP machines can receive the compensation they deserve for their damages.

FDA Investigation Suggests That Philips Knew of the Health Risks for Years Before the Recall Was Finally Issued

In response to the sudden and massive Philips CPAP recall 2021—which now includes as many as 15 million devices worldwide, according to NBC News—the Food and Drug Administration launched its own inspections and investigations.

Upon exploring the digital records maintained by a Philips Respironics manufacturing facility, some of which date back to 2015, the FDA concluded that the company “knew of problems for years, but didn’t act,” NBC News reported. Specifically, the write-up of the FDA investigation reported that “there were at least fourteen instances, assessments, and/or test reports, dated from 04/01/2016 to 01/22/2021, where your firm was aware of issues and concerns” related to those that eventually prompted a recall in June 2021. However, as the FDA noted, “a risk analysis is inadequate and no further design change, corrective action, or field correction was conducted when appropriate or within an appropriate timeframe.”

In other words, the reviewed emails and other correspondence that took place between Philips employees and foam suppliers, technicians, and other parties have documented that at least some level of knowledge of these health risks existed years before the company issued the recall. Yet, the FDA reported, Philips neglected to take the action during this time to mitigate the harms that could result from foam degradation.

If it is determined that the company did knowingly allow the issue of foam degradation to persist for years in products that users were exposed to on a nightly basis, it’s possible that many more consumers suffered harm and an increased risk of serious health issues as a result of this inaction.

Failing to promptly warn users of the potential dangers and to initiate a recall when the health risks first came to light could be determined to constitute negligence. That’s one of the arguments being made in the 100+ Philips CPAP recall lawsuits currently pending in which plaintiffs allege, as evidenced by the FDA investigation report, that Philips Respironics was aware of the health risks long before the company recalled the products that posed these dangers.

If you believe that using one of the now-recalled Philips CPAP machines has caused you to develop any type of serious health issue, you should speak to an attorney right away—at no cost—to learn about your legal rights and options.

Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More | JD Supra (2024)

FAQs

How many people have died from Philips sleep apnea machines? ›

The Food and Drug Administration says 561 deaths have been reported in connection to recalled Philips devices to treat obstructive sleep apnea and other breathing disorders.

What is Philips doing about the recall on CPAP machines? ›

Requiring implementation of a Recall Remediation Plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall by way of receiving a new or reworked/remediated device, or for certain devices, providing the option for a partial refund.

How much will I get from CPAP lawsuit? ›

Again, these are not personal injury or wrongful death lawsuits but a CPAP consumer class action lawsuit that settled for $500 million. How much did plaintiffs get? Plaintiffs will receive compensation between $55 to $1,552 per recalled device and $100 for each returned device.

What's the status of the Philips CPAP lawsuit? ›

September 2023 Update

Philips reached an agreement to settle all economic claims stemming from the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices and respirators. Philips will pay a minimum of $479 million as part of this settlement.

How many people have actually died from sleep apnea? ›

According to the National Commission on Sleep Disorders Research, approximately 38,000 deaths occur on an annual basis that relate to cardiovascular problems that in one way, or another are connected to sleep apnea.

What is the death rate of sleep apnea? ›

The American Sleep Apnea Association estimates that 38,000 people in the United States die each year from heart disease with sleep apnea as a complicating factor. People with sleep apnea have difficulty breathing or stop breathing for short periods while sleeping.

How much will I get from the Philips CPAP settlement? ›

a Device Return Award of $100 for each recalled device returned by Aug. 9, 2024; and/or. a Device Replacement Award for money spent to buy a comparable machine on or after June 14, 2021 and before Sept. 7, 2023 to replace a recalled device.

Can I sue Philips for CPAP recall? ›

Parties Eligible for Filing CPAP Lawsuits for Their Losses

To qualify for filing a lawsuit the user must have developed health-related illnesses due to the faulty Philips CPAP machine.

How serious is being put on BiPAP? ›

BiPap is usually very safe. It has a lower risk of complications, such as infection, compared with ventilator support like a tracheostomy. Most problems from BiPap involve the facemask.

Why are people suing CPAP? ›

Why Are People Filing Philips CPAP Lawsuits? People are filing Philips CPAP lawsuits because the polyester-based polyurethane — PE-PUR — sound abatement foam in recalled Philips CPAP, BiPAP and ventilator devices may degrade. Lawsuits claim that degraded Philips' CPAP foam can cause cancer and organ damage.

How long will it take to settle the CPAP lawsuit? ›

All Phillips CPAP lawsuits have been consolidated before Judge Joy Flowers Conti in United States District Court for the Western District of Pennsylvania. The Philips CPAP recall MDL is growing at a steady pace and we project a potential settlement in 2024.

Why are people suing over CPAP? ›

The lawsuits have claimed that flaking foam and gasses emitted from the machines were linked to health issues including respiratory illnesses, lung cancer and death. The foam was used in the machines to reduce noise and vibration.

Did the CPAP maker agree to pay? ›

CPAP sleep apnea machine maker Philips Respironics agreed to pay at least $479 million in a settlement over alleged health risks from toxic sound reducing foam, lawyers for the plaintiff announced Thursday.

Is Philips CPAP recall serious? ›

Health Risks of Using Recalled Machines

A range of potential health problems could arise in people who use recalled Philips devices. There are two main reasons why it is believed that a breakdown of the PE-PUR foam in these devices could create health risks.

Do I have to return my Philips CPAP? ›

Specifically, it is important that you promptly return your Affected Device. Your returned Affected Device will either be repaired to replace the foam insulation with an approved insulation, or will be destroyed.

Are Philips CPAP machines safe? ›

If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. In June 2021, the FDA alerted people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks.

Is it safe to use Philips CPAP machine? ›

However, many CPAP and BiPAP machines manufactured by Philips Respironics were recalled in June 2021 due to defects that exposed users to carcinogens through the product's airway. The potential damage to a user's internal organs may include...

Is it safe to keep using my Philips CPAP machine? ›

Why Would I Stop Using My CPAP Machine? In 2021, Philips recalled many of its CPAP machines, noting that the devices put people at risk of harm. Here's what you need to know: The foam around Philips CPAP machines' mouthpieces can break off and enter users' airways.

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