Image: CPAP lawsuit 2021

Philips recently issued a voluntary recall for several of its sleep apnea machines which are used by millions of people at home and in medical facilities across the United States. Over a month after the recall, people who rely on these respiratory devices are still unsure what to do.

The Philips CPAP lawsuit allege that the recalled sleep apnea machines – which are supposed to help improve the quality of your breathing while you sleep – can potentially cause lung injuries, respiratory problems, and even cancer.

If you or a loved one suffered from lung and respiratory problems and was diagnosed with cancer after using a recalled Philips sleep apnea machine, you might be eligible for financial compensation.

Why did Philips issue the CPAP recall?

On June 4, 2021, Philips has issued an urgent recall of the following sleep apnea devices:

  • Bi-Level Positive Airway Pressure (Bi-Level PAP)
  • Continuous Positive Airway Pressure (CPAP) machines, and
  • certain models of mechanical ventilator devices

According to the recall notice, the products were recalled over potential health risks and cancer concners associated with the devices.

The company first communicated these concerns during its earnings report in April. The adverse health risks were traced back in the devices’ potentially defective sound abatement foam component made from polyester-based polyutherane (PE-PUR).

This sound dampening foam may break down, releasing particles and potentially toxic chemicals which are harmful if inhaled or swallowed by the breathing device user.

Furthermore, the PE-PUR foam may also off-gas certain potentially carcinogenic or cancer-causing chemicals. Philips also stated that unapproved cleaning processes including ozone, as well as high heat and humidity in places where the devices are being used and stored can also worsen foam degradation.

The FDA gave the recall a Class I designation — the most serious type. As noted by the regulating agency, a Class I recall is

“the most serious type of recall. Use of these devices may cause serious injuries or death.”

Which CPAP machines are affected by the recall?

According to the manufacturer, around 80% of the breathing devices affected by the recall notification are CPAP machines, while 20% are mechanical ventilators.

Most of the recalled devices come from Philips’s DreamStation products. The recall affects the following devices manufactured between 2009 and April 26, 2021:

CPAP and BiPAP Machines

  • C-Series ASV
  • C-Series S/T and AVAPS
  • Dorma 400
  • Dorma 500
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • E30 (Under Emergency Use Authorization)
  • Non-continuous Ventilator
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q-Series)

Mechanical Ventilator Devices

  • A-Series BiPAP A30
  • A-Series BiPAP A40
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 Auto
  • Garbin Plus, Aeris, LifeVent
  • Trilogy 100
  • Trilogy 200

The recall doesn’t affect the manufacturer’s next-generation CPAP platform, DreamStation 2. According to the FDA, Philips will replace the sound abatement foam an affected devices with new material as soon as possible.

The company has also provided an online form you can use to see whether your device is affected by the recall.

Possible Health Risks and Injuries from the Recalled Devices

The recalled CPAP, Bi-Level PAP, and mechanical ventilator devices can pose serious health risks to patients due to foam degradation.

Some potential injuries that particulate exposure due to the PE-PUR degraded foam can cause are:

  • headache
  • irritation of the eye, skin, and/or respiratory tract
  • respiratory issues including asthma
  • inflammatory response
  • adverse effects to the liver, kidneys, and other organs
  • possible toxic effects
  • carcinogenic effects (cancer risks)

Aside from these particle-related side effects, Philips also warned of potential health risks from off-gassing, which releases volatile organic compounds (VOCs) and other potentially harmful chemicals.

Chemical exposure due to off-gassing can cause the following health risks:

  • headache
  • cough
  • hypersensitivity
  • nausea and vomiting
  • irritation
  • possible toxic effects
  • carcinogenic effects (cancer risks)

What is a CPAP machine used for?

A CPAP machine is a common treatment for patients with obstructive sleep apnea (OSA). This device pumps a stream of air into the nose and mouth through a hose and a mask or nosepiece. This keeps a patient’s airways open and helps them breathe normally as they sleep.

This eliminates the concern that patients with obstructive sleep apnea have of their airway temporarily collapsing, which can cause pauses or interruptions in their breathing.

According to Philips, an estimated 3 to 4 million breathing machine devices are in use worldwide, and half of these are in the U.S.

However, due to the recent Philips recall, people who use these devices are struggling to figure out what to do, especially because most breathing device users cannot go without them, as one night without the Philips CPAP or ventilator machine can negatively affect their health.

Some people even need ventilators around the clock. But due to the potentially defective products from Philips, patients now have to wait for replacements from the company, in which not everyone had luck with.

Current Status of the Legal Proceedings

On June 29, 2021, a class action lawsuit was filed in Massachusetts against the Dutch medical equipment company Philips. The complaint alleges that Philips knew about the serious risks associated with its CPAP and BiPAP machines long before the recall.

The complaint also alleges that patients who used the recalled sleep apnea devices have been complaining to Philips about the presence of black particles in their machines for many years prior to the CPAP recall.

However, Philips failed to warn the public about the potential hazards and did not recall its potentially defective machines until June 14.

Litigation is still in its beginning stages, but seeing as how Philips have a large market share of around 65% of the CPAP market, and considering how millions of people across the country depend on these macines to get enough oxygen through the night, many other Philips CPAP litigation will likely follow.

Why should you file a CPAP lawsuit?

Sleep apnea is a potentially serious medical condition that can affect anyone, even children. This sleep disorder also increases one’s risk for other health problems, including heart disease, high blood pressure, and diabetes, among others.

In hopes of treating sleep apnea and possibly easing some of the health issues associated with the condition, a patient may use a CPAP (continuous positive airway pressure) machine to help them breathe better at night and get the rest they need.

But what do you do if the medical device that’s supposed to improve your breathing can possibly contaminate your airways and end up causing more dangers to your health?

Although these products are being regulated by the FDA, a product can still be defective by its design, marketing strategy, or manufacturing process. In Philips’ case, the affected products in the recent Philips CPAP recall are potentially defective and pose serious health risks, injuries, and even cancer.

Needless to say, no patient deserves to sustain injuries and suffer from potentially debilitating health conditions due to a defective medical device.

Who Can Take Legal Action?

If you or a loved one used any of the recalled Philips sleep apnea devices and if you are experiencing any of the symptoms listed above which may mean that you have been exposed to the potentially toxic foam and chemical emissions, it is important that you speak with your doctor immediately.

Another option for victims of the recalled breathing machines is to take legal action by filing a Philips CPAP recall lawsuit today. We all know that dealing with health problems and injuries requires money. If your case qualifies to be brought to the court, you may be eligible for financial compensation, which can help you deal with the mounting medical bills from all the medications and hospital stays you may have gone through.

But perhaps the most important possible outcome from filing a Philips CPAP lawsuit in 2021 is achieving justice from those who harmed you or a loved one through a defective medical device, which, in the first place, is supposed to help you and not cause you to suffer from further medical conditions.

If you or a loved one suffered from lung and respiratory problems, cancer, and other injuries following use of any of the sleep apnea devices manufactured by Philips, you may be entitled to compensation.

Contact us today to find out whether you qualify to join the legal battle against the medical equipment manufacturer Philips.

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