More than five million people with sleep apnea have used CPAP machines hoping to get some rest. Unfortunately, many of them have ended up developing serious health problems. If you relied on a CPAP machine and you suffered illness or injury because of the device, you may be able to pursue compensation for your injuries from the manufacturer. It can be confusing to know if you should pursue a class-action lawsuit or file an individual claim. In this article, we will discuss the differences.

Understanding What Triggered the Recall

Philips Respironics recalled CPAP machines that were manufactured from 2009 to 2021, because the polyurethane foam (PE-PUR) used to soundproof the machine exposed users to toxic particles while they inhaled. 

Since the recall was announced in the summer of 2021, multiple class-action lawsuits have been filed against Philips. However, these lawsuits have been based on claims of consumer fraud rather than injuries suffered by users. These consumers were trying to seek reimbursement to obtain replacement devices to deal with their sleep apnea. People can benefit from a class action lawsuit if there is a large number of people impacted by the negligence of a single company. When a verdict or a settlement is reached, the damages awarded are distributed among those who joined the class-action lawsuit.

Devices that are supposed to help people who suffer from sleep apnea have been harming users. Three types of continuous positive airway pressure or CPAP machines have been recalled to date. That is because millions of people who used these CPAP, BiPAP, or ventilator machines may have been exposed to toxic particles when they were breathing.

The Recall

Philips Respironics has recalled CPAP machines manufactured between 2009 to June 2021, because their soundproofing foam degrades over time. CPAP machines are designed to keep airways open by providing a consistent stream of air through a mask so that people with sleep apnea can get a good night’s rest. But the polyurethane foam (PE-PUR) has exposed users to toxic particles. There is a danger of inhaling and choking on pieces of the foam. This remains an ongoing issue that has yet to be resolved.

Recalled Devices

Here is a list of the devices recalled by Phillips. They are prescribed to people with sleep apnea so that they can breathe more consistently. These are the three types of CPAP machines that have been recalled: 

The number of people impacted by a defective CPAP machine to combat their sleep apnea continues to grow. There have been more than 90,000 reports about problems with the devices, including 260 reports of people who died—all since April 2021. The FDA is now conducting an in-depth review into why these numbers have spiked in the last year and a half. Our attorneys understand that you expected your medical device to work properly and not cause more serious health problems. It is time for you to take action and get the compensation you deserve for your serious injuries.

Health Conditions Caused by Foam

Philips Respironics issued a recall last summer because the machines manufactured between 2009 to June 2021 were defective. The machines used soundproofing foam, but as the PE-PUR foam degraded over time, more than five million people who used these CPAP, BiPAP, or ventilator machines may have been exposed to harmful particles while breathing.

The reports filed by Philips Respironics to the FDA included mandatory reports from Philips and voluntary reports from health professionals and consumers. They mention serious health injuries including various forms of cancer, pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.

As efforts to replace CPAP machines now stretch into next year, what can sleep apnea users do? More than five million people may have been exposed to toxic substances in their effort to get a good night’s rest. Injuries may have led to ongoing chronic health issues and disabilities affecting a person’s quality of life. If the therapy that was meant to give you sound sleep has turned your life upside down with a cancer diagnosis and ongoing medical treatments you are entitled to seek compensation for your CPAP injuries.

Dangerous Foam

Royal Philips recalled the machines last year because the foam used to reduce the noise level of the motor breaks apart releasing toxic chemicals. The pieces of foam have been swallowed by people thereby causing throat, liver, lung, and kidney cancers, among others. Sleep apnea machines have also led to serious injuries and deaths.

Possible Compensation for CPAP Health Injuries

If you used one of the recalled CPAP machines for six months or more between 2009 and May 2021 and you have been diagnosed with cancer, you have every right to seek legal counsel. In most cases, you will have two years to file a lawsuit against the manufacturer after you were diagnosed.

If you are like nearly 30 million Americans who suffer from sleep apnea, all you wanted was to have a restful night. Instead, it may feel like a nightmare if you have been told you have cancer after using CPAP machines. If you have been impacted by these dangerous devices we are committed to helping you with this medical device disaster.

Cancer Due to Foam Dangers

If you are anything like a typical defective CPAP machine victim, you relied on special devices such as CPAP, BiPAP, or ventilator machines to get uninterrupted sleep and be able to go to work and take care of your children. Instead, you woke up coughing phlegm and black specks after using CPAP machines.

Royal Philips announced in the summer of last year that millions of CPAP machines and mechanical ventilators had hidden flaws. The company issued a recall because the machines could expel particles and gasses. The polyester-based polyurethane (PE-PUR) foam used to reduce the noise of the motor had been disintegrating and releasing toxic chemicals and debris into the air hoses. Inhaling or swallowing pieces of the foam could cause various cancers, serious injuries, or deaths.

Properly-functioning lungs are a crucial component of people's overall health. Everyone needs to be able to breathe properly and absorb oxygen into their bloodstream. Any health conditions that affect lung functions can be incredibly harmful, and they may not only impact a person's overall health, but they may put the person at risk of losing their life. To make matters even worse, a person who experiences serious lung illnesses or injuries may also be at a higher risk of contracting lung cancer in the future.

Lung conditions have become a significant concern for many people who have used CPAP machines and similar devices to treat sleep apnea. In 2021, millions of these devices were recalled by the medical device manufacturing company Philips Respironics. The recalled CPAP and BiPAP machines contained a synthetic foam used to dampen the sound of the motors used to force air into users' airways. This foam, which was composed of potentially toxic substances, could break down over months or years of daily use. The inhalation of small particles of foam and other chemicals released due to the breakdown of foam may have led to multiple types of serious lung conditions, and some of these could potentially lead to lung cancer.

CPAP machines are a common treatment for sleep apnea, but some models have been recalled due to defects that may pose a health risk. The recalled devices used a synthetic foam composed of polyester and polyurethane that was meant to reduce the noise when a device was operating. Unfortunately, this foam, which is toxic to humans, could break down during a device's regular use. As air passed through a device and was forced into a user's lungs, it may have picked up particles of foam, which could then be inhaled or swallowed by the user. This could potentially lead to a variety of health issues, including an increased risk of kidney cancer.

Symptoms of Kidney Cancer

The absorption of tiny foam particles into the bloodstream may affect multiple organs and bodily systems. Because the kidneys act as a filter for the blood, foam particles may have accumulated in the kidneys and affected the organ's tissues. This may have led tumors to form, affecting kidney functions. As tumors grow, they may also affect other bodily systems, including spreading to nearby lymph nodes, major blood vessels, or the adrenal gland. In the most serious cases, cancer may metastasize throughout the body, affecting distant lymph nodes or other organs.

If a person has kidney cancer, they may experience the following symptoms:

Sleep apnea, in which a person periodically stops breathing while they are sleeping, can seriously affect the quality of a person's sleep and their overall health. While multiple forms of treatment are available to address this issue, the most effective treatment for most people is to use a CPAP machine. These devices force air into a person’s nose or mouth while they are sleeping, keeping their airways open and ensuring that they do not stop breathing. Unfortunately, many people have lost their access to this form of treatment due to a recall of CPAP machines by a major medical product manufacturer. Due to this recall, people may not only need to deal with the loss of treatment, but they may also have been placed at risk of injury due to toxic materials in the recalled devices. There are a number of injuries and illnesses that may have affected CPAP users, including liver cancer.

Signs and Symptoms of Liver Cancer for CPAP Users

The recalled CPAP machines were found to be dangerous due to a foam that had been used to reduce noise while the devices were operating. This foam, which was composed of polyester-based polyurethane, could break down over the lifetime of a device, and users may have inhaled particles of this toxic substance, as well as dangerous chemicals.

Toluene diisocyanate is one chemical that has been found to be released when the foam in defective CPAPs degrades. This substance has been classified as a possible human carcinogen by the International Agency for Research on Cancer (IARC), and it has been found to cause liver cancer and other forms of cancer in lab animals that had been exposed to the chemical. 

Many people use continuous positive airway pressure (CPAP) devices to treat sleep apnea or similar conditions. CPAP machines provide a steady stream of air that keep a person’s airways open, ensuring that they do not stop breathing while they are sleeping. These devices can provide numerous benefits, including helping people avoid the risks of heart conditions, ensuring that they get enough rest while sleeping, and improving their overall health. 

Unfortunately, a large number of CPAP users have learned that the products that were meant to benefit them may have put them at risk of injury. A massive recall of CPAP machines is currently being performed by Philips Respironics. The recalled devices contained a type of foam composed of polyester-based polyurethane, and the breakdown of this foam over time may have led foam particles and hazardous chemicals to be inhaled by users. These substances have been associated with multiple forms of cancer, including throat cancer and esophageal cancer.

Throat Cancer Symptoms and Treatment

Cancers of the throat may affect the windpipe, the voice box and vocal cords, the pharynx (the passage connecting the back of the nose to the beginning of the windpipe), the tonsils, or other parts of the head and neck. Tumors may form in the cells lining the throat, and they can result in symptoms such as difficulty swallowing, sore throat, persistent coughing, swollen lymph nodes in the neck, hoarseness when speaking, pain in the ears, weight loss, and wheezing or other breathing problems.

For nearly a year, millions of Americans who use CPAP devices to treat sleep apnea have been left up in the air due to a massive recall by Philips Respironics. The medical device manufacturing company began a voluntary recall of CPAP, BiPAP, and ventilator devices in June of 2021. However, because of the scale of the recall, millions of people have not yet been able to receive replacement devices, and many have been forced to choose between going without treatment or potentially putting themselves at risk of harm through the use of devices that may be unsafe. Multiple agencies in the United States government have been looking into the recall, and they may take action against Philips to address the ways consumers have been affected.

Actions Taken Against Philips by the FDA and DOJ

Philips began its recall of CPAP machines and similar devices because it learned that the products contained a dangerous substance that could break down over time. A polyester-polyurethane foam had been used in these devices to dampen sound and help them operate more quietly. Unfortunately, the breakdown of this foam may have led users of the devices to inhale tiny particles and toxic chemicals, leading to potential lung injuries and other health issues.

While Philips announced the recall in June 2021, company records indicate that it knew about the potential health hazards for months or years and failed to take action. After announcing the recall, the company has struggled to ensure that consumers and medical device suppliers are informed about the issue, and many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) has been overseeing the recall, and it recently issued an order requiring Philips to create more effective notification procedures.

Sleep apnea is an issue that affects millions of people throughout the United States. Those who struggle to breathe correctly while sleeping may encounter a variety of health issues related to this condition. For those who have been infected by COVID-19, the effects of sleep apnea may become even more serious, and they may lead to life-threatening issues for those with severe cases. The concerns related to sleep apnea demonstrate the importance of proper treatment for those who suffer from this condition. Unfortunately, the recall of defective CPAP machines and ventilators that is currently being performed by Philips Respironics may make it more difficult for some to receive the treatment they need.

Study Links Sleep Apnea to More Severe COVID-19 Outcomes

A recent medical study looked at the role that sleep apnea may play in COVID-19 infections. Researchers found that those who suffer from sleep apnea are no more likely to be infected than the average person. However, for those with severe infections, sleep apnea is more likely to lead to more serious problems, including higher rates of hospitalization and death.

One of the key issues that affects people with severe Covid infections is hypoxia or a lack of oxygen. Covid can restrict a person’s airways and affect their lungs’ ability to process oxygen, and a lack of sufficient oxygen can lead to damage to multiple bodily systems. This issue can be compounded by sleep apnea. Those who suffer from this condition will often struggle to breathe properly while sleeping, and they may also experience hypoxia. These limitations on a person’s ability to receive sufficient oxygen may lead to permanent damage to organs, and they may experience ongoing health issues, including cognitive impairment. In the most severe cases, the combination of COVID-19 and sleep apnea may lead to a person’s death.

Since June of 2021, Philips Respironics, a Dutch medical device manufacturer, has been undertaking a massive recall of CPAP devices and other types of ventilators. This recall was initiated because the devices used a sound abatement foam that could potentially cause harm to users. When this foam breaks down over time, “black debris” consisting of foam particles may be inhaled by those using the devices, and volatile organic compounds or other dangerous chemicals may also be released. Users of the devices may be at risk of lung injuries and other serious illnesses. 

The CPAP recall involves around 2.6 million devices in the United States and 5.2 million devices worldwide. While Philips has made efforts to notify users about the recall, many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) recently issued a notification stating that the company’s efforts to ensure that people are properly informed about the recall have been lacking, and it is requiring Philips to take certain actions to comply with its requirements.

FDA Requirements Addressing Inadequate Notification Procedures

To determine whether the actions taken by Philips to notify people about the recall have been effective, the FDA contacted 182 suppliers of CPAP devices and other medical equipment. It found that 28 of these suppliers were not aware of the recall, meaning that their customers were also most likely unaware of the potential risks that may affect them when they use these devices.

Many people throughout the United States who rely on CPAP machines to treat sleep apnea have had their lives disrupted by a major recall of these devices. In 2021, Philips Respironics recalled millions of these products, including Dreamstation CPAPs and other CPAP, BiPAP, and ventilator devices. The recalled devices contained a polyester/polyurethane foam that has been found to degrade throughout the months and years of daily use, potentially exposing people to toxic substances that could cause serious health issues. 

People who use devices that have been recalled may be wondering about their options. Since sleep apnea can be a serious issue that may affect a person’s overall health, stopping treatment could lead to a variety of problems. However, because there are millions of defective devices, replacements may not be available for some time. Philips is working to provide replacements, and the company expects this process to take a year or more. Other CPAP manufacturers are also struggling to meet demands and provide people with products that can offer the treatment they need. As CPAP users work to determine their options, they will want to understand the advice that doctors may give about how they can receive effective treatment for sleep apnea.

Treatment Options That May Be Recommended by Doctors

Since every person’s case is unique, there is no single correct answer for what a person should do if they are using a CPAP device that has been recalled. People should consult with their doctor to determine the approach they should take. Doctors may advise patients to take a number of different actions, including:

Following a major recall of CPAP machines, many people are unsure about their options for treating sleep apnea. The recalled devices, which were manufactured by Philips Respironics, contained a type of foam that could break down, and when small foam particles or certain types of chemicals entered a device’s airways, they could be inhaled by a device’s user. This could put users at risk of multiple types of injuries, including lung cancer and other serious illnesses. Unfortunately, many people have struggled to receive replacements for defective CPAP devices, leaving them uncertain about whether they should discontinue their use of a recalled device or go without treatment for sleep apnea. Fortunately, other treatment options may be available.

Alternative Sleep Apnea Treatments

Being able to treat sleep apnea effectively can be crucial for a person’s health. Most people with this condition suffer from obstructive sleep apnea, and the position of their tongue and jaw will interrupt their ability to breathe correctly while sleeping. This can result in a significantly reduced quality of sleep and cause drowsiness and fatigue. It can also lead to additional health issues, such as increased risks of strokes or heart attacks. 

Those who do not want to use a potentially dangerous CPAP machine or who are looking for options until a new CPAP becomes available may want to consider other treatments that can help address sleep apnea. These treatments may include:

Philips Respironics, a medical device manufacturer, has released multiple different types of products used to provide breathing assistance or sleep apnea treatment, and these devices are used by medical facilities or in people’s homes. In June of 2021, the company initiated a massive recall of multiple types of devices, including CPAP and BiPAP machines and ventilators. This recall was done because the devices contained a polyester/polyurethane foam that has been found to degrade over time. When the foam breaks down, particles of the foam could be inhaled by a patient, and toxic chemicals may also be released that could endanger a person’s health. Recently, Philips recalled some additional ventilator devices for the same reason.

Recall of Trilogy Evo Ventilators

On December 12, 2021, Philips notified customers using its Trilogy Evo ventilators that the devices were being recalled, and the company sent an update on January 13, 2022 to provide additional safety information. These devices, which were not included in the June 2021 recall, had used the same foam as the other recalled devices. They were manufactured and distributed to customers in April and May of 2021.

Because the recalled ventilators may be used by patients to provide essential breathing support, it may not be feasible to stop using a device until a replacement can be obtained. This means that some patients may need to continue using these devices and putting themselves at risk. The recall notice stated that patients or caregivers should monitor a device’s bacteria filter and look for foam debris. The use of an additional in-line bacteria filter may also help prevent the inhalation of foam particles.

Millions of people have been affected by the recall of CPAP and BiPAP machines performed by Philips Respironics in 2021. These devices were recalled because of a foam that was used in the machines for noise-dampening purposes. The degradation of the foam, which could occur throughout the life of a device, could potentially lead to small foam particles and toxic chemicals being inhaled by users while they were receiving treatment for sleep apnea. One issue that was raised by Philips in its recall notice was the use of certain types of cleaning devices that purified CPAP parts through the use of ozone. CPAP users who also used ozone cleaners will want to understand how this may have affected their health and safety.

Manufacturer of Ozone Cleaners Sues Philips Respironics

When it issued its notice recalling multiple different types of CPAP and BiPAP devices, as well as medical ventilators, Philips stated that the use of unapproved cleaning methods, including cleaning devices that use ozone, may have exacerbated the degradation of the foam in the devices, increasing the likelihood that users could be exposed to harmful particles and chemicals. In October of 2021, SoClean Inc, a manufacturer of ozone cleaners, filed a lawsuit against Philips, claiming that the company had made false and misleading claims about the causes of foam degradation. The lawsuit stated that SoClean’s sales have fallen and its brand’s reputation has suffered as a result of the statements made by Philips. It also stated that Philips is attempting to divert blame for injuries suffered by CPAP users, when the true reasons for these issues are design flaws and a poor choice of materials. SoClean believes that the use of ozone when cleaning CPAP machines does not lead to the breakdown of foam, but degradation is actually caused by high humidity and contact with water.

Ozone CPAP Cleaners Not Approved by FDA

While it is still unclear whether the use of ozone cleaning devices is a factor in the degradation of foam in CPAP devices, it should be noted that these types of cleaners have not been approved by the FDA. Instead, the FDA recommends that users follow the manufacturer’s cleaning instructions, which usually state that CPAP devices and parts should be cleaned with soap and water.

Since the medical equipment manufacturer Philips Respironics began recalling millions of CPAP and BiPAP machines and ventilators in 2021, users of these devices have been concerned about the potential health risks that may have affected them. The recalled devices contained a polyurethane foam that could break down during regular, daily use, and the inhalation of particles and chemicals may have led to multiple types of health issues. By understanding the specific substances that people may have been exposed to and their potential effects, CPAP users can determine whether they have suffered harm, and they can work with an attorney to determine their legal options.

Potentially Harmful Chemicals That May Affect CPAP Users

Testing performed by Philips determined that the breakdown of the foam used in CPAP machines and other devices may have caused users to inhale small foam particles. These particles contained multiple types of toxic chemicals, including:

• Toluene diamide - This chemical can cause irritation of the nose and throat, as well as skin conditions such as dermatitis. It can also cause nausea and vomiting, respiratory depression, headaches, weakness/fatigue, dizziness, convulsions, loss of muscle coordination, blood disorders, or damage to the liver. A person may experience cyanosis, or a bluish color in their skin, due to decreased amounts of oxygen in the blood. The chemical has also been associated with cancer affecting the liver, skin, and breasts.

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In June of 2021, the medial device manufacturer Philips Respironics recalled more than 15 million CPAP machines and similar devices. This recall was performed because the devices contained a foam that could degrade, causing users to experience health risks because of the inhalation of tiny foam particles or toxic chemicals. While the recall has left many users without the treatments needed to address issues related to sleep apnea, Philips has begun making replacement CPAP devices available. However, some concerns have also been raised about the potential health risks of using the replacement machines.

FDA Asks for Testing to Determine Safety Risks of New CPAP Machines

As part of the recall, the U.S. Food and Drug Administration (FDA) has been investigating Philips’ manufacturing practices, including reviewing records and visiting the company’s facilities. During these investigations, the FDA uncovered potentially troubling information about the plans to replace the noise-abatement foam in the recalled devices.

The recalled CPAP and BiPAP machines and ventilators had used a polyester-polyurethane (PE-PUR) foam that was meant to reduce vibrations and decrease noise when patients were using the devices. The breakdown of this foam over time had put users at risk, since this led to small particles and potentially harmful chemicals entering the devices’ airways. Philips has planned to repair the recalled devices by replacing the PE-PUR foam with a different type of foam that is silicone-based.

CPAP machines provide effective treatment for people who have been diagnosed with sleep apnea. However, many of the users of these devices may have been placed at risk of injuries or illnesses. In 2021, the medical device manufacturer Philips Respironics issued a recall of millions of CPAP and BiPAP devices. This recall was performed because the devices contained a noise-dampening foam that could break down, putting users at risk of harm when they inhaled tiny particles and toxic chemicals. This recall has caused difficulty for many users who have had to decide whether to continue using potentially harmful devices or go without treatment for sleep apnea or other conditions until replacement devices are available. Many people are also troubled by recent findings that Philips may have known about the issue for years before deciding to perform a recall.

FDA Investigation Uncovers Details Showing that Philips May Have Known About Health Risks to CPAP and BiPAP Users

In response to the voluntary recall performed by Philips, the U.S. Food and Drug Administration (FDA) has been investigating the manufacturer’s facilities and records, and it has uncovered some troubling details. The FDA evaluated these records to gain a better understanding of the causes of the health risks and determine whether the correct procedures were used during the design and manufacturing process. The FDA found that at least 14 tests or assessments had been performed since 2016 that indicated that there were concerns about the degradation of the foam used in CPAP and BiPAP devices. 

Internal emails at the company also indicated that Phillips understood the problems with their devices but did not take action to correct the issue. Emails from company employees to a foam supplier dating back to 2015 implied that Phillips had been made aware of the issues with foam degradation. Emails with inspectors from 2018 also found that internal tests at the company had discovered the problem, but Philips decided not to change the design of their devices at this time.

Devices used to treat medical conditions are meant to improve people’s quality of life and help them avoid serious health issues. Unfortunately, these devices may be defective, potentially leading to injuries or illnesses. Millions of people in the United States may face this possibility because they have used CPAP machines that have been recalled due to the presence of harmful substances. Those who have used the recalled CPAP or BiPAP devices may experience multiple types of health concerns, including serious lung injuries.

Interstitial Lung Diseases That May Be Caused by Defective CPAPs

The recalled devices contained a type of foam that could break down over time, causing a person to breathe in microscopic particles and harmful chemicals. In addition to putting users at risk of different forms of chronic obstructive pulmonary disease (COPD), the devices may also cause interstitial lung disease that affects the tissue inside the lungs that support the air sacs and pathways. Interstitial lung disease may include multiple different disorders, including:

• Pulmonary sarcoidosis - Inflammation of lung tissue may cause small lumps of cells to form. These lumps are known as granulomas, and they can affect the function of the lungs, make it more difficult for a person to breathe, and lead to additional damage.

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