Philips Respironics CPAP & BiPAP Recall Lawsuit

Philips is one of the world’s most prominent electrical companies, with a history stretching back to the late 19^th century. While it produced a huge number of consumer electronics, ranging from lightbulbs to coffeemakers, and still does, the company announced in February 2020 that its future lay within the arena of healthcare technology. It is a trusted brand in healthcare, making billions of dollars each year in America alone through selling healthcare technology, including its Respironics range which specializes in breathing equipment and ventilators.

But in June 2021, Philips made the decision to recall millions of breathing devices, such as sleep apnea machines and ventilators, after concerns they might cause serious health problems, including cancers and respiratory diseases. The recall includes a long list of Philips machines that have been in operation from 2009-2021. This was deemed a “Class 1” recall, which is considered the most serious type of product recall. As such, personal injury lawyers have been taking Philips lawsuit cases from anyone who has suffered injuries after using a recalled Philips device.

Philips Respironics is recalling the following devices due to issues with the polyester-based polyurethane foam (PE-PUR), sound abatement foam, used in Philips Continuous Ventilators and NonContinuous Ventilators.

1. The PE-PUR foam could degrade into small particles that can enter the device's airway and be inhaled or inhaled by users.
2. Certain chemicals may off-gas from the foam. Unapproved cleaning methods such as ozone can accelerate foam degradation. Off-gassing could occur during operation.

Following is the recalled devices:

• Trilogy 200
• Trilogy 100
• SystemOne ASV4
• SystemOne (Q-Series)
• REMstar SE Auto
• OmniLab Advanced+
• Garbin Plus, Aeris, LifeVent
• E30
• DreamStation ST, AVAPS
• DreamStation Go
• DreamStation ASV
• DreamStation
• Dorma 500
• Dorma 400
• C-Series S/T and AVAPS
• C-Series ASV
• A-Series BiPAP V30 Auto
• A-Series BiPAP Hybrid A30
• A-Series BiPAP A40
• A-Series BiPAP A30

Source: Philips

• June 1, 2023 - FDA RESPIRONICS, INC Premarket Notification
• May 1, 2023 - Philips Respironics recalls certain reworked DreamStation BiPAP and CPAP machines for the risk that they may deliver insufficient or inaccurate therapy.
• March 1, 2023 - UPDATE: Some Philips Respironics Ventilators and BiPAP Machines were Recalled due to potential health risks: FDA Safety Communication.
• February 19, 2023 - Results of Philips CPAP testing released: Philips Respironics issued a mass recall on certain models of its ventilators and sleep apnea machines in June 2021. It recently completed its first round post-recall safety testing.
• February 1, 2023 - Philips moves to dismiss CPAP lawsuits. Philips Respironics is being sued for allegedly causing economic losses through its recalled CPAP machine. Koninklijke Philips NV, its affiliates, and Philips Respironics have moved to dismiss all claims.
• January 1, 2023 - UPDATE: Some Philips Respironics Ventilators and BiPAP Machines were Recalled due to potential health risks: FDA Safety Communication
• FDA Says: Philips respirator recall reaches 260 reported deaths:
  April 1, 2021 - April 30, 2022 - 126 deaths
  May 1 - July 31, 2022 43 deaths
  August 1 - October 31, 2022 91 deaths
• October 1, 2022 - Philips to pay $1.3M in 2nd kickback settlement in month.
• September 1, 2022 - The FDA is reviewing thousands of reports of foam breaking down in recalled CPAP, BiPAP machines.
• August 24, 2022 - Philips respirator lawsuit builds as plaintiffs' lawyers outline lengthy recall delays.
• August 14, 2022 - Recall of sleep aid devices heads into a 2nd year. More than a year since Philips announced a recall of many sleep-aid devices, customers are still waiting for a new machine or repair kit.
• August 1, 2022 - Philips knew its CPAP sleep machines could cause cancers and other injuries years before the recall.
• July 1, 2022 - Robert Dix of Prairie Village says he got lung cancer from CPAP sleep apnea machine. He’s suing. Dix began using one of the now-recalled machines in 2016, according to a lawsuit filed in the U.S. District Court of Kansas.
• June 1, 2022 - Philips provides an update and voluntary recall notification safety notice for specific CPAP, BiPAP and mechanical ventilator devices.
• May 17, 2022 - Angie Miller, a Sauk County (WI) woman suffering from terminal cancer, joins a lawsuit against CPAP manufacturer Philips alleging that the machine doctors recommended may have led to cancer.
• May 1, 2022 - Philips issued voluntary recall notification safety notice for the V60 ventilator product family (V60 ventilator is a microprocessor-controlled, bilevel positive airway pressure (BiPAP).
• April 1, 2022 - The FDA has published another Philips Respironics recall: certain V60 and V60 Plus ventilators for expired adhesive that may cause ventilator to stop working with or without an alarm.
• March 20, 2022 - Philips Respironics offers an update to the U.S. regarding ongoing CPAP, BiPAP, and Mechanical Ventilator field actions.
• March 8, 2022 - FDA held a Teleconference with Philips and ordered them that due to the severe risk posed to the Recalled Products and the ineffectiveness of Philips' communications to the public about the risks, the Agency was looking at issuing a Notification Order to Philips under Section 518(a).
• March 1, 2022 - MDL No. 3014 - Philips Recalled CPAP, BPAP, and Mechanical Ventilator Products Liability Litigation.
• February 1, 2022 - FDA Recall Update of Certain Trilogy Evo Ventilators - On January 26, 2022, the FDA provided an update related to the recall of certain Philips Respironics ventilators.
• January 1, 2022 - A Food and Drug Administration (FDA) investigation alleges that maker of Philips Respironics knew of problems for years, but did not act.
• December 2, 2021 - SoClean Lawsuit: A recent inspection by the Food and Drug Administration (FDA) revealed that Philips has known for years that the company’s products created a serious risk of harm to consumers. (Source: U.S. District Court District of Massachusetts)
• December 1, 2021 - The FDA provided an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, CPAP and BiPAP machines.
• November 12, 2021 - The U.S. Food and Drug Administration provides update on recall of certain Philips Respironics breathing assistance machines.
• November 5, 2021 - Philips sasked users to stop use of BPAP & CPAP sleep apnea devices. Philips issued a recall notification for the U.S. for specific affected ventilation and sleep apnea devices.
• November 2, 2021 - Joy Flowers (U.S. District Judge, Western District of Pennsylvania) Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation
• October 13, 2021 - Flawed product design & poor choice of materials for sound abatement in Philips' CPAP machines led to product recall
• September 30, 2021 - District Court for the Eastern District of Pennsylvania hearing - Philips Recalled CPAP, BiPAP & Mechanical Ventilator Products Liability Litigation
• September 10, 2021 - The FDA has taken more actions related to the Philips Respironics ventilators, BiPAP & CPAP recall

CPAP Lawsuit is not really a scam but it is a defective product that was manufactured by Philips Respironics. The FDA classified the Philips CPAP recall as a class 1 recall. The recalled product could cause serious injury and even death. The foam could degrade and release toxic gases into the lungs that can be inhaled or swallowed by users.

Source: ASA

Philips has sold millions of CPAP (Continuous Positive Airways Pressure) machines across the world in recent years, but around two-thirds of all sales are in the United States. CPAP machines are often used to treat sleep apnea (a relatively common disorder where someone’s breathing repeatedly stops and starts during sleep). Around 80% of the recalled Philips machines were CPAP devices, mostly from Philips’ DreamStation line.

Another type of breathing device manufactured by Philips is the BiPAP (Bi-Level Positive Airway Pressure) machine. These are commonly used for people with severe breathing difficulties – they were, in fact, discussed as potentially useful for treating patients with Covid-19. They are similar to CPAP machines, although there is a difference in the way that the machines pump air in and out of the lungs. In effect, both these machines are types of ventilators. Other Philips ventilator devices have also been recalled.

So, what is wrong with Philips breathing machines? And why might millions of Americans pursue compensation after using these devices? Philips found that the recalled CPAP, BiPAP devices and ventilators had an issue with a special type of foam – polyester-based polyurethane (PE-PUR) sound abatement foam. This foam is used to lessen the sound and vibrations of the machines, but Philips found that this foam may break down when the machines are in use. The breaking down of the foam may release dangerous particles when ingested, and some of these particles may be carcinogenic (cause cancer).

The FDA has urged anyone who uses Philips BiPAP or CPAP devices to speak to their healthcare providers for advice on their continued treatment. In addition, the FDA gave the following stark warning over the breakdown of PE-PUR foam: “These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.”.

While Philips has been producing ventilator machines for years, the news of the recall broke in June 2021. It is, therefore, early days in terms of the lawsuit against Philips. However, people who believe they have suffered health problems due to these devices are being urged to join the Philips ventilator lawsuits.

One of the most worrying elements of the Philips breathing machine case is the potential carcinogenic properties of the particles and gases released by broken down foam. That is one of the reasons the recall of millions of machines was deemed a Class 1 recall. In its own analysis, Philips found that the degraded foam could contain harmful chemicals like toluene diamine and toluene diisocyanate, both of which have had studies linking them to cancer.

Clearly, as the Philips devices are used to help with breathing and the risk has been cited when ingesting toxic foam particles, there is a concern over lung cancer. But there are also other health risks linked to Philips’ devices. This includes other types of cancer, respiratory problems, heart issues, liver disease and many other serious health problems. If you are experiencing any signs of serious health problems linked to Philips CPAP devices, you should contact your healthcare provider right away.

Various symptoms have been cited as having a possible link to faulty Philips breathing devices. These include, but are not limited to, the following:

• Irritation of the skin, eyes and respiratory tract (nose, mouth, throat, lungs, airways)
• Inflammation of airways and respiratory system
• Coughing and breathing difficulties, asthma
• Headaches
• Pressure on the chest and lungs
• Infection of sinuses and other airways
• Damage to vital organs like kidneys and liver
• Carcinogenic effects linked to cancers

In June 2021, Philips recalled millions of CPAP and BiPAP devices, which has been deemed a “nightmare” by those suffering from sleep apnea across America. Philips has suggested it might take up to a year to fix the problems with the machines, and that has left many Americans struggling to find replacement devices to help with their breathing issues. However, perhaps more worryingly, there is the looming cloud of what permanent damage these machines have potentially caused. Philips cited two main issues: “PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user,” and “the PE-PUR foam may off-gas certain chemicals.”.

In the simplest terms: Philips discovered foam in its ventilators was breaking down, causing the release of potentially deadly particles, chemical gases and (black) debris. These may have been ingested by millions of users of these devices, not just in America but across the world.

One of the products recalled by Philips was the E30 ventilator with a humidifier. The device, which was designed to help those who could not get access to a fully featured critical care ventilator. The E30, which is now on the FDA’s list of recalled respiratory devices, was originally something of a PR triumph for Philips as the company ramped up production of the E30 to help with the fight against Covid-19. Both healthcare workers and Covid patients suffering from breathing difficulties could use the E30, Philips said. Now the E30 joins a long list of recalled Philips breathing devices.

The Philips CPAP foam lawsuit is gathering pace, and law firms are asking people to come forward if they believe they have injuries or illnesses linked to Philips machines. Already, according to the FDA, there have been over 1200 complaints and 100 injuries linked to the issue. But there is a sense that this might be only the tip of the iceberg, particularly if Philips breathing machines are proven to cause serious long-term health problems, including cancers.

Across America, specialist injury law firms are providing dedicated Philips breathing device lawyers to pursue compensation for people who suffered injury or illness after using the devices. Research into what damage the devices may have caused users of Philips ventilators is still ongoing, including by Philips’ own laboratories.

Just weeks after the announcement of Philips CPAP and BiPAP recall, the company was hit with a consumer class-action lawsuit in Massachusetts and others in Pennsylvania, California and Georgia soon after. In addition, there have been dozens of lawsuits filed by individuals pursuing personal injury claims.

It is worth stressing that the Philips CPAP and BiPAP legal cases are in the very early stages, and it is not abundantly clear which structure they will take as more people file lawsuits.

For example, class-action lawsuits are usually filed on behalf of claimants with similar grievances against a company or individual. So, as is the case already with Philips class-actions, consumers might pursue a class-action lawsuit after incurring financial loss, being left out of pocket with expenses due to replacing the faulty Philips ventilators while the company makes repairs.

But if it is proven that Philips breathing devices cause cancer and other serious health problems, then it is not altogether likely they would be a class-action lawsuit. Why? Due to the fact that the injuries and health problems would not be similar to the group as a whole but rather be unique to each claimant. Someone who is suffering from terminal cancer due to a breathing device will have a different case – and expect a different level of financial compensation – compared to someone who had suffered from a short-term breathing problem due to a Philips ventilator.

As such, and particularly if many people come forward with an illness linked to Philips CPAP and BiPAP breathing machines, these might be consolidated into a mass tort lawsuit. This differs from a class action as each claimant’s case is treated as its own separate case. Some of the legal proceedings may be amalgamated in the courts to streamline the process, but each claimant’s case would be judged separately in its outcomes, including compensation.

News about the Philips lawsuits is still rolling in as the company faces a raft of legal cases all across the United States. In August 2021, the New York Times reported that around 40 lawsuits in 20 states had been filed against Philips relating to the CPAP and BiPAP issues.

At the moment, much of the news about the Philips ventilator recalls is dealing with the panic around access to CPAP and BiPAP machines. NBC Miami reported in late August 2021 on how the absence of replacement machines has caused severe consternation among sufferers of sleep apnea.

Also in August, one of Philips rivals for the production of CPAP and BiPAP devices, ResMed, says that the Philips recall may add up to $350 million in revenue through sales of its own devices. ResMed is struggling to meet the demand for ventilators as the need for new devices has surged.

There has not yet been a conclusion of any Philips lawsuit linked to defective ventilators. Moreover, as mentioned, we are still at the earliest stages of the legal process against Philips. At this stage, Philips ventilator attorneys are calling for people with illness or injury linked to the devices to come forward to initiate proceedings against the company.

It is possible that Philips decides to settle the case out of court rather than face years in the court battling claims from those who have suffered damage from the ventilators. It is speculative to estimate how much that financial settlement could be worth, but some will point to the $26 billion paid by Big Pharma companies to settle the infamous opioid cases as evidence that these settlement sums can reach astronomical heights. Much will depend on what Philips knew about the potential defective ventilators and when the company knew it.

There is still much to learn about what damage has been caused to people by the use of Philips CPAP & BiPAP ventilator devices. For some, the worry might be that the latency period (the time that passes between being exposed to something and having symptoms) might be years, as can be the case with asbestos exposure. But again, we simply do not have those facts in the Philips case yet.

Nevertheless, Philips lawsuit lawyers are asking people to come forward if they have any one of a long list of injuries and illnesses potentially caused by Philips devices. These include – but are certainly not limited to – the following:

• Severe inflammation of the throat, nose or ears
• Water on the lungs (pleural effusion)
• Cancers including lung cancer, brain cancer, lymphatic cancer (Non-Hodgkin Lymphoma), liver cancer, rectal cancer, nasal cancer, breast cancer, stomach cancer, kidney cancer, thyroid cancer (papillary carcinoma), hematopoietic cancer, prostate cancer, leukemia, bladder cancer, testicular cancer, bone marrow cancer (multiple myeloma)
• Diseases of the liver, lungs, kidneys
• Heart issues, including heart attack and heart failure
• Respiratory problems, including Acute Respiratory Distress Syndrome (ARDS)
• Reactive Airway Disease
• Chemical Poisoning

Is there a lawsuit against Philips?

Yes. Many lawsuits have been filed across the United States against Philips after the recall of its ventilator devices in June 2021. These range from class-action lawsuits over the lack of replacement ventilators to individual personal injury cases claiming that Philips ventilators cause severe health problems.

What model Philips CPAP machines are being recalled?

The following models (all serial numbers) of CPAP/BiPAP machines are on the FDA’s list of recalled ventilators:

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

What kind of cancer does the Philips CPAP cause?

It is not known yet whether the breakdown of foam in Philips ventilators causes cancers, but studies are ongoing to see whether they do. However, the FDA has issued a warning over the health risks linked to Philips breathing devices, and that includes possible links to different types of cancers.

What do I do if my Philips CPAP has been recalled?

Philips has promised to replace the foam in the recalled devices with a silicon alternative. The company has said this could up to a year. Many people who have been without CPAP and BiPAP machines have joined class-action lawsuits against the company as suitable replacements have not been found.

Should I stop using my Philips CPAP machine?

Consult your healthcare provider so that you can make an informed decision on whether to stop using the Philips CPAP machine.

Can CPAP cause lung damage?

At the moment, there is only a potential link between Philips CPAP machines and serious illnesses like lung damage. CPAP machines are not in and of themselves dangerous. Rather it’s the breakup of the foam used to soundproof the devices (see below). Philips has vowed to replace the foam in all of its CPAP and BiPAP ventilator machines.

Why Is PE-PUR Foam Dangerous?

PE-PUR Foam is dangerous when the fibers of the material begin to break down. These can create particles and toxic gases that may be ingested by the user of the ventilator. Studies are ongoing as to what damage the particles can cause, but the worry is that it may lead to serious diseases, including various cancers.