SoClean Lawsuit and Recalled Philips DreamStation CPAP Machines

By Austin Kirk
Posted December 15, 2021

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UPDATE 03/22/2024: Philips and Plaintiffs’ Co-Lead Counsel have jointly requested a pretrial order setting forth the procedures for Philips to file a Master Third-Party Complaint against SoClean, Inc. If approved, the move could add SoClean as a defendant in thousands of Philips CPAP injury and wrongful death lawsuits being filed over exposure to the deteriorating toxic foam. Read More

UPDATE 01/5/2024: This post has been updated to add information regarding a 2024 counterclaim filed by Philips, which raises allegations that SoClean manufacturers knew the ozone cleaners could cause the sound abatement foam in Philips CPAP and BiPAP machines to degrade.

Following the recent Philips CPAP recall, SoClean lawsuits and class action claims are now being filed against the makers of the popular ozone CPAP cleaner, which was marketed as a safe and effective way to sanitize sleep apnea machines.

These SoClean machine lawsuits allege that false and misleading information has been provided about the high levels of ozone gas released by the CPAP cleaner, which was commonly referred to as “activated oxygen” in marketing material.

How is the SoClean Lawsuit related to the CPAP recall lawsuit?

Allegations raised in the SoClean lawsuit often cause confusion for some owners of recalled Philips DreamStation CPAP machines, which contain a polyester-based polyurethane (PE-PUR) sound abatement foam that has been found to breakdown and release toxic particles directly into the user’s air pathways.

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Since the recall, Philips Respironics has made several statements that suggested the use of ozone cleaning systems may exacerbate the CPAP foam breakdown, leading to questions about whether SoClean is responsible for the Philips DreamStation recall.

The lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are now pursuing a Philips CPAP lawsuit, alleging that they developed serious injuries after breathing the toxic particles or chemicals released by the sound abatement foam, including:

• Cancer, Leukemia, Lymphoma or other Tumors
• Sarcoidosis
• Pulmonary Fibrosis
• Interstitial Lung Disease (ILD)
• Auto-Immune Disorders
• Pneumonia, Bronchitis, Asthma or Pneumoconiosis
• Acute Kidney or Liver Injury
• Wrongful Death

Although allegations presented in the SoClean lawsuit raises serious questions about the safety of ozone CPAP sanitizing devices,  there has not been a SoClean recall and ultimate responsibility for the DreamStation CPAP machine recall still rests squarely on Philips Respironics for selling a defectively designed and unreasonably dangerous breathing product.

SoClean Recall Lawsuit Over Ozone CPAP Cleaner

About two dozen SoClean class action lawsuits have been filed in courts nationwide, each raising similar allegations about problems with SoClean 2 CPAP sanitizing machines. The SoClean lawsuits allege that the CPAP cleaner is unreasonably dangerous and should be removed from the market, seeking damages for all consumers who paid premium prices for SoClean machines that release dangerous levels of ozone gas.

The SoClean recall lawsuits first began to emerge after the FDA issued warnings about the use of ozone gas and ultraviolet (UV) light to clean CPAP machines in February 2020. At that time, the FDA indicated that the agency has not authorized any ozone gas CPAP cleaners, and is continuing to monitor adverse events associated with the devices. This led to immediate questions about whether the FDA would require a SoClean 2 recall.

The concerns over CPAP SoClean cleaners began to increase in July 2021, after Philips Respironics issued a massive CPAP and BiPAP machine recall. Millions of Philips DreamStation machines were recalled that contain a polyester-based polyurethane sound abatement foam, which has been found to degrade and break down, releasing black particles or toxic chemicals directly into the machine’s air pathway.

Following the DreamStation recall, Philips made several statements that seemed to blame the CPAP machine problems on SoClean, indicating that the foam degradation may be caused by use of “unauthorized” ozone cleaners. However, while the SoClean may contribute to the rate at which the foam degrades, so do various environmental factors, such as high humidity or temperatures.

It increasingly appears that these statements were just an attempt to shift focus from their defectively designed CPAP machines, which are even unsafe for individuals who never used a SoClean sanitizing device.

What is wrong with SoClean?

According to allegations raised in SoClean machine lawsuits, the use of unsafe and unacceptably high levels of ozone to sanitize CPAP devices is the root cause of what is wrong with SoClean.

To effectively destroy harmful material, the SoClean 2 machine pumps ozone throughout the inside of the sleep apnea device for seven to 14 minutes, indicating that it “kills up to 99.9% of germs and bacteria that can build up in CPAP and BiPAP equipment without having to disassemble the devices.”

SoClean sends ozone through the supply tube and into the humidifier reservoir, cleaning the water and inner walls of the reservoir. The SoClean ozone then moves through the CPAP hose and tubing. After the SoClean sanitizing process, the manufacturer claims that the ozone gas is supposed to exit the chamber through a special filter that converts the dangerous “activated oxygen” back into common and benign oxygen. However, it appears that may be false and misleading information.

To sanitize CPAP machines, ozone from SoClean must be present at levels above those considered safe for humans, and it appears that the manufacturer failed to disclose this problem. In fact, many users of the CPAP sanitizing machine were unaware that SoClean released any ozone at all, let alone levels that appear to exceed levels the FDA usually considers acceptable for medical devices.

The lawsuits accuse SoClean, Inc. of making defective devices and fraudulently concealing the fact that their devices may emit toxic levels of ozone, by using marketing terms like “activated oxygen” and other deceptive statements that hid the risks associated with ozone in SoClean.

Is the Ozone in SoClean safe?

The same properties that make ozone in SoClean effective at cleaning CPAP machines also make it potentially unsafe and dangerous for humans.

Ozone gas has long been an accepted means of sanitizing medical devices, releasing one of the oxygen molecules that then attaches to other molecules, causing oxidation and the breakdown of harmful material.  However, it is rare to see ozone cleaners sold for consumer use in the home.

As a result of the health risks from ozone cleaners, the FDA regulations make it illegal for any medical device to generate or cause the accumulation of ozone in levels exceeding .05 parts per million by volume of air “in the atmosphere of an enclosed space intended to be occupied by people for extended periods of time,” such as houses, apartments or even hospitals.

SoClean class action lawsuit allegations indicate that the CPAP sanitizing devices generate ozone at levels of about 30 parts per million, by volume of air circulating through the device during a cleaning cycle. This could make SoClean ozone unsafe when used in minimally ventilated spaces, such as a small bathroom. Also, some reports suggest that elevated levels of ozone are commonly found inside CPAP tubing, even after waiting the recommended time after cleaning with products that do not perform an automatic clean air purge toward the end of the ozone cleaning cycle.

Is the SoClean ozone bad for your lungs?

Ozone gas used by SoClean CPAP devices is known to be toxic to humans at high levels, posing serious risks for your lungs after prolonged exposure or high concentrations. While the ozone CPAP cleaners are marketed as “safe”, SoClean lawsuit allegations indicate that false and misleading information has been provided about whether ozone in SoClean is bad for your lungs.

There are several known human health risks associated with exposure to high levels of ozone, which is the primary ingredient in “smog”, along with particulate matter. As a result, many cities monitor ozone levels regularly and sometimes announce “ozone alerts” or “ozone action days”, when ozone levels exceed what is considered safe.

If excessive levels are generated or build up in a confined space, ozone inhalation could cause muscles in the airways to constrict and result in lung inflammation or damage. Even at low levels, SoClean ozone exposure can cause reduced lung function, potentially resulting in a number of health problems, including:

• Coughing
• Eye, Nose and Throat Irritation
• Shortness of Breath
• Susceptibility to Respiratory Infections
• Worsening Asthma Symptoms
• Worsening Heart Disease
• Pulmonary Edema

SoClean maintains that the ozone used to clean the CPAP machine is “sealed” and does not escape the device. In addition, SoClean filters are supposed to convert the ozone into “regular oxygen”. However, SoClean lawsuits allege that the ozone cleaners are only suitable for commercial sanitization under highly controlled conditions.

Did the FDA issue a SoClean Recall?

No. The FDA did not issue a SoClean recall. As of early 2022, the FDA is continuing to work with SoClean and manufacturers to review testing data and determine whether it is appropriate to allow the continued use of ozone CPAP cleaners.

In February 2020, the FDA issued a safety communication warning about ozone CPAP cleaner problems generally, after the agency had received reports of users experiencing respiratory complications from products like SoClean.

The agency raised serious concerns that ozone gas may leak at the tubing connections, filters or through fabric containers used to house CPAP accessories, which could cause a temporary rise in ozone levels.

The FDA also expressed concerns that ozone gas concentrations within the CPAP machine and tubing may remain above safe levels, even after the recommended waiting periods following use of an ozone sanitizing system. If the CPAP machine is used without first allowing fresh air to circulate through the entire CPAP machine to remove any remaining ozone gas, the FDA warned that this may cause lung, nasal or other irritation, as well as worsen chronic respiratory diseases, such as asthma.

While these ozone CPAP cleaner warnings have led many to believe that there was a SoClean 2 machine recall, that has not happened. The FDA pointed out in the statement that it has not specifically evaluated the safety or effectiveness of any products using ozone gas or ultraviolet (UV) light to clean, disinfect or sanitize CPAP machines, as SoClean devices did not require pre-market approval.

The FDA has urged consumers to report information about any injury caused by SoClean or another CPAP cleaner, to help the agency identify and better understand risks associated with the products.

In February 2020, the agency indicated that it would update consumers and medical professionals with any new information or recommendations regarding a potential ozone CPAP cleaner recall.

As of March 2022, a SoClean recall has not been issued and no further updates have been released.

Philips DreamStation CPAP Recall and SoClean

On June 14, 2021, Philips recalled DreamStation, CPAP, BiPAP and mechanical ventilators sold since 2009 with a PE-PUR sound abatement foam, which is now known to degrade and release toxic particles or chemicals directly into the users lungs and airways.

In several statements made around the time of the recall, Philips Respironics and it’s CEO suggested a connection between SoClean and the Philips Dreamstation recall. As one example, the first paragraph of a Philips Respironics recall letter (PDF) sent to all patients indicated:

”The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation.”

Is SoClean responsible for Philips Recall?

No, the Philips CPAP recall can not be blamed on SoClean machines alone, and the real reason Philips recalled DreamStation CPAP/BiPAP devices was due to a defective and unreasonably dangerous design, including:

• Use of polyester-based polyurethane foam material that is known to break down and release toxic chemicals, even though safer alternative materials for sound abatement existed for years before the recall;
• Decision to place the PE-PUR foam directly in the CPAP machine’s air pathways, where particles and gasses would immediately flow into the mouth and lungs of users;
• Failure to recall Philips DreamStation and other CPAP machines for years after learning that the foam was degrading and posing a direct health risk for consumers.

While the use of SoClean or other ozone cleaners may impact the rate at which the Philips CPAP foam degrades, so do other factors, including high heat or humidity. In fact, the PE-PUR foam has been found to release harmful chemicals and gasses right out of the box, and problems have been reported by individuals who never owned or used SoClean with their Philips DreamStation CPAP machine.

In November 2021, the FDA issued a scathing inspection report (PDF), which found that Philips knew about the sound abatement foam problems as early as 2015, but undertook no serious investigation or mitigation efforts. Rather than warning about the problems or issuing a recall, Philips Respironics continued to sell millions of DreamStation 1 CPAP machines.

Why did SoClean sue Philips?

On October 12, 2021, a SoClean lawsuit was filed against Philips Respironics, alleging that the CPAP manufacturer was trying to use SoClean devices as a scapegoat for possible health problems caused by Philips’ use of PE-PUR sound abatement foam.

According to the complaint (PDF), false and misleading statements have caused widespread confusion, leading to the belief that SoClean was the reason for the Philips recall:

The issues that led to the [CPAP] recall were directly associated with Philips’ flawed product design, including Philips poor choice of materials for sound abatement, not the use of ozone cleaners to sanitize and disinfect the devices. Degradation of Philips polyester-based polyurethane foam occurs by hydrolysis, a chemical reaction involving water, without any exposure to ozone. Also, the off-gassing of harmful chemicals by the polyester-based polyurethane foam is wholly unrelated to ozone exposure. If anything, the use of ozone cleaners would help mitigate the off-gassing of harmful chemicals and effectively destroy them through chemical reactions.

SoClean sued Philips over lost sales and the impact these statements had on its brand reputation, indicating that Philips has caused damage to SoClean in excess of $200 million.

Philips Counterclaim Against SoClean Manufacturers

On January 5, 2024, Philips filed a counterclaim (PDF) against SoClean and DW Management Services LLC. in the U.S. District Court for the Western District of Pennsylvania, raising allegations that SoClean was aware that its ozone cleaning devices were not compatible with Philips CPAP and BiPAP machines.

According to Philips, the cleaners use a “toxic gas” that could potentially “eat away” at the PE-PUR sound abatement foam, causing it to deteriorate. Philips’ states that SoClean knew that its ozone cleaners could cause damage to Philips’ CPAP devices since at least 2015, yet continued to market them as safe and compatible.

As a result, Philips claims that it has experienced significant damage to its reputation and financial losses, and is requesting a court order to stop the companies from continuing their alleged false advertising, trademark infringement, and deceptive business practices. Additionally, Philips is seeking compensation for the damages it claims to have sustained.

Philips Seeks to Share Liability in CPAP Injury Claims

Since the initial Philips CPAP and BiPAP recall, Philips has consistently argued that the primary cause of the sound abatement foam’s degradation was the use of SoClean’s unapproved ozone-based cleaning products. Despite this stance, the majority of injury claims have been directed at Philips.

In an effort to jointly hold SoClean responsible for Philips CPAP injury claims, Philips and the plaintiffs’ lead attorneys submitted a joint motion (PDF) to Judge Conti on March 15, 2024, proposing a procedural order for Philips to file a Master Third-Party Complaint against SoClean, Inc. and one of its investors, DW Management Services.

Approval of this Master Third-Party Complaint would enable Philips to formally involve SoClean as a co-defendant across numerous CPAP injury lawsuits consolidated within the Multidistrict Litigation (MDL).

Does Using SoClean void a CPAP warranty?

Philips has issued a statement in the past indicating that the use of a SoClean device does not necessarily void the warranty on one of their CPAP machines. However, the company indicates it reserves the right to void the warranty if the use of SoClean causes a defect that leads to the return of a CPAP device still under warranty.

Regardless of whether the manufacturer attempts to argue that SoClean voided a DreamStation warranty, use of the ozone cleaning product will not allow the company to escape liability for selling a dangerous CPAP machine with defective sound abatement foam that has left users with permanent lung damage, cancer and other injuries.

Individuals who suffered an injury after using a Philips CPAP machine and SoClean sanitizing device still have important legal rights.

Will SoClean lawsuits impact Philips CPAP recall claims?

The Philips DreamStation lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing lawsuits over long-term injuries and side effects from the CPAP sound abatement foam, including:

• Cancer
• Kidney Disease
• Liver Disease
• Heart Attack
• Heart Failure
• Stroke
• Respiratory Failure
• Pulmonary Fibrosis
• Auto-Immune Disorders
• Pneumonia
• Chronic Bronchitis
• Chronic Asthma
• Sarcoidosis
• Pneumoconiosis
• Hypersensitivity
• Wrongful Death

If you or a loved one used SoClean on a recalled Philips DreamStation, CPAP or BiPAP machine, settlement benefits and financial compensation may still be available.

Our lawyers maintain that the reasonable and foreseeable use of a SoClean ozone cleaner with a Philips CPAP does not negatively impact your ability to pursue a claim.

Contact our firm to request a free case evaluation. All cases are reviewed by our attorneys on a contingency fee basis, which means that there are never any fees or expenses unless a Philips CPAP or SoClean lawsuit settlement is obtained.

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