SoClean Lawsuit: Critical Update for CPAP Users

by | Jul 3, 2024 | Product Liability, Medical Devices

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Many people have used CPAP machines to treat sleep apnea for restful sleep and greater well-being. Among the products designed to enhance the CPAP experience, the SoClean CPAP cleaner has gained popularity as a tool to sanitize and maintain these essential devices. However, recent developments have cast a shadow over the reputation of the SoClean cleaning machine.

The SoClean lawsuits revolve around concerns related to the utilization of ozone gas in these cleaning machines and the potential health risks associated with this process.

This article explores the ins and outs of the lawsuits, allegations against Philips, FDA warnings, and the underlying issue of ozone that has ignited these lawsuits.

Ozone’s Role in CPAP Machines

Ozone, an invisible substance, carries hidden dangers making headlines in CPAP machines. Often associated with air purification and cleanliness, ozone has taken center stage due to a series of class action lawsuits filed against the popular SoClean CPAP cleaner manufacturers.

Chemically represented as O3, Ozone is a reactive gas composed of three oxygen atoms. Its high reactivity with various atmospheric components is well-known, contributing to its association with smog and environmental pollution.

While ozone at higher altitudes forms a protective layer, it can be hazardous at ground level. In an unsuspecting twist, ozone is now being spotlighted as a potential danger in a device meant to improve health – the CPAP cleaner.

The Health Risks Associated with Ozone

Ozone gas, distinguished by its three oxygen atoms, is characterized by its high reactivity. This reactivity renders it capable of harming cells and tissues. The potential health complications attributed to ozone gas encompass a range of issues, such as:

  • Respiratory Problems: Ozone gas may lead to irritation in the lungs and airways, resulting in coughing, wheezing, and shortness of breath. Its presence can also exacerbate existing respiratory conditions like asthma.
  • Headaches: Exposure to ozone gas may trigger headaches, along with nausea and dizziness.
  • Eye Irritation: Contact with ozone gas can cause irritation to the eyes, leading to symptoms such as redness, tearing, and discomfort.
  • Nervous System Damage: Ozone gas has the potential to impair the nervous system, causing coordination and balance issues.
  • Immune System Damage: The reactive nature of ozone gas can weaken the immune system, hindering the body’s ability to fight off infections.
  • Cancer Risk: Prolonged exposure to ozone gas is associated with an elevated risk of developing cancer.

Understanding the properties of ozone gas becomes important due to its potential risks. This is especially crucial in cleaning devices, where the potential for human exposure to ozone exists, underscoring the need for awareness and caution.


FDA’s Warning about Ozone

The FDA issued warnings in February 2020 about devices using ozone or UV light to clean CPAP devices, highlighting potential health risks.

Many will have this question in their mind. Is SoClean FDA approved? The FDA cautioned that these devices could actually harm patients and that their marketing was not approved. Philips, the company behind Philips Respironics CPAP devices, has raised concerns.

They’ve cautioned that using unapproved cleaning devices with ozone might break down the foam in some of their CPAP devices, thereby reducing sound insulation. This could expose patients to chemicals released from the foam.

The FDA states that ozone requires high concentrations to eliminate harmful bacteria, which can be unsafe for humans. CPAP cleaning products using ozone may leak at connections, filters, or containers, potentially leading to unsafe ozone levels in poorly ventilated rooms.

Is SoClean dangerous to use? Many users of the CPAP sanitizing machine were unaware of any ozone release from SoClean, much less at levels that seem to exceed what the FDA typically deems acceptable for medical devices.

The Connection between SoClean Cleaners and Philips Recall

In July 2021, attention on CPAP SoClean cleaners grew due to a significant recall by Philips Respironics, affecting millions of Philips DreamStation devices, including CPAP and BiPAP machines.

The recall was due to the degradation of a polyester-based polyurethane foam used for sound reduction in the devices. This deterioration released black particles or harmful chemicals into the machines’ air pathways.

Intriguingly, Philips’ remarks about the recall suggested a potential link between the problems with their CPAP devices and the utilization of “unauthorized” ozone cleaners, such as SoClean.

SoClean Recall

On November 21, 2023, the SoClean2 and SoClean3 devices that are used to clean, sterilize, and disinfect CPAP systems and accessories are being voluntarily recalled by SoClean due to complaints about incorrect setup, unauthorized device modifications, and use by people for whom the device is not advised.

According to its safety alert, SoClean has received 7,417 complaints related to its SoClean machine. 334 complaints were identified by FDA.

Soclean recalled these cleaners including:

  • SoClean2; Unique device identifier number 187293000860
  • SoClean3; Unique device identifier number 187293000860 /(01)00858242007147(21)

The FDA letter states that SoClean would issue updated user manuals and CPAP attachments as part of the recall.

False Advertising of SoClean 

SoClean’s marketing strategy played a pivotal role in the unfolding controversy. While the company promotes its cleaner as utilizing “activated oxygen” for sanitization, legal actions tell a different story.

SoClean promotes its cleaner by utilizing activated oxygen to eliminate 99.9% of microorganisms commonly found on CPAP masks, hoses, and reservoirs. Activated oxygen, boasting an additional oxygen atom, possesses heightened reactivity, enabling it to eradicate bacteria, mold, and viruses effectively.

According to SoClean’s explanation, their cleaner commences by producing activated oxygen. This process involves directing air through a chamber containing a unique catalyst, which breaks down oxygen molecules to generate activated oxygen.

Subsequently, the generated activated oxygen is directed through the CPAP equipment-containing chamber. It’s purported that this activated oxygen eradicates microorganisms on the equipment while contributing to the drying process.

Contrary to SoClean’s description, legal actions have been initiated against the company, alleging false advertising of their CPAP cleaning machines as safe and effective. The SoClean lawsuits assert that these machines emit ozone gas at harmful levels, which may lead to respiratory issues, headaches, and other health complications.

The use of terms like “activated oxygen” and other false advertising phrases concealed the associated risks of ozone gas in SoClean devices.

SoClean Class Action Lawsuit

Now, if you are a person searching for an answer to the question, is there a class action lawsuit against SoClean? The answer is yes.

In September 2021, a class action lawsuit was filed against SoClean in the U.S. District Court for the Southern District of Mississippi by Anthony Sakalarios. The lawsuit targets the SoClean 2 CPAP Sanitizing Machine, accusing the company of misleading advertising and false claims.

The SoClean 2 lawsuit refers to ozone as a “harsh chemical.” This conflicts with SoClean’s statements that their products don’t release any harsh chemicals. According to the lawsuit, this misleading information has allowed SoClean to dominate the CPAP sanitizing market.

SoClean 2 Lawsuit

In June 2022, Dale Vernon, Sr., filed a case seeking a class action lawsuit against SoClean in the U.S. District Court for the Northern District of Ohio. Vernon alleges that the company’s marketing misrepresentation led him to purchase a SoClean 2 CPAP cleaning device, believing it emitted “activated oxygen” that was safe and efficient.

The SoClean lawsuit claims that undisclosed ozone emissions and associated health risks were withheld from consumers, leading to harm and deception.

According to Vernon’s lawsuit, the SoClean devices produce ozone to sanitize and eliminate odors from CPAP machines.

However, for it to effectively act as a germicide, the concentration of ozone needs to be significantly higher than what’s considered safe for humans and animals. The SoClean lawsuit asserts that the manufacturer’s false claims have led to the deception and harm of individual consumers.

A tide of around twenty-four class action lawsuits echoes similar concerns across various courts. These lawsuits challenge the safety and efficacy of SoClean’s CPAP cleaning machines, advocating for compensation and the removal of potentially hazardous devices from the market.

SoClean Lawsuit 2023 Update

In 2022, various class action lawsuits related to the SoClean CPAP cleaning device were brought together into a new Multi-District Litigation (MDL), known as MDL No. 3021, by the Judicial Panel on Multidistrict Litigation (JPML).

The JPML assigned the case to Judge joy flower Conti in the Western District of Pennsylvania. This is the same jurisdiction currently handling the Philips CPAP MDL.

SoClean Lawsuit Update 2024

As of July 2024, there were 41 pending cases in the SoClean CPAP cleaner MDL No 3021 before the Judge Joy Flowers Conti.

How to Join SoClean Lawsuit?

Consult your doctor: If you believe you’ve been affected by the SoClean CPAP cleaner, the first step is to consult your doctor. Detail any symptoms, illnesses, or conditions related to the cleaner. This medical consultation is essential to ascertain if there’s a connection between your health issues and the cleaner’s use.

Gather medical records: Ensure that all medical findings, including symptoms, diagnoses, and treatments related to the potential effects of the cleaner, are well-documented. Your doctor can assist you in compiling these essential records.

Contact a product liability lawyer: Seek professional legal assistance specializing in medical device liability. The attorney will review your situation, assess the strength of your case, and guide you through the SoClean lawsuit.

Medical record review: Utilize a medical record review company, which offers services such as Medical Chronology, Narrative Summary, and Medical Opinion. This is an essential step to analyze and summarize the medical evidence and can help build a robust legal case.

Adhere to your attorney’s guidance throughout the legal proceedings. This may include providing testimonies, attending hearings, or engaging in settlement discussions.

To wrap things up,

The SoClean CPAP cleaner lawsuit has brought to light critical concerns surrounding the use of ozone in medical cleaning devices, particularly CPAP machine sanitization. The numerous allegations against SoClean, revolving around potential health risks, false advertising strategies, and undisclosed ozone emissions, have sparked a series of class action lawsuits that continue to unfold.

The SoClean lawsuit serves as a reminder that pursuing health innovation must always prioritize patient safety, ethical practices, and compliance with regulatory standards. Check this blog for latest updates.

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