SoClean was charged with several lawsuits with the accusation of falsely representing the efficacy and safety of the devices it produces for continuous positive airway pressure (CPAP) machines.
Mississippi attorneys are representing former and current Mississippi residents that have been affected by the SoClean CPAP disinfecting machines.
According to the claim, SoClean failed to inform the customers about the potential damages and dangers stemming from the devices that significantly use ozone to clean CPAP machines.
If your loved ones or you have suffered from pulmonary edema or symptoms of exposure to ozone such as irritation on the lungs, severe side effects on the central nervous system, affected vision, disturbing cardiovascular problems, irritation to the mucous membrane, and any other side effects, you may be entitled to the monetary compensation.
SoClean lawsuit and Consumer protection litigation
According to the FDA’s recommendation, the acceptable level of ozone rule suggests that the devices based on ozone-gas are only allowed to generate 0.05 parts per million volume of ozone for the air circulating a device.
According to the complaint in the SoClean lawsuit, the devices are generating 560 times higher than the number of ozone levels set by the Food and Drug Administration. In addition to that, the CPAP devices were allegedly producing ozone for 8-14 minutes in one standard cycle of cleaning.
According to the FDA’s set rules, if SoClean devices have not informed the customers and failed to mention the ozone generation on its devices, then it would become a violation of the rules and terms set by the FDA for cleaning devices.
FDA indicates in its regulations the maximum limit of generating ozone for medical devices. The rules also prohibit devices from releasing ozone gas in the atmosphere until it is under the ozone concentration acceptable limit. They also state that the manufacturers of the ozone generating devices should indicate the concentration and usage properly on the device labels.
SoClean lawsuit in terms of regulations
Following the regulations, SoClean is accused of failing to comply with the regulations and for misrepresenting the information about its devices that they are sealed properly which prevents the evasion of ‘activated oxygen’.
The SoClean lawsuit also depicts the false purporting of its products that they use ‘no water or chemicals’ and ‘no harsh chemicals in order to sterilize the CPAP machines.
SoClean advertised these claims profusely although they knew that ozone gas can be dangerously harsh to the environment and can potentially initiate and elevate the respiratory problems in the individuals around.
Accusations and allegations in a filed SoClean lawsuit
SoClean cleaning devices manufacturers claimed that these devices are appropriate to use on equipment used for breathing like CPAP machines. CPAP machines are the ones used by patients suffering from snoring and sleep apnea problems.
The SoClean lawsuit 2021, comes into question just after a year when the SoClean settled another lawsuit with an Australian distributor on similar claims.
According to the latest lawsuit, the SoClean Company is accused of failing to comply with the FDA’s rules and regulations. Plus, the lawsuit accuses the company of falsely advertising its CPAP sanitizing machines launched earlier and after.
Additionally, the company has been making the wrong claims about the safety of its cleaning devices for years. The company’s advertisement showed that their devices use ‘activated oxygen’ to disinfect and sterilize the CPAP machines.
On the contrary, the mechanical devices used and generated ozone gas to clean the CPAP machines are not performing according to the standards. The SoClean lawsuit says that the advertisement from the company showed the opposite while encouraging the safe use of the devices, neglecting and avoiding to disclose the fact. Where Federal law obligated companies to meet the set standards of manufacturing devices.
The lawsuit also states that despite knowing the company marketed the products under healthy and safe tags, they were generating toxic levels of ozone gas which was beyond the levels designated by Federal regulatory laws.
Adverse effects due to the SoClean’s falsification
The misrepresentation and wrong claims from the SoClean Company about its cleaning products misled the individuals over these years. They had to believe that the devices use only activated oxygen which is safe for their breathing equipment which intentionally increased the risks of their health.
The allegations further proceed with the claim that this misrepresentation of SoClean’s devices must have contributed to the business’s success. This was the strong marketing campaign that made it possible for SoClean to command over 90% of the cleaning device market.
The lawsuit argues that if the company maintained the procedures of informing customers about the potential health effects, then it may not have had the success it has. Just because of the products that SoClean produces, the customers are having breathing and respiratory issues.
If they previously knew that the products, they are purchasing from a well-known brand are the reason for their adverse health issues then they would substantially not have bought the risky devices in the first place.
The negative effects of the alleged SoClean cleaning products affected its customers as they were largely affected negatively by the devices instead of helping them in breathing.
The lingering ozone dangers
Ozone (O3) has been established as a toxic and unstable gas. It’ has a ‘clean’ scent that is named due to its pungent odor. Its characteristics are also described with the smell of burning metallic wire or chlorine. Besides being significantly toxic, ozone gas is used to disinfect and clean objects.
According to science, ozone is an excellent fumigation and sanitation agent, however, it should be used only for commercial purposes and in an extremely controlled environment. Not only does ozone kill harmful bacteria and germs but also prevents yeast and mold from forming in sanitized places and surfaces. But there may be a concentrated amount of ozone gas that would be required to have long-term effects.
As stated by FDA, “in tests conducted to study the bactericidal properties of ozone, test animals have died before the bacteria were destroyed.”
This means that the amount needed to kill bacteria can potentially affect human and animal health to some extent. The effects of concentrated ozone gas can have potential health risks that can entail from mild to severe symptoms depending on how much you have been exposed to it.
The health effects on living beings can include;
- Chest pain
- Decreased lung function
- Shortness of breath
- Aggravated Asthma
- Throat coughing and irritation
- Lung tissues inflammation
- An increased risk of respiratory infection
According to the FDA, they received around 10 reports between 2017 and 2019 from the users of CPAP machines, stating that they are experiencing worsening respiratory issues, the patients get short of breath, and experience headaches. These reports were all submitted by the users of the CPAP machines. The complaint stated that they use the ozone-based gas machines for sanitizing, cleaning their accessories, and devices used for breathing.
The FDA took notice of the reports and found out that the devices that use ozone gas for cleaning can be leaked. With this, ozone gas can potentially escape into the air which causes health issues. FDA also noted that the threat of leaking ozone gas increased when there are tubes and filters attached to the gas containers which are used to store the CPAP devices.
If these containers are stored in a room with a shorter area like stores that are not properly ventilated, the leaked ozone gas can reach dangerous levels that can cause adverse health effects.
Furthermore, the FDA has also issued warnings regarding the use of CPAP machines that are cleaned under containers filled with ozone gas. They stated that if they are used immediately after cleaning there may still be the ozone gas residues if they are not properly circulated in the fresh air.
These are some of the dangers that are pointed out in the SoClean lawsuit. SoClean misrepresented that the devices are safe to use near individuals that in several situations are already surviving with breathing and respiratory problems.
The products were formally misrepresented, advertised, and encouraged the individuals to use easily near the bedside tables, halls, bathroom counters, and everywhere in the house where the pathways and exposures are possible.
Updates about the SoClean Lawsuit 2022
The multidistrict judicial panel has scheduled a hearing later the following month to hear the claims of the consolidated lawsuit against the SoClean cleaning devices manufacturers in a new MDL.
According to the latest news, there are eleven pending lawsuits against the SoClean CPAP cleaning devices. These class-action lawsuits are accommodating thousands and hundreds of plaintiffs in a single lawsuit filing.
However, SoClean is not opposing or denying the claims and consolidations but requesting the astern District to select a venue for the MDL.
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