In June 2021, Philips Respironics issued a recall after revealing that several of its Sleep & Respiratory Care CPAP and BiPAP sleep apnea machines and ventilators had a defect that exposed users to toxic particles and gasses posing serious health risks to users. According to the company, a type of foam used in the devices could break down into particles and off-gas potentially carcinogenic chemicals into the device’s air pathway that the user can inhale or swallow. The FDA identified the Philips CPAP machines recall as a Class 1, the agency’s most serious type of recall.
Beasley Allen is investigating cases related to the Philips CPAP machines recall. Individuals who used certain Philips Respironics CPAP and BiPAP sleep apnea machines and ventilators and developed asthma, chronic respiratory illness, lung cancer, kidney disease, or kidney cancer may be eligible to file a Philips CPAP Recall Lawsuit.
Philips CPAP Machines Recall
On April 26, 2021, Philips disclosed for the first time that it had received several consumer complaints about the presence of black debris within the device’s air pathway, as well as reports of headache, upper airway irritation, cough, chest pressure, and sinus infection in users of the devices. Those reports led to the discovery that the PE-PUR “sound abatement” foam Philips used to minimize noise in several CPAP and BiLevel PAP (BiPAP) respirators posed serious health risks to users.
Seven weeks later, on June 14, 2021, Philips issued a recall for millions of its CPAP and BiPAP machines, as well as a number of its ventilator devices manufactured between 2009 and April 26, 2021. The recall was due to the potential health risks associated with exposure to the degraded sound abatement foam particles and chemical emissions.
According to the FDA recall notice, the potential risks of particulate exposure include
- irritation to the skin, eye, and respiratory tract
- Inflammatory response
- Toxic or carcinogenic effects to organs, such as the kidneys and liver.
The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include
- Irritation in the eyes, nose, respiratory tract, and skin
- Toxic and carcinogenic effects
The FDA is currently analyzing medical device reports involving affected devices from 2009 to 2021 for issues that may be related to this defect.
Devices Affected by the Philips CPAP Machines Recall
Beasley Allen product liability attorneys are currently investigating Philips CPAP Recall Lawsuit in situations involving the use of one of the following Philips Respironics recalled CPAP or BiPAP devices for one year or more used for the treatment of obstructive sleep apnea:
- Dreamstation (1st Generation Product Family)
- OmniLab Advanced Plus
- Dorma 400
- Dorma 500
- REMStar SE Auto
As well as the use of one of the following Philips Respironics recalled ventilators for one year or more used for the treatment of one or more respiratory conditions:
- Trilogy 100
- Trilogy 200
- Garbin Plus
What are CPAP, BiPAP, and Ventilators Used For?
CPAP, BiPAP, and ventilator machines are medical devices designed to help patients with breathing disorders.
CPAP (continuous airway pressure) machines are most often used to treat obstructive sleep apnea (OSA), a condition in which breathing temporarily stops while a person is sleeping because the tissues in the mouth fall to the back of the throat and block the airway. CPAP machines force continuous pressurized air down the airway to keep the airway open and free from obstruction.
BiPAP (bilevel positive airway pressure) machines are a more complex device used as an alternative to CPAP. It provides two pressures, one for inhalation and one for exhalation.
Ventilators are used for patients who cannot breathe on their own or those suffering from a severe respiratory disease. They are often used in hospital settings; however, some ventilators can be used at home with a mask for patients with severe chronic obstructive pulmonary disease (COPD).
What is the Issue with Philips PE-PUR Foam?
PE-PUR, short for polyester-based polyurethane, is a sound abatement form used in CPAP, BiPAP, and ventilators (as well as other medical devices) to reduce sound and vibration. The PE-PUR foam in the affected Philips CPAP machines recall, which includes CPAP, BiPAP, and ventilators, may:
- Break down/degrade into particles that can enter the device’s air pathway and be inhaled or swallowed by the user.
- Release potentially toxic chemicals into the device’s air pathway, which the user may inhale.
According to the FDA, swallowing or inhaling these particles or gasses can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.
To date, Philips Respironics has received several complaints about the presence of black debris or particles in the air pathways of the devices. The firm has also received reports of physical harm that may be CPAP side effects:
- Upper airway irritation
- Chest pressure
- Sinus Infection
The foam degradation may be exacerbated by high heat and high humidity environments and unapproved cleaning methods, such as ozone.
CPAP Side Effects
People who used one of the recalled devices for obstructive sleep apnea who suffered from one or more of the following CPAP side effects may qualify for a Philips CPAP Recall Lawsuit:
- Chronic respiratory illness
- Lung cancer
- Kidney disease or kidney cancer
People who used one of the recalled ventilators to treat one or more respiratory conditions and suffered from significant worsening of their previous symptoms may qualify for a Philips CPAP lawsuit.
Philips CPAP Recall Lawsuit
Philips Respironics has been hit with several class-action lawsuits and individual injury claims since the company recalled millions of its CPAP, BiPAP, and ventilators. The lawsuits allege that the company knowingly manufactured devices it knew were defectively designed and failed to warn consumers of the serious health risks the devices posed as soon as they became aware of the issue.
“Philips Respironics had not disclosed when it first received reports from users of its Sleep & Respiratory Care devices of the presence of black debris or particles within the airpath circuit. But given how long the devices have been on the market, it’s unlikely that the company only recently learned of these issues,” says Beasley Allen’s product liability lawyer Beau Darley. “Meanwhile, Philips continued to profit from the manufacture and sale of its CPAP and BiPAP machines while putting users at risk of serious health issues, including cancer.”
Millions of people rely on CPAP, BiPAP, and ventilator machines to treat obstructive sleep apnea, COPD, and other health conditions. However, certain Philips Respironics devices have a dangerous design defect that poses serious health risks to consumers. The sound abatement foam used in the recalled CPAP, BiPAP, and ventilators can degrade into tiny particles and release toxic gasses that users can swallow or inhale, putting them at an increased risk for life-threatening health conditions.
If you or a loved one has been diagnosed with asthma, chronic respiratory illness, lung cancer, or kidney disease or kidney cancer after using a recalled Philips CPAP, BiPAP, or ventilator machine or experienced a worsening of a breathing condition, you may qualify for a Philips CPAP Recall Lawsuit. Contact Beasley Allen’s product liability lawyer Beau Darley for a free consultation.
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