When you have a medical condition that severely affects your health and quality of life, you are focused on what you can do to get better. Millions of Americans suffer from obstructive sleep apnea (OSA) and use sleep apnea machines every night to help them breathe.
Many of these people use a Philips CPAP or BiPAP machine containing PE-PUR sound abatement foam, which can cause severe illness and injury. Philips has recalled certain models after receiving reports that they failed to adequately filter air particles and emitted carcinogens.
At Nessler & Associates, our defective medical device lawyers represent individuals harmed by a Philips Respironics CPAP machine involved in this recall and who have received medical treatment for their injuries.
CPAP and BiPAP Machines
CPAP (Continuous Positive Airway Pressure) machines deliver positive pressure through a mask, usually during sleep, to promote oxygen flow. BiPAP (Bilevel Positive Airway Pressure) machines serve the same purpose, but BiPAP delivers higher pressure when you inhale than when you exhale, making exhalation easier with BiPAP.
These machines use increased air pressure to treat obstructive sleep apnea.
Use of CPAP or BiPAP for Obstructive Sleep Apnea
Sleep apnea affects an individual’s quality and quantity. It can also lead to other serious health conditions, including cardiovascular disease and stroke.
Obstructive sleep apnea
Obstructive sleep apnea occurs when the upper airway collapses during sleep, forcing the diaphragm and associated muscles to work harder to open the airway. The person affected often gasps or jerks when they reopen their airway.
Risk factors for sleep apnea include excess weight, smoking, diabetes, high blood pressure, family history, asthma, narrow jaws, large tonsils, and a large tongue. People usually choose to get treated when repeated nightly apneic episodes disturb their sleep, and they notice waking symptoms of OSA, including daytime fatigue, dry mouth, and headaches.
How a BiPAP and CPAP machine can help
A pulmonologist usually prescribes a CPAP or BiPAP machine to treat obstructive sleep apnea. The positive pressure generated by these machines prevents the collapse of the airway, alleviating many medical conditions and allowing for restful sleep.
Sleep apnea machines use an air compressor to move positive pressure to the mask that fits over your nose or nose and mouth with a tight seal. Air compressors cause a lot of vibration and can be loud.
Many manufacturers incorporate sound-dampening foam in the machine’s housing unit to reduce the vibrations. Unfortunately, the foam sound dampener used in the Philips Respironics devices makes them quiet but dangerous.
Consequences of untreated sleep apnea
Leaving obstructive sleep apnea untreated poses serious health risks. Daytime sleepiness occurs in many people with sleep apnea and can raise the risk of car accidents or work accidents. When they have sleep apnea, people with heart disease are at a higher risk of experiencing strokes, atrial fibrillation, and an irregular heart rhythm.
Sleep apnea can also worsen high blood pressure and prevent weight loss or contribute to weight gain. People with diabetes don’t use insulin efficiently when they don’t get enough sleep.
The recall affects millions of machines, leaving many people without treatment options.
Harmful Contaminants in Sleep Apnea CPAP Machines
The harmful compounds in these machines come from the polyester-based polyurethane (PE-PUR) foam used as a noise dampener. This sound abatement foam can produce harmful toxic chemicals, including volatile organic compounds (VOCs) or toxic gases, and degrade into particles that move through the air pathway of the machine and into the user’s lungs, causing upper airway irritation and lung damage.
Philips ordered a class I recall, the most urgent type of recall, which means the use of the item has a reasonable probability of leading to serious adverse health outcomes or death. Philips knew about the defective design in some of its medical devices for years before issuing the voluntary recall.
PE-PUR foam gases
In the recall notice, Philips stated the risks of VOC exposure include headaches, dizziness, irritation to the skin, eyes, and respiratory tract, hypersensitivity, nausea, vomiting, and toxic and carcinogenic effects.
PE-PUR foam particles
The recall notice also stated that the risks of particulate exposure include damage to the skin and eyes, respiratory tract irritation, an inflammatory response, headaches, asthma, liver damage, and toxic and carcinogenic effects.
Foam degradation causes black particles in the air pathway, or tubes or mask, of your Philips CPAP, BiPAP, or ventilator device. If you notice black debris in your machine, contact your healthcare provider immediately to find out your next steps.
A 2021 report from the FDA indicates that Philips Respironics knew about the potential problems with their sound abatement foam as early as 2015 but took no action. The report suggests a biological risk assessment conducted in 2018 didn’t account for current knowledge on PE-PUR foam particulate exposure or the number of complaints the company had received.
Philips Respironics maintains that these exposures cause no long-term harm. An FDA safety communication notes that they could cause permanent impairment or require medical intervention to prevent permanent injury. A personal injury attorney with Nessler & Associates can help you build a case to get financial compensation for your Philips CPAP-related injuries.
Possible Side Effects and Injuries from Philips CPAP Machines
The potential health risks from using a defective device include cancer, chemical poisoning, organ damage, respiratory issues, and death.
The foam particles can cause irritation or injury to the nasal mucosa or sinuses, leading to an infection.
Reactive airway dysfunction syndrome
Reactive airway dysfunction syndrome causes the airway to swell when exposed to certain stimuli. This condition results from an inflammatory response and may cause some thickening and fibrosis.
Some people develop inflammation in the respiratory tract without the constriction of their airways. Symptoms of respiratory inflammation include chest pressure, fatigue, sore throat, runny nose or congestion, wheezing, coughing, or lack of energy after activity. Some people may get inflammation in their ears, leading to ear pain and hearing issues.
Liver or kidney damage
The VOCs off-gassed from the foam can lead to organ damage, particularly to the liver and kidneys. These organs filter toxins from the human body and are exposed to higher concentrations than the rest of the body.
Inhaling particles and gases from a Philips CPAP machine can cause many types of cancer, including:
- Liver cancer
- Stomach cancer
- Breast cancer
- Kidney cancer
- Nasal cancer
- Lung cancer
- Prostate cancer
- Bladder cancer
- Lymphatic cancer
- Rectal cancer
- Testicular cancer
- Thyroid cancer
- Colon cancer
- Esophageal cancer
- Brain cancer
Damage to other organs puts more stress on the heart. When the liver and kidneys are damaged, fluid accumulates in the body, forcing the heart to work harder to get blood to the damaged organs. This stress contributes to the development of congestive heart failure and heart attacks.
A European study showed a decline in respiratory function for Philips CPAP users that had obstructive lung disease and increased airway symptoms for all users.
Most of these conditions can lead to death. At least 124 people have died after using Philips Respironics breathing devices.
What Should I Do if I Am Using an Affected Device?
You may be wondering if your lung injuries, liver disease, kidney disease, or other health issues are due to using Philips CPAP or other breathing machines. Learn what to do if you are using:
- A-Series BiPAP A30
- A-Series BiPAP A40
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto
- C Series ASV
- C Series S/T and AVAPS
- DreamStation ASV
- DreamStation Go
- DreamStation ST
- Dorma 400
- Dorma 500
- E 30
- Garbin Plus
- OmniLab Advanced
- REMstar SE Auto
- System One ASV4
- System One Q Series
- Trilogy 100
- Trilogy 200
Consult with your doctor immediately
Ask your doctor what to do if you’re using an affected device. They may ask you to stop using it, find you an alternative device, or advise you to keep using it until you find a suitable replacement. The decision depends on your health and the severity of your sleep apnea.
Find an alternative
Philips Respironics is replacing machines or sending out repair kits, but it will take time to help everyone affected. Find a safer alternative that is unaffected by the recall.
Get a medical evaluation
If you’ve been exposed to harmful chemicals when using a Philips CPAP, BiPAP, or ventilator, you should get screened for the injuries and illnesses these machines can cause. If you find an issue, a personal injury lawyer with Nessler & Associates can help you hold the medical device manufacturer accountable for concealing potential risks.
Damages You May Recover
You may recover economic damages and non-economic damages during your CPAP lawsuit. You may also receive punitive damages because the company knew about the potential health risk to consumers and concealed it. Punitive damages are designed to financially punish the offending company for their gross negligence and deter them from future misconduct.
Economic damages cover medical expenses for any adverse health effects of using the affected devices. These expenses include current and future medical bills, out-of-pocket costs like medication and assistive devices, and lost wages and earning capacity.
Non-economic damages include mental anguish, pain and suffering, and loss of enjoyment of life, a legal term for losing the ability to perform your usual activities.
CPAP Lawsuit Time Limits
Usually, the statute of limitations in Illinois is 12 years from the date of purchase, but the fact the company concealed problems may affect how long you have to file. Ask a CPAP lawyer at Nessler & Associates if you still have time to file a claim.
CPAP Lawsuit for People Injured by Philips Sleep and Respiratory Devices
Because Philips Respironics knew of the potential adverse health consequences of the degraded foam in their ventilation devices long before they informed consumers, they now face numerous lawsuits.
Wrongful death lawsuit
The FDA has reports of 124 deaths after using a Philips CPAP, BiPAP, or ventilator device. The families of the deceased may pursue wrongful death cases against the company.
Personal injury lawsuit
More than 180 people have filed personal injury claims against Philips Respironics for severe illness and injury.
One hundred class-action lawsuits have already been filed on behalf of people who used a defective machine.
The CPAP lawsuits (CPAP recall MDL) are centralized in the Western District of Pennsylvania because many of the recalled machines were manufactured in Murrysville. U.S. District Judge Joy Flowers Conti, an experienced transferee judge, has been assigned to oversee the Philips CPAP MDL (MDL-3014).
Legal advice from a Nessler & Associates personal injury lawyer can help you choose the right type of lawsuit for your situation.
Case Criteria for a Philips CPAP Lawsuit
To file a suit against Philips Respironics, you must present evidence that you used a defective product, the company failed to protect its consumers, and you suffered a significant injury or illness due to using the product. An experienced dangerous device lawyer at the law firm of Nessler & Associates knows how to gather and present this evidence to build a successful case and maximize your compensation.
Get the Help You Deserve
If exposure to dangerous chemicals in your Philips Respironics CPAP machine or other device has caused you or a loved one renal failure, severe lung injury, or other negative health outcomes, call Nessler & Associates at (800) 727-8010 to schedule your free consultation.
We have been representing victims of product liability and personal injury cases for more than 35 years. Our attorneys accept all personal injury cases and class-action lawsuits through contingency fee agreements. This arrangement ensures you only pay for our services only after we have successfully resolved your case by negotiating a settlement or securing a verdict.