If you’ve suffered an injury because of someone else’s negligence, the team at Richard Schwartz & Associates Injury Lawyers, P.A. is here to fight for the compensation you deserve.
On June 14, 2021, Philips voluntarily recalled its CPAP (continuous positive airway pressure) machines, BiPAP (BiLevel positive airway pressure) devices, and mechanical ventilators due to potential carcinogens and toxic chemical exposure.
Philips found that the polyester-based polyurethane foam used to reduce sound and vibration in the recalled CPAP machines, BiPAP machines, and ventilators has the potential to break down and cause serious health risks. If this occurs, the device’s user may breathe in dangerous chemicals, many of which are not visible to the naked eye.
In the recall notice, Philips states, “The issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude impairment.”
The recall includes the following devices:
CPAP and BiPAP machines
- E30 (Emergency Use Authorization)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30
The recall involves all serial numbers of the affected machines manufactured before April 26, 2021. You can find further information on the products at Philips Respironics medical device recall notice.
According to Philips, any DreamStation 2 products are safe to use. The DreamStation2 product family was released in March of 2021, about a month before Philips announced the recall.
In September 2021, the FDA granted Philips approval to repair recalled DreamStation and other CPAP devices. The original recall did not present any options for users to repair their devices. The FDA has not yet approved the repaired devices for distribution. Their report on Philips independent testing of their repaired devices stated that “At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.”
This also does not eliminate any existing damage or injuries caused by Philips’ machines. If you believe you have experienced any damages to your health or livelihood due to your Philips sleep apnea machine, contact a lawyer today.
Class 1 is the highest level of recall.
According to the U.S. Food and Drug Administration (FDA), a Call 1 recall is initiated when a device violates FDA laws regarding safety, which could lead to severe injuries or death.
For a Class 1 recall, Philips must remove all affected devices that could cause severe injury or death to their consumers rather than repair. They’re also required to notify customers of the recall.
On November 12, 2021, an FDA safety communication opted to continue this recommendation.
If you or a loved one has experienced cancer, lung problems, or other injuries after using a recalled Philips medical device, you may be eligible to file a lawsuit. You may seek compensation for the following damages:
- Physical pain and suffering
- Disabilities resulting from product
- Emotional injuries and mental anguish
- Medical expenses, including any future medical needs
- Lost income and diminished earning capacity
- Wrongful death
If you have any questions regarding your legal rights, please contact us. Each case is unique, and our Jackson-based legal team will work with you to understand and illustrate the full scope of your damages in order to fight for the maximum compensation possible. Our team has the experience you need to win your defective product case.
What Should I Do If I Am Using an Affected Device?
If you are using a recalled CPAP machine, BiPAP machine, or ventilator, the FDA advises you to speak with your healthcare provider as soon as possible regarding next steps.
DO NOT stop using your ventilator, CPAP, or BiPAP until after speaking with your healthcare provider. In some cases, the patient is at more risk if they stop using their device than if they continue to use the recalled product. Your healthcare provider will assess the risk and may provide alternative options to the recalled devices.
According to the FDA, users of recalled CPAP devices and recalled BiPAP devices should NOT add a filter to their machine. There is no evidence that a filter will stop the flow of toxic materials, and it will disrupt the effectiveness of your machine.
The FDA is currently evaluating the effectiveness of adding a filter to recalled Philips Respironics ventilators. At this time, the agency does not have proof that a filter is effective nor proof that it is safe. Therefore, it is best to wait for the FDA’s approval before altering your Philips ventilator.
For further information, you can refer to the FDA’s safety communication regarding the recalled machines.
What Are Symptoms of Exposure to PE-PUR Foam Particles or Chemical Emissions?
If you or a loved one have used a recalled product, it is vital that you look out for any changes to your physical health. Ingesting particles or inhaling chemical emissions from PE-PUR can lead to severe injuries, illness, or even death.
Symptoms may include:
- Upper airway irritation
- Respiratory tract irritation
- Airway inflammation
- Skin, eye, nose irritation
- Sinus infections
- Hypersensitivity, such as an allergic reaction
- Chest pressure
- Carcinogenic effects
- toxic effects
Other potential risks include developing asthma, cancer, or cancer-like symptoms.
If you or a loved one are experiencing any of the above symptoms, Keep the evidence and talk to a lawyer.
If you or a loved one has experienced adverse health effects from any of the recalled products, keep your machine the way it is. Leave any debris in the air pathways, and don’t attempt to fix any complications. Make sure to take photos or videos documenting any black particles, debris, or additional complications. Additionally, keep any medical records and prescriptions associated with your illness.
At Richard Schwartz & Associates Injury Lawyers, P.A., our defective product lawyers have the insight, experience, and resources to help injured victims and families across Mississippi. We strive to level the playing field with large corporations like Philips. Our team is experienced in mass tort claims, taking on large companies like Philips, which put profits over people and attempt to pay as little as possible.
If you are experiencing health problems due to your recalled Philips device, you can submit an adverse event report with the FDA and register your device on the Philips Respironics recall website. However, we recommend that you consult a lawyer before submitting either form, as Philips may try to use this information against you in court. Further updates can be found without submitting any information through the Philips recall and FDA websites.
There is evidence that Philips knew their machines posed a hazard before the recall.
This means the company intentionally allowed hundreds of people to remain at risk for their own profit. If you or a loved one has suffered physical or emotional damage from a Philips device, this claim helps your case. Contact Richard Schwartz & Associates Injury Lawyers, P.A. for more information regarding a lawsuit against Philips.
Contact our lawyers to discuss the CPAP Recall Lawsuit today.
Richard Schwartz & Associates Injury Lawyers, P.A. currently accepts clients who are not already represented by a lawyer. A potential client must have used a recalled Philips Respironics CPAP, APAP, BiPAP device, or mechanical ventilator and then were diagnosed with one or more of the following health conditions.
Individuals must have used the device for a minimum of 12 months before the diagnosis of the following injuries:
- Acute myeloid leukemia
- Blood cancer
- Bone marrow cancer
- Esophageal cancer
- Hematopoietic cancer
- Laryngeal cancer
- Lymphatic cancer
- Multiple myeloma
- Non-Hodgkin’s lymphoma
- Nasal cancer
- Sinus cancer
- Soft palate cancer
- Throat cancer
- Tonsil cancer
- Chemical poisoning
- Kidney damage
- Kidney disease
- Liver damage
- Liver disease
- Lung damage
- Lung disease
- Granulation of the lung
- Acute respiratory distress system (ARDS)
- Pleural effusion
- Reactive airway disease (RAD)
- Respiratory failure
Clients must have used the recalled device for a minimum of 24 months before the diagnosis of the following injuries:
- Thyroid cancer
- Papillary carcinoma
Individuals must have used the device for a minimum of 36 months before the diagnosis of the following injuries:
- Bladder cancer
- Brain cancer
- Breast cancer
- Colon cancer
- Kidney cancer
- Liver cancer
- Lung cancer*
- Prostate cancer*
- Rectal cancer
- Stomach cancer
- Testicular cancer
*Individuals must not have been a smoker in the past 10 years if diagnosed with lung cancer.
*Individuals must be 65 years or younger if diagnosed with prostate cancer.
What is a CPAP or BiPAP Machine?
CPAP and BiPAP machines treat sleep apnea, a condition that causes a person’s breathing to become shallow or stop temporarily while asleep. The lack of oxygen often causes the individual to snore loudly, wake up with a dry mouth, and feel exhausted during the day. It can also lead to high blood pressure, and in extreme cases, a heart attack or stroke.
There are three main types of sleep apnea. The most common form is obstructive sleep apnea, which occurs when throat muscles relax, closing the upper airway during sleep. The other primary forms are central sleep apnea and complex sleep apnea syndrome. The former occurs when your brain doesn’t send the necessary signals to your muscles that are needed to control breathing. Complex sleep apnea (or treatment-emergent central sleep apnea) occurs when both of the other two forms appear simultaneously.
CPAP and BiPAP machines both work to stabilize the flow of air while sleeping. For both products, users wear a mask that provides a constant flow of pressurized air that prevents the soft palate, tongue and uvula from blocking the airway. A CPAP machine provides higher air pressure when you exhale, and a BiPAP provides higher pressure air when you inhale. Your health care provider will determine the best option based on your unique situation and medical history.
Can a CPAP Machine Cause Lung Problems?
The polyester-based polyurethane (PE-PUR) foam that caused the recall can cause various health issues and cancers, including lung cancer. The volatile organic compounds (VOCs) found in the foam are toxic and carcinogenic.
Since the Philips Respironics devices do not have filters to prevent the ingestion or inhalation of these VOC particles and gases, the particles and gases move freely throughout the airpath when the foam degrades. This makes it easier to swallow or breathe in the debris while using the machine.
The FDA has also noted that unapproved cleaning methods, such as ozone cleaners and ultraviolet light products, can increase the rate of foam degradation. This can cause further health problems. Foam degradation can also be affected by climate and environmental conditions. If your CPAP or BiPAP machine is stored in a location with high heat or humidity, this can increase the degradation rate. Often times, climate is out of our control, especially if you live in a region where this weather is the norm
Why Is PE-PUR Foam Harmful?
When intact, PE-PUR sound abatement foam is not necessarily dangerous. It is made from a polyester-based polyurethane, and if this polyurethane foam breaks down, it can cause potential health risks. If the PE-PUR sound abatement foam breaks down, it can create particles and chemical gases that are dangerous to users of the recalled devices. This danger is especially high for patients who already have lung disease. The particles and gases can cause a number of cancers, including lung cancer, heart attacks, and strokes.
Philips’ lab analysis revealed that the polyester based polyurethane pe particles release several dangerous by-products, including Diethylene glycol (DEG), Toluene diamine (TDA), and Toluene diisocyanate (TDI).
The recalled sleep apnea machines also exceed the safe exposure threshold for two toxic gases. The recalled cpap and bipap devices release dimethyl diazine and phenol 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl).
These dangerous chemicals and gases can appear as black debris or particles within the air pathways of the recalled devices, but they can also degrade in such away that the dangerous particles do not appear visible. Even if nothing appears visibly wrong with your machine, Philips devices can still pose potential health hazards to users.
What Is The Philips CPAP Lawsuit?
The U.S. Judicial Panel on Multidistrict Litigation (JPML) heard arguments for 32 lawsuits regarding Philips CPAP machines, BiPAP machines, and mechanical ventilators on September 30, 2021, in the Eastern District of Pennsylvania.
This followed mass tort procedure, otherwise known as a class action lawsuit, in which victims sue a defendant separately in individual lawsuits seeking compensation for the defendant’s negligence. More philips CPAP lawsuits are expected to follow. There is strong evidence that Philips knew about the potential health risks posed by their recalled devices, due to the PUR sound abatement foam. Failure to communicate the health risks of their medical devices with their clientele has caused irreparable damage. If you have experienced health problems due to a defective medical device, speak with our team today.
The voluntary recall was not announced until June 2021, and the Philips CPAP lawsuit claims that the company purposefully delayed the recall. The recall includes the company’s DreamStation CPAP Machines, and Philips may have delayed to recall so that it didn’t interrupt the release of the DreamStation 2 family of sleep apnea products in March of 2021. Philips reports that the DreamStation 2 (second generation) line of products are not affected by the recall and are safe to continue to use.
Legal Reasons For Philips CPAP Lawsuits
Richard Schwartz & Associates Injury Lawyers, P.A. can help you take action against Philips. Some causes of action include:
- Defective design— strict product liability and negligence
- Manufacturing defect
- Breach of express and implied warranties
- Negligence per se
- Gross negligence
- Failure to warn
- Consumer fraud
- Negligent misrepresentation
Choose Richard Schwartz & Associates Injury Lawyers, P.A. to Represent You in Your Philips CPAP, BiPAP, or respironics ventilator lawsuit.
We Have The Experience You Need
Richard Schwartz & Associates is dedicated to protecting the rights of those who have been injured and wronged. Our awarded lawyers are experienced in handling defective product cases, and are dedicated to delivering the justice you deserve. Just one call can make all the difference in your case. Our firm serves clients throughout Mississippi from our Jackson office.