Philips has voluntarily recalled millions of its Philips CPAP (continuous positive airway pressure) machines, BiPAP (BiLevel positive airway pressure) devices, and mechanical ventilators. There is a list of recalled devices below. Philips recalled the machines on June 14, 2021, due to potential carcinogens and toxic chemical exposure.
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.“
What Is A Class 1 Recall?
The U.S. Food and Drug Administration (FDA) has categorized the Philips CPAP recall as a Class 1, the highest level of recall. A Class 1 recalled device violates FDA laws regarding safety. This category is used to recall medical devices that could cause serious injuries or death to consumers.
In Class 1 medical device recalls, either the company manufacturing the device or the FDA removes the device from the market. They also notify consumers of the defect.
Individuals who have had cancer, lung problems, or other injuries after using a defective medical device manufactured by Philips may be eligible to file a lawsuit. A Philips CPAP machine lawsuit could potentially compensate them for their illness or injury.
If you have used any medical devices that are part of the Philips CPAP recall and have questions about your legal rights, please contact us. You can receive a free consultation from anywhere in the U.S. regarding the Philips CPAP lawsuit by calling Gemma Law Associates, Inc. at 401-307-4050 or contacting us online.
Which Philips Devices Are Recalled?
The recalled Philips Respironics machines are listed below. Most of the affected devices are Philips CPAP or BiPap machines. Several of the Philips DreamStation CPAP machines are part of the recall. Some mechanical ventilators are also included. The recall involves all serial numbers of the affected machines manufactured before April 26, 2021. For further details, see the Philips Respironics medical device recall notice.
Philips CPAP, BiPAP, And Ventilator Recall List
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
Philips Respironics released the DreamStation 2 family of products in March of 2021, a short time before Philips announced the voluntary recall. The DreamStation 2 products are safe to use, according to Philips.
A Class 1 medical device recall usually results in removing the device from the market rather than repair. However, sometimes the corporation gets permission to fix the defect somehow. For example, Philips now has regulatory clearance to replace the defective sound abatement foam in the recalled first-generation DreamStation devices.
What Should I Do If I Am Using an Affected Device?
If you are using one of the recalled Philips Respironics sleep apnea machines, talk to your doctor right away. Your healthcare provider will discuss any health risks and other safe treatment options to address your condition. Ideally, you will stop using the recalled Philips CPAP and BiPAP machines immediately.
If you or a family member are using one of the Philips Respironics ventilators at home, do not stop using it or change your ventilator use until you talk to your doctor. There may not be other appropriate options available; however, your healthcare provider can keep you informed of any new developments or alternatives.
Keep The Evidence And Talk to a Lawyer
If you believe you have had adverse health effects from any of the recalled devices, make sure you keep the machine and any debris in the air pathways of the CPAP. Document the black particles or debris with photos or videos to preserve the evidence. Keep all medical records and prescriptions associated with your illness.
Philips is a Dutch company whose full name is Koninklijke Philips N.V. They are a massive company with numerous resources and a lot of money to spend on a legal team. Therefore, if you or a family member had health issues after using a recalled Philips medical device, you need a great team on your side. To get the best results, call a law firm experienced in mass tort claims.
It is crucial to have lawyers who have dealt with large medical companies or corporations like Philips. In addition, every state has its own statute of limitations for someone to file a claim against Philips. Your attorney can tell you how much time you have to sue based on your state’s laws.
It is recommended that you consult with a lawyer before submitting an adverse event report with the FDA and before registering your defective device on the Philips Respironics recall website. This is because Philips might try to use the information against you. In addition, you can get updates and information about device fixes without registering on the Philips recall website.
Why Do People Use a CPAP or BiPAP Machine?
Many people use Philips sleep apnea machines. Sleep apnea is a disorder that causes a person’s breathing to become shallow or stop temporarily. This causes lower blood oxygen levels and waking up frequently. As a result, people with sleep apnea feel exhausted during the day because their sleep is constantly disrupted throughout the night. For some people, it can contribute to high blood pressure. In extreme cases, sleep apnea can cause people to have a heart attack or stroke.
CPAP machines provide a steady flow of air delivered as you breathe in and out through a mask. The constant flow of pressurized air acts like support or an “air splint” that keeps the throat open and prevents the soft palate, tongue and, uvula from shifting and blocking the airway. A CPAP machine also helps decrease the vibration that causes the sound of snoring.
BiPAP devices also provide positive airway pressure when you breathe in and out; however, you receive higher pressure when you inhale than when you exhale. Your doctor decides if a BiPAP machine is a better option for you than a CPAP machine based on your medical issues or diagnosis.
Unfortunately, if you are using one of the recalled sleep apnea machines, a medical intervention meant to keep you safe from obstructive sleep apnea could be causing you harm. In that case, you might be eligible for the Philips CPAP recall lawsuit. Contact Gemma Law Associates, Inc. to find out.
Can a CPAP Machine Cause Lung Problems?
Philips CPAP Machines Linked to Possible Cancer Risk
According to the FDA Safety Communication, the polyester-based polyurethane (PE-PUR) sound abatement foam is used to decrease sound and vibration in the affected devices. However, this foam may break down and enter the device’s air pathway. If this happens, black debris from the foam or chemicals released may be ingested or inhaled by the user.
The PE-PUR foam contains volatile organic compounds or VOCs that are both toxic and carcinogenic. These compounds place users at increased risk of acquiring numerous illnesses and types of cancer.
The recalled Philips Respironics devices do not have filters to prevent the ingestion or inhalation of these particles or gases. Therefore, once the foam begins to degrade, the particles and gases move freely throughout the airpath. This makes it easy to swallow or breathe in the debris while you are using it. So a device meant to help treat sleep apnea could actually be causing you harm.
Unapproved cleaning methods can increase the rate of foam degradation. For example, ozone cleaners and ultraviolet light products may accelerate the breakdown of the foam and cause other health problems.
In addition, climate and environmental conditions can affect the foam. For example, storing CPAP machines in high heat and humidity locations can also increase the degradation rate. This may be difficult to control in some places.
Why Is PE-PUR Foam Harmful?
PE-PUR sound abatement foam is a polyester-based polyurethane foam that is not dangerous when it is intact. However, if the polyurethane foam breaks down, it can create particles and release chemical gases. If these particles and gases are ingested or inhaled, they can cause numerous potential health hazards.
These particles and chemical gases are especially concerning for patients who already have lung disease.
Philips’ lab analysis revealed that the degraded foam produced several by-products that can cause potential health risks, including:
- Diethylene glycol (DEG)
- Toluene diamine (TDA)
- Toluene diisocyanate (TDI)
Philips discovered two toxic gases that exceeded the safe exposure threshold from the PE-PUR sound abatement foam. These toxic gases that can create potential health risks are:
- dimethyl diazine
- phenol 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)
Philips has received complaints regarding black debris or particles within the air pathways of the recalled medical devices. However, the foam can degrade and release volatile organic compounds even if you don’t see particles.
What Are Symptoms of Exposure to PE-PUR Foam Particles or Chemical Emissions?
There is a potential for serious injuries or health problems after ingesting particles or inhaling chemical emissions from PE-PUR foam. Report any symptoms you experience to your healthcare provider right away. Adverse effects of the recalled machines include:
- Upper airway irritation
- Respiratory tract irritation
- Airway inflammation
- Skin, eye, nose irritation
- Sinus infections
- Chest pressure
- Carcinogenic effects
- Toxic effects
What Is The Philips CPAP Lawsuit?
We are in the early stage of litigation. However, the safety recall of the Philips BiPAP and CPAP machines and mechanical ventilators has already resulted in lawsuits. Lawyers have been filing lawsuits for people who used these devices and suffered adverse health effects.
More CPAP recall lawsuits are expected to follow because there is evidence that Philips knew about the defects and increased health risks associated with the PE-PUR foam. However, Philips failed to warn consumers.
In addition, Philip states they have been receiving complaints from users of the recalled sleep apnea machines about black particles and debris in the airpath of the medical devices.
Even though Philips Respironics was aware of these issues for years, they did not make a public safety announcement until April 2021. And the recall wasn’t announced until June 2021. It appears that Philips purposefully delayed the recall to coincide with the release of its DreamStation 2 family of sleep apnea products in March of 2021. Philips reports that DreamStation 2 (second generation) products are safe and do not have the same foam inhalation risks as the first generation DreamStation products.
So, Philips waited to tell consumers their existing products were hazardous until they had a new, safe product to replace them. However, other companies in the CPAP market make CPAP machines that are safe and have been available the entire time, such as ResMed CPAP machines.
Is There a Class Action Suit Against Philips CPAP Machines?
The U.S. Judicial Panel on Multidistrict Litigation (MDL) will hear arguments regarding a possible Philips CPAP MDL on September 30, 2021. The Judicial Panel will decide whether or not to consolidate all federally filed cases against Philips and their recalled CPAP, BiPAP, and ventilator machines into one court for pre-trial proceedings. Both sides agree that consolidation of cases would be best. However, they disagree on where to hold the proceedings.
Legal Reasons For Philips CPAP Lawsuits
There are many causes of action that can be taken against Philips, including:
- 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
What Type of Compensation Can I Receive From a Mass Tort Claim?
You or a loved one may be permanently injured because of a faulty medical device manufactured by Philips. Filing a lawsuit may pay for past and future medical bills. Hold Philips accountable for placing you or a family member at increased risk of health problems. Mass tort compensation may include money for:
- Past and future medical expenses
- Lost wages and loss of earning potential
- Pain and suffering
- Wrongful death
Contact Our Lawyers to Discuss The CPAP Recall Lawsuit Today
Gemma Law is currently accepting clients who used a recalled CPAP device or ventilator machine and then were diagnosed with one or more of the following health conditions:
- Acute inhalation injury
- Acute respiratory distress system (ARDS)
- Autoimmune disorders
- Bladder cancer
- Brain cancer
- Breast cancer
- Cancer (any type)
- Chronic asthma
- Chronic bronchitis
- COPD (Chronic Obstructive Pulmonary Disease)
- Heart attack or heart failure
- Hematopoietic cancer
- Inflammation of the ears, nose, or throat
- Inflammation and fluid build-up in the lungs
- Interstitial lung disease
- Kidney cancer
- Kidney disease
- Liver cancer or liver disease
- Lung cancer or lung damage
- Multiple myeloma
- Nasal cancer
- Papillary carcinoma
- Pleural effusion
- Prostate cancer
- Pulmonary fibrosis
- Reactive airway disease (RAD)
- Rectal cancer
- Respiratory failure
- Stomach cancer
- Testicular cancer
- Thyroid cancer
Choose Gemma Law to Represent You in Your Philips CPAP Lawsuit
Gemma Law Gets Results
Gemma Law has a history of getting excellent financial results for our clients. Our dedicated attorneys value the attorney-client relationship and will work tirelessly to ensure your rights are protected.
Gemma Law Associates, Inc. is talking to victims exposed to harmful particles and chemicals from recalled CPAP, BiPAP, or Philips ventilator machines. Reach out to our product liability attorneys to talk about your potential CPAP machine lawsuit. You might qualify for the current class action lawsuit or mass tort litigations against Philips. If you used one of the recalled machines, you probably have a lot of questions. We are here and happy to answer all of your questions.
We Have The Experience You Need
Our law firm has experience with product liability cases, medical malpractice, and representing clients who have been prescribed dangerous drugs. Gemma Law Associates, Inc. is prepared to fight Philips Respironics on behalf of our clients who used any of the recalled CPAP devices or mechanical ventilator devices.
We are seeking substantial financial compensation for Philips CPAP lawsuit claims through a settlement payout or at trial. You should not be responsible for medical bills due to a defective medical device.
Call For Your Free Consultation
We offer a free case review to evaluate your claim and answer all your questions. Call Gemma Law Associates, Inc. at 401-307-4050 or contact us online today.