Patients using a CPAP machine to treat sleep apnea should be aware of an ongoing medical device recall and emerging consumer litigation.
The health technology company Philips recently announced an urgent medical device recall of certain Continuous Positive Airway Pressure (CPAP) machines and Bi-Level PAP (BiPAP) devices because the foam used to reduce noise from the devices may crumble into particles and be inhaled by the user, resulting in serious injury that may be life-threatening. The majority of the recalled devices are in the first generation DreamStation product family.
The personal injury lawyers at Marks & Harrison are reviewing potential Philips DreamStation CPAP lawsuits on behalf of people who have been harmed by one of the machines. Our product liability attorneys have extensive experience pursuing lawsuits involving defective medical devices. We are committed to protecting the rights of people harmed by unsafe medical equipment in Richmond and throughout Virginia. A consultation with a Philips CPAP recall lawsuit attorney at Marks & Harrison is free.
Which Philips CPAP machines are being recalled?
The use of a CPAP machine is a common treatment for sleep apnea, a type of sleeping disorder in which breathing is temporarily disrupted. The CPAP machine delivers a flow of air through a mask which increases air pressure in the throat so the airway does not collapse during breathing. Patients who use CPAP or BiPAP machines typically use them on a nightly basis while sleeping.
Philips has manufactured millions of CPAP and BiPAP devices, and mechanical ventilators that use the PE-PUR sound abatement foam. Air passes through the foam before it is inhaled into the patient’s lung. Philips sells the devices through its subsidiary, Philips Respironics.
Through testing, Philips has determined that there are two possible serious health risks to users related to the polyurethane foam. The foam may deteriorate into particles that enter the device’s tubing and mask and may be ingested or inhaled by the user. The foam also may release certain chemical gases known as volatile organic compounds that are known to cause cancer.
The model names of the Philips Respironics CPAP and BiPAP machines affected by the recall are:
- DreamStation ASV
- DreamStation ST, AVAPS
- System One ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- Omni Lab Advanced
- System One Q-Series
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
The model names of the Philips Respironics ventilators affected by the recall are:
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30
The defective CPAP devices, BiPAP devices, and ventilators covered by the medical device recall were manufactured between 2009 and April 26, 2021.
What Are the Potential Risks Leading to the Recall?
The inhalation or swallowing of the PE-PUR polyester-based polyurethane foam particles or inhaling of the chemical gases can result in serious injury. The injuries can be life-threatening, cause permanent impairment and require medical treatment, according to the FDA.
According to the recall notice, the potential risks of exposure to the foam particles from the recalled CPAP and BiPAP devices include:
- headache
- inflammation
- respiratory issues
- possible toxic effects
- possible carcinogenic effects on organs such as the liver or kidneys.
Philips said it has received some reports of patient health effects due to degradation of the PE-PUR foam but has not received any reports of deaths associated with the foam.
The potential risks of exposure to chemical gases exposure include:
- headache
- irritation of the airway
- hypersensitivity
- nausea/vomiting
- possible toxic effects
- carcinogenic effects.
The U.S. Food and Drug Administration sent out a safety alert regarding the recall and is working with Philips Respironics to evaluate the scope of the recall. The FDA is analyzing medical device reports concerning the devices for the period from 2009 to 2021 that may be related to the issue.
The FDA advises that patients using the BiPAP and CPAP devices should discontinue the use of the devices and consult with their doctor to determine the best options for continued treatment. Discuss with your doctor whether the benefit of continuing to use the device outweighs the risks outlined in the recall notice.
The recall does not apply to Philips’s recently launched second-generation DreamStation 2 products. Philips said it is increasing the production of its DreamStation 2 CPAP devices in the United States.
Is There a Lawsuit Against Philips Respironics CPAP Machines?
Philips Respironics may face numerous lawsuits from people who have been diagnosed with lung damage, breathing difficulty, worsening asthma, pneumonia, or certain types of cancer after using a Philips CPAP or Philips BiPAP device.
The manufacturers of medical devices have a legal responsibility to design and produce products that are safe and effective when used as directed. Manufacturers are required to provide adequate warning of any known danger from the product.
Patients injured by unsafe medical devices may be entitled to seek significant compensation for the harm they have suffered through a Philips CPAP recall lawsuit and settlement.
What Allegations Are Raised in the Philips DreamStation Recall Lawsuit?
The Philips DreamStation lawsuits allege that patients have complained to Philips about black particles in the breathing machines for a number of years and that Philips was aware of material risks from its CPAP machines long before the recall.
Philips did not warn about the risk of the foam particles until April 2021 and did not recall the devices until June 2021.
The lawsuits claim that Philips timed the recall announcement to coincide with the introduction of its new generation DreamStation CPAP machines that do not contain the same type of foam.
The lawsuits allege that Philips does not have a clear timeline for repairing or replacing the unsafe CPAP and BiPAP machines that patients depend on daily.
Are There Any Costs to Hire a Philips Respironics Recall Attorney?
The process starts with a free case review by a knowledgeable attorney at Marks & Harrison. If we believe that you have a valid DreamStation CPAP injury lawsuit, we will offer to represent you on a contingency fee basis. A contingent fee means we only get paid if we win your case.
You will not be expected to pay any upfront costs. We only charge a legal fee if we are successful in obtaining compensation for you through a negotiated settlement or court award. Our legal fee is a portion of the amount we obtain for you, plus case expenses.
A consultation with a CPAP lawsuit attorney at Marks & Harrison is free.
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