Philips CPAP Lawsuit
Cancer & Lung Injury Linked to Philips CPAP Machines
Beginning in June 2021, millions of Philips CPAP devices have been recalled in the United States due to a possible link to cancer. It is believed that the foam used to reduce the machine’s sound breaks down over time, releasing harmful chemicals and particles. Inhalation of these toxic chemicals and particles has been linked to life-threatening injuries, including cancer and other respiratory illnesses.
If you have suffered an illness or injury after using a Philips CPAP machine or other recalled device, contact our office immediately to determine if you may be entitled to compensation.
At Fibich, Leebron, Copeland & Briggs, we have obtained billions of dollars in settlements and verdicts on behalf of our clients, including those who have been harmed by defective medical devices.
Call (713) 999-3681 to discuss your legal options with an experienced attorney.
Which CPAP Devices Have Been Recalled?
On June 14, 2021, CPAP manufacturer Royal Philips announced that they were issuing a recall of millions of CPAP devices sold in the United States and across the globe.
Consumers were alerted by the U.S. Food and Drug Administration (FDA) on June 30, 2021, that millions of medical devices manufactured by Philips Respironics, a U.S. subsidiary of Royal Philips, had been recalled.
The FDA issued a Class I Recall for the devices, the most serious type of recall for CPAP and BiPAP devices, as well as a series of mechanical ventilators manufactured and sold by Philips Respironics.
The affected devices are believed to have been distributed from July 2009 until April 2021. Many of the recalled machines are part of the first-generation DreamStation product line. If you have used or are continuing to use one of the affected devices, it is strongly recommended that you consult with your healthcare provider.
Recalled Philips CPAP and BiPAP devices:
- Continuous Ventilatory, Minimum Ventilatory Support, Facility Use
- E30 (Emergency Use Authorization)
- Continuous Ventilator, Non-life Supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- Non-continuous Ventilator
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Recalled Philips Ventilators:
- Continuous Ventilator
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
- Continuous Ventilator, Non-Life Supporting
- A-Series BiPAP A40
- A-Series BiPAP A30
Class “I” Recall – The Most Serious
A Class I recall is the most serious type of recall issued by the FDA. It is issued when there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
In the case of the Philips CPAP, BiPAP, and ventilators, it is believed that the polyester-based polyurethane (PE-PUR) sound abatement foam, used to reduce the sound and vibration of the machines, degrades over time. The breakdown of this foam can release harmful chemicals and particulate matter into the device, which is then inhaled or swallowed by the user.
When ingested, these toxic chemicals and particles may cause serious injury. As noted by the FDA in the June 30 Safety Communication, the injuries can be “life-threatening, cause permanent impairment and require medical intervention to prevent permanent damage.”
What Is a CPAP Machine?
A CPAP or Continuous Positive Airway Pressure device uses a constant flow of positive air pressure to keep a person’s airways open while they sleep. The device is one of the most commonly used treatments for obstructive sleep apnea.
Obstructive sleep apnea causes a person to repeatedly stop breathing while they sleep. Individuals with obstructive sleep apnea often wake up abruptly gasping for air and may suffer from serious complications, including a greater risk for heart attack and stroke.
BiPAP (BPAP) devices or Bi-level Positive Airway Pressure machines are also used to treat sleep apnea and other respiratory problems. A BiPAP device works similar to a CPAP but delivers two levels of pressure as compared to a CPAP’s continuous stream of air. Several Philips BiPAP models were included in the June 14 recall.
Injuries Linked to Philips CPAP and BiPAP Machines
According to the FDA and the Press Release issued by CPAP manufacturer Royal Philips, the recalled devices have been linked with a number of potentially serious health complications. In some cases, the injuries may be catastrophic, resulting in long-term or permanent impairment.
The complications are believed to be caused by a design defect that causes the sound abatement foam to break down, resulting in exposure to harmful chemicals (off-gassing) and potential ingestion of dangerous particles.
Chemical emissions from the type of foam (PE-PUR) used in these devices may cause lung damage, including sudden respiratory failure or certain kinds of cancer such as lung cancer, kidney cancer, or liver cancer.
Health risks associated with the use of recalled Philips CPAP, BiPAP, and ventilators:
- Upper airway irritation
- Chest pressure
- Sinus infection
- Irritation to the skin, eyes, or respiratory tract
- Inflammatory response
- Toxic or carcinogenic effects to organs such as the kidneys and liver
- Nausea and vomiting
Responses from the FDA and Philips Regarding Dangers of CPAP Machines
On April 26, 2021, Philips announced in their First-Quarter Results that they had “identified a quality issue” in certain sleep and respiratory care products. The company set aside 250 million euros to take precautionary actions to address the problem.
Despite knowing about the faulty design of the CPAP, BiPAP, and ventilator devices, the company then waited until June 14, 2021, to issue a voluntary recall of the affected machines.
The FDA then issued a Safety Communication on June 30, 2021, regarding the Philips Respironics recall noting that the machines had significant potential health risks. In July, the FDA acknowledged that the recall would be designated as a Class I recall, the most serious type issued by the regulatory agency.
Filing a CPAP Lawsuit
Lawsuits have been filed across the country against CPAP manufacturer Royal Philips (Koninklijke Philips) and its U.S. subsidiaries Philips Respironics and Philips North America.
Studies show that the off-gases emitted by the degradation of the polyester-based polyurethane foam contain “Volatile Organic Compounds (VOCs)” such as dimethyl diazene and phenol. These compounds may cause long-term health problems. An estimated 2 million devices with this potential dangerous defect are expected to be recalled.
Potential causes of action against Philips and other liable parties include:
- Breach of express warranty
- Breach of implied warranty of merchantability
- Fraudulent misrepresentation
- Defective design
- False or misleading advertising
- Negligence/Negligence per se
- Failure to warn
What If I Suffered an Injury or Illness After Using a CPAP Machine?
If you have been diagnosed with a respiratory illness, cancer, or another related injury after using one of the affected devices, you should contact your health provider. It is important to keep all medical records related to your treatment and consult with an attorney as soon as possible.
Reports indicate that users have found black particles in the air pathways and water reservoirs of the affected machines. Take pictures and document any evidence of particulate matter.
As noted in their recall, degradation of the foam may be exacerbated by environments with high heat and high humidity as well as unapproved cleaning methods such as the use of ozone gas or ultraviolet (UV) light.
Get the Skilled Legal Advocacy You Deserve
At Fibich, Leebron, Copeland & Briggs, we have over a century of combined experience. Our legal team has won numerous cases against pharmaceutical companies and negligent medical device manufacturers. In total, we have recovered over $1 billion for our clients.
If you suffered harm as a result of using a recalled Philips CPAP device, contact our office for a free, no-obligation consultation.
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