In July 2021, the U.S. Food and Drug Administration (FDA) released a notice identifying a June 2021 Philips Respironics’ recall of certain ventilators, BiPAP, and CPAP machines as a Class I recall. This classification means the recalled devices can cause serious injuries or death.
The Law Offices of Anidjar & Levine is investigating claims on behalf of people who used the recalled Philips CPAP machines and subsequently developed lung injuries, cancer, or other illnesses associated with the defective devices.
Our legal team has many years of experience representing the injured people of Florida. From our client testimonials you will see our passionate fight against large corporations and insurance companies has brought our clients consistent results. Best of all, we do not get paid unless you do, and your initial consultation is free.
You Have the Means to Recover Damages from Your CPAP Injuries
Class I is the FDA’s most serious classification of recall. Philips’ recalled CPAP machines potentially link to multiple injuries and health risks, such as lung injuries and cancer. By filing a claim or lawsuit against the manufacturer of these defective devices, you could receive compensation for the following:
- Injury-related medical expenses (past and future)
- Loss of wages
- Pain and suffering
- Mental anguish
- Emotional stress
- Diminished future potential earnings
- Diminished quality of life
In some cases, plaintiffs in similar lawsuits have also collected punitive damages.
A class-action lawsuit currently pending in the United States District Court for the District of Massachusetts seeks to recover all damages that consumers have suffered from the use of their Philips CPAP machines. The action further demands that Philips replace users’ devices with free, safe, and effective alternative machines.
How are the Recalled Philips Respironics CPAP Machines Defective?
In June 2021, the FDA issued a Safety Notification about Philips Respironics’ recall of multiple Bi-Level Positive Airway Pressure (Bi-Level PAP); Continuous Positive Airway Pressure (CPAP); and mechanical ventilator devices because of potential risks of lung injuries, cancer, and other health concerns. The product family most affected by the defective design is the first-generation DreamStation line of devices.
Degrading Sound Abatement foam Releases Into Air Pathways
The FDA cautioned device users and healthcare providers that the recalled machines use a polyester-based polyurethane (PE-PUR) sound abatement foam component. The purpose of the foam is to soften the sound and vibration in the CPAP devices.
Philips discovered that the foam could disintegrate, releasing particles into the machines’ air pathways, where users could ingest or inhale them. Off-gassing of potentially toxic chemicals from the foam could also pose health risks to users.
Environmental Conditions Exacerbate foam Degradation
According to Philips, unapproved cleaning methods, including the use of ozone, could contribute to the foam’s degradation. Furthermore, environmental conditions like high temperatures and humidity in places where the machines are stored or used could heighten the risks outlined in the products’ recall.
FDA Reported Risks of Cleaning CPAP Machines with Ozone or UV Light
On February 27, 2020, an FDA Safety Communication reported on the risks of using ozone and ultraviolet (UV) light products to clean CPAP machines. According to the alert, the agency had not authorized using these methods for cleaning such medical devices.
While “activated oxygen” can be useful in killing harmful bacteria, the FDA cautions that the gas must be used at concentration levels beyond what is safe for humans to be effective. Incorrect use of ozone—leading to leaks and unsafe levels within the device and its tubing—could cause the following side effects:
- Irritation in the lung, nasal cavity, or breathing passages
- Asthma and other chronic respiratory diseases
- Heightened risk of respiratory infection
The FDA has received patient reports with complaints of the following symptoms and effects after using ozone to clean their CPAP machines and accessories:
- Cough
- Trouble breathing
- Headaches
- Asthma attacks
- Nasal irritation
No reports have been received about problems from UV light cleaning methods. However, the FDA cautions users that such methods could lead to:
- Eye injury
- Skin burns
- Heightened risk of skin cancer
Philips Discovered Multiple Potentially Harmful Chemicals from Degraded Foam
In its lab analysis of degrading foam from affected CPAP machines, Philips detected several forms of harmful chemicals, including the following:
- Toluene diamine: Could cause cancer, genetic defects, skin reactions, and organ damage, and have a negative impact on fertility
- Toluene diisocyanate: Could be fatal when inhaled and could cause cancer, respiratory irritation, eye damage, and skin irritation
- Diethylene glycol: Could be toxic if ingested and could irritate eyes, mucous membranes, and skin
The lab also detected dimethyl diazene and phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl).
These Defective, Dangerous CPAP Devices are Affected by Philips’ Recall
Reportedly, between three and four million Philips Respironics devices use the sound abatement foam, which prompted this massive recall. Most of the recalled machines are members of the first-generation DreamStation product family. All were manufactured before April 26, 2021, and are within the five-year service life.
DreamStation 2 machines are not affected by issues noted in this recall.
Philips has recalled the following CPAP and Bi-Level PAP devices and ventilators:
Continuous Ventilator, Non-Life Supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus
Non-Continuous Ventilator
- SystemOne Q series
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation Go CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE AutoCPAP
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- E30 (Under Emergency Use Authorization)
Continuous Ventilator
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP V30 Auto Ventilator
If you are unsure whether your CPAP machine falls within the manufacturer’s recall, you can refer to the Philips website and use an online form to verify the status of your device.
Who is Affected by the Philips CPAP Recall?
Philips enjoys a 65 percent share of the CPAP market. Individuals who purchased the machines listed above are affected by the recall and the health risks they have been subjected to since they first began using these devices.
More troubling is that the U.S. Department of Veterans Affairs (VA) has distributed around 300,000 Philips CPAP or BiLevel PAP devices for use by veterans in their homes. Two thousand additional units currently exist in VA clinics or hospital settings.
Understanding the Legal Basis for the Lawsuits Against Philips CPAP Manufacturer
The first mention of the problematic sound abatement foam appeared in Philips Respironics’ quarterly report (first quarter, 2021).
Design Defect
According to tort law, the company could be held liable for damages resulting from the recalled devices under the legal premise of manufacturing defect, which holds that Philips’ devices were designed in such a manner as to render them unsafe or ineffective.
Manufacturing Defect
If the CPAP machines had been safely designed but were subjected to a manufacturing mistake that rendered them unsafe, the company could still be liable under the theory of manufacturing defect.
Failure to Warn
Tort law also holds companies like Philips Respironics liable for failure to warn. This happens when manufacturers fail to warn the public—in this case, users and healthcare providers—of health or safety risks or when they fail to instruct users on operating the devices safely.
Philips failed to warn users of the risks of the recalled medical devices in the CPAP User Manual or elsewhere, opening the company up to liability under failure to warn theory.
Quite possibly, additional causes of action against the recalled CPAP manufacturer could include the following:
- Consumer fraud
- Gross negligence
- Negligence per se
- Fraudulent misrepresentation
- Fraudulent concealment
- Negligent misrepresentation
- Breach of implied and express warranties
A Class-Action Lawsuit is Already Underway
Given the large number of affected machines in use, it is likely that there will be hundreds of thousands of plaintiffs involved in litigation. Many of these cases will be consolidated in multidistrict litigation (MDL), wherein cases that share similar facts also share the pretrial proceedings (discovery, motions to dismiss, evidentiary challenges, etc.). Afterward, each case is decided on its own merits.
Alternatively, in a class action, a court consolidates all claims into a single lawsuit. A Philips CPAP class-action lawsuit—Shelton v. Koninklijke Philips N.V., et al., No. 1:21-cv-11076 (D. Mass.)—was filed on June 29, 2021, in a Massachusetts federal court.
Allegations in the Philips CPAP Class Action
According to a PR Newswire press release from the class-action lawsuit’s filing attorney, the plaintiff’s complaint accuses Philips of knowing about the risks from its medical devices “long before” the manufacturer recalled the machines. The complaint further states that Philips CPAP users have complained to the manufacturer for years about black particles in the medical devices. Despite this early and repeated information, Philips did not warn the public about the risks of their CPAP machines.
Taking their allegations a step further, plaintiffs in the class action accuse Philips of timing the recall of their first-generation DreamStation machines with the release of the next generation of this product family. The newer machines do not have the same problems that prompted the first-generation recall.
The plaintiffs point out that Philips’ DreamStation customers would naturally be forced to replace their defective machines with the company’s newer models, serving only to benefit the manufacturer financially.
Have You Experienced These Side Effects or Injuries from Your Philips CPAP?
The FDA explains that users can ingest black foam particles emitted from the degrading CPAPs’ foam when it enters the airpath circuit (which extends from the machine’s outlet, humidifier, tubing, and mask). Device users can also inhale chemicals released from the machines’ off-gassing. The FDA reports having received more than 1,200 complaints and more than 100 reports of injuries connected with these issues.
As of this writing, the agency says the following injuries and health risks have been reported:
- Eye irritation
- Skin irritation
- Respiratory tract irritation
- Headache
- Inflammation
- Asthma
- Nausea and/or vomiting
- Hypersensitivity
- Adverse effects on kidneys
- Adverse effects on liver
- Toxic, carcinogenic effects
What to Do if You are a User of a Recalled Philips CPAP, Bi-Pap, or Ventilator
Philips recommends that patients and customers who use the affected Philips machines take specific steps, depending on the type of machine.
BiLevel PAP and CPAP Users Should Stop Use
The manufacturer recommends that patients discontinue their use of recalled BiLevel PAP and CPAP machines. Contact your healthcare provider or durable medical equipment (DME) provider to discuss the best alternatives to continue your treatment. In some cases, a physician might determine that the benefits of using your recalled machine outweigh the risks.
Life-Sustaining Mechanical Ventilator Users Should not Discontinue Use
Philips urges patients who use recalled life-sustaining ventilator devices to continue using the machines until they have discussed the matter with their physicians. It could be that the prescribed therapy cannot be interrupted, or possibly no alternative ventilator options exist. The patients’ physicians are best equipped to determine which is more pressing—the risks of continued ventilator use or the importance of continuous treatment.
The Philips website contains information that physicians and health care providers can use when helping patients make decisions about their CPAP machine treatment in light of the recalls.
Philips is Working on a Repair and Replacement Program
A Philips press release states the company plans to launch a “correction” to the defective CPAP devices. Their proposed program involves replacing the existing sound abatement foam with a new material. The manufacturer will need to get the proper regulatory clearance before this can happen.
As soon as the foam in the first-generation machines has been corrected with this new material, the devices will be shipped.
Philips also stated it is scaling up production of the company’s DreamStation 2 CPAP machines. Again, these devices were not affected by the problems posed by the first generation’s sound abatement foam components.
Our Attorneys Stand Ready to Investigate Your Claim
If you or a loved one purchased an affected Philips CPAP, BiPAP, or mechanical ventilator and has been diagnosed with a medical illness, condition, or injury from using the device, let us know. Our lawyers want to help guide you through your pursuit of compensation. We work on contingency, meaning you pay our firm no legal fees unless and until we win a settlement or court award on your behalf.
Call the Law Offices of Anidjar & Levine today for a free consultation: 1-800-747-3733.
