The Philips CPAP lawsuits claim the use of various Philips CPAP machines can cause lung injuries and even cancer.
Our law firm is representing individuals who utilized Philips CPAP machines and have been medically treated for lung injuries or cancer.
We have been handling lawsuits against medical device manufacturers since 1955. Each year we teach 1,500 attorneys how to successfully handle these cases. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
What We Know About the Philips CPAP Lawsuits
On June 14, 2021, Philips announced a voluntary recall for various Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices.
The recall provides potential health risks the company identified in their devices’ polyester-based polyurethane (PE-PUR) sound abatement foam component. This component can disintegrate or outgas, causing users to inhale and/or ingest toxic and possibly carcinogenic substances. The recalled devices include those in the first-generation DreamStation product family.
Philips first publicized the adverse, foam-related effects of its CPAP and Bi-Level PAP devices in its first-quarter 2021 company report. Based on reports and testing, Philips determined the PE-PUR foam could degrade into particles. These particles can then enter the device’s air pathway and be ingested or inhaled by the user. Furthermore, the foam may off-gas certain chemicals.
Philips further explained that unapproved cleaning methods, including ozone, can exacerbate foam degradation, as can specific environmental conditions that involve high humidity and temperature. Philips states these environmental conditions involve the climate and temperatures of the locations where the devices are being used and stored, not the temperature and humidity caused by a patient's use of the devices.
The CPAP User Manual for the first-generation DreamStation product family—which comprises most of the affected medical devices—failed to warn of these potential health risks.
Since the Phillips June 2021 voluntary recall of most of its previous CPAP, Bi-Level PAP, and ventilator machines, several developments have occurred in the realm of litigation:
First, the U.S. Food and Drug Administration (FDA) has since classified this recall as a Class I recall—the most serious type of recall—due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. The FDA noted in classifying this recall that there is around 10 million affected models in circulation, compared to the previous 4-5 Philips previously disclosed.
Second, the Judicial Panel of Multi-District Litigation (JPML) heard oral arguments for consolidation of the litigation on September 30th, 2021.
For clarification, a Multi-District Litigation (MDL) is a civil judicial procedure that can have two components, a class action side and a personal injury side. Each plaintiff in the personal injury or mass tort side has their own particular claim for the personal injuries they suffered, and as a result, each settlement, if and when it occurs, is unique. Plaintiffs in class action lawsuits file as a single "class," with individuals who participate sharing a share of a lump-sum reward if a settlement is reached.
On October 8th, 2021, after hearing arguments for consolidation of the MDL in eight different courts, the panel settled on the Western District of Pennsylvania as the most appropriate place to consolidate the action. The case was assigned to U.S. District Judge Joy Flowers Conti who has experience with MDL’s, class action cases and other complex litigation. The decision was made and backed by the parties' logistical convenience, as well as the proximity to where the devices were largely manufactured, by Philips RS North America LLC (previously Philips Respironics).
Among the districts that were argued, the second most supported district for consolidation was Massachusetts, where Philips maintains its North American headquarters; other options mentioned were California, Oregon, Kansas, West Virginia, Virginia, Georgia, and Louisiana. On November 10th, 2021, Judge Conti administered her first Pre-Trial Order (PTO 001) which contained standard language outlining the basics for all the related actions that will be included in any Conditional Transfer Orders (CTO’s) that have or will be entered. Along with information guiding the transfer of cases, the Order also outlined the Plaintiff leadership selection structure.
Consolidation is a major milestone for this litigation and will allow the Plaintiffs to pool their resources and streamline the pre-trial process for all the litigants involved. Levin, Papantonio, Rafferty looks forward to being a part of this major MDL and will continue to provide updates regarding case progression. If you or a loved one has used a Philips CPAP, BiPAP, or Mechanical Ventilator and have suffered injuries, you may be entitled to compensation. Please contact our firm today.
Possible Side Effects and Injuries from Philips CPAP Machines
Philips reports the following potential health risks caused by the foam degradation in the recalled CPAP and Bi-Level PAP devices.
Particulate Exposure Health Risks
- Possible carcinogenic effects (cancer)
- Possible toxic effects
- Respiratory issues
- Adverse effects to liver, kidneys, and other organs
- Irritation of eye, skin, and respiratory tract
According to Philips, patients have also reported black debris/particles in the airpath circuit of the machines. The company has received patient complaints about sinus infection, chest pressure, upper airway irritation, and headaches.
Off-Gassing Health Risks
Philips reports the following potential health risks from off-gassing (this is the release of volatile organic compounds and other harmful chemicals in vapor form).
- Possible carcinogenic effects (cancer)
- Possible toxic effects
- Irritation of eye, nose, skin, and respiratory tract
What Compensation is Recoverable in a Philips CPAP Lawsuit?
If you were using any of the Philips CPAP machines and experienced lung damage or cancer, we will be seeking the following compensation for you:
- Past and future medical expenses to treat your injuries.
- Past and future pain and suffering that results from your injuries, both from a physical and mental standpoint.
- Wage loss, if any.
- Other economic losses experienced because of your injuries.
- Punitive damages, if appropriate.
Philips CPAP Lawsuit Settlements
In October 2021, an MDL was established for the Philips CPAP recall in federal court in Pennsylvania. The judge in that case has appointed our law firm to the Philips CPAP Plaintiffs’ Steering Committee and to the Science and Expert Committee.
The creation of an MDL is the first step in the litigation process that starts the settlement negotiations. Once the MDL has been formed, discovery of the facts and trials can begin, which then leads to serious settlement discussions.
As of May 16, 2022, more than 300 lawsuits were pending in the MDL.
FDA Issues a Class 1 Recall of Philips CPAP Machines
On June 30, 2021, the Food and Drug Administration issued a safety communication "alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway."
As of July 22, 2021, the FDA issued an official Class 1 recall of numerous Philips CPAP Machines. As noted by the FDA, a class 1 recall is "the most serious type of recall. Use of these devices may cause serious injuries or death." Devices included in this recall are listed in the section below titled "Who Is Affected by the Philips CPAP Recall?."
The FDA urges individuals to stop using their devices and to try using a device not affected by the recall. Users could also try alternative sleep apnea treatments, including oral appliances and positional therapy.
FDA also suggests that BiPap and CPAP users consider long-term sleep apnea therapies, including:
- Surgical procedures
- Avoiding alcohol
- Losing weight
- Cease smoking
BiPap and CPAP users should speak to their physicians to determine which plan of action best suits their sleep apnea condition. In some cases, the benefits of continued use of an affected Philips device could outweigh the risks outlined in the company’s recall, according to the FDA.
The FDA also urged BiPap and CPAP users to follow recommended cleaning and replacement guidelines as provided in the manufacturer’s instructions, including steering away from ozone and ultraviolet light products for cleaning purposes.
For users of recalled ventilators, the FDA recommends talking to a healthcare provider about possible alternate ventilator options. Users should also ask about inline bacterial filters. These devices could serve to filter out foam particles, according to the Philips recall notification. The FDA’s notice conveyed the agency cannot speak to the effectiveness or safety of these filters and points out that the filters would have no impact on chemicals released from the foam. Furthermore, the filters could block the free flow of air through the ventilator, affecting its performance.
The FDA recommends that users keep a watchful eye on their ventilators after outfitting them with filters. They should check for foam debris and effective airflow.
The agency asks users to register their devices on the Philips Respironics recall website so they can receive updates on new information and fixes. Finally, any device user who experiences problems with these devices is encouraged to report their problems via the FDA’s MedWatch Voluntary Reporting Form.
The FDA reports that it continues to work with Philips Respironics on the recall, as well as corrective steps the company must take. The agency is analyzing medical device reports connected to the problems with these devices and will persist in its monitoring trends with supply and demand, and any updates users should be aware.
Who Is Affected by the Philips CPAP Recall?
Philips has a 65% share of the CPAP market. The recall affects 3 to 4 million Philips machines that use the sound abatement foam. Philips has provided an online form you can use to see if your device is affected by the recall.
The following Philips CPAP and BiLevel PAP devices manufactured before April 26, 2021, are affected by the manufacturer’s recall notification:
Continuous Ventilator, Non-life Supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- 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)
- Trilogy 100Ventilator
- Trilogy 200Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP V30 AutoVentilator
How Liability Law Applies to the CPAP Cases
Under most state laws, a patient injured through the use of a defective medical device can bring a lawsuit based on the following legal theories:
- Design Defect: When a medical device is manufactured per design specifications, but the design itself renders the medical device ineffective or unsafe;
- Manufacturing Defect: When a medical device is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
- Failure to Warn: When the medical device manufacturer fails to warn the public of the risks or to provide adequate instructions about the use of the medical device, thereby rendering it unsafe or dangerous.
All states enforce a statute of limitations that limits the amount of time you have to file a lawsuit against a medical device manufacturer. A member of our legal team can inform you of your state’s laws.
Repairing and Replacing the CPAP and Bi-Level PAP Devices
The next generation CPAP platform, DreamStation 2, is not affected by the sound abatement platform. The recall only applies to the first-generation DreamStation product families. The company advises it will replace the first-generation devices’ current sound abatement foam with a new material once they have received the required regulatory clearances.
Meanwhile, Philips advises patients using the recalled BiLevel PAP and CPAP devices to stop using them and to ask their physicians about alternative treatment options. The company advises patients using affected life-sustaining mechanical ventilator devices to not discontinue their use until the patients have spoken with their physicians.
How CPAPs are Utilized
Medline Plus explains the use of PAPs and CPAPs are used to treat patients who suffer from obstructive sleep apnea. According to this source, positive airway pressure (PAP) devices pump air into the airway of patients’ lungs, thereby keeping their windpipes open while they sleep.
A continuous positive airway pressure (CPAP) device eliminates the concern that patients have of airway collapse that would otherwise prevent their breathing.
A bilevel positive airway pressure device uses two different pressure levels—higher when the patient breathes in and lower when they breathe out. This design can be useful for patients with decreased air exchange in the lung, muscle weakness, or airways that collapse while sleeping.
Philips CPAP and BiLevel PAP News
The AARP published this article to warn members of the Philips CPAP recalls. The article reports on the effects that patients have reported and explains the condition of sleep apnea, which Philips’ devices are designed to treat. The page also includes a discussion forum where members can participate in a dialogue about the recall.
CBS News reports on Philips’ recalling of its breathing devices and ventilators that use polyester-based polyurethane sound abatement foam. This foam, used to dampen the noise generated by the machines, can deteriorate, causing gases and tiny particles to be inhaled and/or ingested by the user. The risks run the range from airway irritation and headaches to possible cancer risks, the article says.
Business Insider writes about the recall of Philips’ CPAP, PAP, and mechanical ventilator machines, using much of the information from the manufacturer’s press release announcing the recall notification. According to Business Insider, Philips says it has manufactured millions of Bi-Level PAP, CPAP, and mechanical ventilator devices with the PE-PUR sound abatement foam.
Scientific Studies Regarding Philips CPAP and BiLevel PAP
In 2014, Environmental Science & Technology published a study of volatile organic compounds (VOCs) released from 21 new and used baby crib mattresses. According to the study results, polyurethane foam released a wider variety of VOCs than polyester foam. The authors concluded that crib mattresses provide a meaningful source of VOCs and that when infants sleep in these environments, they suffer an elevated exposure to these compounds.
“National Patient Safety Alert: Philips Ventilator, CPAP And Bipap Devices: Potential for Patient Harm Due to Inhalation of Particles and Volatile Organic Compounds”
On June 23, 2021, Medicines and Healthcare Products Regulatory Agency (MHRA) issued a National Patient Safety Alert about Philips urgent Field Safety Notices. MHRA talks about the risks involved in ceasing treatment with Philips’ recalled devices, as well as the options for using filters for ventilator systems. Most importantly, MHRA points to evidence suggesting the presence of diethylene glycol and degradation by-products Toluene Diamine and Toluene Diisocyanate, which the IARC classifies as Group 2B carcinogens. The alert further reports that diisocynanate is associated with a type of asthma.
This 1993 study was conducted by Lars Hagmar, et al., of the Department of Occupational and Environmental Medicine, University Hospital, in Lund Sweden. Researchers explored the use of Toluene diisocyanate (TDI) and methylene diphenyldiisocyanate (MDI) in the polyurethane foam manufacturing industry. The scientists studied the occupational hazard of cancer for workers in Swedish plants manufacturing this foam. The researchers found non-statistically significant increases for rectal cancer and non-Hodgkin’s lymphoma (NHL) in these workers.
“Incidence of Cancer and Exposure to Toluene Diisocyanate and Methylene Diphenyldiisocyanate: A Cohort Based Case-Referent Study in the Polyurethane Foam Manufacturing Industry”
This additional study by Hagmar, et al., reviewed more than 7,000 subjects working in nine polyurethane foam manufacturing plants between 1958 and 1987 to determine any association between exposure to toluene diisocyanate or methylene diphenyldiisocyanate and the risk of cancer. The researchers found a non-significant association between high exposures to isocyanates and prostate cancer and colon cancer.
The International Journal of Toxicology published a study in 2003 indicating that an identified VOC, diethylene glycol, is known to be associated with renal failure and neurological toxicity when ingested orally.