Philips CPAP Lawsuit – Settlements & Recall - Lung Injury Law Firm

The CPAP lawsuit claims 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

Philips CPAP Lawsuit

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.

 

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

  1. Possible carcinogenic effects (cancer)
  2. Possible toxic effects
  3. Respiratory issues
  4. Adverse effects to liver, kidneys, and other organs
  5. Inflammation
  6. Irritation of eye, skin, and respiratory tract
  7. Headaches

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).

  1. Possible carcinogenic effects (cancer)
  2. Possible toxic effects
  3. Nausea/vomiting
  4. Hypersensitivity
  5. Irritation of eye, nose, skin, and respiratory tract
  6. Headaches
 

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:

  1. Past and future medical expenses to treat your injuries.
  2. Past and future pain and suffering that results from your injuries, both from a physical and mental standpoint.
  3. Wage loss, if any.
  4. Other economic losses experienced because of your injuries.
  5. Punitive damages, if appropriate.

 
 
Why Choose Our Law Firm

Our law firm started handling personal injury cases in 1955. Today, we are recognized as a national leader in lawsuits involving medical device injuries. We have received over 150 jury verdicts for $1 million or more, and have won jury verdicts and settlements in excess of $8 billion.

We are the founder of Mass Torts Made Perfect. This is a national conference attended by 1,500 lawyers each year where we teach how to successfully handle lawsuits against drug manufacturers. For more information, please visit our About Us section.

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Our Fees & Costs

Our lawyers provide free confidential case evaluations, and we never charge any fees or costs unless you first recover.

The contingency fee we charge ranges from 20% to 40%. The amount we charge is based on how much we recover for you. To review a summary of our fees and costs, click Fees & Costs.

 
Free Case Evaluation

To contact us for a free case evaluation, you can call us at (800) 277-1193. You also can request an evaluation by clicking Free & Confidential Philips CPAP Evaluation Form. This form will be immediately reviewed by one of our attorneys handling the Philips CPAP litigation.

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Will My Philips CPAP Case be Handled as a Class Action?

A class action is a lawsuit where a few individuals represent the interest of many individuals. The court rulings are binding on all persons who are a part of the class action. All class members are required to accept the settlement, even if an individual is going to receive little or no compensation.

Our Philips CPAP attorneys will not be pursuing class actions for our clients. Instead, we represent each client on his/her specific facts, and we evaluate each client's damages on his/her specific facts. Each of our clients has the option of settling or not settling his/her case.

For a detailed discussion on class actions, mass torts, and multidistrict litigation, please visit our Class Action Mass Torts Page.

 

Philips CPAP Lawsuit Settlements

Philips CPAP Settlements

As of this time, there have been no large groups of mass torts settlements involving Philips CPAP machine and the link to lung injuries. However, litigation likes this generally takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.

Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (known as an MDL).

 

Attorneys Mike Papantonio & Troy Bouk Discuss the Philips CPAP Lawsuits

 

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

  1. DreamStation ASV
  2. DreamStation ST, AVAPS
  3. SystemOne ASV4
  4. C Series ASV, S/T, AVAPS
  5. OmniLab Advanced Plus In-Lab Titration Device

Non-continuous Ventilator

  1. SystemOne Q series
  2. DreamStation CPAP, Auto CPAP, BiPAP
  3. DreamStation Go CPAP, APAP
  4. Dorma 400, 500 CPAP
  5. REMStar SE AutoCPAP

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  1. E30 (Under Emergency Use Authorization)

Continuous Ventilator

  1. Trilogy 100Ventilator
  2. Trilogy 200Ventilator
  3. Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  1. 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:

  1. Design Defect: When a medical device is manufactured per design specifications, but the design itself renders the medical device ineffective or unsafe;
  2. Manufacturing Defect: When a medical device is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
  3. 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

Philips Recalls Millions of Sleep Apnea CPAP Machines, Ventilators

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.

“Philips Recalls Ventilators and Sleep Apnea CPAP Machines Over Cancer Concerns”

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.

“Philips Recalls Certain Sleep and Respiratory Care Devices”

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

“Infant Exposure to Emissions of Volatile Organic Compounds from Crib Mattresses”

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.

“Cancer Incidence and Mortality in the Swedish Polyurethane Foam Manufacturing Industry”

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.

“Toxicity of Excipients--a Food and Drug Administration Perspective”

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.