The current Philips CPAP lawsuits allege that the following sleep apnea devices:
- Bi-Level Positive Airway Pressure (Bi-Level PAP),
- Continuous Positive Airway Pressure (CPAP), and
- Mechanical Ventilators
all have a design defect that causes users to ingest or inhale degraded foam particles. Prolonged use of these devices may lead to side effects such as lung and respiratory problems, cancer, and other injuries.
Shouse Law Group is a personal injury law firm that is representing Philips CPAP users from throughout the United States. We are bringing lawsuits to recover compensation for medical bills, lost wages, and pain and suffering.
Shouse Law Group is accepting cases where the patient used one or more of the recalled CPAP devices and afterward was medically diagnosed with any of the following health conditions:
- Acute inhalation injury
- Acute respiratory distress system (ARDS)
- Autoimmune disorders
- Bladder cancer
- Brain cancer
- Breast cancer
- Cancer (any type)
- Chronic asthma
- Chronic bronchitis
- Heart attack or failure
- Hematopoietic cancer
- Inflammation of the ears, nose, or throat
- Inflammation and fluid build-up in the lungs
- Interstitial lung disease
- Kidney cancer
- Kidney disease / Renal disease
- Liver cancer or disease
- Lung cancer or damage
- Lymphoma (including Non-Hodgkins and other lymphatic cancers)
- Multiple myeloma
- Nasal cancer
- Organ damage
- Papillary carcinoma
- Pleural effusion
- Prostate cancer
- Pulmonary fibrosis
- Reactive airway disease (RAD)
- Rectal cancer
- Respiratory failure
- Stomach cancer
- Testicular cancer
- Thyroid cancer
A plaintiff will have a stronger case if he or she is not also a smoker or former smoker. Current and former smokers may therefore be ineligible for a lawsuit.
In this article, our attorneys will answer the following key questions about the Philips CPAP class action and mass tort lawsuits:
- 1. Which Philips sleep apnea devices have been recalled?
- 2. Why were they recalled?
- 3. What injuries can the recalled CPAPs cause?
- 4. How big is the potential payout to victims?
- 5. What is the current status of the Philips CPAP lawsuits?
- 6. Who makes the recalled CPAPs?
- 7. What is sleep apnea?
- 8. What if I was injured by the defective devices?
1. Which Philips sleep apnea devices have been recalled?
On June 14, 2021, Philips voluntarily recalled four million of the following CPAP (continuous positive airway pressure), BiLevel PAP (bi-level positive airway pressure), and mechanical ventilator devices:
- A-Series BiPAP A30 (mechanical ventilator – continuous – also non-life supporting)
- C Series ASV, S/T, AVAPS (continuous ventilator, also non-life supporting)
- Dorma 400, 500 CPAP (non-continuous ventilator)
- A-Series BiPAP A40 (mechanical ventilator – continuous – also non-life supporting)
- DreamStation ASV (continuous ventilator, non-life supporting)
- A-Series BiPAP Hybrid A30 (mechanical ventilator – also continuous – minimum ventilatory support – facility use)
- DreamStation CPAP, Auto CPAP, BiPAP (non-continuous ventilator)
- A-Series BiPAP V30 AutoVentilator (mechanical ventilator – also continuous – minimum ventilatory support – facility use)
- DreamStation Go CPAP, APAP (travel-sized, non-continuous ventilator)
- E30 (under emergency use authorization – also continuous ventilator, minimum ventilatory support, facility use)
- DreamStation ST, AVAPS (continuous ventilator, also non-life supporting)
- Garbin Plus, Aeris, LifeVent Ventilator (mechanical ventilator – also continuous)
- OmniLab Advanced Plus In-Lab Titration Device (continuous ventilator, also non-life supporting)
- REMStar SE Auto CPAP (non-continuous ventilator)
- SystemOne ASV4 (continuous ventilator, also non-life supporting)
- Trilogy 100 Ventilator (mechanical ventilator – also continuous)
- SystemOne Q series (non-continuous ventilator)
- Trilogy 200 Ventilator (mechanical ventilator – also continuous)
The FDA classifies this voluntary recall as Class 1 – the most serious.
Note that the following Philips products are still safe and are not recalled:
- Trilogy Evo
- BiPAP A40 EFL
- Trilogy Evo OBM
- BiPAP A40 Pro
- Trilogy EV300
- Trilogy 202
- DreamStation 2 family of products (which hit the market in March of 2021, shortly before the recall)
- Dorma 100
- Omnilab (original based on Harmony 2)
- Dorma 200
- REMStar SE
- Oxygen concentrators
- Respiratory drug delivery products
- Also all airway clearance products
Note that Philips now has regulatory clearance to replace the defective sound abatement foam in the recalled first-generation DreamStation devices.1
2. Why were they recalled?
The recalled Philips Bi-PAP machines, CPAP machines, and mechanical ventilator devices contain sound abatement foam liners made from PE-PUR (polyester-based polyurethane). PE-PUR can disintegrate into particles that users can then inhale or ingest. The devices however contain no filter to prevent this inhalation or ingestion.
PE-PUR foam can also “off-gas” or emit vapors of toxic chemicals – even carcinogenic chemicals – beyond the safe exposure threshold. These volatile organic compounds (VOCs) include:
- Toluene diisocyanate: A liquid ingredient of foams and coatings. Inhalation can cause death. It can also cause cancer, eye injuries, skin problems, and respiratory irritation.
- Toluene diamine: An ingredient of polyurethane, color dyes, hydraulic fluid and explosive sensitizers. This toxic chemical can consequently cause birth defects, cancer, skin problems, infertility, and organ injuries.
- Diethylene glycol: This chemical solvent can be toxic if ingested. It can also irritate skin, the eyes and mucous membranes.
- Dimethyl diazene (also known as Azomethane, (CH3N) 2, 1.2-Dimethyldiazene, Dimethyldiazene): This gas is used to make other chemicals.
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)(a.k.a. carbolic acid): Also a gas used to make other chemicals.
Some users have also reported seeing black debris in their breathing tubes and airpath circuits – visual evidence of foam degradation.
Unapproved cleaning processes – such as ozone or ultraviolet light – can make foam degradation worse. (Philips no longer considers SoClean to be an approved cleaning method.) The foam is more likely to degrade the older the device is and the more users operate it.
Furthermore, climate and environmental conditions such as high heat, high temperatures and humidity in the locations where the devices are being stored can also exacerbate the degradation of foam. (Any body heat or moistness that the user generates should not negatively affect the foam.)2
In short, Philips sleep apnea devices meant to improve people’s breathing are instead contaminating their airways.
3. What injuries can the recalled CPAPs cause?
The Philips recalled CPAP devices, Bi-Level PAP devices, and mechanical ventilator devices can potentially result in lung injury, pulmonary fibrosis, and possibly cancer. A Philips press release said:
These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.
These defective CPAP breathing machines are therefore causing such side effects and symptoms as:
- upper airway irritation,
- inflammation of the lungs, and/or
- toxic and carcinogenic effects (cancer risks)
Particulate exposure from the PE-PUR degraded foam can also cause such health issues as:
- respiratory issues such as asthma,
- irritation to the skin, eyes and/or respiratory tract, and/or
- adverse effects to the liver or kidneys
Meanwhile, chemical exposure from PE-PUR off-gassing can also cause:
- hypersensitivity, and/or
- nausea and vomiting
Philips customers have also reported such symptoms as sore throats, chest pressure, and sinus infections.3
4. How big is the potential payout to victims?
Cancer victims of Philips’ recalled sleep apnea devices may be eligible for a six-figure payout or more depending on the case. Attorneys are fighting to recover the following compensatory damages:
- Medical expenses, including for hospital stays, doctor’s appointments, medications, and new breathing devices to replace the recalled ones;
- Lost wages from having to miss work from being too ill;
- Loss of future earnings, if the recalled device caused the defendant to be too sick to work in the future;
- Pain and suffering; and
- Other economic losses
In cases that go to trial, the court may also award plaintiffs punitive damages if it finds that Philips acted in a malicious or shocking way. Courts could grant punitive damages if plaintiffs can show that Philips knew about the PE-PUR degradation hazards and risks and did nothing about it. There is some emerging evidence that customers have been complaining to Philips about particulate exposure for years prior to the CPAP recall.
Another potential ground for punitive damages is that Philips allegedly coordinated the recall to overlap with a new product launch of safer CPAP products. This would force customers reliant on CPAPs to purchase these new products (or a competitor’s products) at their own expense if Philips fails to immediately replace their recalled products. The new Dreamstation 2 model was launched only on April 13, 2021 – just a few weeks before the recall.
Punitive damages can often far exceed compensatory damages.
5. What is the current status of the Philips CPAP lawsuits?
Litigation is in a very early stage, and there are potentially hundreds of thousands of plaintiffs throughout the United States. It is expected that there will be a federal MDL (multi-district litigation), which expedites the court process by temporarily consolidating all of these personal injury cases during pretrial and discovery proceedings.4 Unlike with class actions, MDL plaintiffs’ cases remain separate.
On September 30, 2021, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments over whether to consolidate all federal Philips cases into an MDL, and where. Potential jurisdictions include the Eastern District of Pennsylvania or the District of Massachusetts (which Philips prefers), amongst others.
Assuming an MDL forms, the judge will eventually allow a few cases to go to a jury trial – called bellwether trials. How the juries decide these cases will set the tone for negotiations for the remainder of the cases in the MDL. In sum, the higher the jury verdict, the higher the settlement amounts.
On June 29, 2021, a class-action lawsuit was filed in a federal court in Massachusetts: Shelton v. Koninklijke Philips N.V., et al., No. 1:21-cv-11076 (D. Mass.). Once an MDL forms, the class action will likely serve the limited purpose of paying for medical monitoring and reimbursing uninjured plaintiffs who paid out-of-pocket for their now recalled CPAP devices. Many patients get their devices for free through Medicare, Medicaid, the VA, or private insurance.
Grounds for Philips CPAP lawsuits
Expected causes of action against Philips include:
- Defective design (strict product liability and negligence) – where the product was manufactured as the design schematics specified, and the design itself is what makes the device unsafe
- Manufacturing defect – where the design may have been sound, but the device was built incorrectly
- Failure to warn – for example, there is no warning to the public about foam degradation in the original first-generation DreamStation CPAP user manual, so consumers were not fully informed about the risks
- Consumer fraud / Deceptive trade practices
- Negligence per se
- Gross negligence
- Fraudulent concealment and also fraudulent misrepresentation
- Negligent misrepresentation
- Breach of implied and express warranties
6. Who makes the recalled CPAPs?
The Dutch medical equipment manufacturer Philips makes and sells the recalled CPAP, Bi-Level PAP, and mechanical ventilator devices. Its full company name is Koninklijke Philips N.V., which translates to Royal Philips.
Philips has a 65% market share of the CPAP market. In 2008 Philips acquired Respironics, which creates the DreamStation products. Then in 2020, Philips made close to $20 billion in revenue, and 49% of its sales were from sleep and respiratory care devices.5
7. What is sleep apnea?
Sleep apnea is a disorder where a person’s breathing gets disrupted during sleep. Breathing can get shallow or stop altogether for a temporary period. People who suffer from sleep apnea often feel fatigued during the day. In serious cases, sleep apnea may cause such health problems as high blood pressure (hypertension), a stroke, and/or a heart attack.
Effective CPAP therapy can treat sleep apnea by delivering a steady oxygen flow through a mask. Therefore, these sleep apnea machines elevate air pressure in the person’s windpipe. By forcing air in, the machine keeps the airway open and prevents respiratory depression while the person is inhaling.
BiPAP machines operate with two different pressure levels. The level increases during inhale but decreases during exhale. BiPAPs are typically prescribed for patients suffering from weak muscles, collapsed airways during sleep, and decreased lung air exchange.
Sleep apnea patients can also consider surgery, positional therapy, or oral appliances for treatment. Lifestyle changes such as losing weight, stopping smoking, and abstaining from alcohol could also alleviate symptoms.6
8. What if I was injured by the defective devices?
If you are using one of the recalled Philips sleep apnea devices, you should consider:
- Consulting with a healthcare provider about how to proceed and the pros and cons of each option. Ideally you should stop using any recalled CPAPs and BiPAPs immediately, and discontinue using any recalled mechanical ventilators as soon as you get a safe replacement. Patients should also discuss whether replacement devices should contain inline bacterial filters. Bacterial filters may serve to filter out particles but would not be effective for filtering out chemicals. The filters may also compromise the airflow, reducing the machine’s efficacy. In any case, patients should remain vigilant about checking their devices for black particles.
- Preserving any evidence, such as the device itself, debris in the air pathways of the CPAP, medical records, and prescription records. Victims should take videos and photographs of the debris as well.
- Contacting an attorney to discuss your claim. Every state has its own statute of limitations by which time victims must file a claim against Philips. Your attorney will be able to inform you what your time limit to sue is.
Is recommended you consult with an attorney before submitting an adverse event report with the FDA.
It is also advised that you consult an attorney before registering your defective device on the Philips Respironics recall website – any information you give Philips could be used against you. And you can get updates and information about device fixes without registering.
Injured? Call us…
In conclusion, the recalled Philips sleep apnea devices are defective products that are unreasonably dangerous and pose a risk of cancer. So are you or your loved one a victim of a Philips CPAP machine? Call our law firm (or fill out the contact form on this page) to see whether you qualify to join the current litigation.
Our mass tort trial lawyers also offer free case evaluations. And our attorney-client relationships operate by contingency fee, so we do not get paid unless you do. Disclaimer: Results cannot be guaranteed.
- Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices, Philips News Center (June 14, 2021)(most of the recalled devices were DreamStations); see also the Philips Recall Letter by Rodney Mell; see also the FDA announcement (June 15, 2021); Toby Sterling, Philips recalls ventilators, sleep apnea machines due to health risks, Reuters (June 14, 2021)(“Spokesman [Steve] Klink said Philips had received some complaints about the devices, representing 0.03% of those sold in 2020.”). See also Positive airway pressure treatment, MedlinePlus. Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemical, FDA (“[class 1 is] the most serious type of recall. Use of these devices may cause serious injuries or death.”).
- See note 1. The catalyst for 1938’s Food, Drug, and Cosmetic Act was the more than a hundred deaths resulting from Diethylene glycol exposure in the Massengill Incident of 1937. Carol Ballentine, Sulfanilamide Disaster, FDA Consumer Magazine (June, 1981). See also Toluene diisocyanate, National Library of Medicine. DI(Hydroxyethyl)ether, National Library of Medicine. See also Diaminotoluene, National Library of Medicine.
- Note 1. Also see Katie Gibson, Philips recalls ventilators and sleep apnea CPAP machines over cancer concerns, CBSNews (June 15, 2021).
- See also Johnson & Johnson Aerosol Sunscreen Marketing, Sales Practices and Products Liability Litigation, MDL NO. 3015, Judicial Panel on Multidistrict Litigation (filed on July 29, 2021).
- See also note 1; Philips Annual Report 2020 (February 23, 2021). Philips is comprised of Philips North America (Andover, MA), Philips RS North America (Murrysville, PA), Philips Holdings USA (Cambridge, MA), and Koninklijke Philips (Amsterdam). See also Joshua Brockman, Breathing Machine Recall Over Possible Cancer Risk Leaves Millions Scrambling for Substitutes, New York Times (August 17, 2021).
- Obstructive Sleep Apnea, Mayo Clinic.
- Lars Hagmar, Hans Welinder, Zoli Mikoczy, Cancer incidence and mortality in the Swedish polyurethane foam manufacturing industry, British Journal of Industrial Medicine1993;50:537-543 (“Cancer incidence and mortality patterns were therefore investigated in a cohort of 4154 workers from nine Swedish plants manufacturing poly-urethane foam, employed for at least one year…slight (not significant) increased risks were found for rectal cancer (SIR 1-66) and non-Hodgkin’s lymphoma (SIR 1.53). The SIR for non-Hodgkin’s lymphoma increased to 2-80 (95% CI 0.76-7-16) when the first 10 years since first exposure were excluded from the observation period.”).
- Lars Hagmar, Ulf Str6mberg, Hans Welinder, Zoli Mikoczy, Incidence of cancer and exposure to toluene diisocyanate and methylene diphenyldiisocyanate: a cohort based case-referent study in the polyurethane foam manufacturing industry, British Journal of Industrial Medicine; 50:1003-1007 (1993)(there was a non-significant association between high isocyanate exposure and prostate and colon cancer in 7,000 people working in nine polyurethane foam manufacturing factories from 1958 to 1987.)
- Robert E Osterberg, Norman A See, Toxicity of excipients--a Food and Drug Administration perspective, Int J. Toxicol, Sep-Oct 2003;22(5):377-80 (“Diethylene glycol may cause renal failure.”).
- Brandon E. Boor, Helena Järnström, Atila Novoselac, and Ying Xu, Infant Exposure to Emissions of Volatile Organic Compounds from Crib Mattresses, Environ. Sci. Technol. 2014, 48, 6, 3541–3549 (February 18, 2014)(“A variety of VOCs were identified, with polyurethane foam releasing a greater diversity of VOCs compared to polyester foam. “).
Other Philips Links
- Sleep and Respiratory Care update – Clinical information for physicians, Philips, (June 14, 2021)(note that Philips is often misspelled Phillips).
- Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification*, Philips (September 1, 2021)(“Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices, which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US. Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The company intends to complete the repair and replacement programs within approximately 12 months.“).
- Medical Device recall notification (U.S. only) / field safety notice (International Markets), Philips Respironics.
- URGENT: Field Safety Notification*, Philips.
- Medical Device Recall Notification, Philips Respironics Sleep and Respiratory Care devices, Philips (“At the time of the June 2021 recall / field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions.“)
Other FDA & government Links
- Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, FDA (June 30, 2021)(“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”). Note that the recalled Philips devices are considered class II devices (which means they carry medium risk), and the FDA approves them through Premarket Notification (a.k.a. the 510(k) process).
- Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions, FDA.
- VHA National Center for Patient Safety, Philips CPAP and BiLevel PAP Recall, U.S. Department of Veterans Affairs (The U.S. Department of Veterans Affairs had distributed approximately 300,000 of the recalled Philips sleep apnea devices to veterans.).
- In re: Philips Recalled CPAP, Bi-Level PAP, and Ventilator Litigation, Motion for Transfer and Coordination or Consolidation under 28 USC 1407, Eastern District of Pennsylvania, MDL 3014. (Filed July 7, 2021).
- Notice of Hearing Session, United States Judicial Panel on Multidistrict Litigation (August 13, 2021)
Other helpful links
- National Patient Safety Alert: Philips Ventilator, CPAP And Bipap Devices: Potential for Patient Harm Due to Inhalation of Particles and Volatile Organic Compounds, Medicines and Healthcare Products Regulatory Agency (MHRA) (June 23, 2021)(“There are 2 identified issues: 1) Degradation of foam causing particles to be blown into the patient’s airway. There have been a small number of reports outside the UK of this causing minor, short-term effects such as irritation to the skin, eye, and respiratory tract; an inflammatory response; headaches; asthma. Inappropriate use and decontamination can worsen the foam degradation. Devices should be used and decontaminated as stated in the manufacturer’s instructions for use. 2) Release of volatile organic compounds (VOC) including Dimethyl diazene and Phenol. Evidence suggests these gases dissipate after 24 hours from first ‘out of box’ use. There is a risk of short-term effects such as headache/dizziness; irritation of the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea and vomiting. There have not been any reports of this to date. Patients with known allergies or sensitivities to these VOCs should be prioritized for an alternative device if available. There is currently no definitive data showing long-term harm to patients, but VOCs and degradation of the foam are associated with possible long-term effects such as genotoxicity; mutagenic and carcinogenic effects; hepatotoxicity; nephrotoxicity; neurotoxicity.” In addition, the International Agency for Research on Cancer classifies diethylene glycol, Toluene Diamine, Toluene Diisocyanate as Group 2B carcinogens. And diisocyanate may be associated with a type of asthma.”).
- Philips Begins Repair, Replacement of Recalled Sleep Apnea Machines, AARP (September 2, 2021)(article includes a discussion forum at the end). ,
- See also Aaron Kassraie, Philips Recalls Millions of Sleep Apnea CPAP Machines, Ventilators, AARP (June 15, 2021).
- Also see Philips Recalls Certain Sleep And Respiratory Care Devices, Market Insider (June 14, 2021).