Shouse Law Group is a personal injury law firm 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.
Here are four key things to know about the current Philips CPAP lawsuits:
- The recalled Philips CPAP, BiPAP, and mechanical ventilators have a design defect causing patients to ingest and inhale degraded polyurethane foam particles.
- An FDA inspection revealed that DreamStation 1 emits intolerable levels of the carcinogen formaldehyde.
- Prolonged use of these defective devices can lead to serious side effects including respiratory problems and certain types of cancer.
- There is evidence that Philips may have known about the recalled devices’ design defects for years before the recall.
Our law firm is accepting cases where you or your loved one used a recalled Philips device and were then diagnosed with either:
- Bladder cancer
- Chronic asthma
- Chronic bronchitis
- COPD
- Head and neck cancer
- Kidney cancer
- Leukemia
- Lip cancer
- Liver cancer
- Lung cancer
- Lymphoma
- Multiple myeloma
- Nasal cancer
- Nasopharynx cancer
- Pneumonitis
- Pulmonary fibrosis (interstitial lung or scarring of the lungs)
- Recurrent pneumonia (3 or more times in 18 months)
- Salivary cancer
- Sarcoidosis
- Sinus cancer
- Throat cancer
- Thyroid cancer causing death
- Tongue cancer
In this article, our attorneys will answer the following key faqs about the Philips CPAP class action and mass tort lawsuits:
- 1. What is the latest with the Philips CPAP litigation?
- 2. Which Philips CPAP machines are on recall?
- 3. Why were they recalled?
- 4. What if my Philips CPAP was recalled?
- 5. What is sleep apnea?
1. What is the latest with the Philips CPAP litigation?
There have been two settlements.
The first is for the thousands of people who have been physically injured by the defective CPAP devices. Following mediation, Philips agreed to a $1.1 billion settlement. This was announced on April 29, 2024.
The second is for the thousands of people who suffered economic loss for buying the defective devices. Philips agreed to pay at least $613.3. This was announced on April 25, 2024.1
The settlement money will be paid in 2025.
Legal grounds of the Philips CPAP lawsuits
CPAP victims sued Philips on product liability- and negligence-based grounds, such as:
- Defective design,
- Manufacturing defect,
- Failure to warn / lack of disclaimers,
- Consumer fraud / deceptive trade practices, and
- Fraudulent concealment
2. Which Philips CPAP machines are on recall?
On June 14, 2021, Philips voluntarily recalled these sleep apnea devices that were manufactured between 2009 and April 26, 2021:
| CPAPs and BiLevel PAPs | Mechanical ventilator machines |
|
|
The U.S. Food and Drug Administration (FDA) classified this recall as Class I – the most serious – because using the affected Philips CPAP/BiPAP and ventilator devices may cause serious injuries or death.
This recall affects more than 15 million breathing devices. Note that the Respironics M-Series REMStar CPAPs were not recalled.2
The recalled Philips sleep apnea machines actually contaminate your airways instead of improving your breathing.
3. Why were they recalled?
The affected Philips Bi-PAP machines, CPAP machines, and mechanical ventilator devices were recalled because their sound abatement foam liners are made from PE-PUR (polyester-based polyurethane). This is hazardous for two reasons:
- PE-PUR can disintegrate into particles that you then inhale or ingest, and there is no filter to prevent this. These particles can be small, even less than 5 microns, which can permeate through your lungs’ alveoli and enter your bloodstream. Some victims reported black debris in their breathing tubes and airpath circuits, which likely represents foam degradation. Climate and environmental conditions such as high heat and humidity in the locations where the devices are stored can also exacerbate foam degradation.
- PE-PUR foam can also emit (off-gas) vapors of toxic chemicals beyond the safe exposure threshold. Some of these dangerous volatile organic compounds (VOCs) include Toluene Diamine, Toluene Disocyanate, and Diethylene Glycol.3
These PE-PUR-related defects may cause serious harm, as revealed by Philips’ recall press release:
These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.
The FDA Inspection Report
On November 9, 2021, the FDA issued a report listing observations made by agency representatives during their inspection of the Philips Respironics facility in Murrysville, Pennsylvania. Its eight damning findings include the following:
| Philips sleep apnea device flaw |
Excerpt from FDA report |
| 1) Risk analysis is inadequate. | “DreamStation 1 device failed emissions testing for VOCs and Aldehydes, which was analyzed/ tested from 01/18/2019 to 01/25/2019. Specifically, Table 3 documents that the tolerable limits of the Formaldehyde compound were exceeded during initial operation[.][emphasis added]“ |
| 2) Procedures for corrective and preventative action have not been adequately established. | “No formal investigation, risk analysis, or CAPA [Corrective and Preventative Action] were initiated, performed, or documented, in response to the at least 222,000 complaints that could potentially be related to foam degradation and received from 2008 to 2017[.]” |
| 3) Design validation did not ensure the device conforms to defined user needs and intended uses. | “The Trilogy user manual recommends the use of a bacterial filter for invasively ventilated patients or if the device will be used on multiple patients. This filter would catch any particulates released into the Trilogy airpath.” |
| 4) Procedures for design change have not been adequately established. | “[There were] multiple field complaints and at least 1 Trilogy unit failure, caused by polyester polyurethane foam degradation. This affected foam was later found to be mutagenic, cytotoxic, carcinogenic, and non-biocompatible.” |
| 5) A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. | “[There were] multiple field complaints and at least 1 Trilogy unit failure, caused by polyester polyurethane foam degradation. This affected foam was later found to be mutagenic, cytotoxic, carcinogenic, and non-biocompatible.” |
| 6) Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. | “[Philips] management, including management with executive responsibility, were aware of potential foam degradation issues concerning CPAPs, BiPAPs, and Trilogy ventilators since at least 01/31/2020, or earlier, and implemented no further corrective actions until April 2021.” |
| 7) Procedures to ensure that all purchased or otherwise received products and services conform to specified requirements have not been adequately established. | “[Philips has] no established data, documentation, or written agreement that clearly describes or references the quality requirements of [Philips’] raw foam supplier[.]” |
| 8) Potential consultants were not evaluated and selected based on their ability to meet specified requirements. | “Additionally, no Supplier Qualification Forms, Form 5077, were completed for the [REDACTED] consultants, as required per [Philips’] supplier quality procedures and work instructions.” |
Most troubling is the documentation showing that the DreamStation 1 emitted unsafe levels of formaldehyde, which is classified as a Group 1 carcinogen – the most dangerous. Formaldehyde can cause myeloid leukemia and cancers of the paranasal sinuses, nasal cavity and nasopharynx in addition to lung injuries.4
4. What if my Philips CPAP was recalled?
Contact your health care provider. It is likely that your doctor will advise you to stop using your CPAP and BiPAP devices right away and to discontinue using your mechanical ventilator once you secure a safe replacement.
Next, contact Shouse Law Group to discuss filing a Philips CPAP lawsuit for financial compensation before the statute of limitations runs. Also be sure to preserve any evidence of the foam degradation, such as:
- the device itself (which contains cards about usage),
- black particles in the air pathways of the CPAP,
- medical records,
- prescription records, and
- photos and videos of the debris.
Consult with Shouse Law Group before submitting an adverse event report with the FDA or registering your defective device on the Philips Respironics recall website. Any information provided to Philips could be used against you.
Illness symptoms
Ten symptoms of particulate exposure and chemical exposure from Philips’ recalled sleep apnea devices include:
- upper airway irritation
- irritation to the skin, eyes, throat, and/or respiratory tract
- headache
- coughs and/or chest pressure
- sinus infections
- toxic and carcinogenic effects
- respiratory issues such as asthma or lung inflammation
- adverse effects to the liver or kidneys
- hypersensitivity
- nausea and vomiting5
Consult with your physician about whether you need a check-up or scans.
Replacing your recalled device
Philips has regulatory clearance to replace the defective sound abatement foam in the recalled first-generation DreamStation devices. For the latest information and instructions, go to the Philips Device Recall Notification page or phone them at 877-907-7508. (Do not sign anything releasing Philips of legal responsibility.)
Recently Philips falsely claimed it so far replaced 2.46 million of the recalled devices. After the FDA issued a statement revealing the number was “considerably less,” Philips admitted it has replaced only 2.2 million devices so far.6
5. What is sleep apnea?
Sleep apnea is a medical disorder where a person’s breathing gets disrupted during sleep. Breathing becomes shallow or stops altogether temporarily. It can lead to fatigue or such health issues as
- high blood pressure (hypertension),
- a stroke, and/or
- a heart attack.
Obstructive sleep apnea is the most common type of sleep apnea. This is when the muscles in the throat relax, keeping you from receiving enough air. Another type of sleep apnea is central sleep apnea: The brain actually fails to transmit signals to the muscles to breathe.
Complex sleep apnea syndrome (a.k.a. treatment-emergent central sleep apnea) is a combination of both types.
How CPAPs and BiPAPS work
CPAP (continuous positive airway pressure) therapy treats sleep apnea by channeling a steady oxygen flow through a mask, elevating air pressure in your windpipe. By forcing purified air in, the machine keeps your airway open and prevents respiratory depression while you inhale.
In contrast, BiPAP (bi-level positive airway pressure) devices operate with two different pressure levels. The level increases while inhaling, but then decreases during exhaling. 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 modifications such as losing weight, quitting smoking, and avoiding alcohol may also alleviate symptoms.7
Philips recalled 15 million sleep apnea devices that can potentially cause serious health issues.
Legal References
- Bill Chappell, What consumers should know as Philips agrees to $1.1 billion CPAP settlement, NPR (April 29, 2024).
- 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); 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 also Laurie McGuinley, For sleep apnea patients with recalled CPAP machines, restless nights, Washington Post (July 23, 2022).
- See note 2. 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. Philips claims unapproved cleaning processes – such as ozone or ultraviolet light – can worsen foam degradation. In retaliation, SoClean is suing Philips for $200 million dollars for blaming the recalled devices’ defects on SoClean’s cleaning products. Barbara Grzincic, SoClean sues Philips for disparaging ozone CPAP cleaners, Reuters (October 13, 2021). SoClean v. Philips, First Amended Complaint (12/2/21).
- FDA Inspectional Observations, FEI # 2518422, Issued 11/9/21.
- See note 2. Also see Katie Gibson, Philips recalls ventilators and sleep apnea CPAP machines over cancer concerns, CBSNews (June 15, 2021).
- Philips clarifies respiratory device replacement numbers after new FDA rebuke, Reuters, April 14, 2023. See also Philips Annual Report 2020 (February 23, 2021). Philips (often misspelled Phillips) includes 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.
Scholarly papers
- 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.).
Legal documents
- In re: Philips Recalled CPAP, Bi-Level PAP, and Ventilator Litigation (with Judge Conti), Motion for Transfer and Coordination or Consolidation under 28 USC 1407, Eastern District of Pennsylvania, MDL 3014. (Filed July 7, 2021).
- 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.).
- Case Management Order: Initial Discovery Plan, MDL No. 3014 (Filed June 17, 2022)
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 … 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.”).
- Aaron Kassraie, Philips Begins Repair, Replacement of Recalled Sleep Apnea Machines, AARP (September 2, 2021)(article includes discussion forum at 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).
Volatile Organic Compounds (VOCs) off-gassed from PE-PUR foam
- 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.