The current Philips CPAP lawsuits allege that its recalled 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 cancer.
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.
Our law firm is accepting cases where the patient used a recalled Philips device and was then diagnosed with either:
- Acute kidney injury (AKI)
- Acute liver injury
- Breast cancer in patients under 40
- Chronic asthma
- Chronic bronchitis
- Colon cancer
- Esophageal cancer
- Hematopoietic cancer
- Hypopharyngeal cancer
- Interstitial lung disease (ILD)
- Kidney cancer
- Laryngeal cancer
- Liver cancer
- Liver disease (acute liver injury only)
- Lung cancer
- Multiple myeloma
- Myeloid leukemia
- Nasal cancer
- Nasopharyngeal cancer
- Oropharyngeal cancer
- Papillary carcinoma
- Paranasal sinus cancer
- Prostate cancer in patients under 50
- Pulmonary fibrosis
- Rectal cancer
- Recurrent pneumonia (4 or more times in one year)
- Scarring of lungs
- Severe or chronic asthma
- Sinus cancer
- Soft palate cancer
- Stomach cancer
- Testicular cancer
- Throat cancer
- Thyroid cancer
- Tonsil cancer
In this article, our attorneys will answer the following key questions about the Philips CPAP class action and mass tort lawsuits:
- 1. What is the latest with the CPAP lawsuits?
- 2. What CPAP machines are on recall?
- 3. How serious is the CPAP recall?
- 4. Is my CPAP making me sick?
- 5. What do I do if my CPAP is recalled?
- 6. How much money can I get if I sue?
- 7. Can I get my recalled device replaced?
- 8. What is sleep apnea?
1. What is the latest with the CPAP lawsuits?
Victims’ lawsuits against medical manufacturer Philips are being consolidated into an MDL (multi-district litigation) in federal court. Like class action lawsuits, MDLs streamline the litigation and settlement process. But unlike class actions, MDLs allow each plaintiff’s case to remain separate.
CPAP victims are suing 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
The Philips CPAP MDL was just formed in October of 2021 and is still in the early stages. But eventually, several of the cases will go to a jury trial. How these bellwether trials turn out will set the stage for settlement talks with the remaining tens of thousands of plaintiffs expected to join the MDL. The bigger the jury verdict, the bigger the settlement amounts.
The Philips CPAP MDL is out of the U.S. District Court, Western District of Pennsylvania. Judge Joy Flowers Conti – who had two decades of experience – is presiding. The case name is In Re: Philips Recalled CPAP, BI-LEVEL PAP, and Mechanical Ventilator Products Liability Litigation (MDL # 3014). As of December 1, 2021, the MDL has 127 cases. Tens of thousands more are expected to join. The first MDL hearing is scheduled for December 15, 2021.1
2. What CPAP machines are on recall?
On June 14, 2021, Philips voluntarily recalled the following sleep apnea devices that were manufactured between 2009 and April 26, 2021:
Recalled CPAPs and BiLevel PAPs:
- C Series S/T, AVAPS
- Dorma 400, 500
CPAP, Auto CPAP
- DreamStation ASV
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP, Auto CPAP
- DreamStation ST, AVAPS
- OmniLab Advanced Plus
- REMstar SE Auto
- System One 50 series
- System One 60 series
- SystemOne ASV4
- SystemOne (Q-Series)
Recalled mechanical ventilator machines:
- A-Series BiPAP A30
- A-Series BiPAP A40
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
This recall affects more than 15 million breathing devices. Note that the Respironics M-Series REMStar CPAPs have not been recalled.2
3. How serious is the CPAP recall?
The U.S. Food and Drug Administration (FDA) classified the Philips CPAP recall as Class 1 – the most serious – because using the affected devices may cause serious injuries or death. Devices meant to improve people’s breathing are instead contaminating their airways.
The recalled Philips Bi-PAP machines, CPAP machines, and mechanical ventilator devices have sound abatement foam liners made from PE-PUR (polyester-based polyurethane). PE-PUR can disintegrate into particles that users 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 the lungs’ alveoli and enter the bloodstream.
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
- Diethylene Glycol
PE-PUR foam is more likely to degrade the older the device is and the more people use it. Climate and environmental conditions such as high heat and humidity in the locations where the devices are stored can also exacerbate foam degradation. Any body heat or moistness that the user generates should not negatively affect the foam.
Some victims reported black debris in their breathing tubes and airpath circuits, which likely represents foam degradation. 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.3
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. Among its damning findings are the following:
- Risk analysis is inadequate. The report said, “There is no documented investigation, risk analysis, or design failure mode effect analysis to support [Philips’] rationale for which polyester polyurethane foam-containing products were affected, included, or not included in [Philips’] ongoing recalls … A risk analysis is inadequate or was not performed when appropriate or within an appropriate time frame of [Philips] becoming aware of potential polyester polyurethane foam degradation and/or Volatile Organic Compound (VOC) emission concerns regarding various CPAP, BiPAP, and ventilator devices…[P]otential foam degradation in Trilogy ventilator devices is not an isolated incident, and [Philips] also ha[s] not documented a detailed rationale for why harm is not likely to occur again, as required by [Philips’] Health Hazard Evaluation’s instructions…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]“
- Procedures for corrective and preventative action have not been adequately established. The report said, “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[.]”
- Design validation did not ensure the device conforms to defined user needs and intended uses. The report says, “‘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.'”
- Procedures for design change have not been adequately established. The report says, “This preventative maintenance procedure, the intended replacement component, or the [REDACTED] time frame were not verified, reviewed, or validated before implementation.”
- A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. The report says, “[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.”
- Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. The report said, “[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.”
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. The report said, “[Philips has] no established data, documentation, or written agreement that clearly describes or references the quality requirements of [Philips’] raw foam supplier[.]”
- Potential consultants were not evaluated and selected based on their ability to meet specified requirements. The report said, “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. Is my CPAP making me sick?
The defects in the recalled Philips CPAP, Bi-Level PAP, and mechanical ventilator devices can result in serious harm. 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.
The 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
- toxic and carcinogenic effects
- respiratory issues such as asthma or lung inflammation
- adverse effects to the liver or kidneys
- coughs and/or chest pressure
- sinus infections
- nausea and vomiting5
5. What do I do if my CPAP is recalled?
Recalled Philips device users should first contact their doctor. It is likely that health care providers will advise patients to stop using their CPAP and BiPAP devices immediately and to discontinue using their mechanical ventilators once they secure a safe replacement.
Next, victims should contact Shouse Law Group to discuss filing a lawsuit for financial compensation. There is a strict statute of limitations for filing suit, so act right away. And 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, and prescription records. Victims should take videos and photographs of the debris as well.
Is recommended that victims consult with Shouse Law Group before submitting an adverse event report with the FDA or registering their defective device on the Philips Respironics recall website. Any information provided to Philips could be used against the victims.
6. How much money can I get if I sue?
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 compensatory damages for:
- Medical expenses
- Lost wages
- Loss of future earnings
- Pain and suffering
- Other economic losses
In cases that reach trial, the court may award plaintiffs punitive damages if Philips knew about the PE-PUR degradation hazards and did nothing to remedy it in a timely manner. There is some evidence that customers have been complaining to Philips for years about particulate exposure.
Another 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 buy 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 often far exceed compensatory damages, and Philips can afford it. Philips has a 65% market share of the U.S. CPAP market. In 2008, Philips acquired Respironics, which creates the DreamStation products. Then in 2020, Philips earned close to $20 billion in revenue, and 49% of its sales came from sleep and respiratory care devices.6
7. Can I get my recalled device replaced?
Philips now has regulatory clearance to replace the defective sound abatement foam in the recalled first-generation DreamStation devices. For the latest information and instructions, go the Philips Device Recall Notification page or call them at 877-907-7508. (Just do not sign anything releasing Philips of legal responsibility.)
8. 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.
The most common type of sleep apnea is obstructive sleep apnea: This is when the muscles in the throat relax, preventing the person 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. And complex sleep apnea syndrome (a.k.a. treatment-emergent central sleep apnea) is a combination of both types.
CPAP (continuous positive airway pressure) therapy treats sleep apnea by delivering a steady oxygen flow through a mask, elevating air pressure in the person’s windpipe. By forcing purified air in, the machine keeps the airway open and prevents respiratory depression while the person inhales.
In contrast, BiPAP (bi-level positive airway pressure) devices operate with two different pressure levels. The level increases while inhaling, but then 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 modifications such as losing weight, quitting smoking, and abstaining from alcohol could also alleviate symptoms.7
Injured? Call us…
The recalled Philips sleep apnea devices are defective products that are unreasonably dangerous and pose a risk of cancer. If you or your loved one is 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 offer free case evaluations. And our attorney-client relationships operate by contingency fee, so we do not receive a paycheck unless you do.
- Also see Barbara Grzincic, Judicial panel consolidates Philips CPAP, J&J sunscreen litigation, Reuters (October 11, 2021).
- 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 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. Barbara Grzincic, SoClean sues Philips for disparaging ozone CPAP cleaners, Reuters (October 13, 2021).
- 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).
- See note 2; 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.
- 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).
- Also see Notice of Hearing Session, United States Judicial Panel on Multidistrict Litigation (August 13, 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.).
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.