A CPAP lawsuit is a legal claim against the sleep apnea device manufacturer Philips. The affected devices:
- Philips 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. This may lead to lung and respiratory problems, cancer, and other injuries.
Shouse Law Group is a personal injury law firm that is representing CPAP users from throughout the United States. We are bringing lawsuits to recover compensation for medical bills, lost wages, and pain and suffering. We are accepting cases where the patient used one or more of the recalled Philips CPAP devices and afterward was medically diagnosed with any of the following health conditions:
- Acute inhalation injury
- Autoimmune disorders
- Cancer (any type)
- Chronic asthma
- Chronic bronchitis
- Heart failure
- Inflammation and fluid build-up in the lungs
- Interstitial lung disease
- Kidney disease
- Liver disease
- Lung cancer
- Pulmonary fibrosis
- Respiratory failure
- Sarcoidosis or
It should be noted that for all of the respiratory conditions, a plaintiff will have a stronger case if he or she is not also a smoker or former smoker. Current and former smokers may be disqualified from meeting the case criteria.
In this article, our Philips CPAP personal injury attorneys discuss:
- 1. Which Philips sleep apnea devices have been recalled?
- 2. Why were they recalled?
- 3. What injuries can Philips’ recalled CPAPs cause?
- 4. What money damages can I get if I sue?
- 5. What is the current status of the Philips CPAP litigation?
- 6. Who makes the recalled CPAPs?
- 7. What is sleep apnea?
- 8. What if I was injured by the recalled CPAPs?
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 – non-life supporting)
- A-Series BiPAP A40 (mechanical ventilator – continuous – non-life supporting)
- A-Series BiPAP Hybrid A30 (mechanical ventilator – continuous – minimum ventilatory support – facility use)
- A-Series BiPAP V30 AutoVentilator (mechanical ventilator – continuous – minimum ventilatory support – facility use)
- C Series ASV, S/T, AVAPS (continuous ventilator, non-life supporting)
- Dorma 400, 500 CPAP (non-continuous ventilator)
- DreamStation ASV (continuous ventilator, non-life supporting)
- DreamStation CPAP, Auto CPAP, BiPAP (non-continuous ventilator)
- DreamStation Go CPAP, APAP (non-continuous ventilator)
- DreamStation ST, AVAPS (continuous ventilator, non-life supporting)
- E30 (under emergency use authorization – continuous ventilator, minimum ventilatory support, facility use)
- Garbin Plus, Aeris, LifeVent Ventilator (mechanical ventilator – continuous)
- OmniLab Advanced Plus In-Lab Titration Device (continuous ventilator, non-life supporting)
- REMStar SE AutoCPAP (non-continuous ventilator)
- SystemOne ASV4 (continuous ventilator, non-life supporting)
- SystemOne Q series (non-continuous ventilator)
- Trilogy 100Ventilator (mechanical ventilator – continuous)
- Trilogy 200Ventilator (mechanical ventilator – continuous)
The U.S. Department of Veterans Affairs has distributed approximately 300,000 of these recalled devices to veterans.
Note that the following Philips products are still considered safe and have not been recalled:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- BiPAP A40 EFL
- BiPAP A40 Pro
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100
- Dorma 200
- REMStar SE
- Oxygen concentrators
- Respiratory drug delivery products
- Airway clearance products1
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 degrade into particles that users can then inhale or ingest. The devices contain no filter to prevent this inhalation or ingestion.
PE-PUR can also “off-gas” or emit toxic chemicals – even carcinogenic chemicals. These volatile organic compounds (VOCs) include Diethylene glycol, Toluene Diisocyanate, Toluene Diamine, and Phenol Dimethyl Diazine. Furthermore, high heat or humidity can cause the PE-PUR foam to degrade further. Some users have even reported seeing black debris in their breathing tubes – visual evidence of foam degradation.2
In short, Philips sleep apnea devices meant to improve people’s breathing are instead contaminating their airways. These recalled Philips devices are defective products that are unreasonably dangerous and pose a risk of cancer.
3. What injuries can Philips’ recalled CPAPs cause?
The Philips recalled CPAP device, Bi-Level PAP, 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 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:
- 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. What money damages can I get if I sue?
Victims of Philips’ recalled sleep apnea devices may be able 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; and
- Pain and suffering
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. Allegedly, 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.
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 proceedings. Unlike with class actions, MDL plaintiffs’ cases remain separate.
Expected causes of action against Philips include:
- Defective design (strict product liability and negligence)
- Failure to warn
- Consumer fraud / Deceptive trade practices
- Negligence per se
- Gross negligence
- Fraudulent concealment
- Fraudulent misrepresentation
- Negligent misrepresentation
- Breach of implied and express warranties
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 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.
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. The 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. In 2020, Philips made close to $20 billion in revenue.4
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 are often fatigued during the day. In serious cases, sleep apnea may cause high blood pressure, a stroke, and/or a heart attack.
Effective CPAP therapy can treat sleep apnea by delivering a steady oxygen flow through a mask. These sleep apnea machines elevate air pressure in the person’s throat. This, in turn, keeps the airway open while the person is inhaling.5
8. What if I was injured by the recalled CPAPs?
If you are using one of the recalled Philips sleep apnea devices, you should consider:
- Consulting with a healthcare provider;
- Preserving any evidence (such as debris in the air pathways of the CPAP); and
- Contacting an attorney to discuss your claim
Have you or your loved one been injured by a Philips CPAP machine? Call our law firm (or fill out the contact form on this page) for legal advice and to discuss creating an attorney-client relationship. Our mass tort trial lawyers offer free case evaluations. 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); Medical Device recall notification (U.S. only) / field safety notice (International Markets), Philips Respironics; see also the Philips Recall Letter by Rodney Mell; see also the FDA announcement (June 15, 2021).
- 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 note 1. See also Katie Gibson, Philips recalls ventilators and sleep apnea CPAP machines over cancer concerns, CBSNews (June 15, 2021). See also Aaron Kassraie, Philips Recalls Millions of Sleep Apnea CPAP Machines, Ventilators, AARP (June 15, 2021).
- See note 1; Philips Annual Report 2020 (February 23, 2021).
- Obstructive Sleep Apnea, Mayo Clinic.