Philips® CPAP Lawsuit | Philips CPAP Lawyer, Attorney

Lawsuits have been filed after Philips recalled millions of breathing machines, ventilators and CPAP & BiPAP Machines for sleep apnea due to a risk of cancer and other side effects.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Philips CPAP Machine induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer or other health problems after using a recalled CPAP or BiPAP Machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: Nearly 400 Deaths Linked to Recalled Philips CPAP Machines

On June 2, 2023, the FDA posted an Update on the Philips CPAP Recall and reported that 385 deaths were linked to Philips CPAP devices and other recalled breathing machines since April 2021.

Furthermore, from April 2021 through the end of 2022, the FDA reported that it received more than 105,000 medical device reports (MDRs) describing serious injuries related to the recalled devices, including:

Cancer
Pneumonia
Asthma
Other respiratory problems
Infection
Headache
Cough
Difficulty breathing (dyspnea)
Dizziness
Nodules
Chest pain

FDA Orders Philips to Warn Users About Health Risks of Using Recalled Breathing Machines

In March 2022, the FDA ordered Philips to inform all device users, suppliers, distributors, retailers and health care providers about the recall and the “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products,”

Philips Recalls Certain EVO Ventilators for Toxic Foam Risks

In January 2022, Philips Respironics recalled more than 200 EVO Ventilators and repair kits because a supplier mistakenly used toxic PE-PUR foam, putting users at risk of cancer and other serious health problems. The recalled ventilators were distributed from April 15, 2021 through May 24, 2021.

FDA Announces Class 1 Recall for 3.5 Million Philips Breathing Machines

On July 22, 2021, the FDA announced Class 1 recalls (the most serious type of recall) for around 3.5 million Philips ventilators and CPAP and BiPAP machines that have been sold since 2009 due to a risk of cancer and other health problems from toxic PE-PUR foam.

How Many People Have Been Injured?

More than 1,200 complaints and over 100 injuries have been linked to PE-PUR foam (Polyester-based Polyurethane) breaking down in a Philips breathing machine, according to MassDevice. The actual number of injured people may be far higher, because the recall involves millions of breathing machines.

The FDA warned about the following health risks linked to PE-PUR foam:

“The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.”

Philips Recalls CPAP Machines

In June 2021, Philips recalled millions of breathing machines due to a risk of cancer and other side effects, including:

Continuous Positive Airway Pressure (CPAP) Machines
Bi-Level Positive Airway Pressure (Bi-Level PAP) Machines
DreamStation Sleep Apnea Machines
Mechanical ventilators

What is the Problem?

The recalled contain polyester-based polyurethane (“PE-PUR”) foam to reduce noise made by the machine. Philips designed the machines with this toxic foam inside the same tube that carries the air that a user breathes. Unfortunately, the foam can break down into tiny bits, or release cancer-causing gases, which a user may inhale or swallow.

Breathing Defective Philips CPAP Machines May Cause Cancer

Breathing air containing tiny bits of PE-PUR foam can result in cancer, organ damage, and other serious health issues. PE-PUR foam can also produce toxic gases, called Volatile Organic Compounds (“VOCs”), resulting in cancer, lung irritation, organ damage, and more. Philips said this may result in “serious injury which can be life-threatening or cause permanent impairment.”

What is the Health Risk?

The recalled breathing machines have been sold since 2009, so some patients have been exposed to these serious health risks for more than a decade. Tragically, many people now have health issues from these devices. Some of the health risks include:

Cancer
Lung cancer
Asthma
Sinus infections
Kidney failure
Liver failure
Organ damage
Headaches
Dizziness
Irritation to the skin, eye, and lungs
Headache
Toxic or carcinogenic effects to organs, such as kidney cancer and liver cancer
And more

What Breathing Machines Were Recalled?

Philips recalled the following ventilators, CPAP and BiPAP breathing machines:

Mechanical ventilation devices: Trilogy 100, Trilogy 200, Trilogy EVO, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, BiPAP A30/Hybrid/A40
Continuous Ventilator, Minimum Ventilatory Support, Facility Use: Philips Respironics E30 with Humidifier
Continuous Ventilator, Non-life Supporting devices: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+
Noncontinuous Ventilators: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto)

Philips CPAP Class Action Lawsuit Filed in Massachusetts

In June 2021, a class action lawsuit in Massachusetts claimed that Philips knew about the health hazards from its CPAP machines long before the recall.

The plaintiff, Gerry S., is a truck driver with sleep apnea who had to stop working because he could not safely drive with untreated breathing problems, and had no replacement for his CPAP Machine.

Without a working CPAP machine, some patients may experience “severe symptoms, including heart attack, stroke, and death by asphyxiation,” according to the lawsuit.

The lawsuit also claims that patients who used the recalled machines have complained about black particles of foam for many years, but Philips delayed warning the public until April 2021, and failed to recall the breathing devices for another two months.

In fact, Philips timed its recall to coincide with the launch of its next-generation products. Patients who rely on these machines have purchased Philips’ newer model, thus profiting the company further.

The Philips CPAP Lawsuit was filed on June 29, 2021 in the U.S. District Court for the District of Massachusetts — Case Number 1:21-CV-11076.

For More Information

- - Sleep and Respiratory Care Update: Clinical Information for Physicians. https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-clinical-information-for-physicians-and-providers.pdf
  - Philips Issues Dreamstation CPAP Recall Notification. American Academy of Sleep Medicine. https://aasm.org/philips-dreamstation-cpap-recall-notification/

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Philips CPAP Lawsuit