Defective Philips CPAP Device Lawsuit

In June 2021, Philips issued a recall after revealing that several of its CPAP and BiPAP sleep apnea devices and home ventilators had a defect that exposed users to toxic particles and gasses posing serious health risks to users. According to the company, a type of foam used in the devices could break down into particles and off-gas potentially carcinogenic chemicals into the device’s air pathway that the user can inhale or swallow. The FDA identified the Philips CPAP device recall as a Class 1, the agency’s most serious type of recall.

Medical device companies are required to perform safety tests, meet all quality standards, and provide adequate warnings of potential risks before placing their products on the market. If a patient or doctor does not know the possible adverse effects associated with a medical device, they don’t have the ability to make an informed decision regarding treatment options or choosing a different device to protect oneself from injury or illness. Companies should be held liable for failing to adequately warn patients about the harmful effects of using their medical devices.

At FrancoLaw, we have the experience and resources to stand up against device manufacturers and hold them accountable for the harm they have caused. We will be your advocate and fight by your side for the justice and compensation you deserve. For a free consultation to discuss the circumstances of your injury and determine the available legal options, call FrancoLaw today at (888) 213-0761.

What is CPAP, BiPAP and Ventilators Used For?

CPAP, BiPAP, and ventilator machines are medical devices designed to help patients with breathing disorders such as sleep apnea.

CPAP stands for Continuous Positive Airway Pressure. It is the most popular sleep apnea treatment for obstructive sleep apnea (OSA), a condition in which breathing temporarily stops while a person is sleeping because the tissues in the mouth fall to the back of the throat and block the airway. CPAP machines force continuous pressurized air, delivered through a tube into a mask that fits over the nose or mouth, down the airway to keep the airway open and free from obstruction.

BiPAP refers to Bilevel or two-level Positive Airway Pressure. Like CPAP, this sleep apnea treatment works by sending air through a tube into a mask that fits over the nose. While CPAP generally delivers a single pressure, BiPAP delivers two: an inhale pressure and an exhale pressure. BiPAP machines are typically used to treat central sleep apnea, complex sleep apnea or patients with heart, lung, or neurological disorders.

Ventilators are used for patients who cannot breathe on their own or those suffering from a severe respiratory disease. They are often used in hospital settings; however, some ventilators can be used at home with a mask for patients with severe chronic obstructive pulmonary disease (COPD).

Philips manufacturers CPAP, BiPAP and home ventilators and has a 65% share of the CPAP market. It has sold millions of these devices in the U.S.

Philips CPAP, BiPAP and Home Ventilator Device Recall

On April 26, 2021, Philips disclosed for the first time that it had received several consumer complaints about the presence of black debris within the device’s air pathway, as well as reports of headache, upper airway irritation, cough, chest pressure, and sinus infection in users of the devices. Those reports led to the discovery that the PE-PUR “sound abatement” foam Philips used to minimize noise in several CPAP and BiPAP devices posed serious health risks to users.

Seven weeks later, on June 14, 2021, Philips issued a recall for millions of its CPAP and BiPAP machines, as well as a number of its ventilator devices manufactured between 2009 and April 26, 2021. The recall was due to the potential health risks associated with exposure to the degraded sound abatement foam particles and chemical emissions.

According to the FDA recall notice, the potential risks of particulate exposure include:

Irritation to the skin, eye, and respiratory tract
Lung Inflammation
Coughing
Headache
Asthma
Toxic or carcinogenic effects to organs, such as the kidneys and liver.

The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include:

Headache
Dizziness
Irritation in the eyes, nose, respiratory tract, and skin
Hypersensitivity
Nausea/vomiting
Toxic and carcinogenic effects

The FDA is currently analyzing medical device reports involving affected devices from 2009 to 2021 for issues that may be related to this defect.

Devices Affected by the Philips Recall

The following Philips CPAP and BiPAP devices manufactured before April 26, 2021, are subject to the recall notification.

Continuous Ventilator, Non-life Supporting

DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C Series ASV, S/T, AVAPS
OmniLab Advanced Plus In-Lab Titration Device

Non-continuous Ventilator

SystemOne Q series
DreamStation CPAP, Auto CPAP, BiPAP
DreamStation Go CPAP, APAP
Dorma 400, 500 CPAP
REMStar SE AutoCPAP

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 (Under Emergency Use Authorization)

Continuous Ventilator

Trilogy 100Ventilator
Trilogy 200Ventilator
Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP V30 AutoVentilator

Repairing and Replacing the CPAP and BiPAP Devices

The next generation CPAP platform, DreamStation 2, is not affected by the sound abatement platform. The recall only applies to the 1^st generation DreamStation product family. The company advises it will replace the first-generation devices’ current sound abatement foam with a new material once they have received the required regulatory clearances.

Meanwhile, Philips advises patients using the recalled BiPAP and CPAP devices to stop using them and to ask their physicians about alternative treatment options. The company advises patients using affected life-sustaining mechanical ventilator devices to not discontinue their use until the patients have spoken with their physicians.

Why were these Philips CPAP Devices Recalled?

There are two reasons for the recall – foam and chemical emissions. In both scenarios, all the devices recalled were manufactured prior to April 26, 2021, and caused a variety of adverse health effects, including lung cancer.

Foam – PE-PUR, short for polyester-based polyurethane, is a sound abatement foam used inside the affected devices to reduce sound and vibration. The foam inside the machines can deteriorate and particles can enter the device’s air pathway and be inhaled or ingested by the user. The foam degradation or breakdown may be exacerbated by high heat and high humidity environments and unapproved cleaning methods, such as ozone.
Chemical Emissions – the PE-PUR foam may also be prone to “off-gas” chemicals which may be toxic. In turn, these toxic vapors may lead to lung injury or lung cancer as well as other adverse side effects.

According to the FDA, swallowing or inhaling these particles or gasses can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.

Possible Side Effects and Injuries Caused by Defective Philips CPAP Devices

Individuals who used one of the recalled devices and suffered one or more of the following side effects or injuries may qualify for a Philips CPAP Device recall lawsuit:

Respiratory Failure
Bronchiectasis
Lung damage
Pneumonia
New or worsening asthma
Lung cancer
Colon cancer
Liver cancer
Kidney cancer
Nasal cancer
Throat cancer
Acute Respiratory Distress System (ARDS)
Pulmonary Fibrosis

Philips CPAP Device Recall Litigation

Philips has been hit with several class-action lawsuits and individual injury claims since the company recalled millions of its CPAP, BiPAP, and ventilators. The lawsuits allege that Philips knowingly manufactured devices it knew were defectively designed and failed to warn consumers of the serious health risks the devices posed as soon as they became aware of the issue.

The litigation is pending before Judge Joy Flowers Conti in federal court in Pennsylvania. Judge Flowers is presiding over the coordination of all discovery and pretrial proceedings. As of December 2021, more than 130 lawsuits have been filed against Philips. This number is expected to grow to thousands.

Contact Us Today

If you or a loved one used a recalled Philips CPAP or BiPAP device and developed a respiratory illness, lung cancer or lung damage, you may be eligible to file a Philips CPAP Device recall lawsuit. You can discuss your case with us during a free consultation and receive the legal advice you need to make an informed decision about what to do next. Let us fight for you to hold the manufacturer accountable for your injuries and recover the compensation you deserve. Our firm is experienced in handling defective medical device cases and we welcome any questions you may have. Call us now at (888) 213-0761 for a free consultation.