Sometimes, breathing is harder than it ought to be.  Millions of Americans use breathing assistance devices regularly for chronic health problems, such as obstructive sleep apnea and forms of chronic obstructive pulmonary disease (COPD), including emphysema. These devices are sometimes used on a short-term basis for people with acute breathing difficulties, but generally, they are used long-term for chronic breathing problems. Unfortunately, problems with the materials used to manufacture many of these devices have led to millions of Philips CPAP and BiPAP ventilators being recalled.  If you are impacted by this defective medical device recall, the Law Offices of Edward A. Smith may be able to help.

Respironics was founded in Pennsylvania in the 1970s as a manufacturer of anesthesia masks and associated equipment. It introduced the first CPAP device for obstructive sleep apnea in the 1980s, and the success of this equipment prompted the company to go public. In the 1990s, it patented and produced the first BiPAP devices for both sleep apnea and other chronic pulmonary diseases.

The company merged with Philips — a multinational conglomerate based in the Netherlands — in 2007 and is now known as Philips Respironics. The Respironics portion of the business has about $1 billion per year and employs about 5,000 people. However, only a small portion of the Philips corporation manufactures products ranging from light bulbs to electric shavers.

Philips Respironics is now the largest manufacturer of CPAP and BiPAP ventilators, with nearly two-thirds of the total market and only one other significant competitor. The entire recall list has been published by Philips and includes the following models:

• DreamStationASV
• DreamStationST, AVAPS
• SystemOneASV4
• C SeriesASV, S/T, AVAPS
• OmniLab AdvancedPlus
• SystemOne QSeries
• DreamStation CPAP, AutoCPAP, BiPAP
• DreamStationGO CPAP, APAP
• Dorma400, Dorma500 CPAP
• REMStarSE Auto CPAP

This recall involves millions of units — the VA clinics alone have distributed some 300,000 units to veterans for home use.  In addition to these models designed for home use, several other ventilator models designed for use in hospitals and other facilities are also on the recall list.

These devices are manufactured to include polyurethane foam as a sound absorption material. Unfortunately, this foam gives off — “outgasses” — two toxic gases. The foam also degrades and gradually breaks down over time, producing tiny particles. Both the toxic gases and the particles enter the devices’ airstream and then the users’ lungs.

The two toxic gases that are being outgassed are:

• Dimethyl diazine, also known as azomethane.
• Phenol (or carbolic acid).

This polyurethane foam is not contained in all CPAP and BiPAP devices — numerous machines both from Philips and its competitors do not include the material.

Scientific and medical research continues to identify specific injuries or diseases that may result from exposure to these materials. The possibility of these substances being directly introduced into the lungs does not appear to have been previously considered or studied.

For the two toxic gases, Azomethane is associated with organ failure and cancers in the liver and kidneys. Phenol is caustic and can cause chemical burns.

Small particulate contamination in the lungs can result in the tissues attempting to encapsulate the foreign substances (e.g., mesotheliomas from talc or asbestos) or the particles breaking down into their component chemicals and entering the bloodstream.

CPAP stands for “Continuous Positive Airway Pressure” — these devices typically consist of an airflow generator connected by a plastic tube to a face mask that covers a person’s mouth and nose. The device generates and maintains a constant air pressure designed to support the upper airway from collapse for people suffering from obstructive sleep apnea. Although mostly used for sleep apnea, these devices can also support breathing for some types of pulmonary and cardiac patients by reducing the effort of breathing. CPAP devices maintain a continuous level of air pressure to support the airway.

BiPAP devices look and are constructed similar to CPAP devices but provide “BiLevel Positive Airway Pressure” — a higher pressure during inspiration (breathing in) and a lower level during expiration (breathing out). BiPAP devices, also called Non-Invasive Ventilation (NIV), are typically used to treat more serious breathing problems short-term, acute, or long-term chronic basis. This might include acute cases of respiratory diseases like Covid-19 or asthma attacks that aren’t serious enough to require intubation and chronic diseases such as emphysema, other forms of chronic obstructive pulmonary disease (COPD), and some types of obstructive apnea.

Since CPAP and BiPAP Ventilators are directly connected by tube and face masks to users’ respiratory systems, any contaminants present within the ventilator equipment are directly introduced into the users’ lungs.

For users of non-life-sustaining ventilators (those listed above), the Philips recall notice advises users to discontinue using the Philips device and work with their physician or equipment provider to find appropriate options for further treatment.

As to actual and potential injuries and potential product liability claims, it is important to note that this potential device hazard becoming apparent is a very recent development. The device recall was released on April 26, 2021. Research into exposure to the substance, along with claims and litigation related to these devices, will be certain to produce more specific information as to the potential and actual injuries that may result.

Certainly, anyone who has made use of these devices and has subsequently identified a new lung injury or disease or a secondary injury that may have resulted from further decreased pulmonary activity (such as a heart attack) should consult with an experienced medical device lawyer to determine their rights and options.

Watch the YouTube Video Below. This video helps explains the difference between CPAP and BiPAP devices and which conditions are treated with each type:

The personal injury lawyers at our firm have the skills, experience, and resources to effectively pursue claims and litigation against negligent manufacturers of defective medical devices. If you have been injured by a Philips CPAP or BiPAP device, please give us a call today for free and friendly advice. You can reach us by phone at (916) 921-6400 or (800) 404-5400 or by using our online contact form.

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Photo Attribution: Image by Clker-Free-Vector-Images from Pixabay.

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