Why is there a recall on Philips CPAP Machines?

In June 2021, Philips Respironics issued a major recall of several models of their CPAP, BiPAP, and ventilator machines due to potential health risks associated with the sound abatement foam used in these machines. The polyester-based polyurethane (PE-PUR) foam used to reduce noise in the devices was found to potentially degrade into particles and release volatile organic compounds (VOCs), which could be inhaled or ingested by users. This degradation poses risks such as respiratory issues, toxic and carcinogenic efforts, and other health complications.

1. Recalled Devices: The recall includes a wide range of BiPAP and CPAP machines manufactured before April 26, 202. Notable models affected include the DreamStation, System One and Trilogy ventilators.

2. Regulatory Actions: The US Food and Drug Administration (FDA) classified this as a Class 1 recall, indicating the most serious level of potential harm. The FDA continues to monitor the situation and has provided guidance for users and healthcare providers.

Health Risks Associated with the Philips CPAP Machine Recall

The recall of Philips Respironics CPAP, BiPAP, and ventilator devices was prompted by potential health risks associated with the degradation of the foam used to quiet the machines down. The foam is PE-PUR based and this foam can degrade into particles and release VOCs that are toxic to our health.

The primary health risks from inhaling or ingesting VOCs include:

1. Irritation and Inflammation: Inhalation of VOCs can cause irritation and inflammation of the respiratory tract, leading to symptoms such as excessive coughing, chest tightness and difficulty breathing.

2. Asthma and Other Respiratory Conditions: Prolonged exposure to these particles can exacerbate existing respiratory conditions, such as asthma and chronic obstructive pulmonary disease.

3. Chemical Exposure: Potentially harmful chemicals such as toluene di-isocyanate and diethylene glycol are a few components in VOCs, which are known to have toxic effects on the liver, kidneys and other organs.

4. Cancer Risk: Benzene, a common VOC, is strongly linked to leukemia and is found in emissions. Prolonged exposure to certain VOCs, such as formaldehyde, has been linked to an increased risk of lung cancer.

5. Damage to Organs: The toxic compounds can cause damage to vital organs, particularly the liver and kidneys.

About the Philips CPAP Lawsuit

The Philips CPAP lawsuit revolves around legal actions taken by individuals who used a Philips Respironics’ ventilator, BiPAP or a CPAP machine that were recalled due to potential health risks. Announced in June 2021, the recall affects millions of devices used for treating sleep apnea and other respiratory conditions. The main issue is the degradation of the polyester-based polyurethane (PE-PUR) foam used in these devices, which can release harmful particles and volatile organic compounds that users can inhale or ingest. These chemicals pose significant health risks which includes respiratory issues, organ damage and cancer.

Plaintiffs allege that Philips was aware of these risks but failed to provide adequate warnings to users and the medical community, which forms the basis for claims of negligence, failure to warn and breach of warranty. Due to the large number of similar cases, the Judicial Panel on Multi-district Litigation (JPML) centralized the Philips CPAP lawsuits into a Multi-district Litigation (MDL) in the Western District of Pennsylvania to streamline pretrial processes and improve efficiency.

As of 2024, the litigation is in the discovery phase, with thousands of cases pending and new claims being filed as more individuals report health issues linked to the recalled Philips CPAP machines.

CPAP Lawsuit Update 2024