Sleep apnea is one of the most prevalent sleep disorders in the United States. According to the American Medical Association, approximately 30 million U.S. residents suffer from sleep apnea, but most cases go undiagnosed. Since sleep apnea disrupts normal sleep patterns, victims endure drowsiness, irritability, fatigue, and difficulty concentrating. To improve their quality of life, sleep apnea patients turn to CPAP or BiPAP ventilator machines. However, Philips CPAP and BiPAP machines may prove more detrimental than helpful.
Our law firm is currently handling lawsuits on behalf of individuals harmed by Philips CPAP machines. Lawsuits against the manufacturer claim that some Philips CPAP and BiPAP ventilator machines may lead to cancer and other adverse health issues.
CPAP and BiPAP devices are machines used in positive airway therapy. CPAP stands for continuous positive airway pressure and BiPAP stands for bi-level positive airway pressure. These ventilators produce pressurized air that opens and supports a person’s airways during sleep. People with sleep apnea suddenly stop breathing while asleep, but these machines use a hose and mask system to deliver compressed air to the user. The airflow prevents obstruction of the airway and allows a person to breathe more regularly during sleep. CPAP machines have one pressure setting, while BiPAP machines have two: one for inhalation and another for exhalation.
In June 2021, ventilator manufacturer, Philips, recalled millions of its CPAP and BiPAP ventilators manufactured between 2009 and April 2021. These machines designed to help people breathe were actually putting countless people at risk. The company found that the PE-PUR foam located inside the machines degrades and releases toxic particles and carcinogenic gasses. This sound abatement foam served to reduce noise while the device operates.
Users of CPAP or BiPAP machines can inhale these particles which may lead to various types of cancer or other injuries. Furthermore, Philips did not manufacture the machines to have a filter to prevent this ingestion of dangerous particles and chemicals. The FDA categorized the Philips CPAP decision as a Class I recall. This is the FDA’s most severe type of recall, products in this class pose a serious risk of injury or even death.
The FDA issued a subsequent report in November 2021 to detail its observations after an inspection of the Philips facility in Pennsylvania. The agency determined that:
The FDA continues to release updated safety communications on the recalled Philips CPAP and BiPAP ventilators. As of November 2022, the agency revealed that it has received more than 90,000 medical device reports since April 2021. Of these 90,000 medical reports, the FDA noted 260 reports of death, associated with the PE-PUR foam breakdown.
Unrelated to PE-PUR foam breakdown, the FDA announced in late August that Philips recalled various BiPAP models for contaminated plastic. If the contaminated plastic enters the motor it may release volatile organic compounds or even stop the machine from working. Additionally, Philips recalled magnetic masks for its CPAP and BiPAP ventilators because the magnets can result in serious injury or even death if they interfere with metallic implants in the body. Philips has distributed more than 17 million masks containing magnetic clips to date. Again, the FDA stressed that these recalls are not associated with the PE-PUR foam breakdown. In October 2022, the FDA labeled the Philips CPAP and BiPAP magnetic masks recall as a Class I recall. This is the agency’s most serious recall since products given a Class I designation present a risk of injury or death to users.
Inhalation of particles or chemicals released by the degraded foam in CPAP machines may cause:
Many people nationwide have filed lawsuits against Philips for its dangerous ventilator machines. An inspection by the FDA revealed that the company knew that PE-PUR foam could degrade in its machines as far back as 2015. Yet, the company chose to remain silent on this matter. In fact, Philips tried to blame ozone-cleaning machines for the degradation of the foam rather than accept accountability. Ventilator cleaning device manufacturer, SoClean, filed a lawsuit against Philips in 2021 for the company’s false statements that ozone cleaners contributed to the CPAP and BiPAP recall. SoClean amended this lawsuit in 2022 and accused Philips of using SoClean as a scapegoat in the aftermath of the massive 2021 ventilator recall. Despite multiple studies and illnesses related to Philips CPAP and BiPAP ventilators, the company does not believe the level of chemical gasses released by the foam is enough to cause harm.
As of November 2022, there are over 346 Philips CPAP and BiPAP lawsuits pending in multidistrict litigation in federal court.
If you or a loved one has been injured by a Philips CPAP machine, you may recover compensation for any or all of the following:
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 274-0139 or submit an inquiry on this page.
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