Philips Recall Lawsuit:
Personal Injury Lawyers for Philips CPAP or Ventilator Injuries
If you’ve used a Philips CPAP (continuous positive airway pressure) sleep apnea machine and experienced injuries or illnesses as a result, you may be eligible to receive financial compensation through a Philips CPAP lawsuit. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Dutch-based medical equipment maker Philips is recalling CPAP machines, ventilators, and other breathing devices because of concerns that the polyester-based polyurethane (PE-PUR) sound-reducing foam on the devices can degrade and be inhaled by the users, causing possible health risks, including cancer.
Based on testing, Philips determined there are possible risks to users related to this type of foam. The risks include degrading of the PE-PUR foam used in these machines into particles, which may enter the device’s air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. The foam degradation may be accelerated by use of unapproved cleaning methods. High heat and high humidity environments may also contribute to the foam’s degradation.
The off-gassed chemicals and foam particles may lead to serious or life-threatening injuries such as difficulty breathing (respiratory distress), swelling (inflammation), a lack of oxygen (hypoxia), too much carbon dioxide (hypercarbia), or toxic reactions.
Our personal injury attorney can help. If you believe you were harmed by your Philips CPAP machine or ventilator, contact us immediately. We can answer your questions and if necessary, we will speak to the FDA on your behalf.
Potential Symptoms of Particulate and Chemical Exposure Include:
- Skin, eye, and respiratory tract infection
- Inflammatory response
- Kidney, liver, and other organ problems
- Toxic carcinogenic effects
What to Do
The FDA recommends that BiPAP and CPAP patients affected by the recall talk to their health care providers about alternative treatments. Patients using ventilators at home shouldn’t stop using or change their ventilator until talking to their health care provider.
Philips CEO Frans van Houten announced between 3 million and 4 million devices would be recalled. Since the recall was announced, the FDA has recorded more than 1,200 complaints and over 100 injuries related to the issue. In a separate announcement, the FDA warned that many at-home CPAP cleaning devices are not legally marketed for cleaning purposes — in fact, a CPAP typically won’t need a separate machine of any kind to clean it.
Philips spokesman Steve Klink noted nearly 80% of the affected devices were CPAP machines used by people with sleep apnea, which accounts for approximately two-thirds of Philips CPAP machine sales in the U.S. Ventilators make up the other 20%, with some BiPAP (bi-level positive airway pressure) machines also recalled.
Recalled Products Info
- Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, BiPAP A30/Hybrid/A40
- Serial Numbers: Devices manufactured before April 26, 2021, all serial numbers
- Distribution Dates: November 5, 2005, to April 23, 2021
- Devices Recalled in the U.S.: 204,776
- Date Initiated by Firm: June 14, 2021
List of Recalled Philips CPAP Machines and Ventilators
- E30 (Emergency Use Authorization)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne (Q series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP V30 Auto Ventilator
The recently launched next-generation CPAP platform, DreamStation 2, is not included in the recall.
Sleep Apnea Explained
Sleep Apnea is a common condition in the U.S. that occurs when the upper airway becomes blocked during sleep, reducing or stopping airflow. The majority of those affected with sleep apnea remain undiagnosed. A mechanical device such as a CPAP machine can be used to treat sleep apnea by pumping air through a tube into a mask worn by a person while sleeping.
The risk for sleep apnea increases with age. Sleep apnea may affect between 38% and 68% of people over 60, a study from the Centers for Disease Control and Prevention (CDC) found. According to the National Institutes of Health (NIH), normal age-related changes in how the brain controls breathing during sleep partially explain the increased risk with age. Another reason may be that more fatty tissue builds up in the neck and tongue with age.
Other causes of sleep apnea include obesity, large tonsils, endocrine disorders, neuromuscular disorders, heart or kidney failure, genetics, and premature birth.
Class Action Lawsuit
In June 2021, a class action lawsuit was filed against Philips in Massachusetts. The lawsuit claims that Phillips knew about the toxic foam and the severe health issues it can cause for years. There are some claims users had complained about the issues for some time, but Philips didn’t issue a public warning until April 2021. It was another two months, June 14, 2021, before Philips officially recalled the devices.
Philips Lawsuits Include 2 Possible Violations
1. Defective Design
One of the reasons people were filing lawsuits against Philips is the devices they sold to patients were defective and dangerous.
2. Failure to Warn
Not only did Philips use dangerous PE-PUR foam in their machines, but they also didn’t warn the public as soon as they were aware of the risks. Philips noted they were aware of the issue in April 2021 and didn’t issue a recall until the middle of June 2021. Patients continued to buy and use their machines for at least two months after Philips knew.