Sleep apnea affects millions of people in the United States. This condition blocks the upper airways during sleep, reducing or stopping airflow and leaving the person gasping for air throughout the night. It affects millions of people in the United States.
Since the person is sleeping, they may not even realize they have sleep apnea. Often, a spouse will notice the person gasping for air during the night. Sometimes, the person themselves will recognize some of the signs of sleep apnea, such as a dry mouth in the morning, never feeling fully rested the next day, and waking up with a headache.
A primary way to treat sleep apnea is through a continuous positive airway pressure (CPAP) device. This mechanical device continuously pumps air through a tube into a mask that the person with sleep apnea wears throughout the night. A bilevel positive airway pressure (BPAP) machine is another way to treat sleep apnea.
Recently, the U.S. Food and Drug Administration (FDA) announced that Philips Respironics had voluntarily recalled some of its CPAP and BPAP machines. Millions of devices, mostly CPAPS, were recalled because the polyester-based polyurethane (PE-PUR) foam in the devices could be a health risk.
This foam, used to reduce noise and vibration, could break down and potentially enter the air pathway in the device, releasing toxic debris and chemicals. CPAP and BPAP users could potentially inhale or swallow the toxins, leading to potentially life-threatening conditions or permanent damage, including cancers. Philips reports that foam degradation could be exacerbated by high heat and humidity and using unapproved CPAP/BPAP cleaning methods. They fully acknowledged the potential risks.
Known users of the affected devices and health care providers were notified of the recall. Affected devices were manufactured between 2009 and April 26, 2021.
First, check with your doctor immediately. They may instruct you to do the following:
Affected users should also follow the manufacturer’s instructions provided on the recall notice for cleaning and replacement of the device and accessories. The notice also offers options for registering your device and reporting problems. Health care providers and facilities should also follow the procedures listed in the recall notice.
First, visually inspect the device for the presence of black debris or particles in the air pathway. This is an indicator that the foam may be breaking down. Also, reported symptoms have included headache, upper airway irritation, chest pressure, sinus infection, and cough. These may or may not be related to the device, but see a medical professional to be sure.
Exposure to the debris particles could result in irritation to the eyes, skin, and respiratory tract, inflammation, headache, onset or worsening of asthma, cancer, and damage to internal organs. Potential symptoms from exposure to toxic chemicals include headache, dizziness, eye and nose irritation, respiratory ailments, nausea/vomiting, fertility problems, genetic defects, and cancer. No deaths have been reported to date, but Philips has received more than 1,200 complaints of illness.
Anyone who has been using an affected device should see a doctor and remain vigilant about their health. Any new symptoms, even if they develop after you stop using the machine, should be checked.
If you are suffering from health problems from using a recalled CPAP or BPAP machine, you may be legal recourse. A lawsuit can be filed in most cases if you and your legal counsel can establish a link between using the recalled defective medical product and your medical condition. Some conditions that may develop include:
A lawyer will start with a consultation on your case to see if you qualify. If a lawsuit proceeds, it will generally be a medical products liability lawsuit. You may be able to seek compensation for current and future medical bills and care, lost wages, and pain and suffering. Be sure to consult with a lawyer as soon as you become aware of symptoms or are diagnosed with a potential CPAP/BPAP-related illness. There is a time limit to file a lawsuit.
In Pennsylvania, consumers can pursue a medical products liability claim based on certain defects:
Harm from using a defective medical product can be devastating. Let our Philadelphia defective medical products attorneys at Brookman, Rosenberg, Brown & Sandler help ease some of the worries if you were affected by a faulty CPAP or BPAP device. Contact us online or call us at 215-569-4000 to schedule a free consultation. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.