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Certain Philips CPAP and BPAP Machines Recalled Due to Potential Health Issues

September 27, 2021

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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.

What if I am Using a Recalled CPAP or BPAP Machine?

First, check with your doctor immediately. They may instruct you to do the following:

• Stop using the device.
• Use a CPAP or BPAP device that is not part of the recall.
• Continue using the affected device if your doctor feels the benefits outweigh the potential risks.
• Use an alternative treatment for your sleep apnea. Oral appliances have become popular in treating the condition. Positional therapy may also help.
• Make lifestyle changes to reduce the occurrence of sleep apnea, such as losing weight and stopping smoking.
• Undergo surgery for moderate to severe sleep apnea.

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.

What are Possible Symptoms?

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.

Can I be Compensated for Health Problems?

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:

• Kidney disease, kidney failure, and kidney cancer
• Liver cancer, liver disease, liver failure
• Bladder cancer
• Brain cancer
• Breast cancer
• Acute respiratory distress system (ARDS)
• Heart failure, heart attack
• Lung disease, lung failure, and lung cancer
• Reactive airway disease (RAD)
• Respiratory failure
• Leukemia
• Lymphatic cancers
• Severe ear, nose, and throat conditions
• Other cancers and conditions

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.

What is a Medical Products Liability Lawsuit?

In Pennsylvania, consumers can pursue a medical products liability claim based on certain defects:

• Design defect: In a design defect claim, a plaintiff alleges that the product lacked proper safety features or had other unsafe elements that a change in design could have prevented. With design defects, all products with that design will have the same problems. Examples of design defects include a hairdryer that causes electrical shock, or toys with parts a child could choke on. A plaintiff in a design defect lawsuit must prove they were using the product in the way it was intended when they were injured.
• Manufacturing defect: Some products have flaws resulting form the construction or manufacturing process that happens after the design phase. Manufacturing defects generally occur in some items rather than every product. Examples of manufacturing defects include the use of inferior materials, or improperly assembling or attaching the wrong parts. In Pennsylvania, a plaintiff in a manufacturing defect lawsuit will need to prove that there was a defect, that the defect caused the injury while the product was being used correctly, and it rendered the product unreasonably dangerous.
• Marketing defect: Some products carry risk no matter what. These products must carry a clear and understandable warning to consumers about the risk. Failure to do so can result in manufacturer liability. Examples of marketing defects include no warning on products that have potential choking or suffocation hazards. A plaintiff must show that the manufacturer knew of the danger or should have known of the danger. The warning provided to the consumer must be adequate and considered understandable to an ordinary person.

Philadelphia Defective Medical Products Attorneys at Brookman, Rosenberg, Brown & Sandler Advocate for Clients Harmed by CPAP and BPAP Devices

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.