American Academy of Sleep Medicine Issues Guidance on CPAP Recalls

It has been difficult for users of Phillips CPAP and BiPAP machines to get the facts underlying the recall involving the devices they use. They certainly cannot trust the company itself. First, Phillips hid the defects for years until it could bring a new line of products to the market. Second, the company tried to replace the defective part with one made of a different material that could be equally dangerous. The American Academy of Sleep Medicine (AASM) has given guidance to patients about whether to continue using Phillips devices in the wake of the news of the defect.

Phillips CPAP and BiPAP machines contain a layer of polyurethane foam that is used as sound abatement. The problem is that the foam breaks down over time. The machine has tiny bits of chemical particles in it that users breathe in continuously at night. The breakdown of the foam also released harmful chemicals. Patients who have used the machine for an extended period of time could develop cancer or suffer from organ damage.

Phillips Knew About this Problem for Years

Phillips’ proposed recall solution was really not much of a solution. The FDA initially approved Phillips’ recall plan, which was to send consumers a kit to replace the polyurethane foam with a silicone-based foam. However, the FDA learned that the silicone foam failed at least one safety test. After Phillips had sent out 250,000 kits, the FDA reversed course on the recall. Now, consumers must make a decision about whether to keep using their machines, knowing that they are defective and dangerous.

Patients Should Work with their Healthcare Provider

The AASM’s guidance was to tell patients to make their own decision in concert with their doctor. The ideal thing would be for patients to be able to use a machine that is not subject to the recall. However, the AASM recognized that this is not always possible. The average CPAP machine can cost between $400-600. Machines with more advanced features can cost more. Many patients cannot afford the cost of a new CPAP machine, especially during these tough economic times. Health Insurance companies may refuse to cover the cost of a new device if they already paid for one.

On the other hand, there is a danger for the patient to stop using the machine, especially considering what it treats. Sleep apnea could cause a patient to stop breathing during their sleep. It may not be safe for someone to suddenly stop using the machine and go without a CPAP machine entirely.

Factors to Consider in Your Decision About Using Your CPAP Device

According to the AASM, the patient needs to consult with their doctor and consider their own unique situation before they make a decision about using the machine. Specifically, the patient and their doctor should bear the following in mind:

• Comorbidities
• Severity of symptoms
• Risks associated with PAP discontinuation
• Safety-sensitive roles

Regardless of what decision you come to with your provider, this is a conversation that you should have as soon as possible – if you have not done so already. Some patients may have such severe issues that doctors will advise them to keep using the current machine until the problem can be fixed. Others may suggest that you stop using the devices temporarily.

The American Thoracic Society has issued similar guidance, namely that patients should not stop using the machines on their own. Some may need to continue using it in spite of the risks until they can get a replacement for the defective machine or its parts.

Product Liability Lawsuits Against Phillips

Even if users are forced to continue using the older CPAP machines while waiting for a suitable replacement, they can still file a lawsuit against Phillips for the defect. There are several theories that could entitle plaintiffs to financial compensation:

• The use of polyurethane foam that could degrade over time and sicken users makes the product unreasonably dangerous and is a design defect.
• The fact that Phillips knew of the design defect for so long (some estimates say six years) and did not warn of the danger is a marketing defect.

In addition, lawsuits will likely allege that Phillips committed fraud by intentionally withholding information about the product defects until there was a new line of products available to be sold.

In their latest earnings guidance, Phillips explained that quarterly earnings had taken a hit from the effects of the recalls. Now, the company estimates that there were 5.2 million devices affected by the recall globally. This will likely lead to a surge of lawsuits in the United States. The number of cases has topped 200, but we expect it to grow into the thousands.

If you have used a Phillips CPAP machine and have been diagnosed with mouth, nose, throat, or lung cancer or other significant lung problems, you may be entitled to financial compensation.

Hire a Houston Product Liability Lawyer Today

Blizzard Greenberg, PLLC helps injured consumers go after large companies like Phillips when their products have hurt people who trusted them. We are not afraid of large corporations or their lawyers, and we will take the fight to them. Call us today at (866) 560-1867 or fill out a contact form online to schedule your free initial consultation.