FDA faces lawsuits over information on recalled CPAP machines

On Behalf of | Oct 3, 2023 | Personal Injury

Sleep apnea is more than just loud snoring. It’s a medical disorder characterized by obstructed breathing during sleep, which can lead to insomnia, grogginess and irritability. It’s usually treated with continuous positive airway pressure (CPAP) machines. These devices help users breathe by pressurizing room air before delivering it into a breathing mask.

However, even a helpful medical device such as a CPAP machine can be defective and cause more harm than good.

The U.S. Food and Drug Administration (FDA) is facing lawsuits from news outlets ProPublica and the Pittsburgh Post-Gazette related to one such flaw. According to the complaints, the agency is allegedly holding back records related to a recall of defective CPAP machines.

Respiratory device manufacturer Philips Respironics acknowledged in 2021 that its CPAP machines contained industrial foam that could break down during use. The resulting foam particles and fumes could then find their way into the breathing masks, causing health risks to users such as nausea and headaches. The foam was also potentially carcinogenic and toxic in nature.

The FDA had categorized Philips Respironics’ recall of the machines as Class 1, meant for product defects that can cause severe or potentially fatal harm. But when asked by news outlets to release documents related to test reports on the degrading foam and updates from Philips Respironics about the recall status, the agency denied the requests, saying it would take about two years to produce the records.

Product liability lawsuits as recourse

Because the recall scale is unclear, there could be many unwitting users of Philips Respironics’ defective CPAP machines.

What can you do if you’ve suffered health problems using a defective CPAP machine? You may be able to file a product liability lawsuit against the medical device’s manufacturer.

In a product liability lawsuit, you’ll have to establish that the product was defective when it left the manufacturer’s hand and was the direct cause of your illness or injuries. A court may also use the risk-utility standard to decide on the case. Under the standard, a product is defective if there are more cons to its use than pros.

But establishing these facts can be tough, especially when you need expert testimony to support your claims. If you’re going to file a product liability lawsuit, consider seeking legal counsel.


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