FDA Confirms CPAP Machine Deaths

by | Jun 22, 2022 | Products Liability

During 2021, the Food and Drug Administration received confirmed reports of 124 deaths linked to defective Philips Continuous Positive Airway Pressure machines. 

The FDA stressed that the findings are preliminary. “We are in the process of evaluating each report while communicating this early information to the public. There is, based solely on the reports, no immediate causal link between the deaths and the foam breakdown,” an agency spokesperson said. “The 124 deaths have not been verified beyond the medical device reports submitted to the FDA.” 

In response, the company only said that it “regrets any inconveniences caused by this issue and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions.” Company lawyers also denied there was a link between malfunctioning CPAP machines and cancer.

The recall affects over fifteen million machines. 

FDA Recalls

A hundred years ago, the Food and Drug Administration was an effective safety watchdog agency. Today, the FDA doesn’t have the power, and usually doesn’t have the will, to fill this role.

Contrary to popular myth, the FDA cannot unilaterally recall dangerous products. It can only inform the public about a dangerous product and ask the manufacturer to voluntarily stop selling it. Generally, the manufacturer can start selling the drug or other product again once it assures the FDA the product is safe. Maybe that assessment is accurate and maybe it isn’t.

Lack of will might be an even more serious deficiency. The same agency that approves new products must admit it allowed an unsafe product to enter the stream of commerce. No one likes to admit their mistakes. 

Money matters come into play as well. The FDA doesn’t get much tax money. Instead, it mostly depends on industry-generated user fees. The more goods these industries sell, the more user fees they pay.

On a related note, voluntary recalls do nothing to compensate victims. Tens of thousands of people have suffered serious injuries because of Philips’ defective CPAP machine. These victims must turn to a Lexington personal injury attorney to receive the compensation they need and deserve. More on that below.

Philips CPAP Issues

CPAP machines treat sleep apnea, a condition that affects millions of people. When these individuals sleep, their primary airways collapse. Mild sleep apnea is simply annoying. Severe sleep apnea could be life threatening. These gadgets force compressed air into the airway and keep it open.

Excessive noise was the big drawback among early CPAP machines. The air compressors made so much noise they kept people awake, which defeated the purpose of the treatment.

To combat the noise problem, Philips engineers surrounded the compressor with a layer of polyurethane foam. Because the foam muffled the noise, sales quickly skyrocketed.

Polyurethane foam is highly toxic. As long as the foam stays in one piece, no one can get hurt. Unfortunately, the air compressor’s vibrations broke up the foam. These tiny particles entered the user’s lungs, where they cause cancer and a host of other problems.

The number of lawsuits skyrocketed even faster than the number of sales. Legally, the issue could be a:

  • Design Defect: The Philips CPAP machine may have had a defective design. Engineers probably knew that the vibrations would tear up the foam. However, they proceeded with the design and put profits before people.
  • Manufacturing Defect: Not all foam layers are created equally. Some break up more easily than others. Normally, manufacturers use the cheapest available parts, no matter how dangerous they are.

As these cases move through the legal system, Philips will most likely blame the users for their own injuries. These gadgets have warning labels which advise users that if the setting exceeds a certain level, the foam could break up and cause injury.

Product misuse is a defense to defective product claims, if the misuse was unforeseeable. Turning a device up too high is a foreseeable misuse. Using the CPAP machine as a SCUBA mask is an unforeseeable misuse.

Damages Available

Compensatory damages are available in defective product claims. These damages, wait for it, compensate victims for their economic losses, such as medical bills, and their noneconomic losses, such as pain and suffering.

Economic losses are normally straightforward. To determine a fair amount of compensation for noneconomic losses, most Lexington personal injury attorneys multiply the economic losses by two, three, or four, depending on the facts of the case and a few other variables.

Usually, additional punitive damages are available in defective product claims as well. Jurors may award these damages if there is clear and convincing evidence that the manufacturer intentionally disregarded a known risk.

Such evidence exists regarding defective Philips CPAP machines. The Department of Justice has subpoenaed documents in this case relating to the recall, and the events leading up to the recall.

Injury victims are usually entitled to substantial compensation. For a free consultation with an experienced personal injury lawyer in Lexington, contact the Goode Law Office, PLLC. Virtual, home, and hospital visits are available.