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Recall on CPAP Machines Causes Great Hardship

I’m David Holub, an attorney focusing on personal injury law in northwest Indiana.

Welcome to Personal Injury Primer, where we break down the law into simple terms, provide legal tips, and discuss personal injury law topics.

Today’s question comes from another caller who was forced to stop using a CPAP machine due to a recall notice that told him that using the machine could make him sick or give him cancer.

In Podcast 153 we addressed the recall by Philips on various models of Continuous Positive Airway Pressure (CPAP) machines, and mechanical ventilator devices. The recall addressed health risks associated with polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. The soundproofing foam can degrade and result in a patient inhaling or ingesting diethylene glycol (DEG).

In that episode, we explained how Diethylene glycol (DEG) is used as a solvent. And how Diethylene glycol is used to manufacture polyester resins and polyurethanes, as well as brake fluid.

Here is the problem, people have been told by Philips that they should check with their doctor on whether or not to use the machines until a new unit could be obtained.

Since no one has been documented to have gotten sick, you would think that doctors would give the green light to use the machines short-term until a new device could be obtained.

But that apparently has not been the case.

Instead, probably because they’re afraid of being sued, many doctors tell people not to use the machines.

But because so many machines have been taken out of service, many callers complain that they can’t get replacement machines.

Now keep in mind that people who have been prescribed CPAP machines by doctors have severe breathing problems that require the use of such a machine to survive.

Some CPAP users can even risk death if they have a severe condition and fail to use a machine. But yet because of the unavailability of replacement machines, people are being told that it may be months before they can get one, and they are doing their best to survive without such a machine.

One lady called to say that she couldn’t sleep at night for several months and was getting very ill.

Another person called to explain that his sister, who stopped using a recalled unit, had developed pneumonia, and her doctor finally told her she must start using the machine again. But she’s deathly afraid of using it and won’t use it.

If the question is between certain death by not using a medical device, and possible long-term harm by using the medical device, you would think that medical providers would sit down with a patient and come up with a plan that is in the best interest of the patient.

So, due to a recall of a strategic medical device, for which there is no replacement immediately available, the user’s health has been put at great risk.

But is there a legal remedy? My guess is that if one of these patients sued to seek compensation due to worsening health created by the recall, a court would find the law ill-equipped to deal with the situation.

Here’s our suggestion: the FDA should immediately work with the Phillips company to test the recalled machines by an independent lab to determine if they are temporarily safe to use for several months while replacement machines are being manufactured and shipped.

If a machine is not immediately harmful, the patient should know that fact and have the opportunity to decide with their doctor what is in their best interest. If a machine is tested and presents an immediate danger, the patient should be told.

Patients, of course, could try to find testing labs on their own. But, many are on social security and would have no way to pay what could be a hefty fee to test the product.

Sometimes the courts are not able to offer the best remedy. Sometimes it’s another branch of government. … Still, with the proper proof, a creative court might be persuaded to enter an injunction that required the manufacturer to screen its machines for patient safety at the manufacturer’s expense.

I hope you found this information helpful. If you are a victim of someone’s carelessness, substandard medical care, a product defect, work injury, or another personal injury, please call (219) 736-9700 with your questions. You can also learn more about us by visiting our website at DavidHolubLaw.com – while there, make sure you request a copy of our book “Fighting for Truth.”