Recall on CPAP Machines and Possible Contamination

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 a caller who uses a CPAP machine. He got a recall notice that told him that using the machine could make him sick or give him cancer. He wanted to know his legal options.

Indeed, users of Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices received recall notices on specified machines. 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).

Is inhaling or ingesting diethylene glycol (DEG) bad? Yes. It can be quite bad depending on the exposure. The greater the exposure level, the greater the harm.

Diethylene glycol (DEG) is used as a solvent. But, it can kill those who come in contact with it.

Diethylene glycol is used to manufacture polyester resins and polyurethanes.  DEG is also used as a component in brake fluid, lubricants, wallpaper strippers, and cooking fuel canisters.

So how can you tell if you have been exposed to DEG? Well, not very easily. In addition to being poisonous, it is colorless and practically odorless.

The mechanism of harm primarily leads to renal difficulties, leading to metabolic acidosis and liver and kidney damage. Signs and symptoms of poisoning can include gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhea. It also can lead to neurological symptoms like altered mental status, central nervous system depression, and coma.

 

A good prognosis depends on prompt diagnosis and treatment due to the high mortality rate DEG intoxication produces. Patients who survive but develop kidney failure remain dialysis-dependent.

Philips’ recall notice says: “The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues. Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.”

Philips also warns patients using the affected products to only discontinue use in consultation with a physician. Realistically, the short-term exposure of patients to DEG, if any, may be so minute as to only produce the symptoms noted in the recall notice. … The real risk is long-term exposure.

So the recall notice makes good sense for Philips and patients.

From a legal perspective, though a patient has suffered toxic or carcinogenic exposure, it may take time and medical monitoring to discover the full extent of an injury. The device components Philips may seek to voluntarily replace may constitute evidence. Often, a company will request a return of a defective part and then destroy it, destroying the evidence. If the patient wants to preserve a right to sue, some steps can be taken to preserve evidence and avoid forfeiture of legal rights.

It is wise to consult an attorney in addition to consulting your doctor if you receive a recall notice. If you have suffered an injury using a recalled product, your time to sue will be ticking. If you think you may have been exposed to a harmful chemical, checking in with your doctor should be your first priority, however. To date, there have been no reports of harm suffered by patients using the recalled product. That is good news.

Latent harm, such as cancer that shows up 10 years in the future may be deadly, so when you speak to your doctor, ask about monitoring you should be doing. Maybe getting a CTscan every few years will be needed. Be sure to ask your doctor about the future ramifications of exposure.

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.”