Occasionally devices designed to solve medical problems can create additional problems. Such is the case with certain Continuous Positive Airway Pressure devices (CPAP) and Bilevel Positive Airway Pressure devices (BiPAP) manufactured by Philips Respironics.
CPAP and BiPAP devices keep one’s airways open during sleep, helping to improve oxygen levels in the blood. The devices are mainly used to treat sleep apnea. Without proper treatment, sleep apnea sufferers can go on to develop serious long-term conditions such as high blood pressure, stroke, diabetes and heart problems. Untreated sleep apnea is also a major cause of road traffic accidents, due to sleep deprivation. Nearly 24 million people in the United States suffer from moderate or severe sleep apnea.
Since 2015, Philips Respironics knew about a problem with the devices’ polyurethane foam in the devices. However, the company did not make a public safety announcement until April 2021. A voluntary recall was not launched until June 2021.
In a letter to device users, Phillips Respironics explained the reasons for the recall, saying that it “is voluntarily recalling the devices due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in the devices. (1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and (2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods.”
In July 2021, the FDA classified the Philips Respironics recall as a Class 1 recall. This type of recall is the highest level of recall for a medical device by the FDA. It occurs in “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Initially Philips was expected to repair or replace three to four million devices world-wide, half of which are in the United States. As more device users came forward, the number increased to 5.5 million devices.
Potential Health Risks
Medical issues associated with defective CPAP and BiPAP devices range from relatively mild to life-threatening. They can include:
- headache
- unpleasant smell
- dizziness
- cough
- dyspnea
- chest pain
- airway inflammation/irritation
- lung damage
- asthma
- pneumonia
- heart attack/failure
- respiratory failure
- stroke
Cancers potentially caused by degrading foam and off-gassing can include:
- lung cancer
- kidney cancer
- liver cancer
- rectal cancer
- esophageal cancer
- bladder cancer
- brain cancer
- colon cancer
- stomach cancer
- testicular cancer
- nasal cancer
- throat cancer
- laryngeal cancer
- thyroid cancer
- papillary cancer
- leukemia
- non-Hodgkin’s lymphoma
- multiple myeloma
From April 2021 through April 30, 2022, the FDA received more than 21,000 MDRs medical device reports (MDRs). They included 124 reports of death associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices.
It is important to note that the FDA said the MDR system is limited in its effectiveness because the incidence, prevalence or cause of an event can’t typically be determined from the reporting system alone.
Manufacturer’s Duty
Device manufacturers owe a duty of care to test their products extensively before marketing and to warn users of any known risks. Failure to do so may give rise to a civil lawsuit against the manufacturer.
To speak with a knowledgeable personal injury attorney, call Comitz Law at 570-829-1111 or email info@comitzlaw.com.