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Philips Recall of Millions of CPAP Devices Creates National Health Crisis

Recently, the Journal of the American Medical Association published an article that addressed the national health crisis created by Philips and their June 2021 recall of more than 10 million CPAP, BiPAP, and Ventilator devices in the United States.

The recall has affected millions of people across the U.S. who now worry about the impact the recalled devices may have had on their long-term health.

These medical devices were recalled after Philips disclosed that the polyester-based polyurethane (PE-PUR) foam degrades over time causing the users of the devices to inhale and ingest toxic particles. Medical experts are concerned that ingestion of the toxic foam particles may lead to a host of injuries, including lung cancer and other lung-related injuries, as well as cancers in the head and neck region.

The U.S. Food and Drug Administration (FDA) categorized the recall as a Class 1 recall, which is the most serious and involves a health hazard situation in which there is a reasonable probability that using the device will cause serious adverse health consequences or death. Virginia Buchanan, a senior partner with Levin Papantonio Rafferty (LPR), notes that this is one of the largest recalls and involves one of the most important medical devices on the market. It is also one of the most concerning recalls, as there is no ready replacement for the devices, given the millions that have been recalled.

The medical devices were intended to help individuals who suffer from obstructive sleep apnea (OSA). Approximately 25 million adults in the U.S. experience OSA, a chronic disease that increases the risk of high blood pressure, heart disease, Type 2 diabetes, stroke, and depression.

Troy Bouk, an LPR attorney, explained that sleep apnea is a disorder that affects a person while they sleep. The individual’s airway either completely closes off or becomes so narrowed that the person’s oxygen level drops because not enough air is getting in. As a person’s oxygen level is dropping, their brain causes them to wake up to take a breath of air. Throughout the night, this cycle can occur many times, causing a person to never get a restful night of sleep.

The treatment for sleep apnea is positive airway pressure therapy, which prevents a person’s airway from collapsing, thereby allowing them to have an uninterrupted night of sleep.

“When our clients purchased their now-recalled Philips CPAP devices, they believed they were improving their long-term health by treating their sleep apnea,” Bouk explained. “Now, after many of our clients have used their devices for a number of years, they can’t help but worry about their future health.”

Sadly, many clients have already suffered significant injuries, according to Buchanan.

Unfortunately, as of October 25th, 2022, the most recent figures reported by Philips indicate only two million replacement devices have been shipped in the United States, and 3.95 million repair kits and replacement devices have been produced globally.

“This is unacceptably slow,” Bouk said, “given that Philips has known for many years that the foam in their CPAP devices degrades over time and has the potential to cause harm to the device user. Philips even studied possible solutions but simply failed to take corrective action in a timely manner.”

Bouk stated that while the physicians treating millions of affected patients scramble to find a workable solution, he and Virginia aim to get to the bottom of why and how this happened.

“We look forward to holding Philips accountable for this national health crisis,” Bouk said. “Our firm is steadfast in our fight to bring justice to our clients and advocate for the compensation they deserve.”

Virginia Buchanan serves on the Plaintiffs’ Steering Committee (PSC) and Co-chairs the Discovery Committee, and Troy Bouk serves on the Science and Expert Committee in the Philips CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation (MDL No. 3014).