Philips Respironics faces a class action lawsuit over its recalled DreamStation CPAP machines, Bi-PAP machines and ventilators, which contain allegedly defective sound abatement foam that may break down and releases black particles or toxic chemicals directly into the air pathways of individuals using the devices.
The case is the first of what is expected to be thousands of Philips CPAP machine lawsuits likely to be filed by owners of devices sold in recent years with a polyester-based polyurethane foam intended to reduce sound and vibrations, known as PE-PUR sound abatement foam.
A massive Philips CPAP machine recall was issued on June 14, impacting about 3.5 million DreamStation products, CPAP machines, BiPAP machines and mechanical ventilators, which are commonly used among individuals with problems ranging from sleep apnea and COPD, to an inability to breath on their own.
According to allegations raised in a complaint (PDF) filed by Gerry Shelton late last week in the U.S. District Court for the District of Massachusetts, Philips has known about problems with the recalled sleep apnea machines for years. However, the company allegedly concealed the information and delayed announcing any recall until new version of the machines, known as “DreamStation2”, was introduced in April 2021, allowing the company to profit further by the defective and dangerous design.
Shelton is a truck driver with sleep apnea, and indicates he had to stop working because he cannot drive with untreated breathing problems, and has no replacement CPAP machine available. The lawsuit indicates he has begun suffering from atrial fibrillation because he cannot get sufficient sleep.
“Philips has no concrete timeline for replacing or repairing any of the Recalled Breathing Machines,” Shelton’s lawsuit states. “In fact, Philips timed its recall of the Recalled Breathing Machines to coincide with the launch of its next generation of products, which purportedly do not suffer from the same PE-PUR foam issues. Thus, the only safe option that Philips offers to its customers – many of whom need and rely on the Recalled Breathing Machines – is to purchase Philip’s newer model, thus profiting Philips further.”
The lawsuit seeks class action status to pursue damages on behalf of all individuals who purchased a recalled Philips CPAP machine, which may increase the risk of cancer, pulmonary fibrosis and other injuries, including headaches, irritation, inflammation and respiratory issues.
Shelton calls for the Court to require Philips to refund the cost of recalled machines, replace them with non-defective devices for free and pay for medical monitoring for those who may have inhaled cancer causing black particles released by the foam, as well as toxic chemicals released by the breathing machines for years.
FDA Highlights Philips Respironics CPAP Machine Health Risks
The complaint was filed one day before the FDA issued a safety communication warning consumers and healthcare providers about the health risks from the recalled breathing machines.
The FDA indicates people who use Philips DreamStation, CPAP or BiPAP machines should immediately stop using their device and contact their healthcare providers for a suitable treatment alternative. Unfortunately, there is likely to be limited availability for other breathing machines, and alternative treatments for sleep apnea or lifestyle changes may not provide immediate relief.
For users with recalled Philips ventilators, which provide mechanical breathing assistance, the FDA indicates not to stop or change ventilator until after speaking with a doctor, as some patients require the life-sustaining therapy.
While an inline bacterial filter can be used to catch the foam particles before they enter the airways, this may impede the ventilator performance and increase resistance of airflow through the device, according to federal health officials. In addition, this will not protect against problems caused by “off-gassing” of chemicals from the degraded foam.
Philips has suggested individuals living in areas with high temperatures or humidity may face an increased risk of the CPAP machine foam degrading, and certain ozone or UV light cleaning products may further accelerate the problems.
The Dutch manufacturer, Koninklijke Philips, N.V. generated over $23 billion in revenue last year, and is expected to face massive liability from lawsuits and CPAP machine settlements over the next few years.