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After millions of individuals were recently warned to stop using their popular CPAP and BiPAP devices, which may release toxic particles and gases directly into the air pathway, a number of Philips Respironics class action lawsuits have been filed, calling for the manufacturer to cover the full cost of replacing the recalled sleep apnea machines.
A massive Philips CPAP machine recall was issued on June 14, impacting CPAP, BiPAP and mechanical ventilator products sold since 2009, which contained a PE-PUR sound abatement foam that may degrade and release black particles and chemicals directly into the mouth, nose or throat.
Shortly before announcing the recall, Koninklijke Philips N.V. announced it was introducing a new version of the CPAP and BiPAP machines, known as the “DreamStations 2”, which it indicates does not experience the same foam degradation issues.
While individuals who rely on the breathing machines for treatment of sleep apnea have been told to immediately stop using the devices, the manufacturer has not offered free replacements or provided any time-line for when recall repairs may begin to replace the defective sound abatement foam.
At least two class action lawsuits have already been filed against Koninklijke Philips N.V., seeking to force the company to reimburse the costs of replacing the recalled CPAP and BiPAP machines, including one complaint (PDF) filed by Elizabeth Heilman in the U.S. District Court for the Western District of Pennsylvania on July 5, and a separate complaint (PDF) filed by a group of four plaintiffs in the District of Massachusetts on July 9.
The cases are the first of what is expected to be a flood of Philips CPAP/BiPAP machine class action claims, as well as individual injury lawsuits that will be filed by individuals diagnosed with cancer, respiratory issues or other health problems that may be the result of exposure to chemicals and debris released by the PE-PUR foam.
According to Heilman’s lawsuit, she bought a Philips Respironics DreamStation CPAP machine about three years ago, and used the device every night on the advice of her doctor. Although it was expected to last for at least five years, Heilman indicates that Philips will not reimburse her for the cost of purchasing a new CPAP machine to replace the one with defective foam.
“Plaintiff consulted with her doctors and has ordered a new machine, which she will have to pay for out of her health insurance deductible,” the lawsuit states. “Plaintiff would not have purchased the DreamStation machine if she had known it was defective. Plaintiff seeks a refund, reimbursement for the replacement, and all other appropriate damages for all the injuries she has suffered as a result of her defective DreamStation.”
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.
The other complaint, filed by Matthew Hufnus, Christopher Ludgate, Tony Shapiro-Bey and Stephen Smith makes virtually identical claims, each indicating that devices they purchased are now worthless, and pose a potential threat to their health, claiming Philips should be required to pay to have them replaced.
“Plaintiffs have been advised by Philips to discontinue use of their devices,” that lawsuit states. “Plaintiffs must now spend a substantial amount of time and incure substantial expenses to replace the device.”
Philips CPAP Machine Health Risks
After Philips Respironics first disclosed the health risks posed by the CPAP/BiPAP machine foam, the FDA issued a safety communication on June 30, warning consumers and healthcare providers to immediately stop using the recalled breathing machines and seek medical attention if they are experiencing side effects.
The FDA warns replacement devices may not be readily available, and indicates individuals who use Philips DreamStation, CPAP or BiPAP machines should contact their healthcare providers to discuss a suitable treatment alternatives, which may involve more long-term life-style changes or more invasive CPAP treatment options.
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 these users can place an inline bacterial filter in the device 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.