CPAP machines recalled with no replacements issued; evidence points to defective polyurethane foam causing cancer in users.
Koninklijke Philips NV (Philips) issued a major recall on around 3.5 million DreamStation sleep-apnea medical devices sold since 2009, all of which contained a defective noise-canceling foam. However, the company has made no moves to provide customers who rely on the machines for treatment with refunds or replacements.
On July 16 complaint (PDF) was filed in the U.S. District Court for the Central District of California on behalf of Lisa Mitrovich, claiming that Philips should have to provide a refund for owners of the recalled devices and provide replacements not containing the defective foam.
Each recalled device, namely CPAP and BiPAP machines and mechanical ventilators, contains a special foam made of polyester-based polyurethane (PE-PUR) designed to make them quieter. According to the Report on Carcinogens, Urethane is a known potential carcinogen.
As the foam degrades, it releases toxic gases and compounds that are inhaled, ingested into the airways, or even absorbed into the bloodstream. Things like time, humidity, and cleaning methods have been found to expedite the process, factors most patients are likely unaware of and not in control of.
These toxins can cause several adverse symptoms, including headaches, nausea and vomiting, asthma, respiratory problems, cognitive issues, and numerous types of cancers. Research shows that polyurethane exposure enhances the risks of cancer, particularly in women.
Later, in the recall notification itself, Philips urged patients to stop using the defective devices and in a shameless move to promote their recently launched DreamStation 2 line, suggested those relying upon their machines for life-sustaining treatment look to purchasing from their new and improved line for replacements.
Soon after, the FDA released a safety communication of its own, urging consumers to stop using the machines and seek medical treatment immediately if any side effects were experienced. The FDA also encouraged consumers to speak with healthcare providers regarding other options for sleep apnea treatment.
The report also notes that while bacteria filters may be an option, they may obstruct the machines from performing optimally. Additionally, these filters do not protect against the toxic gases emitted by any degraded foam.
Having generated over $23 billion in revenue in the last year alone, it is expected that Koninklijke Philips will face thousands of cases of DreamStation device settlements and lawsuits in the coming years. As the number of class-action lawsuits brought before the corporation grows, we understand you may be interested in taking legal action as well.
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At Rheingold, Giuffra, Ruffo & Plotkin LLP, we aggressively represent our clients and have recovered billions in medical malpractice, mass tort, personal injury, and product liability cases. If you or a loved one has been harmed by Philips’ DreamStation products and want to know if you have a lawsuit, please call (888) 260 – 0473 to speak with us directly and receive a free consultation.