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Months after it recalled millions of CPAP, BiPAP and other breathing machines, leaving individuals nationwide without critical treatment for their sleep apnea, Philips announced this week it has received approval to begin repairing or replacing devices.
In a press release issued on September 1, Philips indicates it has received authorization from the FDA to “rework” recalled first-generation DreamStation CPAP devices, including the replacement of polyester-based polyurethane (PE-PUR) foam in the recalled devices.
The announcement comes as the manufacturer faces a growing number of class action lawsuits by customers nationwide who say the recent Philips CPAP recall left them without much needed sleep apnea therapy with no indication whether the company would repair or replace the recalled machines.
An estimated 3.5 million Philips Respironics DreamStation, CPAP, BiPAP and mechanical ventilators were recalled in June, due to a risk that defective sound abatement foam used in the machines may degrade and release black particles or toxic chemicals in the lungs of users who rely on the machines for treatment of sleep apnea or other conditions.
Exposure to the toxic particles and gases released by PE-PUR foam inside has been linked to reports of cancer, severe respiratory problems and other health complications, according to allegations raised in a growing number of Philips CPAP machine lawsuits and class action claims filed in courts nationwide in recent weeks.
Now, the company says it anticipates starting to replace the foam this month and says it has already begun CPAP recall repairs for some customers’ first-generation machines, replacing the devices with newer versions that do not experience the same problems with foam degradation. The company expects the reworking program to take a year.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” CEO of Royal Philips, Frans Van Houten, said in the press release. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected devices to register these on the dedicated recall notification website.”
The website, which contains information to customers, users and healthcare professionals, and where those affected by the recall can register their devices, is at www.philips.com/src-update.
Philips CPAP Lawsuits
The announcement comes as Philips faces a growing number of lawsuits from consumers, most of which are seeking class action status.
On August 30, another class action lawsuit was filed by George James, of Missouri, in the U.S. District Court of the Western District of Missouri. The complaint (PDF), like numerous others, claims the company left users with devices that may be dangerous to their health, with no indications of whether they would repair or replace them.
James indicates he has suffered headaches, respiratory irritants and skin irritation during his use of one of the recalled devices.
Another complaint (PDF) was filed the very next day by 24 different plaintiffs in Massachusetts federal court, making similar accusations and claiming Philips left users of the devices with a “choice between a risk of cancer or a lack of oxygen.”
On September, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments on the CPAP recall lawsuits, to decide whether to consolidate and centralize claims filed in federal courts nationwide before one judge for pretrial proceedings.
Consolidation is common in complex product liability litigation, where a large number of claims have been presented by former users of the same product, alleging similar injuries. Centralizing the Philips CPAP/BiPAP claims would help avoid duplicative discovery, prevent contradictory rulings from different judges, and serve the convenience of the parties, witnesses, and the courts, according to the motion.