Only a few weeks after a massive Philips DreamStation CPAP machine recall was issued, there are already so many lawsuits being filed throughout the federal court system that a request has been filed to consolidate all claims before one judge for coordinated management, as part of an MDL, or multidistrict litigation.

Koninklijke Philips, also known as Royal Philips, just announced on June 14 that an estimated 3.5 million CPAP, BiPAP and ventilator breathing machines were distributed with unsafe and defective sound abatement foam, which may degrade and release black particles or toxic chemicals directly into the air pathway.

Exposure to the toxic particles and gases released by a polyester-based polyurethane (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 recall lawsuits filed over the past few weeks.

On July 7, Thomas R. Starner, a plaintiff who was one of the first to file a lawsuit submitted a Motion for Transfer and Coordination (PDF) to the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting that his case and all similar complaints filed brought throughout the federal court system be consolidated for pretrial proceedings as part of a Philips DreamStation multidistrict litigation (MDL), before U.S. District Judge Timothy J. Savage in the Eastern District of Pennsylvania.

Such 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 DreamStation CPAP 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.

As of the date the motion was filed, there were at least ten different lawsuits filed in five different U.S. District Courts nationwide. However, Starner points out that several of those are class action lawsuits, and millions of consumers may be affected, so that number is expected to continue to mount in the coming weeks and months.

“The Actions and any additional tag-along actions, pending against Defendants will involve similar if not identical questions of fact, and will involve common discovery and pretrial motion practice, and will have numerous overlapping class claims,” the motion states.

Philips CPAP Machine Concerns

Most owners of recalled Philips CPAP machines remain unaware of the problems or risks their device may face, as the first recall letters were sent out less than a month ago, and it appears that many individuals who regularly use the DreamStation sleep apnea machines never bothered to register their product with the manufacturer.

Due to concerns about the serious health risks, the FDA issued a safety communication on June 30, urging people who use Philips DreamStation, CPAP or BiPAP machines to 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, leaving many sleep apnea patients concerned about side effects they may experience without the CPAP machine to keep their airway open at night. However, the FDA has indicated that for these users, the risk of continuing to use the machine may exceed the benefits, and owners are being encouraged to immediately contact their doctors for further guidance.

While only a small number of the recalled breathing machines were Philips ventilators, which provide mechanical breathing assistance, the FDA has warned patients relying on those machines to continue using the product until after they have spoken with their doctor and discussed the treatment options, as discontinuing the life-sustaining therapy may have catestrophic consequences.

An inline bacterial filter can be used to catch the foam particles before they enter the airways, but federal health officials warn that this may impede the ventilator performance and increase resistance of airflow through the device. In addition, this will not protect against problems caused by “off-gassing” of chemicals from the degraded foam, according to federal health officials.

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.

Tags: Cancer, Class Action Lawsuit, CPAP, Medical Device Recall, Particulate Matter, Philips, Respiratory, Sleep Apnea