Philips Agrees Respiratory Device Recall Lawsuits Should Be Centralized in Federal MDL Featured

As a growing number of class action lawsuits and individual injury lawsuits continue to be filed on behalf of owners of recalled DreamStation CPAP machines, Bi-PAP machines and mechanical ventilators, which have been found to release toxic particles into the air pathways, Philips indicates it agrees the litigation should be consolidated before one judge for coordinated pretrial proceedings in the federal court system.

On June 14, Philips Respironics, also known as Koninklijke Philips, issued a massive recall for 3.5 million breathing machines which were distributed with unsafe and defective sound abatement foam that may degrade and release black particles or toxic chemicals directly into the lungs of users who rely on the devices for treatment of sleep apnea and other conditions.

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 29, Philips agreed the cases should be centralized, but indicates the litigation should be consolidated in the District of Massachusetts.

“Philips agrees that centralization of the Actions and follow-on actions is appropriate because it will promote judicial efficiency and prevent duplicative discovery, as well as serve to enable consistency in pretrial rulings,” the response states. “Philips, however, disagrees that centralization in the Eastern District of Pennsylvania is most appropriate. Only one of the 32 cases is pending in that District, and none of the defendants are located there.”

Philips’ North American offices are located in Massachusetts. In addition, 15 of the 32 cases filed nationwide are currently filed in the federal Massachusetts court system, the company noted.

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.

Philips CPAP Machine Health Concerns

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.

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.

Recalled CPAP and BiPAP Devices

Device TypeModel Name and Number
Continuous Ventilator, Non-life Supporting- E30 (Emerrgency Use Authorization)
Continuous Ventilator, Non-Life Supporting- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV
- C Series S/T and AVAPS
- OmniLab Advanced+
Noncontinous Ventilator- SystemOne (Q-Series)
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto

Recalled Ventilators

Device TypeModel Name and Number
Continuous Ventilator- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventillatory Support, Facility Use- A Series BiPAP Hybrid A30
- A Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting- A Series BiPAP A40
- A Series BiPAP A30



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