As of September 28, 2021, a total of 93 class actions had been filed against Continuous Positive Air Pressure (CPAP) maker Philips Respironics. The Judicial Panel on Multidistrict Litigation announced it will hear motions to consolidate or coordinate pretrial proceedings for these lawsuits.
A motion has been filed to create the MDL in the Eastern District of Pennsylvania where three CPAP lawsuits are currently pending. Philips, on the other hand, filed a motion with the judicial panel requesting that they consolidate the cases in Massachusetts. Twenty-six cases are pending in this area, which also happens to be home to Philips North America headquarters. The company also supports consolidating the cases in the Western District of Pennsylvania, which is where Philips Respironics—and 18 additional cases—are located.
The lawsuits follow Philips’ June 2021 voluntary recall of its CPAP, Bi-Level PAP, and ventilator machines manufactured before April 26, 2021. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall—the most serious type of recall—due to the “reasonable probability” that use of the devices will cause serious injury or death.
According to the recall notice, the sound abatement foam used in some of these devices tends to degrade, entering the airpath, where particles can be inhaled or ingested by users. In addition, users can suffer the effects of exposure to chemical emissions from the foam component.
The potential risks of the defective device’s degraded foam include:
- Eye irritation
- Skin irritation
- Respiratory tract irritation
- Inflammatory response
- Adverse effects to kidneys, liver, and other organs
- Toxic carcinogenic effects
Philips Respironics further reported having received multiple complaints from device users who reported seeing black debris in the airpath circuit, which extends from the outlet, humidifier, tubing, and mask. The company says that customers have reported headaches, cough, upper airway irritation, sinus infection, and chest pressure.
The potential risks from exposure to chemical emissions from the defective devices include:
- Dizziness or headache
- Irritation to nose
- Irritation to eyes
- Irritation to skin
- Irritation to the respiratory tract
- Nausea or vomiting
- Toxic and carcinogenic effects
Philips announced plans to replace the existing sound abatement foam with a more stable material that does not present these problems. The FDA approved this plan, but the effort has experienced a setback due to a shortage of ready replacement kits. As such, the recall will persist until September 2022.
The medical company has not provided users with “loaner” devices. Furthermore, most insurers—and Medicaid—decline payment for new units unless the user’s previous unit was at least five years old. The devices cost between $500 and $1,000 retail.