The Law Firm of Piacentile, Stefanowski & Malherbe LLP
Cpap/Bi-Level Respironics Device Lawsuit

CPAP, Bi-Level Pap, and Philip's Ventilators 

Attorneys for Defective CPAP Device Litigation 

On June 30, 2021, The U.S. Food and Drug Administration (FDA) alerted people who use Philips Respironics ventilators, BiPAP (“bilevel positive airway pressure”), and CPAP ("continuous positive air pressure") machines and their healthcare providers that Philips Respironics has recalled certain devices due to potential health risks. The FDA classified the Philips CPAP recall as Class 1, the most serious kind, because using the affected devices is potentially carcinogenic and toxic chemical exposure may cause a wide variety of health problems, injuries like organ damage, various cancers, and in some cases death. 

What's the Mass Tort About? 

The polyester-based polyurethane sound abatement foam, which is used to reduce the sound and vibration in and from these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

The victims are suing Philips on product liability and negligence-based grounds, legal claims that include:

  • Defective design
  • Manufacturing defect
  • Failure to warn / lack of disclaimers
  • Consumer fraud / deceptive trade practices
  • Fraudulent concealment

As of this publication, CPAP and BiPAP defect’s latest updates, include: 

  • Degradation and off-gassing of Polyester-based Polyurethane Foam. 
  • The foam degrades into toxic and potentially carcinogenic particles that are delivered directly to the user’s nose and/or mouth and inhaled and/or ingested by the user while they sleep. 
  • Off Gasses passively release other toxic and potentially carcinogenic (Volatile Organic Compounds, aka “VOCs”).
  • Some experts say the products of the degradation are acidic, and it could be the biggest driving factor on further degradation and continuously causing more 
  • The PE-PUR foam that Phillips used was highly susceptible to hydrolysis or water degradation.
  • Lab analysis of the degraded foam revealed the presence of potentially harmful underlying chemicals including, Toluene Diamine (TDA), Toluene Diisocyanate (TDI) and, Diethylene Glycol (DEG). 


Background and Updates

The Philips CPAP MDL is being conducted out of the U.S. District Court, Western District of Pennsylvania and it was formed in October of 2021. The Judicial Panel on Multidistrict Litigation ("JPML") chose Senior U.S. District Judge Joy Flowers Conti to handle consumer class-wide claims over the risks posed by the sound-abatement foam used in several models of Philips’ CPAP, Bi-Level PAP, and mechanical ventilators.

The JPML noted that the recalled devices were primarily manufactured by Philips RS North America LLC (formerly known as Philips Respironics) in the Pittsburgh area, and the Pittsburgh-based court was acceptable to both Philips and the plaintiff who had asked for the cases to be consolidated. As of December 1, 2021, MDL No. 3014 has at least 137 cases with tens of thousands more expected to join. 

Applications for the steering committee were considered on January 4, 2022. Judge Conti interviewed applicants on January 27th and 28th. The Plaintiffs’ Steering Committee is a panel of lawyers from the plaintiffs’ side that makes certain decisions on behalf of all plaintiffs in the MDL, including coordinating discovery, selecting core issue experts, motions practice, and the selection of bellwether trial cases.

By the middle of February 2022, 233 actions had been filed with thousands more expected to join. Judge Joy Flowers Conti oversees the MDL.

As of March 28, 2022, Judged Conti conducted some MDL structure changes. He appointed 4 Co-lead counsels composed of 3 class action lawyers and 1 personal injury lawyer. A settlement team and a leadership development team were appointed as well. 

According to the FDA’s investigation, there is evidence that Philips knew about the problems with the sound abatement foam for at least 6 years but deliberately decided not to take any action. The FDA cited numerous product tests and assessment reports dating back to 2016, which indicated that Philips employees knew about issues related to potential foam degradation. 

Regarding evidence, although Judge Conti has allowed Philips to fix the defects present in recalled devices, Philips has been ordered to preserve any evidence that may be relevant. 

Currently, cases are in their initial stages. As such, no settlements or jury verdicts have occurred. Decisions from bellwether cases are yet to be emitted. 

Concerning the statute of limitations ("SOL") issues for these cases, it is understood that the SOL started on June 14, 2021, when the recall was announced. Each state has its own applicable SOL, so potential plaintiffs must move quickly to ensure that their claims are filed in a timely manner. 

If you have used CPAP devices and developed illnesses, please contact us to see if you qualify to join this mass tort. Call (800) 689-8552 or submit an online form here.