AMSTERDAM—Royal Philips, the parent company of Philips Respironics, has settled a class action lawsuit over its recall of some of its sleep and respiratory devices for an estimated $615 million.
The settlement agreement was expected to be submitted to the U.S. District Court for the Western District of Pennsylvania on Thursday, Sept. 7, and was in response to multi-district litigation, which is a federal class action suit. The company said the agreement “does not include or constitute any admission of liability, wrongdoing or fault by any of the Philips parties.”
In June of 2021, Philips voluntarily recalled about 11 million CPAP and BiPAP devices and ventilators in the United States after reports that the polyester-based polyurethane (“PE-PUR”) foam used to dampen sound in the devices could break down and off-gas volatile organic compounds.
The lawsuit claimed Philips knew about issues with the PE-PUR foam as early as 2008 due to customer complaints, and that in 2015, the company received test reports and data “confirming that the Recalled Devices pose serious, indeed life-threatening, health risks to users, but Philips failed to timely disclose that they were defective when manufactured and sold,” the suit reads.
Under the settlement, those who bought recalled CPAPs and ventilators are eligible for cash payments, extended warranties on replacement devices and an additional cash award if they return the recalled device to Philips Respironics. Some customers who bought replacement devices after the recall may get additional compensation.
The Dutch-based company said it has recorded a provision for 575 million Euros in the first quarter of 2023 to cover the estimated cost of the settlement—that works out to $615.6 million under current exchange rates—although the final cost may vary based on legal fees and how many patients participate. Patient payments are not expected to begin until the first quarter of 2024 at the earliest.
The agreement doesn’t settle any personal injury or medical monitoring claims in the suit; Philips has moved to dismiss those.
More details of the settlement as it affects patients will be available at respironicscpap-elsettlement.com. At this time, patients and sleep labs in the U.S. that are eligible for benefits don’t need to take any action to participate. The settlement still requires court approval.
The following devices are included in the recall settlement:
- C-series S/T, AVAPS (C-series and C-series HT)
- DreamStation ASV
- DreamStation BiPAP
- DreamStation CPAP
- DreamStation Go
- DreamStation ST, AVAPS
- E30
- OmniLab Advanced Plus
- System One 50 Series ASV4 (Auto SV4)
- System One 50 Series Base
- System One 50 Series BiPAP
- System One 60 Series ASV4 (Auto SV4)
- System One 60 Series Base
- System One 60 Series BiPAP
- Trilogy 100/200, Garbin Plus, Aeris LiveVent
- V30 auto
