By Veronica Salib
Concluding ongoing class action and personal injury litigations, Philips announced it had reached an agreement through mediation under Judge Diane M. Welsh. The deal does not require Philips Respironics to admit fault or liability in the case; however, it does require them to make US$1.1 billion in settlement payments.
Since 2021, Philips Respironics has been under fire for several recalls related to the company’s bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines and ventilators.
These machines are one of the primary tools for managing sleep apnea, and many patients across the United States utilize them for chronic disease management.
The polyester-based polyurethane foam in the devices, intended to minimize some of the sound and vibrations associated with machines, has broken down and released certain chemicals. If the foam or the chemical byproducts are inhaled, patients may have adverse reactions, including inflammatory responses, headaches, asthma, and organ toxicity.
This set of recalls included the following devices: A-Series BiPAP A30, A40 (ventilator), Hybrid A30 and Auto (ventilator), C-Series ASV (ventilator) and S/T and AVAPS, DreamStation ASV, Go, and ST, AVAPS, Dorma 40 and 500, E30, Garbin Plus, Aeris, LifeVent (ventilator), OmniLab Advanced+, REMstar SE Auto, SystemOne ASV4, SystemOne (Q-Series), Trilogy 100 (ventilator), and Trilogy 200 (ventilator)
The affected devices were sold between 2008 and 2021, contributing to 116,000 medical device reports and 561 reports of death sent to the FDA.
According to reporting from NPR, approximately $25 million of the settlement money will be allocated to medical monitoring. Additionally, consumers are entitled to up to a $100 award under the financial-loss settlement.
Beyond the issues associated with the foam, in September 2022, a set of recalls was issued for BiPAP and CPAP machines because of magnets inside the masks that interfered with other medical devices, including but not limited to brain stents, insulin pumps, neurostimulators, aneurysm clips, and pacemakers. This recall included the DreamWisp, DreamWear, Amara View, Wisp, and Wisp Youth masks.
While the settlement is not finalized, the company will likely make these payments in 2025.
