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TopicBiotechnologyGenetics & GenomicsPathologyReproductive HealthMedical Devices
& ImagingPediatrics



MEDICAL DEVICES & IMAGING NEWS


PHILIPS AGREES TO $1.1 BILLION SETTLEMENT FOLLOWING CPAP RECALLS


A FIRST-QUARTER REPORT FROM PHILIPS REVEALED THAT THE COMPANY WOULD PAY $1.1
BILLION IN LITIGATION SETTLEMENTS FROM THE RESPIRONICS CLASS ACTION LAWSUITS.

Source: Getty Images

By Veronica Salib



May 06, 2024 - 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 $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.

DIG DEEPER

 * FDA Issues Update on the Philips BiPAP and CPAP Recalls
 * FDA Identifies Class I Recall on Philips CPAP and BiPAP Machines
 * FDA Recalls Philips BiPAP and CPAP Machine Masks



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.

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