Philips Continues to Cope with Difficulties Following CPAP Device Recall
Philips Office image by Wodgester and Emilie FH via Wikimedia Commons
Philips Continues to Cope with Difficulties Following CPAP Device Recall
By Admin
Philips Respironics, one of the largest CPAP developers in the world, continues to cope with ongoing litigation and other difficulties following the recall of devices determined unsafe due to potentially toxic foam insulation. The recall, which began in the summer of this year, includes several of the company’s primary PAP-therapy devices such as the popular DreamStation product line (excluding the new DreamStation 2). According to lawyers on the case, such as Michael London of law firm Doubland & London in New York City, there are layers of potential claims being filed, including class-action suits and those seeking medical coverage for ongoing treatment and monitoring of CPAP users. While the company is doing what it can to provide recall services to its customers, lawsuits have been filed on behalf of device users as well as by companies that sell ozone-based device cleaners, which Philips has previously attributed to health concerns and device problems. Philips, one of the largest medical device companies in the world, continues to work with its customers as well as the FDA in a voluntary effort to compensate those affected and defend the reputation of its products.
The Background
In June of this year, Philips Respironics issued a recall for some of their CPAP, BiPAP, ASV, and ventilator devices due to safety concerns over a sound-proofing foam made from polyester-based polyurethane (PE-PUR). The concern, according to a recall notification published on the Philips website, is that a series of complaints (.03 percent of those received in 2020) have been made about the presence of particles or debris within the air pathway of some devices. In the case of degradation due to age and/or wear, Philips has determined that there may be risks associated with inhalation of the foam particles or related off-gassing of chemicals, potentially causing headaches, upper airway irritation, coughs, chest pressure, or sinus infections, as well as the possible exacerbation of existing conditions such as asthma. There is also a concern that the foam may degrade due to unrecommended cleaning methods such as those using ozone gas, or using devices in high heat and high humidity environments.
The Ozone Cleaner Debate
According to the Philips website, the foam degradation in their products “may be exacerbated by use of unapproved cleaning methods, such as ozone.” The recall notification warns that, according to a FDA safety communication on use of ozone cleaners, off-gassing may occur during the initial operation of PAP and ventilator devices and “may possibly continue throughout the device’s useful life.” While the company cites FDA communications in its warnings, ozone cleaning product company SoClean has filed a suit claiming defamation and loss of sales due to the warnings and other statements made by Philips concerning ozone products. SoClean Inc, an independent supplier of ozone-based sanitizing systems, said in a lawsuit filed October12 in federal court that Philips is “pointing the finger at SoClean’s ozone cleaners” to divert attention away from a “poor choice of materials.”
According to SoClean’s lawyer, Colin Cabral of Proskauer Rose, the company’s brand reputation has been “tarnished,” in addition to the loss of sales. While Philips has not yet published a statement in response to the litigation, their claims regarding ozone-based CPAP cleaners were based on FDA statements concerning ozone product off-gassing and its potential risks The lawsuit is seeking over $200 million in damages.
Class-Action Suits
Royal Philips, the parent company of Philips Respironics, is facing over 100 U.S. lawsuits over its device recall, many associated with ongoing health concerns of patients who used their products. While Philips is based in the Netherlands, its primary U.S. plant is located in Pittsburgh, which is where the claims are being filed, many of them class-action suits seeking medical expenses and more.
Lawyers representing the plaintiffs, such as Michael London in New York, are expecting thousands of device users to sue over the proposed risks associated with the recalled devices. These lawsuits will take some time, and while Philips is prepared to help its customers with the recall effort, its lawyers are planning to defend some of the larger claims of high risk or injury associated with their products, including claims that Philips machines pose a cancer risk. In defense of its repair and replacement program, Philips plans to follow FDA recommendations and provide easy-access services for any customer who has purchased a recalled Philips product.
FDA Recommendations
Although the Philips recall is categorized as a class-1 recall for possible injury or other health effects, the Food and Drug Administration (FDA) recommends following the Philips guidelines already set in place to help patients avoid these concerns. The guidelines are designed to help patients with the recall or allow the company to replace the PE-PUR foam with a new material that is compliant with FDA regulations.
Philips Instructions and Guidelines
Philips published instructions for patient guidance and support, which we have repeated in summary below:
For patients using affected life-sustaining mechanical ventilator devices:
Do not stop or disrupt your prescribed therapy until you have talked to your physician. Philips recommends immediate consultation with a healthcare professional to determine the best options for your specific health needs.
Ventilator options for life-sustaining therapy may be limited in cases where therapy disruption can have immediate harmful consequences. In these situations, the company explains, the benefit of continued therapy may outweigh the risks of PE-PUR foam degradation. If recommended by a physician, Philips suggests an alternative inline bacterial filter.
For patients using affected CPAP or BiPAP therapy devices:
Do discontinue use of your device and work with your physician and/or a Durable Medical Equipment (DME) provider to determine how to proceed with a replacement or repair process.
To ensure that your product is one of the recalled models, use the Philips registration process to look up the serial number, check for updates, and begin a claim if your device is one of the recalled models.
Keep in mind that Philips advises customers to contact their medical provider as soon as possible. A medical provider can help determine how to proceed if you are using an affected device, and whether it is recommended to stop or pause treatment during the process. A healthcare provider can also prescribe a new PAP device as needed.
List of Affected Devices
The following list was obtained from the Philips Respironics Recall Notification and Field Safety Notice, published in June of this year.
Note: Affected Devices All Manufactured Before 26 April 2021.
1. CPAP and BiPAP Devices
Continuous Ventilators, Minimum Ventilatory Support, Facility Use:
E30 (Emergency Use Authorization only)
Continuous Ventilators, Non-life Supporting:
DreamStation: ASV
DreamStation: ST, AVAPS
SystemOne: ASV4
C Series : ASV, S/T, AVAPS
OmniLab Advanced Plus: In-Lab Titration Device
Non-Continuous Ventilators:
SystemOne: (Q series)
DreamStation: CPAP, APAP, BiPAP
DreamStation GO: CPAP, APAP
Dorma 400, 500: CPAP
REMStar SE Auto: CPAP
2. Mechanical Ventilators
Continuous Ventilators:
Trilogy 100 and 200 Ventilators
Garbin Plus, Aeris, LifeVent: Ventilator
Continuous Ventilators, Minimum Ventilatory Support, Facility Use:
A-Series BiPAP Hybrid A30
A-Series BiPAP V30 Auto: Ventilator
Continuous Ventilator, Non-life Supporting:
A-Series BiPAP A30 and A40
List of Products Not Affected by the Recall
Trilogy Evo, Evo OBM, EV300, and 202
BiPAP A40 EFL and A40 Pro
M-Series
DreamStation 2
Omnilab (original based on Harmony 2)
Dorma 100, Dorma 200, & REMStar SE
Other products such as oxygen concentrators and airway clearance devices.
Repair and Replacement Program
Philips has created a repair and replacement program to streamline the recall process and better serve those patients at risk of using the potentially compromised products. Working with the U.S. health and medical-device regulatory agencies, the company is ensuring an effective recall and a swift replacement process for the PE-PUR foam components of their devices. The PE-PUR foam will be replaced with a new, safe material to reduce sound, and if necessary, the devices themselves may be replaced to minimize risk
As part of the repair and replacement program, the new sound reduction materials will be thoroughly tested to ensure the safest possible replacement product. And to facilitate the shift to safer products, Philips is increasing the production of its DreamStation 2 CPAP devices, which do not contain PE-PUR foam.
For further information, visit the Philips recall webpage or call the company directly at: 877-907-7508
Sources
Insurancejournal.com - https://www.insurancejournal.com/news/national/2021/10/12/636533.htm
Law360.com - https://www.law360.com/cases/616600eb2db3acc347d5c365
Philips Respironics: Information for Physicians and Other Medical Care Providers - https://www.usa.philips.com/healthcare/e/sleep/communications/src-update/information-for-physicians-and-providers
Philips Respironics: Recall Notification and Field Safety Notice - https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
U.S. Food and Drug Administration: Company Announcement - https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam
U.S. Food and Drug Administration: Potential Risks Associated With the Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories - https://www.fda.gov/medical-devices/safety-communications/potential-risks-associated-use-ozone-and-ultraviolet-uv-light-products-cleaning-cpap-machines-and
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