Many sleep apnea patients who have used certain CPAP, BiPAP, or ventilators made by Philips Respironics are now facing cancer and other diseases due to a defect in these devices. These injuries have resulted in a Class 1 recall of specific models and ensuing lawsuits.
Questions our litigation lawyers hear often are,
- Should I preserve my recalled CPAP device as evidence for a lawsuit against Philips?
- How does a plaintiff preserve evidence when it’s been recalled?
These are excellent questions that have many parts. This post summarizes the factors involved in preserving recalled CPAP and BiPAP machines as physical evidence for mass tort litigation against Philips.
If possible, it is best to keep your recalled sleep apnea device as evidence in your potential case for compensation. If you believe your device might be defective, do not throw it away. If the insurance company or your medical equipment supplier is asking you to return it for repairs or replacement and you are unsure what to do, reach out to Marc Whitehead & Associates for experienced counsel.
While these defective product cases have been centralized as a mass tort, every case remains an individual lawsuit with its own facts. We urge you to request a free consultation with a product liability lawyer before returning your CPAP machine for any Philips repair or replacement.
Destruction of evidence has been a concern from the early stages of the Philips CPAP litigation.
As with any product liability or defective medical device case, the product itself is essential evidence. In these cases, the CPAP and BiPAP machines, ventilators, or specific component parts within a device, would become prime evidence of PE-PUR foam degradation.
Philip’s recalled sleep apnea machines use a type of polyester polyurethane foam called PE-PUR. Used to make the DreamStation units run quieter, this foam is at the heart of the lawsuit. The foam may degrade and release toxic particles and potentially carcinogenic chemicals into users’ airways.
FDA had authorized Philips to remediate the defective devices for users who opted to have their units repaired or replaced. However, the plaintiff’s counsel realized that in doing so, Philips was actually destroying or altering tangible evidence as it stripped and disposed of the faulty foam from the machines.
Pretrial Order #1
In November 2021, the Judge presiding over the litigation issued Pretrial Order #1, which set the stage for the “Preservation of Evidence.” The pretrial order directs all parties to preserve “any tangible things” that could be considered evidence in the litigation.
Philips came back and stated that this order would put a halt on their repair-replacement efforts. They would be unable to meet their remediation commitments and also take steps to preserve evidence. Philips pled for the Court to modify the pretrial order.
Plaintiff’s attorneys further argued that at minimum Philips should preserve the defective foam, and make copies of the device’s memory cards as evidence of user’s exposure to the foam.
Interim Preservation Order – Options for Preserving a Recalled CPAP Device as Evidence
In January 2022, the presiding Judge issued an Interim Preservation Order on which all parties could agree.
The Interim Preservation Order currently refers to DreamStation 1 units only. The Preservation Order (1) instructs Philips to create a Preservation Registry (2) informs users how to register their devices online on the Preservation Registry and (2) explains how to bag and store the recalled sleep apnea machines as physical evidence for later use in litigation.
To summarize:
In each case below, users are asked to submit identifying information for inclusion on a Preservation Registry maintained by Philips. This is so Philips can track what devices are and are not being returned under the recall remediation. Participation in the Preservation Registry is optional.
- If you submit your device to Philips for “repair,” the interim preservation order requires Philips to take pictures and preserve certain parts of the device before reworking it.
-Or-
- If you choose not to repair your CPAP machine, you can elect to send it back to Philips and have it preserved as evidence but not repaired.
-Or-
- You may elect to keep your CPAP/BiPAP device or have your attorney retain it. As a plaintiff, you are not required to return the sleep apnea machine to receive a replacement machine from Philips. You are not required to return the machine to Philips at all. The Interim Preservation Order refers to these units as User-Preserved Devices.
What Evidence Is Helpful to Your CPAP Recall Claim?
You should collect and organize as much physical evidence as possible to support your claim. Evidence available to plaintiffs includes:
- The actual CPAP, BiPAP, or Ventilator unit – including the following components:
- CPAP SD memory cards. You need to retain the SD cards and retrieve the data recorded on the unit. The memory card stores weeks of data so you can track and view how your sleep therapy is going. The card is removed from the machine, and the data is downloaded. Your doctor or sleep lab monitors the data to ensure you comply with CPAP therapy. This verification is required by insurance companies and gives physicians information about your apnea and the effectiveness of treatment. This retrieval of data, along with the Memory Card registration, may also become evidence regarding legal action against the manufacturer, such as if the device causes apnea–hypopnea events.
- Humidifier, masks, air pathways, tubing, and possible evidence of black particulates present in the CPAP’s air pathways, etc.
- Internal Philips Respironics company documents, such as user manuals.
- Purchase receipts – any receipts relating to the purchase of your CPAP device or other proofs concerning your use of a recalled machine and for how long it was used.
- Medical records, medical bills, prescription records and other evidence of your total medical costs.
- Photos and videos of your sleep apnea units and specific component parts.
Consult Your Doctor
Discuss your situation with your healthcare provider to determine if you should stop using your sleep apnea machine immediately. Your doctor may prescribe alternative treatment methods or prescribe a different CPAP or BiPAP unit. In some cases, your healthcare provider may advise you to continue using your recalled device while waiting for a repaired or new device.
Contact Philips CPAP Mass Tort Lawyers
No one’s legal rights should later be compromised because evidence was altered or destroyed during the refurbishing process or otherwise mishandled.
If you or a family member experienced severe health concerns after using a defective CPAP, BiPAP, or ventilator manufactured by Philips, your entire life may be impacted. Marc Whitehead & Associates has product liability litigation experience when you need it most.
We are standing by to assess your situation to establish whether you have a claim against Philips Respironics. We will answer questions about preserving your CPAP device, and explain what comes next.
Gathering solid evidence to make your case is a crucial task we will handle for you. Our mass tort litigation lawyers will fight for your compensation, and we are ready to help you now.
Recap of Philips CPAP Lawsuit and Recalled Devices
The Philips CPAP lawsuit is a product liability tort. The medical device manufacturer, Philips Respironics, designed devices in a faulty way that causes harm to the consumer.
Your lawyer’s goal is to prove that you suffered adverse health effects because Philips created, released, and managed a defective product. Evidence shows that Philips was fully aware of the defects in their machines related to the PE-PUR foam and did not warn consumers about the risks. Additionally, Philips acknowledged that PE-PUR foam releases toxic chemicals.
The recalled devices include DreamStation 1, SystemOne CPAP models, and several other Philips machines, including Trilogy ventilators. The recall involves all serial numbers of the affected machines manufactured before April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
Access the current list at FDA’s Recalled CPAP and BiPAP Devices list.
Severe and fatal health problems can develop from prolonged use of these machines. Long-term injuries include respiratory illnesses, organ damage, and cancer. Philips estimates this foam was used in 3 to 4 million devices, therefore, the ensuing injury cases will be litigated as a mass tort.
