Status of CPAP Litigation
- Updated: March 17, 2023
Quick Links
Patients inhaling these toxic, broken-down PE-PUR foam particles can suffer injuries, including respiratory problems like asthma, upper airway irritation, cough, chest pressure, and sinus infections. Current lawsuits against Philips Respironics focus on the defective design of the company’s CPAP, BiPAP, and mechanical ventilator devices, leading to the foam’s breakdown and subsequent harm to users.
January 2023 Update
Litigation is progressing slowly in MDL 3014, with the case currently in discovery. On December 12, 2022, the parties jointly stipulated to the Deposition Protocol, which limits most depositions to seven hours. This was approved in Pretrial Order #29.
On September 14, 2022, in Pretrial Order #25, Judge Conti granted a joint motion to approve a census registry form, which allows plaintiffs to file complaints on a short form directly with Philips Respironics. Completing this information has the effect of tolling the statute of limitations until a case can be filed or Philips withdraws the agreement. This replaces a private tolling agreement that had been approved on February 8, 2022.
The case against Philips has garnered the attention of the U.S. Justice Department. Philips is currently engaged in negotiations with the Justice Department regarding a consent decree the Justice Department proposed in 2022 with regards to the recall.
In May 2022, the Food and Drug Administration’s Center for Devices and Radiological Health issued a “Notice of Opportunity for a Hearing” to Philips Respironics that the FDA had determined the Philips CPAP machines create an unreasonable risk of substantial harm to the public.
In the notice, the FDA specifically refuted Philips Respironics’ claim that the use of ozone cleaners may be the true cause of the foam breaking down, with the following statement:
“There is sufficient evidence for FDA to determine that there are reasonable grounds to believe that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue. In particular, although the use of ozone cleaners by device users may have exacerbated degradation of the PE-PUR foam, evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”
According to a December 2022 FDA update, the silicone material being used to replace the foam may move and block the air pathway, resulting in reduced air flow and the potential to activate the device alarm. The FDA also found residual foam in the replacement devices.
The devices affected include the first-generation DreamStation CPAP and BiPAP machines, with Philips’ DreamStation CPAP machines accounting for about 80 percent of the recalled sleep apnea devices, according to ConsumerNotice.org. The other 20 percent are mechanical ventilators.
Personal injury lawyers opting to litigate CPAP cases could see many clients interested in recovering damages for serious injuries caused by Philips Respironics’ sleep apnea devices and the defects found with the sound abatement foam. Case Works offers case development and management tasks for lawyers with large caseloads, including those caseloads arising from CPAP litigation.
Current Status of Philips CPAP Litigation
Class actions differ from MDLs in that it's one plaintiff filing the lawsuit and acting as the representative for many other similarly injured people. One settlement or court award is divided among each person in the class, often yielding much less significant payouts. MDLs consider variations among injuries, some being more severe than others, doling out compensation accordingly. In contrast, class actions do not consider each case and each person's respective losses or damages.
Ingesting or inhaling the foam components and other chemicals from the foam's degradation can cause lung or other cancers, respiratory distress, and lung or further organ damage. More specifically, breathing in the black foam particles can cause skin and eye irritation, respiratory tract inflammation, asthma, headaches, inflammatory responses, toxic carcinogenic effects, and damage to the kidneys and liver.
Latest Update on the Philips Recall
By September, Philips had a plan to replace the PE-PUR foam with silicone-based foam. However, the silicone-based foam had not undergone testing for “volatile organic compounds” or VOCs. The FDA requested that Philips have the silicone-based foam independently tested.
While Philips began the testing process, the FDA continued its investigation of the manufacturer’s CPAP machines. The government agency determined that as early as 2015, Phillips was aware of the problem with the PE-PUR-containing foam decomposing and causing illness, yet continued to sell the devices until recalling them in June 2021, nearly six years after the discovery of potential or likely harm to consumers using its products.
What are the volatile organic compounds found in PE-PUR?
Recall Status for Philips Respironics CPAP Machines
Additionally, Philips recommends cleaning the machine as recommended and approved, avoiding ozone and UV light cleaners. Finally, the company reminds users to check the age of their CPAP machines and replace them if they’ve been using the medical device for more than five years.
What is a CPAP machine?
Due to the lack of airflow, the lungs and brain cannot get enough oxygen, causing pauses in breathing and interrupted sleep.
Due to the lack of airflow, the lungs and brain cannot get enough oxygen, causing pauses in breathing and interrupted sleep.
The FDA estimates that the recall affects about 3.5 million CPAP, BiPAP, and ventilator machines. The product recall is for all devices manufactured before April 26, 2021, covering all serial numbers.
The recall includes:
- E30
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Trilogy 100
- Garbin Plus, Aeris, LifeVent
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30
Why are people filing Philips CPAP lawsuits?
However, testing found that continuous use of the machines containing the defective PE-PUR foam could cause serious injury or permanent impairment. The company issued a voluntary recall notice before the FDA’s recall to “preclude permanent impairment.”
Investigative Testing Found Health Risks
Additionally, the FDA determined that Philips knew of the problem with the CPAP machines since 2015 but didn’t take action until 2021, continuing to sell the defective medical devices throughout that time.
The FDA determined that exposure to the foam particles and chemicals released by the CPAP machines may cause dizziness, hypersensitivity, nausea, and vomiting.
Lastly, the agency found that ozone gas or UV light used to clean the sleep apnea devices can lead to additional health risks. Also, storing or using the CPAP, BiPAP, or mechanical ventilator machines in high heat or humid settings can further degrade the sound abatement foam, thereby increasing the risk of harm to patients.
Filing a CPAP Lawsuit
Even if the patient believes their health complications are minor, symptoms like headache or nausea could lead to more severe health issues from breathing in the toxic foam through the device’s air pathway. CPAP users should ask their health care providers to check their lungs immediately if they are currently using or previously used an affected Philips Respironics sleep apnea machine.
Obtaining copies of patients’ medical records connected to evaluation and treatment from breathing in the black foam particles or toxins from an affected CPAP device can be burdensome for law firm staff. Due to the number of documents, especially if the patients used the recalled sleep apnea machines for several years, your legal team might spend hours, days, weeks, or months trying to request, obtain, organize, and analyze many patients’ medical records.
Patients can recover compensation for health complications stemming from defective CPAP machine use. Still, they’ll need to provide medical bills and other evidentiary records to their lawyer, who can properly investigate the case to determine if the harm suffered was due to toxic foam in the device’s air pathway. Case Works can help attorneys retrieve and manage the plethora of documents and other evidence uncovered during the investigation phase.
Injured CPAP users can recover the following compensatory damages:
Past and future medical expenses
Lost wages
Loss of earning capacity
Pain and suffering
Recovering Punitive Damages
Many states require plaintiffs to go through bifurcated trials to recover punitive damages, requiring another round of discovery to prove that the defendant was grossly negligent or willful in its behavior.