Minneapolis CPAP Injury Attorneys
Defective CPAP Machine Lawsuits
On June 14, 2021, Philips announced the recall of millions of ventilators, BiPAP, and CPAP machines due to the degradation of its polyester-based polyurethane (PE-PUR) noise-canceling foam. The PE-PUR foam was found to disintegrate into particles that can enter the device’s air pathway and be inhaled and ingested by users. The foam may also release dangerous gas chemicals. Inhalation of the foam particles or gas chemicals is linked to serious injuries, including cancer.
Injuries linked to the defective CPAP machines include:
- Esophageal cancer
- Liver cancer or failure
- Lung cancer
- Kidney cancer or failure
- Pulmonary fibrosis
- Lymph node cancer
- Nasal or paranasal cancer
- Sinus cancer
- Tonsil cancer
- Respiratory system damage or failure
- Heart attack and complications
- And others
Do I Have a Philips CPAP Lawsuit?
GoldenbergLaw is currently hearing from and representing individuals who have used a recalled Philips CPAP, BiPAP, or ventilator device for at least 6 months and have been diagnosed with one of the injuries listed above. If you have received a recall letter for your Philips CPAP machine and experienced one of these injuries, you may be eligible for a Philips CPAP machine recall lawsuit. Our Minnesota attorneys have more than 35 years of experience helping victims of defective medical devices recover the compensation they deserve.
Contact us today for a free Philips CPAP lawsuit consultation.
Devices Impacted by Philips CPAP Recall
It is estimated that more than 15 million devices globally are impacted by the Philips recall with 80% of those devices being sleep apnea machines and 20% being mechanical ventilators. An unknown but assumedly high percentage of the devices were sold in the United States. The full list of affected devices by the CPAP Recall can be found below.
Recalled Philips CPAP & BiPAP Machines
The long and varied list of recalled Philips CPAP machinesincludes:
Continuous ventilator, minimum ventilatory support, and facility use devices:
- E30(Emergency Use Authorization)
- A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
Continuous ventilator and non-life supporting:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- A-Series BiPAP A40
- A-Series BiPAP A30
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Philips CPAP Recall Timeline
On June 14, 2021, Philips announced a voluntary recall of millions of their ventilators, BiPAP, and CPAP machines due to the degradation of the polyester-based polyurethane (PE-PUR) noise-canceling foam. The foam can disintegrate into particles that can enter the device’s air pathway which causes them to be inhaled or ingested by the person using the device. The foam can also release dangerous chemicals through a gas. Exposure to the particles or gas can lead to serious injuries including cancers, such as:
Liver cancer or failure
Kidney cancer or failure
Lymph node cancer
Nasal or paranasal cancer
Respiratory system damage or failure
Heart attack and complications
See the full list of recalled devices on the FDA’s website here.
In July 2021, the U.S. Food and Drug Administration (FDA) classified Philips’ voluntary recall as a Class 1 recall. Class 1 recalls are the most serious recalls because it means the devices either contributed to serious injuries or death, or a malfunction has been uncovered that could cause serious harm or death.
In August 2021, the FDA announced the findings of their investigation into the Philips recall. The investigation revealed that Philips knew about the PE-PUR foam degradation problem as early as 2016 but did not recall the devices until June 2021.
The investigation also uncovered over 220,000 customer complaints, and more than 100 were about the PE-PUR foam problem. Additionally, at least 14 instances, assessments, and internal test reports from Philips from 2016 to 2021 noted the foam problem. The FDA also learned that Philips failed to conduct sufficient risk analysis or take proper corrective action once it learned about the health risks to consumers.
Philips started replacing the PE-PUR foam in the recalled devices with silicone foam.
The replacement process halted when the FDA and Philips announced that the replacement silicone foam may still pose a health risk.
On March 10, 2022, the FDA ordered Philips to notify all patients and any other relevant parties about the CPAP, BiPAP, and ventilator recalls. The FDA explained the requirement was “necessary to eliminate the unreasonable risk of harm posed by the recalled products because the company’s notification efforts to date have been inadequate.”
The order was issued under section 518(a) of the Federal Food, Drug, and Cosmetic Act. Under the Act, the FDA has the power to order manufacturers to provide notification if the FDA determines a device presents an “unreasonable risk of substantial harm to the public” and the notification is needed to “eliminate the unreasonable risk of such harm and no more practical means are available [under the Federal Food, Drug, and Cosmetic Act] to eliminate such risk.” The FDA can also order that notification be provided to all device users, health care providers who prescribe the device, and others who need to be notified to eliminate the risk of harm to the public. In the March 2022 order, the FDA directed Philips to provide the notifications within 45 days.
In April 2022, the U.S. Department of Justice subpoenaed Philips’ parent company, Royal Philips, regarding the company’s poor handling of the June 2021 device recall. According to Philips, the subpoena instructed the company to “provide information relating to events leading to the Respironics recall.” Philips CEO Frans van Houten explained that he thinks the DOJ will start an investigation: “They are preparing an investigation and we just have to accept that.”
In May 2022, the FDA sent a notice to Philips that they were considering a second order under section 518(a) of the Federal Food, Drug, and Cosmetic Act. The second order would require Philips to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices that were manufactured before November 2015. Philips was provided the opportunity to request an informational hearing about the proposed order before the FDA makes its final determination.
How Do CPAP & BiPAP Machines Work?
Sleep apnea occurs when the upper airway is blocked during sleep, which reduces or stops airflow. Continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines are used to restore airflow by pumping air through a tube into a mask worn by a person suffering from sleep apnea. Sleep apnea is an extremely common condition, especially among older adults. The risk for sleep apnea increases with age, and it’s estimated that sleep apnea may affect between 38% to 68% of adults over 60.
What is PE-PUR?
The polyester-based polyurethane (PE-PUR) sound abatement foam is used to reduce the machine’s sound and vibration. However, Philips discovered and the FDA warned that the foam can degrade into particles that can enter the device’s air pathway and be ingested or inhaled by the user. The degraded foam may expose users to toxic chemicals. Exposure to the degraded particles or chemicals can be toxic and potentially cause cancer.
What are the Risks Associated with PE-PUR Exposure?
Health risks linked to exposure to degraded foam and related chemical emissions include:
- Skin, eyes, and respiratory tract irritation
- Inflammatory response
- Kidney and liver damage
- Certain cancers
Should I Keep My Recalled Device?
If you have been notified that your BiPAP or CPAP device has been recalled, you should stop using your device and consult your healthcare provider to discuss alternative treatment devices, as directed by the FDA. If you have been notified that your ventilator device has been recalled, you should consult your healthcare provider. If you have used your recalled Philips CPAP, BiPAP, or ventilator device for at least one year and been diagnosed with one of the cancers or injuries linked to the PE-PUR foam inhalation, you may have a claim against Philips. Therefore, you should keep your device to be preserved as evidence in your potential lawsuit.
In August 2021, the FDA announced that an investigation of the Philips recall concluded that Philips likely knew of the PE-PUR foam degradation problems as early as 2016. The FDA uncovered over 220,000 customer complaints, more than 100 relating to PE-PUR foam disintegration. The investigation documented at least 14 instances, assessments, and test reports internally produced by Philips between 2016 and 2021 that corroborated the issues with the faulty PE-PUR foam. Further, the FDA determined that Philips failed to conduct an adequate risk analysis or take proper corrective action once it learned of the risks of degradation.
On March 10, 2022, the FDA required Philips to notify all patients and any other relevant parties of the ventilator, CPAP, and BiPAP recall. The agency stated that this requirement was “necessary to eliminate the unreasonable risk of harm posed by the recalled products because the company's notification efforts to date have been inadequate.”
Call GoldenbergLaw Today
The Minneapolis CPAP recall attorneys at GoldenbergLaw are currently investigating cases where an individual has been diagnosed with cancer or injuries linked to the inhalation of foam from a recalled Philips CPAP device. The more people we hear from, the stronger each case becomes as more usable and related evidence is uncovered. Please do not hesitate to reach out and let us know what happened.