Minnesota CPAP Injury Attorney

Defective CPAP Machine Lawsuits

On the 14th of June, 2021, Philips announced the recall of millions of ventilators, BiPAP, and CPAP machines due to the fragmentation 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.

Our CPAP law firm – Goldenberg Lauricella, PLLC – serves the Twin Cities area and offers experienced and dedicated representation for victims of faulty CPAP machines.

Goldenberg Lauricella Is No Longer Accepting New CPAP Cases.

Injuries linked to the defective CPAP machines include:

• Esophageal cancer
• Lung cancer
• Pulmonary fibrosis
• Nasal or paranasal cancer
• Tonsil cancer
• Heart attack and complications
• Lymph node cancer
• Sinus cancer
• Respiratory system damage or failure
• And others

Do I Have a Philips CPAP Lawsuit?

Goldenberg Lauricella, PLLC 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 Minneapolis injury attorneys have more than 38 years of experience helping victims of defective medical devices recover the compensation they deserve.

Goldenberg Lauricella Is No Longer Accepting New CPAP Cases

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 machines includes:

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:

• SystemOne ASV4
• DreamStation ST, AVAPS
• DreamStation ASV
• OmniLab Advanced+
• C-Series S/T and AVAPS
• C-Series ASV
• A-Series BiPAP A40
• A-Series BiPAP A30

Continuous ventilator:

• Garbin Plus, Aeris, LifeVent
• Trilogy 100
• Trilogy 200

Noncontinuous ventilator:

• SystemOne (Q-Series)
• DreamStation
• DreamStation Go
• Dorma 400
• Dorma 500
• REMstar SE Auto

Philips CPAP Recall Timeline

June 2021

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:

• Esophageal cancer
• Lung cancer
• Pulmonary fibrosis
• Lymph node cancer
• Nasal or paranasal cancer
• Sinus cancer
• Tonsil cancer
• Respiratory system damage or failure
• Heart attack and complications

See the full list of devices recalled on the FDA’s website here.

July 2021

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.

August 2021

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 learned also that Philips failed to conduct sufficient risk analysis or take proper corrective action once it learned about the health risks to consumers.

September 2021

Philips started replacing the PE-PUR foam in the recalled devices with silicone foam.

November 2021

The replacement process halted when the FDA and Philips announced that the replacement silicone foam may still pose a health risk.

March 2022

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 in accordance with the Federal Food, Drug, and Cosmetic Act, Section 518(a). Under the Act, the FDA has the power to order manufacturers to supply notification if the FDA identifies a device as posing an unreasonable risk and a potential source of considerable harm to the public and the notification is needed to remove such an unreasonable threat of or with no practical way provided by the Federal Food, Drug, and Cosmetic Act to remove such a risk.

The Food and Drug Administration can also order that a notification be sent to all healthcare providers that prescribed such a device, users of the device, 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 send these notifications within 45 days.

April 2022

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.”

May 2022

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
• Headaches
• Asthma
• 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. A CPAP recall lawyer from our team is ready to help you with any potential legal claim you may have.

FDA Investigation

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.”

2024 FDA Consent Decree: What You Need To Know

In a landmark moment for the healthcare industry, the FDA’s consent decree against Philips represents a significant shift in how medical devices are regulated and monitored for safety and efficacy. Under the consent decree, Philips is barred from manufacturing and distributing new sleep apnea devices until it meets safety benchmarks defined under the agreement.  

The consent decree follows Philips Respironics’ recall of millions of ventilators, CPAP, and BiPAP machines in June 2021 due to potential health risks affecting users worldwide. The recall arose from the breakdown of the devices’ polyester-based polyurethane (PE-PUR) sound abatement foam, leading to the release of plastic particles into the air passageway that can cause serious injuries if ingested.  

The injuries linked to the Philips CPAP recall include: 

• Asthma  
• Bronchitis  
• COPD  
• Lung cancer 
• Pneumonitis  
• Pulmonary Fibrosis  
• Respiratory failure 
• Sarcoidosis 

 The consent decree imposes restrictions on manufacturing and distribution of sleep apnea devices until Philips meets specified safety requirements, including completion of a Recall Remediation Plan and compliance with regulatory standards. The consent decree complaint documents Philips’ violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including failure to comply with good manufacturing practices and provide necessary information to the FDA.  

The Consent Decree 

On April 9, 2024, a federal court issued a consent decree against Philips Respironics (Philips), which entails the following: 

• Imposes restrictions, with few exceptions, on the production and sale of new CPAP machines, BiPAP machines, and related devices until specific safety benchmarks are met. 
• Mandates the implementation of a Recall Remediation Plan, jointly agreed upon by the FDA and Philips, to ensure affected patients receive relief through either receiving a new or refurbished device, or in certain cases, being offered a partial refund. 
• Generally prohibits Philips from exporting CPAP and BiPAP devices for commercial distribution unless certain conditions specified in the consent decree are met. 
• Obliges Philips to engage an independent testing expert to scrutinize and assess its testing protocols for the new silicone-based foam used to replace and rework some machines affected by the June 2021 recall. 
• Requires Philips to enlist an independent expert to inspect its Sleep and Respiratory Care facilities to ensure there is compliance with the FD&C Act and to rectify any identified deficiencies. 

Recall Remediation Plan  

The Recall Remediation Plan requires a roadmap for fixing problems that still remain from the 2021 recall, including providing patients with remediated devices or refunds. The plan also requires that Philips communicates remediation options to patients and healthcare providers in a timely manner. Philips was previously reprimanded by the FDA in March 2022 for failing to communicate important information about the June 2021 recall to patients, distributors, and healthcare providers.  

The finalization of this consent decree represents a significant milestone in medical device regulation. It reflects a collective effort to address safety concerns, enhance regulatory oversight, and uphold the highest standards of patient care. While the journey to ensuring the safety and effectiveness of medical devices is ongoing, the FDA’s CPAP consent decree sets a precedent for regulatory action in safeguarding public health. 

Call Goldenberg Lauricella, PLLC Today

The Minneapolis CPAP injury lawyers at Goldenberg Lauricella, PLLC 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.

Goldenberg Lauricella Is No Longer Accepting New CPAP Cases.

Frequently Asked Questions