There is currently a mass tort multidistrict litigation (MDL) against Philips Respironics, Inc., manufacturers of CPAP and BiPAP machines used to treat sleep apnea. In June 2021, Philips issued a recall of over 15 million of these machines. The FDA's subsequent investigation classified the recall as a Class I recall. This classification is the most serious (among Class I, II, and III) and designates a "reasonable chance that a product will cause serious health problems or death."
The MDL has now been centralized in the Western District of Pennsylvania under the presiding judge, The Honorable Joy Flowers Conti. Hundreds of federal lawsuits are currently being investigated, with more expected case filings to occur in the coming months.
CPAP Lawsuit Settlement Amounts
You may be wondering how much each CPAP recall lawsuit is worth. Current estimates suggest that individual settlements for Philips CPAP lawsuits may range from $100,000 to the millions, depending on the case. However, it's still too early to say definitively what payouts from the Philips CPAP MDL will be. Bellwether trials are expected to provide more concrete estimations of what verdicts will mean for claimants in the Philips CPAP recall MDL.
CPAP settlement value will likely vary based on the severity of the case and the damage experienced by claimants. More severe injuries will likely result in a higher settlement amount in these mass tort cases.
Mass Tort Cases vs. Class Action Lawsuits
These two types of legal actions serve similar purposes but have some important differences that can affect how a consumer receives compensation for injuries caused by a defective product. Both seek to consolidate a large number of claims and expedite their resolution. However, in a class action lawsuit, claimants generally experience similar degrees of injury, and thus, the compensation awarded from a settlement is divided evenly among all parties.
In a mass tort case, individuals with varying degrees of damages may recover compensation adjusted to their injuries. This action allows claimants to pursue maximum settlement value. An attorney specializing in mass tort cases can help you determine which category your case will fall into and help you determine what actions you can take to recover compensation for your damages.
Health Risks of Philips CPAP Machines
CPAP and BiPAP machines are used to treat sleep apnea, a condition that affects an estimated 5-to-10% of people worldwide. Sleep apnea causes disruptions in normal breathing during the sleep cycle, causing sufferers to frequently wake up during the night when oxygen levels run low. CPAP (continuous positive air pressure) machines treat this condition by providing a continuous flow of air to the sleeper through a mask. BiPAP (bi-level positive air pressure) machines work by regulating the air pressure in the lungs. Over 8 million people in the United States rely on CPAP and BiPAP devices to treat their condition.
In addition to Philips CPAP devices, the company also included several assisted breathing ventilator devices. The recalled devices (manufactured between 2009 and April 26, 2021) include the following:
- E30 Continuous Ventilator
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- A-Series BiPAP Hybrid A30 (not marketed in the US)
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30
Philips Respironics' voluntary recall of BiPAP and CPAP machine devices cited potential risks of inhaling or swallowing small pieces of polyester-based polyurethane (PE-PUR) foam. This PE-PUR sound abatement foam is used to minimize noise and vibrations while the machines are in use. However, this material can degrade, especially when exposed to high heat, humidity, or certain cleaning agents used to disinfect CPAP sleeping machines. PE-PUR foam can then release particles and debris which can enter the user's airways.
Potential side effects of exposure to PE-PUR sound abatement foam can include:
- Irritation to eyes, skin, and respiratory tract
- Chest infections
- Nausea and vomiting; and
- Inflammatory response
Carcinogenic Side Effects
Thus far, no studies have conclusively linked new cancer patients to the use of Philips CPAP machines. The FDA has yet to confirm that these devices can directly contribute to the development of certain cancers or connect any deaths to their use. However, the organization confirmed that degraded foam in these recalled sleep apnea machines has toxic and carcinogenic effects on major bodily organs, such as the kidneys and liver. Use of CPAP machines containing PE-PUR foam could carry an elevated risk for cancers such as:
- Bone marrow cancer
- Breast cancer
- Multiple myeloma
- Bladder cancer
- Brain cancer
- Esophageal cancer
- Lung cancer
- Thyroid cancer
- Tonsil cancer
- Non-Hodgkin's lymphoma
- Nasal cancer; and
- Testicular cancer
For several years before the recall was issued on Philips CPAP devices, many users had already been reporting issues with the devices anecdotally in support groups and internet message boards. They were disturbed to find black particles on their faces and in the airways of the CPAP machines. Many reported serious side effects, such as those mentioned above.
Former users of Philips CPAP machines now wait anxiously for replacement devices. Claimants who were diagnosed with these cancers or other serious side effects are now seeking compensation through the Philips CPAP recall mass tort litigation. More investigation will likely continue to yield evidence and strong connections to support these claims.
Internal Email Reveals What Philips Knew About CPAP Machine Dangers
Following the FDA's investigation of the Philips CPAP recall, an internal email from 2015 was discovered, which revealed that the company had prior knowledge of foam degradation in its machines. The FDA subsequently ordered Philips to expand its communication strategy to consumers and alert them of potential risks from the recalled devices. In a recall audit check performed by the FDA, 28 of 182 consignees that participated said that they had not received a recall notice.
In March of 2022, the FDA released a 518(a) Notification to Philips Respironics; this demand requires Philips to notify consignees and users of the recalled products of their health risks, including "irreversible harm to lung tissues, organ impairment, and long-lasting respiratory dysfunction."
What is the Status of the MDL CPAP Lawsuits?
November 22, 2022: Medical Device Reports from Philips CPAP Recall
As part of the safety protocols that all manufacturers must adhere to, Philips released 30 medical device reports (MDR) to the FDA detailing adverse effects in connection to the degradation of the PE-PUR foam used in the company's CPAP machines. The FDA has now received over 90,000 MDRs associated with this risk. The reports cite numerous serious health problems, such as cancer, pneumonia, asthma, and difficulty breathing, and 260 reports of death.
November 17, 2022: New Philips Ventilator Devices Present More Defects
Philips Respironics Trilogy Ventilators replaced the previous PE-PUR foam with silicone material. However, these reworked ventilators were shown to contain samples of PE-PUR foam in laboratory testing and the potential for particulate matter to degrade and enter airways, as it did in the recalled devices.
September 6, 2022: Masks in CPAP and BiPAP Devices Found to Pose Serious Risk
The FDA alerted consumers that in addition to the carcinogenic risks and respiratory complications caused by Philips sleep apnea machines, the masks used in these devices also have the potential to cause severe harm or death. These masks, which transport oxygen from the devices to the user's mouth, contain magnets that can interfere with other magnetic devices, such as pacemakers or other types of metallic implants. Complications induced by this interference included pacemaker failure, leading to the need to replace the device. This recall was classified as a Class I recall, meaning that it is likely to cause serious harm or death to the consumer. The recalled masks used with CPAP devices include:
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp and Wisp Youth Nasal Mask
- Therapy Mask 3100 NC/SP
In addition to interference with pacemakers, the magnetic components in these masks can also disrupt the function of many other metallic devices worn by the user, such as aneurysm clips, metallic plates, screws, or implants, magnetic denture attachments, and metallic joint replacements. Complications from the interference of these devices may prove fatal or result in serious injury.
How Many People Have Been Affected by the Recalled CPAP Devices?
In September 2021, Philips initiated a program to repair and replace the recalled CPAP machines for customers. However, the 750,000 devices it claims to have manufactured pale compared to the number of individuals affected by its defective sleep apnea machines. The company initially stated that it planned to complete replacements within 12 months of the recall. However, current demand has pushed that date forward, and Philips now says that efforts to replace the recalled devices may well stretch into 2023. Many who have waited for a replacement device since June 2021 are still waiting. They may also continue to live with the health consequences brought on by the devices they rely on to treat their underlying conditions.
According to the American Association of Retired Persons (AARP), an estimated 3-4 million devices were affected by the Philips CPAP machine recall. As of October 2022, 340 CPAP machine lawsuits had been consolidated into the Philips CPAP MDL. However, this number can be expected to increase as more claimants bring their complaints forward. We can expect thousands of individuals to participate in the mass tort Philips CPAP lawsuit in the coming months.
Who is Eligible for a CPAP Lawsuit?
You may be eligible to file a Philips CPAP lawsuit if you are:
- Affected by sleep apnea
- Are under 80 years of age
- Used a recalled Philips BiPAP or CPAP machine or ventilator
- Experienced serious side effects such as respiratory illness, cancer, or other condition associated with recalled Philips CPAP machines.
Those wondering if they are able to file Philips CPAP machine lawsuits as part of the pending multidistrict litigation should reach out to an experienced mass tort law firm for more information about their individual cases.
Find Out More About the Philips CPAP and BiPAP Multidistrict Litigation
If you've been injured by a recalled Philips CPAP machine and would like to know more about the pending CPAP recall MDL and your rights to compensation, a skilled legal team of mass tort lawyers can help. Legal Lawsuit News is your one-stop shop for receiving news about developments in mass tort cases across the country and contacting a skilled attorney who can help you learn about your legal rights.