The CPAP lawsuit alleges the medical device manufacturers knew of problems long before Philips initiated the recall.

Millions of recalled Philips DreamStation, CPAP, BiPap and ventilator machines may release toxic foam particles and chemicals.

Based on the device’s design, foam sits directly in the air pathway. That foam breaks down into fine particles which the user can ingest or inhale. The foam from the CPAP machines is both cytotoxic and genotoxic. It is believed to cause health risks that include:

• Lung cancer
• Head and Neck cancers
• Respiratory illnesses, including Asthma, COPD, Pneumonitis, Pulmonary Fibrosis, Sarcoidosis, etc.

What Is a CPAP Machine?

The CPAP acronym stands for Continuous Positive Airway Pressure. These durable CPAP devices designed to treat obstructive sleep apnea deliver a constant flow of filtered and pressurized air into a patient’s airway. They work to hold the airway open, to keep it from collapsing during sleep.

Similar machines called Bilevel Positive Airway Pressure machines or BiPap machines use two pressures to hold the airway open. Most CPAP or BiPAP users employ them every night during sleep.

Related – FDA: Certain Philips Respironics Ventilators BiPAP and CPap machines recalled

CPAP machines made by Philips NV are the subject of a recall that triggered various lawsuits by people who allege they were harmed by them. The machines were subject to a Class 1 recall. The CPAP lawsuits now allege that Philips knew foam in its devices was defective, but did nothing. The company didn’t report the problem to the FDA, and did not inform its customers of the problem. Philips waited until it had launched a new product line to inform users that there were problems with the old line. The devices were designed to last many years, but the foam in them begins to degrade during the first year of use.

New CPAP Lawsuit Updates

So many lawsuits have been filed over the CPAP devices that the have been consolidated into a multi-district litigation court. MDLs are used to coordinate complex cases into a single court before a single judge.

The CPAP MDL also includes:

• proposed class actions with claims for violations of state consumer protection statutes
• breach of warranties cause of action
• unjust enrichment cause of action
• personal injury cases

The CPAP MDL was assigned to Senior U.S. District Judge Joy Flowers Conti. It is overseeing several hundred cases so far. In addition, lawsuits filed in other courts are likely to be transferred into the MDL.

Philips settles with U.S. Government for $24 Million

In September 2022, Phillips settled a claim made by the U.S. government. Philips was accused of paying illegal kickbacks to promote its machines. The company agreed to pay $24 million to settle the suit.

In October 2022, Philips set up a new registry for claims which lets people harmed by the product register their complaint directly with Phillips without having to file their own lawsuit. It requires registrants to use a short form complaint to simplify the process. However, registrants would be wise to proceed with caution, to be wary of acting in haste and signing away any legal rights. We would urge potential claimants to consult a lawyer with experience in medical device claims.

In December 2022, all the documents in the case were posted to an MDL litigation web site created for that purpose. Meanwhile, Phillips filed a motion to dismiss the MDL. The company claimed plaintiffs could have had their machines replaced or repaired by Phillips. That motion has not yet been decided.

Also last month, a plaintiff filed another lawsuit that alleged mouth and and tongue cancer was caused by the machine’s toxic foam particles. U.S. news media reported the DOJ was negotiating a consent decree with Phillips to settle the MDL.

In January 2023, the MDL court issued an order regarding electronic discovery. The cases are expected to continue moving forward.

Which CPAP Machines Were Recalled?

Philips NV, based in Amsterdam, Netherlands, made the recalled machines. Philips maintains U.S. headquarters in the state of Delaware. The company researched, developed, designed, manufactured, sold, distributed, and marketed CPAP machines. It also produced and marketed other medical devices, such as BiPAP machines, meant to treat respiratory failure and breathing disorders.

On June 14, 2021, Philips announced it was recalling some BiPAP and CPAP machines and other ventilators due to health risks linked with polyester-based polyurethane foam in the devices. Used to reduce sound and vibration, the foam can deteriorate, break, and enter the device’s air pathway. A user can inhale or swallow toxic chemicals or foam from the machines, potentially causing cancer or other effects.

More than 15 million devices were involved in the recall. It includes several device types with different model names and numbers. In addition, more devices and some masks were recalled later. Device types and model names and numbers can be seen at this link and this link.

The U.S. FDA CPAP Recall

The U.S. Food and Drug Administration classified the recall as Class I. This is the most serious recall, which indicates the devices could cause serious injuries or death.

The FDA requires Phillips and other medical device makers to complete medical device reports for the agency whenever information suggests a device may have caused or contributed to a death or serious injury. Philips submitted 30 reports from 2011 through the first quarter of 2021. FDA received 90,000 medical device reports through November 2022. The agency had counted 260 deaths linked with foam and plastic breakdown. In addition, magnets in the mask can interfere with pacemakers and medical devices. The reports came from Philips and also from health professionals, consumers, and patients.

Anyone whose device is part of the recall is advised to stop using it. If the device is on the recall list but the user has not registered it with Philips, that user should register it on Philips recall website. Anyone with a Philips device not on the list is advised to  register it for potential new updates.

CPAP Machine Injuries

Philips’ recall notice said potential risks of particulate exposure linked with the foam include:

• headache
• irritation
• inflammation
• respiratory issues

Injuries reported to the FDA include:

• cancer
• Pneumonia
• Asthma
• other respiratory problems
• infection
• headache
• cough
• dyspnea (difficulty breathing)
• dizziness
• nodules
• chest pain

CPAP Lawsuits

Philips CPAP recall lawsuits allege the company knew or should have known the devices posed potentially life-threatening health risks, yet failed to warn doctors or their patients. The suits say Philips has used the foam since 2009.

The CPAP lawsuits center on causes of action that include design defect and failure to warn. They allege Philips has known about the potential health risks since it began using the foam in 2009. They say Philips knew or should have known of the risk that degraded PE-PUR foam could produce harmful chemicals which CPAP users inhale.

A report from the FDA Manufacturer and User Facility Device Experience said Philips  was aware of a female user’s report as early as 2011 which said she found black dust on her nose after using the device. Meanwhile, other users complained on Internet message boards for years, prior to the 2021 recall, that they also found black particles post use.

RELATED

• December 2022 Philips CPAP Recall Update
• Philips CPAP Recall Lawsuit | Attorney
• FDA: Certain Philips Respironics Ventilators, Bipap and-CPAP Machines recalled
• Philips to $24.8M CPAP Machine Settlement
• PFDA announces CPAP (Philips) Machine Recall

by Matthews & Associates