Philips agrees to pay $1.1 billion settlement after wide-ranging CPAP machine recall

Under an settlement agreement with the FDA and Justice Department, Philips will not be able to sell its breathing devices and ventilators used to treat sleep apnea until it meets a number of safety regulations.

Medical device company Philips reached a settlement Monday to shell out $1.1 billion to cover hundreds of personal injury lawsuits linked to its respiration and sleep apnea machines.

The manufacturer has recalled more than 15 million breathing devices since 2021, primarily due to health hazards caused by the breakdown of foam materials that users could inhale, according to the Food and Drug Administration.

The issues have largely surrounded the brand’s popular DreamStation CPAP, or continuous positive airway pressure, machines used to treat sleep apnea and other nighttime breathing difficulties at home and in healthcare settings.

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Philips did not admit any fault as part of the settlement and did not admit any liability for any of the reported injuries. However, the company said in a statement that the settlement was made to “end the uncertainty associated with litigation in the US.”

This personal injury settlement comes after several other hits to Philips Respironics’ pockets in recent years. In September of last year, Philips agreed to a $445 million tentative economic loss settlement to compensate users who had to replace their devices. In April, the company also agreed to a consent decree that halted production in the U.S.

“Patient safety and quality is our highest priority, and we have taken important steps in further resolving the consequences of the Respironics recall,” said Roy Jakobs, CEO of Royal Philips, in a statement. “The approved consent decree and economic loss settlement, and now the resolution of the personal injury and medical monitoring litigation in the US, are significant milestones and provide further clarity on the way forward for Philips.”

Who receives money?

Cash from the settlement will be sent to those used the now-recalled CPAP and “other respiratory devices who suffer from significant physical injuries,” plaintiff attorneys Sandra Duggan, Kelly Iverson, Christopher Seeger and Steven Schwartz told NPR.

The related payments are expected in 2025 and will be funded from Philips’ cash flow generation.

USA TODAY has reached out to the attorneys for comment.

Philips stops U.S. manufactering: CPAP maker Phillips enters consent decree that stops company from selling machines

Philips’ yearslong legal back and forth

Philips announced a recall for millions of their Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices in 2021.

The recall was attributed to a potential defect in the devices in which foam used in them could degrade and cause inhalation of particles and fumes.

The FDA warned that ingesting sound-dampening foam comes with the risks of headache, asthma and allergic reactions among more serious problems, like cancer. In February, the agency also released a report saying officials have received 116,000 complaints about the devices, with more than 500 of those resulting in death, from people or lawyers who attributed the incidents to Philips’ machines. The agency has since clarified that further investigation needs to be done on these claims.

In a statement to USA TODAY at the time, Philips denied any link between the deaths and injuries and its machines. The company previously said there were no reports of deaths due to product defects but acknowledged that the risks of particulate exposure could cause “headache, irritation, inflammation, respiratory issues and possible toxic and carcinogenic effects.”

Earlier this year, Philips agreed to a consent decree that stopped the company from selling sleep apnea machines in the United States and was ordered to offer a payment option as a part of a remediation plan.

A 2023 investigation into the recall by Pro Publica and the Pittsburg Post Gazette found that Phillips had withheld complaints about the foam for over a decade before warning customers.

Recalled devices

Existing devices manufactured between 2009 and April 2021 are subject to recall, as they may pose a serious injury risk due to the breakdown of the PE-PUR foam used in them.

Devices included in the recall include:

• A-Series BiPAP A30
• A-Series BiPAP A40 (ventilator)
• A-Series BiPAP Hybrid A30
• A-Series BiPAP V30 Auto (ventilator)
• C-Series ASV (ventilator)
• C-Series S/T and AVAPS
• DreamStation
• DreamStation ASV
• DreamStation Go
• DreamStation ST, AVAPS
• Dorma 400
• Dorma 500
• E30
• Garbin Plus, Aeris, LifeVent (ventilator)
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne (Q-Series)
• Trilogy 100 (ventilator)
• Trilogy 200 (ventilator)
• Certain Trilogy Evo ventilators with specific serial numbers.

Some products that were modified in an attempt to resolve the issue have been recalled as well. Specifically, certain reworked Philips Respironics Trilogy 100/200 Ventilators, as the FDA has asked for additional safety testing on the silicone foam material used to replace the PE-PUR foam.

These products include:

• Trilogy Evo ventilator model numbers with certain serial numbers as listed in the recall database:
  • DS2110X11B
  • KR2110X15B (not distributed in the U.S.)
• Repair kits for Trilogy Evo muffler assembly model and lot numbers as listed in the recall database:
  • Part number 1135257
  • Lot numbers between 210414 and 210524

Contributing: James Powel, Anthony Robledo and Adrianna Rodriguez.

This article originally appeared on USA TODAY: Philips agrees to pay $1.1 billion settlement after wide-ranging CPAP machine recall