Philips AVAPS Lawsuit | 2026 Latest Updates

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips AVAPS (Average volume-assured pressure support) machines that the company is recalling certain devices because they have been linked to an increased risk for cancer and other serious side effects.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

Philips Respironics recalled certain CPAP, BiPAP and ventilator devices in June 2021. The recall included AVAPS-designated models. Sound-dampening foam inside the machines could break down. The foam could release particles or chemicals into the air a patient breathes.

Lawsuits allege Philips knew about the foam problem years before the recall. They also allege that people who used a recalled AVAPS device faced a higher risk of respiratory injury and cancer from the exposure.

The claims are consolidated in MDL No. 3014, in a federal court in western Pennsylvania. An economic-loss settlement there is final, a medical-monitoring settlement is pending, and a roughly $1.1 billion personal-injury settlement was announced in April 2024.

Lawsuit at a glance
  • Case or litigation name: In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation (MDL No. 3014)
  • Defendants: Philips Respironics and its parent, Koninklijke Philips N.V.
  • Court and docket number, when available: W.D. Pa., Case No. 2:21-mc-01230-JFC, Judge Joy Flowers Conti. Docket
  • MDL number, judge, and case count, when an MDL exists: MDL No. 3014, Judge Joy Flowers Conti, formed October 8, 2021 from 10 actions in 5 districts
  • Filing date: MDL formed October 8, 2021. Earlier individual suits were filed in several districts
  • Main allegations: Product liability, failure to warn, breach of warranty and consumer-protection violations, plus individual personal-injury claims
  • Products or people involved: DreamStation ST, AVAPS and C-Series S/T and AVAPS devices, among other recalled Philips Respironics CPAP, BiPAP and ventilator models made 2009-April 26, 2021

Latest AVAPS Lawsuit Updates

April 29, 2024: Philips Announces $1.1 Billion Settlement

Philips Respironics announced a $1.1 billion settlement for personal-injury claims, separate from its medical-monitoring settlement, to resolve U.S. lawsuits over its recalled CPAP, BiPAP and ventilator devices, CNN reported [1].

The company admitted no fault. Payments to eligible claimants under the personal-injury settlement are expected to begin in 2025, once the settlement receives final approval from the MDL court in Pennsylvania.

April 25, 2024: Economic Loss Settlement Gets Final Approval

The MDL court granted final approval of a separate Economic Loss Settlement covering people who owned a recalled Philips CPAP, BiPAP or ventilator device. That settlement resolves claims over the devices’ reduced value rather than personal injuries [2].

This settlement is separate from the personal-injury and medical-monitoring settlements, and it does not release any individual claim for a physical injury caused by a recalled device.

April 9, 2024: Federal Court Enters Consent Decree Against Philips

A federal district court entered a consent decree against Philips Respironics, requiring the company to follow a recall remediation plan meant to get patients a new, reworked or refunded device [3].

The decree also restricts new production and sales of CPAP and BiPAP machines at named Philips Respironics facilities in Pennsylvania and California. A few limited exceptions apply. The FDA says the step is meant to protect device users.

October 5, 2023: FDA Says It Remains Unsatisfied with Recall Progress

The FDA’s Center for Devices and Radiological Health said it remained unsatisfied with the pace of the Philips recall. It continued to take steps meant to protect people using the recalled devices [4].

The agency also said Philips’ own foam testing was not adequate to fully evaluate the health risks. It ordered more testing before it would change its safety recommendations for device users.

October 8, 2021: Cases Consolidated into MDL No. 3014

A federal panel combined ten filed lawsuits from five federal districts, plus 104 additional related actions pending in 31 districts, into one case in the U.S. District Court for the Western District of Pennsylvania [5].

The panel assigned the consolidated litigation, MDL No. 3014, to Judge Joy Flowers Conti, who oversees pretrial proceedings for both class and individual personal-injury claims filed nationwide against Philips Respironics and its parent company.

June 14, 2021: Philips Recalls AVAPS and Other Devices

Philips Respironics recalled certain ventilators, BiPAP machines and CPAP machines, including AVAPS-designated devices made between 2009 and April 26, 2021. It took that action after finding that sound-dampening foam inside them could degrade [6].

The breakdown, worsened by heat, humidity or ozone cleaners, could let a patient breathe in or swallow foam particles or related chemicals. The agency classified the action as a Class I recall.

October 30, 2015: Records Show Philips Learned of Foam Concerns Early

An FDA inspection found that Philips first learned of possible foam-degradation problems through a message to its foam supplier dated October 30, 2015. The supplier confirmed the message on August 5, 2016 [7].

The inspection also documented at least 14 further instances of awareness between April 1, 2016 and January 22, 2021. In each instance, Philips did not complete a risk analysis, the agency said.

What Is AVAPS?

Average volume-assured pressure support (AVAPS) is a mode of non-invasive ventilation. It automatically adjusts a device’s inspiratory pressure to deliver a pre-set target tidal volume, according to a National Library of Medicine medical reference [8].

It combines volume- and pressure-controlled ventilation and first appeared on the Respironics V60 ventilator in 2009. Philips built the same mode into DreamStation ST and other devices named in this litigation, exposing users to the same degradable foam here.

Who May Be Affected?

Anyone who used a Philips DreamStation ST, AVAPS or C-Series S/T and AVAPS device was exposed to the foam behind the recall and the lawsuits. Philips made these devices over more than a decade, ending in April 2021.

The recall notice says the foam breakdown may be worse after several years of use. It may be worse when a device was stored or cleaned in hot, humid conditions or with an ozone cleaner instead of the recommended method.

People who match those circumstances and later received a diagnosis of a respiratory condition, cancer or another illness tied to the exposure are the group the recall and lawsuits address.

A device’s model name and serial number are printed on the unit itself. They show whether it appears on the FDA’s list of recalled Philips Respironics models, which includes DreamStation ST and AVAPS units made through April 26, 2021.

An individual legal review, not this page, is the only way to confirm whether a specific case qualifies for compensation.

Think you may qualify?
Schmidt & Clark offers a free, no-obligation review of a Philips AVAPS or other recalled Philips Respironics device case. A review does not guarantee that a case qualifies for compensation or any particular result.

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Reported Injuries or Damages

Philips’ own recall notice lists the possible risks of inhaling degraded foam particles as headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.

It lists the risks of breathing related off-gassed chemicals as headache, irritation, hypersensitivity, nausea, vomiting, and similar toxic and carcinogenic effects. As of June 2021, it stated, the company had received no reports of death tied to the issue.

Lawsuits allege these exposures caused respiratory injury and raised cancer risk among people who used the recalled devices, separating that allegation from confirmed medical evidence.

The same FDA Form 483 inspection that documented Philips’ early awareness of the foam problem also found the company’s risk-analysis process inadequate, without concluding what harm any specific patient suffered.

Recall and Regulatory Background

Philips Respironics recalled DreamStation, C-Series and other CPAP machines, BiPAP machines and ventilators, including AVAPS-designated models, built over more than a decade before the 2021 action. The Class I recall affects an estimated 15 million devices worldwide.

The FDA maintained its safety recommendations after an October 2023 review, and a 2024 consent decree now limits new production and sales at named Philips Respironics facilities.

See the Philips CPAP recall page for the full recall record, including every affected model, the official remedy and the consumer instructions the notice sets out.

Evidence to Preserve

Anyone considering a claim over a recalled Philips AVAPS device should keep the following records and materials:

  • The unit’s model and serial numbers, along with any purchase, lease or rental records
  • Prescription and physician records showing why the device was originally prescribed for sleep or breathing therapy
  • Photographs of the device, and of its foam if the foam has been inspected or removed
  • Medical records, test results and diagnosis dates for any respiratory or related illness that developed after use
  • Correspondence with Philips, a durable medical equipment provider or a settlement administrator
  • Records showing whether the device was returned, repaired or replaced through the recall

Keeping these records now can make it easier for a lawyer to evaluate whether a claim is worth pursuing later.

Filing Deadlines

Deadlines for filing a claim over a Philips AVAPS device come from state law and vary with where a person lives and when the exposure, illness or injury happened.

Some states start the clock on the diagnosis date rather than the date of first exposure, so the same set of facts can have different deadlines in different places.

Missing a deadline can end a claim even when the underlying facts are strong, so anyone considering a claim should speak with a lawyer promptly to learn which deadline applies.

Potential Compensation

Three settlement tracks exist in the AVAPS litigation. An Economic Loss Settlement, covering the reduced value of a recalled device, received final court approval in April 2024.

A proposed Medical Monitoring Settlement, funded with $25 million, would cover certain testing costs for up to 15 years if approved.

A personal-injury settlement of about $1.1 billion, announced in April 2024, is a separate track from the Medical Monitoring Settlement described above.

Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation amounts and eligibility differ by settlement track and by individual claim.

Frequently Asked Questions

Did the Recalled AVAPS Machines Actually Cause Cancer?

The recalled AVAPS machines have not been proven to cause cancer in every user. Philips’ own recall notice lists possible toxic and carcinogenic effects among the risks of inhaling or breathing the degraded foam’s particles or chemicals. Lawsuits allege this exposure raised cancer risk in some users.

Does Philips Agree Its Devices Caused Health Problems?

Philips has not agreed that its devices caused health problems. The company told the FDA that exposure to the recalled foam’s particles and chemicals is unlikely to cause appreciable harm. The FDA disagrees. It has said Philips’ own testing is not adequate to support that conclusion.

When Will the Medical Monitoring Settlement Be Finalized?

The Medical Monitoring Settlement is not final yet. The court scheduled a Final Approval Hearing for October 30, 2024, in Pittsburgh, Pennsylvania, after requiring objections to the proposed settlement to be filed by September 25, 2024.

What Fees Will Be Deducted from the Medical Monitoring Settlement?

Fees from the Medical Monitoring Settlement could total up to 20 percent of its $25 million fund. Class counsel may ask the court for attorneys’ fees, costs and service awards from that amount, but the court still has to approve any fee request before it is paid.

Can I Still File a Philips AVAPS Lawsuit?

Yes, people can still file a Philips AVAPS lawsuit, and new cases can be added to the existing multidistrict litigation as tag-along filings at the Joseph F. Weis, Jr. U.S. Courthouse in Pittsburgh, where the MDL is based, though a state filing deadline may still apply.

Is Philips Still Making DreamStation Devices?

Yes, Philips is still making DreamStation devices. Its next-generation DreamStation 2 CPAP platform was not part of the recall. That platform continued to be produced and sold throughout the recall and litigation, unlike the recalled first-generation DreamStation models.

Do I Need a Lawyer for an AVAPS Lawsuit Claim?

A lawyer is not legally required to file an AVAPS lawsuit claim. A claim must still plead a legal theory, such as failure to warn or breach of warranty, and show which recalled model a person used. Deadlines set by the settlement administrator are easy to miss without help.

References

  1. https://www.cnn.com/2024/04/30/health/philips-1-billion-cpap-settlement-agreement/index.html
  2. https://www.pawd.uscourts.gov/sites/pawd/files/3014_Class_Action_Notice_July.pdf
  3. https://www.fda.gov/medical-devices/respiratory-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines
  4. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-provides-update-philips-june-2021-recall-and-maintains-recommendations-related-potential-health
  5. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3014-Transfer%20Order-09-21.pdf
  6. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam
  7. https://www.fda.gov/media/154244/download
  8. https://www.ncbi.nlm.nih.gov/books/NBK560600/

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