The aftershock of 2021 Philips CPAP Machine Recall continues to reverberate as the company announced that it will halt new sales of sleep apnea devices under the terms of a pending FDA consent decree.
The company will continue to service existing CPAP and BiPAP machines but will not be able to sell new respiratory devices until it follows “a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business.”
Goldenberg Lauricella is currently representing hundreds of individuals who have suffered serious respiratory injuries or been diagnosed with certain cancers after using a Philips respiratory device to treat sleep apnea. Contact our Minneapolis attorneys today for a free Philips CPAP recall lawsuit consultation.
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Defective Foam Caused Initial CPAP Recall
The halting of new respiratory care device sales is thelatest in a series of extraordinary developments stemming from Philips’ recallof millions of CPAP, BiPAP, and other respiratory devices. The June 2021 recallwas prompted by the discovery that sound abatement foam in sleep apnea devicescan disintegrate into the devices’ air passageway and be inhaled by users.
This defect caused millions of CPAP users to breathe insmall particles of potentially toxic foam every time the device wasused. Instead of issuing new devices after the recall, Philips hadcustomers send in their defective CPAP machines to be repaired and reissued.
CPAP Recall Injuries
The injuries associated with the 2021 CPAP machine recall include:
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- COPD
- New or worsening asthma
- Pneumonitis
- Pulmonary Fibrosis
- Sarcoidosis
- Chronic Bronchitis
- Serious Respiratory Injuries
- Head and Neck Cancers
- Lung Cancer
Minnesota CPAP Lawyers
Goldenberg Lauricella’s Minnesota CPAP Recall Attorneys are helping CPAP users injured by recalled Philips devices recover compensation for their injuries. We have represented customers injured by defective medical devices for nearly four decades. If you or a loved one was harmed by a defective Philips sleep apnea machine, contact the Defective Medical Device Attorneys at Goldenberg Lauricella today.
Philips Knew Of Defective Foam Well Before Recall
The FDA investigation into the CPAP recall found that Philips knew about the possibility of foam disintegration as far back as 2015. The agency also found internal e-mails from 2018 confirming that company testing showed the foam breaks down when exposed to heat and humidity. A growing body of evidence from the FDA investigation and documents released in the Philips CPAP Multidistrict Litigation suggest the company knowingly withheld information of the dangers of the sound abatement from the public for years before the recall.
Philips’s problems did not stop with the June 2021 CPAP recall.
- In December 2021, the FDA disclosed that the silicone-based foam in Philips’ replacement CPAP devices failed safety tests and ordered independent testing of the devices.
- The FDA then admonished the company in March 2022 for its “inadequate” effort to notify patients and healthcare providers of the recall.
- Philips recalled over 1,000 replacement respiratory devices in February 2023 because the machines were programmed with duplicate or incorrect serial numbers. As a result, users of the recalled machines received the wrong sleep apnea therapy or not receiving any therapy through the CPAP device.
- In November 2023, the FDA rejected the findings of Philips’ sponsored safety testing that concluded its foam is safe and ordered the company to conduct additional testing.
- In January 2024, the U.S. Food and Drug Administration (FDA) issued an update on the CPAP recall, saying that the machines may be linked to at least 561 reported deaths. The agency said it has received more than 116,000 reports about the respiratory devices since April 2021.
Consent Decree Prohibits Sales of CPAP Devices
The terms of the consent decree have been agreed upon by Philips and the FDA but the settlement has not been finalized. Until the company meets all requirements outlined in the consent decree, it will be prohibited from selling respiratory care devices in the U.S. However, the company will be permitted to provide customers with new and replacement components and support services to maintain previously sold machines.
The multi-year plan outlined in the decree signals a comprehensive approach to addressing regulatory concerns and implementing corrective measures. The decree is being finalized and will be submitted to the relevant U.S. court for approval. It is not clear how long that would take. The FDA has refrained from commenting on the consent decree until it is filed and approved by a judge.
CPAP Users Deserve Better
Patients who use CPAP devices must be able to trust that their sleep apnea devices are safe. It is crucial to prioritize patient safety and advocate for transparent communication from medical device manufacturers. We applaud the FDA for taking the extraordinary steps to protect patients from Philips’ negligence, however the consent decree will do little for patients who have already suffered serious injuries from recalled CPAP machines.
If you or a loved one has been injured by a Philips sleep apnea device, contact the Minneapolis CPAP recall lawyers at Goldenberg Lauricella today. We have the expertise and experience you need to obtain compensation for your CPAP injuries. Contact us today for a free consultation.