Federal Authorities Investigating Increase in CPAP-Related Injuries

 Posted on December 12,2022 in Dangerous CPAP and BiPAP Machines

The number of people impacted by a defective CPAP machine to combat their sleep apnea continues to grow. There have been more than 90,000 reports about problems with the devices, including 260 reports of people who died—all since April 2021. The FDA is now conducting an in-depth review into why these numbers have spiked in the last year and a half. Our attorneys understand that you expected your medical device to work properly and not cause more serious health problems. It is time for you to take action and get the compensation you deserve for your serious injuries.

Health Conditions Caused by Foam

Philips Respironics issued a recall last summer because the machines manufactured between 2009 to June 2021 were defective. The machines used soundproofing foam, but as the PE-PUR foam degraded over time, more than five million people who used these CPAP, BiPAP, or ventilator machines may have been exposed to harmful particles while breathing.

The reports filed by Philips Respironics to the FDA included mandatory reports from Philips and voluntary reports from health professionals and consumers. They mention serious health injuries including various forms of cancer, pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.

Department of Justice Investigation

Philips has received a subpoena from the U.S. Department of Justice (DOJ) to turn over information related to the events that led to the recall. If an investigation reveals that Philips knowingly sold harmful products, the company could face criminal consequences. Company records have indicated that Philips knew about the potential health hazards for months and perhaps even years before it announced the recall and failed to take action.

Consumers in Limbo

This additional FDA oversight is necessary so that consumers get the treatment they need. Many consumers remain frustrated as they have yet to receive replacements for the defective machines. Philips has struggled to be transparent and ensure that consumers and medical device suppliers stay informed. Meantime, the FDA has been overseeing the recall and ordered the company to improve its notification procedures. In the spring, it also proposed that Philips submit a plan detailing how it would repair or replace defective devices or issue refunds to consumers.

Is there a Deadline to File a Lawsuit?

If you have been diagnosed with cancer after using a recalled CPAP machine between 2009 and May 2021 you should seek legal advice. Most people will have two years to file a lawsuit against the manufacturer after a diagnosis.

Contact a CPAP Injury Lawyer

Contact CPAP Injury Attorneys to discuss your legal options if you have been seriously injured after using a CPAP machine. A CPAP injury attorney will handle the legal side of things so that you have some peace of mind as we work to try to get you the compensation you rightfully deserve.

Sources:

https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due#mdr 

https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20221122-philips-respironics-provides-update-on-filed-mdrs-in-connection-with-the-voluntary-recall-notification-field-safety-notice.html