U.S. Government Continues to Address the Philips CPAP Recall

 Posted on May 13, 2022 in Recalled Devices

For nearly a year, millions of Americans who use CPAP devices to treat sleep apnea have been left up in the air due to a massive recall by Philips Respironics. The medical device manufacturing company began a voluntary recall of CPAP, BiPAP, and ventilator devices in June of 2021. However, because of the scale of the recall, millions of people have not yet been able to receive replacement devices, and many have been forced to choose between going without treatment or potentially putting themselves at risk of harm through the use of devices that may be unsafe. Multiple agencies in the United States government have been looking into the recall, and they may take action against Philips to address the ways consumers have been affected.

Actions Taken Against Philips by the FDA and DOJ

Philips began its recall of CPAP machines and similar devices because it learned that the products contained a dangerous substance that could break down over time. A polyester-polyurethane foam had been used in these devices to dampen sound and help them operate more quietly. Unfortunately, the breakdown of this foam may have led users of the devices to inhale tiny particles and toxic chemicals, leading to potential lung injuries and other health issues.

While Philips announced the recall in June 2021, company records indicate that it knew about the potential health hazards for months or years and failed to take action. After announcing the recall, the company has struggled to ensure that consumers and medical device suppliers are informed about the issue, and many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) has been overseeing the recall, and it recently issued an order requiring Philips to create more effective notification procedures.

As of May 2, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) is also proposing that Philips should be required to submit a plan for how it will complete the recall, including repairing or replacing recalled devices or refunding the purchase price to consumers. While Philips has been voluntarily proceeding with the recall process, this plan would put additional FDA oversight in place to ensure that consumers who have been affected will be able to receive the treatment they need.

At the same time, Philips has announced that it has received a subpoena from the U.S. Department of Justice (DOJ) requiring the company to turn over information related to the events that led to the recall. This indicates that the DOJ will be performing an investigation, and it may take action to prosecute the company for violations of the law. If the investigation determines that Philips knowingly sold products that were harmful, the company could face criminal consequences.

Contact Our CPAP Recall Attorneys

As the government continues to put pressure on Philips, CPAP users who have been affected by the recall may also be able to take legal action against the company. Our attorneys can help determine the best options for those who have suffered injuries after using a recalled device, and we will work to protect the rights and interests of victims and help them pursue financial compensation. Contact our CPAP injury lawyers today at 888-826-8682 for a free consultation.

Sources:

https://www.medicaldesignandoutsourcing.com/doj-subpoenas-philips-over-respironics-recall-ceo-addresses-investigation/

https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recalls-frequently-asked-questions