FDA Proposes Order to Require Philips Respironics Refund, Repair or Replace Recalled Sleep Apnea Machines

Federal regulators say Philips has failed to properly address recalled sleep apnea machines, leading to confusion among consumers and health concerns.

Federal regulators intend to order Philips Respironics to submit a plan to repair, replace or refund recalled sleep apnea machines, after the manufacturer has failed to adequately address life-threatening problems with millions of CPAP, BiPAP and ventilators sold since 2015.

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced this week that is proposing the order under the Federal Food, Drug, and Cosmetic Act, which will require a new plan from Philips for handling the massive CPAP machine recall issued last summer.

The Philips DreamStation, CPAP, BiPAP and mechanical ventilators recall was announced in June 2021, after the manufacturer acknowledged that defective polyester-based polyurethane (PE-PUR) sound abatement foam inside the machines may degrade and breakdown, releasing toxic chemicals and debris directly into the machine air pathways as consumers use the breathing machines.

These problems have already been linked to reports of long-term side effects for Philips CPAP users, including respiratory injuries, lung damage and cancer, and thousands of former users are now pursuing lawsuits against the company.

The FDA has accused Philips of botching the recall, and botching its investigation into the root problems that led to it. The agency approved of an initial Philips CPAP repair and replacement plan in September 2021, but has criticized the plan and the company’s lack of transparency in the following months.

An inspection of the Philips manufacturing facility led to the discovery that the silicone foam Philips chose to replace the toxic sound abatement foam might not itself be safe. A similar silicone foam used in another device marketed outside of the U.S. had failed safety tests due to “chemicals of concern” which could also potentially cause respiratory problems. As a result, the FDA ordered Philips to have a third party investigate the safety of the new foam and warned consumers some devices that had already been replaced may be unsafe.

In March, the agency sent a letter to Philips Respironics, notifying the company that it has provided inadequate recall notifications for sleep apnea machines sold since 2019, have left many patients and medical equipment suppliers unaware of the recall and the health risks posed by continuing to use the devices.

The notification order was an official acknowledgement that the company had failed to adequately inform the public of the CPAP recall, and came after the FDA received numerous complaints by patients and consumers.

“CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015,” the FDA’s latest update on the recall states. “Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more).”

It is unclear when that formal hearing would take place.

In addition to close scrutiny by the FDA, the company also has received a subpoena from the U.S. Department of Justice, which Philips executives believe is a sign that a federal investigation into handling of hte CPAP machine recall is being considered.

In November, FDA investigators suggested Philips knew about the sound abatement foam problem for years before issuing a recall, but criticized the company for failing to follow up on complaints and warnings.

According to allegations raised in thousands of Philips CPAP recall lawsuits filed over the past year, the manufacturer placed its desire for profits before consumer safety, delaying any warnings about the serious health risks associated with the machines, while it worked to develop a new version marketed as the DreamStation 2, which supposedly does not experience the same foam degradation.