CPAP Recall Gone Wrong Nearing Settlement with Philips and Justice Department

Santa Clara, CAMore than a year after Philips Respironics announced its CPAP recall, which led to the U.S. Justice Department investigating possible criminal violations, The New York Times reported that Philips and government attorneys are negotiating a settlement, which would include Philips to implement a plan that would prevent another product failure and recall gone wrong.

The Justice Department (DOJ) slammed Philips with a subpoena in April 2022 over its recall of CPAP machines. In June 2021 the company recalled millions of its DreamStation, CPAP and BiPAP machines after Philips fessed up to a life-threatening defect: the sound abatement foam inside the devices could release toxic particles into the sleep machines. But not before Philips announced foam problems to its investors in April 2021. Sleep machines sold from 2009 to April 2021 contained the PE-PUR sound abatement foam. In fact, 18 different products have been recalled during that time.

In the recall letter to device customers, Philips acknowledged that it had received “several complaints” about the foam, but tried to blame the use of unapproved cleaning methods, such as ozone. It also had backup from the FDA regarding ozone  in a February 2020 report. The New York Times reported that Philips Respironics knew its breathing devices had a problem with the foam back in 2015. “The company did nothing at the time. Years went by as complaints mounted, and the company made cursory efforts to examine the problem, according to an investigation conducted later by the Food and Drug Administration.”

And long before the recall, hundreds of users (not several) had reported cancer, respiratory problems and other serious health issues.

Recall Gone Wrong

Besides the delay, many users had not been notified of the recall and users that had been notified continued to use the sleep devices because they directions and information about the devices posing a serious health issue were unclear. The FDA finally intervened because Philips had failed to clearly notify consumers of health risks. Next up, a government inspection of the Philips manufacturing facility found that the silicone foam used to replace the toxic sound abatement foam might not be safe either. The FDA ordered Philips to hire and independent lab to test the new foam. The FDA also discovered that similar silicone foam used in another device marketed outside the U.S. failed a safety test for the release of certain “chemicals of concern”, which may also enter the machine’s air pathways. 

The New York Times in November 2022 reported that more than two million individuals who used the CPAP machines to treat their sleep apnea had not received device replacements by early October 2022 – almost 18 months after the recall was announced. Many users needed to find alternative ways to help them breathe at night, to get the oxygen needed or risk a heart attack. And many users have developed adverse health issues, which has resulted in even more CPAP lawsuits.

According to the NYT, Philips’ recently announced thousands of layoffs as a result of its market value and stock plummeting by 70 percent. The recall has exposed not only poor record-keeping but “the systemic, industrywide absence of a device tracking system that would allow companies to alert device users of significant problems.”

Since the June 2021 recall, the FDA has received more than 90,000 reports about problems with the devices. The agency announced in November 2022 an in-depth review of complaints since April of 2021, including more than 69,000 pertaining to cancer, difficulty breathing and chest pain. The complaints include 168 reports of death, although experts have said it can be difficult to determine whether the device caused any singular illness or death.