Philips CPAP Recall and Test Results Update

Santa Clara, CAPhillips Respironics, manufacturer of CPAP/ BiPAP sleep machines, on May 16 announced test results of its recalled devices. About two weeks previously the company announced it has set aside another $630 million to settle CPAP lawsuits, adding to $1 billion already earmarked to cover the cost of recalling, replacing or repairing millions of its recalled sleep apnea machines.

Test Results

On May 16, 2023 Philips announced completed test results for CPAP/ BiPAP sleep machines. The tests and research assessed potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific sleep therapy and ventilator devices included in the June 2021 recall. As well, tests and analyses were completed for first-generation DreamStation devices that have been exposed to ozone cleaning. (SoClean Inc. filed a lawsuit against Philips in October 2021 for attempting to blame its ozone cleaning machines for the defective sound abatement foam that led to the recall.)

“Appreciable Harm”

According to Philips’ update, the test results and analyses for its Dream Machine sleep therapy devices “indicate that potential patient exposure to foam particulate matter (PM) and volatile organic compounds (VOCs) from the PE-PUR foam within these devices is unlikely to result in an appreciable harm to health in patients.” They arrived at these results after expanded testing and toxicological risk assessments on multiple devices with New, Used, and Lab-Aged foam. And tests were also conducted on devices treated with ozone cleaning.

But what is meant by appreciable harm? By definition, it means  “sufficient to be easily seen, measured, or noticed”. According to the Cambridge University Press, “appreciable” harm is harm that is significant – i.e., not trivial or inconsequential – but less than “substantial”. So it could mean that its sleep machines can cause some harm…?

Settlement Funds

On April 25, 2023 Philips added another $630 million to the $1billion set aside to cover the costs of millions of recalled CPAP/BiPAP sleep machines. The funding was announced in Philips’ 2023 first-quarter earnings, explaining that the additional funds will help it resolve CPAP lawsuits filed by thousands of individuals in the U.S. who used recalled devices that exposed them to a risk of cancer, lung damage and other respiratory conditions. In the report, Philips told investors that “Resolving the Philips Respironics recall for patients remains our highest priority. In the first quarter, we have recorded a provision in anticipation of a resolution of the economic loss class action in the US…This is an important step in addressing the litigation related to the recall.”

The $1billion already set aside supposedly covers the cost of recalling millions of devices and repairing and replacing them, but does not include legal costs. One week before this announcement, AboutLawsuits.com reported that Philips CEO Roy Jakobs said the company hopes to resolve individual personal injury lawsuits sometime in 2024; a cost likely to far exceed the economic loss settlement.