Philips awaits results of further testing

AMSTERDAM, the Netherlands – Philips expects to share additional research and test data on patient risk from recalled CPAP devices and ventilators in the fourth quarter. 

The company recalled certain devices, including the first-generation DreamStation CPAP devices, in June to address potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices. 

“When we announced the recall, we acted on the assumption of a worst-case clinical impact scenario assessment related to the foam issues based on the test data and information available at that point of time,” said Franz van Houten, CEO, during a conference call on Oct. 18 to discuss the company’s latest financial results. “We continue with further research and testing to better scope any potential patient risk and are getting expert assessments on these. We aim to make this information available to the authorities and health care providers as soon as possible, which is still anticipated in the fourth quarter.” 

A number of civil and personal injury lawsuits related to the recall have been filed against Philips and, earlier this month, SoClean filed a lawsuit against company, alleging it has misled the public into thinking ozone, not design flaws, is to blame for the recall. 

Philips has pulled in additional testing houses and third-party specialists to conduct subsequent research, in what van Houten described as a three-month process that started in July and should end in October, though there may be “some delay.” He said the company wouldn’t comment on pending litigation until the process is complete. 

“We see the advantage in being open and transparent on this, as it influences the assessment of litigation,” he said. “I mean, we fully realize that investors and analysts find it difficult to assess the litigation risk, but we don’t want to add to speculation and, therefore, we think waiting for these test results will be the best way to go forward to assess the risk that we believe will be there.”