Australian regulator takes Philips to court over sleep apnea devices

The legal troubles for Philips regarding issues with sleep apnea devices continue. Following the US regulator, the Australian Therapeutic Goods Administration (TGA) has now targeted Philips.

The Australian medical regulator is taking Philips to court due to problems that arose four years ago with the Dreamstation, Philips' device designed to help sleep apnea patients. TGA alleges that Philips imported medical devices that did not meet Australian safety standards, thereby violating the law.

TGA estimates that over 4,400 machines failed to meet requirements. The machines had insulation foam that could detach, potentially causing users to inhale foam particles during sleep. The foam could also block the device, leading to malfunctions and insufficient oxygen supply to patients.

In the US, the sleep apnea issue has already cost Philips over a billion dollars. Last year, users were compensated with a total of $1.1 billion to avoid lawsuits over injuries. No complaints have been reported in Europe.

Philips responded by stating that the charges do not reflect the quality and safety of the currently available sleep apnea devices worldwide. The company describes this as a "new chapter" following the 2021 recall and is reviewing the charges.