Australia’s Therapeutic Goods Administration is suing Dutch multinational Philips Electronics, alleging the technology giant unlawfully sold more than 44,000 breathing ventilators which did not meet local safety standards and threatened the health of users.

The TGA launched Federal Court action against Philips Electronics on Monday over issues with several assisted breathing devices such as CPAP, BiPAP, and AVAPS machines used by people with sleep apnoea or breathing issues, including in some Australian hospitals.

The devices, which were recalled in 2021, used a polyurethane foam to reduce noise, which was found to be at risk of degrading and being inhaled by users — potentially causing irritation, breathing, and reproductive issues as well as long-term harm from toxicity and carcinogenic effects, according to the TGA.

Despite the recall, the TGA has accused Philips of continuing to sell its Trilogy 100 ventilator with a replacement silicone foam until October 2022, which also held “a real risk” of “dislodging from its position and blocking the air pathway”, potentially harming the user and the device.

Due to risks from foams, the TGA has alleged certain devices sold between June 2019 and October 2022 “were unsafe, did not perform as intended, and were therefore unlawfully supplied”.

Most of the devices were in the first-generation DreamStation range of products, made by Philips subsidiary Respironics.

"The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences to patients," the lawsuit claimed.

The TGA has called for Philips to pay a fine set by the court, as well as the agency’s legal costs.

Philips is also facing a class action lawsuit from thousands of Australian users of some of the recalled CPAP devices, following a similar case which was settled in the United States last year.


Philips faces a class action lawsuit in Australia over its CPAP devices, after settling a US case in 2024. Image: Shutterstock

Risk analysis called into question

Respironics “failed to conduct adequate risk analysis” of its polyurethane foam until early 2021, the TGA has alleged.

It also argued the company would have been aware of the foam's risks “by at least November 2015”, and cited reports connected to Respironics from as early as 2013 — including one which found a Trilogy 100 ventilator “may have caused or contributed” to a user’s death.

A 2016 report allegedly found “polyester urethanes show bad resistance against high humidity in combination with high temperature”, while another in 2017 found a motor on a Trilogy 100 device failed “due to ingesting of the enclosure foam”.

Philips Australia told Information Age that Respironics had “conducted extensive testing since June 2021 together with five independent, certified testing laboratories and third-party experts”.

“Based on the test results to date, Philips Respironics and the third-party experts concluded that use of the sleep therapy devices is not expected to result in appreciable harm to health in patients,” the company said.

Philips Australia said it would “engage constructively in the required court processes” as the TGA’s lawsuit progressed.

“Patient safety and quality is our number one priority, and we are focused on working closely with regulators to ensure we achieve the highest standards in the delivery of healthcare,” it said.


Most of the products recalled by Philips in 2021 were in its first-generation DreamStation range. Image: Supplied

Thousands sign up for Australian class action

An Australian class action lawsuit over adverse health effects allegedly caused by some Philips CPAP devices was first lodged in October 2021.

The case has since been taken up by law firm Gerard Malouf & Partners (GMP Law), which has alleged Philips sold defective devices which exposed users to serious health risks, and did not adequately warn them of those risks.

More than 4,000 group members had so far registered for the class action, GMP Law told Information Age.

The firm's chairman, Gerard Malouf, said some CPAP users had required surgery to help manage side effects they experienced.

"Philips must be held accountable for the harm they have caused," he said.

GMP Law said it was willing to work with the TGA and the Federal Court to avoid unnecessary duplication of costs or court resources, given "there are a number of overlapping issues between the two proceedings".

Philips reached a $1.7 billion ($US1.1 billion) settlement with US users of some recalled CPAP machines in 2024, after the US Food and Drug Administration (FDA) said it had received hundreds of reports of deaths “reportedly associated with” the breakdown of foam on the machines.

Philips and Respironics did not admit any fault or wrongdoing as part of that settlement.