6 days ago
Philips Electronics faces legal action for selling allegedly 'unsafe' breathing devices
The Therapeutic Goods Administration has started legal proceedings against tech giant Philips Electronics over allegations the company unlawfully sold assisted breathing devices in Australia.
The devices were used by many people with sleep apnoea and were subject to a global recall in 2021 due to the risks associated with the foam used in the products.
The TGA alleges 11 models of Philips mechanical ventilators, continuous positive airway pressure (CPAP) machines and bi-level positive airway pressure (BiPAP) machines sold between June 2, 2019, and October 13, 2022, were unsafe, did not perform as intended and were therefore "unlawfully supplied".
It estimates 44,000 devices were sold in that period.
The devices contained a polyester-based polyurethane (PE-PUR) foam to reduce noise and vibration from the machine but Philips found the foam could degrade into particles that could be inhaled or ingested by the user.
"The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences to patients," the TGA's statement of claim to the Federal Court states.
The TGA alleges Philips was aware of the risks associated with the foam as early as 2015 but failed to take any action until 2021, when the devices were recalled.
The TGA has submitted a range of documents it alleges demonstrate that Philips had prior knowledge of the defect, including a report from 2013 which refers to the death of a patient that year who used a particular ventilator called the Trilogy 100, which is named in the legal action.
Following the global recall, Philips replaced the PE-PUR foam in the Trilogy 100 with silicone foam but by the following year it announced the new silicone foam could potentially separate from the plastic backing it was adhered to and block the air inlet.
The statement of claim said this could lead to "ventilation failure or underventilation … [which] could in turn result in hypoventilation, hypoxemia, hypercapnia and asphyxia".
The TGA alleges Philips did not conduct adequate risk analysis of the use of silicone foam with the adhesive.
The TGA alleges exposure to the foam particles could cause short-term effects such as skin, eye and respiratory tract irritation, inflammatory responses, headaches, asthma, effects on the reproductive system and neoplasia (abnormal growth of tissue), while long-term exposure could be carcinogenic (potentially cause cancer).
In a statement to the ABC, Philips Australia said since June 2021 it had conducted extensive testing with five independent, certified testing laboratories and third-party experts, and that, based on the test results, the experts concluded the devices were "not expected to result in appreciable harm to health in patients".
"Philips will review the concise statement filed in the Federal Court by the Therapeutic Goods Administration and engage constructively in the required court processes," a spokesperson said.
"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 health care."
The company noted the proceedings covered alleged activities in the lead-up to and during the 2021 recall but did not make allegations regarding the quality of Philips's current products.
A class action against Philips lodged by consumers of the affected devices is also currently before the Federal Court in Victoria.
The claim is being led by retired nurse Eva Lindbloom and aims to seek compensation for those who have suffered injury, loss or damage due to their use of the products.
Last year Philips reached a $US1.1 billion ($1.7 billion) deal to settle legal action in the US over the devices. And a cross-border European class action is currently underway.
