The Australian government has initiated legal proceedings against the multinational health technology firm Philips due to concerns about the safety of their sleep apnoea devices. Allegations suggest that patients were at risk of inhaling or ingesting small foam particles from these deteriorating sleep aids, prompting the Therapeutic Goods Administration (TGA) to file the lawsuit.
Philips is accused of distributing defective ventilators designed for sleep apnoea, which were recalled in June 2021. Following the recall, it is claimed that the company continued to market another hazardous device. According to the TGA, these products failed to comply with Australian safety standards.
Devices sold before the June 2021 recall were equipped with a polyurethane foam intended for noise suppression. However, concerns were raised about the risk of this foam degrading, leading to potentially harmful particles being inhaled or swallowed by users. The agency detailed a variety of potential health risks, including skin and eye irritation, respiratory issues, headaches, asthma, and reproductive problems. The long-term exposure to these particles could result in severe cellular damage, genetic harm, or even cancer.
The lawsuit asserts that the likelihood of foam degradation and subsequent health risks was deemed unacceptable, given the serious potential consequences. It highlights that Philips did not conduct any risk assessment regarding these devices until early 2021, well after concerns had been raised.
In June 2021, ten models, including those under the BiPAP, DreamStation, OmniLab, and REMstar brands, were globally recalled. Post-recall, Philips allegedly marketed a new defective model, the Trilogy 100, which utilised silicone foam that could detach, potentially obstructing airflow and leading to adverse health effects such as elevated carbon dioxide levels or reduced oxygen in patients’ blood.
The TGA is seeking financial penalties and also requests that Philips covers the legal costs associated with the case. In response, a Philips spokeswoman noted that the lawsuit focuses solely on the company’s practices surrounding the 2021 recall and does not pertain to the current quality and safety of their products in Australia. She asserted that extensive testing, including evaluations by independent laboratories and third-party experts, has shown that the Philips sleep therapy devices presently available pose no significant health risks to users.
Philips plans to thoroughly examine the court documents filed by the TGA and intends to engage with the government constructively throughout the proceedings.