Philips Respironics, facing severe backlash over its handling of the 2021 recall of millions of sleep apnea machines, has agreed to halt sales of its respiratory devices in the United States. The recall was prompted by a defect in the devices where industrial foam could break apart, releasing potentially toxic particles and fumes into patients’ masks. The company, under a settlement with the Justice Department, must meet specified requirements before resuming sales, which could take years. Philips’ decision follows extensive criticism and revelations that it withheld complaints about the defect for over a decade. The agreement is seen as “very punitive,” impacting the company’s U.S. market position, with potential long-term consequences. Federal lawmakers have called for a criminal probe, and the FDA has challenged the safety claims regarding the foam. The halt in sales raises concerns about the impact on patients and doctors, as Philips holds a significant market share in sleep apnea devices. The company’s stock prices plummeted by 7% following the announcement. The settlement comes amid ongoing investigations and heightened scrutiny of the FDA’s oversight of medical device recalls. Philips emphasized its commitment to complying with the consent decree and providing ongoing service for existing machines. The announcement marks another development in Philips’ response to the global health emergency triggered by the recall, including discontinuation of some devices and ongoing concerns about the safety of replacement foams. The recall has significantly affected the company’s reputation, leading to frustration and loss of trust among patients and professionals in the sleep field
February 2, 2024