Amid Recall Crisis, Philips Agrees To Stop Selling Sleep Apnea Machines In the United States

An anonymous reader quotes a report from ProPublica: Reeling from one of the most catastrophic recalls in decades, Philips Respironics said it will stop selling sleep apnea machines and other respiratory devices in the United States under a settlement with the federal government that will all but end the company's reign as one of the top makers of breathing machines in the country. The agreement, announced by Philips early Monday, comes more than two years after the company pulled millions of its popular breathing devices off the shelves after admitting that an industrial foam fitted in the machines to reduce noise could break apart and release potentially toxic particles and fumes into the masks worn by patients.

It could be years before Philips can resume sales of the devices, made in two factories outside Pittsburgh. The company said all the conditions of the multiyear consent decree -- negotiated in the wake of the recall with the Department of Justice on behalf of the Food and Drug Administration -- must be met first. The move by a company that aggressively promoted its machines in ad campaigns and health conferences -- in one case with the help of an Elvis impersonator -- follows relentless criticism about the safety of the machines. A ProPublica and Pittsburgh Post-Gazette investigation found the company held back thousands of complaints about the crumbling foam for more than a decade before warning customers about the dangers. Those using the machines included some of the most fragile people in the country, including infants, the elderly, veterans and patients with chronic conditions.

'It's about time,' said Richard Callender, a former mayor in Pennsylvania who spent years using one of the recalled machines. 'How many people have to suffer and get sick and die?' Philips said the agreement includes other requirements the company must meet before it can start selling the machines again, including the marquee DreamStation 2, a continuous positive airway pressure, or CPAP, device heralded by Philips when it was unveiled in 2021 for the treatment of sleep apnea. The settlement, which is still being finalized, has to be approved by a court and has not yet been released by the government. It remains unclear how the halt in sales will impact patients and doctors. The company's U.S. market share for sleep apnea devices in 2020 was about 37% -- behind only one competitor, medical device maker ResMed, according to an analysis by iData Research. Philips has dominated the market in ventilator sales, the data shows.

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