by Debbie Cenziper, ProPublica, and Michael D. Sallah, Pittsburgh Post-Gazette
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.
The FDA said it could not comment until the agreement is finalized and filed with the court. The DOJ could not be immediately reached for comment.
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.
One global market report on Monday referred to the agreement as “very punitive” and noted, “It will be very difficult for Philips to recover its U.S Respironics market position.”
After the announcement, the company’s stock prices plunged by 7% in early trading.
Philips did not address the safety of the recalled devices in its announcement, but the company has previously said that new testing shows the foam causes no “appreciable harm” to patients. The FDA has challenged those claims, saying the company’s tests are not “adequate.”
The settlement comes just weeks after federal lawmakers called for an immediate criminal probe of Philips by the DOJ, and the Government Accountability Office, the investigative arm of Congress, said it will launch an inquiry of the FDA’s oversight of medical device recalls for the first time in years.
ProPublica and the Post-Gazette identified thousands of reported cases of cancer, respiratory illnesses and liver and kidney conditions among users of the recalled machines, as well as more than 370 reports of deaths.
The news organizations found that scientists inside Philips repeatedly raised concerns about the foam and that the company’s own testing called into question its safety claims.
The news organizations also reported that a new and different foam used in the DreamStation 2 and millions of other replacement machines sent out by Philips in the wake of the recall was found to emit dangerous chemicals as well, including formaldehyde, a known carcinogen. The company has said the new foam is safe, but scientists involved in the testing have again raised alarms and the FDA has said additional safety tests are still needed.
In its announcement, the company said it would provide ongoing service and parts for machines already in the hands of doctors and patients and continue selling its devices outside the United States subject to requirements in the agreement.
“Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” said Roy Jakobs, CEO of parent company Royal Philips. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
The announcement was the latest in a series of developments at Philips since the recall prompted a global health emergency that sent millions of patients scrambling to find replacement machines and assess the risk of long term exposure.
Philips has discontinued some of the recalled devices, including ventilators and, just last week, the widely promoted DreamStation Go, a portable CPAP.
In an online update and email to U.S. customers, Philips said the decision to pull the devices off the market in the United States was a “strategic” choice that “streamlined” its portfolio. The email reignited anger and frustration among patients and doctors.
“They used to be one of the most respected industry leaders,” said Dr. Radhika Breaden, a sleep medicine specialist in Oregon. “They have lost the trust of many of our sleep patients and many professionals in the sleep field.”