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After one of the most disastrous recalls in decades, Philips Respironics announced it would stop selling sleep apnea machines and other ventilators in the United States as part of a deal with the federal government that would all but end the company's reign as a top manufacturer of ventilators in the country.
The deal, announced by Philips early Monday, comes more than two years after the company pulled millions of its popular breathing devices from shelves after admitting that industrial foam built into the devices to reduce noise could break apart and release potentially toxic particles and fumes in the masks worn by patients.
It could be years before Philips can resume sales of the devices made at two factories outside Pittsburgh. The company said it must first meet all conditions of the multi-year consent decree negotiated with the Justice Department on behalf of the Food and Drug Administration following the recall.
The move by a company that has aggressively promoted its machines in advertising campaigns and health conferences – in one case with the help of an Elvis impersonator – follows relentless criticism over the machines' safety.
An investigation by ProPublica and the Pittsburgh Post-Gazette found that the company withheld thousands of complaints about the crumbling foam for more than a decade before warning customers about the dangers. The machines' users included some of the country's most vulnerable people, including young children, the elderly, veterans and patients with chronic illnesses.
“It’s about time,” said Richard Callender, a former mayor in Pennsylvania who used one of the recalled machines for years. “How many people have to suffer, get sick and die?”
Philips said the agreement includes additional requirements the company must meet before it can begin selling the devices again, including the popular DreamStation 2, a continuous positive airway pressure (CPAP) machine that Philips introduced when it was introduced in 2019 announced in 2021 for the treatment of sleep apnea. The settlement, which is still in the final stages, still needs to be approved by a court and has not yet been cleared by the government.
The FDA declined to comment until the agreement is final. The DOJ could not immediately be reached for comment.
It remains unclear how the sales halt will affect patients and doctors. According to an analysis by iData Research, the company's U.S. market share for sleep apnea devices was about 37% in 2020, trailing only one competitor, medical device maker ResMed. The data shows that Philips has dominated the market in ventilator sales.
A global market report on Monday called the agreement “very punitive” and noted: “It will be very difficult for Philips to regain its market position in the US Respironics market.”
Following the announcement, the company's share prices plunged 7% in early trading.
Philips did not address the safety of the recalled devices in its announcement, but the company has previously said new tests show the foam does not cause “significant harm” to patients. The FDA has disputed these claims, saying the company's tests were not “sufficient.”
The settlement comes just weeks after federal lawmakers called for an immediate criminal investigation of Philips by the DOJ and the Government Accountability Office, Congress's investigative arm, said it would open an investigation into 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 disease among users of the recalled machines, as well as more than 370 reports of deaths.
The news organizations noted that scientists at Philips had repeatedly raised concerns about the foam and that the company's own testing called its safety claims into question.
The news organizations also reported that a new and different foam used in the DreamStation 2 and millions of other replacement devices that Philips shipped following the recall also emits dangerous chemicals, including formaldehyde, a known carcinogen. The company said the new foam was safe, but scientists involved in the testing raised the alarm again and the FDA said more safety testing was needed.
In its announcement, the company said it will provide ongoing service and parts for machines already in the hands of physicians and patients and will continue to sell its devices outside the United States, subject to the requirements of the agreement.
“Addressing the consequences of the Respironics recall for our patients and customers is a key focus, and I recognize and apologize for the distress and concern this has 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 sparked a global health emergency, prompting millions of patients to scramble for replacement devices and assess the risk of long-term exposure.
How patients and doctors are dealing with the consequences of the massive recall of Philips ventilators
Philips has discontinued some of the recalled devices, including ventilators and, just last week, the widely advertised DreamStation Go, a portable CPAP.
In an online update and email to U.S. customers, Philips said the decision to withdraw the devices from the U.S. market was a “strategic” decision that “streamlined” the portfolio. The email again sparked anger and frustration among patients and doctors.
“They used to be some of the most respected industry leaders,” said Dr. Radhika Breaden, a sleep doctor from Oregon. “They have lost the trust of many of our sleep patients and many sleep professionals.”
Michael Korsh of the Pittsburgh Post-Gazette contributed reporting.