Philips Respironics has reached a $1.1 billion settlement over claims that people who used their CPAP and other breathing devices were harmed by noxious gasses and flecks of foam that lodged in their airways, sometimes for years.
Thousands of people contended in lawsuits that they had been injured by popular Philips DreamStation machines. The settlement affects CPAP, or continuous positive airway pressure, machines that people with sleep apnea or other respiratory difficulties use at night to improve their breathing, as well as other types of machines used at home and in hospitals.
Philips did not admit any fault in the settlement, including whether the devices caused the injuries, according to a financial report issued Monday.
The personal injury settlement follows a $479 million settlement reached in September over economic losses to the patients and medical equipment sales companies that financed replacement devices. Philips also agreed to a consent decree earlier this year that forced the company to halt U.S. sales of new devices until certain conditions are met.
Monday’s agreement largely settles years of litigation over a problem that was deeply upsetting to patients and doctors, who had to weigh the risk of letting patients’ interrupted breathing go untreated against the use of a machine that might cause harm. Patients flooded lawmakers and the Food and Drug Administration with complaints about a chaotic recall and replacement effort that left many waiting for months or more than a year for an updated device.
In a letter to Philips in May 2022, the F.D.A. noted that the company had received reports about the problem as early as 2015, but failed to evaluate the information and address the device’s problems.
The recall started in the summer of 2021 amid concerns that the machines blew out potentially cancer-causing gases. The initial recall affected about 15 million breathing machines produced since 2006, though roughly five million were still in circulation in mid-2021.
The F.D.A. reported earlier this year that since Philips first warned of the problems, officials had received 116,000 complaints, including 561 reports of deaths, that people or lawyers said were linked to the faulty foam in the device.
The company has since tempered its warnings, saying that further testing showed that the gasses were not as toxic as initially believed.
Investors recognized the resolution, as the company stock surged by about 33 percent Monday morning, to about $28 per share. The company said that part of the settlement would be covered by insurance.
Plaintiffs’ lawyers welcomed the settlement.
“Ultimately, these combined agreements accomplish what we sought to achieve when this litigation began — holding Philips accountable by obtaining care for those with physical injuries and compensation for those needing new respiratory devices,” Sandra L. Duggan, Kelly K. Iverson and Christopher A. Seeger, lawyers representing the plaintiffs, said in a statement.
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