Philips Respironics has reached a $1.1 billion settlement over allegations that people using its CPAP and other breathing devices were harmed by harmful gases and specks of foam that lodged in their airways, sometimes for years.
Thousands of people claimed in lawsuits that they had been injured by the popular Philips DreamStation machines. The agreement affects CPAP, or continuous positive airway pressure, machines that people with sleep apnea or other breathing difficulties use at night to improve their breathing, as well as other types of machines used in the home and in the hospitals.
Philips did not admit any defects in the deal, including whether the devices caused the injuries, according to a financial report released Monday.
The personal injury settlement follows a $479 million settlement reached in September for financial losses to patients and medical equipment sales companies that financed the replacement devices. Philips also agreed to a consent decree earlier this year that forced the company to stop sales of new devices in the United States until certain conditions were met.
Monday’s settlement largely resolves years of litigation over an issue that deeply bothered patients and doctors, who had to weigh the risk of letting patients’ interrupted breathing go untreated versus using a machine that could cause harm. . Patients inundated 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 FDA noted that the company had received reports about the problem as early as 2015, but did not evaluate the information or address the problems with the device.
The recall began in the summer of 2021 amid concerns that the machines were venting potentially carcinogenic gases. The initial recall affected about 15 million respirators produced since 2006, although approximately five million were still in circulation as of mid-2021.
The FDA reported earlier this year that since Philips first warned of the problems, officials had received 116,000 complaints, including 561 reports of deaths, which people or lawyers said were related to defective foam in the device.
The company has since tempered its warnings, saying additional testing showed the gases were not as toxic as initially believed.
Investors recognized the resolution, as the company’s shares rose about 33 percent Monday morning, to about $28 per share. The company said part of the deal would be covered by insurance.
The plaintiffs’ attorneys welcomed the settlement.
“Ultimately, these combined agreements achieve what we sought when this litigation began: holding Philips accountable by getting care for those who suffer physical injuries and compensation for those who need new breathing devices,” Sandra L. Duggan, Kelly K. Iverson and Christopher A. Seeger, attorneys representing the plaintiffs, said in a statement.