Philips Respironics has reached a $1.1 billion settlement over claims that people using CPAP and other breathing devices suffered harm from harmful gases and pieces of foam that sometimes stayed in their airways for years.
Thousands of people have filed lawsuits claiming they were injured by the popular Philips DreamStation device. The settlement affects continuous positive airway pressure (CPAP) machines, which are used by people with sleep apnea or other breathing difficulties to improve breathing at night, as well as other types of machines used at home and in hospitals.
Philips did not admit any wrongdoing in the settlement, including whether the device caused any injuries, according to a financial report released Monday.
The personal injury settlement follows a $479 million settlement reached in September for economic losses to patients who financed replacement devices and companies selling medical equipment. Philips also agreed to a consent decree earlier this year that would halt U.S. sales of the new device until certain conditions are met.
Monday's settlement mostly resolves years of litigation over an issue that has deeply angered patients and doctors, compared to using machines that could harm patients rather than treat them when their breathing stops. Patients have flooded lawmakers and the Food and Drug Administration (FDA) with complaints about confusing recall and replacement efforts that have left them waiting months or more than a year for updated devices.
In a May 2022 letter to Philips, the FDA noted that the company received reports of problems as early as 2015 but failed to evaluate the information and address issues with the device.
The recall began in the summer of 2021 amid concerns that the machines were emitting potentially cancer-causing gases. The initial recall affected about 15 million breathing machines produced since 2006, but about 5 million were still in circulation as of mid-2021.
The FDA reported that officials have received 116,000 complaints, including 561 reports of deaths, that people or lawyers have linked to the device's defective foam since Philips first alerted it to the problem earlier this year.
The company later toned down its warnings, saying further testing showed the gas was not as toxic as initially believed.
Investors recognized the resolution, as the company's stock price soared about 33% on Monday morning, reaching about $28 per share. The company said a portion of the settlement will be covered by insurance.
Plaintiffs' lawyers welcomed the settlement.
“Ultimately, this consolidated settlement achieves what we set out to achieve when this litigation began: to hold Philips accountable by caring for people who have suffered physical injuries and to obtain compensation for those who need new breathing devices. will,” said Sandra L. Duggan, Kelly K. Iverson, and Christopher A. Seeger, the plaintiff's attorney, said in a statement: