Philips Respironics has settled for $1.1 billion over claims that people who used CPAP and other breathing devices were harmed by noxious gases and foam patches that remained in their airways, sometimes for years.
Thousands of people claimed in lawsuits that they were injured by popular Philips DreamStation machines. The settlement 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 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 which was issued on Monday.
The personal injury settlement follows a $479 million settlement reached in September for financial damages to patients and medical equipment sales companies that funded replacement devices. Philips also agreed to a consent decree earlier this year that forced the company to halt sales of new devices in the US until certain conditions were met.
Monday’s settlement largely settles years of litigation over a problem that has deeply upset patients and doctors, who have had to weigh the risk of leaving patients’ interrupted breathing untreated against using a machine that could cause harm . Patients flooded lawmakers and the Food and Drug Administration with complaints about a chaotic recall and replacement effort that left many waiting 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 of the problem as early as 2015, but failed to evaluate the information and address the device’s problems.
The recall began in the summer of 2021 amid concerns that the machines spewed gases that could cause cancer. The initial recall affected about 15 million ventilators manufactured since 2006, although about five million were still in circulation as of mid-2021.
The FDA said 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 toned down its warnings, saying further tests showed the gases were not as toxic as first thought.
Investors recognized the decision, as the company’s stock rose about 33 percent on Monday morning to about $28 a share. The company said part of the settlement will be covered by insurance.
Lawyers for the plaintiffs welcomed the settlement.
“Ultimately, these combined settlements achieve what we sought to achieve when this litigation began – to hold Philips accountable by providing care for those with physical injuries and compensation for those who need new ventilators,” Sandra L. Duggan, Kelly K Iverson and Christopher A. Seeger, attorneys representing the plaintiffs, said in a statement.