Philips Respironics announced Monday that it will stop selling all of its ventilators in the United States after reaching a settlement with the Food and Drug Administration over ongoing problems with the devices.
Millions of the company’s ventilators and CPAP machines, used to help breathing at night, have been recalled after reports they blew chunks of foam and potentially toxic gases into consumers’ airways.
As part of the settlement, Philips said it would have to meet a list of standards in a “multi-year” plan before it could resume operations in the United States. The company said more details will be revealed when the settlement is finalized in court. However, it added that it will continue to repair existing devices and provide services to people who use them.
The company initially began recalling millions of devices in June 2021 and halted sales of new sleep therapy machines in the United States, according to Steve Klink, a Philips spokesman. At the time, the company and the FDA cited the possibility of serious injury or permanent damage from the potentially carcinogenic chemicals emitted by the devices.
The company has since released additional test results, saying the devices were “not expected to cause significant harm to patients’ health” and said it was continuing to conduct tests. The FDA withdrew some of the company’s updated claims, at one point calling them “unconvincing.” Philips has also faced constant scrutiny and undertaken more recalls in its efforts to upgrade the devices.
Dr. Jeff Suren, director of the FDA’s device division, said the agency could not comment until the agreement is finalized and filed with the court.
The initial recall affected about 15 million ventilators manufactured since 2006, although about five million were still in circulation as of mid-2021.
As replacements were not readily available, the recall caused confusion and upheaval for many doctors and patients. Many struggled to weigh the risk of continuing to use a faulty device against the risk of sleep apnea.
Millions of people suffer from sleep apnea, or interrupted breathing, which is associated with increased rates of stroke, heart attack, and possible cognitive impairment. The recalled machines included CPAP or continuous positive airway pressure machines. BiPap devices. and respirators.
Philips, which is based in Amsterdam, revealed that it had reached an agreement, or consent decree, it had mediated with the US Department of Justice and the FDA, along with its fourth-quarter earnings announcement. The company said it recorded approximately €363 million related to the costs of completing settlement claims. Its stock, which is traded in the United States, was down about 7 percent on Monday morning.
The company said it will continue to sell its products in other countries.
Thousands of patients have since sued Philips, alleging the machines led to a wide range of respiratory and other ailments, including claims of lung cancer deaths. In September, the company reached a $479 million settlement with plaintiffs intended to cover financial damages related to repairing or replacing the machines. Still pending are lawsuits over illnesses and medical expenses.
