Philips Respironics has agreed to a $479 million partial settlement over claims over defects in the company’s breathing devices that released gases and foam particles into consumers’ airways and sparked recalls involving millions devices, attorneys for the plaintiffs in the lawsuit announced Thursday. .
As a segment of the pending class action lawsuits over the devices, the settlement only covers monetary reimbursements to device users and vendors who may have funded consumer replacements, the attorneys say. There is no cap on the amount of economic claims, which will allow other device users to seek compensation.
This tentative settlement, which is subject to Federal Court approval, does not address other material claims in the plaintiffs’ cases relating to bodily injury or the cost of medical care related to the use of the respirators. Philips has not admitted any wrongdoing or liability under the proposed agreement.
The company faced a years-long setback after it began recalling about five million of its breathing devices in the United States, intended for people with sleep apnea and other conditions. The lawsuits claimed that the flaking foam and gases emitted from the machines were linked to health problems, including respiratory illnesses, lung cancer and death. Foam was used in machinery to reduce noise and vibration.
In June 2021, the Food and Drug Administration announced a recall of Philips machines that also included BiPAP devices and ventilators manufactured since 2009, warning that foam deterioration in the products could cause “serious injury” to users. Philips originally issued a note to doctors saying the degradation of the foam posed risks of “toxic carcinogenic effects”, but the company has since issued updates stating a much lower level of concern.
“We are confident in these allegations and look forward to holding Philips accountable for the physical harm it caused to patients,” plaintiffs’ attorneys said in a statement.
Millions of people suffer from sleep apnea, a condition associated with interrupted breathing that carries a number of risks, including strokes, heart attacks and possible cognitive decline due to decreased oxygen supply. .
The flurry of recalls in recent years has frustrated doctors and device users alike, wondering if they should continue using the devices and face potential health risks, or give up all treatment. Competing companies struggled to fill orders from those looking for replacements, leaving many consumers with no choice.
The agreement announced Thursday would provide compensation ranging from approximately $50 to $1,500 to each consumer, in addition to $100 for each device returned to Philips. The company said it replaced and shipped nearly 2.5 million devices to US consumers and providers.
“Patient safety and quality are our top priorities, and we want patients to feel confident when using their Philips Respironics devices,” the company said in a statement.
The FDA and some experts have criticized Philips for not informing consumers when it became aware of potential flaws with some of its devices. Agency and court records show concerns at Philips emerged in 2015. More than 105,000 injuries and 385 death reports possibly related to foam degradation in Philips machines were reported to the FDA.
The US Department of Justice has been in contact with Philips about a possible consent judgment to resolve issues with the recall process, the company said in a July earnings statement. As part of a subpoena issued in April 2022 as part of another investigation into the events leading up to the recall, Philips continued to provide information, according to the July report.