Philips Cuts Deal with Owners of Recalled CPAP Machines and Lawsuit Claims FDA Fails CPAP Users

Santa Clara, CAPhilips Respironics has cut a deal with CPAP machine consumers who are part of the class action lawsuits. The $479 million proposed settlement covers reimbursement costs to consumers who purchased, leased or rented the defective devices. Depending on the CPAP, BiPAP or mechanical ventilator model, claimants can expect from $55 to $1,552 per device, and an extra $100 for every device returned. And of that amount, $34 million is allocated to health insurance companies and others who paid to reimburse users to replace the machines.

CPAP Personal Injury Claims

The proposed settlement does not include costs associated with injuries. Thousands of people who were diagnosed with cancer, leukemia, lymphoma, pulmonary fibrosis, lung damage and other health problems and filed a Philips CPAP injury lawsuit have their claims ongoing. Reuters reported in March that Philips CEO Roy Jakobs told a Dutch newspaper that “we can at least reach a settlement on economic damages this year," adding that he "hopes and expects" to also reach a settlement with the U.S. Food and Drug Administration this year. As well, Jakobs “hopes to resolve individual personal injury lawsuits sometime in 2024; a cost likely to far exceed the economic loss settlement”. 

Philips CPAP Claims - Predictions

According to About Lawsuits, many experts predict that Philips ultimately faces billions in legal liability and CPAP settlement payouts, including economic loss class action lawsuits that seek medical monitoring and damages associated with replacing or repair the machines, as well as substantially larger claims involving personal injuries experienced by former users. Also predicted: the number of claims this year is expected to surge. Both claims involving injuries diagnosed long before the recall, and new injuries that continue to be diagnosed months after users breathed the toxic particles inside their machines are being filed.

Philips Investigation and the FDA

Since June 2021, 10.8 million Philips sleep apnea machines have been recalled, and 2.5 million devices have been replaced, including ventilators and BiPAP and CPAP models. The oldest of the 16 models it has recalled date back to 2009. The devices were recalled when the foam used to dampen noise from the devices might degrade and become toxic, carrying potential cancer risks.  According to ProPublica, Philips knew back in 2010 that its breathing machines had a dangerous defect. But Philips decided to keep the FDA in the dark. (Federal law requires medical device manufacturers to turn over to the government within 30 days all reports of patient injuries, deaths and malfunctions that have the potential to cause harm, and to take action to investigate them.)  Pro Publica and the Pittsburgh Post-Gazette’s year-long investigation found that more than 100,000 reports had been filed with Philips or the government since 2010 by patients, doctors and others.

The news organizations requested dozens of additional documents from the FDA, to no avail. In April, ProPublica and the Post-Gazette sued the FDA in federal court in New York over the agency’s refusal to expeditiously release the records. Despite the FDA categorizing the recall as Class 1, (reserved for defects that can cause serious harm or death), the agency denied many requests by Pro Publica and the Post-Gazette to quickly release documents under the Freedom of Information Act, including the company’s prior test reports on the degrading foam and monthly updates by Philips about the status of a recall that has impacted millions of people in the United States and other countries. The FDA said it would take as long as two years to produce the records, but it agreed to produce documents when the lawsuit was filed.

By all accounts, Philips is in store for some restless nights.