Since Philips recalled millions of its CPAP, BiPAP and mechanical ventilators, the FDA has received more than 21,000 adverse health reports connected with the machines’ toxic foam. Health problems reported to the FDA in connection with the Philips recalled CPAP machines have included cancer, pneumonia, respiratory problems, and various other conditions – and death. The agency recently announced it has also received reports of 124 fatalities involving users inhaling the foam particles.
“We are in the process of evaluating each report while communicating this early information to public. There is, based solely on the reports, no immediate causal link between the deaths and the foam breakdown,” an FDA spokesperson told NBC 5 Responds. “The 124 deaths have not been verified beyond the medical device reports submitted to the FDA.” And after Philips announced the recall in June 2021, it “received a steep increase in complaints allegedly associated with possible foam degradation.”
Wrongful Death Lawsuit
A Philips CPAP machine wrongful death complaint was filed in January 2022 by the family of a Missouri man. They claim that Terrance P. Flynn’s sleep apnea device caused esophageal cancer. He died just weeks before Philips announced the recall.
According to the lawsuit, Koninklijke Philips and its North American subsidiaries knew or should have known about these potentially life-threatening health risks prior to the recall, but did nothing to warn patients or their physician. Flynn had used a recalled device since 2011 through May 2020. He died on May 31, 2021.
More Woes for Philips
Royal Philips NV is getting hit-- hard. The company and its subsidiaries were served subpoenas on April 8 by the U.S. Department of Justice (DOJ) in connection to an ongoing investigation into the recall that's led to more than 100 lawsuits and multidistrict litigation, the company announced in a recent U.S. Securities and Exchange Commission filing.
The subpoena from the DOJ was “to provide information related to events leading to the Respironics recall,” said Philips’ Chief Executive Officer Frans van Houten. “The relevant subsidiaries are cooperating with the agency.” He added that no specific allegations were raised in the subpoenas, rather it was only a general request for information about the recall.
And Philips is feeling the pinch from the FDA. Nearing the one-year anniversary of its official recall notice, the company may not make the agency’s preferred timeline to repair and replace the 5.2 million affected devices, which leaves many users in the dark – the lights may be out but they may not be getting a good night’s sleep. The Netherlands-based company told Nieuwsuur that over 70 percent of Dutch users have not yet been helped. The company currently aims to give 90 percent of affected people worldwide a new or repaired machine by the end of this year.
READ MORE CPAP LUNG CANCER LEGAL NEWS
In the U.S. Philips is currently facing 185 personal injury lawsuits and more than 100 class-action lawsuits tied to the device recall. Those class-action lawsuits are expected to be combined into two lawsuits this summer, according to Philips.