In an update posted on August 16, the FDA reported another 44 deaths linked to millions of breathing machines made by Philips Respironics.
The issue is that the machines were made with a toxic PE-PUR foam (polyester-based polyurethane foam) to muffle noises and vibrations.
Over time, PE-PUR foam can break down and sent tiny particles of toxic material and chemical “off-gas” into the user’s airstream.
Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown.
Many of those reports were sent to the FDA between May 1 an July 31, after the FDA ordered Philips back in March to immediately notify all users, suppliers, distributors, and retailers about the recall.
Philips is facing more than 300 separate lawsuits and class actions, according to a tally of cases in the MDL where the sprawling litigation has been centralized.
The serious injuries include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, and chest pain, according to the FDA.
Philips is still working to provide a remedy to approximately 5.5 million people who are affected by the recall. In the meantime, users can register their recalled devices for a repair-and-replace program.
Philips has produced around 3 million replacement devices and repair kits by the end of July 2022, with the estimated end-date for the program sometime in early 2023.