In the wake of a massive recall, Philips Respironics has agreed to stringent terms with the Justice Department, including hiring an independent safety monitor and paying part of its revenue to the federal government. The settlement follows revelations that industrial foam in its breathing machines degraded, releasing toxic substances into patient masks.
Michael Korsh and Evan Robinson-Johnson report for ProPublica in partnership with the Pittsburgh Post-Gazette.
In short:
- Philips Respironics must hire an independent safety monitor and undergo regular inspections for five years.
- The company faces scrutiny over the testing of replacement machines issued after the recall.
- The agreement prohibits Philips from selling certain devices in the U.S. and requires revenue sharing with the government.
Key quote:
“If a manufacturer misleads [the] FDA, how do they reestablish integrity?”
— Michael Twery, former director of sleep disorders research at the National Institutes of Health
Why this matters:
The industrial foam used in Philips breathing machines contained substances that could degrade over time, releasing toxic particles and fumes into the masks worn by patients. Specifically, these toxics included formaldehyde, a known carcinogen, among other dangerous chemicals. The presence of these harmful substances posed serious health risks to users, potentially leading to respiratory tract illnesses, headaches, nausea, and even toxic and carcinogenic effects.
