French Criminal Investigation against Philips Begins in Ventilator Recall Case

Prosecutors in Paris have begun a preliminary criminal investigation into Philips regarding the recall of its CPAP, BiPAP, and ventilator devices. The investigation, which began in June of this year, will look into complaints of “aggravated deception, involuntary attacks on physical integrity, endangerment of life of others and administration of harmful substances.” The devices were implicated in nearly 3,000 adverse event reports prior to the recall.

According to Andrea Park, “The recall began last year after Philips received a surplus of reports describing the tendency of the polyurethane foam—which is used to muffle sound and vibrations in the devices—to break down over time, releasing potentially harmful chemicals and particles into a user’s airflow. Filings in an ongoing class-action lawsuit against the company showed that Philips staffers had been alerted to issues with the foam as early as 2015, several years before the recall formally began.”

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(Source: Fierce Biotech, September 8^th, 2022)