French prosecutors launch criminal investigation into Philips ventilator recall

The legal troubles continue for Philips and the seemingly never-ending recall of around 5.5 million of its breathing support machines.

The Dutch devicemaker is now in the crosshairs of French prosecutors. The Paris public prosecutor’s office confirmed to Reuters on Thursday that they’ve opened a preliminary criminal investigation into the recall, which began in June 2021 and concerns the polyester-based foam embedded in many of Philips’ CPAP and BiPAP machines, ventilators and other respiratory devices.

The French investigation kicked off a year later, on June 20. A spokesperson for the prosecutors told Reuters that the probe stems from “complaints filed on the grounds of aggravated deception, involuntary attacks on physical integrity, endangerment of the life of others and administration of harmful substances.”

According to a France Info report, the country’s National Medicines Agency has received almost 3,000 reports of adverse effects linked to the recalled respiratory devices. An estimated 370,000 of the affected machines had been distributed in France at the time of the recall; so far, only about a third of them have been fixed or replaced since Philips began its repair program last fall, per the report.

Philips did not immediately respond to Fierce Medtech’s request for comment.

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.

The recall originally comprised between 3 million and 4 million devices distributed around the world but has since been expanded to include about 5.5 million machines manufactured since 2009.

The FDA recently reported that it has received more than 69,000 complaints related to the affected respiratory devices since the recall began—including 168 reports of death—compared to the mere 30 complaints it received in the decade leading up to the safety alert. The bulk of the reports arrived between May 1 and July 31 of this year, per the agency, totaling more than 48,000 complaints that included 44 patient deaths.

In addition to the French investigation and the class-action suit—which currently comprises more than 300 separate actions, according to an Aug. 15 tally (PDF)—Philips is also in “confidential discussions” with the U.S. Department of Justice (DOJ), according to Roy Jakobs, chief business leader for Philips’ connected care division and the company’s incoming CEO.

During a late July call with investors, Jakobs didn’t disclose any details about the conversations but confirmed that the DOJ had issued a consent decree proposal earlier that month. The possible settlement agreement came not long after the DOJ subpoenaed Philips in April for more information about the recall, as the devicemaker disclosed in another earnings report that month.