In what appears to be another consequence of the various health crises that have occurred in France in recent decades (others include the cases of PIP and Mediator), the French National Agency for Medicines and Health Products Safety (“ANSM”) is taking unprecedented action against Philips Respironics Dreamstation (“Philips”) by escalating the case to the Paris Prosecutor after Philips failed to comply with a remedial injunction the ANSM had issued last year.
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for sleep apnea or respiratory assistance.
In a replacement plan dated August 5, 2021, Philips committed to replacing and repairing 50 percent of the defective devices by the end of the first quarter of 2022, 75 percent by June 2022, and 100 percent by September 2022.
This schedule however was pushed back several times. As of February 4, 2022, Philips had replaced only 7 percent of the defective devices.
As a result, on February 9, 2022, the ANSM issued an injunction ordering Philips to replace or repair 75 percent of the affected devices by June 2022 and 100 percent by December 2022. Philips was also required to send monthly progress reports to the ANSM and, within one year, the preliminary results of a study assessing the risk of cancer potentially induced by exposure to the devices in question.
Philips was late in complying with this injunction, and the ANSM issued a formal notice against Philips to employ, without delay, all means at its disposal to proceed with the replacement of the remaining defective equipment. The ANSM also referred the case to the Paris Prosecutor, who may decide to prosecute Philips before the Criminal Court.
The ANSM’s decision should not have been a surprise, given that Article 40 of the French Criminal Procedure Code requires public authorities to refer potential crimes or misdemeanors to the Public Prosecutor as soon as they are informed.
By being proactive, the ANSM seems to be breaking its usual wait-and-see attitude in similar cases, which in the earlier Mediator case had led to the ANSM being found guilty of negligence.
This prosecution adds to the administrative powers entrusted to the ANSM which may impose an administrative fine of up to €750,000 for not complying with the product recall measures required by the ANSM.
It is therefore very likely that the ANSM will try to escape such liability by a more and more frequent use of such tool.
This makes it even more crucial for the health industry to be very careful and transparent in designing and monitoring field safety actions.