the drug agency takes legal action

The National Agency for the Safety of Medicines and Health Products (ANSM) is taking legal action in the case of Philips brand respirators. More than a year after the health policy decision (February 2022) imposing on Philips a timetable for the replacement of potentially carcinogenic respirators, thousands of potentially carcinogenic sleep apnea machines have still not been replaced.

The Paris public prosecutor’s office was seized by the ANSM in this case of the Philips respirators, under article 40 of the code of criminal procedure, an article according to which any public authority must seize the prosecutor as soon as it becomes aware of a felony or misdemeanor. According to the prosecution, this report relates to the “compliance of medical devices with the essential requirements”. This report is currently being processed by the Public Health Unit, which announced the launch of a preliminary investigation last September.

More than 500 people seized a lawyer

Patients now want the prosecution to open a judicial inquiry and appoint an investigating judge to conduct the investigation. More than 500 people have already seized a lawyer. As a reminder, this announcement comes at a time when the ANSM had taken a health policy decision against Philips, more than a year ago, in February 2022, to force the company to replace all its devices and to carry out studies in order to to determine the real danger of the machines. None of these obligations has, to date, been fulfilled. According to documents consulted by franceinfo, Philips continued to use a possibly carcinogenic foam to equip these respirators against sleep apnea despite several alerts issued by an American manufacturer.

Also as a reminder, the FDA (Food and Drug Administration) in the United States, estimated on February 9 that certain “reconditioned” Philips appliances (Philips has not changed its appliances, but has replaced the problematic foam with another foam) again pose safety problems.