In February 2022, the ANSM took a health policy decision to force Philips to replace all its potentially carcinogenic devices.
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 confirms to franceinfo that it was seized by the ANSM in this case of 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 has knowledge of a felony or misdemeanor. According to the prosecution, this report relates to the “compliance of medical devices put into circulation 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
This referral 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 quickly launch an independent study in order to determine the real danger of machines for patients. To date, none of these obligations has been fulfilled to date. Thousands of potentially dangerous machines are still in circulation.
As a reminder, according to documents consulted by franceinfo, Philips had continued to use a possibly carcinogenic foam to equip its respirators against sleep apnea despite several alerts issued by an American manufacturer.
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 contacted a lawyer, Maître Christophe Lèguevaques, an expert in collective proceedings. Contacted by franceinfo, the lawyer reacts to the referral to justice by the drug agency: “By being proactive in a medical file, the ANSM seems to be breaking with its wait-and-see tradition, even as a servant of industrialists, for which it was criticized and earned it a conviction in the Mediator file and an indictment in the Levothyrox file. Now it is time for the prosecution to hand over to an investigating judge. Indeed, the investigating judge will be able to carry out an in-depth investigation involving expertise and international cooperation made necessary by the global nature of this case, which concerns 5 million devices..”
In the United States, the American health security agency, la FDA (Food and Drug Administration)estimated on February 9 that certain “reconditioned” Philips devices, whose incriminated “foam” has been changed, also again posed serious safety problems for patients.
