Philips-Respironics: Milan Court of Appel upholds 1st degree decision on recall injunction

With a decision that is now final, the Milan Court of Appeal upheld the Milan Tribunal decision of March 2023.

Agreeing with the claimants, the Court recognized that Philips is late with its recall and ordered it to pay a fine on a daily basis until the remediation is complete. It also ordered that the decision is to be displayed by Philips on its website for 30 continuous days.

It is considered a huge victory for the class action of 106.000 claimants in Italy and a huge setback for the defendants.

Our member Stefano Bertone from Ambrosio & Commodo reminds that the decision agrees with the plaintiffs that the material facts of the case (exposure to toxic substances) fall into the definition of “serious incident” according to Article 2(65) of EU Reg. 2017/745.

According to Art. 2(65), a serious incident “may directly or indirectly lead, might have led, or might lead to any of the following: (a) the death of a patient, user, or other person, (b) the temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, (c) a serious public health threat.”

In addition, the Court of Appeal confirmed that the corrective action put in place by the company was not completed “within a time-limit suitable for ensuring the protection of the health of the persons concerned.”

The Court of Appeal in Milan also declared that as laid down in EU Reg. 2017/745, the responsibility for a timely conclusion of a recall of Medical Devices lies with both the manufacturer and its local dealers. The Court hence rejected Philips’s theory that such responsibility was of the dealers only.

GJN is carefully planning all future initiatives to protect the health of exposed users and to obtain full and just redress.