Philips sleep apnea medical devices litigation – injunctive relief class action in Italy.

May 1, 2023.

Since 2021 Philips has been involved in several lawsuits related to the CPAP and BiPAP medical devices.

One of the subsidiaries in the U.S.A. of the Dutch conglomerate issued recall and remediation notices worldwide in 2021 based on health risks because the foam within the device could disintegrate and be inhaled by the user. Chemical components are considered dangerous, even life-threatening, by the manufacturer: “These problems can cause serious, life-threatening injuries, cause permanent damage or require medical intervention to prevent permanent damage“. Devices are used to treat sleep apneas as well as major respiratory issues.

Millions of units were sold across the world, about 100.000 in Italy.

GJN board member and current president Stefano Bertone of Ambrosio & Commodo filed an injunctive relief class action in Italy in September 2022 demanding Italian Courts to order Philips an acceleration of the remediation campaign which was due December 2022 according to Italian authorities.

Defendants are Philips S.p.A. (an Italian subsidiary of Koninklijke Philips Electronics NV, the Dutch parent company) and Respironics Deutschland GmbH & Co KG as the authorized representative of U.S.-based Philips Respironics Inc.. According to art. 2, paragraph 32 and Recital 35 of EU Medical Device Regulation 2017/745, authorized representatives are natural or legal person established in the Union who “act on behalf of the manufacturer in relation to certain activities with reference to obligations of the same pursuant to this regulation” whenever a manufacturer is based outside the Union.

The first instance court of Milan agreed with the plaintiffs on March 30, 2023 with temporary confirmation by the Milan Court of Appeal on April 24, 2023. The defendants were given a deadline (April 30, 2023) to complete the remediation campaign.

Defendants are to pay 20.000 € per day per every day beyond April 30, 2023 if the campaign is not completed, to the claimants’ association. The merits of the case will be discussed again at the end of October, 2023.

More info at https://ambrosioecommodo.it/ventilatori-e-respiratori-philips-cpap-bipap/