In its ruling of 12 December 2025, the Court of Milan made an important decision¹ on admissibility under the new Italian class action proceedings introduced in 2019 by Articles 840‑bis et seq. of the Italian Code of Civil Procedure (hereinafter referred to as CPC IT). The court declared inadmissible a collective action brought by European users of medical devices manufactured by Philips S.P.A. / Respironics Deutschland GmbH & Co. KG, Koninklijke Philips N.V. and Philips RS North America LLC, who claimed to have suffered non-pecuniary damage due to the alleged deterioration of a sound-absorbing foam component in CPAP, BiPAP, and Trilogy ventilators.

The ruling deals with the interpretation of the requirement of similarity pursuant to Art. 840‑ter, paragraph 4, letter b) CPC IT.

Case Facts

The claimants – a group of individuals, predominantly from Italy and including some individuals from various EU countries – alleged three categories of non-pecuniary damage: 1) compensation for pain and suffering due to anxiety reactions or exposure to risk; 2) damage to health; and 3) loss of a close relative.

All damages were allegedly caused by exposure to particulate matter emitted by allegedly degrading foam in Philips respiratory devices used to treat sleep apnea or severe neuromuscular respiratory diseases.

The court examined whether a class action seeking compensation for non-pecuniary damage fulfilled the requirement of similarity of claims under the law.

The defendant companies argued that the lawsuit was structurally incompatible with the collective mechanism due to the diversity of the plaintiffs, devices, intended uses, damages, and applicable laws. The court agreed with this view.

The Court’s Reasoning

The court dismissed the lawsuit as inadmissible. It based its decision on four main categories of dissimilarity, each of which was sufficient on its own to defeat the requirement of similarity.

Subjective Variety of Users

The plaintiffs differed widely in terms of age, pre-existing conditions, comorbidities, and the duration and intensity of device use. These differences have a direct impact on both the existence of damage and the causal link between exposure to the device and the alleged damage.

Since each assessment would require highly individualized investigations, the court ruled that a standardized or serial assessment (the core rationale for class actions) was not possible.

Objective Differences Between The Devices

The court stated also that the devices in question – CPAP, BiPAP, and Trilogy – are not technically similar. They serve different medical purposes, contain foams with different compositions, can cause different degradation processes, and expose users to different risks. There is no common damage event capable of binding the class together.

Variety of Damage Categories

The damages claimed – pain and suffering, personal injury, and bereavement – are inherently individual.

As the court noted, non-pecuniary damages can only be claimed collectively if they are standardizable, which is not the case here. Each asserted claim for damages requires distinct evidence tailored to the personal health condition, age, individual exposure, and nature and extent of the alleged harm.

Comment

This ruling provides one of the clearest explanations to date of the limits of collective redress in Italy, particularly for non-pecuniary damages.

The court reaffirms 1) that there must be a single common set of facts (“uniform damage event”); 2) that the harmful consequences must be serial and uniform; and 3) that the damages must be assessable through common criteria. In the present case, none of these requirements was met.

The decision aligns with the Supreme Court ruling of 31 May 2019 (No. 14886), according to which non-pecuniary damages can be compensated by means of a class action only if they can be standardized.

The Milan court confirms this restrictive approach and severely restricts the admissibility of class actions if the assessment of the damage depends on personal, medical, or relational circumstances.

Structural Limits of Class Actions For Non-pecuniary Damage

The ruling highlights the recurring legal opinion that non-pecuniary harm is not presumed (in re ipsa). Even in cases of serious legal violations, the claimant must prove the specific negative consequences suffered. This individual burden of proof is fundamentally inconsistent with collective redress mechanisms.

Conclusion

This decision underscores a clear message: class actions are possible in Italy only in cases of genuinely uniform and serial damages – typically minor economic losses or standardized injuries such as delayed deliveries, service disruptions, or unfair commercial practices. For complex, medically sensitive, and highly individual non-pecuniary damages, the class action mechanism is structurally unsuitable.

The reasoning behind the ruling reflects a prudent and consistent approach that limits class actions to cases where the plaintiffs have a common basis of liability for their claims, an identical damage event, and uniformly assessable damages. The Philips case did not meet any of these criteria, so the class action was declared inadmissible.

Endnote

1. Milan Commercial Court – Division XIV, inadmissibility order No. 3923/2025 of 12 December 2025.