The Italian Supreme Court upholds the first class action relating to medical devices

By a recent judgment published on 31 January 2018, the Italian Supreme Court brought to an end - after more than seven years from its beginning - the first product-related class action promoted in Italy.

The judgement of the Italian Supreme Court in Codacons vs. Voden Medical Instruments S.p.A. is also the first final decision issued in connection with a class action relating to a medical device.



"Ego-test-Flu", a do-it-yourself test of the A flu virus known as swine flu, was widely marketed in Italy by Voden Medical when swine flu outburst in 2009. The flu test was presented as being "practical, simple and safe" and having a "sensitivity at 99,1%".

In early 2010, consumers' association Codacons, acting on behalf of a claimant, sponsored the class action against Voden Medical claiming product-related damage as well as damage related to unfair commercial practices.

By the order published on 27 December 2010, the Court of Milan declared the class action admissible limiting the relevant claims to unfair commercial practices. The order by the Court of Milan was the first decision in Italy to declare a class action admissible. On the merits, however, the Court of Milan dismissed the class claim as groundless.

In 2013 the Court of Appeal of Milan, overruling the first instance decision, ordered the reimbursement by Voden Medical of the sum of €14.50, equal to the cost of the kit purchased, as compensation for damages suffered by consumers. The decision was rendered on the grounds that the information and advertising material of the product were misleading, in particular because they did not warn of the risk that the test could produce false-negative results. Voden Medical challenged the decision before the Supreme Court.


The Judgment by the Italian Supreme Court

The Italian Supreme Court rejected the appeal filed by Voden Medical against the decision the Court of Appeal of Milan.

The Supreme Court acknowledged that even a single claimant can represent the interests of the class of consumers who could potentially have purchased the product. Indeed, class actions are aimed at protecting consumers against unlawful conducts that could produce effects on many individuals.

In the case at hand, the advertising on Ego-test-Flu's packaging as well as the instructions provided with the package insert erroneously evoked in consumers the feeling that the product could diagnose the swine flu with a success probability close to 100%.


The law

Class actions were introduced in Italy by Law No. 99/2009 and subsequently amended over recent years. The procedure is currently regulated by Article 140-bis of the Italian Consumer Code, according to which consumers may bring, directly or through a representative body, class actions to protect their collective or their individual interests.

The Court, before a class action can be decided on the merits, shall assess whether the class is admissible and can declare the class action non admissible in any of the following cases: if the claim is manifestly groundless; if there is a conflict of interest; if the rights infringed are not homogenous; if the lead plaintiff is not able to adequately represent the interest of the class.

Class actions may be brought, inter alia, to seek redress for the violation of rights arising from product liability, provided that such rights are homogenous for the entire class.

Unlike the US, Italy has adopted an "opt-in" model for class actions. Accordingly, if the class action is deemed to be admissible, the court orders the defendant to publish a notice at its own expense, so as to allow other potential members of the class to opt-in within a certain deadline (which cannot exceed 120 days from the publication of the class action notice). In the case decided by the Supreme Court, no opt-in had occurred: as noted above, the Supreme Court ruled that the class need not be numerous.



Despite the paltry sum awarded, the decision is noteworthy considering that to date very few class actions have been declared admissible, also due to the strict admissibility requirements, and even less have been upheld on the merits.

Indeed, the – albeit limited – case law appears to exclude commonality whenever the facts underlying the claim require the assessment of different individual circumstances, a situation which would often occur where health damage is sought. Also for these reasons, Italian consumers associations (which have been considered the driving forces behind class action) appear to have progressively lost their interest in bringing class actions in Italy and are rather looking again at the other side of the Atlantic, as the US-style class action regime seems to be less restrictive.

The Supreme Court's recent judgment might reverse this trend. Thus, also considering the reform of class action law currently under the scrutiny of the Parliament, which should enhance the effectiveness of class actions, companies who might be potential targets should start preparing to get ready to react.

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