Country:

Italy

Court:

Tribunal of Milano 24 September 2014

Topics:

Casual link between hexavalent vaccine and autism.

Entitlement for the Indemnity awarded by the public compensation fund under L. 210/92.

Articles:

L. 210/92 art. 2.

Facts:

In 2006, the claimants baby received the injection of three doses of the hexavalent vaccine Infanrix Hexa SK. In 2010, following the appearance of different symptoms, autism was diagnosed. The parents claimed for an indemnity provided by the public compensation fund in cases of collateral effects caused by a compulsory vaccine (L. 210/92). The Ministry of Health rejected the request for lack of proven causality between the vaccine and autism. Consequently the parents filed a lawsuit against the Ministry of Health before the Tribunal of Milano, claiming the application of Law n. 210/92.

Legal Questions:

Is there a causal link between the injection of the vaccine and the autism?

Decision:

Italian courts of private law apply a standard of proof on causation based on a balance of probabilities (namely that it is "more probable than not" that the damage has been caused by the alleged factor rather than any other plausible factor). Given so, the Tribunal of Milano stated that in, the instant case, causation is inferred from different elements. Firstly, the expert appointed by the judge had shown that it is more probable that the autism was caused by the vaccine rather than by any other plausible cause, on the basis that batches of this vaccine seem to have contained mercury, which has a toxic effect (very rarely an Italian judge departs from the opinion expressed by his own expert). Secondly, there was an internal document of the manufacturer (addressed to the regulator) that revealed that 2 cases of autism have been reported out of more than 6 million persons exposed to the vaccine within a period of 24 months. Lastly, the Tribunal remarked that there is a time coincidence between the vaccination made in 2006 and the diagnosis of autism in 2010, following the appearance of different symptoms.

Therefore the Tribunal recognized the right of the claimants to be awarded the indemnity provided by the public compensation fund in case of side-effects caused by a compulsory vaccines.

Comments:

From a scientific point of view, this reasoning is certainly quite unsatisfactory. In particular, the presumed absence of any other possible cause is questionable, since the real causes of autism are still unknown (what about pesticide in the food, or bisphenol in the plastic bottles, or pollution in the air?). The tribunal is quite aware of the weakness of proof on causation. The underlined idea however seems to be the fact that the manufacturer (and consequently the public authority) has accepted the risk that his product might cause autism, among other side effects, because of the reports mentioned in the internal document. Consequently, the Tribunal has configured a new kind of liability, which is a liability for the creation of a potential risk rather than for damages.

It must however be remembered that the claim was brought against the Ministry of Health in order to be awarded with the indemnity provided by the public compensation fund. The public compensation fund has been set up for solidarity reasons, in order to award an indemnity to victims of side effects caused by a compulsory vaccine or by a transfusion of infected blood. The underlying idea is that whenever an individual has to suffer a sacrifice for the benefit of the community, then he deserves compensation from the community (the Italian constitutional court has extended the legal provision also in favor of victims of non-compulsory vaccines, but strongly recommended by the government with decision n.27/1998 and n. 423/2000). The solidarity issue is therefore particularly influential on the decision of the judge in this sort of case. In another context, the same case filed against the manufacturer would have given a different result, as the issue of solidarity would have been less effective and because the manufacturer would have presented a stronger defense (for example appointing his own expert in order to prove that there might be other plausible causes of the disease). So said, the present decision of the Tribunal of Milano, which has also been published in several newspapers, will not be without consequences in vaccine litigation in Italy.

Previous cases reported:

Characterizing the existence of a causal link between vaccine and autism:

Trib. Pesaro 11-11-2013.

Trib. Rimini 15-3-2012

Trib. Milano 14-12-2012

Rejecting the qualification of a causal link between vaccine and autism:

Trib. Napoli Sez. II, 25-06-2013