Country:

Italy

Court:

Cass. civ. 15-7-1987 n. 6241, in Foro it., 1988, I, 144.

Topics:

Exemption from strict liability for defective pharmaceutical product.

Articles:

Before the implementation of the directive.

Facts:

The claimant argued that she got hepatitis because of an infected blood product used for the manufacture of Trilergan, a medicine she was taking for her cephalalgia treatment. She claimed compensation for her physical injuries from the manufacturer assuming that he was to be held strictly liable under art. 2050 c.c. The defendant objected that to put into commerce a supposed injurious product is not a dangerous activity under art. 2050; secondly he alleges that, in any case, he was to be kept exempt from the liability because he had taken all the appropriate measures in order to avoid the risk of damage. The claimant remarked that in the date in which the manufacturer put the product into circulation the test for the detection of hepatitis infection in blood product was already existing (even if only in the experimental phase). Therefore the claimant argued that the manufacturer did not succeed in fulfilling the exemption legal provision.

Legal questions:

Is it a dangerous activity under art. 2050 to put into commerce a potentially injurious product ? Did the manufacturer take all the appropriate measures in order to avoid the risk of damage?

Decisions:

The court held that putting into commerce a potentially injurious product is a dangerous activity under art. 2050 c.c. Therefore the manufacturer was held strictly liable considering also that he did not succeed in proving that he had taken all the appropriate measures in order to avoid the risk of damage, because he should have use the test for hepatitis detection even if it was only experimental at the time.

Comments:

Before the implementation of the EC directive (and after the Trilergan cases) the Courts were use to apply a more strict regime to the cases of injurious pharmaceutical product than the fault liability law applied to the cases of defective products.