Pharmaceutical manufacturer liability for defective medication information

Under Italian law and recent jurisprudence, such as Cassation ruling n. 8139/2024, pharmaceutical manufacturers are held liable for damages caused by defective products. A product is considered defective not only due to technical manufacturing errors but also if the information provided in the package leaflet is insufficient or unclear.

To ensure informed consent, the package leaflet must provide detailed information that allows patients to balance the benefits of a treatment against potential risks. If warnings are too superficial or fail to allow for a correct risk assessment, the manufacturer may be held directly responsible, as information is considered an integral part of the product itself.

To claim compensation, a patient must prove three elements: the damage suffered, the defect in the product, and a causal link between the two. According to the Consumer Code, the right to claim compensation is subject to a three-year statute of limitations.