On AboutPharma, an article by David Maria Santoro and Federica Bortolotti, together with Leonardo Toso and Matilde Bissolo from the Department of Diagnostics and Public Health – Section of Legal Medicine at the University of Verona, examines the issue of investigating the causal link in adverse reactions to medicinal products.
The article clarifies that, in the civil law context, the assessment of causation must combine epidemiological data deriving from the circulation of the medicinal product with the findings of a rigorous clinical analysis of the specific individual case, conducted according to medico-legal standards, seeking a “preponderance of the evidence” rather than certainty “beyond any reasonable doubt.”
The analysis of recent case law confirms this methodological approach, showing that the mere temporal correlation between the intake of a medicinal product and the onset of an adverse reaction is not sufficient, in itself, to establish liability for compensation.
When can the causal link between a medicinal product and an adverse event be considered proven?