Science, rhetoric and the causality of adverse events

Article type: Research Article

Authors: Healy, David

Affiliations: Department of Psychological Medicine, Cardiff University, Hergest Unit, Bangor LL57 2PW, Wales, UK E-mail: [email protected]

Abstract: This paper outlines aspects of the interface between law and science in the domain of treatment induced injury, using examples drawn from litigation on SSRIs. In the face of claims that randomized controlled trials provide uniquely appropriate evidence and that there should be a statistically significant doubling of the risks on treatment, the examples used demonstrate that the methods of assessing the possibility of causal links between treatment and injuries must necessarily be tailored to both the injury and the treatment.

Keywords: Paroxetine, suicide, dependence, birth defects, controlled trials, case studies

DOI: 10.3233/JRS-2011-0534

Journal: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 149-162, 2011