Interpreting risk as evidence of causality: lessons learned from a legal case to determine medical malpractice

Translating risk estimates derived from epidemiologic study into evidence of causality for a particular patient is problematic. The difficulty of this process is not unique to the medical context; rather, courts are also challenged with the task of using risk estimates to infer evidence of cause in particular cases. Thus, an examination of how this is done in a legal context might provide insight into when and how it is appropriate to use risk information as evidence of cause in a medical context. A careful study of the case of Goodman v. Viljoen, a medical malpractice suit litigated in the Ontario Superior Court of Justice in 2011, reveals different approaches to how risk information is used as or might be considered a substitute for evidence of causation, and the pitfalls associated with these approaches. Achieving statistical thresholds, specifically minimizing the probability of falsely rejecting the null hypothesis, and exceeding a relative risk of 2, plays a significant role in establishing causality of the particular in the legal setting. However, providing a reasonable explanation or establishing “biological plausibility” of the causal association also seems important, and (to some) may even take precedent over statistical thresholds for a given context.