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The Swine Flu Vaccine and Guillain-Barré Syndrome: A Case Study in Relative Risk and Specific Causation

University of California, Berkeley

Philip B. Stark

University of California, Berkeley

Epidemiologic methods were developed to prove general causation: identifying exposures that increase the risk of particular diseases. Courts often are more interested in specific causation: On balance of probabilities, was the plaintiff's disease caused by exposure to the agent in question? Some authorities have suggested that a relative risk greater than 2.0 meets the standard of proof for specific causation. Such a definite criterion is appealing, but there are difficulties. Bias and confounding are familiar problems; individual differences must be considered too. The issues are explored in the context of the swine flu vaccine and Guillain-Barré syndrome. The conclusion: There is a considerable gap between relative risks and proof of specific causation.

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