Articles | Jul 22, 2021

Kraus, Regulatory Risk Assessment vs. Tort Law Causation

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Written By: Eric M. Kraus

Regulatory Risk Assessment vs. Tort Law Causation: A Distinction with a Difference


Those of us in the business of defending clients in toxic tort and pharmaceutical product liability cases often take it for granted that pronouncements by regulatory agencies regarding risk are distinct and quite different in key ways from what is required in civil litigation for proof of causation. But how are they different, why are they different and where is the evidence that they are intended to be different? The answers are fundamental to defending cases in which a regulatory opinion regarding risk associated with a chemical or pharmaceutical product may be introduced to a jury, particularly if plaintiffs’ attorneys try to use risk assessments and maximum exposure limits set by regulatory agencies as “proof” of causation. To a juror, and even to a judge, the simplicity of this approach can be appealing. People (generally) put faith in the opinions of agencies that are tasked with protecting their well-being. The problem is that the opinions of agencies about potential hazards from exposure to chemicals or pharmaceutical products are not opinions about causation as required in the courtroom. To appreciate the differences, we start with some fundamental concepts about how causation is established in a product liability or toxic tort action.

The article, “Regulatory Risk Assessment vs. Tort Law Causation: A Distinction with a Difference,” was featured in the BioPharma Dive Newsletter, Daily Dive, and can be read in its entirety in the above pdf.

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