Over on the Drug & Device Law blog, the team maintains several scorecards and cheat sheets on product liability litigation topics relevant to pharmaceutical and medical device manufacturers. Reed Smith associate Kevin Hara has updated the blog's adverse event report cheat sheet to include the most recent decisions from across the country addressing whether adverse event reports can be used as admissible evidence on the grounds of causation. In discussing this issue, Kevin advocates the legal principle that if a plaintiff cannot prove a particular product's capability of adverse event causation, the court should rule in favor of the defendent.… Continue Reading
The Washington Legal Foundation has published "Causation in Court: Working Principles for Toxic Tort Cases" by Reed Smith partner Antony Klapper. This interesting paper describes six working principles that get at aspects of causation that sometimes confuse judges and juries when litigation involves allegations that a substance is toxic and has caused disease.
The principles the article explains in more depth are:
1. Causation in science is not synonymous with causation in law, but the gap has closed.
2. Proof of general causation requires, at a minimum, reliable epidemiology and a statistically significant estimated relative risk of more than 2.0.
3. Proving causation does not end with the general causation inquiry. Proof of specific causation is absolutely essential before any causal conclusions can be drawn.
4. Risk assessment is the best tool available to answer questions of causation.
5. Although risk assessment is the best tool available, regulatory rules for implementing risk assessments should not be used, and too often are abused.
6. Where there are multiple exposure sources for the same toxin, a more principled, objectively reliable methodology should be used to answer questions of causation. Concepts such as "substantial contributing" cause should be jettisoned.… Continue Reading