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Avoiding the Adverse Effects of Causality Assessments

By Andrea E.K. Thomas and Joseph K. Scully
February 28, 2008

In the present climate of constant news reports of product recalls and runaway verdicts, pharmaceutical manufacturers are concerned about certain information that can infiltrate and unfairly influence product liability trials. Manufacturers should not have to worry that a court might permit a plaintiff to utilize the manufacturer's post-marketing surveillance data ' which is collected pursuant to governmental regulations and for the purpose of keeping manufacturers apprised of the possibility of an adverse effect associated with their product ' to prove actual causation. In addition, consumers should not have to worry about such legal disincentives impacting industry pharmacovigilance efforts. Post-marketing surveillance is absolutely critical to balancing the competing public policy concerns that favor speeding up the initial approval of useful drugs and assuring that only safe drugs reach the public.

Unfortunately, adverse drug reaction reports collected and causality assessments made in the course of post-marketing surveillance have increasingly become fodder for plaintiffs' attorneys attempting to prove causation. Courts, however, properly have precluded plaintiffs from presenting post-marketing surveillance materials, most recently refusing to allow plaintiffs to introduce company causality assessments based on adverse drug reaction reports as evidence of causation and from using these reports and assessments as bases for expert opinions on causation.

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