Judge Excludes Evidence Related to Post-Marketing Accutane Events

TAMPA, Fla. - Opinions regarding an adverse event reporting system used by Hoffmann-La Roche to assess the safety of Accutane cannot be introduced as evidence supporting plaintiffs' claims that the drug causes inflammatory bowel disease, a judge ruled. In Re: Accutane Products Liability Litigation, 04-MD-2523 (M.D. Fla.).

In a May 2 order, Judge James S. Moody Jr. of the U.S. District Court for the Middle District of Florida said that information or testimony related to the company's "causality assessments" for Accutane does not rise to the level of permissible evidence and shouldn't be considered by jurors.

Causality assessments are part …