Keeping Adverse Event Reports Out Of The Courtroom
Law360, New York (June 25, 2007, 12:00 AM EDT) -- A federal district court in Florida recently rejected personal injury plaintiffs’ attempt to have Adverse Event Reports (AERs), which were collected and maintained by a defendant drug manufacturer, admitted as evidence of notice and medical causation. In re Accutane Prods. Liab., 2007 WL 1288354 (M.D. Fla. May 2, 2007).
This decision is important for drug manufacturers who elect, or are required, to gather and maintain AERs regarding the drugs they market to the public.
Plaintiffs in Accutane were former users of an FDA-approved drug for the...