Category — Pharmacovigilance

Aug. 30, 2011 -  Virginia Products Liability blog contributors Melissa Tannery and Nick Klaiber published an article entitled, “Defending (and Defending With) Pharmacovigilance After Wyeth v. Levine” in The Defense Research Institute (“DRI”)’s August 2011 issue of For the Defense magazine.  In the article, Melissa and Nick offer advice on how to combat attacks on pharmaceutical company clients’ pharmacovigilance programs, including arguments to exclude evidence of lapses in postmarketing surveillance, exclude plaintiffs’ expert on pharmacovigilance and exclude adverse drug event reports (“AERs”) as unreliable evidence of causation.  They also suggest ways to use the strong points of a company’s pharmacovigilance program to show that the company quickly discovers and acts on safety information and makes safety a top priority.  Lawyers defending claims of negligent pharmacovigilance should present evidence and offer testimony from a knowledgeable and well spoken company witness who will explain how the company carefully and efficiently handles, investigates and responds to the AERs it receives.  The article is a useful resource for lawyers defending pharmaceutical products liability claims in Virginia and elsewhere.