© 2007 Dechert LLP Pharmacovigilance Reporting and Analysis: Product Liability Concerns Diane P. Sullivan

Missed A Signal? Plaintiffs allege AEs: put the company on notice of potential health risk of the product create a duty to change the product labeling to warn of the alleged risk support claims that the company failed to conduct proper review and analysis of pre- or post-marketing safety signals show failure to hire or train competent personnel to review pharmacovigilance data

Fraud on the FDA AEs are subject to FDA internal analysis, and can lead to the suggestion of a safety signal, especially compared to other products in a therapeudic class Plaintiffs may claim that failure to make timely AE reports constitutes a punishable fraud on the FDA

Dr. David Graham, Office of Drug Safety

Plaintiff’s Try to Use AE to Prove Causation Plaintiffs present a “parade of horribles” to prejudice the jury Post-hoc analyses lend themselves to “Monday morning quarterbacking” AEs describe, by definition, events that occur after drug ingestion, and can be abused to suggest causation

Food and Drug Administration Potential for more mischief: post hoc “meta-analysis” from posted clinical trial data “re-adjudication” of events from posted data allows criticism made with 20/20 hindsight FDA quarterly AE report analysis FDA reports provide plaintiffs with more ammunition for claims of “missed signals” - that the company was on notice and failed to warn consumers

Prevention Preventing your courtroom AE problems: 1.Extensive disclosure and discussion with FDA as data comes in 2.Use of outside experts to assist in early signal assessment 3.Public disclosures of information 4.Prompt and aggressive labeling changes in response to signals