Transcript Pharmacovigilance Reporting and Analysis: Product Liability

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