Pharmaceutical Products Liability Cases and the FDA | The American Association For Justice

Pharmaceutical Products Liability Cases and the FDA

February 6, 2014

Litigation Packet: Document Details

Packet Name: Pharmaceutical Products Liability Cases and the FDA

Updated Date: 2/16/2016 | Created Date: 6/1/2005 | Number of Pages: 3157
Summary of Packet:
  • Provides plaintiff attorneys with the tools to pursue pharmaceutical products liability cases and addresses important issues relating to the FDA and drug companies
  • FDA prescription drug approval and post-market surveillance procedures, and their inherent flaws
  • Information on the symbiotic relationship between the FDA and the drug industry
  • Pharmaceutical marketing tactics, including the use of drug reps and ghostwritten medical literature, and the effect on the learned intermediary doctrine
  • Promotion of off-label use by drug companies, and the adverse effects  
  • Pharmacology and epidemiology, and their role in proving causation
  • Preemption issues and cases, including Mutual Pharmaceutical Company Inc. v. Bartlett, Wyeth v. Levine, Pliva, Inc. v. Mensing, and Riegel v. Medtronic
  • Sample complaints, client intake and evaluation forms, written discovery, and briefs
  • Obtaining electronically-maintained information in discovery and an explanation of the adverse event reporting system
  • Selecting and “Daubert-proofing” experts
  • Important statutory and regulatory materials
To review the table of contents or purchase, please log in.
Access to the AAJ Exchange and Litigation Packets is restricted to plaintiff attorneys who are AAJ Regular, Sustaining, Life, Presidents Club, or Leaders Forum members.