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: 12/8/2005 | 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
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