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
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.
