Publications
Litigation Packet
Litigation Packet
Pharmaceutical Products Liability Cases and the FDA
$249.00
Delivery method: Download
- 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
