Easy for the nonmedical professional to follow, the book is divided into three useful sections. The first section deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. The second section examines high-risk drug therapies that result in pharmaceutical litigation. You'll read about important litigation regarding drugs like Prozac, Accutane and Rezulin, as well as anabolic steroids, insulin and oral diabetic drugs, and more. Whether or not your case involves the drug cited you'll find that the theories applicable to one pharmaceutical case are often applicable to another. The third section of the book looks at the professional pharmacist and malpractice claims. It also includes appendices of FDA regulations relating to drug product liability, guidance for industry, use of risk minimization plans, and FDA pregnancy classifications.

You'll find this text indispensable because it provides comprehensive information for all those affiliated with the pharmaceutical industry.

New chapters:

• The failed system of drug warnings in America
• Clinical research: Testing treatments in humans
• FDA regulation of clinical investigations
• Identification of regulated solid dosage forms
• Evaluation of Causation in drug injury cases
• The role of pharmacoepidemiology and expert testimony in drug injury
• E-ferol disaster
• Drugs for asthma, allerfies and anaphylaxis: Harm from use, misuse and non-use
• Nephrotoxic drugs
• Statins and Baycol-Questionable cholesterol
• The Rezulin litigation
• Drug-induced movement disorders
• Ephedra
• The emergency department pharmacist
• Drug testing in the workplace