If you are involved with the healthcare system, you know that drug-induced injury cases are as complex as they are common. While the injury to the patient might seem obvious, in reality that has very little effect on the course that the litigation will take. This makes it especially important to accurately evaluate the case. You’ll want to be sure that the case you take on has merit and will prove economically sound for both you and your client. To successfully accomplish this, you need the knowledge of pharmacy and the drug manufacturing industry, which is carefully detailed in this book.
Easy for the non-medical professional to follow, the book is divided in 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. Whether or not your case involves one of the drugs 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.
Topics include:
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 Nephrotoxic drugs Evaluation of causation in drug injury cases The role of pharmacoepidemiology and expert testimony in drug injury E-Ferol disaster The Fen-Phen-Redux Debacle Drugs for asthma, allergies, and anaphylaxis: harm from use, misuse, and non-use. The Dietary Supplement and Health Education Act of 1994 Anti-depressants: clinical use and litigation Performance enhancing substances Pain medications and OxyContin Ephedra Compounding pharmacy regulations and litigation The NABP Model Act and Rules Initiative
