title: Clinical trials litigation: practical realities as seen from the trenches.
abstract: Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position.
authors: College of Medicine, University of Tennessee Health Science Center, 956 Court, Suite B328, Memphis, TN 38163, USA. hmorreim@utmem.edu
authors: E Haavi
authors: EH
authors: Morreim
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000191:economics / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress / Q000331:legislation & jurisprudence*; D016265:Conflict of Interest; D032982:Contracts / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence; D006354:Heart, Artificial / Q000009:adverse effects*; D006761:Hospitals; D006801:Humans; D020007:Implants, Experimental / Q000009:adverse effects* / Q000191:economics; D007221:Industry / Q000331:legislation & jurisprudence; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007351:Insurance, Liability / Q000191:economics / Q000331:legislation & jurisprudence*; D007603:Jurisprudence; D033241:Lawyers; D016365:Liability, Legal; D008318:Malpractice / Q000331:legislation & jurisprudence; D008402:Mass Media; D010344:Patient Advocacy; D019919:Prosthesis Implantation; D012108:Research Personnel / Q000331:legislation & jurisprudence; D035842:Research Subjects; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence*