Adverse drug events, compensation, and the courts

摘要

Anyone who has spent much time working with adverse drag reactions knows how many facets they present. A series of sub-specialisms have grown up around their study, tackling issues as diverse as the detection of adverse events through spontaneous reporting ("pharmacovigilance"), their quantification, the means available to predict them, the mechanisms which they involve, and the dilemmas which they may present to the prescriber. Some of the most acute problems naturally arise with respect to the individual who finds himself or herself right at the end of the chain of causation: the patient who has suffered an adverse reaction, perhaps so serious as to comprise permanent injury. That is a situation - all too familiar - in which all efforts to avoid doing harm have failed; the patient is a victim of that failure. What should happen next?Different western societies have found their various ways of supporting the victim of drug injury, some more effective than others. In communities with a well developed social conscience that may involve practical and financial support - a wheelchair, a disability pension, perhaps even permanent care in an institution. Yet even in such societies - and much more so in those where the individual is left largely to fend for himself or herself - one final instrument to relieve the lot of the injured patient may be to have recourse to a court of law. Seeking some form of financial compensation, the patient may try to bring a legal action against a physician who has prescribed misguidedly, a pharmacist who has dispensed incorrectly, a manufacturer who has failed in some way in his duties or a government agency which has taken - or failed to take - some crucial decision. The former two situations essentially involve "adverse events" resulting from dealing inappropriately with what may well be a reasonably safe drag; the latter two commonly relate to drags any use of which involves appreciable and even disproportionate risks. In either case, one can often pinpoint some fault and allocate a degree of blame. The primary reason for bringing such actions in either situation is obviously to obtain some material compensation which the patient cannot gain in any other way, though it has often enough been stressed that the injured patient may also be looking for some sort of moral correction - an acknowledgement that there has indeed been fault and a recognition that something will be done to ensure that it does not happen again.