Compensation for drug injury: A novel solution for diethylstilbestrol?

摘要

Over a period of some eighty years, the community has repeatedly been confronted by the social problems arising from large-scale injury caused by new medicines [11]. The severe organic damage induced by the organical arsenical Neoarsphenamine (Neosalvarsan), used for the treatment of venereal disease, was the subject of a Royal Commission report in Britain following the first World War [19]. A little over a decade later, an epidemic of deaths due to the use of Elixir of Sulfanilamide (employing an untested solvent) led to drastic reform of the Food and Drug legislation in force in the United States [16]. Subsequent years saw the tragic consequences of the use of the hypnotic thalidomide in pregnancy [22], the appearance of ocular and internal fibrosis due to practolol [7] and the occurrence of hepatic injury in the elderly following treatment with benoxaprofen (OprenR). Of the many drug disasters on record during the twentieth century, these are some of the most prominent, either because of the gravityof the injury caused or the scale of its occurrence. At the present time, the discussion is largely dominated by the very widespread incidence of cardiovascular complications attributed to the non-steroidal anti-inflammatory drug rofecoxib, marketed as VioxxR, currently thought to involve as many as 200,000 individuals worldwide [17]. From all these occurrences and others one may distil some conclusions as to the manner in which society should handle these issues, either in terms of prevention of such events or measures to accommodate such injury when it occurs. A prominent facet of the discussion naturally relates to the adequate compensation of the victim, insofar as financial remedies can ever make good a physical injury, let alone a fatal complication. Some countries have introduced no-fault compensation schemes, which have been most extensively developed in the Nordic region [21]. Others, such as the United States, have relied primarily on individual or mass civil litigation against those responsible, particularly those manufacturers who have been considered to have been at fault [11]. One very recent and novel approach recently developed is that chosen in The Netherlands regarding one of the longest-running dramas of all: that surrounding diethylstilbestrol (DES).