Medical lawsuits judged by using drug package inserts as criteria for the judicial decisions

DOI 27 References
  • KAKU YOHKO
    Department of Anesthesiology, Nihon University School of Dentistry at Matsudo
  • ENAMI KOJI
    Department of Anesthesiology, Nihon University School of Dentistry at Matsudo
  • FUKUMOTO MASAFUMI
    Department of Anesthesiology, Nihon University School of Dentistry at Matsudo
  • YAMAGUCHI MASAMI
    Department of Anesthesiology, Nihon University School of Dentistry at Matsudo
  • SHIBUTANI KOH
    Department of Anesthesiology, Nihon University School of Dentistry at Matsudo

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  • 医療用医薬品添付文書情報が判断材料とされた医療訴訟について

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Abstract

We conducted a study of judicial decisions on medical accidents covered between 1994 and 2000 by the Japanese press and Hanrei Times, a Japanese magazine specializing in judicial precedents, to obtain information on drug package inserts, and the extent to which these inserts are used as criteria for the judicial decisions.<BR>During the period studied, judicial decisions were issued regarding 514 cases of medical accidents, and a total of 1, 238 articles covering the decisions were published in the media referred to above. Looking at the changes in the number of cases by year, there were between 51 and 81 cases yearly from 1994 through 1999, while this number significantly increased in 2000, to 121.<BR>Out of the 514 cases, 34 (6.6%) were associated with drugs; drug package inserts were used as criteria for the decisions in four of the 34 cases, and 19 articles covering these four cases were carried in the media. Meanwhile, in 374 of the 514 cases (72.8%), it was judged that medical care personnel were to blame for the accidents, and these cases were covered in 1, 010 of the 1, 238 articles (81.6%) in the media.<BR>Common cases of malpractice pointed out to doctors and other medical personnel included violation of due care in terms of drug package inserts. Furthermore, a link between medical practice and the level of medical care was also indicated, as well as a link between package inserts and the level of medical care. The level of medical care varies due both to differences in medical services and the individual circumstances surrounding medical care providers, and negligence in collecting the latest information for medical findings is also included among the various types of malpractice.<BR>Other cases of malpractice included violations of accountability, in which medical care personnel neglected to inform patients of items mentioned in drug package inserts.<BR>Doctors, dentists, and other medical personnel must fully understand the descriptious given in drug package inserts.

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