[Significance of product documents (tenpubunsho) cited in judicial precedents in the field of anesthesiology].

The significance of the product documents (Tempubunsho) was mentioned in 21 out of 94 medical malpractice cases published in several laws reports 1963-97. The number of such cases has been increasing in recent years. Among the items described in the product documents, the precautions for use were most frequently mentioned (12 cases) followed by the instructions for administration and dosage (3 cases). In most cases, the judgment was against the medical institution involved due to the violation of legal obligations with respect to the contents of the product documents. Product documents will be taken much more seriously in future lawsuits. Attention should be focused on the contents of the product documents, especially when revised. When the administration of a drug deviates from the contents of the product document, medical evidence is required to support this deviation.