Study of Legal Cases Involving Refractive Surgery in Japan and the United States by Using Court Case Databases

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  • 判例データベースを利用した日米の屈折矯正手術裁判例に関する考察

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1995年頃より,日本において屈折矯正手術(視力矯正手術)が普及しはじめ広く宣伝広告されている.アメリカでは,既に1985年頃より普及している.本考察においては,日米の屈折矯正手術裁判例を収集解析し,その特徴を明らかにすると共に双方を比較検討した.アメリカ裁判例の検索に『レクシス』を,日本裁判例の検索に『判例マスター』を使用した.抽出した両国の裁判例の中で,術後に後遺症の残ったものについて,判決年度,判決期間,被害者の転帰,違法点・論争の争点など,9項目について検討した.日本では,今回抽出された裁判例のすべてで原告が勝訴し,高額の損害賠償が認められている.一方,アメリカではそのほとんどが原告の敗訴であった.この背景には両国の法律・司法制度とそれをとりまく環境,医療指針,医師側の対応の違い,医療過誤に対する対処の違いがあると考えられる.両国の裁判例における最大の争点はインフォームドコンセントが十分であったか否かである.患者は,屈折矯正手術によって現状よりもよく見えるようになることを期待し,信じて手術を受ける.それだけに結果が悪かった場合の患者の後悔の念は非常に強い.術者は患者が手術を受けるか否かを患者自身が判断できるように努めなければならない.そのためには,手術のプラス面,マイナス面の両方についてインフォームドコンセントを尽くすことが要求される.また,両国ともに眼科医以外のものの手術への関与,利潤追求を優先し手術適応外の患者の獲得などの問題点がある.屈折矯正手術が患者にとって正しい方向に進むためには強力なリーダーシップのもとで手術適応基準,および術者選定基準を定め,それを順守させる必要がある.さらには医療過誤防止のための徹底した情報公開,再発防止システムの構築,万が一のための医療被害者救済基金の設置などの対策が進められなければならない.

In Japan, refractive surgery began to spread and was advertised widely from around 1995. In the United States, it became popular from around 1985. In this study, the court cases involving refractive surgery were compiled in Japan and the United States to analyze and compare the characteristics of the cases from each country. "Lexis" was used to refer to those in the United States and "Hanrei Master" to the Japanese cases. From those related to the sequelae of surgery, nine points were investigated-the year of decision, period of deliberation, victim' s condition caused by the surgery, the point of illegality, the issue of the suit, among others. All plaintiffs examined in this study won their cases and large sums of money were awarded by the Japanese courts. By contrast, the majority of the plaintiffs lost their suits in the United States. This comparison revealed the differences that exist between the two countries in their laws, judicial systems, guidelines, related to the practice of refractive surgery, and the attitudes of ophthalmologists and reactions to medical mistakes. The biggest dispute issue in the court cases of both countries is the question as to whether informed consent was enough or not. It was found that prior to surgery, the Japanese patients had anticipated marked improvement in their visual acuity and therefore felt betrayed when the results did not measure up to their expectations. Ophthalmologists should try to make patients decide as to whether they undergo surgery. It is essential that patients be informed of both good effects and bad effects of the surgery. In both countries, non-ophthalmologists operate refractive surgery, take precedence of profits and compete in gaining patients who cannot afford to undergo refractive surgery economically. It is necessary to establish requirements of this surgery and of physicians selection and impose these requirements on them under strong leadership so that this surgery can advance toward to a right direction for patients. Further, information should be made public thoroughly to avoid medical mistakes and recurrence prevention system and funds for relieving medical victims in case should also be established.

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