혈액제제 제조물책임 소송과 증명책임 - 대법원 2011. 9. 29. 선고 2008다16776 판결과 관련하여

다국어 초록 (Multilingual Abstract)

This article analyzes the case (2008Da16776) which has the issue how patients have to prove causal relationship when patients claim against pharmaceutical companies alleging that patients were infected with virus due to contaminated blood products. The Supreme court held that: (1) if patients prove that they didn't have symptoms suggesting virus infection before administration of blood products, the virus infection had been confirmed after administration of blood products, and there were significant potential of contamination of the blood products with the virus, the defect in blood products or the negligence of pharmaceutical company in making blood products shall be presumed to cause the infection of the victim. (2) The pharmaceutical companies could reverse the presumption by proving the blood products were not contaminated, but the fact that the victims were treated with the blood products manufactured by other companies or had received blood transfusions is not enough to reverse the presumption. The case is the first decision whether the burden of proof about causal relationship could be reduced in pharmaceutical product liability lawsuit. Hereafter pharmaceutical product liability cases, it would be necessary to reduce the burden of proof about causal relationship in order to make substantive equality between patients and pharmaceutical companies.

목차 (Table of Contents)

• I. 개요
• II. 사건의 개요
• 1. 기초사실
• 2. 당사자들 주장
• 3. 소송의 경과
• 4. 대법원의 판단 : 파기환송
• 5. 수혈을 통하여 HIV에 감염된 우리나라의 사례
• III. 의약품(혈액제제) 제조 관련 손해배상청구에서의 증명책임
• 1. 개설
• 2. 증명책임 완화의 필요성
• 3. 우리나라에서 증명책임이 완화되고 있는 사례들
• 4. 혈액제제를 통한 HIV 등 감염에 관한 외국의 사례
• 5. 추정요건에 대한 검토
• 6. 다른 혈액제제 또는 수혈을 받았을 경우 추정이 번복되는지 여부
• 7. 대법원의 판시내용
• IV. 맺음말
• 참고문헌
• ABSTRACT

참고문헌 (Reference)

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3 김태천, "의약품제조자책임에 있어서 과실과 인과관계의 입증" 대구지방변호사회 1986

4 문성제, "의약품제조자의 책임(Ⅰ)- Hoffman v. Sterling Drug Inc 사건을 중심으로" 대한의료법학회 4 (4): 2003

5 김오수, "의약품제조자의 민사책임" 법원도서관 27 : 1985

6 윤석찬, "의약품의 잠재적 위험에 근거한 위험책임" 한국법학회 (22) : 165-189, 2006

7 연기영, "의약품사고와 제조물책임" 한국사법행정학회 3 (3): 2002

8 전병남, "의약품사고와 민사책임" 사법연수원 2010

9 안법영, "독일 의약품법과 제조물책임법" 한국사법행정학회 3 (3): 2002

10 藤原正則, "輸血ㆍ血液製劑によるHIV感染: ドイツの判例を手掛りに”, 民法と著作權法の諸問題" 1993

11 鹽野隆史, "藥害HIV訴訟と藥害HCV訴訟について, I n醫事法の方法と課題: 植木哲先生還曆記念" 信山社 2005

12 浦川道太郞, "ドイツにおける血液製劑によるHIV感染と法的諸問題:原因究明, 被害者救濟および安全對策について" (1097) : 1996

13 Zöller, "Zivilprozessordnung Kommentar, In Vor 284" 2005

14 Joseph Kelly, "The liability of blood banks and manufacturers of clotting products to recipients of hiv-infected blood: a comparison of the law and reaction in the united states, canada, great britain, ireland, and australia" 27 : 1994

15 Rehmann, Arzneimittelgesetz (AMG), "Kommentar" 2008

16 家令和典, "HIV(ヒト免疫不全ウイルス)に汚染された非加熱血液製劑を投與された患者がエイズ(後天性免疫不全症候群)を發症して藥害事件について, 厚生省藥務局生物製劑課長であった者に業務上過失致死罪の成立が認められた事例" (1361) :