Earticle

초록

영어

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

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

키워드

의약품 혈액제제 제약회사 제조물책임 인과관계 결함 과실 증명책임(입증책임) 간접사실 추정 손해배상 감염 혈우병 HIV AIDS(에이즈) Drug Pharmaceutical product Blood product Pharmaceutical company Product liability (PL) Causal relationship Defect Negligence Burden of proof Presumption Damages Infection HIV AIDS.

저자

• 문현호 [ Hyeon-ho, Moon | 대법원 재판연구관 ]

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