医疗产品侵权案件中医疗产品缺陷鉴定问题探讨

Discussion on defect identification of medical products in medical product infringement cases

了解医疗产品缺陷鉴定在司法实践中发挥的作用,为完善医疗产品缺陷鉴定程序提供参考。收集了200个医疗产品侵权案件,对产品缺陷鉴定案件一般情况、鉴定申请情况、鉴定结论采信度进行分析。结论显示,200个案件中有173个案件焦点是医疗产品缺陷,但仅有66个案件申请了医疗产品缺陷鉴定;未成功启动鉴定的案件有35个,未成功受理的案件17个;申请了医疗产品缺陷鉴定,并被法官采信的案件有43个。结合相关文献,对申请医疗产品缺陷鉴定的案件数量较少、医疗产品缺陷鉴定启动和受理难度大、医疗产品缺陷鉴定结论采信度不高、鉴定没有在司法实践中发挥很好的作用等进行了总结和讨论,并提出规范鉴定制度以降低鉴定启动难度;合理增加鉴定机构数量;以不合格标准代替不合理的危险标准等建议。

In order to understand the function of defect identification of medical products in medical product infringement cases so as to provide reference for improving identification procedures of medical products’defect.It collected 200 medical product infringement cases,and analyzed common situation,identification application and reliability of identification results.The results showed that there were 173 cases of medical products defect in 200 cases,but only 66 cases applied for defect identification of medical products.There were 35 cases did not started identification,and 17 unaccepted cases;there were 43 cases applied for medical products defect and were admissible by judge.The number of applying for medical products defect case which combines with relevant literature is less.It is difficult for the starting and acceptance of defect identification of medical products,its reliability is not high.It sums up and discusses that identification does not give good play to juridical practice.It puts forward that standardized system may decrease the difficulty of identification starting.Reasonable increase the number of identification institute.Take disqualification standard to instead of unreasonable risk standard.