從柔沛案論處方藥之消保法商品製造人責任

Products Liability of Prescription Drug Manufacturers under Taiwan Consumer Protection Act: From the Perspective of the FINASTERIDE Case

吳淑莉(Shu-Li Wu)

《中正大學法學集刊》 32期 (2011/01) Pp. 1-48

https://doi.org/10.30094/NCCULJ.201101.0001

摘要

處方藥品於性質上，屬不可避免危險的商品，其化學成分之調配設計無法達到絕對安全，所以就製造藥品之企業經營者而言，其所應負之無過失商品責任，關於藥品是否符合當時科技或專業水準可合理期待之安全性之認定，應與一般商品有所區分。而藥品製造商有何抗辯無過失商品責任之事由，以及是否課以藥品製造商消保法所規定之懲罰性賠償金，亦有闡明之必要。本文以柔沛案之相關判決所涉及之重要議題，藉美國關於藥品產品責任之判例法、學說及侵權行爲整編第2版、第3版與其補充評論之規定，以探討相關理論，並評析法院於柔沛案之相關判決，試歸納出我國對此些議題應有之解釋，以期爲處方藥品之消保法商品製造人責任，注入新思維。

關鍵字

商品製造人責任 ； 設計上瑕疵 ； 指示或警告上瑕疵 ； 加工過失 ； 懲罰性賠償金

並列摘要

Prescription drugs are unavoidably unsafe products since they are incapable of being made safe for their intended and ordinary use in terms of the design of chemical compounds. In light of that scientific fact, the product liability law under Taiwan Consumer Protection Act should treat prescription drug products liability differently from liability stemming from other products. This Article discusses three main issues raised in the FINASTERIDE case, including the requirements and standards of prescription drug product liability, the extent to which concepts of misuse, contributory negligence and assumption of risk should be considered to be legal defenses to the liability, and whether we should subject pharmaceutical manufacturers to punitive damages if they have obtained drug approval in good faith.
This Article conducts a doctrinal analysis of prescription drug products liability based on case law, and academic comments in the U.S., and explores the special products liability rules for prescription drugs stated in section 402A of the 1965 Second Restatement of Torts, Restatement (Third) of Torts: Products Liability (1998), and related comments to the basic text. As this Article describes prescription drug products liability in the U.S., and criticizes the courts’ opinions in the FINASTERIDE Case, it proposes a new approach to the appropriate liability regime for prescription drugs in this country.

並列關鍵字

Manufacturers' products liability ； Design defect ； Inadequate instructions or warnings ； Contributory negligence ； Punitive damages

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