《侵權行為法重述（第三次）：產品責任》中有設計缺陷嗎？

美國法律協會產品責任法第三次重述採用了 “更安全的可選擇設計” 標準來判斷產品的責任缺陷。即如果產品本來可以被設計得更加安全，而製造商卻沒有做到，產品就會被認定具有設計缺陷，製造商就要為此而承擔責任。但是，重述對藥品、疫苗和醫療設備卻採取另一套判斷標準，即只要它們對至少一類用戶有益無害，製造者就可以被免除責任。重述還將血液製品完全排除出了產品責任法的管轄範圍。二十餘年來， 由於沒有對血液製品實行嚴格的產品責任，致使血液製品製造商沒有及時發展出血液滅菌技術，導致大量血友病患者染上肝炎和艾滋病。這一悲劇性的事件說明，應當對藥品、疫苗和醫療設備和其他產品一樣適用同樣的產品缺陷檢驗標準。因此，對重述應當加以修改：對可以進行更安全設計的產品實施“可選擇的更安全的設計”標準，對無法合理地應用這一標準的其他產品應實行一般的成本收益分析標準。這種對傳統的過失法的回歸可以構成一種更為一致的判斷設計缺陷的方法。

In the Restatement (Third) of Torts: Products Liability, the American Law Institute (ALI) announced a general rule to resolve the problem of the meaning of the word “defect,” a problem that has haunted the law of torts since section 402A of the ALI’s 1965 Restatement (Second) ushered in the era of strict liability for defective products....Part I also details the crippling effect of the blood shield Statutes on product--defect litigation brought by hemophiliac plaintiffs infected with HIV and hepatitis from blood products....Whether a drug is unavoidably unsafe should be decided on a case-by-case basis; we perceive no justification for giving all prescription drug manufacturers a blanket immunity from strict liability manufacturing and design defect Claims under commentk.....The court emphasized that“whether a drug, vaccine, or any other product....triggers unavoidably dangerous product exemption from strict liability design-- defect analysis poses a mixed question of law and fact and can be made only after evidence is first taken, out of the jury ’s presence, on the relevant factors to be considered. ”....The Feldman-Kearl-Toner approach has resolved single-drug, combinationdrug, vaccine, and medical-device cases in two ways.....The basic message here is that, in general, ethical drugs and harms that arise out of their use should not subject their manufacturer, distributor or retailer to strict liability.....FDA review thus asks less of drug and medical device manufacturers than the common law of products liability asks of other kinds of manufacturers:....