真正的檢驗標準：專利壟斷市場中對藥品和醫療設備採用的“可選擇的更安全設計”

美國法律協會(ALI)報告人James Henderson教授和Aaron Twerski教授反對產品責任法重述第6條C款中針對處方藥和醫療設備的產品設計缺陷採用普通的檢驗標準（重述第2條B款規定的“合理的可選擇的設計檢驗標準”）。美國法律協會闡述了對這些醫療設備應採用保護製造商的標準的原則，並宣稱製造商僅在“罕見”的情泥下才承擔產品責任。根據重述第6條C款的規定，某一產品僅在不能為任何可預見的患者帶來淨收益時，該產品才有缺陷。Conk教授在之前的一篇文章中對該原則提出了异議。Nebraska州最高法院針對這一問題否決了重述中的這項原則。本文討論了有關設計缺陷證據特點，Nebraska州法院指出將在以後對該問題進行解釋。在一篇回應文章中，兩位報告人現已接受對藥品採用“可選擇的更安全的設計”標準，但該檢驗標準僅限於將涉案產品同同一時間內書面上有的經由美國食品和藥品管理局（FDA) 批准的產品進行比較。兩報告人提出的寬松的、帶有挽救性質的解釋是受人歡迎的。但Conk教授發現報告人的新提議盡管向前邁出了一小步，但是沒有給出令人信服的解釋。報告人堅持認為法院沒有審理和裁判藥品的產品設計缺陷訴訟的資格，因為法院必須尊重FDA複雜的審批程序才能對原告提出的可選擇的更安全的設計作出裁決。因此，藥品的產品設計缺陷的證明責任比所有其他類型的產品的責任更加嚴格，其他類型的產品既不需要提供原產品，也不需要市場上出現可選擇的替代產品。這種新的更寬松的建議仍然不夠充分。人們對專利壟斷市場中存在的可選擇的更安全的設計這一問題進行了討論。Conk教授認為，在專利壟斷市場中，原告承擔的提供可選擇的設計的責任應當比在開放的競爭市場中所承擔的責任要輕。在比較開放的市場中，市場上沒有更安全的產品會令原告就其所提出的可選擇的設計的可行性和實用性承擔更重的證明責任。本文討論了根據重述第2條B款規定的“可選擇的更安全的設計”的標準應承擔的產品責任，而根據第6條C款規定的“保護製造商”的標準應免除責任的三個藥品案例分析，即治療痤瘡的异構維生素A酸（Accutane)、未經巴氏殺菌消毒的抗血友病凝血因子(AHF)和薩賓(Sabin)口服弱活性小兒麻痹症疫苗(OPV)。最後，本文指出諸如IUD’s和止血墊這類醫療設備比藥品更應當適用更安全的可選擇的設計標準，同時還討論了重述第6條C款的“最終的致命的缺陷”，即藥品和醫療設備適用的相同的保護製造商的產品責任標準。

In section 6(c) of the Products Liability Restatement, Professors James Henderson and Aaron Twerski, the American Law Institute (ALI) reporters, rejected the ordinary test of product design defect (the section 2(b) reasonable alternative design test) for prescription drugs and medical devices. For such medical products the ALI rule enunciates a manufacturer-protective Standard, declaring that under it liability would only“rarely” be imposed. A product is defective under section 6(c) only if it provides no net benefit for any foreseeable class of patients. The rule was challenged in an earlier article by Professor Conk. The first state supreme court to confront the issue, Nebraska’s, rejected the Restatement rule. This Article discusses the issue of the character of the proofs of design defect, which the Nebraska court indicated it will address in the future. In a rebuttal, the reporters now embrace an alternative safer design test for drugs. But they would limit the test to comparison with FDA-approved products actually available o n the market at the time of sale of the challenged product. The reporters’ broad. saving construction is welcomed. But Conk finds the reporters’new reading to be an unconvincing exegesis, if nonetheless a small Step forward. The reporters assert that courts are incompetent to judge drug product design defect claims because they would have to replicate the complex FDA approval process in order to pass upon a plaintiff’s alternative safer design. This is a much greater burden than that for all other classes of products--or which no prototype need be produced, nor an alternative be shown to be on the market. The new broader construction is still inadequate. The problem of showing the existence of an alternative safer design in a patent-monopolized market is discussed. Conk argues that in patent-monopolized markets the burden on the plaintiff to produce an alternative design should be lighter than in robust markets open to competition. In more open markets the absence of a safer product on the market may carry greater evidentiary weight on the issues of the feasibility and practicality of the plaintiff’s proposed alternative design. Three case studies of drugs for which liability could be found under the alternative safer design test of section 2(b), but would be excused under the manufacturer-protective test of section 6 (c), are discussed--the anti-acne drug Accutane, unpasteurized Anti-hemophilic Factor concentrate (AHF), and Sabin live virus oral polio vaccine. Finally, pointing to medical devices like IUD’s and tampons, and the fact that mechanical devices are more amenable to alternative safer design analysis than are drugs, the Article discusses the“final fatal flaw” of section 6 (c)--its treatment of both drugs and devices by the same manufacturer-deferential Standard of liability.