Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2015-01-01
Cameron T Norris
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Abstract

The Supreme Court's decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a "plausible" claim to relief before they can access discovery. Plausibility pleading, however, presents a unique burden for plaintiffs who have been injured by a Class III medical device. In Riegel, the Supreme Court held that state-law claims against device manufacturers are preempted unless they "parallel" federal requirements. However, the relevant federal requirements are located in the manufacturer's premarket approval agreement, which is confidential. Thus, it is nearly impossible for plaintiffs to allege a plausible claim against a Class III device manufacturer because they do not know what to plead in the first place. The Seventh Circuit tried to remedy this Catch-22 by lowering the pleading standards for parallel claims. However, its approach misapplies Twombly and Iqbal and overburdens device manufacturers. Instead of tinkering with pleading standards, this paper advocates a different approach. Congress should create a one-way fee-shifting mechanism that allows plaintiffs to access premarket approval agreements if they agree to pay the defendant's discovery fees (should their claim prove unsuccessful). Fee-shifting is a middle-ground approach that would better compensate plaintiffs without overdeterring device manufacturers.

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药物,器械和发现:使用费用转移来解决FDCA下平行索赔的Twombly/Iqbal问题。
最高法院在托姆布雷案和伊克巴尔案中的裁决开创了一种新的联邦辩护标准,要求原告在获得证据开示之前陈述一个“合理的”救济要求。然而,对于被第三类医疗器械伤害的原告来说,合理性抗辩是一种独特的负担。在Riegel案中,最高法院认为,除非与联邦要求“平行”,否则州法律对设备制造商的索赔是优先的。然而,相关的联邦要求位于制造商的上市前批准协议中,这是保密的。因此,原告几乎不可能对III类器械制造商提出合理的索赔,因为他们首先不知道该为什么辩护。第七巡回法院试图通过降低平行诉讼的辩护标准来纠正这一困境。然而,它的方法误用了Twombly和Iqbal,给设备制造商带来了过重的负担。本文提倡一种不同的方法,而不是对辩护标准进行修修补补。国会应该建立一个单向的费用转移机制,如果原告同意支付被告的发现费(如果他们的索赔被证明不成功),就允许原告获得上市前批准协议。收费转移是一种中间方法,既能更好地补偿原告,又不会过度震慑设备制造商。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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