{"title":"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。","authors":"Cameron T Norris","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.3000,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA.\",\"authors\":\"Cameron T Norris\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":12282,\"journal\":{\"name\":\"Food and drug law journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2015-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Food and drug law journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and drug law journal","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA.
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.
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.
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