PharmSciRN: Pharmaceutical Regulation (Topic)最新文献

{"title":"Clear Evidence Clarified","authors":"E. Lindenfeld","doi":"10.2139/ssrn.3529684","DOIUrl":"https://doi.org/10.2139/ssrn.3529684","url":null,"abstract":"In 2009, the Supreme Court in Wyeth v. Levine articulated a standard of federal preemption for failure-to-warn claims in the brand name drug context. Specifically, the Court ruled that a defendant could only be afforded the benefit of federal preemption if it could present “clear evidence” that the warning which plaintiffs argued should have been included on the label would have been rejected by FDA. Over the next decade, courts took wildly divergent approaches to Levine’s clear evidence standard, creating uncertainty amongst plaintiffs and defendants alike. Courts disagreed, for example, on whether FDA denial of the warning must be actual or hypothetical. Moreover, courts applying the clear evidence standard disagreed on the relevance and import of similar drug label rejections, years-old label rejections for the same drug, scientific literature, independent FDA studies, emails, correspondence, or materials buried in thousand-page submissions. The confusion spawned a labyrinth of conflicting rulings and decade worth of confusing and inconsistent precedent. It has also generated a significant amount of scholarship, including scholarship by this author, calling on the high court to revisit and rearticulate the standard. \u0000 \u0000Recognizing, perhaps, that clarification of the clear evidence standard was long overdue, in May 2019, the Supreme Court issued a ruling in Merck Sharp & Dohme Corp. v. Albrecht, with major impact on the product liability landscape. Most significantly, the Court rejected the use of hypothetical preemption, clarifying that clear evidence requires that defendants show that FDA actually and expressly rejected the warning which plaintiffs argued was necessary under state tort law standards. The Court’s newly articulated five-part test also establishes that in order to receive the benefit of federal preemption, defendants must demonstrate that they provided FDA all material and relevant information. While certain nuances were left unaddressed by the Court, and certain interpretive issues have been hotly debated amongst the first wave of commentators, the newly stated rule provides much needed clarification on the clear evidence inquiry. This clarification is especially important given that the standard’s application is most common in high stakes, consolidated litigation involving thousands of lawsuits and some of the most innovative and complex drugs and devices ever sold. \u0000 \u0000This paper proceeds in five Parts. Part I provides a background on the federal regulatory regime governing prescription drugs, including the mechanisms available to manufactures and FDA to supplement a brand name drug’s label. Part II briefly lays the groundwork of the evolution of federal preemption principles in the brand name preemption context, including the foundation of the clear evidence standard. Part III explains the conflicting applications of the traditional clear evidence standard, and then progresses into the genesis and holding of the Supreme Court","PeriodicalId":150514,"journal":{"name":"PharmSciRN: Pharmaceutical Regulation (Topic)","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131052552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Mensing Conundrum: Litigating Generic Drug Injuries in California","authors":"Richard E. Custin, Michelle O'Connor-Ratcliff, R. Ratcliff","doi":"10.2139/SSRN.2246777","DOIUrl":"https://doi.org/10.2139/SSRN.2246777","url":null,"abstract":"As long as there have been prescription drugs, people have suffered injuries caused by those drugs. While a perfect level of safety is just not possible, state tort laws have long provided protection to injured drug consumers and incentive to drug manufacturers to improve and maintain the safety of their products. However, the United States Supreme Court has recently revealed an alarming gap in this supposed consumer protection and safety incentive scheme. A series of cases now reveals that some state claims of injury resulting from a prescription drug are not preempted by federal law if the drug is a brand name, but are preempted if the drug is a generic. This incongruity in federal law may leave a consumer injured by a generic drug without a viable civil remedy. Consumers are likely to be completely unaware of the protections they are giving up when they accept a cheaper, generic prescription, leaving them at a significant legal disadvantage. Generic drugs continue to capture an increased market share of prescriptions, so the number of consumers affected by federal preemption will grow. This article will provide a brief history of generic drugs, outline the recent United States Supreme Court cases that have revealed the consumer protection problem related to generics, and address potential solutions for litigating generic prescription drug injury claims in California.","PeriodicalId":150514,"journal":{"name":"PharmSciRN: Pharmaceutical Regulation (Topic)","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2013-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123918949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}