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21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
University of Michigan Journal of Law Reform
The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …
A Post-Spokeo Taxonomy Of Intangible Harms, Jackson Erpenbach
A Post-Spokeo Taxonomy Of Intangible Harms, Jackson Erpenbach
Michigan Law Review
Article III standing is a central requirement in federal litigation. The Supreme Court’s Spokeo decision marked a significant development in the doctrine, dividing the concrete injury-in-fact requirement into two subsets: tangible and intangible harms. While tangible harms are easily cognizable, plaintiffs alleging intangible harms can face a perilous path to court. This raises particular concern for the system of federal consumer protection laws where enforcement relies on consumers vindicating their own rights by filing suit when companies violate federal law. These plaintiffs must often allege intangible harms arising out of their statutorily guaranteed rights. This Note demonstrates that Spokeo’s …