Penny Morris took metoclopramide from early 2006 to July 2008. However, ingesting the drug for more than

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Penny Morris took metoclopramide from early 2006 to July 2008. However, ingesting the drug for more than twelve weeks had already been contraindicated on FDA-approved labels since 2004 and by "black box" labeling since 2009. Morris developed tardive dyskinesia and akathisia, two movement disorders, as a result of taking the medication and filed suit against generic drug manufacturers PLIVA, TEVA, and Actavis, asserting theories of defective construction and composition of the drug, defective design, breach of express warranty, and inadequate warning. The suit was subsequently stayed to await the Supreme Court's decision in Mensing, which held that while state-law "failure to warn" claims are allowed against brand name manufacturers, they were preempted by federal laws against generic manufacturers. The district court took into account the Supreme Court decision and dismissed the complaint. Morris moved the district court under Rule 59(e) to amend its earlier ruling based on four assertions: (1) Appellant PLIVA failed to comply with the 2004 FDA-approved label change; (2) the generic defendants failed to properly test their products and report that information; (3) breach of express warranty; and (4) Appellant TEVA may be held liable for a "failure to warn" because of its status as a reference listed drug (RLD) holder. What is the "duty of sameness" as defined by the court, and how is it relevant in this case? The court cites the FDCA to show that Morris' claim that "the generic defendants failed to test and inspect the product according to federal law" failed. "[A]ll such proceedings for the enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United States." Why would legislatures limit claims that manufacturers failed to properly test their drugs to the government? Who are the relevant stakeholders in this case, and how would such a limitation affect the stakeholders? [Morris v. Pliva, Inc., 713 F. 3d 774 (2013).]

Stakeholders
A person, group or organization that has interest or concern in an organization. Stakeholders can affect or be affected by the organization's actions, objectives and policies. Some examples of key stakeholders are creditors, directors, employees,...
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Dynamic Business Law The Essentials

ISBN: 978-1259917103

4th edition

Authors: Nancy Kubasek, Neil Browne, Daniel Herron

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