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The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness
The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness
Law Faculty Scholarly Articles
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …
The Impact Of The Cipollone Case On Federal Preemption Law, Richard C. Ausness
The Impact Of The Cipollone Case On Federal Preemption Law, Richard C. Ausness
Law Faculty Scholarly Articles
The United States Supreme Court handed down an opinion in the Cipollone case on June 24, 1992. Justice Stevens, writing for the majority, concluded that the Federal Cigarette Labeling and Advertising Act preempted all tort claims against cigarette manufacturers based on failure to provide adequate warnings about the health risks of smoking. However, the Court also held that claims based on breach of express warranty, misrepresentation, and conspiracy were not preempted by the Act. Thus, although Cipollone represents a clear victory for tobacco companies, it also leaves the door open for future litigation. The first part of this Article will …