Add to ORKGThe U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government. After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, in light of Wyeth, agency claims of preemption with respect to other products or services are likely...
Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety mat...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied pre...
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court c...
This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s deci...
The article reports on the benefits of federal preemption on the regulation of prescription drug war...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally st...
Part II of this paper analyzes the history and background of federal preemption to give context to t...
Patient safety depends on tort litigation to identify a brand-name drug’s undisclosed risks, illumin...
Most people think of preemption as a technical constitutional doctrine, but it is pivotally importan...
The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Ba...
The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers faci...
Should the Food and Drug Administration (FDA)’s determination that a product is safe negate a privat...
Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety mat...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied pre...
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court c...
This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s deci...
The article reports on the benefits of federal preemption on the regulation of prescription drug war...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally st...
Part II of this paper analyzes the history and background of federal preemption to give context to t...
Patient safety depends on tort litigation to identify a brand-name drug’s undisclosed risks, illumin...
Most people think of preemption as a technical constitutional doctrine, but it is pivotally importan...
The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Ba...
The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers faci...
Should the Food and Drug Administration (FDA)’s determination that a product is safe negate a privat...
Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety mat...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...