Add to ORKGPart II of this paper analyzes the history and background of federal preemption to give context to the current environment after Wyeth. Part III analyzes the Supreme Court‘s decision in Wyeth, holding that the FDCA and corresponding regulations do not preempt state tort claims. Finally, Part IV discusses and analyzes what drug makers may do now to continue to produce and market pharmaceuticals profitably while limiting their liability for state tort claims
Part I provides a brief and basic explanation of pharmaceutical liability treatment. Part II explain...
This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers ...
The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products li...
Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally st...
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court c...
The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied pre...
The article reports on the benefits of federal preemption on the regulation of prescription drug war...
This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s deci...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Ba...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
Since the citadel of privity first crumbled for manufacturers of defective products decades ago, sta...
The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers faci...
It is readily agreed that federal preemption of state tort law alters the balance between federal an...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
Part I provides a brief and basic explanation of pharmaceutical liability treatment. Part II explain...
This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers ...
The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products li...
Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally st...
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court c...
The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied pre...
The article reports on the benefits of federal preemption on the regulation of prescription drug war...
This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s deci...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Ba...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
Since the citadel of privity first crumbled for manufacturers of defective products decades ago, sta...
The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers faci...
It is readily agreed that federal preemption of state tort law alters the balance between federal an...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
Part I provides a brief and basic explanation of pharmaceutical liability treatment. Part II explain...
This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers ...
The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products li...