This Comment uses the recent Paxil litigation as an example of how the rise of federal bureaucratic powers, specifically those exercised by the FDA to administer the Food Drug and Cosmetic Act (hereinafter FDCA ), increasingly challenge the role of courts in adjudicating tort claims of injury inflicted by prescription drugs. Part I explains the current labeling requirements for prescription drugs. Part II describes product liability law regarding claims involving prescription drugs. Part III analyzes the drug manufacturers\u27 and FDA\u27s defenses to state tort claims, specifically preemption and primary jurisdiction. Part IV discusses the current law as it applies to the recent Paxil litigation. Part V analyzes alternative interpretation...
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rule...
Part II of this paper analyzes the history and background of federal preemption to give context to t...
The law of strict liability, as set forth in Section 402A of the Restatement (Second) of Torts, prov...
This Comment uses the recent Paxil litigation as an example of how the rise of federal bureaucratic ...
Federally approved prescription drug labeling has not been considered conclusive on the reasonablene...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
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 important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
This Comment will review the history of strict products liability and the policies which have shaped...
IN THE PAST DECADE, SEVERAL WIDELY USED PRESCRIPTIONmedications have been observed to cause life-thr...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
Many have been bewitched, bedazzled, and bewildered in attempting to figure just how the principles ...
The article reports on the benefits of federal preemption on the regulation of prescription drug war...
Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally st...
This Article examines the interaction between direct regulation of pharmaceuticals under the Federal...
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rule...
Part II of this paper analyzes the history and background of federal preemption to give context to t...
The law of strict liability, as set forth in Section 402A of the Restatement (Second) of Torts, prov...
This Comment uses the recent Paxil litigation as an example of how the rise of federal bureaucratic ...
Federally approved prescription drug labeling has not been considered conclusive on the reasonablene...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
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 important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
This Comment will review the history of strict products liability and the policies which have shaped...
IN THE PAST DECADE, SEVERAL WIDELY USED PRESCRIPTIONmedications have been observed to cause life-thr...
The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for...
Many have been bewitched, bedazzled, and bewildered in attempting to figure just how the principles ...
The article reports on the benefits of federal preemption on the regulation of prescription drug war...
Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally st...
This Article examines the interaction between direct regulation of pharmaceuticals under the Federal...
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rule...
Part II of this paper analyzes the history and background of federal preemption to give context to t...
The law of strict liability, as set forth in Section 402A of the Restatement (Second) of Torts, prov...