Golden Gate University Law Review


Denise K. Top


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' and FDA's 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 interpretations that would achieve fairer results. Finally, Part VI of this Comment concludes that FDA prescription drug labeling requirements should be viewed as minimal guidelines subject to enhancement by state court jury verdicts.