Green Medicine: Using Lessons From Tort Law and Environmental Law to Hold Pharmaceutical Manufacturers and Authorized Distributors Liable for Injuries Caused by Counterfeit Drugs

Stephanie Feldman Aleong

Abstract


The majority of the American public would be astonished by the frequency with which counterfeit prescription drugs appear on reputable drug store shelves. In 2004, the Food and Drug Administration (FDA) noted that those who counterfeit prescription drugs “deny ill patients the therapies that can alleviate suffering and save lives.” In 2006, the World Health Organization (WHO) estimated that there exists a $30 billion market in fake drugs. Although the FDA has tried to characterize the incidence of counterfeit medications in the United States prescription drug marketplace as “rare,” numerous instances of counterfeit drugs reaching consumers from the shelves of large, retail pharmacy chains have been well-documented. As a result, the FDA has lifted the stay on a nearly fifteen-year-old regulation that requires distributors of prescription drugs to document the sources of the drugs they peddle. In fact, the high risk of receiving fake or diverted drugs in the United States has been referred to as “pharmaceutical roulette” for millions of American patients.

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DOI: https://doi.org/10.5195/lawreview.2007.113

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