Faculty Scholarship

Document Type


Publication Date



Counterfeit and adulterated prescription drugs have caused serious harm to consumers when these tainted products have easily permeated the legitimate marketplace over the last decades. Criminals and other actors introduce fake, adulterated, expired and foreign drugs into the drug distribution network which puts unsafe medicine into the hands of innocent consumers.

Due to the FDA’s identification of the dramatic rise in counterfeit drug investigations, in June of 2006, the FDA finally lifted the nearly twenty-year-old stay on requiring pedigree documentation, an actual history of the distribution transactions of a medicine before reaching a dispensing pharmacy, only to find that a federal court stayed implementation of the scheduled regulation at the behest of pharmaceutical distributors. Both manufacturers and distributors of prescription medicine are well aware of the risk posed by counterfeit drugs and simply refuse either to self-regulate in any meaningful manner and continue to fight FDA measures to regulate the industry as well. Manufacturers and authorized distributors have maintained that once they sell their drugs to other distributors, they bear no responsibility for the well-known and often-occurring lapses in security and safety of the distribution system that allow counterfeit drugs to reach innocent consumers.

This article poses two alternative approaches to holding manufacturers and authorized distributors accountable for the harm caused by counterfeit drugs. To protect the health and safety of consumers, the courts should recognize that manufacturers and authorized distributors bear a non-delegable duty of safe distribution that makes them accountable for the injuries to innocent consumers caused by counterfeit medication. Alternatively, Congress could codify a strict liability standard when counterfeit drugs may present a substantial and imminent hazard to health, drawing on the lessons learned in the environmental arena which led to the passage of Resource Conservation and Recovery Act and the Comprehensive Environmental Response, Compensation and Liability Act.

Publication Title


Included in

Law Commons