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Journal of Pharmacy Practice
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Potential Liability for Counterfeit Medications

Donald E. deKieffer, JD

Dekieffer & Horgan: An International Trade Law Firm, 729 15th Street NW, Suite 800, Washington, DC, 20005; ddekieffer{at}dhlaw.com

Counterfeit drug cases have increased over the past 5 years. More people have been taking counterfeit drugs, and surprisingly, there have been relatively few lawsuits. Because of this, there still exists a question as to who will be liable. Counterfeit drugs usually enter the market through diversion. Once the drugs have entered the market, they are still difficult to detect because they appear like the real drug, and they are often destroyed through ingestion. Also, if a patient does not recover, that does not mean the drugs were counterfeit. This makes it difficult to prove liability because there needs to be causation. Proving that a counterfeit drug actually caused the injury can be very difficult. After causation is shown, there is the question of whom to sue. Often the wholesaler is the most vulnerable. The Fagan case illustrates the potential liability faced by wholesalers and others in the pharmaceutical industry. That litigation has raised the awareness of wholesalers and others about the potential liability of buying drugs in the secondary market.

Key Words: Liability • counterfeit • drugs • pharmaceuticals • supply chain

Journal of Pharmacy Practice, Vol. 19, No. 4, 215-220 (2006)
DOI: 10.1177/0897190006293517


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