Pharmaceutical Product Development and Liability With Chantix~®: A Teaching Case

摘要

In 2006, Pfizer introduced Chantix® to the American medical marketplace. Touted as an effective tool for smoking cessation, the drug experienced first-year sales of just under $900 million. With smokers costing employers thousands of dollars more each year than nonsmokers, and with public pressure to give up cigarettes, many embraced Chantix® as a miracle drug. What many did not understand was that the drug was rushed to market before extensive testing and clinical trials could be conducted to prove its safety for a wide variety of users, especially those with psychiatric conditions. This case tells the story of Chantix®: how it works, how it came to market, and the more than 2,700 lawsuits that were filed as a result of injuries claimed to be caused by the drug. Students are given the opportunity to consider the ramifications of risk management decisions made throughout the development and marketing of the drug, as well as how litigation involving the medication might have been handled.