Selected Cases

Pharmaceutical Off-Label Promotion Settlements

Analysis Group assisted counsel on numerous recent high-profile settlements with United States Attorneys Offices (USAOs) around the country on cases in which off-label promotion was alleged. We worked with counsel to quantify the extent of off-label prescribing and to assess the causal connection between off-label promotion and off-label sales. Our recent work in this context included attention to allegations concerning inappropriate promotion of a disease, high dose, target patient population (e.g., pediatric use), venue of care (e.g., nursing homes), pattern of care (e.g., line of therapy) comparative claims (e.g., better than a competing product), and benefit associated with use of the drug (e.g., cardioprotective, reduces cancer risk). In assessing the magnitude of these claims, we built flexible models that consider a variety of alternative scenarios, and presented our damages findings to USAOs. Analysis Group Managing Principal Paul Greenberg, Vice Presidents Richard Mortimer and Crystal Pike have made presentations to USAOs, and have worked with a case leadership team including Vice Presidents David MisholBrad RiceDov Rothman, Tamar Sisitsky, and Mihran Yenikomshian; and Manager Andree-Anne Fournier.


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