Judge Brian Cogan
Labels approved in 2005 and 2009 were at issue in Polansky’s False Claims Act (FCA) qui tam action asserting Pfizer’s off-label marketing of its anti-cholesterol statin Lipitor to patients whose risk profiles fell outside of parameters listed in National Cholesterol Education Program (NCEP) guidelines. By marketing Lipitor to patients not within the guidelines, Pfizer allegedly improperly induced doctors to prescribe Lipitor, which would be paid for by Medicare and Medicaid, which do not reimburse off-label prescriptions. The only relevant difference between the two labels was the omission of a guidelines chart from the 2009 labelwhich comprised more than 20 single-spaced pages of small font. District court found Pfizer did not engage in off-label marketing of Lipitor, and thus did not violate the act. Interpreting both labels and analogizing to the U.S. Sentencing Guidelines, the court found that as long as Pfizer markets Lipitor to lower cholesterol it is doing what the 2009 labelwhich demonstrated the advisory nature of the 2005 label’s inclusion of the NCEP guidelines chartpermits. Further a footnote to the 2005 label made plain the advisory, rather than mandatory, application of the NCEP chart.
