United States ex rel. Polansky v. Pfizer, No. 14-4774 (2d Cir. 2016)
Annotate this CasePlaintiff appealed the dismissal of his suit brought under the False Claims Act (FCA), 31 U.S.C. 3729(a)-(b), and state analog. Plaintiff alleged that Pfizer, his former employer, improperly marketed Lipitor as appropriate for patients whose risk factors and cholesterol levels fall outside the National Cholesterol Education Program Guidelines; the Guidelines are incorporated into and made mandatory by the drug’s label; and Pfizer thus induced doctors to prescribe the drug, pharmacists to fill the prescriptions, and federal and state health care programs to pay for “off‐label” prescriptions. Judge Cogan dismissed the claims because he determined that the FDA’s approval of Lipitor was not dependent upon compliance with the Guidelines. The court expressly endorsed and adopted Judge Cogan’s carefully considered and thorough analysis, and affirmed on that basis.
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