UNITED STATES OF AMERICA; THE STATE OF CALIFORNIA; THE STATE OF CONNECTICUT; THE STATE OF DELAWARE; THE STATE OF FLORIDA; THE STATE OF GEORGIA; THE STATE OF HAWAII; THE STATE OF ILLINOIS; THE STATE OF INDIANA; THE STATE OF LOUISIANA; THE COMMONWEALTH OF MASSACHUSETTS; THE STATE OF MICHIGAN; THE STATE OF MONTANA; THE STATE OF NEVADA; THE STATE OF NEW HAMPSHIRE; THE STATE OF NEW JERSEY; THE STATE OF NEW MEXICO; THE STATE OF NEW YORK; THE STATE OF NORTH CAROLINA; THE STATE OF OKLAHOMA; THE STATE OF RHODE ISLAND; THE STATE OF TENNESSEE; THE STATE OF TEXAS; THE COMMONWEALTH OF VIRGINIA; THE STATE OF WISCONSIN; THE DISTRICT OF COLUMBIA, ex rel. RONALD J. STRECK v. ALLERGAN, INC.; AMGEN, INC.; ASTRAZENECA PHARMACEUTICALS LP; AZTRAZENECA LP; BIOGEN IDEC INC., BRADLEY PHARMACEUTICALS INC. n/k/a FOUGERA PHARMACEUTICALS, INC.; CEPHALON, INC.; EISAI, INC.; GENZYME CORPORATION; MALLINCKRODT INC. n/k/a MALLINCKRODT LLC; NOVO NORDISK, INC.; RELIANT PHARMACEUTICALS, INC; SEPRACOR n/k/a SUNOVION PHARMACEUTICALS INC.; UPSHER-SMITH LABORATORIES, INC., Ronald J. Streck, Appellant, 746 Fed. Appx. 101

Summary

HOLDINGS: [1]-In an action alleging that drug manufacturers violated the FCA by underpaying Medicaid rebates to the States by excluding certain credits they received from their customers in calculating a drug's average manufacturer price (AMP), 42 U.S.C.S. § 1396r-8 was found to be ambiguous and susceptible of multiple interpretations because applicable versions of the statute lacked temporal limitations when referring to "price"; [2]-Because the statute was ambiguous the available administrative guidance failed to articulate a coherent position on AMP and price-appreciation credits, the drug manufacturers' interpretation that they could exclude price-appreciation credits from their calculations of AMP was not objectively unreasonable between 2004 and 2012.