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Expert Analysis

US V. Takeda Will Be Useful In Off-Label Promotion Cases

Law360, New York (January 25, 2013, 12:26 PM EST) -- On Jan. 11, 2013, the United States Court of Appeals for the Fourth Circuit issued an opinion reaffirming the requirement that False Claims Act relators plead presentment of a false claim with particularity. United States ex rel. Nathan v. Takeda Pharmaceuticals NA Inc. (No. 11-2077). The Fourth Circuit's decision requires relators proceeding under the civil False Claims Act, 31 U.S.C. Section 3729(a)(1)(A), to offer concrete details that plausibly allege — not just speculate — that actual presentment of a false claim occurred....

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