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DOJ releases detailed statistics on FCA recoveries through FY 2012

USA - December 21 2012 On December 4, 2012, Acting Associate Attorney General Tony West announced that the Justice Department's Civil Division had recovered nearly $5 billion in…

Scott D. Stein.

Sixth Circuit holds that regulatory ambiguity precludes a “knowing” violation of the FCA

USA - October 22 2012 A recurring issue in FCA cases based on alleged violations of complex statutory or regulatory requirements is the extent to which, as a practical matter, “regulatory ambiguity” is a viable response to the argument that defendants knowingly submitted false claims to the government.

Scott D. Stein.

Court allows claims of off-label marketing to proceed against Part D plan

USA - September 20 2012 In an area of evolving False Claims Act jurisprudence, a district court in Georgia has found that the Medicare Part D program does not cover off-label uses of drugs that are not supported by a medically accepted indication.

Scott D. Stein.

Government seeks to limit application of Caronia to FCA cases

USA - December 19 2013 As we reported last year, the Second Circuit held in U.S. v. Caronia that truthful, non-misleading off-label promotion is constitutionally-protected…

Scott D. Stein.

Second Circuit declares that the First Amendment shields off-label marketing

USA - December 6 2012 On December 3, 2012, the Court of Appeals for the Second Circuit issued a landmark ruling in United States v. Caronia, No. 09-5006 (2d Cir. December 3, 2012) declaring that truthful, non-misleading off-label promotion is constitutionally-protected commercial speech.

Scott D. Stein.