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…
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.
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.
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.