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First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

US Supreme Court Clarifies Knowledge Requirement in False Claims Act Cases—Raising New Interpretive Issues

A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

In Landmark Decision, Second Circuit Reverses Conviction For Off-Label Promotion

On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor...more

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