Supreme Court Denies Cert. Petition Accusing Fifth Circuit of “Sabotage of Off-Label Enforcement”

By Jennifer M. Thomas & Andrew J. Hull — Last September, we posted on the Fifth Circuit’s decision to uphold summary judgment and award of costs in favor of Solvay Pharmaceuticals, Inc. in a False Claims Act (FCA) case (see post here). The relators pursued an FCA theory against Solvay based on allegations of widespread off-label marketing and violations of the Anti-Kickback Statute.  However, the Fifth Circuit agreed with the district court that relators (the government declined to intervene) had failed to establish, beyond mere speculation, that any alleged kickbacks or off-label marketing caused the submission of a false claim. Although it appeared in dicta, the Fifth Circuit’s discussion of the FCA’s materiality element in Solvay was of particular interest to us.  The court noted that, if it is true that Medicaid pays for claims “without asking whether the drugs were prescribed for off-label uses or asking for what purpose the…

Read more detail on Recent Products Liability posts –

This entry was posted in Products Liability and tagged , , , , , , , , , , . Bookmark the permalink.

Leave a Reply