The company agreed to settle federal and state False Claims Act (FCA) allegations resulting from the off-label promotion of LC Bead, which is approved only for embolization of hypervascular tumors.
The settlement includes $25m to resolve the civil qui tam action that alleged fraud, while $11m is a criminal fine against Biocompatibles.
Ryan Bliss, a whistleblower represented by Jeffrey A. Newman Esq of Jeffrey Newman Law, and co-counsel Paul Lawrence II of Waters & Kraus of Dallas, filed a complaint against Biocompatibles.
The complaint was filed against Biocompatibles for violating marketing regulations in its promotion activities to US doctors for promoting LC Bead as a chemotherapy drug-delivery device that can be used by physicians to treat patients with various forms of cancer, a use the FDA had never approved
It was only approved for bland embolization of blood vessels, helping in the treatment of hypervascular tumors.
The US Government alleged that the unapproved use of LC Bead as a drug-delivery device caused health care providers across the country to submit false claims for payment to Medicare, Medicaid and other federal health care programs.
Newman attorney said: “What’s remarkable about this case is that Biocompatibles had obtained clearance from the FDA for one use, when LC Bead was specifically designed and exclusively marketed to U.S. doctors for a completely different use that the FDA had refused to approve.
“The company went on to instruct providers to submit claims using the code established for approved procedures knowing that insurers would have denied coverage otherwise.”
