A settlement reached to resolve False Claims Act Allegations against Biocompatibles Inc.
The allegations arose by a lawsuit claiming Biocompatibles Inc misbranded its embolic device LC Bead, which is used to treat liver cancer and other diseases.
LC Bead was approved by the FDA as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations. LC Bead was never approved by FDA as a drug-device combination product or for use as a drug-delivery device or “drug-eluting” bead.
According to the Department of Justice, Biocompatibles will pay an $8.75 million criminal fine for the misbranding of LC Bead and a criminal forfeiture of $2.25 million. Biocompatibles told the FDA in 2004, that it would not use FDA clearance for the device for embolization to market the device for drug delivery. Yet, two years later, Biocompatibles began marketing LC Bead for drug delivery through the company it hired to carry out its sales and distribution in the United States. According to the statement of offense, the distribution company told its sales representatives that LC Bead was “[a] drug-delivery device” and trained its sales representatives to “aggressively penetrate the chemoembolization market.”
The whistleblowers' share of the settlement will be $5.1 million.
