Biocompatibles Inc. has pleaded guilty to misbranding its embolic device called LC Bead and will pay more than $36 million in criminal and civil fines, the Justice Department announced.
Pennsylvania-based Biocompatibles combined LC Bead with prescription drugs for use as a drug-delivery device or “drug-eluting” bead even though the FDA has not approved LC Bead as a drug-device combination product or for drug delivery.
In addition, the Justice Department said Biocompatibles marketed the device for drug delivery against express FDA wishes and told healthcare providers that LC Bead provided a superior therapy for certain types of cancer, despite a lack of evidence to support those claims.
Under the terms of the plea agreement before the U.S. District Court for the District of Columbia, Biocompatibles pleaded guilty to a misdemeanor charge in violation of the Food, Drug and Cosmetic Act. It also will pay an $8.75 million criminal fine for misbranding LC Bead and a criminal forfeiture of $2.25 million.
In addition, Biocompatibles will pay $25 million to resolve civil allegations under the False Claims Act that the company submitted false claims to government healthcare programs for procedures in which LC Bead was loaded with chemotherapy drugs and used as a drug-delivery device.
LC Bead is used to treat liver cancer and other diseases. It was cleared 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.