Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said.
Under the terms of the plea agreement before the US District Court for the District of Columbia, Biocompatibles pleaded guilty to a misdemeanor charge in connection with the company’s misbranding of the device, known as LC Bead, in violation of the Federal Food, Drug and Cosmetic Act.
LC Bead was initially approved by the US Food and Drug Administration (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, but the device has never been cleared as a drug-device combination product or for use as a drug-delivery device or “drug-eluting” bead.
