Devicemaker BTG settles false claims allegations for $36M

British devicemaker BTG and its subsidiary Biocompatibles will pay $36 million to resolve false claims allegations surrounding the off-label promotion of its medical device LC Bead.

The Food and Drug Administration approved LC Bead as an embolization treatment for hypervascular tumors. However, Biocompatibles allegedly promoted the device to physicians as a chemotherapy drug-delivery device — a use unapproved by the FDA, according to Ryan Bliss, who oversaw the marketing of Biocompatibles' medical products in North America.

As a result, healthcare providers across the U.S. allegedly submitted false claims for the unapproved use of the device for payment to Medicare, Medicaid and other federal healthcare programs, according to the report.

As part of the settlement, BTG and Biocompatibles will pay $25 million to resolve the civil qui tam action, which alleged fraud, along with an $11 million criminal fine, according to the report.


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