Marketing of Medical Device for Unapproved Use
We represented whistleblower Ryan Bliss in a False Claims Act qui tam case against U.K. medical device maker Biocompatibles and its United States distributor, Angiodynamics. Bliss, who was a Senior Product Manager for Biocompatibles, alleged that the two companies marketed a product called LC Bead (or Gelspheres) as a chemotherapy drug delivery device, even though they knew that the United States Food and Drug Administration had refused to approve the device for that use. The companies also allegedly instructed physicians to bill for the device under a separate approved use, even when the physicians used it for its unapproved use. Biocompatibles paid a total of $36 million to resolve criminal and civil charges against it, and Angiodynamics paid $12.5 million to resolve Mr. Bliss’s False Claims Act suit. For more information, see our press releases about the Biocompatibles resolution and the Angiodynamics settlement.