Whistleblower Receives $5.1 Million for Reporting Misuse of Medical Device

Mary Jane Wilmoth

Published On: December 21st, 2016

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, plead guilty on November 7, 2016 to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct. LC Bead is used to treat liver cancer, among other diseases.

“The FDA approval process serves an important role in ensuring that federal health care participants receive devices that are safe, effective and medically appropriate,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “We will not permit companies to circumvent that process and put profits over patient safety.”

The civil settlement with Biocompatibles resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The civil lawsuit was filed in the Western District of Texas and is captioned United States ex rel. Ryan Bliss v. Biocompatibles, Inc., et al. As part of today’s resolution, Bliss will receive approximately $5.1 million from the civil settlement.