WASHINGTON (Legal Newsline) — The Department of Justice announced this week that medical device maker Biocompatibles Inc., a subsiadiary of BTG plc, will pay more than $36 million after allegations it misbranded its embolic device LC Bead. LC Bead is used for the treatment of liver cancer and 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.”
According to the department, Biocompatibles violated the Food, Drug and Cosmetic Act when it misbranded its FDA label. The FDA cleared the product for use 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. The agency did not, however, clear the product as a drug-device combination product or for use as a “drug-eluting” bead.
“This company is being held criminally and civilly responsible for misbranding a medical device and marketing it for the treatment of seriously ill cancer patients,” said U.S. attorney Channing D. Phillips for the District of Columbia. “Working with the FDA and other law enforcement partners, we are committed to holding companies accountable for violating the integrity of the FDA approval process.”