Biocompatibles Pleads Guilty to Misbranding Cancer Device

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pleaded guilty today to misbranding its embolic device LC Bead, a product used in treating liver cancer. The company will pay more than $36 million to resolve both criminal liability and civil allegations under the False Claims Act, the Justice Department announced. The case, prosecuted in the U.S. District Court for the District of Columbia, exposes a years-long scheme to illegally market a medical device for unapproved uses, putting vulnerable cancer patients at risk.

Biocompatibles pleaded guilty to a misdemeanor charge under the Food, Drug, and Cosmetic Act for misbranding LC Bead, which the FDA cleared only as an embolization device to block blood flow to tumors. It was never approved as a drug-delivery or ‘drug-eluting’ device. Despite this, the company — through a U.S. sales and distribution partner — began aggressively marketing LC Bead as a chemotherapy delivery tool by 2006, directly contradicting assurances it gave the FDA in 2004. The company had explicitly told regulators that ‘under no circumstance’ would it market the device for drug delivery.

The distribution arm trained sales representatives to ‘aggressively penetrate the chemoembolization market,’ instructing them to present LC Bead as a ‘[a] drug-delivery device.’ Sales staff then told healthcare providers the device boosted chemotherapy levels in liver tumors and improved tumor response rates — claims unsupported by FDA clearance or statistically significant evidence. These misrepresentations directly influenced medical decisions for seriously ill patients and paved the way for fraudulent billing.

As part of the criminal resolution, Biocompatibles will pay an $8.75 million criminal fine and forfeit $2.25 million. The Justice Department emphasized that the FDA approval process exists to protect patient safety, not corporate profits. ‘We will not permit companies to circumvent that process and put profits over patient safety,’ said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Civil Division.

In parallel, the company agreed to pay $25 million to settle civil allegations that it caused false claims to be submitted to Medicare and other federal health care programs. When LC Bead was loaded with chemotherapy drugs, it became a new, uncleared combination product ineligible for federal reimbursement. The federal share of the civil settlement is $23.6 million; states will receive $1.4 million from Medicaid recoveries.

‘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. The case was investigated with critical support from the FDA and other law enforcement partners, underscoring ongoing efforts to protect the integrity of federal health programs and medical oversight.