Justice Investigating Biliary Stent Sales, Marketing Practices

The Justice Department has subpoenaed Abbott Laboratories, seeking information about its biliary stent product sales and marketing activities, the company says in a recent SEC filing.

The agency notified the company in June that it is investigating whether Abbott violated civil or criminal laws in connection with Medicare or Medicaid reimbursement paid to third parties. Justice is focusing specifically on the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute, according to the filing.
 
Abbott had no comment other than to say it was cooperating with the investigation.

The FDA met with Abbott, Boston Scientific, Johnson & Johnson and other companies in March 2007 to discuss curbing off-label promotion of biliary stents. The FDA said it was aware that the devices were being promoted and used to open arteries in the vascular system — a use that has not been approved.

In its annual report issued in February, Boston Scientific said it was informed last December that Justice was conducting a civil investigation “of allegations that we and other suppliers improperly promoted biliary stents for off-label uses.”

Biliary stents are inserted into bile ducts to treat obstructions. According to Abbott’s website, the company markets six biliary stents and stent systems.