Boston Scientific Probed for Off-Label Marketing of Bile Duct Stents

Boston Scientific as well as some medical device competitors are under federal investigation for possible off-label and unapproved marketing of their bile duct stents. The US Justice Department is investigating whether the company marketed the stents for off label use, a violation of FDA rules. The FDA met with Boston Scientific last March to discuss their concerns over possible off-label use of the stents in blood vessels rather than in bile ducts. The stents have been approved to prop open the bil ducts in patients whose ducts have become obstructed due to pancreatic cancer.