Abbott said it has received a subpoena from the Department of Justice related to the sales and marketing of its bile-duct stents, according to a release published on devicelink.com. It is estimated that about 90% of the time, bile-duct stents are used off-label, and last year FDA held a meeting for bile-duct stent manufacturers to go over what they can and cannot promote to doctors. Abbott said that the government is seeking to determine whether the activities violated laws such as the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute in connection with Medicare or Medicaid reimbursement paid to third parties.
UPDATE: Johnson & Johnson and Boston Scientific have also received subpoenas.
UPDATE 2: Medtronic has received a subpoena as well.
