The Justice Department has subpoenaed Johnson & Johnson as part of a broader investigation into the marketing of bile duct stents by the company and several of its competitors. The Justice Department hopes to determine whether the company has marketed the devices for unapproved uses. The devices, which are plastic or metal tubes, are intended to treat obstructions to the liver. According to the New York Times, the bile duct stents comprised approximately $40 million in sales in 2007 (for approved uses).
The FDA is allegedly reviewing if Johnson & Johnson (and others) manufactured the stents for unapproved uses. While a physician is free to use a medical device for any means, F.D.A. guidelines say drug companies and device makers may not promote their products for unapproved purposes or patient categories, like prescribing adult medicines for children.
Boston Scientific and Abbott have also been asked to cooperate in the investigation. I’ll keep my ears open on this dispute.
