Department of Justice Probing Bile-Duct Stent MarketingAug 5, 2008 | Parker Waichman LLP Johnson & Johnson disclosed, in a regulatory filing yesterday, that its Cordis subsidiary received a subpoena regarding marketing practices concerning stent devices that are implanted to open bile ducts—biliary stents—carrying digestive fluids to the intestines. The subpoena was received in June from the U.S. Attorney’s Office in Massachusetts. And, in a recent Securities and Exchange Commission (SEC) filing, Abbott Laboratories confirmed it received a subpoena from the same office in July regarding marketing of its biliary stents.
Device-maker Ev3 Inc. reported in a March SEC filing that "it is our understanding that certain biliary stent manufacturers recently have become involved in civil investigations by the U.S. Department of Justice alleging that they have improperly promoted their biliary stents for off-label uses." Ev3 had not received notice of an investigation at that time and it is unclear if that status has changed. In February, Boston Scientific Corporation reported that the DOJ notified it two months prior that the DOJ was probing allegations that Boston Scientific and other manufacturers improperly marketed biliary stents for off-label uses. Boston Scientific said—at the time—that it had not received a subpoena on the matter and is not denying or confirming that such a subpoena has been received since. Spokesman Paul Donovan simply said yesterday that it is the company's policy not to comment on ongoing investigations and that the company continues to cooperate with the investigation.
Medtronic Inc.—another maker of biliary stents—through its spokesman, Daniel Beach, also declined to comment on whether Medronic had recently received a subpoena. Medronic would also not comment on the matter when it filed its annual report with the SEC in late June. And, according to a Dow Jones report, a spokeswoman for stent manufacturer, C.R. Bard Inc., could not be reached for comment on the matter.
A Massachusetts U.S. Attorney's Office spokeswoman said that she could neither confirm nor deny the issuance of subpoenas, nor was she at liberty to discuss the matter, but it seems as if the U.S. Department of Justice is looking into how such medical devices are being marketed. Meanwhile, companies have reported that the DOJ is looking into whether biliary stents are being improperly marketed for other uses, such as clearing of leg arteries. Doctors often use products "off-label,” or in ways the U.S. Food and Drug Administration (FDA) has not approved, which is perfectly legal. What is illegal, is for companies to market products for off-label usage.
The Wall Street Journal reported in March 2007 that the Food & Drug Administration (FDA) was planning “to review the issue of heavy, unapproved usage of biliary stents.” Three years prior, in 2004, Johnson and Johnson’s Cordis recalled a biliary stent instruction sheet when nine patients were injured in off-label cases.
How drugs and medical devices are marketed has been under heavy scrutiny, reporting, and review in recent months, with a number of government investigations probing how products are advertised in print and television ads, how doctors and hospitals are marketed by drug company representatives, and how experts are compensated by drug makers to lead studies and speak on products.