Is Off-label Promotion Out of Control?

The situation raises the question of whether more regulatory clarity is needed regarding the use of medical devices for off-label treatments.

Qmed Staff

Off-label promotion of medical products has been a central issue in many U.S. product liability lawsuits. But when it comes to marketing a device for uses not expressly indicated, it has proven hard to draw the line between legal off-label use and illegal promotion that skirts FDA's authority.

Stryker is facing two new product liability lawsuits related to its bone morphogenetic protein (BMP) OP-1 products, which had been approved by FDA as a "humanitarian device exemption," absolving the manufacturer from having to prove the effectiveness of the product. Stryker has faced many legal problems related to its OP-1 and and Calstrux BMP products. There was even a 2009 federal grand jury indictment with 13 felony charges against the company and several of its top executives, with the U.S. Justice Department agreeing to toss the felony charges in lieu of a $15 million settlement and a single misdemeanor charge.

Stryker's putty is similar to Medtronic's Infuse (shown above), which just received FDA approval for use with two additional indications. Having reached sales of close to $1 billion at its height, the combination product, originally approved as the Infuse Bone Graft/LT-Cage, has also been mired with lawsuits, and has also been the subject of a U.S. Senate probe. According to MedPageToday, as much as 80% of Medtronic's Infuse product had been used for off-label applications.

Two former Acclarent (now owned by Johnson & Johnson) executives are facing fraud charges in Massachusetts related to off-label promotion as well.

The issue of off-label promotion is gaining even more notoriety because the U.S. Justice Department is increasingly holding medtech executives personally accountable for the marketing of their companies' products. Facing potential prison time, the executives are responding with an argument straight out of the U.S. Constitution: You can't prosecute people for saying things that are true.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker