Off-Label Promotion Continues to Make News

Last week, Novartis agreed to settle criminal allegations involving Trileptal, an anti-epilepsy drug, as it deals with similar investigations involving five other Novartis drugs: Diovan, Exforge, Zelnorm, Keturna and Sandostatin. Novartis has agreed to plead guilty to violations of the U.S. Food, Drug, & Cosmetic Act and pay a fine of $185 million. The settlement is pending court approval.

The spate of recent settlements involving illegal off-label promotion of drugs, is encouraging. The question remains, however, whether drug companies view this as the cost of doing business and are deterred from this illegal practice or whether they will continue to market their drugs for any and all potential indications, no matter what the consequences. My guess is that we will see several new qui tam or whistleblower suits in the coming months.

Pogust, Braslow & Millrood represents numerous clients who have developed an irreversible shoulder injury, called PAGCL or chondrolysis following the injection of pain medications directly into the shoulder joint. Recently, the FDA announced that it will require pain pump manufacturers and the manufacturers of the pain medications used in the pain pumps to update their product labels concerning this risk. The FDA stated that it has not cleared any infusion device with an indication for use in intra-articular infusions of local anesthetics. Accordingly, promotion of these products for this purpose is and has been illegal and off-label.

If you are a physician or a sales representative who is personally aware of this off-label marketing for pain pumps, please contact our firm and we will explore what legal options are available.