Smith & Nephew Plc (Smith & Nephew), has received a subpoena from the US Department of Justice (DOJ) in Massachusetts in connection with its ultrasound stimulation product known as EXOGEN. EXOGEN is FDA approved for specific fresh fractures and long bone non-unions. The DOJ has asked for documents relating to EXOGEN and other matters from 1995 onwards.
Smith & Nephew first started to market EXOGEN in 1998. It is believed that similar enquiries have been directed to a number of Smith & Nephew’s US competitors. Smith & Nephew is co-operating fully with this request.
In addition, a qui tam complaint, filed four years ago in March 2005, was recently unsealed in federal court in Boston against the primary US manufacturers of bone growth stimulation products, including Smith & Nephew. The complaint makes allegations concerning the industry’s sales and marketing of these products. Smith & Nephew will respond to this action.
Smith & Nephew is committed to compliance with law and ethical business standards and a robust programme to ensure compliance.