Synthes has recently issued a press release saying that the company had learned of the U.S. Attorney for the Eastern District of Pennsylvania charging the company in connection with alleged off-label promotion of Norian XR, a spine product the company stopped selling in 2004.
Off-label promotion involves marketing a product in a manner not approved by the FDA. Synthes reiterates that it has fully cooperated with the Government’s investigation, which began in 2006, and believes that its marketing practices in connection with Norian XR were proper. The news release says the company intends to vigorously defend itself against the charges.
Norian XR is a calcium phosphate-based bone void filler that was cleared for sale by the U.S. FDA in 2002 as a medical device to treat bone voids or defects in the skeletal system. Synthes marketed Norian XR from 2002 to 2004, having sold approximately 200 units, and realising total net sales of approximately US$ 400,000.
The news release also says as a global leader in the medical device industry, Synthes has a long reputation for setting the highest legal and ethical standards in the development and commercialisation of medical products focused on improvement in patient care. The company says it maintains a comprehensive legal and ethical compliance program, which is regularly reviewed and updated.