Genzyme to pay $32.6 million to resolve criminal liability relating to Seprafilm, says DoJ

French pharma major Sanofi’s (Euronext; SAN) biotech subsidiary Genzyme agreed to resolve criminal charges that it violated the US Food, Drug and Cosmetic Act (FDCA) with regard to the unlawful distribution of Seprafilm, a surgical device it markets and promotes, the Justice Department announced.

As part of the agreed resolution, the department filed a two-count criminal information in the US District Court for the Middle District of Florida charging that between 2005 and 2010, Genzyme caused a medical device to become adulterated and misbranded while being held for sale.  The conduct occurred prior to Sanofi’s acquisition of Genzyme, based in Cambridge, Massachusetts, in 2011.

Although Seprafilm was approved for use in laparotomy surgeries involving large incisions, sales staff instructed surgeons to blend the film into a “slurry” for use in laparoscopic surgeries involving tiny incisions and tubes, prosecutors said.