Genzyme Corp. Pays $32.5 Million To Resolve Criminal Charges Related to Med Device Promotion

Last week, Genzyme Corporation, a wholly-owned subsidiary of the French company Sanofi, agreed to pay $32.5 million to resolve criminal charges that it violated the federal Food, Drug and Cosmetic Act (FDCA) with regard to the unlawful distribution of Seprafilm, a surgical device it markets and promotes. The DOJ targeted two aspects Seprafilm promotion in particular--that the company (1) encouraged surgeons to use its Seprafilm surgical product in unapproved ways, and (2) suggested without enough proof that it was safe for certain cancer surgeries.This follows a separate $22.28 million civil agreement the government reached with Genzyme in December 2013 to resolve allegations under the False Claims Act related to Seprafilm.  Seraphim is a clear film used to reduce abnormal internal scarring following pelvic and abdominal surgery by separating the internal tissues and organs while they heal. The anti-adhesion barrier device was approved by the Food and Drug Administration in 1996. According to the DOJ’s press release, the product was approved for use in patients undergoing open abdominal or pelvic laparotomy, which is a traditional surgical technique that utilizes a relatively large incision to permit the surgeon to open and view the patient’s abdominopelvic contents.  “Over time, laparotomy became a less common surgical technique in favor of laparoscopic surgery, which is perceived to have several advantages for the patient,” the governme...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs