September 3, 2015 — Genzyme Corp. has agreed to pay a $32.6 million to resolve criminal charges that Seprafilm was unlawfully marketed for unapproved uses from 2005-2010, according to a statement from the Justice Department.
Seprafilm is a clear film that is designed to keep organs and tissues from sticking together after surgery. It is only approved for use in laparotomy surgeries involving large incisions, which allow surgeons to open and view abdominal or pelvic organs.
As the popularity of laparotomies declined in favor of minimally-invasive “keyhole” surgeries (laparoscopy), sales representatives began teaching surgeons how to mix Seprafilm into a liquid “slurry” that could be squirted through tubes into a patient’s abdomen — even though Seprafilm was never FDA-approved or evaluated for such use.
In December 2013, Genzyme agreed to pay $22.28 million to resolve false claims related to “slurry” used in patients. After today’s agreement, the company will have paid nearly $55 million to resolve allegations involving Seprafilm.
Genzyme also admitted marketing Seprafilm as safe and effective for gynecological cancer surgeries, despite warnings on the label that it had never been evaluated in the presence of malignancies. The claim was based on a study involving only 14 patients, which was much too small to support such claims.
In July 2015, the consumer advocacy group Public Citizen petitioned the FDA to recall Seprafilm due to safety issues and a lack of studies showing it was effectiveness. Public Citizen documented extensive flaws in two clinical trials and one post-marketing study. The group also warned about life-threatening side effects like sepsis, bacterial abscess, poor healing after surgery, inflammatory reactions, and more.